Abstract 17725: Growth in Non-Emergency PCI at Hospitals Without Surgery-On-Site Since the Completion of the MASS COMM Trial - A Comparison of the MASS COMM RCT and Cohort Study
Background: The MASSCOMM randomized clinical trial (RCT) compared PCI performed in Massachusetts (MA) hospitals with and without surgery on site (SOS) among non-emergency patients. After trial completion, non-SOS hospitals were permitted to continue non-emergency PCIas part of amandated cohort study. We investigated whether patient rates of enrollment, characteristics, andoutcomes differed between the RCT and cohort study.
Methods: The MASS COMM RCT enrolledpatients undergoing non-emergency PCI between 7/2006 and 9/2011, and the cohort study for PCIs between 10/2011 and 4/2013. Quarterly enrollment into the studies were examined. Baseline demographic, clinical, procedural characteristics, and 30-dayMACE (mortality, MI,and revascularization) were compared in the RCTvs. the cohort study.
Results: Mean enrollment in the RCT(both treatment arms) was 175.8patients per quarter vs. 300.5 for the cohort study (p < 0.01, Figure). Among baseline factors, significant differences were noted forprior PCI (28.5% versus 40.4%, p<0.01) and prior CABG (5.8% versus 8.8%, p<0.01) for RCT and cohort patients, respectively, but not for other characteristics. At 30 days, mortality (0.6% vs. 0.6%), MI (6.5% vs. 6.3%), repeat revascularization (2.9% vs. 2.8%), and the composite of these (9.4% vs. 9.2%) were similar in the RCT and cohort study (P = NS for all comparisons).
Conclusion: Non-emergency PCI occurring at non-SOS hospitals increased markedlysince completion of the MASS COMM RCT. Nevertheless, patient characteristics have changed minimally, and outcomes in the cohort study are no different to those observed in the RCT. This cohort study suggests that the findings observed in the MASS COMM RCT are generalizable to settings outside of a randomized clinical trial, and lends further support to the conclusion that PCI can be performed safely at hospitals without surgery-on-site. Examining whether non-SOS PCI improves patient access to PCI is warranted.
- © 2013 by American Heart Association, Inc.