Effectiveness and Safety of Polymer-free Biolimus-eluting Stents (PF-BES): a 1-year Single-center Study
Keywords:
Polymer-free Biolimus-eluting stents, High bleeding risk, Dual antiplatelet therapyAbstract
Background: An estimated one-fifth of patients undergoing percutaneous coronary intervention are at high bleeding risk (HBR), which has a high mortality rate. Most of these HBR patients are excluded from stent trials. In response, many studies have used polymer-free Biolimus-eluting stents (PF-BESs), mainly for HBR patients. However, there is a lack of data on the clinical outcomes of the effectiveness and safety of PF-BESs in Thailand. Objectives: To evaluate the effectiveness and safety profile of PF-BES in real-world, all-comer patients with coronary artery disease undergoing percutaneous coronary intervention at the Central Chest Institute of Thailand. Methods: An observational, retrospective (chart review), single-arm study was conducted. All consecutive patients who were implanted with a PF-BES at the Central Chest Institute of Thailand were included in the analysis. Results: A total of 208 patients were enrolled. Half of these patients (54.3%) had an HBR according to the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria. Within 1 year following the indexing procedure, the primary endpoint (a composite of cardiac death, target-vessel myocardial infarction, and clinically driven target lesion revascularization) was reached by 3.8% of the patients. Notably, there was no occurrence of stent thrombosis. Bleeding per the Bleeding Academic Research Consortium 5 definition was not seen for any patient. Conclusion: The PF-BES is safe and effective for real-world patients, irrespective of HBR status.
References
Morice MC, Urban P, Greene S, Schuler G, Chevalier B. Why are we still using coronary bare-metal stents? J Am Coll Cardiol. 2013;61(10):1122-1123. doi:10.1016/ j.jacc.2012.11.049
Urban P, Abizaid A, Chevalier B, et al. Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy. Am Heart J. 2013;165(5):704-709. doi:10.1016/j.ahj.2013.01.008
Kirtane AJ, Gupta A, Iyengar S, et al. Safety and efficacy of drug-eluting and bare metal stents: comprehensive meta-analysis of randomized trials and observational studies. Circulation. 2009;119(25):3198-3206. doi:10.1161/CIRCULA TIONAHA.108.826479
Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013; 368(3):254-265. doi:10.1056/NEJMra1210816
Windecker S, Latib A, Kedhi E, et al. Polymer-based or polymer-free stents in patients at high bleeding risk. N Engl J Med. 2020;382(13):1208-1218. doi:10.1056/ NEJMoa1910021
Valgimigli M, Bueno H, Byrne RA, et al. 2017 ESC focused update on dual antiplatelet therapy in coronary artery disease developed in collaboration with EACTS: The Task Force for dual antiplatelet therapy in coronary artery disease of the European Society of Cardiology (ESC) and of the European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2018;39(3):213-260. doi:10.1093/ eurheartj/ehx419
Writing Committee Members, Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, et al. 2011 ACCF/AHA/SCAI guideline for percutaneous coronary intervention: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions. Circulation. 2011;124(23):e574-e651. doi:10.1161/CIR.0b013e3 1823ba622
Levine GN, Bates ER, Bittl JA, Brindis RG, Fihn SD, Fleisher LA, et al. 2016 ACC/AHA guideline focused update on duration of dual antiplatelet therapy in patients with coronary artery disease. Circulation. 2016;134(10):e123-e155. doi:10.1161/CIR.00000 00000000404
Tada N, Virmani R, Grant G, et al. Polymer-free biolimus a9-coated stent demonstrates more sustained intimal inhibition, improved healing, and reduced inflammation compared with a polymer-coated sirolimus-eluting cypher stent in a porcine model. Circ Cardiovasc Interv. 2010;3(2):174-183. doi:10.1161/ CIRCINTER VENTIONS.109.877522
Costa RA, Abizaid A, Mehran R, et al. Polymer-free Biolimus A9-coated stents in the treatment of de novo coronary lesions: 4- and 12-month angiographic follow-up and final 5-year clinical outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial. JACC Cardiovasc Interv. 2016;9(1):51-64. doi:10.1016 /j.jcin.2015. 09.008
Urban P, Meredith IT, Abizaid A, et al. Polymer-free drug-coated coronary stents in patients at high bleeding risk. N Engl J Med. 2015;373(21):2038-2047. doi:10. 1056/ NEJMoa1503943
Garot P, Morice MC, Tresukosol D, Pocock SJ, Meredith IT, Abizaid A, et al. 2-year outcomes of high bleeding risk patients after polymer-free drug-coated stents.J Am Coll Cardiol. 2017;69(2):162–71.
