TY - JOUR
T1 - Multifaceted Intervention to Improve P2Y12 Inhibitor Adherence After Percutaneous Coronary Intervention
T2 - A Stepped Wedge Trial
AU - Ho, P. Michael
AU - O’donnell, Colin I.
AU - McCreight, Marina
AU - Bavry, Anthony A.
AU - Bosworth, Hayden B.
AU - Girotra, Saket
AU - Grossman, P. Michael
AU - Helfrich, Christian
AU - Latif, Faisal
AU - Lu, David
AU - Matheny, Michael
AU - Mavromatis, Kreton
AU - Ortiz, Jose
AU - Parashar, Amitabh
AU - Ratliff, Devona M.
AU - Grunwald, Gary K.
AU - Gillette, Michael
AU - Jneid, Hani
N1 - Funding Information:
Dr Ho is supported by grants from National Heart, Lung, and Blood Institute, Veterans Affairs Health Services Research and Development, and University of Colorado School of Medicine. He has a research agreement with Bristol-Myers Squibb through the University of Colorado. He serves as the Deputy Editor for Circulation: Cardiovascular Quality and Outcomes. Dr Bosworth acknowledges funding from Veterans Affairs Health Services Research and Development Senior Career Development Award 08-027, Veterans Affairs Office of Rural Health, National Institutes of Health (NIH) 1 K12 HL138030 and U01 HL142099, as well as grant funding from NIH, Sanofi, Pharma Foundation, Novo Nordisk, Improved Patient Outcome, Preventic Diagnostic, Novartis, and Otsuka. Dr Latif discloses speaker fees from Abbott Vascular, Inc. Dr Grossman discloses research funding from Medtronic Cardiovascular, Edwards Life Sciences, Cardiovascular Systems Incorporated, and NIH; discloses registry support from Blue Cross Blue Shield of Michigan; and is a physician proctor for Medtronic Cardiovascular and Edwards Life Sciences.
Funding Information:
The study was made possible by funding from Veterans Affairs Health Services Research and Development Quality Enhancement Research Initiative grant (SDP 12-179). The sponsor did not have a role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the article.
Publisher Copyright:
© 2022 The Authors. Published on behalf of the American Heart Association, Inc., by Wiley.
PY - 2022/7/5
Y1 - 2022/7/5
N2 - BACKGROUND: P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. METHODS AND RESULTS: This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients’ bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per pro-tocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (−3.4%; 98.3% CI, −1.2% to −5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%–7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%– 4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (−1.7%; 98.3% CI, −2.3% to –1.1%). CONCLUSIONS: A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.
AB - BACKGROUND: P2Y12 inhibitor medications are critical following percutaneous coronary intervention (PCI); however, adherence remains suboptimal. Our objective was to assess the effectiveness of a multifaceted intervention to improve P2Y12 inhibitor adherence following PCI. METHODS AND RESULTS: This was a modified stepped wedge trial of 52 eligible hospitals, of which 15 were randomly selected and agreed to participate (29 hospitals declined, and 8 eligible hospitals were not contacted). At each intervention hospital, patient recruitment occurred for 6 months and enrolled patients were followed up for 1 year after PCI. Three control groups were used: patients at intervention hospitals undergoing PCI (1) before the intervention period (preintervention); (2) after the intervention period (postintervention); or (3) at the 8 hospitals not contacted (concurrent controls). The intervention consisted of 4 components: (1) P2Y12 inhibitor delivered to patients’ bedside after PCI; (2) education on importance of P2Y12 inhibitors; (3) automated reminder telephone calls to refill medication; and (4) outreach to patients if they delayed refilling P2Y12 inhibitor. The primary outcomes were as follows: (1) proportion of patients with delays filling P2Y12 inhibitor at hospital discharge and (2) proportion of patients who were adherent in the year after PCI using pharmacy refill data. Primary analysis compared intervention with preintervention control patients. There were 1377 (intent-to-treat) potentially eligible patients, of whom 803 (per pro-tocol) were approached at intervention sites versus 5910 preintervention, 2807 postintervention, and 4736 concurrent control patients. In the intent-to-treat analysis, intervention patients were less likely to delay filling P2Y12 at hospital discharge (−3.4%; 98.3% CI, −1.2% to −5.6%) and more likely to be adherent to P2Y12 (4.1%; 98.3% CI, 1.0%–7.1%) at 1 year, but had more clinical events (3.2%; 98.3% CI, 2.3%– 4.1%) driven by repeated PCI compared with preintervention patients. In post hoc analysis looking at myocardial infarction, stroke, and death, intervention patients had lower event rates compared with preintervention patients (−1.7%; 98.3% CI, −2.3% to –1.1%). CONCLUSIONS: A 4-component intervention targeting P2Y12 inhibitor adherence was difficult to implement. The intervention produced mixed results. It improved P2Y12 adherence, but there was also an increase in repeat PCI. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01609842.
KW - P2Y12 inhibitor
KW - clinical trial
KW - medication adherence
UR - http://www.scopus.com/inward/record.url?scp=85134855043&partnerID=8YFLogxK
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U2 - 10.1161/JAHA.121.024342
DO - 10.1161/JAHA.121.024342
M3 - Article
C2 - 35766258
AN - SCOPUS:85134855043
SN - 2047-9980
VL - 11
JO - Journal of the American Heart Association
JF - Journal of the American Heart Association
IS - 13
M1 - e024342
ER -