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

Abstract

Background: No randomized data exist on ultrathin-strut stents in patients at high bleeding risk (HBR) undergoing an abbreviated dual antiplatelet therapy after coronary stenting. The aim of this study was to compare the safety and effectiveness of the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent with the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent in patients at HBR with abbreviated dual antiplatelet therapy after stenting.

Methods: In the investigator-initiated, randomized, open-label COMPARE 60/80 HBR trial (Comparison of the Supraflex Cruz 60 Micron Stent Strut Versus the Ultimaster Tansei 80 Micron Stent Strut in HBR Percutaneous Coronary Intervention Population), 741 patients at HBR according to the Academic Research Consortium HBR criteria were randomized to receive either the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent or thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent. Dual antiplatelet therapy was recommended according to the applicable guidelines and trial data for patients at HBR. The primary outcome was net adverse clinical events, the composite of cardiovascular death, myocardial infarction, target vessel revascularization, stroke, and major bleeding, and was powered for noninferiority with an absolute margin of 4.0% at 1-sided 2.5% alpha.

Results: Between September 2020 and August 2022, 371 patients were randomized to the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent and 370 patients to the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent at 11 sites in the Netherlands. At 1 year, the primary outcome was observed in 56 (15.4%) patients in the ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent group and 61 (17.1%) in the thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent group (risk difference, -1.65%; upper boundary of the 1-sided 95% CI, 3.74; P=0.02 for noninferiority at a 0.025 significance level and P=0.55 for 2-sided superiority at a 0.05 significance level).

Conclusions: Among patients at HBR with abbreviated dual antiplatelet therapy post-stenting, the use of an ultrathin-strut biodegradable-polymer sirolimus-eluting Supraflex Cruz stent was noninferior compared with the use of a thin-strut biodegradable-polymer sirolimus-eluting Ultimaster Tansei stent.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT04500912.

Keywords: atherosclerosis; hemorrhage; percutaneous coronary intervention; platelet aggregation inhibitors; polymers; randomized controlled trials as topic; stents.

Figure 1.

Patient flow. FAS indicates full analysis set; PCI, percutaneous coronary intervention; and PP, per protocol.

Figure 2.

Antiplatelet usage at discharge and 1-, 6-, and 12-month follow-up (FU). Median (interquartile range [IQR]) dual antiplatelet therapy (DAPT) duration (days) was equal in both study arms. APT indicates antiplatelet therapy; and SAPT, single antiplatelet therapy.

Figure 3.

Kaplan-Meier time-to-event curves for the primary outcome. The primary was the composite of cardiovascular death, myocardial infarction (MI), target vessel revascularization (TVR), stroke, and Bleeding Academic Research Consortium (BARC) bleeding 3 or 5.

Figure 4.

Kaplan-Meier time-to-event curve for the components of the primary end point and stent thrombosis. Death from cardiovascular causes (A), myocardial infarction (B), target vessel revascularization (TVR; C), stroke (D), major bleeding according to the Bleeding Academic Research Consortium (BARC) 3 or 5 (E), and definite or probable stent thrombosis (F).