Trial Outcomes & Findings for EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease (NCT NCT00531011)

Results Overview

Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

200 participants

Primary outcome timeframe

at 270 days

Results posted on

2015-06-08

Participant Flow

The patient population was comprised of male and female patients derived from the general interventional cardiology population from 9 centers in Italy.

Participant milestones

Participant milestones
Measure	XIENCE V Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Overall Study STARTED	103	97
Overall Study COMPLETED	99	90
Overall Study NOT COMPLETED	4	7

Reasons for withdrawal

Reasons for withdrawal
Measure	XIENCE V Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Overall Study Withdrawal by Subject	2	4
Overall Study Death	1	0
Overall Study Lost to Follow-up	1	0
Overall Study Physician Decision	0	3

Baseline Characteristics

EXecutive RCT: Evaluating XIENCE V® in a Multi Vessel Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System	Total n=200 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	46 Participants n=5 Participants	48 Participants n=7 Participants	94 Participants n=5 Participants
Age, Categorical >=65 years	57 Participants n=5 Participants	49 Participants n=7 Participants	106 Participants n=5 Participants
Age, Continuous	64.7 years STANDARD_DEVIATION 10.1 • n=5 Participants	63.8 years STANDARD_DEVIATION 10.2 • n=7 Participants	64.2 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	24 Participants n=7 Participants	51 Participants n=5 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	73 Participants n=7 Participants	149 Participants n=5 Participants
Region of Enrollment Italy	103 participants n=5 Participants	97 participants n=7 Participants	200 participants n=5 Participants

PRIMARY outcome

Timeframe: at 270 days

Population: Descriptive statistics for this measure are based on one random lesion per patient, 167 patients performed angiographic follow-up.

Full Analysis Set (FAS). LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In stent is measured within the confines of the stent edges.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
In-stent Late Loss (LL)	0.052 millimeters Standard Deviation 0.513	0.238 millimeters Standard Deviation 0.504

SECONDARY outcome

Timeframe: at 9 months

Population: ITT, 167 patients performed angiographic follow-up.

This measures the percentage of patients who have \> 50% diameter stenosis of the assessed vessel, within the stent edges.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
In-stent Binary Restenosis Rate	5.8 percentage of participants	3.6 percentage of participants

SECONDARY outcome

Timeframe: at 9 months

Population: 167 patients performed angiographic follow-up.

This measures the percentage of patients who have \> 50% diameter stenosis of the assessed vessel, within the stent edges In-segment is measured within the confines of the stent edges plus within 5 mm on either side of the stent.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
In-segment Binary Restenosis Rate	6.2 percentage of participants	4.6 percentage of participants

SECONDARY outcome

Timeframe: at 9 months

Population: 167 patients performed angiographic follow-up. Descriptive statistics for this measure are based on one random lesion per patient.

LL is defined as the difference between the post-procedure (immediately post placement of the stent) minimal lumen diameter (MLD) and the follow-up MLD (at 270 days). In segment LL is measured within the confines of the stent edges and within 5 mm of those edges.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
In-segment Late Loss (LL)	-0.100 millimeters Standard Deviation 0.484	0.037 millimeters Standard Deviation 0.421

SECONDARY outcome

Timeframe: at 30 days

Population: ITT

This measure is a calculation of the percentage of participants who experience any of the components of this composite measure.

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Composite Rate of Cardiac Death, Myocardial Infarction (MI, Both Q-wave and Non Q-wave), and Ischemia-driven Target Lesion Revascularization (TLR) .	1 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: at 30 days

Population: ITT

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Composite Rate of All Death, MI (Q-wave and Non Q-wave), and Target Vessel Revascularization (TVR).	1 percentage of participants	2.1 percentage of participants

SECONDARY outcome

Timeframe: at the time of PCI

Population: Intent to treat (ITT)

defined as attainment of \< 30% residual in-stent stenosis (by visual assessment) using any percutaneous method.

Outcome measures

Outcome measures
Measure	XIENCE V n=259 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=234 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Lesion Success	99.2 Percentage of participants	99.6 Percentage of participants

SECONDARY outcome

Timeframe: at the time of PCI

defined as: residual in-stent %DS of \< 30% using a percutaneous method, without cardiac death, Q-wave MI, non Q-wave MI, or repeat revasc of the target during hospitalization.

Outcome measures

Outcome measures
Measure	XIENCE V n=259 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=234 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Procedural Success	98.1 percentage of participants	97 percentage of participants

SECONDARY outcome

Timeframe: at the time of PCI

defined as achievement of a final residual in-stent diameter stenosis of \< 30% (visual assessment) using the assigned device only.

Outcome measures

Outcome measures
Measure	XIENCE V n=256 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=224 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Device Success	97.7 percentage of participants	98.2 percentage of participants

SECONDARY outcome

Timeframe: at 30 days

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Adjudicated Stent Thrombosis.	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: ITT

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Adjudicated Stent Thrombosis.	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: at 30 days

Population: ITT

(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Revascularizations	0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: ITT

(TLR/TVR/any revascularization)both ischemia-driven and not ischemia-driven.

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Revascularizations	5.8 percentage of participants	11.3 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: ITT

ITT

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Composite Endpoint of Cardiac Death, MI (Q-wave and Non Q-wave), and Ischemia-driven TLR .	4.9 percentage of participants	7.2 percentage of participants

SECONDARY outcome

Timeframe: 9 months

Population: ITT

Outcome measures

Outcome measures
Measure	XIENCE V n=103 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=97 Participants Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Composite Endpoint of All Death, MI (Q-wave and Non Q-wave), and TVR.	6.8 percentage of participants	12.4 percentage of participants

SECONDARY outcome

Timeframe: at 9 months.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
In-stent Minimum Lumen Diameter (MLD).	2.29 millimeters Standard Deviation 0.64	2.17 millimeters Standard Deviation 0.61

SECONDARY outcome

Timeframe: at 9 months.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
In-segment Minimum Lumen Diameter (MLD).	2.10 millimeters Standard Deviation 0.57	2.04 millimeters Standard Deviation 0.52

SECONDARY outcome

Timeframe: at 9 months.

Proximal refers to the immediate 5 mm outside of the proximal end of the stent.

Outcome measures

Outcome measures
Measure	XIENCE V n=90 Participants Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Proximal Minimum Lumen Diameter (MLD).	2.67 millimeters Standard Deviation 0.65	2.61 millimeters Standard Deviation 0.62

SECONDARY outcome

Timeframe: at 9 months.

Distal refers to the immediate 5 mm outside of the distal end of the stent.

Outcome measures

Outcome measures
Measure	XIENCE V n=225 Lesions Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=194 Lesions Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Distal Minimum Lumen Diameter (MLD).	2.28 millimeters Standard Deviation 0.59	2.25 millimeters Standard Deviation 0.57

Adverse Events

XIENCE V

Serious events: 21 serious events

Other events: 0 other events

Deaths: 0 deaths

TAXUS® Liberté™

Serious events: 19 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Maria Jose' M. Lopera

Abbott Vascular, Italy

Phone: +39-02-516251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The publication of the aggregate data is subject to the prior agreement of all the various sites participating in the study. Publication of the clinical data collected during the Study, can be only after notifying the SPONSOR in advance in order to allow the SPONSOR to verify compliance with confidentiality obligations and intellectual property rights of the SPONSOR.
Publication restrictions are in place

Restriction type: OTHER

Measure	XIENCE V n=101 participants at risk Patients randomized to receive the XIENCE V® Everolimus Eluting Coronary Stent System (XIENCE V® EECSS)	TAXUS® Liberté™ n=91 participants at risk Patients randomized to receive the TAXUS® Liberté™ Paclitaxel Eluting Coronary Stent System
Cardiac disorders Cardiac death	0.99% 1/101 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	0.00% 0/91 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Cardiac disorders Cardiac failure congestive	0.00% 0/101 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Cardiac disorders Coronary artery dissection	5.9% 6/101 • Number of events 6 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	6.6% 6/91 • Number of events 6 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Cardiac disorders Coronary artery stenosis	2.0% 2/101 • Number of events 2 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Cardiac disorders Myocardial infarction	0.99% 1/101 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	3.3% 3/91 • Number of events 3 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Cardiac disorders Pericarditis	0.99% 1/101 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	0.00% 0/91 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/101 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
General disorders Chest pain	0.99% 1/101 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
General disorders Thrombosis in device	0.99% 1/101 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	0.00% 0/91 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Injury, poisoning and procedural complications In-stent coronary artery restenosis	5.9% 6/101 • Number of events 6 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	11.0% 10/91 • Number of events 11 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Injury, poisoning and procedural complications Medical device complication	4.0% 4/101 • Number of events 4 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	2.2% 2/91 • Number of events 2 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
General disorders Procedural complications	2.0% 2/101 • Number of events 2 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	0.00% 0/91 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Investigations Arteriogram coronary	0.00% 0/101 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Renal and urinary disorders Renal failure	0.00% 0/101 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Vascular disorders Carotid artery stenosis	0.00% 0/101 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.
Vascular disorders Ischaemia NOS	0.00% 0/101 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.	1.1% 1/91 • Number of events 1 • 9 months Only serious adverse events were collected in the conduct of this trial. "Other" adverse events were not collected.