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

Status:	Archived
Conditions:	Peripheral Vascular Disease, Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	Any
Updated:	7/1/2011
Start Date:	June 2006
End Date:	December 2012

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

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).

We found this trial at

sites

Tufts Clinical Pharmacology Study Unit

Boston, Massachusetts 02111