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Published on: June 28, 2019
Safety and efficacy of coronary sinus narrowing in chronic refractory angina: Insights from the RESOURCE study
Francesco Ponticelli1, Arif A Khokhar1, Geert Leenders2
1Interventional Cardiology Unit, GVM Care & Research Maria Cecilia Hospital, Cotignola, Italy.
Insights
Coronary sinus Reducer (CSR) implantation safely reduces angina in refractory angina patients. The RESOURCE registry shows significant symptom improvement and acceptable safety in a large, real-world cohort.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina (RA) represents end-stage coronary artery disease with limited treatment options.
- Coronary sinus Reducer (CSR) is a novel therapy for RA, but its efficacy requires evaluation in larger populations.
- The RESOURCE registry offers insights into CSR therapy in a real-world setting.
Purpose of the Study:
- To evaluate the safety and efficacy of Coronary sinus Reducer (CSR) implantation in patients with refractory angina (RA).
- To assess symptom amelioration, procedural success, complications, and major adverse cardiovascular events (MACE) following CSR implantation.
Main Methods:
- Observational, retrospective registry (RESOURCE) including 658 RA patients from 20 European, UK, and Israeli centers.
- Primary endpoint: improvement in Canadian Cardiovascular Society (CCS) score.
- Secondary endpoints: procedural success, complications, and MACE (all-cause mortality, acute coronary syndromes, stroke).
Main Results:
- At median 502-day follow-up, 39.7% improved by ≥2 CCS classes and 76% by ≥1 class.
- Procedural success was 96.7%; complications occurred in 5.7% without severe adverse events.
- Overall mortality and MACE at last follow-up were 10.4% and 14.6%, respectively.
Conclusions:
- Coronary sinus Reducer (CSR) implantation is a safe and effective procedure for reducing angina symptoms in refractory angina patients.
- The RESOURCE registry supports CSR as a viable therapeutic option for end-stage coronary artery disease.
Introduction:
Refractory angina (RA) is considered the end-stage of coronary artery disease, and often has no interventional treatment options. Coronary sinus Reducer (CSR) is a recent addition to the therapeutic arsenal, but its efficacy has only been evaluated on small populations. The RESOURCE registry provides further insights into this therapy.
Methods:
The RESOURCE is an observational, retrospective registry that includes 658 patients with RA from 20 centers in Europe, United Kingdom and Israel. Prespecified endpoints were the amelioration of anginal symptoms evaluated with the Canadian Cardiovascular Society (CCS) score, the rates of procedural success and complications, and MACEs as composite of all-cause mortality, acute coronary syndromes, and stroke.
Results:
At a median follow-up of 502 days (IQR 225-1091) after CSR implantation, 39.7% of patients improved by ≥2 CCS classes (primary endpoint), and 76% by ≥1 class. Procedural success was achieved in 96.7% of attempts, with 3% of procedures aborted mostly for unsuitable coronary sinus anatomy. Any complication occurred in 5.7% of procedures, but never required bailout surgery nor resulted in intra- or periprocedural death or myocardial infarction. One patient developed periprocedural stroke after inadvertent carotid artery puncture. At the last available follow-up, overall mortality and MACE were 10.4% and 14.6% respectively. At one, three and five years, mortality rate at Kaplan-Meier analysis was 4%, 13.7%, and 23.4% respectively.
Conclusions:
CSR implantation is safe and reduces angina in patients with refractory angina.
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