Prospective multicentre open-label randomised controlled trial of 3-month versus 12-month dual antiplatelet therapy after implantation of the new generation biodegradable polymer sirolimus TARGET-eluting coronary stent: protocol of the TARGET DAPT trial

Hongbo Yang, Feng Zhang, Ji'e Yang, Ming Zheng, Ruifen Cao, Yuxiang Dai, Chenguang Li, Kang Yao, Juying Qian, Junbo Ge, TARGET DAPT trial investigators, Hongbo Yang, Feng Zhang, Ji'e Yang, Ming Zheng, Ruifen Cao, Yuxiang Dai, Chenguang Li, Kang Yao, Juying Qian, Junbo Ge, TARGET DAPT trial investigators

Abstract

Introduction: Dual antiplatelet therapy (DAPT) with aspirin and thienopyridine is required after placement of coronary stents to prevent thrombotic complications. However, current recommendation for duration of DAPT remains controversial. Firehawk is a biodegradable polymer applied to recessed abluminal grooves, sirolimus target-eluting stent associated with early excellent healing response and almost complete strut coverage, as well as possibly reduced myocardial ischaemic events. But the optimal DAPT duration for such a new generation stent is less known. Therefore, the present trial seeks to evaluate the safety and efficacy of 3-month versus 12-month DAPT in broad patients receiving Firehawk stents.

Methods and analysis: The TARGET DAPT study is designed to access the benefits and risks of short-term (3 months) versus long-term (12 months) DAPT in preventing stent thrombosis or major adverse cardiovascular and cerebrovascular events in subjects undergoing percutaneous coronary intervention for the treatment of coronary artery obstructive lesions. The TARGET DAPT trial is a large, prospective, multicentre, randomised (1:1) non-inferiority clinical trial that will enrol 2446 subjects treated with Firehawk stents. The primary endpoint is net adverse clinical and cerebral events, a composite of all-cause death, myocardial infarction, cerebral vascular accident and major bleeding (BARC 2,3 or 5) at 18 months clinical follow-up postindex procedure.

Ethics and dissemination: Ethics approval was obtained from the Ethics Committee of Zhongshan Hospital, Shanghai. The reference number is B2018-146R. Study findings will be made available to interested participants. Study results will be submitted for publication in a peer-reviewed journal. Also the protocol will be submitted and approved by the institutional Ethics Committee at each participating clinical centre.

Trial registration: NCT03008083.

Keywords: coronary heart disease; coronary intervention; protocols & guidelines.

Conflict of interest statement

Competing interests: JG has received research grants and speaker fees from MicroPort. HY and FZ have received speaker fees from MicroPort. MZ and RC are Microport employees.

© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
TARGET DAPT study design flow chart. DAPT, dual antiplatelet therapy; PCI, percutaneous coronary intervention.

