Department of Medicine, Interventional Cardiology, Montreal Heart Institute, Montreal, Quebec, Canada
Antwerp Cardiovascular Institute, ZNA Middelheim Hospital, Antwerpen, Belgium.
Heart. 2021 Jan;107(1):41-46. doi: 10.1136/heartjnl-2020-316644. Epub 2020 Jul 21.
Reduction of the coronary sinus was shown to improve angina in patients unsuitable for revascularisation. We assessed whether a percutaneous device that reduces the diameter of the coronary sinus improved outcomes across multiple endpoints in a phase II trial.
We conducted a novel analysis performed as a post hoc efficacy analysis of the COSIRA (ronary nus educer for Treatment of Refractory ngina) trial, which enrolled patients with Canadian Cardiovascular Society (CCS) class 3-4 refractory angina. We used four domains: symptoms (CCS Angina Scale), functionality (total exercise duration), ischaemia (imaging) and health-related quality of life. For all domains, we specified a meaningful threshold for change. The primary endpoint was defined as a probability of ≥80% that the reducer exceeded the meaningful threshold on two or more domains (group-level analysis) or that the average efficacy score in the reducer group exceeded the sham control group by at least two points (patient-level analysis).
We randomised 104 participants to either a device that narrows to coronary sinus (n=52) or a sham implantation (n=52). The reducer group met the prespecified criteria for concordance at the group level and demonstrated improvement in symptoms (0.59 CCS grade, 95% credible interval (CrI)=0.22 to 0.95), total exercise duration (+27.9%, 95% CrI=2.8% to 59.8%) and quality of life (stability +11.2 points, 95% CrI=3.3 to 19.1; perception +11.0, 95% CrI=3.3 to 18.7).
The reducer concordantly improved symptoms, functionality and quality of life compared with a sham intervention in patients with angina unsuitable for coronary revascularisation. Concordant analysis such as this one can help interpret early phase trials and guide the decision to pursue a clinical programme into a larger confirmatory trial.
ClinicalTrials.gov identifier: NCT01205893.
减少冠状窦已被证明可改善不适合血运重建的患者的心绞痛。我们评估了一种经皮装置，该装置缩小冠状窦的直径是否可以通过多个终点改善结果在 II 期试验中。
我们进行了一项新的分析，作为 ronary nus educer for Treatment of Refractory ngina（COSIRA）试验的事后疗效分析，该试验招募了加拿大心血管学会（CCS）3-4 级难治性心绞痛患者。我们使用了四个领域：症状（CCS 心绞痛量表）、功能（总运动时间）、缺血（影像学）和健康相关生活质量。对于所有领域，我们都指定了有意义的变化阈值。主要终点定义为降低器在两个或更多领域超过有意义阈值的概率≥80%（组水平分析）或降低器组的平均疗效评分至少比假手术对照组高 2 分（患者水平分析）。
我们将 104 名参与者随机分配到缩小冠状窦的装置（n=52）或假植入组（n=52）。降低器组在组水平上符合一致性预设标准，并在症状（0.59CCS 等级，95%置信区间（CrI）=0.22 至 0.95）、总运动时间（增加 27.9%，95%CrI=2.8%至 59.8%）和生活质量（稳定性增加 11.2 分，95%CrI=3.3 至 19.1；感知增加 11.0，95%CrI=3.3 至 18.7）方面均有所改善。
与假手术干预相比，降低器在不适合冠状动脉血运重建的心绞痛患者中一致改善了症状、功能和生活质量。这种一致性分析可以帮助解释早期阶段的试验，并指导决策是否进行更大规模的确认性试验。
ClinicalTrials.gov 标识符：NCT01205893。
