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 protocol) 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.
This prospective study included patients with heart failure (HF) with reduced ejection fraction (HFrEF) with LVEF < = 40% to evaluate the impact of pharmacist on guideline directed medical therapy (GDMT). The primary outcome was to compare proportion of triple GDMT achieved for Angiotensin-Converting-Enzyme-Inhibitors (ACEI)/Angiotensin-Receptor-Blockers (ARB)/Angiotensin-Receptor-Neprilysin-Inhibitors (ARNI), beta-blockers, aldosterone antagonists (AA), and quadruple GDMT which in additional to triple therapy, included Sodium glucose co-transporter 2 inhibitor (SGLT2i) at 90-day post-enrollment compared to baseline. Secondary endpoints included achieving target and/or maximally tolerated ACEI/ARB/ARNI and beta-blockers combined and individually as well as SGLT2i and AA GDMT at 90-day post-enrollment compared to baseline. We also compared combined and individual HF-related hospitalization/emergency room (ER) visits 90 days pre-/post-enrollment. Of the total 974 patients screened, 80 patients seen at least once in the heart failure medication titration clinic (HMTC) were included in the analysis. Median (IQR) age was 71 (57–69) years with majority white male. There was a significant improvement in the proportion of patients who achieved quadruple GDMT ( p = 0.001) and triple GDMT ( p -value = 0.020) at 90-day post-enrollment compared to baseline. The secondary GDMT outcomes were also significantly increased at 90 days post-enrollment compared to baseline. Significant difference in mean as well as proportion of combined HF-related hospitalization/ER-visits was found 90 days pre-/post-enrollment ( p = 0.047). Our study found that pharmacist’s intervention increased the proportion of patients who achieved GDMT at 90 days. Graphical abstract Supplementary Information The online version contains supplementary material available at 10.1007/s12265-022-10262-9.
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