Trial Outcomes & Findings for A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population (NCT NCT01115933)

NCT ID: NCT01115933

Last Updated: 2015-08-13

Results Overview

Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 65 participants
• Primary outcome timeframe: 9 Months
• Results posted on: 2015-08-13

Participant Flow

A total of 65 subjects at 15 Japanese sites were enrolled between April, 2010 and August, 2011.

Participant milestones

Measure	XIENCE PRIME SV EECSS XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Overall Study STARTED	65
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	XIENCE PRIME SV EECSS XIENCE PRIME SV EECSS: XIENCE PRIME Small Vessel (2.25 mm) Everolimus Eluting Coronary Stent System XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS
Overall Study Did not receive XIENCE PRIME SV	1

Baseline Characteristics

A Clinical Evaluation of the XIENCE PRIME Small Vessel Everolimus Eluting Coronary Stent System in Japanese Population

Baseline characteristics by cohort

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV Everolimus Eluting Coronary Stent System XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=5 Participants
Age, Categorical >=65 years	49 Participants n=5 Participants
Age, Continuous	69.63 years STANDARD_DEVIATION 7.65 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	49 Participants n=5 Participants
Region of Enrollment Japan	64 participants n=5 Participants

PRIMARY outcome

Timeframe: 9 Months

Population: Full Analysis Set (FAS population)

Target lesion failure (TLF) is the composite of any of the following adverse events: Cardiac death, target vessel myocardial infarction (TV-MI) (per Protocol definition), Clinically indicated target lesion revascularization (CI-TLR)

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: The period during an in-hospital stay of less than or equal to 7 days post index procedure.

Population: Intent to Treat Population (ITT)

Device success is achievement final in-stent residual diameter stenosis of < 50% (by QCA). If adjunct treatment devices other than protocol defined device is used for target lesion treatment, malfunction of the investigational device occurring during the index procedure, are not regarded as device success. Use of a bail-out stent is still regarded as device success unless a device malfunction has occured. If QCA %DS is not available, the data is not included in analyses.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=65 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Device Success (Lesion Based Analysis, Only for XIENCE PRIME SV)	100.00 percentage of participants Interval 94.48 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: The period during an in-hospital stay of less than or equal to 7 days post index procedure.

Population: ITT population

Procedure success is defined as achievement of a final in-stent diameter stenosis of < 50% (by QCA) using the investigational device (AVJ-09-385), without the occurrence MACE during the hospital stay (up to 7 days if a subject still in the hospital). If QCA %DS is not available, the data is not included in analyses.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=65 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Procedural Success(Subject Base Analysis)	100.00 percentage of participants Interval 94.48 to 100.0	—	—	—	—

SECONDARY outcome

Timeframe: 8 months

Population: Full Analysis Set (FAS population)

IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.

PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Percent Diameter Stenosis (%DS), In-segment, In-stent, Proximal and Distal	19.80 percentage of DS Standard Deviation 10.59	6.11 percentage of DS Standard Deviation 11.65	12.32 percentage of DS Standard Deviation 17.03	14.91 percentage of DS Standard Deviation 8.12	—

SECONDARY outcome

Timeframe: 8 months

Population: Full Analysis Set (FAS population)

LATE LOSS (LL) calculated as MINIMUM LUMEN DIAMETER [MLD] post-procedure MINUS MLD at follow-up:

In-segment Late Loss: in-segment MLD post-procedure - in segment MLD at follow-up In-stent Late Loss: in-stent MLD post-procedure - in-stent MLD at follow-up Proximal Late Loss: proximal MLD post-procedure - proximal MLD at follow-up (proximal defined as within 5 mm of healthy tissue proximal to stent placement) Distal Late Loss: distal MLD post-procedure - distal MLD at follow-up (distal defined as within 5 mm of healthy tissue distal to stent placement)

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Late Loss (LL), In-segment, In-stent, Proximal and Distal	0.12 mm Standard Deviation 0.24	0.13 mm Standard Deviation 0.25	0.08 mm Standard Deviation 0.30	0.08 mm Standard Deviation 0.25	—

SECONDARY outcome

Timeframe: 8 months

Population: Full Analysis Set (FAS population)

IN-STENT is defined as within the margins of the stent. IN-SEGMENT is defined as within the margins of the stent and 5 mm proximal and 5 mm distal to the stent.

PROXIMAL is defined as within 5 mm of healthy tissue proximal to stent placement DISTAL is defined as within 5 mm of healthy tissue distal to stent placement

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Angiographic Binary Restenosis (ABR), In-segment, In-stent, Proximal and Distal	4.8 percentage of participants Interval 1.01 to 13.5	0 percentage of participants Interval 0.0 to 5.78	3.7 percentage of participants Interval 0.45 to 12.75	0 percentage of participants Interval 0.0 to 6.38	—

SECONDARY outcome

Timeframe: 1 month

DEATH (Per ARC Circulation 2007; 115: 2344-2351)

All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	—	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

DEATH (Per ARC Circulation 2007; 115: 2344-2351) All deaths are considered cardiac unless an unequivocal non-cardiac cause can be established. Specifically, any unexpected death even in patients with coexisting potentially fatal non-cardiac disease (e.g. cancer, infection) should be classified as cardiac.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Death (Cardiac, Vascular, Non-Cardiovascular, Per ARC Definition)	1.6 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	1.6 percentage of participants	—

SECONDARY outcome

Timeframe: 1 month

Population: Full Analysis Set (FAS population)

Definitions in SPIRIT III Study:

Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

Definitions in SPIRIT III Study:

Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	—

SECONDARY outcome

Timeframe: 1 month

Population: Full Analysis Set (FAS population)

Definitions in SPIRIT III Study:

Q wave MI: Development of new, pathological Q wave on the ECG

Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves

Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

Definitions in SPIRIT III Study:

Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Attributable to Target Vessel (TV-MI)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	—

SECONDARY outcome

Timeframe: 1 month

Population: FAS Population

Definitions in SPIRIT III Study:

Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

Definitions in SPIRIT III Study:

Q wave MI: Development of new, pathological Q wave on the ECG Non-Q wave MI: Elevation of CK levels to >=two times the upper limit of normal (ULN) with elevated CK-MB in the absence of new pathological Q waves Per ARC definition as published in 'Academic Research Consortium., Clinical end points in coronary stent trials: a case for standardized definitions.' Circulation 2007; 115: 2344-2351

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Myocardial Infarction (MI: QMI and NQMI, Both Per SPIRIT III Protocol and Per ARC Definitions) Not Attributable to Target Vessel (NTV-MI)	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	—

SECONDARY outcome

Timeframe: 1 month

Population: Full analysis set (FAS) population

Any revascularization for in-segment restenosis will be considered TLR."Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Lesion Revascularization (TLR, Per ARC Definition)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: FAS Population

Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Lesion Revascularization (TLR, Per ARC Definition)	3.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full analysis set (FAS) population

Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Lesion Revascularization (TLR, Per ARC Definition) Clinically-indicated TLR (CI-TLR)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full analysis set (FAS) population

Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: FAS population

Any revascularization for in-segment restenosis will be considered TLR. "Segment" is defined as the area within the margins of the stent and 5 mm proximal and 5 mm distal to the stent. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Lesion Revascularization (TLR, Per ARC Definition) Not Clinically-indicated TLR (NCI-TLR)	3.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: FAS Population

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Vessel Revascularization (TVR, Per ARC Definition)	0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: FAS population

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Vessel Revascularization (TVR, Per ARC Definition)	3.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full analysis set (FAS) population

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Vessel Revascularization (TVR, Per ARC Definition) Clinically-indicated TVR (CI-TVR)	1.6 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full Analysis Set (FAS population)

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion which includes upstream and downstream branches and the target lesion itself. Revascularization was considered clinically indicated if there was >70% diameter stenosis on angiography or >50% stenosis together with a positive stress test or ischaemic symptoms.