References

    1. Moses JW, Leon MB, Popma JJ, et al. . Sirolimus-Eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 2003;349:1315–23. 10.1056/NEJMoa035071
    1. Stone GW, Ellis SG, Cox DA, et al. . A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 2004;350:221–31. 10.1056/NEJMoa032441
    1. Mauri L, Hsieh W-hua, Massaro JM, et al. . Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med 2007;356:1020–9. 10.1056/NEJMoa067731
    1. Mauri L, Kereiakes DJ, Yeh RW, et al. . Twelve or 30 months of dual antiplatelet therapy after drug-eluting stents. N Engl J Med 2014;371:2155–66. 10.1056/NEJMoa1409312
    1. Hahn J-Y, Song YB, Oh J-H, et al. . 6-Month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndrome (SMART-DATE): a randomised, open-label, non-inferiority trial. Lancet 2018;391:1274–84. 10.1016/S0140-6736(18)30493-8
    1. Brener SJ, Kirtane AJ, Stuckey TD, et al. . The impact of timing of ischemic and hemorrhagic events on mortality after percutaneous coronary intervention. JACC: Cardiovascular Interventions 2016;9:1450–7. 10.1016/j.jcin.2016.04.037
    1. Kandzari DE, Koolen JJ, Doros G, et al. . Ultrathin Bioresorbable polymer sirolimus-eluting stents versus thin durable polymer everolimus-eluting stents. J Am Coll Cardiol 2018;72:3287–97. 10.1016/j.jacc.2018.09.019
    1. Gwon H-C, Hahn J-Y, Park KW, et al. . Six-Month versus 12-month dual antiplatelet therapy after implantation of drug-eluting stents: the efficacy of Xience/Promus versus Cypher to reduce late loss after stenting (excellent) randomized, multicenter study. Circulation 2012;125:505–13. 10.1161/CIRCULATIONAHA.111.059022
    1. Valgimigli M, Campo G, Monti M, et al. . Short- versus long-term duration of dual-antiplatelet therapy after coronary stenting: a randomized multicenter trial. Circulation 2012;125:2015–26. 10.1161/CIRCULATIONAHA.111.071589
    1. Feres F, Costa RA, Abizaid A, et al. . Three vs twelve months of dual antiplatelet therapy after zotarolimus-eluting stents: the optimize randomized trial. JAMA 2013;310:2510–22. 10.1001/jama.2013.282183
    1. Stefanini GG, Byrne RA, Serruys PW, et al. . Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention: a pooled analysis of individual patient data from the ISAR-TEST 3, ISAR-TEST 4, and leaders randomized trials. Eur Heart J 2012;33:1214–22. 10.1093/eurheartj/ehs086
    1. Kim B-K, Hong M-K, Shin D-H, et al. . A new strategy for discontinuation of dual antiplatelet therapy: the reset trial (real safety and efficacy of 3-month dual antiplatelet therapy following endeavor zotarolimus-eluting stent implantation). J Am Coll Cardiol 2012;60:1340–8. 10.1016/j.jacc.2012.06.043
    1. Kandzari DE, Barker CS, Leon MB, et al. . Dual antiplatelet therapy duration and clinical outcomes following treatment with zotarolimus-eluting stents. JACC: Cardiovascular Interventions 2011;4:1119–28. 10.1016/j.jcin.2011.06.017
    1. Park S-J, Park D-W, Kim Y-H, et al. . Duration of dual antiplatelet therapy after implantation of drug-eluting stents. N Engl J Med 2010;362:1374–82. 10.1056/NEJMoa1001266
    1. Watanabe H, Domei T, Morimoto T, et al. . 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. JAMA 2019;321:2414–27. 10.1001/jama.2019.8145
    1. Hahn J-Y, Song YB, Oh J-H, et al. . Effect of P2Y12 inhibitor monotherapy vs dual antiplatelet therapy on cardiovascular events in patients undergoing percutaneous coronary intervention. JAMA 2019;321:2428–37. 10.1001/jama.2019.8146
    1. Mehran R, Baber U, Sharma SK, et al. . Ticagrelor with or without aspirin in high-risk patients after PCI. N Engl J Med Overseas Ed 2019;381:2032–42. 10.1056/NEJMoa1908419
    1. Frigoli E, Smits P, Vranckx P, et al. . Design and rationale of the management of high bleeding risk patients post Bioresorbable polymer coated stent implantation with an abbreviated versus standard DAPT regimen (master DAPT) study. Am Heart J 2019;209:97–105. 10.1016/j.ahj.2018.10.009
    1. Neumann F-J, Sousa-Uva M, Ahlsson A, et al. . 2018 ESC/EACTS guidelines on myocardial revascularization. Eur Heart J 2019;40:87–165. 10.1093/eurheartj/ehy394
    1. Gao R-L, Xu B, Lansky AJ, et al. . A randomised comparison of a novel abluminal groove-filled biodegradable polymer sirolimus-eluting stent with a durable polymer everolimus-eluting stent: clinical and angiographic follow-up of the target I trial. EuroIntervention 2013;9:75–83. 10.4244/EIJV9I1A12
    1. Lansky A, Wijns W, Xu B, et al. . Targeted therapy with a localised abluminal groove, low-dose sirolimus-eluting, biodegradable polymer coronary stent (target all Comers): a multicentre, open-label, randomised non-inferiority trial. The Lancet 2018;392:1117–26. 10.1016/S0140-6736(18)31649-0
    1. Dudek D, Dziewierz A, Stone G, et al. . The year in cardiology 2018: coronary interventions. Eur Heart J 2019;40:195–203. 10.1093/eurheartj/ehy882
    1. Baumbach A, Lansky AJ, Onuma Y, et al. . Optical coherence tomography substudy of a prospective multicentre randomised post-market trial to assess the safety and effectiveness of the Firehawk cobalt-chromium coronary stent (rapamycin target-eluting) system for the treatment of atherosclerotic lesions: target all Comers. EuroIntervention 2018;14:1121–8. 10.4244/EIJ-D-18-00226
    1. Brener SJ, Kirtane AJ, Stuckey TD, et al. . The impact of timing of ischemic and hemorrhagic events on mortality after percutaneous coronary intervention: the ADAPT-DES study. JACC Cardiovasc Interv 2016;9:1450–7. 10.1016/j.jcin.2016.04.037
    1. Valgimigli M, Patialiakas A, Thury A, et al. . Zotarolimus-Eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol 2015;65:805–15. 10.1016/j.jacc.2014.11.053
    1. Ariotti S, Adamo M, Costa F, et al. . Is bare-metal stent implantation still justifiable in high bleeding risk patients undergoing percutaneous coronary intervention?: a Pre-Specified analysis from the Zeus trial. JACC Cardiovasc Interv 2016;9:426–36. 10.1016/j.jcin.2015.11.015
    1. 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;373:2038–47. 10.1056/NEJMoa1503943

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться