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

J 2022

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

VALGIMIGLI, Marco, Enrico FRIGOLI, Pascal VRANCKX, Yukio OZAKI, Marie-Claude MORICE et. al.

Basic information

Original name

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

Authors

VALGIMIGLI, Marco (guarantor), Enrico FRIGOLI, Pascal VRANCKX, Yukio OZAKI, Marie-Claude MORICE, Bernard CHEVALIER, Yoshinobu ONUMA, Stephan WINDECKER, Laurent DELORME, Petr KALA (203 Czech Republic, belonging to the institution), Sasko KEDEV, Rajpal K ABHAICHAND, Vasil VELCHEV, Willem DEWILDE, Jakub PODOLEC, Gregor LEIBUNDGUT, Dragan TOPIC, Carl SCHULTZ, Goran STANKOVIC, Astin LEE, Thomas JOHNSON, Pim A L TONINO, Aneta KLOTZKA, Maciej LESIAK, Renato D LOPES, Pieter C SMITS and Dik HEG

Edition

Journal of the American College of Cardiology, New York, Elsevier Science INC, 2022, 0735-1097

Other information

Language

English

Type of outcome

Článek v odborném periodiku

Field of Study

30201 Cardiac and Cardiovascular systems

Country of publisher

United States of America

Confidentiality degree

není předmětem státního či obchodního tajemství

References:

URL

Impact factor

Impact factor: 24.000

RIV identification code

RIV/00216224:14110/22:00128437

Organization unit

Faculty of Medicine

DOI

http://dx.doi.org/10.1016/j.jacc.2022.04.065

UT WoS

000863530300004

Keywords in English

drug-eluting stent; dual antiplatelet therapy; high bleeding risk; P2Y12 inhibitor; acetylsalicylic acid

Abstract

V originále

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-ofcensoring 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]

Citovat

VALGIMIGLI, Marco, Enrico FRIGOLI, Pascal VRANCKX, Yukio OZAKI, Marie-Claude MORICE, Bernard CHEVALIER, Yoshinobu ONUMA, Stephan WINDECKER, Laurent DELORME, Petr KALA, Sasko KEDEV, Rajpal K ABHAICHAND, Vasil VELCHEV, Willem DEWILDE, Jakub PODOLEC, Gregor LEIBUNDGUT, Dragan TOPIC, Carl SCHULTZ, Goran STANKOVIC, Astin LEE, Thomas JOHNSON, Pim A L TONINO, Aneta KLOTZKA, Maciej LESIAK, Renato D LOPES, Pieter C SMITS and Dik HEG. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. Journal of the American College of Cardiology. New York: Elsevier Science INC, 2022, vol. 80, No 8, p. 766-778. ISSN 0735-1097. Available from: https://dx.doi.org/10.1016/j.jacc.2022.04.065.

@article{2251419,
   author = {Valgimigli, Marco and Frigoli, Enrico and Vranckx, Pascal and Ozaki, Yukio and Morice, MarieandClaude and Chevalier, Bernard and Onuma, Yoshinobu and Windecker, Stephan and Delorme, Laurent and Kala, Petr and Kedev, Sasko and Abhaichand, Rajpal K and Velchev, Vasil and Dewilde, Willem and Podolec, Jakub and Leibundgut, Gregor and Topic, Dragan and Schultz, Carl and Stankovic, Goran and Lee, Astin and Johnson, Thomas and Tonino, Pim A L and Klotzka, Aneta and Lesiak, Maciej and Lopes, Renato D and Smits, Pieter C and Heg, Dik},
   article_location = {New York},
   article_number = {8},
   doi = {http://dx.doi.org/10.1016/j.jacc.2022.04.065},
   keywords = {drug-eluting stent; dual antiplatelet therapy; high bleeding risk; P2Y12 inhibitor; acetylsalicylic acid},
   language = {eng},
   issn = {0735-1097},
   journal = {Journal of the American College of Cardiology},
   title = {Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy},
   url = {https://www.sciencedirect.com/science/article/pii/S0735109722053827?via%3Dihub},
   volume = {80},
   year = {2022}
}

TY  - JOUR
ID  - 2251419
AU  - Valgimigli, Marco - Frigoli, Enrico - Vranckx, Pascal - Ozaki, Yukio - Morice, Marie-Claude - Chevalier, Bernard - Onuma, Yoshinobu - Windecker, Stephan - Delorme, Laurent - Kala, Petr - Kedev, Sasko - Abhaichand, Rajpal K - Velchev, Vasil - Dewilde, Willem - Podolec, Jakub - Leibundgut, Gregor - Topic, Dragan - Schultz, Carl - Stankovic, Goran - Lee, Astin - Johnson, Thomas - Tonino, Pim A L - Klotzka, Aneta - Lesiak, Maciej - Lopes, Renato D - Smits, Pieter C - Heg, Dik
PY  - 2022
TI  - Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy
JF  - Journal of the American College of Cardiology
VL  - 80
IS  - 8
SP  - 766-778
EP  - 766-778
PB  - Elsevier Science INC
SN  - 07351097
KW  - drug-eluting stent
KW  - dual antiplatelet therapy
KW  - high bleeding risk
KW  - P2Y12 inhibitor
KW  - acetylsalicylic acid
UR  - https://www.sciencedirect.com/science/article/pii/S0735109722053827?via%3Dihub
N2  - 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-ofcensoring 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]
ER  -

VALGIMIGLI, Marco, Enrico FRIGOLI, Pascal VRANCKX, Yukio OZAKI, Marie-Claude MORICE, Bernard CHEVALIER, Yoshinobu ONUMA, Stephan WINDECKER, Laurent DELORME, Petr KALA, Sasko KEDEV, Rajpal K ABHAICHAND, Vasil VELCHEV, Willem DEWILDE, Jakub PODOLEC, Gregor LEIBUNDGUT, Dragan TOPIC, Carl SCHULTZ, Goran STANKOVIC, Astin LEE, Thomas JOHNSON, Pim A L TONINO, Aneta KLOTZKA, Maciej LESIAK, Renato D LOPES, Pieter C SMITS and Dik HEG. Impact of Medication Nonadherence in a Clinical Trial of Dual Antiplatelet Therapy. \textit{Journal of the American College of Cardiology}. New York: Elsevier Science INC, 2022, vol.~80, No~8, p.~766-778. ISSN~0735-1097. Available from: https://dx.doi.org/10.1016/j.jacc.2022.04.065.

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