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

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 internatio...

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Main Authors: Jaya Chandrasekhar, Usman Baber, Samantha Sartori, Melissa B. Aquino, Petr Hájek, Borislav Atzev, Martin Hudec, Tiong Kiam Ong, Martin Mates, Borislav Borisov, Hazem M. Warda, Peter den Heijer, Jaroslaw Wojcik, Andres Iniguez, Zdeněk Coufal, Ahmed Khashaba, Muhammad Munawar, Robert T. Gerber, Bryan P. Yan, Paula Tejedor, Petr Kala, Houng Bang Liew, Michael Lee, Deborah N. Kalkman, George D. Dangas, Robbert J. de Winter, Antonio Colombo, Roxana Mehran
Format: Article
Language:English
Published: Elsevier 2020-12-01
Series:International Journal of Cardiology: Heart & Vasculature
Subjects:
Online Access:http://www.sciencedirect.com/science/article/pii/S2352906720303031
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author Jaya Chandrasekhar
Usman Baber
Samantha Sartori
Melissa B. Aquino
Petr Hájek
Borislav Atzev
Martin Hudec
Tiong Kiam Ong
Martin Mates
Borislav Borisov
Hazem M. Warda
Peter den Heijer
Jaroslaw Wojcik
Andres Iniguez
Zdeněk Coufal
Ahmed Khashaba
Muhammad Munawar
Robert T. Gerber
Bryan P. Yan
Paula Tejedor
Petr Kala
Houng Bang Liew
Michael Lee
Deborah N. Kalkman
George D. Dangas
Robbert J. de Winter
Antonio Colombo
Roxana Mehran
author_facet Jaya Chandrasekhar
Usman Baber
Samantha Sartori
Melissa B. Aquino
Petr Hájek
Borislav Atzev
Martin Hudec
Tiong Kiam Ong
Martin Mates
Borislav Borisov
Hazem M. Warda
Peter den Heijer
Jaroslaw Wojcik
Andres Iniguez
Zdeněk Coufal
Ahmed Khashaba
Muhammad Munawar
Robert T. Gerber
Bryan P. Yan
Paula Tejedor
Petr Kala
Houng Bang Liew
Michael Lee
Deborah N. Kalkman
George D. Dangas
Robbert J. de Winter
Antonio Colombo
Roxana Mehran
author_sort Jaya Chandrasekhar
collection DOAJ
description 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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spelling doaj.art-e55423582fb44594b38687802ca065412022-12-21T23:16:27ZengElsevierInternational Journal of Cardiology: Heart & Vasculature2352-90672020-12-01311006051-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registryJaya Chandrasekhar0Usman Baber1Samantha Sartori2Melissa B. Aquino3Petr Hájek4Borislav Atzev5Martin Hudec6Tiong Kiam Ong7Martin Mates8Borislav Borisov9Hazem M. Warda10Peter den Heijer11Jaroslaw Wojcik12Andres Iniguez13Zdeněk Coufal14Ahmed Khashaba15Muhammad Munawar16Robert T. Gerber17Bryan P. Yan18Paula Tejedor19Petr Kala20Houng Bang Liew21Michael Lee22Deborah N. Kalkman23George D. Dangas24Robbert J. de Winter25Antonio Colombo26Roxana Mehran27Icahn 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 NetherlandsIcahn School of Medicine at Mount Sinai Hospital, New York, United StatesIcahn School of Medicine at Mount Sinai Hospital, New York, United StatesIcahn School of Medicine at Mount Sinai Hospital, New York, United StatesMotol University Hospital, Prague, Czech RepublicUniversity Hospital St. Ekaterina, Sofia, BulgariaSUSCCH, a.s., Banska Bystrica, SlovakiaSarawak Heart Centre, Sarawak, MalaysiaNemocnice na Homolce - Kardiologie, Prague, Czech RepublicMBAL St. Ivan Rilski, BulgariaAlhyatt Cardiovascular Center and Tanta University Hospital, EgyptBreda Amphia, Breda, NetherlandsHospital of Invasive Cardiology IKARDIA - Lublin/Nałęczów, PolandHospital Álvaro Cunqueiro, Vigo, SpainT. Bata Regional Hospital Zlin, Zlin, Czech RepublicAl-Dorrah Heart Center, Cairo, EgyptBina Waluya Hospital, Jakarta, IndonesiaConquest Hospital, East Sussex, UKDepartment of Medicine and Therapeutics, The Chinese University of Hong Kong, Hong KongHospital Universitario Burgos, Burgos, SpainUniversity Hospital Brno, Brno, Czech RepublicHospital Queen Elizabeth II, Sabah, MalaysiaQueen Elizabeth Hospital, Kowloon, Hong KongAmsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the NetherlandsIcahn School of Medicine at Mount Sinai Hospital, New York, United StatesAmsterdam UMC, Heart Center, Department of Clinical and Experimental Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam, the NetherlandsSan Raffaele Hospital, Milan, ItalyIcahn School of Medicine at Mount Sinai Hospital, New York, United States; Corresponding author at: Mount Sinai Medical Center, One Gustave L. Levy Place, Box 1030, New York, NY 10029, USA.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.http://www.sciencedirect.com/science/article/pii/S2352906720303031PARIS bleeding risk scoreCOMBO stentEndothelial progenitor cell captureDual therapy stent
spellingShingle Jaya Chandrasekhar
Usman Baber
Samantha Sartori
Melissa B. Aquino
Petr Hájek
Borislav Atzev
Martin Hudec
Tiong Kiam Ong
Martin Mates
Borislav Borisov
Hazem M. Warda
Peter den Heijer
Jaroslaw Wojcik
Andres Iniguez
Zdeněk Coufal
Ahmed Khashaba
Muhammad Munawar
Robert T. Gerber
Bryan P. Yan
Paula Tejedor
Petr Kala
Houng Bang Liew
Michael Lee
Deborah N. Kalkman
George D. Dangas
Robbert J. de Winter
Antonio Colombo
Roxana Mehran
1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
International Journal of Cardiology: Heart & Vasculature
PARIS bleeding risk score
COMBO stent
Endothelial progenitor cell capture
Dual therapy stent
title 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
title_full 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
title_fullStr 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
title_full_unstemmed 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
title_short 1-Year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
title_sort 1 year combo stent outcomes stratified by the paris bleeding prediction score from the mascot registry
topic PARIS bleeding risk score
COMBO stent
Endothelial progenitor cell capture
Dual therapy stent
url http://www.sciencedirect.com/science/article/pii/S2352906720303031
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