The Supreme healing-targeted drug-eluting stent (Sinomed) is effective and safe at one year across a broad range of lesion complexity compared with standard, durable-polymer everolimus-eluting stents.
This was the conclusion of a sub-study from the PIONEER III trial, a multicentre, prospective, single-blind clinical trial that enrolled 1,629 patients from centres in Belgium, Canada, France, Germany, Japan, Netherlands, Spain, Switzerland, UK, and USA. Results of the sub study, which compared outcomes for 1,137 patients who were deemed to have complex lesions (American College of Cardiology/American Heart Association type B2/C) were published in the Journal of the Society for Cardiovascular Angiography & Interventions (JSCAI).
In the analysis, Kush Patel (University College London, London, UK) and colleagues compared outcomes for specific parameters of lesion complexity, including severe calcification, long length (>20mm), and severe tortuosity. The primary end point was target lesion failure at one year.
Patel and colleagues report that at one year, there was no difference in target lesion failure between the Supreme stent and the everolimus-eluting stents (5.7% vs. 5.6%; hazard ratio 1.00, 95% confidence interval 0.59‒1.68, p=0.99), adding that there were no differences in the secondary endpoints of lesion success (99.7% vs. 99.4%, p=0.41), device success (97% vs 98.5%, p=0.14), target vessel failure (6.5% vs. 7.4%, p=0.5), major adverse cardiac events (7.8% vs. 8.5%, p=0.64), or stent thrombosis (0.7% vs 1.1%, p=0.48).
Furthermore, the authors report that a trend was observed toward a higher rate of target lesion revascularisation with the Supreme drug-eluting stent (2.5% vs 0.9%, p=0.06).
The findings led the study’s authors to conclude that the Supreme drug-eluting stent is as safe and effective as the durable-polymer everolimus-eluting stents at one year for the treatment of complex coronary lesions.
Speaking to Cardiovascular News, Andreas Baumbach (Queen Mary University of London, London, UK), European co-principal investigator in the PIONEER III trial, detailed that the low overall rate of target lesion revascularisation was an important finding of the study.