慢性稳定型心绞痛患者的慢性远程缺血预处理治疗（EARLY-MYO-CSA）：一项随机、对照的概念验证试验。
Chronic remote ischemic conditioning treatment in patients with chronic stable angina (EARLY-MYO-CSA): a randomized, controlled proof-of-concept trial.
机构信息
Department of Cardiology, Department of Coronary Heart Disease of Central China Fuwai Hospital, Henan Key Laboratory for Coronary Heart Disease, Central China Fuwai of Zhengzhou University, Henan Provincial People's Hospital, People's Hospital of Zhengzhou University, No. 1 Fuwai Road, Zhengzhou, Henan Province, China.
Department of Cardiology, School of Medicine, Ren Ji Hospital, Shanghai Jiao Tong University, 160 Pujian Road, Shanghai, 200127, China.
出版信息
BMC Med. 2023 Aug 25;21(1):324. doi: 10.1186/s12916-023-03041-z.
BACKGROUND
Chronic remote ischemic conditioning (CRIC) has been shown to improve myocardial ischemia in experimental animal studies; however, its effectiveness in patients with chronic stable angina (CSA) has not been investigated. We conducted a proof-of-concept study to investigate the efficacy and safety of a six-month CRIC treatment in patients with CSA.
METHODS
The EARLY-MYO-CSA trial was a prospective, randomized, controlled trial evaluating the CRIC treatment in patients with CSA with persistent angina pectoris despite receiving ≥ 3-month guideline-recommended optimal medical therapy. The CRIC and control groups received CRIC (at 200 mmHg) or sham CRIC (at 60 mmHg) intervention for 6 months, respectively. The primary endpoint was the 6-month change of myocardial flow reserve (MFR) on single-photon emission computed tomography. The secondary endpoints were changes in rest and stress myocardial blood flow (MBF), angina severity according to the Canadian Cardiovascular Society (CCS) classification, the Seattle Angina Questionnaire (SAQ), and a 6-min walk test (6-MWT).
RESULTS
Among 220 randomized CSA patients, 208 (105 in the CRIC group, and 103 in the control group) completed the treatment and endpoint assessments. The mean change in MFR was significantly greater in the CRIC group than in the control group (0.27 ± 0.38 vs. - 0.04 ± 0.25; P < 0.001). MFR increased from 1.33 ± 0.48 at baseline to 1.61 ± 0.53 (P < 0.001) in the CRIC group; however, a similar increase was not seen in the control group (1.35 ± 0.45 at baseline and 1.31 ± 0.44 at follow-up, P = 0.757). CRIC treatment, when compared with controls, demonstrated improvements in angina symptoms assessed by CCS classification (60.0% vs. 14.6%, P < 0.001), all SAQ dimensions scores (P < 0.001), and 6-MWT distances (440 [400-523] vs. 420 [330-475] m, P = 0.016). The incidence of major adverse cardiovascular events was similar between the groups.
CONCLUSIONS
CSA patients benefit from 6-month CRIC treatment with improvements in MFR, angina symptoms, and exercise performance. This treatment is well-tolerated and can be recommended for symptom relief in this clinical population.
TRIAL REGISTRATION
[chictr.org.cn], identifier [ChiCTR2000038649].
背景
慢性远程缺血预处理（CRIC）已被证明可改善实验动物模型中的心肌缺血，但尚未在慢性稳定性心绞痛（CSA）患者中进行研究。我们进行了一项概念验证研究，以调查 CSA 患者接受为期 6 个月的 CRIC 治疗的疗效和安全性。
方法
EARLY-MYO-CSA 试验是一项前瞻性、随机、对照试验，评估了持续心绞痛的 CSA 患者接受至少 3 个月的指南推荐的最佳药物治疗后，CRIC 治疗的疗效。CRIC 组和对照组分别接受 6 个月的 CRIC（200mmHg）或假 CRIC（60mmHg）干预。主要终点是单光子发射计算机断层扫描的 6 个月心肌血流储备（MFR）变化。次要终点是静息和应激心肌血流（MBF）、根据加拿大心血管学会（CCS）分类的心绞痛严重程度、西雅图心绞痛问卷（SAQ）和 6 分钟步行试验（6-MWT）的变化。
结果
在 220 名随机分配的 CSA 患者中，208 名（CRIC 组 105 名，对照组 103 名）完成了治疗和终点评估。CRIC 组的 MFR 变化明显大于对照组（0.27±0.38 对-0.04±0.25；P<0.001）。CRIC 组 MFR 从基线时的 1.33±0.48 增加到 1.61±0.53（P<0.001）；然而，对照组未见类似增加（基线时为 1.35±0.45，随访时为 1.31±0.44，P=0.757）。与对照组相比，CRIC 治疗改善了 CCS 分类评估的心绞痛症状（60.0%对 14.6%，P<0.001）、所有 SAQ 维度评分（P<0.001）和 6-MWT 距离（440[400-523]对 420[330-475]m，P=0.016）。两组主要不良心血管事件的发生率相似。
结论
CSA 患者接受 6 个月的 CRIC 治疗后，MFR、心绞痛症状和运动能力均得到改善。这种治疗方法耐受性良好，可推荐用于该临床人群的症状缓解。
试验注册
[chictr.org.cn]，标识符[ChiCTR2000038649]。
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