Safety and efficacy of the reducer: A multi-center clinical registry - REDUCE study.

BACKGROUND

The coronary sinus (CS) Reducer is a novel device designed to aid in the management and to improve quality of life of patients with severe angina symptoms refractory to optimal medical and interventional therapies. This study aims to assess the safety and efficacy of the Reducer in a real-world cohort of patients presenting with refractory angina.

METHODS

One hundred forty-one consecutive patients were treated with CS Reducer implantation. The primary efficacy endpoint was reduction in angina symptoms from baseline as assessed by Canadian Cardiovascular Society (CCS) class status and Seattle Angina Questionnaire (SAQ) scores. The primary safety endpoint was successful Reducer device delivery and deployment in the absence of any device-related events.

RESULTS

Procedural success was achieved in 139 (98.6%) patients. Reducer implantation was not obtained in 2 (1.4%) patients because of unfavorable anatomy of the CS. There were no CS perforations, cardiac tamponade, peri-procedural death or myocardial infarction during a median follow-up of 14 months (range from 6- to 70-month). In patients undergoing Reducer implantation, mean CCS class improved from 3.05 ± 0.53 at baseline to 1.63 ± 0.98 at follow-up (p < 0.001). Overall, 113 (81%) patients experienced at least 1 CCS improvement, and 63 (45%) patients at least 2 CCS-class improvement. All SAQ items improved significantly (p < 0.001 for all) and translated into a significant reduction in the mean number of anti-ischemic drugs prescribed (2.37 ± 0.97 vs 2.17 ± 0.95; p = 0.003).

CONCLUSIONS

In a real-world multi-center experience, implantation of the CS Reducer appears safe, and efficacious in reducing symptoms of angina and improving quality of life.