Design and Rationale of the BIOFLOW-DAPT Trial: a Prospective, Randomized, Multicenter Study to Assess the Safety of the Orsiro Mission Stent Compared to the Resolute Onyx Stent in Subjects at High Risk for Bleeding in Combination with 1-Month Dual Antiplatelet Therapy.
Antiplatelet therapy
Dual antiplatelet therapy
High bleeding risk
Percutaneous coronary intervention
Journal
Journal of cardiovascular translational research
ISSN: 1937-5395
Titre abrégé: J Cardiovasc Transl Res
Pays: United States
ID NLM: 101468585
Informations de publication
Date de publication:
10 2023
10 2023
Historique:
received:
05
12
2022
accepted:
17
05
2023
medline:
1
11
2023
pubmed:
2
6
2023
entrez:
1
6
2023
Statut:
ppublish
Résumé
The optimal duration of dual antiplatelet therapy (DAPT) in high bleeding risk (HBR) patients undergoing percutaneous coronary intervention (PCI) with implantation of the Orsiro Mission stent remains unclear. The BIOFLOW-DAPT (clinicaltrials.gov, NCT04137510) trial is a prospective, multi-center, randomized controlled study designed to assess the safety of the Orsiro Mission versus the Resolute Onyx stent in HBR patients. Patients are treated with DAPT (aspirin and a P2Y
Identifiants
pubmed: 37264295
doi: 10.1007/s12265-023-10400-x
pii: 10.1007/s12265-023-10400-x
doi:
Substances chimiques
Platelet Aggregation Inhibitors
0
Aspirin
R16CO5Y76E
Banques de données
ClinicalTrials.gov
['NCT04137510']
Types de publication
Randomized Controlled Trial
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
1135-1143Informations de copyright
© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.
Références
Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Jüni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007;369(9562):667–78.
doi: 10.1016/S0140-6736(07)60314-6
pubmed: 17321312
Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006;48(12):2584–91.
doi: 10.1016/j.jacc.2006.10.026
pubmed: 17174201
Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH. 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention. Circulation. 2011;124(23):e574-651.
pubmed: 22064601
Wijns W, Kolh P, Danchin N, Di Mario C, Falk V, Folliguet T, Garg S, Huber K, James S, Knuuti J, Lopez-Sendon J, Marco J, Menicanti L, Ostojic M, Piepoli MF, Pirlet C, Pomar JL, Reifart N, Ribichini FL, Schalij MJ, Sergeant P, Serruys PW, Silber S, Sousa Uva M, Taggart D. Guidelines on myocardial revascularization. Eur Heart J. 2010;31(20):2501–55.
doi: 10.1093/eurheartj/ehq277
pubmed: 20802248
Cao D, Mehran R, Dangas G, Baber U, Sartori S, Chandiramani R, Stefanini GG, Angiolillo DJ, Capodanno D, Urban P, Morice MC, Krucoff M, Goel R, Roumeliotis A, Sweeny J, Sharma SK, Kini A. Validation of the Academic Research Consortium high bleeding risk definition in contemporary PCI patients. J Am Coll Cardiol. 2020;75(21):2711–22.
doi: 10.1016/j.jacc.2020.03.070
pubmed: 32466887
Corpataux N, Spirito A, Gragnano F, Vaisnora L, Galea R, Svab S, Gargiulo G, Zanchin T, Zanchin C, Siontis GCM, Praz F, Lanz J, Hunziker L, Stortecky S, Pilgrim T, Räber L, Capodanno D, Urban P, Pocock S, Heg D, Windecker S, Valgimigli M. Validation of high bleeding risk criteria and definition as proposed by the academic research consortium for high bleeding risk. Eur Heart J. 2020;41(38):3743–9.
doi: 10.1093/eurheartj/ehaa671
pubmed: 33029615
Ueki Y, Bär S, Losdat S, Otsuka T, Zanchin C, Zanchin T, Gragnano F, Gargiulo G, Siontis GCM, Praz F, Lanz J, Hunziker L, Stortecky S, Pilgrim T, Heg D, Valgimigli M, Windecker S, Räber L. Validation of the Academic Research Consortium for High Bleeding Risk (ARC-HBR) criteria in patients undergoing percutaneous coronary intervention and comparison with contemporary bleeding risk scores. EuroIntervention. 2020;16(5):371–9.
doi: 10.4244/EIJ-D-20-00052
pubmed: 32065586
Valgimigli M, Bueno H, Byrne RA, Collet JP, Costa F, Jeppsson A, Jüni P, Kastrati A, Kolh P, Mauri L, Montalescot G, Neumann FJ, Petricevic M, Roffi M, Steg PG, Windecker S, Zamorano JL, Levine GN. 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. Eur Heart J. 2018;39(3):213–60.
