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. 2020 Sep 6:31:100605.
doi: 10.1016/j.ijcha.2020.100605. eCollection 2020 Dec.

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

Jaya Chandrasekhar  1   2 , Usman Baber  1 , Samantha Sartori  1 , Melissa B Aquino  1 , Petr Hájek  3 , Borislav Atzev  4 , Martin Hudec  5 , Tiong Kiam Ong  6 , Martin Mates  7 , Borislav Borisov  8 , Hazem M Warda  9 , Peter den Heijer  10 , Jaroslaw Wojcik  11 , Andres Iniguez  12 , Zdeněk Coufal  13 , Ahmed Khashaba  14 , Muhammad Munawar  15 , Robert T Gerber  16 , Bryan P Yan  17 , Paula Tejedor  18 , Petr Kala  19 , Houng Bang Liew  20 , Michael Lee  21 , Deborah N Kalkman  2 , George D Dangas  1 , Robbert J de Winter  2 , Antonio Colombo  22 , Roxana Mehran  1 ; MASCOT investigators
Affiliations

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

Jaya Chandrasekhar et al. Int J Cardiol Heart Vasc. .

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.

Keywords: COMBO stent; Dual therapy stent; Endothelial progenitor cell capture; NCT02183454; PARIS bleeding risk score.

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Figures

Fig. 1
Fig. 1
Cumulative incidence of 1-year ischemic events in Low versus Intermediate to high bleeding risk patients.
Fig. 2
Fig. 2
Cumulative incidence of 1-year bleeding events in Low versus Intermediate to high bleeding risk patients.
See this image and copyright information in PMC

References

    1. Levine G.N., Bates E.R., Bittl J.A. 2016 ACC/AHA Guideline Focused Update on Duration of Dual Antiplatelet Therapy in Patients With Coronary Artery Disease: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention, 2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery, 2012 ACC/AHA/ACP/AATS/PCNA/SCAI/STS Guideline for the Diagnosis and Management of Patients With Stable Ischemic Heart Disease, 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction, 2014 AHA/ACC Guideline for the Management of Patients With Non-ST-Elevation Acute Coronary Syndromes, and 2014 ACC/AHA Guideline on Perioperative Cardiovascular Evaluation and Management of Patients Undergoing Noncardiac Surgery. Circulation. 2016;134:e123–155. - PubMed
    1. Chandrasekhar J., Martin K., Mehran R. Role of coronary drug-eluting stents in current clinical practice. Clin. Pharm. 2016 doi: 10.1211/CP.2016.20201885. - DOI
    1. Bangalore S. The Elusive Late Benefit of Biodegradable Polymer Drug-Eluting Stents. Circulation. 2019;139:334–336. - PubMed
    1. Granada J.F., Inami S., Aboodi M.S. Development of a novel prohealing stent designed to deliver sirolimus from a biodegradable abluminal matrix. Circ. Cardiovasc. Interv. 2010;3:257–266. - PubMed
    1. Nakazawa G., Granada J.F., Alviar C.L. Anti-CD34 antibodies immobilized on the surface of sirolimus-eluting stents enhance stent endothelialization. JACC Cardiovasc. Interv. 2010;3:68–75. - PubMed

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