Cardiovascular Research Center, Massachusetts General Hospital, 185 Cambridge Street, CPZN 3.184, Boston, MA 02114, United States; Cardiovascular Disease Prevention Center, Massachusetts General Hospital, Boston, MA, United States; Department of Medicine, Harvard Medical School, Boston, MA, United States; Program in Medical and Population Genetics and Cardiovascular Disease Initiative, Broad Institute of Harvard and MIT, Cambridge, MA, United States.
Cardiovascular Research Center, Massachusetts General Hospital, 185 Cambridge Street, CPZN 3.184, Boston, MA 02114, United States.
EBioMedicine. 2021 Oct;72:103593. doi: 10.1016/j.ebiom.2021.103593. Epub 2021 Oct 14.
BACKGROUND: The interval between inpatient hospitalization for symptomatic coronary artery disease (CAD) and post-discharge office consultation is a vulnerable period for adverse events. METHODS: Content was customized on a smartphone app-based platform for hospitalized patients receiving percutaneous coronary intervention (PCI) which included education, tracking, reminders and live health coaches. We conducted a single-arm open-label pilot study of the app at two academic medical centers in a single health system, with subjects enrolled 02/2018-05/2019 and 1:3 propensity-matched historical controls from 01/2015-12/2017. To evaluate feasibility and efficacy, we assessed 30-day hospital readmission (primary), outpatient cardiovascular follow-up, and cardiac rehabilitation (CR) enrollment as recorded in the health system. Outcomes were assessed by Cox Proportional Hazards model. FINDINGS: 118 of 324 eligible (36·4%) 21-85 year-old patients who underwent PCI for symptomatic CAD who owned a smartphone or tablet enrolled. Mean age was 62.5 (9·7) years, 87 (73·7%) were male, 40 of 118 (33·9%) had type 2 diabetes mellitus, 68 (57·6%) enrolled underwent PCI for MI and 59 (50·0%) had previously known CAD; demographics were similar among matched historical controls. No significant difference existed in all-cause readmission within 30 days (8·5% app vs 9·6% control, ARR -1.1% absolute difference, 95% CI -7·1-4·8, p = 0·699) or 90 days (16·1% app vs 19·5% control, p = 0.394). Rates of both 90-day CR enrollment (HR 1·99, 95% CI 1·30-3·06) and 1-month cardiovascular follow up (HR 1·83, 95% CI 1·43-2·34) were greater with the app. Weekly engagement at 30- and 90-days, as measured by percentage of weeks with at least one day of completion of tasks, was mean (SD) 73·5% (33·9%) and 63·5% (40·3%). Spearman correlation analyses indicated similar engagement across age, sex, and cardiovascular risk factors. INTERPRETATIONS: A post-PCI smartphone app with live health coaches yielded similarly high engagement across demographics and safely increased attendance in cardiac rehabilitation. Larger prospective randomized controlled trials are necessary to test whether this app improves cardiovascular outcomes following PCI. FUNDING: National Institutes of Health, Boston Scientific. CLINICAL TRIAL REGISTRATION: NCT03416920 (https://clinicaltrials.gov/ct2/show/NCT03416920).
背景：有症状的冠状动脉疾病（CAD）住院治疗和出院后门诊咨询之间的间隔是不良事件的脆弱期。
方法：我们为接受经皮冠状动脉介入治疗（PCI）的住院患者定制了一个基于智能手机应用程序的平台上的内容，其中包括教育、跟踪、提醒和实时健康教练。我们在一个单一的医疗系统中的两个学术医疗中心进行了基于应用程序的单臂开放标签试点研究，研究对象于 2018 年 2 月至 2019 年 5 月入选，1：3 比例倾向性匹配历史对照组来自 2015 年 1 月至 2017 年 12 月。为了评估可行性和疗效，我们评估了健康系统中记录的 30 天院内再入院（主要）、门诊心血管随访和心脏康复（CR）登记情况。结局采用 Cox 比例风险模型评估。
结果：在符合条件的 324 名 21-85 岁接受 PCI 治疗有症状 CAD 的患者中，有 118 名（36.4%）拥有智能手机或平板电脑。平均年龄为 62.5（9.7）岁，87 名（73.7%）为男性，40 名（33.9%）患有 2 型糖尿病，68 名（57.6%）因心肌梗死而接受 PCI 治疗，59 名（50.0%）有已知 CAD；匹配的历史对照组中，这些人群的人口统计学特征相似。30 天内全因再入院率无显著差异（应用程序 8.5% vs 对照组 9.6%，ARR-1.1%绝对差值，95%CI-7.1-4.8，p=0.699）或 90 天（应用程序 16.1% vs 对照组 19.5%，p=0.394）。应用程序组的 90 天 CR 登记率（HR 1.99，95%CI 1.30-3.06）和 1 个月心血管随访率（HR 1.83，95%CI 1.43-2.34）均较高。以每周至少有一天完成任务的周数的百分比衡量，30 天和 90 天的平均（SD）参与度分别为 73.5%（33.9%）和 63.5%（40.3%）。Spearman 相关分析表明，不同年龄、性别和心血管危险因素的参与度相似。
解释：具有实时健康教练的 PCI 后智能手机应用程序在不同人群中产生了类似的高参与度，并安全地增加了心脏康复的参与度。需要更大规模的前瞻性随机对照试验来测试该应用程序是否能改善 PCI 后的心血管结局。
资金来源：美国国立卫生研究院、波士顿科学公司。
临床试验注册：NCT03416920（https://clinicaltrials.gov/ct2/show/NCT03416920）。
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