Remote Postdischarge Treatment of Patients With Acute Myocardial Infarction by Allied Health Care Practitioners vs Standard Care: The IMMACULATE Randomized Clinical Trial.

Autor:	Chan MY; Cardiovascular Research Institute, Yong Loo-Lin School of Medicine, National University of Singapore, Singapore.; National University Heart Centre, Singapore., Koh KWL; National University Heart Centre, Singapore.; National University Hospital, Singapore., Poh SC; National University Heart Centre, Singapore.; National University Hospital, Singapore., Marchesseau S; Medsavana S.L., Madrid, Spain.; Clinical Imaging Research Centre, National University of Singapore, Singapore., Singh D; National University Heart Centre, Singapore., Han Y; Clinical Imaging Research Centre, National University of Singapore, Singapore., Ng F; National University Heart Centre, Singapore.; National University Hospital, Singapore., Lim E; National University Heart Centre, Singapore.; National University Hospital, Singapore., Prabath JF; Department of Cardiology, Tan Tock Seng Hospital, Singapore., Lee CH; Cardiovascular Research Institute, Yong Loo-Lin School of Medicine, National University of Singapore, Singapore.; National University Heart Centre, Singapore., Sim HW; Cardiovascular Research Institute, Yong Loo-Lin School of Medicine, National University of Singapore, Singapore., Chen R; Department of Cardiology, Tan Tock Seng Hospital, Singapore., Carvalho L; Universidade Federal de São Paulo, Sao Paolo, Brazil., Tan SH; Cardiovascular Research Institute, Yong Loo-Lin School of Medicine, National University of Singapore, Singapore., Loh JPY; National University Heart Centre, Singapore., Tan JWC; National Heart Center, Singapore., Kuwelker K; Betanien Hospital, Skien, Norway., Amanullah RM; National Heart Center, Singapore., Chin CT; National Heart Center, Singapore., Yip JWL; National University Heart Centre, Singapore., Lee CY; National University Heart Centre, Singapore., Gan J; National University Heart Centre, Singapore., Lo CY; National University Heart Centre, Singapore., Ho HH; Department of Cardiology, Tan Tock Seng Hospital, Singapore., Hausenloy DJ; National Heart Center, Singapore.; Cardiovascular & Metabolic Disorders Program, Duke-National University of Singapore Medical School, Singapore.; Cardiovascular Research Center, College of Medical and Health Sciences, Asia University, Taichung, Taiwan., Tai BC; Saw Swee Hock School of Public Health, National University of Singapore, Singapore., Richards AM; Cardiovascular Research Institute, Yong Loo-Lin School of Medicine, National University of Singapore, Singapore.; National University Heart Centre, Singapore.; Christchurch Heart Institute, University of Otago, Christchurch, New Zealand.
Jazyk:	angličtina
Zdroj:	JAMA cardiology [JAMA Cardiol] 2021 Jul 01; Vol. 6 (7), pp. 830-835.
DOI:	10.1001/jamacardio.2020.6721
Abstrakt:	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.
Databáze:	MEDLINE
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