Randomized Study Comparing Endeavor With Cypher Stents (PROTECT) (PROTECT)

• Sponsor: Medtronic Vascular
• Collaborator: Medtronic Bakken Research Center
• Information provided by (Responsible Party): Medtronic Vascular

Study Description

Brief Summary:

The PROTECT TRIAL is a randomized stent trial with 8800 patients in approximately 200 hospitals, which is designed to evaluate whether the Endeavor stent PROTECTS against late stent thrombosis resulting in less deaths and myocardial infarctions.

Study Stents:

Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System or next generation model Cordis Cypher® Sirolimus-eluting Coronary Stent, Cordis Cypher Select® Sirolimus-eluting Coronary Stent or next generation model

Primary Objective: To compare overall 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

Secondary Objective: To compare the composite endpoint of total death or cardiac death combined with the number of patients with all non-fatal myocardial infarctions as well as the number of patients with large non-fatal myocardial infarctions for Endeavor® Zotarolimus Eluting Coronary Stent System versus the Cypher® Sirolimus-eluting Coronary Stent in a patient population requiring stent implantation.

To assess the safety and efficacy in patient subgroups with specific demographics, clinical indications and/or vessel- or lesion characteristics.

Condition or disease	Intervention/treatment	Phase
Ischemic Heart Disease	Device: Stent	Phase 4

Study Design

Layout table for study information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	8709 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Health Services Research
Official Title:	PROTECT Trial: Patient Related OuTcomes With Endeavor Versus Cypher Stenting Trial
Study Start Date :	June 2007
Actual Primary Completion Date :	May 2012
Actual Study Completion Date :	July 2014

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: 1; Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System	Device: Stent; Stent implantation; Other Name: Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Active Comparator: 2; Cordis Cypher® Sirolimus-eluting Coronary Stent	Device: Stent; Stent implantation; Other Name: Cordis Cypher® Sirolimus-eluting Coronary Stent

Outcome Measures

Primary Outcome Measures :

1. 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 [ Time Frame: 3 years ]
   Definite or probable stent thrombosis rate.

Secondary Outcome Measures :

1. Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions [ Time Frame: 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

Eligibility Criteria

Layout table for eligibility information

Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

1. Patient is > 18 years of age (or minimum age as required by local regulations).
2. The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form".
3. All lesions requiring interventions (target lesions - one to a maximum of four) in one or more native coronary arteries are amendable for implantation of one or more Endeavor® Zotarolimus Eluting Coronary Stent System or Cypher® Sirolimus-eluting Coronary Stent*.
4. Patient indication, lesion length and vessel diameter of the target lesion(s) are according to the 'Indications for Use' as mentioned in the 'Instructions for Use' that comes with every Endeavor® Zotarolimus Eluting Coronary Stent System and Cypher® Sirolimus-eluting Coronary Stent. Patients should qualify for both systems before randomization*.
5. The patient is willing and able to cooperate with study procedures and required follow up visits.

Exclusion Criteria:

1. Women with known pregnancy or who are lactating.
2. Planned elective surgery necessitating discontinuation of clopidogrel within the regular planned period of clopidogrel administration.
3. Patients expected not to be compliant with the anti-platelet and/or anticoagulation therapy regimen.
4. Previous brachy-therapy.
5. Previous implantation of a drug eluting stent.
6. Previous implantation of a bare metal stent in the preceding year.
7. Simultaneous or planned intervention other non cardiac vessels including but not limited to renal artery or carotid artery.
8. Current medical condition with a life expectancy of less than 3 years.
9. Manifest acute severe heart failure (Killip class III-IV).
10. The patient is currently, and during the first 3 years of the PROTECT trial, participating in another investigational device or drug study that clinically interferes with the PROTECT-study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the PROTECT-study once.
11. Patients with medical conditions that preclude the follow-up as defined in the protocol or that otherwise limits participation in this study.
12. Patients on warfarin or similar anti-coagulant therapy.
13. Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
14. Patients who are judged to have a lesion that prevents complete inflation of an angioplasty balloon.
15. Patients in whom anti-platelet and/or anticoagulation therapy is contraindicated.
16. Transplant patients.

