Percutaneous Coronary Intervention (PCI) Outcomes in Community Versus Tertiary Settings

The primary objective of the trial is to compare the acute safety and long term outcomes between hospitals with cardiac surgery on-site (SOS hospitals) and hospitals without cardiac surgery on-site (non-SOS hospitals) for patients with ischemic heart disease treated with elective percutaneous coronary intervention (PCI) (stable angina, acute coronary syndrome, or non-Q wave MI) presenting to non-SOS hospitals.

The MASS COMM trial is a prospective, multi-center, randomized, controlled two-arm trial of PCI performed at non-SOS hospitals (non-SOS-PCI arm) versus PCI performed at SOS hospitals (SOS-PCI arm). The trial is designed to reject the null-hypothesis of inferiority, and thereby show the non-inferiority of the non-SOS-PCI arm to the SOS-PCI arm.

Specifically, 3690 subjects will be enrolled in a multi-center, randomized, controlled trial (RCT), in which eligible subjects will be consented and randomized in a 3:1 ratio at the non-SOS hospitals for PCI to be performed at either the enrolling non-SOS hospital (3 chances out of 4) or a corresponding SOS hospital (1 chance out of 4).

Eligibility Criteria:
Inclusion Criteria:

1. Subject is at least 18 years old.
2. Subject requires single- or multi-vessel percutaneous coronary intervention (PCI) of de novo or restenotic target lesion (including in-stent restenotic lesions).
3. Subject's lesion(s) is (are) amenable to stent treatment with currently available FDA-approved bare metal or drug eluting stents.
4. Subject is an acceptable candidate for elective, urgent or emergency coronary artery bypass graft (CABG).
5. Subject has clinical evidence of ischemic heart disease in terms of a positive functional study, or documented symptoms.
6. Documented stable angina pectoris \[Canadian Cardiovascular Society Classification (CCS) 1, 2, 3, or 4\], unstable angina pectoris with documented ischemia (Braunwald Class IB-C, IIB-C, or IIIB-C), non-ST segment elevation myocardial infarction, or documented silent ischemia.
7. Subject is willing and able to undergo percutaneous intervention at SOS hospital, if randomized to SOS study arm.
8. Subject and the treating physician agree that the subject will comply with all follow-up evaluations.
9. Subject has been informed of the nature of the study and agrees to its provisions and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee of the respective clinical site.
10. The target lesion(s) is (are) de novo or restenotic (including in-stent restenotic) native coronary artery lesion(s) with greater than 50 and less than 100% stenosis (visual estimate), or the target lesion is an acute (less than 1 month) total occlusion as evidenced by clinical symptoms.
11. Target lesions(s) is (are) located in an infarct (if not treated with primary PCI) or non-infarct-related artery with a 70% or greater stenosis (by visual estimate) more than 72 hours following the ST segment elevation myocardial infarction (STEMI).

Lesions treated with PCI more than 72 hours following STEMI would be subject to the same protocol inclusion/exclusion criteria listed above and below with the exception that a target lesion of 70% or greater stenosis may be treated with or without symptoms or abnormal stress test).

Exclusion Criteria:

1. The patient is pregnant or breastfeeding.
2. Evidence of STEMI within 72 hours of the intended treatment on infarct related or non-infarct related artery.
3. Cardiogenic shock on presentation or during current hospitalization.
4. Left ventricular ejection fraction less than 20%.
5. Known allergies to: aspirin, clopidogrel (Plavix) and ticlopidine (Ticlid), heparin, bivalirudin, stainless steel, or contrast agent (which cannot be adequately premedicated).
6. A platelet count less than 75,000 cells/mm3 or greater than 700,000 cells/mm3 or a WBC less than 3,000 cells/mm3.
7. Acute or chronic renal dysfunction (creatinine greater than 2.5 mg/dl or less than 150µmol/L).
8. Subject is currently participating in an investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials).
9. Prior participation in this study.
10. Within 30 days prior to the index study procedure, the subject has undergone a previous coronary interventional procedure of any kind. Note: This exclusion criterion does not apply to post-STEMI patients.
11. Stroke or transient ischemic attack within the prior 3 months.
12. Active peptic ulcer or upper gastrointestinal bleeding within the prior 3 months.
13. Subject has active sepsis.
14. Unprotected left main coronary artery disease (stenosis greater than 50%).
15. In the investigator's opinion, subject has a co-morbid condition(s) that could limit the life expectancy to less than one year, or limit the subject's ability to participate in the study or comply with follow-up requirements or impact the scientific integrity of the study.
16. Subject has normal or insignificant coronaries (i.e. coronary lesion(s) less than 50% stenosis).
17. Any target vessel has evidence of:

    * excessive thrombus (e.g. requires target vessel thrombectomy)
    * tortuousity (greater than 60 degree angle) that makes it unsuitable for proper stent delivery and deployment,
    * heavy calcification.
18. Any target lesion requires treatment with a device other than percutaneous transluminal coronary angioplasty (PTCA) prior to stent placement (e.g. but not limited to, directional coronary atherectomy, excimer laser, rotational atherectomy, etc.).
19. Any lesion that is located in a saphenous vein graft, however, lesions located within the native vessel but accessed through the graft are eligible.
20. The target vessel is in a "last remaining" epicardial vessel (e.g. greater than 2 non-target epicardial vessels and the bypass grafts to these territories \[if present\] are totally occluded).