Ultrathin vs Thin-Strut Stents in PCI Patients at High Bleeding Risk

Several in vivo studies have shown that ultrathin stents present lower thrombogenic risk vs. thin-strut stents, which reflects in lower rates of target lesion failure. However, there are no data on ultrathin stents in patients at high bleeding risk undergoing dual antiaggregation therapy (DAPT) during and after percutaneous coronary intervention (PCI).

This is the rationale behind the COMPARE 60/80 HBR comparing the 60 micron Supraflex Cruz against the 80 micron Ultimaster. The latter was selected because it had been used in the MASTER-DAPT trial (Management of High Bleeding Risk After Polymer Bioresorbable Stent Implantation with an Abbreviated DAPT Regimen), and was shown effective and safe with short DAPT in high bleeding risk patients undergoing PCI. 

The main goal of this randomized non-inferiority study was to assess the safety and efficacy of the Supraflex with ultrathin struts vs. the Ultimaster with thin struts in patients with high bleeding risk treated with short DAPT.

Primary end point included net clinical adverse events (NACE), defined as a composite of cardiovascular death, acute myocardial infarction (AMI), target vessel revascularization (TVR) stroke and major bleeding. 

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A total 732 patients were included, 368 were randomized to the Supraflex Cruz and 364 to the Ultimaster. Mean age was 75 and most patients were men. The main indication for PCI was chronic coronary syndrome (69,8%). At one-year follow-up, primary end point was seen in 15,4% of Supraflex patients, vs. 17,1% of Ultimaster (risk difference: −1,65%; superior CI limit 95% unilateral: 3,74; P = 0,02 for non-inferiority with significance level 0,025, and P = 0,55 for bilateral superiority with significance level 0,05).

Conclusion
In patients at high bleeding risk undergoing PCI with short DAPT, the use of sirolimus eluting ultrathin stent Supraflex Cruz resulted non-inferior in terms of net clinical adverse events (NACE) at 12 months vs. the thin-strut sirolimus-eluting Ultimaster .

Original Title: Comparison of Ultrathin- Versus Thin-Strut Stents in Patients With High Bleeding Risk PCI: Results From the COMPARE 60/80 HBR Trial: An Open-Label, Randomized, Controlled Trial.

Reference: Pieter C. Smits et al Circ Cardiovasc Interv. 2024;17:e014042.