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

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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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

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

Bangalore S. The Elusive Late Benefit of Biodegradable Polymer Drug-Eluting Stents. Circulation. 2019;139:334–336. PubMed

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

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

Saito S., Krucoff M.W., Nakamura S. Japan-United States of America Harmonized Assessment by Randomized Multicentre Study of OrbusNEich's Combo StEnt (Japan-USA HARMONEE) study: primary results of the pivotal registration study of combined endothelial progenitor cell capture and drug-eluting stent in patients with ischaemic coronary disease and non-ST-elevation acute coronary syndrome. Eur. Heart J. 2018;39:2460–2468. PubMed PMC

Colombo A., Chandrasekhar J., Aquino M. Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-Year final clinical outcomes from the MASCOT post-marketing registry. Int. J. Cardiol. 2019;283:67–72. PubMed

Baber U., Mehran R., Giustino G. Coronary Thrombosis and Major Bleeding After PCI With Drug-Eluting Stents: Risk Scores From PARIS. J. Am. Coll. Cardiol. 2016;67:2224–2234. PubMed

Cutlip D.E., Windecker S., Mehran R. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007;115:2344–2351. PubMed

Thygesen K., Alpert J.S., Jaffe A.S. Third universal definition of myocardial infarction. Eur. Heart J. 2012;33:2551–2567. PubMed

Mehran R., Rao S.V., Bhatt D.L. Standardized bleeding definitions for cardiovascular clinical trials: a consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123:2736–2747. PubMed

Mehran R., Baber U., Steg P.G. Cessation of dual antiplatelet treatment and cardiac events after percutaneous coronary intervention (PARIS): 2 year results from a prospective observational study. Lancet. 2013;382:1714–1722. PubMed

Sorrentino S., Claessen B., Mehran R., Kandzari D., Morice M.C., Leon M., Gersh B., Ben-Yehuda O., Redfors B., Dressler O., Pocock S., Kappetein A.P., Sabik J., Serruys P., Stone G. Validation of PARIS Risk Scores in Patients Treated With Everolimus-Eluting Stents for Left Main Coronary Artery Disease: Analysis From the EXCEL Trial. J. Am. Coll. Cardiol. 2018;72(13) doi: 10.1016/j.jacc.2018.08.2078. Supplement. DOI

Jensen C.J., Naber C.K., Urban P. Two-year outcomes of high bleeding risk patients with acute coronary syndrome after Biolimus A9 polymer-free drug-coated stents: a LEADERS FREE substudy. EuroIntervention. 2018;13:1946–1949. PubMed

Chandrasekhar J, Mehran, R., Genereux, P., Dangas, G., Zhang, Y., McAndrew, T., Kirtane, A., Stone, G. Effect of thrombotic risk and bleeding risk by platelet reactivity status on 2-year mortality: A report from the ADAPT DES study. Journal of the American College of Cardiology March 21, 2017, 69 (11 Supplement) 1012; DOI: 10.1016/S0735-1097(17)34401-7.

Sorrentino S., Sartori S., Baber U. Bleeding Risk, Dual Antiplatelet Therapy Cessation, and Adverse Events After Percutaneous Coronary Intervention: The PARIS Registry. Circ. Cardiovasc. Interv. 2020;13(4) PubMed

Sorrentino S., Baber U., Claessen B.E. Determinants of Significant Out-Of-Hospital Bleeding in Patients Undergoing Percutaneous Coronary Intervention. Thromb. Haemost. 2018;118:1997–2005. PubMed

De Luca G., Damen S.A., Camaro C. Final results of the Randomised Evaluation of short-term DUal antiplatelet therapy in patients with acute Coronary syndromE treated with a new generation stent (REDUCE) trial. EuroIntervention. 2019;15(11):e990–e998. doi: 10.4244/EIJ-D-19-00539. PubMed DOI

Kirtane A.J., Stone G.W. How to minimize stent thrombosis. Circulation. 2011;124:1283–1287. PubMed

Chandrasekhar J., Baber U., Sartori S. Associations Between Complex PCI and Prasugrel or Clopidogrel Use in Patients With Acute Coronary Syndrome Who Undergo PCI: From the PROMETHEUS Study. Can. J. Cardiol. 2018;34:319–329. PubMed

Vogel B, Claessen, B., Baber, U., Sorrentino, S., Zhao, W., Krucoff, M., Kozuma, K., Ge, J., Seth, A., Makkar, R., Bangalore, S., Bhatt, D., Angiolillo, D., Saito, S., Neumann, FJ., Hermiller, J. and Valgimigli, M. Clinical outcomes in high bleeding risk patients undergoing complex PCI with the Xience everolimus eluting stent: a patient-level pooled analysis from four Xience post-approval trials. Journal of the American College of Cardiology. Volume 72, Issue 13 Supplement, September 2018. DOI: 10.1016/j.jacc.2018.08.1723.

Watanabe H., Domei T., Morimoto T. Effect of 1-Month Dual Antiplatelet Therapy Followed by Clopidogrel vs 12-Month Dual Antiplatelet Therapy on Cardiovascular and Bleeding Events in Patients Receiving PCI: The STOPDAPT-2 Randomized Clinical Trial. JAMA. 2019;321:2414–2427. PubMed PMC

Mehran R., Baber U., Sharma S.K. Ticagrelor with or without Aspirin in High-Risk Patients after PCI. N. Engl. J. Med. 2019;381(21):2032–2042. doi: 10.1056/NEJMoa1908419. PubMed DOI

Jeremias A, Davies JE, Maehara A. Blinded Physiological Assessment of Residual Ischemia After Successful Angiographic Percutaneous Coronary Intervention: The DEFINE PCI Study. JACC Cardiovasc Interv. 2019;12(20):1991–2001. doi: 10.1016/j.jcin.2019.05.054. PubMed DOI

Chandrasekhar J., Allada C., O'Connor S. Efficacy of non-compliant balloon post-dilation in optimization of contemporary stents: A digital stent enhancement study. Int. J. Cardiol. Heart Vessel. 2014;3:43–48. PubMed PMC

Hibbert B., Simard T., Ramirez F.D. The effect of statins on circulating endothelial progenitor cells in humans: a systematic review. J. Cardiovasc. Pharmacol. 2013;62:491–496. PubMed