Jensen LO, Maeng M, Raungaard B, et al. Randomized Comparison of the Polymer-Free Biolimus-Coated BioFreedom Stent With the Ultrathin Strut Biodegradable Polymer Sirolimus-Eluting Orsiro Stent in an All-Comers Population Treated With Percutaneous Coronary Intervention: The SORT OUT IX Trial. Circulation. 2020;141(25):2052-2063. doi:10.1161/CIRCULATIONAHA.119.040 241
Hicks KA, Tcheng JE, Bozkurt B, Chaitman BR, Cutlip DE, Farb A, et al. 2014 ACC/AHA key data elements and definitions for cardiovascular endpoint events in clinical trials. J Am Coll Cardiol. 2015;66(4):403–69.
Mehran R, Rao SV, Bhatt DL, et al. Standardized bleeding definitions for cardiovascular clinical trials: A consensus report from the Bleeding Academic Research Consortium. Circulation. 2011;123(23):2736-2747. doi:10.1161/CIRCULA TIONAHA.110.009449
Ryan TJ, Faxon DP, Gunnar RM, et al. Guidelines for percutaneous transluminal coronary angioplasty. A report of the American College of Cardiology/American Heart Association Task Force on Assessment of Diagnostic and Therapeutic Cardiovascular Procedures (Subcommittee on Percutaneous Transluminal Coronary Angioplasty). Circulation. 1988;78(2):486-502. doi:10.1161/01.cir.78.2.486
Kufner S, Sorges J, Mehilli J, et al. Randomized trial of polymer-free sirolimus- and probucol-eluting stents versus durable polymer zotarolimus-eluting stents: 5-year results of the ISAR-TEST-5 Trial. JACC Cardiovasc Interv. 2016;9(8):784-792. doi:10.1016/j.jcin.2016.01.009
Sgueglia GA, D'Errico F, Gioffrè G, et al. Angiographic and clinical performance of polymer-free biolimus-eluting stent in patients with ST-segment elevation acute myocardial infarction in a metropolitan public hospital: The BESAMI MUCHO study. Catheter Cardiovasc Interv. 2018;91(5):851-858. doi:10.1002/ccd.27206
Massberg S, Polzin A. Update ESC-Leitlinie 2017: Duale Antiplättchentherapie [Update ESC-Guideline 2017: Dual Antiplatelet Therapy]. Dtsch Med Wochenschr. 2018;143(15):1090-1093. doi:10.1055/a-0549-8230
Sardella G, Stefanini GG, Briguori C, et al. Safety and efficacy of polymer-free biolimus-eluting stents in all-comer patients: The RUDI-FREE study. EuroInter vention. 2018;14(7):772-779. doi:10.4244/EIJ-D-18-00148
Valgimigli M, Cao D, Makkar RR, et al. Design and rationale of the XIENCE short DAPT clinical program: An assessment of the safety of 3-month and 1-month DAPT in patients at high bleeding risk undergoing PCI with an everolimus-eluting stent. Am Heart J. 2021;231:147-156. doi:10.1016/j.ahj.2020.09.019
Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, et al. 2018 ESC/EACTS guidelines on myocardial revascularization. EuroIntervention. 2019;14(14):1435–534.
Collet JP, Thiele H, Barbato E, Barthélémy O, Bauersachs J, Bhatt DL, et al. 2020 ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation. Eur Heart J. 2021;42(14):1289–367.
Theuerle J, Yudi MB, Farouque O, Andrianopoulos N, Scott P, Ajani AE, et al. Utility of the ACC/AHA lesion classification as a predictor of procedural, 30-day and 12-month outcomes in the contemporary percutaneous coronary intervention era. Cathet Cardiovasc Intervent. 2018;92(3):E227–34.
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