Trial Outcomes & Findings for The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s) (NCT NCT01665053)
NCT ID: NCT01665053
Last Updated: 2019-01-30
Results Overview
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1684 participants
Primary outcome timeframe
12 months
Results posted on
2019-01-30
Participant Flow
A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013. The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018.
Participant milestones
| Measure |
Promus Element Plus
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Overall Study
STARTED
|
838
|
846
|
|
Overall Study
Completed 12-Month Clinical F/U
|
797
|
822
|
|
Overall Study
No 12-Month F/U
|
32
|
15
|
|
Overall Study
Death With No 12-month Clinical FU
|
9
|
9
|
|
Overall Study
COMPLETED
|
806
|
831
|
|
Overall Study
NOT COMPLETED
|
32
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)
Baseline characteristics by cohort
| Measure |
Promus Element Plus
n=838 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=846 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
Total
n=1684 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.92 yr
STANDARD_DEVIATION 10.50 • n=5 Participants
|
63.48 yr
STANDARD_DEVIATION 10.44 • n=7 Participants
|
63.70 yr
STANDARD_DEVIATION 10.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
229 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
478 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
609 Participants
n=5 Participants
|
597 Participants
n=7 Participants
|
1206 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
100 participants
n=5 Participants
|
100 participants
n=7 Participants
|
200 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black,of African heritage
|
37 participants
n=5 Participants
|
52 participants
n=7 Participants
|
89 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
664 participants
n=5 Participants
|
655 participants
n=7 Participants
|
1319 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
16 participants
n=5 Participants
|
15 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
5 participants
n=5 Participants
|
4 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Disclosed
|
13 participants
n=5 Participants
|
20 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
Singapore
|
12 participants
n=5 Participants
|
15 participants
n=7 Participants
|
27 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
506 participants
n=5 Participants
|
514 participants
n=7 Participants
|
1020 participants
n=5 Participants
|
|
Region of Enrollment
Japan
|
81 participants
n=5 Participants
|
74 participants
n=7 Participants
|
155 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
20 participants
n=5 Participants
|
18 participants
n=7 Participants
|
38 participants
n=5 Participants
|
|
Region of Enrollment
New Zealand
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
56 participants
n=5 Participants
|
58 participants
n=7 Participants
|
114 participants
n=5 Participants
|
|
Region of Enrollment
Latvia
|
12 participants
n=5 Participants
|
11 participants
n=7 Participants
|
23 participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
13 participants
n=5 Participants
|
12 participants
n=7 Participants
|
25 participants
n=5 Participants
|
|
Region of Enrollment
Austria
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
50 participants
n=5 Participants
|
50 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Region of Enrollment
Finland
|
14 participants
n=5 Participants
|
16 participants
n=7 Participants
|
30 participants
n=5 Participants
|
|
Region of Enrollment
Denmark
|
9 participants
n=5 Participants
|
10 participants
n=7 Participants
|
19 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
10 participants
n=5 Participants
|
11 participants
n=7 Participants
|
21 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
16 participants
n=5 Participants
|
17 participants
n=7 Participants
|
33 participants
n=5 Participants
|
|
Region of Enrollment
France
|
20 participants
n=5 Participants
|
23 participants
n=7 Participants
|
43 participants
n=5 Participants
|
|
Height
|
67.44 inches
STANDARD_DEVIATION 4.07 • n=5 Participants
|
67.23 inches
STANDARD_DEVIATION 4.00 • n=7 Participants
|
67.33 inches
STANDARD_DEVIATION 4.04 • n=5 Participants
|
|
Weight
|
190.45 lbs
STANDARD_DEVIATION 44.29 • n=5 Participants
|
190.92 lbs
STANDARD_DEVIATION 44.09 • n=7 Participants
|
190.69 lbs
STANDARD_DEVIATION 44.18 • n=5 Participants
|
|
Smoking
Smoking, Ever
|
519 participants
n=5 Participants
|
510 participants
n=7 Participants
|
1029 participants
n=5 Participants
|
|
Smoking
Smoking,Unknown
|
12 participants
n=5 Participants
|
19 participants
n=7 Participants
|
31 participants
n=5 Participants
|
|
Smoking
Smoking, Never
|
307 participants
n=5 Participants
|
317 participants
n=7 Participants
|
624 participants
n=5 Participants
|
|
Current Diabetes Mellitus
