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Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy.

Publication ,  Journal Article
Valgimigli, M; Frigoli, E; Vranckx, P; Ozaki, Y; Morice, M-C; Chevalier, B; Onuma, Y; Windecker, S; Delorme, L; Kala, P; Kedev, S; Velchev, V ...
Published in: J Am Coll Cardiol
August 23, 2022

BACKGROUND: Nonadherence to antiplatelet therapy after percutaneous coronary intervention (PCI) is common, even in clinical trials. OBJECTIVES: The purpose of this study was to investigate the impact of nonadherence to study protocol regimens in the MASTER DAPT (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen) trial. METHODS: At 1-month after PCI, 4,579 high bleeding risk patients were randomized to single antiplatelet therapy (SAPT) for 11 months (or 5 months in patients on oral anticoagulation [OAC]) or dual antiplatelet therapy (DAPT) for ≥2 months followed by SAPT. Coprimary outcomes included net adverse clinical events (NACE), major adverse cardiac and cerebral events (MACE), and major or clinically relevant nonmajor bleeding (MCB) at 335 days. Inverse probability-of-censoring weights were used to correct for nonadherence Academic Research Consortium type 2 or 3. RESULTS: In total, 464 (20.2%) patients in the abbreviated-treatment and 214 (9.4%) in the standard-treatment groups incurred nonadherence Academic Research Consortium type 2 or 3. At inverse probability-of-censoring weights analyses, NACE (HR: 1.01; 95% CI: 0.88-1.27) or MACE (HR: 1.07; 95% CI: 0.83-1.40) did not differ, and MCB was lower with abbreviated compared with standard treatment (HR: 0.51; 95% CI: 0.60-0.73) consistently across OAC subgroups; among OAC patients, SAPT discontinuation 6 months after PCI was associated with similar MACE and lower MCB (HR: 0.47; 95% CI: 0.22-0.99) compared with SAPT continuation. CONCLUSIONS: In the MASTER DAPT adherent population, 1-month compared with ≥3-month DAPT was associated with similar NACE or MACE and lower MCB. Among OAC patients, SAPT discontinuation after 6 months was associated with similar MACE and lower MCB than SAPT continuation (Management of High Bleeding Risk Patients Post Bioresorbable Polymer Coated Stent Implantation With an Abbreviated Versus Prolonged DAPT Regimen [MASTER DAPT]; NCT03023020).

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Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

August 23, 2022

Volume

80

Issue

8

Start / End Page

766 / 778

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Polymers
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Medication Adherence
  • Humans
  • Hemorrhage
  • Drug-Eluting Stents
  • Drug Therapy, Combination
  • Cardiovascular System & Hematology
 

Citation

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Valgimigli, M., Frigoli, E., Vranckx, P., Ozaki, Y., Morice, M.-C., Chevalier, B., … MASTER DAPT Investigators, . (2022). Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol, 80(8), 766–778. https://doi.org/10.1016/j.jacc.2022.04.065
Valgimigli, Marco, Enrico Frigoli, Pascal Vranckx, Yukio Ozaki, Marie-Claude Morice, Bernard Chevalier, Yoshinobu Onuma, et al. “Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy.J Am Coll Cardiol 80, no. 8 (August 23, 2022): 766–78. https://doi.org/10.1016/j.jacc.2022.04.065.
Valgimigli M, Frigoli E, Vranckx P, Ozaki Y, Morice M-C, Chevalier B, et al. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol. 2022 Aug 23;80(8):766–78.
Valgimigli, Marco, et al. “Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy.J Am Coll Cardiol, vol. 80, no. 8, Aug. 2022, pp. 766–78. Pubmed, doi:10.1016/j.jacc.2022.04.065.
Valgimigli M, Frigoli E, Vranckx P, Ozaki Y, Morice M-C, Chevalier B, Onuma Y, Windecker S, Delorme L, Kala P, Kedev S, Abhaichand RK, Velchev V, Dewilde W, Podolec J, Leibundgut G, Topic D, Schultz C, Stankovic G, Lee A, Johnson T, Tonino PAL, Klotzka A, Lesiak M, Lopes RD, Smits PC, Heg D, MASTER DAPT Investigators. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. J Am Coll Cardiol. 2022 Aug 23;80(8):766–778.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

August 23, 2022

Volume

80

Issue

8

Start / End Page

766 / 778

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Polymers
  • Platelet Aggregation Inhibitors
  • Percutaneous Coronary Intervention
  • Medication Adherence
  • Humans
  • Hemorrhage
  • Drug-Eluting Stents
  • Drug Therapy, Combination
  • Cardiovascular System & Hematology