英国伦敦帝国理工学院国家心肺研究所Rasha K Al-Lamee团队，研究了冠状窦减压器改善稳定型冠状动脉疾病患者心绞痛的效果。2024年4月8日出版的《柳叶刀》杂志发表了这项成果。

冠状窦减压器（CSR）旨在通过改善心肌灌注来减少稳定型冠状动脉疾病患者的心绞痛。该研究旨在测量其与安慰剂相比在减少心肌缺血和改善症状方面的疗效。

ORBITA-CSMIC是一项在英国六家医院进行的双盲、随机、安慰剂对照试验。年龄在18岁及以上的心绞痛、稳定型冠状动脉疾病、缺血且无进一步治疗选择的患者符合条件。所有患者在进入为期两周的症状评估阶段之前，都完成了定量腺苷负荷灌注心脏磁共振扫描、症状和生活质量问卷以及跑步机运动测试，患者使用智能手机应用程序（ORBITA app）报告了心绞痛症状。患者被随机分配（1:1）接受CSR或安慰剂治疗。参与者和研究者都被双盲接受研究任务。CSR植入或安慰剂手术后，患者进入为期6个月的双盲随访阶段，在该阶段，他们在ORBITA app中报告了自己的日常症状。6个月时，重复所有评估。主要结局是在腺苷负荷灌注心脏磁共振扫描中登记时指定为缺血节段的心肌血流。主要症状结果是每日心绞痛发作次数。采用意向治疗法进行分析，并遵循贝叶斯方法。

2021年5月26日至2023年6月28日，共有61名患者入组，其中51名（44名[86%]男性；7名[14%]女性）被随机分配到CSR组（n=25）或安慰剂组（n=26）。其中，50名患者被纳入意向治疗分析（CSR组24名，安慰剂组26名）。800个成像的心脏节段中有454个（57%）在入组时出现缺血性，中位负荷心肌血流量为1.08 mL/min/g（IQR 0.77–1.41）。与安慰剂相比，CSR并没有改善缺血性节段的心肌血流量（差异为0.06 mL/min/g[95%CrI–0.09至0.20]；Pr（效益）=78.8%）。与安慰剂相比，CSR可减少每日心绞痛发作次数（OR 1.40[95%CrI1.08-1.83]；Pr（效益）=99.4%）。CSR组发生两次CSR栓塞事件，两组均无急性冠状动脉综合征事件或死亡。

研究结果表明，未发现CSR改善透壁心肌灌注的证据，但与安慰剂相比，CSR确实改善了心绞痛。这些发现为CSR作为稳定型冠状动脉疾病患者的进一步抗心脏病选择提供了证据。

附：英文原文

Title: Coronary sinus reducer for the treatment of refractory angina (ORBITA-COSMIC): a randomised, placebo-controlled trial

Author: Michael J Foley, Christopher A Rajkumar, Fiyyaz Ahmed-Jushuf, Florentina A Simader, Shayna Chotai, Rachel H Pathimagaraj, Muhammad Mohsin, Ahmed Salih, Danqi Wang, Prithvi Dixit, John R Davies, Tom R Keeble, Claudia Cosgrove, James C Spratt, Peter D O’Kane, Ranil De Silva, Jonathan M Hill, Sukhjinder S Nijjer, Sayan Sen, Ricardo Petraco, Ghada W Mikhail, Ramzi Khamis, Tushar Kotecha, Frank E Harrell, Peter Kellman, Darrel P Francis, James P Howard, Graham D Cole, Matthew J Shun-Shin, Rasha K Al-Lamee

Issue&Volume: 2024-04-08

Abstract:

Background

The coronary sinus reducer (CSR) is proposed to reduce angina in patients with stable coronary artery disease by improving myocardial perfusion. We aimed to measure its efficacy, compared with placebo, on myocardial ischaemia reduction and symptom improvement.

Methods

ORBITA-COSMIC was a double-blind, randomised, placebo-controlled trial conducted at six UK hospitals. Patients aged 18 years or older with angina, stable coronary artery disease, ischaemia, and no further options for treatment were eligible. All patients completed a quantitative adenosine-stress perfusion cardiac magnetic resonance scan, symptom and quality-of-life questionnaires, and a treadmill exercise test before entering a 2-week symptom assessment phase, in which patients reported their angina symptoms using a smartphone application (ORBITA-app). Patients were randomly assigned (1:1) to receive either CSR or placebo. Both participants and investigators were masked to study assignment. After the CSR implantation or placebo procedure, patients entered a 6-month blinded follow-up phase in which they reported their daily symptoms in the ORBITA-app. At 6 months, all assessments were repeated. The primary outcome was myocardial blood flow in segments designated ischaemic at enrolment during the adenosine-stress perfusion cardiac magnetic resonance scan. The primary symptom outcome was the number of daily angina episodes. Analysis was done by intention-to-treat and followed Bayesian methodology. The study is registered with ClinicalTrials.gov, NCT04892537, and completed.

Findings

Between May 26, 2021, and June 28, 2023, 61 patients were enrolled, of whom 51 (44 [86%] male; seven [14%] female) were randomly assigned to either the CSR group(n=25) or the placebo group (n=26). Of these, 50 patients were included in the intention-to-treat analysis (24 in the CSR group and 26 in the placebo group). 454 (57%) of 800 imaged cardiac segments were ischaemic at enrolment, with a median stress myocardial blood flow of 1·08 mL/min per g (IQR 0·77–1·41). Myocardial blood flow in ischaemic segments did not improve with CSR compared with placebo (difference 0·06 mL/min per g [95% CrI –0·09 to 0·20]; Pr(Benefit)=78·8%). The number of daily angina episodes was reduced with CSR compared with placebo (OR 1·40 [95% CrI 1·08 to 1·83]; Pr(Benefit)=99·4%). There were two CSR embolisation events in the CSR group, and no acute coronary syndrome events or deaths in either group.

Interpretation

ORBITA-COSMIC found no evidence that the CSR improved transmural myocardial perfusion, but the CSR did improve angina compared with placebo. These findings provide evidence for the use of CSR as a further antianginal option for patients with stable coronary artery disease.

DOI: 10.1016/S0140-6736(24)00256-3

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)00256-3/abstract