Current Diabetes Mellitus
|
276 participants
n=5 Participants
|
275 participants
n=7 Participants
|
551 participants
n=5 Participants
|
|
Current Diabetes Mellitus
No Current Diabetes Mellitus
|
562 participants
n=5 Participants
|
571 participants
n=7 Participants
|
1133 participants
n=5 Participants
|
|
Hyperlipidemia Requiring Medication
Hyperlipidemia Requiring Medication
|
621 participants
n=5 Participants
|
625 participants
n=7 Participants
|
1246 participants
n=5 Participants
|
|
Hyperlipidemia Requiring Medication
No Hyperlipidemia requiring Medication
|
217 participants
n=5 Participants
|
221 participants
n=7 Participants
|
438 participants
n=5 Participants
|
|
Hypertension Requiring Medication
Hypertension requiring medication
|
629 participants
n=5 Participants
|
652 participants
n=7 Participants
|
1281 participants
n=5 Participants
|
|
Hypertension Requiring Medication
No Hypertension requiring medication
|
209 participants
n=5 Participants
|
194 participants
n=7 Participants
|
403 participants
n=5 Participants
|
|
History of bleeding disorder
Hystory of bleeding disorder
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
History of bleeding disorder
No history of bleeding disorder
|
837 participants
n=5 Participants
|
844 participants
n=7 Participants
|
1681 participants
n=5 Participants
|
|
History of GI bleeding
History of GI Bleeding
|
0 participants
n=5 Participants
|
2 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
History of GI bleeding
No History of GI Bleeding
|
838 participants
n=5 Participants
|
844 participants
n=7 Participants
|
1682 participants
n=5 Participants
|
|
History of Transient Ischemic Attack
History of Transient Ischemic Attack
|
23 participants
n=5 Participants
|
24 participants
n=7 Participants
|
47 participants
n=5 Participants
|
|
History of Transient Ischemic Attack
No History of Transient Ischemic Attack
|
815 participants
n=5 Participants
|
822 participants
n=7 Participants
|
1637 participants
n=5 Participants
|
|
History of cerebrovascular accident
History of Cerebrovascular Accident
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
History of cerebrovascular accident
No History of Cerebrovascular Accident
|
806 participants
n=5 Participants
|
816 participants
n=7 Participants
|
1622 participants
n=5 Participants
|
|
History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA)
History of TIA or CVA
|
49 participants
n=5 Participants
|
48 participants
n=7 Participants
|
97 participants
n=5 Participants
|
|
History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA)
No history of TIA or CVA
|
789 participants
n=5 Participants
|
798 participants
n=7 Participants
|
1587 participants
n=5 Participants
|
|
History of peripheral vascular disease (PVD)
History of PVD
|
59 participants
n=5 Participants
|
68 participants
n=7 Participants
|
127 participants
n=5 Participants
|
|
History of peripheral vascular disease (PVD)
No History of PVD
|
779 participants
n=5 Participants
|
778 participants
n=7 Participants
|
1557 participants
n=5 Participants
|
|
History of renal disease
History of renal disease
|
52 participants
n=5 Participants
|
56 participants
n=7 Participants
|
108 participants
n=5 Participants
|
|
History of renal disease
No History of renal disease
|
786 participants
n=5 Participants
|
790 participants
n=7 Participants
|
1576 participants
n=5 Participants
|
|
Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set
Left Anterior Descending (LAD)
|
433 Number of lesions
n=5 Participants
|
437 Number of lesions
n=7 Participants
|
870 Number of lesions
n=5 Participants
|
|
Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set
Left Circumflex Artery (LCx)
|
275 Number of lesions
n=5 Participants
|
265 Number of lesions
n=7 Participants
|
540 Number of lesions
n=5 Participants
|
|
Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set
Right Coronary Artery (RCA)
|
334 Number of lesions
n=5 Participants
|
357 Number of lesions
n=7 Participants
|
691 Number of lesions
n=5 Participants
|
|
Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set
Left Main Coronary Artery (LMCA)
|
1 Number of lesions
n=5 Participants
|
0 Number of lesions
n=7 Participants
|
1 Number of lesions
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.
TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
Outcome measures
| Measure |
Promus Element Plus
n=796 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=823 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
|
6.4 percentage of participants
|
6.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-Treat population
The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) \& TLR Coronary Artery Bypass Graft (CABG).
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
|
1.7 percentage of participants
|
2.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to- Treat
TVR overall includes: TVR PCI \& TVR CABG.
