Trial Outcomes & Findings for Randomized Study Comparing Endeavor With Cypher Stents (PROTECT) (NCT NCT00476957)

NCT ID: NCT00476957

Last Updated: 2014-11-10

Results Overview

Definite or probable stent thrombosis rate.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 8709 participants
• Primary outcome timeframe: 3 years
• Results posted on: 2014-11-10

Participant Flow

8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.

80 patients were excluded because there was no validly signed consent available during monitoring and 2 patients retracted their consent before the procedure, resulting in a total of 8709 patients randomised.

Participant milestones

Measure	E-ZES Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation
Overall Study STARTED	4357	4352
Overall Study COMPLETED	4181	4159
Overall Study NOT COMPLETED	176	193

Reasons for withdrawal

Measure	E-ZES Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation
Overall Study Lost to Follow-up	176	193

Baseline Characteristics

Randomized Study Comparing Endeavor With Cypher Stents (PROTECT)

Baseline characteristics by cohort

Measure	E-ZES n=4357 Participants Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES n=4352 Participants Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation	Total n=8709 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2428 Participants n=5 Participants	2468 Participants n=7 Participants	4896 Participants n=5 Participants
Age, Categorical >=65 years	1929 Participants n=5 Participants	1884 Participants n=7 Participants	3813 Participants n=5 Participants
Age, Continuous	62.3 years STANDARD_DEVIATION 10.6 • n=5 Participants	62.1 years STANDARD_DEVIATION 10.7 • n=7 Participants	62.2 years STANDARD_DEVIATION 10.6 • n=5 Participants
Sex: Female, Male Female	1017 Participants n=5 Participants	1044 Participants n=7 Participants	2061 Participants n=5 Participants
Sex: Female, Male Male	3340 Participants n=5 Participants	3308 Participants n=7 Participants	6648 Participants n=5 Participants
Region of Enrollment Europe	3180 participants n=5 Participants	3179 participants n=7 Participants	6359 participants n=5 Participants
Region of Enrollment South Asia	623 participants n=5 Participants	622 participants n=7 Participants	1245 participants n=5 Participants
Region of Enrollment North America	115 participants n=5 Participants	115 participants n=7 Participants	230 participants n=5 Participants
Region of Enrollment South America	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants
Region of Enrollment Australia	207 participants n=5 Participants	207 participants n=7 Participants	414 participants n=5 Participants
Region of Enrollment New Zealand	43 participants n=5 Participants	42 participants n=7 Participants	85 participants n=5 Participants
Region of Enrollment Middle East	164 participants n=5 Participants	162 participants n=7 Participants	326 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years

Definite or probable stent thrombosis rate.

Outcome measures

Measure	E-ZES n=4357 Participants Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES n=4352 Participants Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation
To Compare Overall Definite or Probable Stent Thrombosis Rate of the Endeavor® Zotarolimus Eluting Coronary Stent System Versus the Cypher® Sirolimus-eluting Coronary Stent in a Patient Population Requiring Stent Implantation	61 participants	75 participants

SECONDARY outcome

Timeframe: 3 years

Total death and large non-fatal myocardial infarctions Total death and non-fatal myocardial infarctions Cardiac death and large non-fatal MI Cardiac death and non-fatal myocardial infarctions

Outcome measures

Measure	E-ZES n=4357 Participants Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES n=4352 Participants Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Total death and large non-fatal myocardial infarct	225 participants	255 participants
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Total death and non-fatal myocardial infarctions	331 participants	360 participants
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Cardiac death and large non-fatal MI	157 participants	174 participants
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Cardiac death and non-fatal MI	265 participants	282 participants
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Target lesion revascularization	249 participants	156 participants
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Stroke	77 participants	72 participants
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions Bleeding events	201 participants	184 participants

Adverse Events

E-ZES

Serious events: 579 serious events

Other events: 201 other events

Deaths: 0 deaths

C-SES

Serious events: 507 serious events

Other events: 184 other events

Deaths: 0 deaths

Serious adverse events

Measure	E-ZES n=4357 participants at risk Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES n=4352 participants at risk Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation
Cardiac disorders MACCE (major adverse cardiac and cerebrovascular event	13.3% 579/4357 • Number of events 579	11.6% 507/4352 • Number of events 507

Other adverse events

Measure	E-ZES n=4357 participants at risk Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System Stent : Stent implantation	C-SES n=4352 participants at risk Cordis Cypher® Sirolimus-eluting Coronary Stent Stent : Stent implantation
Blood and lymphatic system disorders Bleeding	4.6% 201/4357 • Number of events 201	4.2% 184/4352 • Number of events 184

Additional Information

Dr. Frank van Leeuwen, Director Clinical Research Coronary and Renal Denervation

Medtronic Bakken Research Center

Phone: +31 43 3566622

Email: frank.van.leeuwen@medtronic.com

Results disclosure agreements

• Principal investigator is a sponsor employee For any publication or presentation of the Protected Materials or any portion thereof, a manuscript of the paper, abstract or other materials will be provided by Consultant to Sponsor for its approval at least sixty (60) days for manuscripts and thirty (30) days for presentations prior to outside submission. Medtronic shall have the right to request reasonable modifications of any manuscript or other materials to be published or presented.
• Publication restrictions are in place

Restriction type: OTHER