SAN FRANCISCO, CA – October 30, 2013 – A new study shows that a conservative approach to revascularization for patients with intermediate coronary lesions determined by angiographic diameter stenosis is safe and non-inferior to an aggressive approach. Findings of the SMART-CASE trial were presented today at the 25th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.
Angiographic diameter stenosis (DS) is the most widely used criteria to perform percutaneous coronary intervention in daily practice. While DS between 50 and 70 percent has been termed an "intermediate stenosis," the clinical outcome of PCI based on the angiographic criteria of 50 percent or 70 percent has never been studied.
The SMART-CASE trial evaluated the relative efficacy and safety of a conservative revascularization strategy for intermediate stenoses compared to a more aggressive approach of anatomical complete revascularization in the treatment of coronary stenosis. The investigator-initiated, multicenter, open label, prospective trial randomized 899 patients undergoing coronary angiography to be evaluated for PCI based on a conservative strategy (revascularization of DS>70 percent) or an aggressive strategy (DS>50 percent). The primary endpoint was a composite of all cause death, myocardial infarction or any revascularization at one year.
After one year, both the conservative strategy group and aggressive strategy group had similar rates of adverse events (7.3 percent vs. 6.8 percent, respectively). Rates for all cause death (0.5 percent vs. 2.1 percent), myocardial infarction (0.9 percent in each group) and any revascularization (6.8 percent vs. 4.8 percent) were also similar, demonstrating the non-inferiority of the conservative strategy.
"Conservative revascularization using criteria of 70 percent diameter stenosis was found to be non-inferior to aggressive revascularization," said the lead investigator Hyeon-Cheol Gwon, MD, PhD. Dr. Gwon is a Professor at the Samsung Medical Center in Seoul, South Korea.
"These results demonstrate that revascularization of angiographically intermediate lesions can be safely deferred."
The SMART-CASE trial was funded by Sungkyunkwan University Foundation for Corporate Collaboration (Seoul, Korea) and Abbott Vascular Korea (Seoul, Korea.) Dr. Gwon reported research support from Abbott Vascular Korea and Medtronic Korea; and consulting fees from Medtronic Asia Pacific.
About CRF and TCT
The Cardiovascular Research Foundation (CRF) is an independent, academically focused nonprofit organization dedicated to improving the survival and quality of life for people with cardiovascular disease through research and education. Since its inception in 1991, CRF has played a major role in realizing dramatic improvements in the lives of countless numbers of patients by establishing the safe use of new technologies and therapies in interventional cardiovascular medicine. CRF is the sponsor of the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Celebrating its 25th anniversary this year, TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine. For more information, visit http://www.crf.org and http://www.tctconference.com.