Trial Outcomes & Findings for Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty (NCT NCT01121224)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

597 participants

Primary outcome timeframe

12 months

Results posted on

2022-07-26

Participant Flow

Participant milestones

Participant milestones
Measure	Bare Metal Stent Group Patients who receive a bare metal stent (BMS) in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or Drug Eluting Stent (DES) in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Drug Eluting Stent Group Patients who receive a drug-eluting stent (DES) in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-acute coronary syndrome (ACS) patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive Bare Metal Stent (BMS) or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Overall Study STARTED	305	292
Overall Study COMPLETED	280	275
Overall Study NOT COMPLETED	25	17

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Total n=597 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 7.7 • n=5 Participants	69.0 years STANDARD_DEVIATION 7.4 • n=7 Participants	68.6 years STANDARD_DEVIATION 7.6 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Male	305 Participants n=5 Participants	290 Participants n=7 Participants	595 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	286 Participants n=5 Participants	270 Participants n=7 Participants	556 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	254 Participants n=5 Participants	263 Participants n=7 Participants	517 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	32 Participants n=5 Participants	17 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized Other	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized Not Answered	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment United States	305 Participants n=5 Participants	292 Participants n=7 Participants	597 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Vessel Failure (TVF), Defined as the Composite of Cardiac Death	16 Participants	17 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Myocardial Infarction	20 Participants	16 Participants	—	—	—	—	—	—	—	—	—	—

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Vessel Failure (TVF), Defined as the Target Vessel Revascularization	34 Participants	34 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Incremental Cost-effectiveness of DES Relative to BMS	20939 U.S. Dollars Standard Error 1051	21051 U.S. Dollars Standard Error 1075	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Discharge from Index Hospitalization (an average of 36 hours)

The procedural success rate and the incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Procedural Success	291 Participants	274 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participant Deaths (All Cause and Cardiac). All Deaths Will be Considered Cardiac Unless an Unequivocal Non-cardiac Cause Can be Established.	51 Participants	55 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Myocardial Infarction (MI)	62 Participants	53 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation. Angiographic Confirmation of Stent Thrombosis will be defined as the presence of thrombus originating in a study stent, or in the segment 5mm proximal or distal to the stent AND fulfillment of at least one of the following 5 criteria within a 48 hour time window: * Acute onset of ischemic symptoms at rest * New ischemic ECG changes suggestive of acute ischemia * Rise and fall of cardiac biomarkers * Nonocclusive intracoronary thrombus seen in multiple projections, or persistence of contrast material within the lumen, or a visible embolization of intraluminal material downstream * Occlusive intracoronary thrombus Pathological Confirmation of stent thrombosis will be defined as evidence of recent thrombus with the stent determined at autopsy or via examination of tissue retrieved following thrombectomy.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Definite Stent Thrombosis as Defined Using the Academic Research Consortium (ARC) Definition	7 Participants	6 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Vessel Revascularization (TVR)	105 Participants	108 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

The patient-oriented composite endpoint is defined as the composite of all-cause death, any myocardial infarction and target vessel revascularization. Target vessel (SVG) revascularization (TVR) will be defined as any repeat percutaneous intervention or surgical bypass of any segment of the target SVG and the native coronary vessel distal to the SVG anastomosis. Non-target vessel revascularization will be defined as any repeat percutaneous intervention or surgical bypass of any SVG or any native coronary vessel apart from the target SVG and the native coronary artery supplied by the target SVG.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Patient-Oriented Composite Endpoint Will be Used as Secondary Outcome	68 Participants	62 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

This outcome is for the in-segment binary restenosis.

Outcome measures

Outcome measures
Measure	BMS Group n=137 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=139 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.	57 Participants	56 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Stroke	3 Participants	2 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=292 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) n=292 Participants Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) n=292 Participants Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) n=292 Participants Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) n=292 Participants Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) n=292 Participants Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) n=292 Participants Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) n=292 Participants Interaction effects of this DES Subgroup	Lesion Location (Body) n=292 Participants Interaction effects of this DES Subgroup	Antiplatelet n=292 Participants Interaction effects of this DES Subgroup	Baseline ACS Score n=292 Participants Interaction effects of this DES Subgroup
Incremental Cost-effectiveness Ratios (ICERs) for Subgroups of Patients, Such as Those With Highest Risk of Restenosis, Tallies of Cost by Type, and a Cost-outcomes Analysis Such as Cost Per Restenosis Avoided.	-2578.71 U.S. Dollars Standard Error 3059.08	-2971.90 U.S. Dollars Standard Error 22,730.43	-17998.43 U.S. Dollars Standard Error 23914.95	-11768.06 U.S. Dollars Standard Error 4723.68	-5069.18 U.S. Dollars Standard Error 4448.96	-14152 U.S. Dollars Standard Error 4550.29	-771.50 U.S. Dollars Standard Error 4073.11	-4,487.11 U.S. Dollars Standard Error 4082.83	8433.33 U.S. Dollars Standard Error 3598.76	4780.21 U.S. Dollars Standard Error 5671.55	-1483.97 U.S. Dollars Standard Error 3062.72	-3733.04 U.S. Dollars Standard Error 3038.69