doi: 10.1093/eurheartj/ehx419
pubmed: 28886622
Capodanno D, Alfonso F, Levine GN, Valgimigli M, Angiolillo DJ. J Am Coll Cardiol. 2018;72(23):2915–31. https://doi.org/10.1016/j.jacc.2018.09.057 .
doi: 10.1016/j.jacc.2018.09.057
pubmed: 30522654
Byrne RA, Stone GW, Ormiston J, Kastrati A. Coronary balloon angioplasty, stents, and scaffolds. Lancet. 2017;390(10096):781–92.
doi: 10.1016/S0140-6736(17)31927-X
pubmed: 28831994
Kang SH, Park KW, Kang DY, Lim WH, Park KT, Han JK, Kang HJ, Koo BK, Oh BH, Park YB, Kandzari DE, Cohen DJ, Hwang SS, Kim HS. Biodegradable-polymer drug-eluting stents vs. bare metal stents vs. durable-polymer drug-eluting stents: a systematic review and Bayesian approach network meta-analysis. Eur Heart J. 2014;35(17):1147–58.
doi: 10.1093/eurheartj/eht570
pubmed: 24459196
Palmerini T, Benedetto U, Biondi-Zoccai G, Della Riva D, Bacchi-Reggiani L, Smits PC, Vlachojannis GJ, Jensen LO, Christiansen EH, Berencsi K, Valgimigli M, Orlandi C, Petrou M, Rapezzi C, Stone GW. Long-term safety of drug-eluting and bare-metal stents: evidence from a comprehensive network meta-analysis. J Am Coll Cardiol. 2015;65(23):2496–507.
doi: 10.1016/j.jacc.2015.04.017
pubmed: 26065988
Valgimigli M, Patialiakas A, Thury A, McFadden E, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Airoldi F, Ferlini M, Liistro F, Dellavalle A, Vranckx P, Briguori C. ZEUS Investigators. Zotarolimus-eluting versus bare-metal stents in uncertain drug-eluting stent candidates. J Am Coll Cardiol. 2015;65(8):805–15.
doi: 10.1016/j.jacc.2014.11.053
pubmed: 25720624
Ariotti S, Adamo M, Costa F, Patialiakas A, Briguori C, Thury A, Colangelo S, Campo G, Tebaldi M, Ungi I, Tondi S, Roffi M, Menozzi A, de Cesare N, Garbo R, Meliga E, Testa L, Gabriel HM, Ferlini M, Vranckx P, Valgimigli M. ZEUS Investigators. 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(5):426–36.
doi: 10.1016/j.jcin.2015.11.015
pubmed: 26965932
Urban P, Meredith IT, Abizaid A, Pocock SJ, Carrié D, Naber C, Lipiecki J, Richardt G, Iñiguez A, Brunel P, Valdes-Chavarri M, Garot P, Talwar S, Berland J, Abdellaoui M, Eberli F, Oldroyd K, Zambahari R, Gregson J, Greene S, Stoll HP, Morice MC. LEADERS FREE Investigators. Polymer-free drug-coated coronary stents in patients at high bleeding risk. N Engl J Med. 2015;373(21):2038–47.
doi: 10.1056/NEJMoa1503943
pubmed: 26466021
Krucoff MW, Urban P, Tanguay JF, McAndrew T, Zhang Y, Rao SV, Morice MC, Price MJ, Cohen DJ, Abdel-Wahab M, Mehta SR, Faurie B, McLaurin B, Diaz C, Stoll HP, Pocock S, Leon MB. Global approach to high bleeding risk patients with polymer-free drug-coated coronary stents. Circ Cardiovasc Interv. 2020;13(4):e008603.
doi: 10.1161/CIRCINTERVENTIONS.119.008603
pubmed: 32279567
Varenne O, Cook S, Sideris G, Kedev S, Cuisset T, Carrié D, Hovasse T, Garot P, El Mahmoud R, Spaulding C, Helft G, Diaz Fernandez JF, Brugaletta S, Pinar-Bermudez E, Mauri Ferre J, Commeau P, Teiger E, Bogaerts K, Sabate M, Morice MC, Sinnaeve PR. SENIOR investigators. Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial. Lancet. 2018;391(10115):41–50.
doi: 10.1016/S0140-6736(17)32713-7
pubmed: 29102362
Windecker S, Latib A, Kedhi E, Kirtane AJ, Kandzari DE, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Hudec M, Poliacikova P, Abdul Ghapar AKB, Selvaraj K, Petrov I, Mylotte D, Pinar E, Moreno R, Fabbiocchi F, Pasupati S, Kim HS, Aminian A, Tie C, Wlodarczak A, Hur SH, Marx SO, Jankovic I, Brar S, Bousquette L, Liu M, Stone GW. ONYX ONE Investigators. Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk. N Engl J Med. 2020;382(13):1208–18.