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Target Vessel Revascularization (TVR, Per ARC Definition) Not Clinically-indicated TVR (NCI-TVR)	3.1 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full Analysis Set (FAS population)

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of Cardiac Death/All MI	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of Cardiac Death/All MI	0.0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full Analysis Set (FAS population)

DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of All Death/All MI/All Revascularization (DMR)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: Full Analysis Set (FAS population)

DMR event (all death, all MI (per protocol or per ARC), all revascularization, respectively).

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of All Death/All MI/All Revascularization (DMR)	10.9 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: FAS population

Target lesion failure (TLF) is defined as a composite of cardiac death, target-vessel related myocardial infarction (TV-MI) and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of Cardiac Death/TV-MI/CI-TLR (TLF)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 month

Population: Full Analysis Set (FAS population)

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of Cardiac Death/All MI/CI-TLR (MACE)	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: FAS population

Major adverse cardiac events (MACE) is defined as the composite of cardiac death, all myocardial-infarction, and clinically-indicated target lesion revascularization (CI-TLR).

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Composite Endpoint of Cardiac Death, All MI and CI-TLR (MACE)	0.0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 1 months

Population: Full Analysis Set (FAS population)

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
All Coronary Revascularization	0.00 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: 9 months

Population: FAS population

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
All Coronary Revascularization	0.0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: <24 hours

Population: FAS population

Stent thrombosis (ST) was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible n=64 Participants XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Acute Stent Thrombosis	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 1-30 days

Population: FAS population

Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible n=64 Participants XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Subacute Stent Thrombosis	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 0-30 days

Population: FAS population

Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible n=64 Participants XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Acute/Subacute Stent Thrombosis	0.0 percentage of participants	0.0 percentage of participants	0.00 percentage of participants	0.00 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 31 - 298 days

Population: FAS population

Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible n=64 Participants XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Late Stent Thrombosis	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

SECONDARY outcome

Timeframe: 0 - 298 days

Population: FAS population

Stent thrombosis was defined according to the ARC guidelines as follows: definite: acute coronary syndrome and angiographic or pathological confirmation of ST; probable: unexplained death ≤30 days or target vessel MI without angiographic information; and possible: unexplained death >30 days after stent placement."

Outcome measures

Measure	XIENCE PRIME SV EECSS n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS In-stent n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Proximal n=64 Participants XIENCE PRIME SV EECSS: Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS %DS Distal n=64 Participants XIENCE PRIME SV EECSS : Patients receiving XIENCE PRIME SV EECSS	XIENCE PRIME SV EECSS - ST Definite/Probable/Possible n=64 Participants XIENCE PRIME SV EECSS : Patients receivingXIENCE PRIME SV EECSS
Overall Stent Thrombosis	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants	0.0 percentage of participants

Adverse Events

AVJ-09-385 SV EECSS

Serious events: 10 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	AVJ-09-385 SV EECSS n=64 participants at risk SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS
Cardiac disorders Angina unstable	1.6% 1/64 • Number of events 1 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Cardiac disorders Angina pectoris	3.1% 2/64 • Number of events 2 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Nervous system disorders Cerebral haemorrhage	1.6% 1/64 • Number of events 1 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Cardiac disorders Coronary artery stenosis	1.6% 1/64 • Number of events 1 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Injury, poisoning and procedural complications Coronary artery restenosis	3.1% 2/64 • Number of events 2 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Eye disorders	1.6% 1/64 • Number of events 1 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Infections and infestations	1.6% 1/64 • Number of events 1 • Nine (9) month post procedure data which includes events which occurred up to 298 days.
Musculoskeletal and connective tissue disorders	1.6% 1/64 • Number of events 1 • Nine (9) month post procedure data which includes events which occurred up to 298 days.

Other adverse events

Measure	AVJ-09-385 SV EECSS n=64 participants at risk SV EECSS: Small Vessel Everolimus Eluting Coronary Stent System AVJ-09-385 EECSS : Patients receiving AVJ-09-385 EECSS
Infections and infestations hordeolum, influenza, nasopharyngitis	6.2% 4/64 • Number of events 4 • Nine (9) month post procedure data which includes events which occurred up to 298 days.

Additional Information

David R Rutledge

Abbott Vascular

Phone: (408) 845-3820

Email: david.rutledge@av.abbott.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60