Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial

MASTER DAPT Investigators; Antonio Landi; Dik Heg; Enrico Frigoli; Pascal Vranckx; Stephan Windecker; Patrick Siegrist; Guillaume Cayla; Adrian Włodarczak; Stephane Cook; Iván Gómez-Blázquez; Yair Feld; Park Seung-Jung; Martin Mates; Chaim Lotan; Sengottuvelu Gunasekaran; Mamoru Nanasato; Rajiv Das; Henning Kelbæk; Emmanuel Teiger; Javier Escaned; Yuki Ishibashi; Gilles Montalescot; Hitoshi Matsuo; Dragan Debeljacki; Pieter C Smits; Marco Valgimigli

doi:10.1016/j.jcin.2023.01.366

Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial

MASTER DAPT Investigators
, Antonio Landi
, Dik Heg
, Enrico Frigoli
, Pascal Vranckx
, Stephan Windecker
, Patrick Siegrist
, Guillaume Cayla
, Adrian Włodarczak
, Stephane Cook
, Iván Gómez-Blázquez
, Yair Feld
, Park Seung-Jung
, Martin Mates
, Chaim Lotan
, Sengottuvelu Gunasekaran
, Mamoru Nanasato
, Rajiv Das
, Henning Kelbæk
, Emmanuel Teiger

Javier Escaned, Yuki Ishibashi, Gilles Montalescot, Hitoshi Matsuo, Dragan Debeljacki, Pieter C Smits, Marco Valgimigli

Kardiologisk Afdeling

Publikation: Bidrag til tidsskrift › Artikel › Forskning › peer review

Abstract

BACKGROUND: Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown.

OBJECTIVES: The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial.

METHODS: The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding.

RESULTS: At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI.

CONCLUSIONS: At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

Originalsprog	Engelsk
Sider (fra-til)	798-812
Antal sider	15
Tidsskrift	JACC: Cardiovascular Interventions
Vol/bind	16
Udgave nummer	7
DOI	https://doi.org/10.1016/j.jcin.2023.01.366
Status	Udgivet - 10 apr. 2023

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10.1016/j.jcin.2023.01.366

Citationsformater

MASTER DAPT Investigators, 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., ... Valgimigli, M. (2023). Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial. JACC: Cardiovascular Interventions, 16(7), 798-812. https://doi.org/10.1016/j.jcin.2023.01.366

@article{198bcd1b2e844d778a2a7c5f1c8e2243,

title = "Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial",

abstract = "BACKGROUND: Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown.OBJECTIVES: The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial.METHODS: The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding.RESULTS: At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95\% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95\% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95\% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95\% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95\% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI.CONCLUSIONS: At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).",

keywords = "Humans, Drug Therapy, Combination, Drug-Eluting Stents/adverse effects, Hemorrhage/chemically induced, Myocardial Infarction/complications, Percutaneous Coronary Intervention/adverse effects, Platelet Aggregation Inhibitors, Stroke/etiology, Treatment Outcome, High bleeding risk, Percutaneous coronary intervention, Dual antiplatelet therapy, KEY WORDS antiplatelet therapy",

author = "\{MASTER DAPT Investigators\} and Antonio Landi and Dik Heg and Enrico Frigoli and Pascal Vranckx and Stephan Windecker and Patrick Siegrist and Guillaume Cayla and Adrian W{\l}odarczak and Stephane Cook and Iv{\'a}n G{\'o}mez-Bl{\'a}zquez and Yair Feld and Park Seung-Jung and Martin Mates and Chaim Lotan and Sengottuvelu Gunasekaran and Mamoru Nanasato and Rajiv Das and Henning Kelb{\ae}k and Emmanuel Teiger and Javier Escaned and Yuki Ishibashi and Gilles Montalescot and Hitoshi Matsuo and Dragan Debeljacki and Smits, \{Pieter C\} and Marco Valgimigli",

year = "2023",

month = apr,

day = "10",

doi = "10.1016/j.jcin.2023.01.366",

language = "English",

volume = "16",

pages = "798--812",

journal = "JACC: Cardiovascular Interventions",

issn = "1936-8798",

publisher = "Elsevier",

number = "7",

}

MASTER DAPT Investigators, 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 2023, 'Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial', JACC: Cardiovascular Interventions, bind 16, nr. 7, s. 798-812. https://doi.org/10.1016/j.jcin.2023.01.366