doi: 10.1056/NEJMoa1910021
pubmed: 32050061
Kandzari DE, Kirtane AJ, Windecker S, Latib A, Kedhi E, Mehran R, Price MJ, Abizaid A, Simon DI, Worthley SG, Zaman A, Choi JW, Caputo R, Kanitkar M, McLaurin B, Potluri S, Smith T, Spriggs D, Tolleson T, Nazif T, Parke M, Lee LC, Lung TH, Stone GW. Onyx ONE US/Japan Investigators. One-month dual antiplatelet therapy following percutaneous coronary intervention with zotarolimus-eluting stents in high-bleeding-risk patients. Circ Cardiovasc Interv. 2020;13(11):e009565.
doi: 10.1161/CIRCINTERVENTIONS.120.009565
pubmed: 33167705
pmcid: 7665241
Mehran R, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Wang J, Valgimigli M. XIENCE 90 and XIENCE 28 Investigators. 3- or 1-Month DAPT in patients at high bleeding risk undergoing everolimus-eluting stent implantation. JACC Cardiovasc Interv. 2021;14(17):1870–83.
doi: 10.1016/j.jcin.2021.07.016
pubmed: 34503737
Valgimigli M, Frigoli E, Heg D, Tijssen J, Jüni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stanković G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Donahue M, Leonardi S, Smits PC. MASTER DAPT Investigators. Dual antiplatelet therapy after PCI in patients at high bleeding risk. N Engl J Med. 2021;385(18):1643–55. https://doi.org/10.1056/NEJMoa2108749 .
doi: 10.1056/NEJMoa2108749
pubmed: 34449185
Valgimigli M, Cao D, Angiolillo DJ, Bangalore S, Bhatt DL, Ge J, Hermiller J, Makkar RR, Neumann FJ, Saito S, Picon H, Toelg R, Maksoud A, Chehab BM, Choi JW, Campo G, De la Torre Hernandez JM, Kunadian V, Sardella G, Thiele H, Varenne O, Vranckx P, Windecker S, Zhou Y, Krucoff MW, Ruster K, Zheng Y, Mehran R. XIENCE 90 and XIENCE 28 Investigators. Duration of dual antiplatelet therapy for patients at high bleeding risk undergoing PCI. J Am Coll Cardiol. 2021;78(21):2060–72.
doi: 10.1016/j.jacc.2021.08.074
pubmed: 34794687
Smits PC, Frigoli E, Tijssen J, Jüni P, Vranckx P, Ozaki Y, Morice MC, Chevalier B, Onuma Y, Windecker S, Tonino PAL, Roffi M, Lesiak M, Mahfoud F, Bartunek J, Hildick-Smith D, Colombo A, Stankovic G, Iñiguez A, Schultz C, Kornowski R, Ong PJL, Alasnag M, Rodriguez AE, Moschovitis A, Laanmets P, Heg D, Valgimigli M. MASTER DAPT Investigators. Abbreviated antiplatelet therapy in patients at high bleeding risk with or without oral anticoagulant therapy after coronary stenting: an open-label, randomized, controlled trial. Circulation. 2021;144(15):1196–211.
doi: 10.1161/CIRCULATIONAHA.121.056680
pubmed: 34455849
pmcid: 8500374
Valgimigli M, Smits PC, Frigoli E, Bongiovanni D, Tijssen J, Hovasse T, Mafragi A, Ruifrok WT, Karageorgiev D, Aminian A, Garducci S, Merkely B, Routledge H, Ando K, Diaz Fernandez JF, Cuisset T, Nesa Malik FT, Halabi M, Belle L, Din J, Beygui F, Abhyankar A, Reczuch K, Pedrazzini G, Heg D, Vranckx P. MASTER DAPT Investigators. Duration of antiplatelet therapy after complex percutaneous coronary intervention in patients at high bleeding risk: a MASTER DAPT trial sub-analysis. Eur Heart J. 2022;43(33):3100–14.
doi: 10.1093/eurheartj/ehac284
pubmed: 35580836
Price MJ, Shlofmitz RA, Spriggs DJ, Haldis TA, Myers P, Popma Almonacid A, Maehara A, Dauler M, Peng Y, Mehran R. Safety and efficacy of the next generation Resolute Onyx zotarolimus-eluting stent: primary outcome of the RESOLUTE ONYX core trial. Catheter Cardiovasc Interv. 2018;92(2):253–9.
doi: 10.1002/ccd.27322
pubmed: 28940882