Research in context
Evidence before this study
We searched PubMed and checked the listings of the EuroPCR, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, and American College of Cardiology conferences for complete reports of clinical studies comparing Supraflex, a sirolimus-eluting coronary stent with biodegradable polymer coating, with any other drug-eluting stents. We used the search terms “Supraflex” AND “all-comers” for reports published in English up to Aug 29, 2018. We identified one multicentre, single-group, observational registry—the FLEX Registry. At 12 months, the primary device-oriented composite endpoint occurred in 36 (3·7%) of 980 patients who received Supraflex implantation. However, this registry, which had site-reported events without central adjudication, was a non-randomised trial.
Added value of this study
To our knowledge, this is the first randomised trial with a clinical primary endpoint comparing Supraflex with a contemporary drug-eluting stent in an all-comer population. The Supraflex stent was non-inferior to Xience, an everolimus-eluting stent with durable polymer coating, for the device-oriented composite endpoint of cardiac death, target-vessel myocardial infarction, or clinically indicated target lesion revascularisation at 12 months. Per-protocol analysis showed a significantly lower clinically indicated target lesion revascularisation in the Supraflex group than in the Xience group.
Implications of all the available evidence
The sirolimus-eluting Supraflex coronary stent with absorbable polymer coating was non-inferior to a currently best-in-class drug-eluting stent at 12 months and further benefits might emerge in long-term follow-up.