Ischemic Heart Disease
Conditions
Keywords
Drug Eluting Stents, Interventional Cardiology
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.
Interventions
DEVICEStent
Stent implantation
Sponsors
Medtronic Cardiac Rhythm and Heart Failure
Medtronic Vascular
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 years | Definite or probable stent thrombosis rate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | 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 |
Countries
Netherlands
Participant flow
Recruitment details
8709 patients were randomized from May 2007 until December 2008 in 196 participating hospitals in 36 countries across five continents.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| E-ZES Medtronic Endeavor® Zotarolimus Eluting Coronary Stent System
Stent : Stent implantation | 4,357 |
| C-SES Cordis Cypher® Sirolimus-eluting Coronary Stent
Stent : Stent implantation | 4,352 |
| Total | 8,709 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 176 | 193 |
Baseline characteristics
| Characteristic | E-ZES | C-SES | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1929 Participants | 1884 Participants | 3813 Participants |
| Age, Categorical Between 18 and 65 years | 2428 Participants | 2468 Participants | 4896 Participants |
| Age, Continuous | 62.3 years STANDARD_DEVIATION 10.6 | 62.1 years STANDARD_DEVIATION 10.7 | 62.2 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Australia | 207 participants | 207 participants | 414 participants |
| Region of Enrollment Europe | 3180 participants | 3179 participants | 6359 participants |
| Region of Enrollment Middle East | 164 participants | 162 participants | 326 participants |
| Region of Enrollment New Zealand | 43 participants | 42 participants | 85 participants |
| Region of Enrollment North America | 115 participants | 115 participants | 230 participants |
| Region of Enrollment South America | 25 participants | 25 participants | 50 participants |
| Region of Enrollment South Asia | 623 participants | 622 participants | 1245 participants |
| Sex: Female, Male Female | 1017 Participants | 1044 Participants | 2061 Participants |
| Sex: Female, Male Male | 3340 Participants | 3308 Participants | 6648 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 201 / 4,357 | 184 / 4,352 |
| serious Total, serious adverse events | 579 / 4,357 | 507 / 4,352 |
Outcome results
Primary
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
Definite or probable stent thrombosis rate.
Time frame: 3 years
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| E-ZES | 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 |
| C-SES | 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 | 75 participants |
Secondary
Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions
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
Time frame: 3 years
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Cardiac death and large non-fatal MI | 157 participants |
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Target lesion revascularization | 249 participants |
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Total death and non-fatal myocardial infarctions | 331 participants |
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Stroke | 77 participants |
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Cardiac death and non-fatal MI | 265 participants |
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Bleeding events | 201 participants |
| E-ZES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Total death and large non-fatal myocardial infarct | 225 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Bleeding events | 184 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Total death and large non-fatal myocardial infarct | 255 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Total death and non-fatal myocardial infarctions | 360 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Cardiac death and large non-fatal MI | 174 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Cardiac death and non-fatal MI | 282 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Target lesion revascularization | 156 participants |
| C-SES | Composites of (Cardiac) Death and (Large) Non-fatal Myocardial Infarctions | Stroke | 72 participants |