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稳定性冠心病门诊患者心绞痛症状和心肌缺血的患病率及其对临床结局的影响:来自国际观察性 CLARIFY 登记研究的数据。

Prevalence of anginal symptoms and myocardial ischemia and their effect on clinical outcomes in outpatients with stable coronary artery disease: data from the International Observational CLARIFY Registry.

机构信息

Université Paris-Diderot, Sorbonne Paris-Cité, Paris, France2Unit 1148, Institut National de la Santé et de la Recherche Médicale, Paris, France3Département Hospitalo-Universitaire FIRE (Fibrosis, Inflammation and Remodeling), Department of Cardiology, Hô

Robertson Centre for Biostatistics, University of Glasgow, Glasgow, Scotland.

出版信息

JAMA Intern Med. 2014 Oct;174(10):1651-9. doi: 10.1001/jamainternmed.2014.3773.

DOI:10.1001/jamainternmed.2014.3773
PMID:25110899
Abstract

IMPORTANCE

In the era of widespread revascularization and effective antianginals, the prevalence and prognostic effect of anginal symptoms and myocardial ischemia among patients with stable coronary artery disease (CAD) are unknown.

OBJECTIVE

To describe the current clinical patterns among patients with stable CAD and the association of anginal symptoms or myocardial ischemia with clinical outcomes.

DESIGN, SETTING, AND PARTICIPANTS: The Prospective Observational Longitudinal Registry of Patients With Stable Coronary Artery Disease (CLARIFY) registry enrolled outpatients in 45 countries with stable CAD in 2009 to 2010 with 2-year follow-up (median, 24.1 months; range, 1 day to 3 years). Enrollees included 32 105 outpatients with prior myocardial infarction, chest pain, and evidence of myocardial ischemia, evidence of CAD on angiography, or prior revascularization. Of these, 20 291 (63.2%) had undergone a noninvasive test for myocardial ischemia within 12 months of enrollment and were categorized into one of the following 4 groups: no angina or ischemia (n = 13 207 [65.1%]); evidence of myocardial ischemia without angina (silent ischemia) (n = 3028 [14.9%]); anginal symptoms alone (n = 1842 [9.1%]); and angina and ischemia (n = 2214 [10.9%]).

EXPOSURES

Stable CAD.

MAIN OUTCOME AND MEASURE

The composite of cardiovascular (CV)-related death or nonfatal myocardial infarction.

RESULTS

Overall, 4056 patients (20.0%) had anginal symptoms and 5242 (25.8%) had evidence of myocardial ischemia on results of noninvasive testing. Of 469 CV-related deaths or myocardial infarctions, 58.2% occurred in patients without angina or ischemia, 12.4% in patients with ischemia alone, 12.2% in patients with angina alone, and 17.3% in patients with both. The hazard ratios for the primary outcome relative to patients without angina or ischemia and adjusted for age, sex, geographic region, smoking status, hypertension, diabetes mellitus, and dyslipidemia were 0.90 (95% CI, 0.68-1.20; P = .47) for ischemia alone, 1.45 (95% CI, 1.08-1.95; P = .01) for angina alone, and 1.75 (95% CI, 1.34-2.29; P < .001) for both. Similar findings were observed for CV-related death and for fatal or nonfatal myocardial infarction.

CONCLUSIONS AND RELEVANCE

In outpatients with stable CAD, anginal symptoms (with or without ischemia on noninvasive testing) but not silent ischemia appear to be associated with an increased risk for adverse CV outcomes. Most CV events occurred in patients without angina or ischemia.

TRIAL REGISTRATION

isrctn.org Identifier: ISRCTN43070564.

摘要

重要性

在广泛的血运重建和有效的抗心绞痛治疗时代,稳定型冠状动脉疾病(CAD)患者的心绞痛症状和心肌缺血的流行情况及其预后影响尚不清楚。

目的

描述稳定型 CAD 患者的当前临床模式,以及心绞痛症状或心肌缺血与临床结局之间的关联。

设计、地点和参与者:前瞻性观察性稳定型冠状动脉疾病患者纵向登记研究(CLARIFY)于 2009 年至 2010 年在 45 个国家招募了稳定型 CAD 的门诊患者,随访时间为 2 年(中位数为 24.1 个月;范围为 1 天至 3 年)。入组患者包括 32105 名既往有心肌梗死、胸痛和心肌缺血证据、冠状动脉造影有 CAD 证据或既往血运重建的门诊患者。其中,20291 名(63.2%)在入组后 12 个月内接受了心肌缺血的非侵入性检查,并分为以下 4 组之一:无心绞痛或缺血(n=13207[65.1%]);有心肌缺血但无症状(无症状性缺血)(n=3028[14.9%]);仅有心绞痛症状(n=1842[9.1%]);以及心绞痛和缺血(n=2214[10.9%])。

暴露情况

稳定型 CAD。

主要结局和测量指标

心血管(CV)相关死亡或非致死性心肌梗死的复合终点。

结果

共有 4056 名患者(20.0%)有胸痛症状,5242 名患者(25.8%)在非侵入性检查结果中有心肌缺血证据。469 例 CV 相关死亡或心肌梗死中,58.2%发生在无胸痛或缺血的患者中,12.4%发生在仅有缺血的患者中,12.2%发生在仅有胸痛的患者中,17.3%发生在同时有胸痛和缺血的患者中。与无胸痛或缺血的患者相比,主要结局的风险比为 0.90(95%CI,0.68-1.20;P=0.47),调整年龄、性别、地理区域、吸烟状况、高血压、糖尿病和血脂异常后,仅有缺血的风险比为 1.45(95%CI,1.08-1.95;P=0.01),仅有胸痛的风险比为 1.45(95%CI,1.08-1.95;P=0.01),同时有胸痛和缺血的风险比为 1.75(95%CI,1.34-2.29;P<0.001)。在 CV 相关死亡和致命或非致命性心肌梗死的结局中也观察到了类似的发现。

结论和相关性

在稳定型 CAD 的门诊患者中,心绞痛症状(有或无非侵入性检查的缺血)而不是无症状性缺血似乎与不良 CV 结局风险增加相关。大多数 CV 事件发生在无胸痛或缺血的患者中。

试验注册

国际标准随机对照试验注册平台(ISRCTN)编号:ISRCTN43070564。

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