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 - 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
UR - http://www.scopus.com/inward/citedby.url?scp=85134855043&partnerID=8YFLogxK
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 -