1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry

Abstract

Background The COMBO stent is a biodegradable-polymer sirolimus-eluting stent with endothelial progenitor cell capture technology for faster endothelialization. Objective We analyzed COMBO stent outcomes in relation to bleeding risk using the PARIS bleeding score. Methods MASCOT was an international registry of all-comers undergoing attempted COMBO stent implantation. We stratified patients as low bleeding-risk (LBR) for PARIS score ≤ 3 and intermediate-to-high (IHBR) for score > 3 based on baseline age, body mass index, anemia, current smoking, chronic kidney disease and need for triple therapy. Primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a non-target vessel or clinically-driven target lesion revascularization (TLR). Bleeding was adjudicated using the Bleeding Academic Research Consortium (BARC) definition. Dual antiplatelet therapy (DAPT) cessation was independently adjudicated. Results The study included 56% (n = 1270) LBR and 44% (n = 1009) IHBR patients. Incidence of 1-year TLF was higher in IHBR patients (4.1% vs. 2.6%, p = 0.047) driven by cardiac death (1.7% vs. 0.7%, p = 0.029) with similar rates of MI (1.8% vs. 1.1%, p = 0.17), TLR (1.5% vs. 1.6%, p = 0.89) and definite/ probable stent thrombosis (1.2% vs. 0.6%, p = 0.16). Incidence of 1-year major BARC 3 or 5 bleeding was significantly higher in IHBR patients (2.3% vs. 0.9%, p = 0.0094), as was the incidence of DAPT cessation (29.3% vs. 22.8%, p < 0.01), driven by physician-guided discontinuation. Conclusions Patients with intermediate-to-high PARIS bleeding risk in the MASCOT registry experienced greater incidence of 1-year TLF, major bleeding and DAPT cessation than LBR patients, without significant differences in stent thrombosis.

Endothelial progenitor cells and coronary artery disease: Current concepts and future research directions

“…The rate of 1-year target lesion failure (TLF) was 4.1% in the IHBR and 2.6% in the LBR groups. The AMI rates were 1.8% in the IHBR and 1.1% in the LBR groups, and the incidence of stent thrombosis was 1.2% in the IHBR and 0.6% in the LBR groups[ 88 ], which showed a higher 1-year TLF rates. Animal studies of CD133 combination stents mainly investigated restenosis and endothelialization, and two compared CD133 with CD34.…”