SECONDARY outcome

Timeframe: 12 months

Population: The study did not collect information needed from the IVUS procedures to calculate neointima proliferation.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Lesion Revascularization (TLR)	25 Participants	26 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Vessel Myocardial Infarction	40 Participants	35 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Any Revascularization	53 Participants	56 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Definite stent thrombosis will be considered to have occurred by either angiographic or pathologic confirmation. Probable Stent Thrombosis will clinically be considered to have occurred after index Saphenous Vein aortocoronary bypass Graft (SVG) stenting (the Percutaneous Coronary Intervention (PCI) immediately after randomization) in the following cases: a) any unexplained death within the first 30 days OR b) Irrespective of the time after the index procedure, any MI which is related to documented acute ischemia in the territory of the implanted stent without angiographic confirmation of stent thrombosis and in the absence of any other obvious cause.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Definite or Probable Stent Thrombosis	30 Participants	26 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Discharge from Index Hospitalization (an average of 36 hours)

Incidence of post-procedural myocardial infarction and post-procedural GUSTO moderate or severe bleeding were compared between the DES and BMS groups by the difference between two independent proportions. Cumulative incidence curves and stratified log-rank tests were used to compare the two stent groups on the incidence of the secondary clinical outcomes listed above. When appropriate, competing risks analyses with plots of cumulative incidence curves and comparisons of cumulative incidences with Gray's test and Fine and Gray's methods were done. Proportional hazards regression for sub-distributions of competing risks were also done. SAS 9.2 (TS2M3; SAS Institute, Cary, NC, USA) and R version 3.4.4 were used for the analyses.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Procedural Complications (Post-procedural Myocardial Infarction and Post-procedural Bleeding)	22 Participants	15 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

The Device-oriented composite endpoint of Target lesion failure is defined as the composite of cardiac or unknown death, target vessel myocardial infarction, and target lesion revascularization. Target lesion revascularization (TLR) will be defined as any repeat percutaneous intervention of the target SVG lesion or bypass surgery of the target SVG lesion performed for restenosis or other complication of the target lesion. The target lesion will be defined as the treated SVG segment from 5 mm proximal to the stent to 5 mm distal to the stent.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Device-oriented Composite Endpoint of Target Lesion Failure Will be Used as a Secondary Outcome	51 Participants	45 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Target Lesion Revascularization (TLR)	40 Participants	47 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Non-Target Revascularization	26 Participants	33 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Non-Target Revascularization	60 Participants	69 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

The patient-oriented composite endpoint is defined as the composite endpoint of any death, any myocardial infarction, or target vessel revascularization.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Patient-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.	127 Participants	127 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

The device-oriented composite endpoint for target lesion failure is defined as the composite endpoint of cardiac death, target vessel myocardial infarction, or target lesion revascularization.

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Device-oriented (for Target Lesion Failure) Composite Endpoints Will be Used as Secondary Outcomes as Proposed by Cutlip et al, and as Recommended in the Draft FDA Guidance for Industry Statement.	95 Participants	94 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Entire Duration of Follow-up (median 2.7 years)

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Number of Participants With Stroke	12 Participants	10 Participants	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=305 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
Quality Adjusted Life Years of DES Relative to BMS	0.467 years Standard Error 0.017	0.503 years Standard Error 0.018	—	—	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	BMS Group n=292 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) n=292 Participants Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) n=292 Participants Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) n=292 Participants Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) n=292 Participants Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) n=292 Participants Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) n=292 Participants Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) n=292 Participants Interaction effects of this DES Subgroup	Lesion Location (Body) n=292 Participants Interaction effects of this DES Subgroup	Antiplatelet n=292 Participants Interaction effects of this DES Subgroup	Baseline ACS Score n=292 Participants Interaction effects of this DES Subgroup
Quality Adjusted Life Years for Subgroups of Patients	-0.03 years Standard Error 0.05	-0.04 years Standard Error 0.21	-0.03 years Standard Error 0.19	0.03 years Standard Error 0.08	0.02 years Standard Error 0.07	0.04 years Standard Error 0.07	-0.04 years Standard Error 0.07	-0.13 years Standard Error 0.07	-0.15 years Standard Error 0.06	0.02 years Standard Error 0.09	-0.04 years Standard Error 0.05	-0.01 years Standard Error 0.05

SECONDARY outcome

Timeframe: 12 months

This outcome is for the angiographic late in-segment luminal loss.

