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Effectiveness of Coronary Sinus Reducer for Treatment of Refractory Angina: A Meta-analysis
Aviram Hochstadt1, Tamar Itach2, Ilan Merdler1
1Division of Cardiology, Tel Aviv Sourasky Medical Centre and Sackler School of Medicine, Tel Aviv University, Tel Aviv, Israel.
Insights
Coronary sinus reducer implantation offers significant symptom improvement for refractory angina patients. This therapy demonstrates a low complication rate, enhancing quality of life for those with limited treatment options.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina significantly impacts patient quality of life, often leaving them with no further treatment options.
- Coronary sinus (CS) reducer implantation is an emerging therapy for refractory angina, gaining traction due to demonstrated effectiveness.
- Previous research includes one randomized trial and multiple uncontrolled studies, necessitating a comprehensive meta-analysis.
Purpose of the Study:
- To conduct a meta-analysis evaluating the efficacy and safety of coronary sinus (CS) reducer implantation for refractory angina.
- To synthesize data from existing prospective studies to provide a clearer understanding of CS reducer therapy outcomes.
- To assess the impact of CS reducer implantation on Canadian Cardiovascular Society (CCS) angina scores, quality of life, and procedural safety.
Main Methods:
- A meta-analysis of prospective studies on CS narrowing published in English up to June 2021 was performed.
- Primary outcome: proportion of patients with ≥ 1 class improvement in CCS angina score.
- Secondary outcomes included ≥ 2 CCS class improvement, procedural success, complications, Seattle Angina Questionnaire (SAQ) scores, and 6-minute walk test (6MWT) distance.
Main Results:
- Data from 9 studies involving 846 patients were analyzed.
- 76% of patients experienced ≥ 1 CCS class improvement, and 40% showed ≥ 2 class improvement.
- Procedural success was high (98%) with a low rate of nonmajor complications (3%); significant improvements in SAQ scores and 6MWT distance were observed.
Conclusions:
- Coronary sinus reducer implantation effectively improves symptoms and quality of life in refractory angina patients.
- The procedure is associated with a low complication rate, making it a viable option for patients unresponsive to other therapies.
- Findings are consistent across a randomized trial and multiple prospective studies, supporting the therapy's efficacy and safety profile.
Background:
Refractory angina is a debilitating condition that affects the quality of life of patients worldwide, who after exhausting standard available therapies are regarded as "no option" patients. Recently, CS (coronary sinus) reducer (Neovasc Reducer) implantation became available and is gaining popularity in the treatment of refractory angina. The effectiveness of this therapy was demonstrated in 1 randomised sham-control trial and numerous uncontrolled prospective studies entailing several hundred patients altogether. We performed a meta-analysis to incorporate the data and elucidate its efficacy and safety.
Methods:
A meta-analysis of prospective studies assessing the effects of CS narrowing published in English to June 2021 was performed. The primary outcome was the proportion of patients improving ≥ 1 class in the Canadian Cardiovascular Society (CCS) angina score. Other end points included proportion of patients improving ≥ 2 CCS classes, procedural success, periprocedural complications, changes in Seattle Angina Questionnaire (SAQ) scores, and 6-minute walk test (6MWT).
Results:
Data from 9 studies including 846 patients were included. An improvement of ≥ 1 CCS class occurred in 76% (95% confidence interval [CI] 73%-80%) of patients. Improvement of ≥ 2 CCS classes was observed in 40% of patients (95% CI 35%-46%). Procedure success was 98%, with no major and 3% nonmajor periprocedural complications. Post procedural SAQ scores and 6MWT distance were significantly improved.
Conclusions:
In patients suffering from angina refractory to medical and interventional therapies, Reducer implantation improves symptoms and quality of life with a low complication rate. These results are consistent in 1 randomised trial and multiple prospective uncontrolled studies.
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