Please use this identifier to cite or link to this item: https://doi.org/10.1001/jamacardio.2020.6721
Title: Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care The IMMACULATE Randomized Clinical Trial
Authors: Chan, Mark Y 
Koh, Karen WL
Poh, Sock-Cheng
Marchesseau, Stephanie 
Singh, Devinder
Han, Yiying 
Ng, Faclin
Lim, Eleanor
Prabath, Joseph F
Lee, Chi-Hang 
Sim, Hui-Wen
Chen, Ruth
Carvalho, Leonardo 
Tan, Sock-Hwee 
Loh, Joshua PY
Tan, Jack WC
Kuwelker, Karishma
Amanullah, RM 
Chin, Chee-Tang 
Yip, James WL
Lee, Choy-Yee
Gan, Juvena
Lo, Chew-Yong 
Ho, Hee-Hwa
Hausenloy, Derek J
Tai, Bee-Choo 
Richards, A Mark 
Keywords: Science & Technology
Life Sciences & Biomedicine
Cardiac & Cardiovascular Systems
Cardiovascular System & Cardiology
LEFT-VENTRICULAR DYSFUNCTION
CONVERTING-ENZYME INHIBITOR
CARDIOVASCULAR EVENTS
Issue Date: 30-Dec-2020
Publisher: AMER MEDICAL ASSOC
Citation: Chan, Mark Y, Koh, Karen WL, Poh, Sock-Cheng, Marchesseau, Stephanie, Singh, Devinder, Han, Yiying, Ng, Faclin, Lim, Eleanor, Prabath, Joseph F, Lee, Chi-Hang, Sim, Hui-Wen, Chen, Ruth, Carvalho, Leonardo, Tan, Sock-Hwee, Loh, Joshua PY, Tan, Jack WC, Kuwelker, Karishma, Amanullah, RM, Chin, Chee-Tang, Yip, James WL, Lee, Choy-Yee, Gan, Juvena, Lo, Chew-Yong, Ho, Hee-Hwa, Hausenloy, Derek J, Tai, Bee-Choo, Richards, A Mark (2020-12-30). Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care The IMMACULATE Randomized Clinical Trial. JAMA CARDIOLOGY 6 (7) : 830-835. ScholarBank@NUS Repository. https://doi.org/10.1001/jamacardio.2020.6721
Abstract: Importance: There are few data on remote postdischarge treatment of patients with acute myocardial infarction. Objective: To compare the safety and efficacy of allied health care practitioner-led remote intensive management (RIM) with cardiologist-led standard care (SC). Design, Setting, and Participants: This intention-to-treat feasibility trial randomized patients with acute myocardial infarction undergoing early revascularization and with N-terminal-pro-B-type natriuretic peptide concentration more than 300 pg/mL to RIM or SC across 3 hospitals in Singapore from July 8, 2015, to March 29, 2019. RIM participants underwent 6 months of remote consultations that included β-blocker and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACE-I/ARB) dose adjustment by a centralized nurse practitioner team while SC participants were treated face-to-face by their cardiologists. Main Outcomes and Measures: The primary safety end point was a composite of hypotension, bradycardia, hyperkalemia, or acute kidney injury requiring hospitalization. To assess the efficacy of RIM in dose adjustment of β-blockers and ACE-I/ARBs compared with SC, dose intensity scores were derived by converting comparable doses of different β-blockers and ACE-I/ARBs to a scale from 0 to 5. The primary efficacy end point was the 6-month indexed left ventricular end-systolic volume (LVESV) adjusted for baseline LVESV. Results: Of 301 participants, 149 (49.5%) were randomized to RIM and 152 (50.5%) to SC. RIM and SC participants had similar mean (SD) age (55.3 [8.5] vs 54.7 [9.1] years), median (interquartile range) N-terminal-pro-B-type natriuretic peptide concentration (807 [524-1360] vs 819 [485-1320] pg/mL), mean (SD) baseline left ventricular ejection fraction (57.4% [11.1%] vs 58.1% [10.3%]), and mean (SD) indexed LVESV (32.4 [14.1] vs 30.6 [11.7] mL/m2); 15 patients [5.9%] had a left ventricular ejection fraction <40%. The primary safety end point occurred in 0 RIM vs 2 SC participants (1.4%) (P =.50). The mean β-blocker and ACE-I/ARB dose intensity score at 6 months was 3.03 vs 2.91 (adjusted mean difference, 0.12 [95% CI, -0.02 to 0.26; P =.10]) and 2.96 vs 2.77 (adjusted mean difference, 0.19 [95% CI, -0.02 to 0.40; P =.07]), respectively. The 6-month indexed LVESV was 28.9 vs 29.7 mL/m2(adjusted mean difference, -0.80 mL/m2[95% CI, -3.20 to 1.60; P =.51]). Conclusions and Relevance: Among low-risk patients with revascularization after myocardial infarction, RIM by allied health care professionals was feasible and safe. There were no differences in achieved medication doses or indices of left ventricular remodeling. Further studies of RIM in higher-risk cohorts are warranted. Trial Registration: ClinicalTrials.gov Identifier: NCT02468349.
Source Title: JAMA CARDIOLOGY
URI: https://scholarbank.nus.edu.sg/handle/10635/205819
ISSN: 23806583
23806591
DOI: 10.1001/jamacardio.2020.6721
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