Benefits of abbreviated antiaggregant treatment in high bleeding risk patients.
Dual antiplatelet therapy (DAPT), established by different guidelines, reduces the risk of ischemic events at the expense of increased bleeding. This habitual APT strategy cannot be applied to patients at high risk of bleeding, which is why this populations are treated with shorter DAPT schemes (1 to 6 months).
The original MASTER DAPT had shown high bleeding risk (HBR) patients, ischemic and hemorrhagic event-free after one month of Ultimaster stenting, presented fewer adverse events and lower risk of non-major bleeding at one year followup (non-inferiority).
This study included HBR patients receiving the Ultimaster stent both for acute and chronic coronary syndrome, free from events within one-month randomization.
Patients with prior PCI (within 6 months prior randomization), and those treated for instent restenosis on instent thrombosis were excluded.
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Patients received abbreviated APT 1:1 (1 month DAPT followed by single antiplatelet therapy, SAPT, except for anticoagulated patients with 6-month SAPT) vs standard (6-month DAPT, and 3-month DAPT for anticoagulated patients).
Co-primary outcomes were net clinical adverse events (NACE: composite of all cause death, AMI, stroke or major bleeding), major cardiovascular events (MACE: composite of all cause death, AMI or stroke) and major or clinically relevant bleeding.
From February 2017 to December 2019, 4579 patients were randomized to abbreviated APT scheme (n=2292) vs standard (n=2284), with 99.8%. complete 15-month followup. 4.2% of the standard APT patients with oral anticoagulation (OAC) presented DAPT, as well as 16.2% of patients without OAC (schemes prolonged beyond protocol). The antiaggregant strategy most used was aspirin plus clopidogrel, while DOAC was more often preferred over vitamin K antagonists in patients with OAC.
There was lower incidence, non-significant, of NACE (8.7%) with abbreviated APT vs. 9.5% standard therapy (HR 0.92, CI 95% 0.76-1.12; P=0.399). MACE was observed in 6.9% of the abbreviated scheme patients vs 7.4% of the standard scheme patients (HR 0.94, CI 95% 0.76-1.17; P=0.579). Major or clinically relevant bleeding rates were lower with the shorter scheme (HR 0.68, CI 95% 0.56-0.83; P=0.0001). It also rendered lower BARC 1,2 and 3/5 bleeding vs standard DAPT. When looking at neurological events, there were fewer strokes at 15 months (HR 0.53, CI 95% 0.28-0.99; P=0.048).
All-cause mortality was lower with the abbreviated therapy (0.4% vs 1.0%, HR 0.42, CI 95% 0.18-0.95; P=0.038), even though at the expense of non-cardiovascular mortality. Landmark analysis showed consistency between co-primary and secondary outcomes of MACE and NACE, with attenuated risk of bleeding.
The subgroup of patients treated with OAC showed consistent outcomes as regards NACE and MACE, with increased bleeding risk (at the expense of BARC 2 bleeding) and ischemic stroke vs. patients with no OAC.
Also, when looking at potential causes of prolonged DAPT (16% of patients), there are predisposing factors, precursors of net/ischemic events (diabetes, carotid artery disease, advance Killip or TIMI <3).
Conclusions
This followup of the MASTER DAPT is the first analysis to show the benefit of abbreviated DAPT in patients at high risk of bleeding beyond one year, with attenuated bleeding events, with no rebound effect after one year, with no difference in MACE or NACE between the groups, and prolonged benefits as regards bleeding.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Abbreviated or Standard Antiplatelet Therapy in HBR Patient.
Reference: Landi A, Heg D, Frigoli E, Vranckx P, Windecker S, Siegrist P, Cayla G, Włodarczak A, Cook S, Gómez-Blázquez I, Feld Y, Seung-Jung P, Mates M, Lotan C, Gunasekaran S, Nanasato M, Das R, Kelbæk H, Teiger E, Escaned J, Ishibashi Y, Montalescot G, Matsuo H, Debeljacki D, Smits PC, Valgimigli M; MASTER DAPT Investigators. Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial. JACC Cardiovasc Interv. 2023 Apr 10;16(7):798-812. doi: 10.1016/j.jcin.2023.01.366. PMID: 37045500.
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