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
|
3.6 percentage of participants
|
3.8 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat analysis
Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
|
8.2 percentage of participants
|
8.2 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat
The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Myocardial Infarction at 12 Month.
|
5.0 percentage of participants
|
5.4 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Cardiac Death at 12 Month.
|
0.9 percentage of participants
|
0.5 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With Non-Cardiac Death at 12 Month.
|
0.2 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
The Death rate includes Cardiac- \& Non-Cardiac Death.
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Patients That Died at 12 Months.
|
1.1 percentage of participants
|
1.1 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
|
5.6 percentage of participants
|
5.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
|
5.8 percentage of participants
|
6.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
|
8.4 percentage of participants
|
9.3 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-treat population.
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
|
0.7 percentage of participants
|
0.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Intent-to-Treat population.
The stroke rate includes: Ischemic- , Hemorraghic- \& Undetermined Stroke.
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Patients With a Stroke at 12 Month.
|
0.9 percentage of participants
|
0.7 percentage of participants
|
SECONDARY outcome
Timeframe: Day 1 (periprocedure)Population: Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions. SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions.
Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.
Outcome measures
| Measure |
Promus Element Plus
n=838 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=846 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Periprocedural Technical Success Rate.
|
96.9 percentage of lesions
|
98.3 percentage of lesions
|
SECONDARY outcome
Timeframe: Day 1 (periprocedure)Population: Intent-to-Treat population
Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.
Outcome measures
| Measure |
Promus Element Plus
n=838 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=846 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Periprocedural Clinical Procedural Success Rate
|
94.3 percentage of subjects
|
94.9 percentage of subjects
|
SECONDARY outcome
Timeframe: 12 monthPopulation: Intent-to-Treat population
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
|
6.4 percentage of participants
|
6.6 percentage of participants
|
SECONDARY outcome
Timeframe: 12 MonthPopulation: Intent to treat population
All CEC adjudicated revascularization at 12 month (Intent to treat population).
Outcome measures
| Measure |
Promus Element Plus
n=808 Participants
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=832 Participants
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
|
3.6 percentage of patients
|
4.0 percentage of patients
|
Adverse Events
Promus Element Plus
Serious events: 262 serious events
Other events: 576 other events
Deaths: 0 deaths
SYNERGY
Serious events: 265 serious events
Other events: 567 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Promus Element Plus
n=838 participants at risk
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=846 participants at risk
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Cardiac disorders
Cardiac disorders
|
15.0%
126/838 • Site-Reported Serious Adverse Events to 12 Months
|
16.9%
143/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
General disorders
General disorders and administration site conditions
|
5.8%
49/838 • Site-Reported Serious Adverse Events to 12 Months
|
5.3%
45/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Nervous system disorders
Nervous sysytem disorders
|
2.1%
18/838 • Site-Reported Serious Adverse Events to 12 Months
|
3.1%
26/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Injury, poisoning and procedural complications
Injury, poisining and procedural complications
|
2.7%
23/838 • Site-Reported Serious Adverse Events to 12 Months
|
3.1%
26/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders
|
2.4%
20/838 • Site-Reported Serious Adverse Events to 12 Months
|
2.7%
23/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Infections and infestations
Infections and infestations
|
2.7%
23/838 • Site-Reported Serious Adverse Events to 12 Months
|
2.6%
22/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Vascular disorders
Vascular disorders
|
2.4%
20/838 • Site-Reported Serious Adverse Events to 12 Months
|
2.2%
19/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
|
1.7%
14/838 • Site-Reported Serious Adverse Events to 12 Months
|
1.7%
14/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Gastrointestinal disorders
Gastrointestinal disorders
|
3.3%
28/838 • Site-Reported Serious Adverse Events to 12 Months
|
1.8%
15/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders
|
0.60%
5/838 • Site-Reported Serious Adverse Events to 12 Months
|
1.5%
13/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Renal and urinary disorders
Renal and Urinary disorders
|
1.8%
15/838 • Site-Reported Serious Adverse Events to 12 Months
|
1.7%
