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.

Al Dorrah Heart Center Cairo Egypt

Alhyatt Cardiovascular Center and Tanta University Hospital Egypt

Amsterdam UMC Heart Center Department of Clinical and Experimental Cardiology Amsterdam Cardiovascular Sciences Amsterdam the Netherlands

Bina Waluya Hospital Jakarta Indonesia

Breda Amphia Breda Netherlands

Conquest Hospital East Sussex UK

Department of Medicine and Therapeutics The Chinese University of Hong Kong Hong Kong

Hospital Álvaro Cunqueiro Vigo Spain

Hospital of Invasive Cardiology IKARDIA Lublin Nałęczów Poland

Hospital Queen Elizabeth 2 Sabah Malaysia

Hospital Universitario Burgos Burgos Spain

Icahn School of Medicine at Mount Sinai Hospital New York United States

Icahn School of Medicine at Mount Sinai Hospital New York United States Amsterdam UMC Heart Center Department of Clinical and Experimental Cardiology Amsterdam Cardiovascular Sciences Amsterdam the Netherlands

MBAL St Ivan Rilski Bulgaria

Motol University Hospital Prague Czech Republic

Nemocnice na Homolce Kardiologie Prague Czech Republic

Queen Elizabeth Hospital Kowloon Hong Kong

San Raffaele Hospital Milan Italy

Sarawak Heart Centre Sarawak Malaysia

SUSCCH a s Banska Bystrica Slovakia

T Bata Regional Hospital Zlin Zlin Czech Republic

University Hospital Brno Brno Czech Republic

University Hospital St Ekaterina Sofia Bulgaria

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$a Chandrasekhar, Jaya $u Icahn School of Medicine at Mount Sinai Hospital, New York, United States. Amsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the Netherlands.

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$a 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry / $c J. Chandrasekhar, U. Baber, S. Sartori, MB. Aquino, P. Hájek, B. Atzev, M. Hudec, T. Kiam Ong, M. Mates, B. Borisov, HM. Warda, P. den Heijer, J. Wojcik, A. Iniguez, Z. Coufal, A. Khashaba, M. Munawar, RT. Gerber, BP. Yan, P. Tejedor, P. Kala, H. Bang Liew, M. Lee, DN. Kalkman, GD. Dangas, RJ. de Winter, A. Colombo, R. Mehran, MASCOT investigators,

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$a 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.

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$a Dangas, George D $u Icahn School of Medicine at Mount Sinai Hospital, New York, United States.

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$a Colombo, Antonio $u San Raffaele Hospital, Milan, Italy.

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