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根据现行指南管理的新发稳定型心绞痛患者的临床结局。ARCA(慢性稳定性心绞痛注册研究)注册研究:一项前瞻性、观察性、全国性研究。

Clinical outcomes of newly diagnosed, stable angina patients managed according to current guidelines. The ARCA (Arca Registry for Chronic Angina) Registry: A prospective, observational, nationwide study.

机构信息

University Division of Cardiology, Cardiothoracic and Vascular Department, Azienda Ospedaliera Universitaria Pisana, Pisa, Italy.

Department of Surgery, Medical, Molecular and Critical Area Pathology, University of Pisa, Italy.

出版信息

Int J Cardiol. 2022 Apr 1;352:9-18. doi: 10.1016/j.ijcard.2022.01.056. Epub 2022 Feb 1.

Abstract

BACKGROUND

Clinical outcomes of stable angina patients treated according to guidelines recommendations (medical therapy first, selective revascularization in high risk or unresponsive patients) are not fully known.

METHODS AND RESULTS

Eight hundred thirty-three patients with newly diagnosed, stable angina were enrolled in a prospective, observational, nationwide registry and followed for 1 year. Symptoms and quality of life were evaluated with the CCS angina grading, with a self-assessment scale and with the SAQ-7. A composite end-point of MACEs (all-cause death, non-fatal myocardial infarction, non-fatal stroke or hospitalization for unstable angina) at 1 year was considered. Upon enrollment, all patients were prescribed guidelines directed medical therapy. After one month of therapy, angina relieved or improved in 47% of the overall population. Patients in CCS class I significantly increased from 28.4% at enrollment to 67.1% at 12 months, and the SAQ-7 score from 58.4 ± 20 to 85.9 ± 14. The rate of MACEs was low (2.9%) in the overall population. After one month of medical therapy, 40.6% of patients were referred for coronary angiography and revascularization for resistant symptoms (invasive strategy). Among these, 38.2% had normal coronary arteries and 47% actually underwent revascularization. No difference between invasive and medical groups was found at 12 months in symptoms, quality of life and MACEs, except for a greater improvement in self-assessed symptoms in the invasive group. Combined medical and invasive strategies left 28.5% of patients still symptomatic at the end of the study.

CONCLUSIONS

The study confirms the efficacy and safety of a tailored approach to stable angina, as recommended by guidelines, with medical therapy first followed by selective revascularization when needed.

摘要

背景

根据指南建议(首先进行药物治疗,对高危或无反应患者进行选择性血运重建)治疗稳定型心绞痛患者的临床结局尚不完全清楚。

方法和结果

833 例新诊断的稳定型心绞痛患者参与了一项前瞻性、观察性、全国性注册研究,并随访 1 年。通过 CCS 心绞痛分级、自我评估量表和 SAQ-7 评估症状和生活质量。将 1 年时的 MACEs(全因死亡、非致死性心肌梗死、非致死性卒中和不稳定型心绞痛住院)复合终点作为观察终点。入组时,所有患者均接受指南指导的药物治疗。在治疗 1 个月后,整体人群中 47%的心绞痛得到缓解或改善。CCS 分级 I 级患者比例从入组时的 28.4%显著增加到 12 个月时的 67.1%,SAQ-7 评分从 58.4±20 增加到 85.9±14。整体人群的 MACEs 发生率较低(2.9%)。在药物治疗 1 个月后,40.6%的患者因症状顽固(侵入性策略)行冠状动脉造影和血运重建。其中,38.2%患者冠状动脉正常,47%患者实际进行了血运重建。在 12 个月时,侵入性组和药物组在症状、生活质量和 MACEs 方面没有差异,除了侵入性组自我评估症状的改善更大。联合药物和侵入性策略使 28.5%的患者在研究结束时仍有症状。

结论

该研究证实了根据指南推荐的针对稳定型心绞痛的个体化治疗方法的疗效和安全性,首先进行药物治疗,必要时进行选择性血运重建。

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