14/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorders
|
1.3%
11/838 • Site-Reported Serious Adverse Events to 12 Months
|
1.7%
14/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Metabolism and nutrition disorders
Metabolism and nutrition disorders
|
0.84%
7/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.95%
8/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Psychiatric disorders
Psychiatric disorders
|
0.48%
4/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.71%
6/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Eye disorders
Eye disorders
|
0.84%
7/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.47%
4/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Hepatobiliary disorders
Hepatobiliary disorders
|
0.60%
5/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.47%
4/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Investigations
Investigations
|
0.60%
5/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.47%
4/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Endocrine disorders
Endocrine disorders
|
0.12%
1/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.24%
2/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Ear and labyrinth disorders
Ear and labyrinth disorders
|
0.24%
2/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.12%
1/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders
|
0.24%
2/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.12%
1/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Immune system disorders
Immune system disorders
|
0.12%
1/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.12%
1/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Congenital, familial and genetic disorders
Congenital, familial and genetic disorders
|
0.12%
1/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.00%
0/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Reproductive system and breast disorders
Reproductive system and breast disorders
|
0.12%
1/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.00%
0/846 • Site-Reported Serious Adverse Events to 12 Months
|
|
Surgical and medical procedures
Surgical and medical procedures
|
0.12%
1/838 • Site-Reported Serious Adverse Events to 12 Months
|
0.00%
0/846 • Site-Reported Serious Adverse Events to 12 Months
|
Other adverse events
| Measure |
Promus Element Plus
n=838 participants at risk
PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
PROMUS Element Plus: A drug eluting coronary stent system
|
SYNERGY
n=846 participants at risk
SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
SYNERGY: A drug eluting coronary stent system
|
|---|---|---|
|
Cardiac disorders
Angina Pectoris
|
12.4%
104/838 • Number of events 125 • Site-Reported Serious Adverse Events to 12 Months
|
11.8%
100/846 • Number of events 116 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Myocardial infarction
|
8.4%
70/838 • Number of events 70 • Site-Reported Serious Adverse Events to 12 Months
|
8.7%
74/846 • Number of events 74 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Coronary artery dissection
|
3.2%
27/838 • Number of events 28 • Site-Reported Serious Adverse Events to 12 Months
|
3.8%
32/846 • Number of events 33 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Angina unstable
|
2.1%
18/838 • Number of events 19 • Site-Reported Serious Adverse Events to 12 Months
|
2.4%
20/846 • Number of events 24 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Acute myocardial infarction
|
1.3%
11/838 • Number of events 12 • Site-Reported Serious Adverse Events to 12 Months
|
2.0%
17/846 • Number of events 17 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Atrial fibrillation
|
1.9%
16/838 • Number of events 17 • Site-Reported Serious Adverse Events to 12 Months
|
1.5%
13/846 • Number of events 15 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Cardiac failure congestive
|
1.2%
10/838 • Number of events 13 • Site-Reported Serious Adverse Events to 12 Months
|
1.1%
9/846 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Bradycardia
|
1.3%
11/838 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
0.95%
8/846 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Palpitations
|
1.2%
10/838 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
0.83%
7/846 • Number of events 7 • Site-Reported Serious Adverse Events to 12 Months
|
|
Cardiac disorders
Ventricular tachycardia
|
0.95%
8/838 • Number of events 8 • Site-Reported Serious Adverse Events to 12 Months
|
0.47%
4/846 • Number of events 4 • Site-Reported Serious Adverse Events to 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
40/838 • Number of events 45 • Site-Reported Serious Adverse Events to 12 Months
|
5.2%
44/846 • Number of events 49 • Site-Reported Serious Adverse Events to 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.7%
14/838 • Number of events 17 • Site-Reported Serious Adverse Events to 12 Months
|
2.2%
19/846 • Number of events 22 • Site-Reported Serious Adverse Events to 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.95%
8/838 • Number of events 8 • Site-Reported Serious Adverse Events to 12 Months
|
1.7%
14/846 • Number of events 15 • Site-Reported Serious Adverse Events to 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.95%
8/838 • Number of events 9 • Site-Reported Serious Adverse Events to 12 Months
|
1.3%
11/846 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
|
Nervous system disorders
