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

Coronary Artery Diseases Clinical Trial

— MASS COMM  

Official title:

A Randomized Trial to Compare Percutaneous Coronary Intervention Between Massachusetts Hospitals With Cardiac Surgery-On-Site and Community Hospitals Without Cardiac Surgery-On-Site

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116882
• Other study ID #: DPH00
• Status: Completed
• Phase: N/A
• First received: April 29, 2010
• Last updated: March 18, 2015
• Start date: June 2006
• Est. completion date: December 2012

Study information

• Verified date: March 2015
• Source: Harvard Clinical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3691
• Est. completion date: December 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Artery Diseases
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• PCI

Locations

Country	Name	City	State
United States	Beth Israel Deaconnes Medical Center	Boston	Massachusetts
United States	Boston University Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	Caritas St. Elizabeth's Hospital	Brighton	Massachusetts
United States	Brockton Hospital	Brockton	Massachusetts
United States	Caritas Good Samaritan Medical Center	Brockton	Massachusetts
United States	Lahey Clinic	Burlington	Massachusetts
United States	Metrowest Medical Center	Framingham	Massachusetts
United States	Lawrence General Hospital	Haverhill	Massachusetts
United States	Lowell General Hospital	Lowell	Massachusetts
United States	Saints Memorial Medical Center	Lowell	Massachusetts
United States	Melrose Wakefield Hospital	Melrose	Massachusetts
United States	Caritas Holy Family Hospital	Methuen	Massachusetts
United States	Caritas Norwood Hospital	Norwood	Massachusetts
United States	South Shore Hospital	Weymouth	Massachusetts

Sponsors (11)

Lead Sponsor	Collaborator
Harvard Clinical Research Institute	Brockton Hospital, Good Samaritan Hospital Medical Center, New York, Holy Family Hospital, Methuen, MA, Lawrence General Hospital, Lowell General Hospital, Melrose Wakefield Hospital, Metro West Medical Center, Norwood Hospital, Saints Memorial Medical Center, South Shore Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day Composite Major Adverse Cardiac Event (MACE)		30 days	No
Primary	12-month Composite Major Adverse Cardiac Event (MACE)		12 month	No
Secondary	All Cause Mortality at 30 Days		30 days	No
Secondary	Ischemia-driven Target Lesion Revascularization		30 days	No
Secondary	Ischemia-driven Target Lesion Revascularization		12 months	No
Secondary	Rate of Stent Thrombosis		12 months	No
Secondary	Any Repeat Revascularization		12 months	No
Secondary	Emergency or Urgent Revascularization		30 days	No
Secondary	Procedural Success	Procedural success is defined as residual stenosis of the target lesion of less than 20%	Post-Procedure	No
Secondary	Major Vascular Complications		30 days	No
Secondary	Complete Revascularization	Complete revascularization was defined as the successful treatment, according to the criteria of procedural success, of all epicardial vessels with more than 70% and less than 100% stenosis.	Post-Procedure	No
Secondary	Met Indication Criteria for PCI	Included here are the number of treated lesions that met the class I or II recommendations for anatomical indications for PCI, according to the PCI guidelines fo the American College of Cardiology Foundation-American Heart Association-Society for Cardiovascular Angiography and Interventions.	Post-Procedure	No
Secondary	All Cause Mortality at 12 Months		12 months	No
Secondary	Ischemia-driven Target Vessel Revascularization		30 days	No
Secondary	Ischemia-driven Target Vessel Revascularization		12 months	No
Secondary	Rate of Stent Thrombosis		30 days	No
Secondary	Any Repeat Revascularization		30 days	No