Outcome measures

Outcome measures
Measure	BMS Group n=137 Participants Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=139 Participants Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	Number of Lesions (2 or More Lesions) Interaction effects of this DES Subgroup	Stent Diameter (2.25 to Less Than 3) Interaction effects of this DES Subgroup	Stent Diameter (3 to Less Than 3.5) Interaction effects of this DES Subgroup	Stent Diameter (3.5 to Less Than 4) Interaction effects of this DES Subgroup	Recipient Target Vessel (Laddiag) Interaction effects of this DES Subgroup	Recipient Target Vessel (Cxom) Interaction effects of this DES Subgroup	Lesion Location (Aortic/Ostial) Interaction effects of this DES Subgroup	Lesion Location (Body) Interaction effects of this DES Subgroup	Antiplatelet Interaction effects of this DES Subgroup	Baseline ACS Score Interaction effects of this DES Subgroup
In Patients Who Clinically Require Follow-up Angiography, Two Angiographic Endpoints Will be Assessed: (a) In-segment Binary Restenosis and (b) Angiographic Late In-segment Luminal Loss.	1.05 lesions Standard Deviation 1.21	0.96 lesions Standard Deviation 1.15	—	—	—	—	—	—	—	—	—	—

Adverse Events

BMS Group

Serious events: 244 serious events

Other events: 18 other events

Deaths: 58 deaths

DES Group

Serious events: 231 serious events

Other events: 12 other events

Deaths: 57 deaths

Serious adverse events

Serious adverse events
Measure	BMS Group n=305 participants at risk Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 participants at risk Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Cardiac disorders ACS/MI	32.8% 100/305 • Number of events 166 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	31.5% 92/292 • Number of events 142 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Cardiac disorders Stroke	5.6% 17/305 • Number of events 18 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	4.8% 14/292 • Number of events 18 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Cardiac disorders Bleed	9.5% 29/305 • Number of events 41 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	9.6% 28/292 • Number of events 36 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Cardiac disorders Stent Thrombosis	5.6% 17/305 • Number of events 18 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	3.8% 11/292 • Number of events 11 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Cardiac disorders Other	71.8% 219/305 • Number of events 866 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	74.0% 216/292 • Number of events 859 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).

Other adverse events

Other adverse events
Measure	BMS Group n=305 participants at risk Patients who receive a bare metal stent in the saphenous vein graft target lesion(s). Bare Metal Stent: Patients receive one or more bare metal stents in the saphenous vein graft target lesion. Placebo: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.	DES Group n=292 participants at risk Patients who receive a drug-eluting stent in the saphenous vein graft target lesion(s). Drug-Eluting Stent: Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion. Blinded clopidogrel: For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion. Thienopyridine (open-label): For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Gastrointestinal disorders Barrett's oesophagus	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.00% 0/292 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
General disorders Chest pain	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.00% 0/292 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Injury, poisoning and procedural complications Contusion	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.00% 0/292 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Gastrointestinal disorders Duodenal ulcer	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.00% 0/292 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.00% 0/292 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Respiratory, thoracic and mediastinal disorders Epistaxis	2.3% 7/305 • Number of events 7 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	1.4% 4/292 • Number of events 6 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Gastrointestinal disorders Gastrointestinal haemorrhage	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.34% 1/292 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Vascular disorders Haematoma	0.33% 1/305 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.34% 1/292 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Renal and urinary disorders Haematuria	0.66% 2/305 • Number of events 2 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.68% 2/292 • Number of events 2 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Respiratory, thoracic and mediastinal disorders Haemoptysis	0.66% 2/305 • Number of events 2 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.00% 0/292 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Nervous system disorders Headache	0.00% 0/305 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.34% 1/292 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Gastrointestinal disorders Oesophagitis	0.00% 0/305 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.34% 1/292 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Injury, poisoning and procedural complications Post procedural haemorrhage	0.00% 0/305 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.34% 1/292 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/305 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).	0.34% 1/292 • Number of events 1 • Active monitoring of Adverse Events (AEs) started once a participant is randomized at the following time periods: 18-24 hours post procedure, hospital discharge, 1 month, 3 month, 6 month, 9 month, 12 month, 18 month, 24 month, 30 month and end of study (after 12-60 months of follow-up depending on when the patient was randomized during the enrollment period).

Additional Information

Dr. Subhash Banerjee

VA North Texas Health Care System

Phone: (214) 857-1608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place