TY - JOUR

T1 - Abbreviated or Standard Antiplatelet Therapy in HBR Patients

T2 - Final 15-Month Results of the MASTER-DAPT Trial

AU - MASTER DAPT Investigators

AU - Landi, Antonio

AU - Heg, Dik

AU - Frigoli, Enrico

AU - Vranckx, Pascal

AU - Windecker, Stephan

AU - Siegrist, Patrick

AU - Cayla, Guillaume

AU - Włodarczak, Adrian

AU - Cook, Stephane

AU - Gómez-Blázquez, Iván

AU - Feld, Yair

AU - Seung-Jung, Park

AU - Mates, Martin

AU - Lotan, Chaim

AU - Gunasekaran, Sengottuvelu

AU - Nanasato, Mamoru

AU - Das, Rajiv

AU - Kelbæk, Henning

AU - Teiger, Emmanuel

AU - Escaned, Javier

AU - Ishibashi, Yuki

AU - Montalescot, Gilles

AU - Matsuo, Hitoshi

AU - Debeljacki, Dragan

AU - Smits, Pieter C

AU - Valgimigli, Marco

PY - 2023/4/10

Y1 - 2023/4/10

N2 - BACKGROUND: Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown.OBJECTIVES: The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial.METHODS: The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding.RESULTS: At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI.CONCLUSIONS: At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

AB - BACKGROUND: Clinical outcomes and treatment selection after completing the randomized phase of modern trials, investigating antiplatelet therapy (APT) after percutaneous coronary intervention (PCI), are unknown.OBJECTIVES: The authors sought to investigate cumulative 15-month and 12-to-15-month outcomes after PCI during routine care in the MASTER DAPT trial.METHODS: The MASTER DAPT trial randomized 4,579 high bleeding risk patients to abbreviated (n = 2,295) or standard (n = 2,284) APT regimens. Coprimary outcomes were net adverse clinical outcomes (NACE) (all-cause death, myocardial infarction, stroke, and BARC 3 or 5 bleeding); major adverse cardiac and cerebral events (MACCE) (all-cause death, myocardial infarction, and stroke); and BARC type 2, 3, or 5 bleeding.RESULTS: At 15 months, prior allocation to a standard APT regimen was associated with greater use of intensified APT; NACE and MACCE did not differ between abbreviated vs standard APT (HR: 0.92 [95% CI: 0.76-1.12]; P = 0.399 and HR: 0.94 [95% CI: 0.76-1.17]; P = 0.579; respectively), as during the routine care period (HR: 0.81 [95% CI: 0.50-1.30]; P = 0.387 and HR: 0.74 [95% CI: 0.43-1.26]; P = 0.268; respectively). BARC 2, 3, or 5 was lower with abbreviated APT at 15 months (HR: 0.68 [95% CI: 0.56-0.83]; P = 0.0001) and did not differ during the routine care period. The treatment effects during routine care were consistent with those observed within 12 months after PCI.CONCLUSIONS: At 15 months, NACE and MACCE did not differ in the 2 study groups, whereas the risk of major or clinically relevant nonmajor bleeding remained lower with abbreviated compared with standard APT. (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

KW - Humans

KW - Drug Therapy, Combination

KW - Drug-Eluting Stents/adverse effects

KW - Hemorrhage/chemically induced

KW - Myocardial Infarction/complications

KW - Percutaneous Coronary Intervention/adverse effects

KW - Platelet Aggregation Inhibitors

KW - Stroke/etiology

KW - Treatment Outcome

KW - High bleeding risk

KW - Percutaneous coronary intervention

KW - Dual antiplatelet therapy

KW - KEY WORDS antiplatelet therapy

U2 - 10.1016/j.jcin.2023.01.366

DO - 10.1016/j.jcin.2023.01.366

M3 - Article

C2 - 37045500

SN - 1936-8798

VL - 16

SP - 798

EP - 812

JO - JACC: Cardiovascular Interventions

JF - JACC: Cardiovascular Interventions

IS - 7

ER -

Abbreviated or Standard Antiplatelet Therapy in HBR Patients: Final 15-Month Results of the MASTER-DAPT Trial

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