Dizziness
|
3.2%
27/838 • Number of events 28 • Site-Reported Serious Adverse Events to 12 Months
|
3.5%
30/846 • Number of events 31 • Site-Reported Serious Adverse Events to 12 Months
|
|
Nervous system disorders
Headache
|
2.5%
21/838 • Number of events 22 • Site-Reported Serious Adverse Events to 12 Months
|
2.0%
17/846 • Number of events 19 • Site-Reported Serious Adverse Events to 12 Months
|
|
Nervous system disorders
Syncope
|
1.3%
11/838 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
1.5%
13/846 • Number of events 15 • Site-Reported Serious Adverse Events to 12 Months
|
|
Gastrointestinal disorders
Nausea
|
1.9%
16/838 • Number of events 16 • Site-Reported Serious Adverse Events to 12 Months
|
1.4%
12/846 • Number of events 12 • Site-Reported Serious Adverse Events to 12 Months
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
1.3%
11/838 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
0.59%
5/846 • Number of events 5 • Site-Reported Serious Adverse Events to 12 Months
|
|
Gastrointestinal disorders
Abdominal pain
|
1.1%
9/838 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
0.59%
5/846 • Number of events 5 • Site-Reported Serious Adverse Events to 12 Months
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
1.1%
9/838 • Number of events 9 • Site-Reported Serious Adverse Events to 12 Months
|
0.35%
3/846 • Number of events 3 • Site-Reported Serious Adverse Events to 12 Months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.6%
13/838 • Number of events 13 • Site-Reported Serious Adverse Events to 12 Months
|
2.5%
21/846 • Number of events 21 • Site-Reported Serious Adverse Events to 12 Months
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
2.3%
19/838 • Number of events 21 • Site-Reported Serious Adverse Events to 12 Months
|
1.9%
16/846 • Number of events 16 • Site-Reported Serious Adverse Events to 12 Months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.1%
9/838 • Number of events 9 • Site-Reported Serious Adverse Events to 12 Months
|
1.7%
14/846 • Number of events 14 • Site-Reported Serious Adverse Events to 12 Months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
1.2%
10/838 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
1.2%
10/846 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
|
Infections and infestations
Pneumonia
|
1.8%
15/838 • Number of events 15 • Site-Reported Serious Adverse Events to 12 Months
|
2.0%
17/846 • Number of events 17 • Site-Reported Serious Adverse Events to 12 Months
|
|
Infections and infestations
Urinary tract infection
|
1.3%
11/838 • Number of events 12 • Site-Reported Serious Adverse Events to 12 Months
|
1.2%
10/846 • Number of events 12 • Site-Reported Serious Adverse Events to 12 Months
|
|
Infections and infestations
Nasopharyngitis
|
1.3%
11/838 • Number of events 13 • Site-Reported Serious Adverse Events to 12 Months
|
1.1%
9/846 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
|
Injury, poisoning and procedural complications
Contusion
|
2.1%
18/838 • Number of events 18 • Site-Reported Serious Adverse Events to 12 Months
|
1.4%
12/846 • Number of events 13 • Site-Reported Serious Adverse Events to 12 Months
|
|
Vascular disorders
Hypertension
|
3.6%
30/838 • Number of events 33 • Site-Reported Serious Adverse Events to 12 Months
|
2.8%
24/846 • Number of events 25 • Site-Reported Serious Adverse Events to 12 Months
|
|
Vascular disorders
Hypotension
|
2.4%
20/838 • Number of events 20 • Site-Reported Serious Adverse Events to 12 Months
|
1.1%
9/846 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
|
Investigations
Cardiac enzymes increased
|
1.6%
13/838 • Number of events 13 • Site-Reported Serious Adverse Events to 12 Months
|
0.59%
5/846 • Number of events 5 • Site-Reported Serious Adverse Events to 12 Months
|
|
Investigations
Troponin increased
|
1.2%
10/838 • Number of events 10 • Site-Reported Serious Adverse Events to 12 Months
|
0.59%
5/846 • Number of events 5 • Site-Reported Serious Adverse Events to 12 Months
|
|
Renal and urinary disorders
Haematuria
|
1.8%
15/838 • Number of events 15 • Site-Reported Serious Adverse Events to 12 Months
|
0.71%
6/846 • Number of events 6 • Site-Reported Serious Adverse Events to 12 Months
|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
9/838 • Number of events 9 • Site-Reported Serious Adverse Events to 12 Months
|
1.1%
9/846 • Number of events 11 • Site-Reported Serious Adverse Events to 12 Months
|
|
Immune system disorders
Drug hypersensitivity
|
1.7%
14/838 • Number of events 14 • Site-Reported Serious Adverse Events to 12 Months
|
1.8%
15/846 • Number of events 16 • Site-Reported Serious Adverse Events to 12 Months
|
Additional Information
Patricia O'Mara, Clinical Trial Manager
Boston Scientific
Phone: 518-792-5673
Email: patricia.o'[email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor can review results communications to public release and can embargo communications regarding trial results for a period less or equal to 45 days from the time submitted to the sponsor. If the sponsor determines the communication would be detrimental to the intellectual property, the PI will redact or modify or will refrain the publication to a publisher or other party for an additional 120 days to permit the sponsor to file patent applications or take other steps to protect interests
- Publication restrictions are in place
Restriction type: OTHER