Rates for hospitals without and with SOS were 5.2% vs. 5.3% for bleeding, 1.2% vs. 1.1% for vascular repair, 0.5% vs. 0.6% for stroke and 0.8% vs. 0.9% for renal insufficiency, respectively.
CABG was performed significantly more often at hospitals without SOS than those with SOS (2.3% vs. 1.5%).
An exploratory analysis of the intention-to-treat population that excluded CABG as part of TVR showed that MACE rates were 11.9% at hospitals without SOS and 10.5% at those with SOS.
An exploratory per protocol analysis also showed higher MACE rates at hospitals without SOS than at those with SOS (12% and 10.4% respectively), although these differences are within the range of noninferiority used in other recent stent trials, Dr. Aversano noted.
TVR may be higher in patients having PCI at hospitals without cardiac surgery because of a higher rate of bare metal stents used, which is a more conservative approach to PCI at relatively inexperienced hospitals, and a lack of a full complement of interventional devices, he suggested.
Johns Hopkins University and participating sites provided support for this trial. Dr. Brindis is a consultant to Ivivi Health Sciences. Dr. Harrington disclosed ties with numerous pharmaceutical companies. Dr. Aversano reported that he has no conflicts of interest.