Contacts and Locations

Locations

Layout table for location information

Netherlands
196 enrolling sites Worldwide
Maastricht, Netherlands

Sponsors and Collaborators

Medtronic Vascular

Medtronic Bakken Research Center

Investigators

Layout table for investigator information

Principal Investigator:	Edoardo Camenzind, MD	University of Geneva, Switzerland
Principal Investigator:	Laura Mauri, MD	Brigham and Women's Hospital, US
Principal Investigator:	William O'Neill, MD	University of Miami Miller School of Medicine, US
Principal Investigator:	Prof. Patrick W. Serruys, MD, PhD	Erasmus MC, Rotterdam, the Netherlands
Principal Investigator:	Prof. Philippe Gabriel Steg, MD, PhD	Département de Cardiologie, Hôpital Bichat-Claude Bernard, Assistance Publique - Hôpitaux de Paris, France
Principal Investigator:	William Wijns, MD, PhD	O.L.V. Hospital, Aalst, Belgium

More Information

Publications of Results:

Camenzind E, Wijns W, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Boersma E, Vranckx P, McFadden E, Serruys PW, O'Neil WW, Jorissen B, Van Leeuwen F, Steg PG; PROTECT Steering Committee and Investigators. Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. Lancet. 2012 Oct 20;380(9851):1396-405. doi: 10.1016/S0140-6736(12)61336-1. Epub 2012 Aug 27.

Other Publications:

Camenzind E, Wijns W, Mauri L, Boersma E, Parikh K, Kurowski V, Gao R, Bode C, Greenwood JP, Gershlick A, O'Neill W, Serruys PW, Jorissen B, Steg PG; PROTECT Steering Committee and Investigators. Rationale and design of the Patient Related OuTcomes with Endeavor versus Cypher stenting Trial (PROTECT): randomized controlled trial comparing the incidence of stent thrombosis and clinical events after sirolimus or zotarolimus drug-eluting stent implantation. Am Heart J. 2009 Dec;158(6):902-909.e5. doi: 10.1016/j.ahj.2009.10.002.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Roguin A, Camenzind E, Kerner A, Beyar R, Boersma E, Mauri L, Steg PG, Wijns W. Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial. JACC Cardiovasc Interv. 2017 Mar 27;10(6):548-556. doi: 10.1016/j.jcin.2016.12.028.

Secemsky EA, Matteau A, Yeh RW, Steg PG, Camenzind E, Wijns W, McFadden E, Mauri L; PROTECT Trial Investigators. Comparison of Short- and Long-Term Cardiac Mortality in Early Versus Late Stent Thrombosis (from Pooled PROTECT Trials). Am J Cardiol. 2015 Jun 15;115(12):1678-84. doi: 10.1016/j.amjcard.2015.03.010. Epub 2015 Mar 23.

Wijns W, Steg PG, Mauri L, Kurowski V, Parikh K, Gao R, Bode C, Greenwood JP, Lipsic E, Alamgir F, Rademaker-Havinga T, Boersma E, Radke P, van Leeuwen F, Camenzind E; PROTECT Steering Committee and Investigators. Endeavour zotarolimus-eluting stent reduces stent thrombosis and improves clinical outcomes compared with cypher sirolimus-eluting stent: 4-year results of the PROTECT randomized trial. Eur Heart J. 2014 Oct 21;35(40):2812-20. doi: 10.1093/eurheartj/ehu318. Epub 2014 Aug 8.

Camenzind E, Boersma E, Wijns W, Mauri L, Rademaker-Havinga T, Ordoubadi FF, Suttorp MJ, Al Kurdi M, Steg PG; PROTECT Steering Committee and Investigators. Modifying effect of dual antiplatelet therapy on incidence of stent thrombosis according to implanted drug-eluting stent type. Eur Heart J. 2014 Aug 1;35(29):1932-48. doi: 10.1093/eurheartj/ehu084. Epub 2014 Mar 13.

Layout table for additonal information

Responsible Party:	Medtronic Vascular
ClinicalTrials.gov Identifier:	NCT00476957 History of Changes
Other Study ID Numbers:	Version 1.0 - 12 April 2007
First Posted:	May 22, 2007
Results First Posted:	March 17, 2014
Last Update Posted:	November 10, 2014
Last Verified:	November 2014

Keywords provided by Medtronic Vascular:

Drug Eluting Stents; Interventional Cardiology

Additional relevant MeSH terms:

Layout table for MeSH terms

Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Sirolimus	Anti-Bacterial Agents; Anti-Infective Agents; Antibiotics, Antineoplastic; Antineoplastic Agents; Antifungal Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs