Sharon-Lise T. Normand is the principal investigator on this project. Ann Lovett is the project contact: 617-432-0005. 

There is an ongoing health policy debate regarding the use of elective percutaneous coronary intervention (PCI) in hospitals without on-site cardiac surgery. Increasingly, elective PCI without on-site cardiac surgery is common and is performed in 28 states across the country. Because of the lack of consensus on this issue, Massachusetts has opted to study this question.

The primary objective of the trial is to compare the acute safety and long-term outcomes between community 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 by elective percutaneous coronary intervention. Dr. Normand and Mass-DAC researchers are responsible for overseeing the statistical aspects of the overall study, including study design and analyses.

The MASS COMM trial is a prospective, multicenter, nested, randomized controlled two-arm trial of PCI performed at non-SOS hospitals versus PCI performed at SOS hospitals. The trial is planning to enroll 4,800 eligible subjects. The subjects will be randomized in a 3:1 ratio at the non-SOS hospitals for PCI to be performed at either the enrolling non-SOS hospital or a corresponding SOS hospital. The “nested” portion refers to an additional 1,200 subjects who will be randomly chosen from the patient pool undergoing routine PCI at the SOS hospitals and who meet the eligibility criteria for the trial. An angiographic subset will be reviewed by an independent committee to assess appropriateness and completeness of revascularization. The subset will include the first 10% of subjects consecutively enrolled at all study sites enrolling subjects in both randomized and nested portions of the trial.

The trial is overseen by several investigators and the Massachusetts Department of Public Health. Dr. Alice Jacobs from Boston Medical Center is overall principal investigator, Dr. Laura Mauri from Brigham and Women’s Hospital and Harvard Clinical Research Institute; and Paul Dreyer from the Division of Health Care Quality at the Massachusetts Department of Public Health.