In:
PLOS ONE, Public Library of Science (PLoS), Vol. 17, No. 2 ( 2022-2-16), p. e0263180-
Abstract:
The Non-adherence Academic Research Consortium (NARC) has recently developed a consensus-based standardized classification for medication non-adherence in cardiovascular clinical trials. We aimed to assess the prevalence of NARC-defined self-reported non-adherence to P2Y12 inhibitors and its impact on clinical outcomes in patients undergoing percutaneous coronary intervention (PCI). Methods and results Using a standardized questionnaire administered at 1 year after PCI, we assessed the 4 NARC-defined non-adherence levels including type, decision-maker, reasons, and timing within the Bern PCI registry. The primary endpoint was the patient-oriented composite endpoint (POCE) defined as a composite of death, myocardial infarction, stroke, and any revascularization at 1 year. The recommended P2Y12 inhibitor duration was 12 months. Among 3,896 patients, P2Y12 inhibitor non-adherence was observed in 647 (17%) patients. Discontinuation was permanent in the majority of patients (84%). The decision was mainly driven by a physician (94%), and rarely by patients (6%). The most frequent reason was risk profile change (43%), followed by unlisted reasons (25%), surgery (17%), and adverse events (14%). Non-adherence occurred early ( 〈 30 days) in 21%, late (30–180 days) in 45%, and very late ( 〉 180 days) in 33%. The majority of POCE events (n = 421/502, 84%) occurred during adherence to the prescribed P2Y12 inhibitor. Permanent discontinuation, doctor-driven non-adherence, and risk profile change emerged as independent predictors for POCE. Conclusions In real-world PCI population treated with 1-year DAPT, non-adherence was observed in nearly one-fifth of patients. Non-adherence to P2Y12 inhibitors was associated with worse clinical outcomes, while the risk was related to underlying contexts. ClinicalTrials.gov identifier NCT02241291 .
Type of Medium:
Online Resource
ISSN:
1932-6203
DOI:
10.1371/journal.pone.0263180
DOI:
10.1371/journal.pone.0263180.g001
DOI:
10.1371/journal.pone.0263180.g002
DOI:
10.1371/journal.pone.0263180.g003
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10.1371/journal.pone.0263180.g004
DOI:
10.1371/journal.pone.0263180.t001
DOI:
10.1371/journal.pone.0263180.t002
DOI:
10.1371/journal.pone.0263180.s001
DOI:
10.1371/journal.pone.0263180.s002
DOI:
10.1371/journal.pone.0263180.s003
DOI:
10.1371/journal.pone.0263180.s004
DOI:
10.1371/journal.pone.0263180.s005
DOI:
10.1371/journal.pone.0263180.s006
DOI:
10.1371/journal.pone.0263180.s007
DOI:
10.1371/journal.pone.0263180.s008
DOI:
10.1371/journal.pone.0263180.s009
DOI:
10.1371/journal.pone.0263180.s010
DOI:
10.1371/journal.pone.0263180.s011
DOI:
10.1371/journal.pone.0263180.s012
DOI:
10.1371/journal.pone.0263180.s013
Language:
English
Publisher:
Public Library of Science (PLoS)
Publication Date:
2022
detail.hit.zdb_id:
2267670-3
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