背景:提出了冠状静脉窦减少器(CSR)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。我们的目的是衡量它的功效,与安慰剂相比,减少心肌缺血和改善症状。
方法:ORBITA-COSMIC是双盲,随机化,在英国六家医院进行的安慰剂对照试验。18岁或以上心绞痛患者,稳定型冠状动脉疾病,缺血,并且没有进一步的治疗选择合格.所有患者都完成了腺苷负荷灌注心脏磁共振定量扫描,症状和生活质量问卷,在进入为期2周的症状评估阶段之前进行跑步机运动测试,其中患者使用智能手机应用程序(ORBITA-app)报告其心绞痛症状。患者被随机分配(1:1)接受CSR或安慰剂。参与者和研究人员都被掩盖了研究任务。在CSR植入或安慰剂手术后,患者进入为期6个月的盲法随访阶段,在随访阶段,他们在ORBITA-app中报告了每日症状.6个月时,重复所有评估.主要结果是在腺苷负荷灌注心脏磁共振扫描期间注册时指定为缺血段的心肌血流。主要症状结果是每日心绞痛发作次数。采用意向治疗和贝叶斯方法进行分析。这项研究在ClinicalTrials.gov注册,NCT04892537,并完成。
结果:在2021年5月26日至2023年6月28日之间,招募了61名患者,其中51人(44[86%]男性;7人[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)。入选时,800个成像心脏段中的454个(57%)为缺血,中位压力心肌血流量为1·08mL/min/g(IQR0·77-1·41)。与安慰剂相比,CSR没有改善缺血段的心肌血流量(每克差异0·06mL/min[95%CrI-0·09至0·20];Pr(获益)=78·8%)。与安慰剂相比,CSR的每日心绞痛发作次数减少(OR1·40[95%CrI1·08至1·83];Pr(获益)=99·4%)。CSR组有两次CSR栓塞事件,两组均无急性冠脉综合征事件或死亡。
结论:ORBITA-COSMIC没有发现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。这些发现为使用CSR作为稳定型冠状动脉疾病患者的进一步抗心绞痛选择提供了证据。
背景:医学研究委员会,帝国理工学院医疗保健慈善机构,帝国生物医学研究中心,国家健康与护理研究所,圣玛丽冠状动脉流信托基金,英国心脏基金会
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.
RESULTS: 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.
CONCLUSIONS: 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.
BACKGROUND: Medical Research Council, Imperial College Healthcare Charity, National Institute for Health and Care Research Imperial Biomedical Research Centre, St Mary\'s Coronary Flow Trust, British Heart Foundation.