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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
3,691
Tufts New England Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
30-day Composite Major Adverse Cardiac Event (MACE)
Time frame: 30 days
12-month Composite Major Adverse Cardiac Event (MACE)
Time frame: 12 month
All Cause Mortality at 30 Days
Time frame: 30 days
Ischemia-driven Target Lesion Revascularization
Time frame: 30 days
Ischemia-driven Target Lesion Revascularization
Time frame: 12 months
Rate of Stent Thrombosis
Time frame: 12 months
Any Repeat Revascularization
Time frame: 12 months
Emergency or Urgent Revascularization
Time frame: 30 days
Procedural Success
Procedural success is defined as residual stenosis of the target lesion of less than 20%
Time frame: Post-Procedure
Major Vascular Complications
Time frame: 30 days
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.
Time frame: Post-Procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Boston University Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconnes 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
...and 7 more locations
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.
Time frame: Post-Procedure
All Cause Mortality at 12 Months
Time frame: 12 months
Ischemia-driven Target Vessel Revascularization
Time frame: 30 days
Ischemia-driven Target Vessel Revascularization
Time frame: 12 months
Rate of Stent Thrombosis
Time frame: 30 days
Any Repeat Revascularization
Time frame: 30 days