Narrowing of the Coronary Sinus for the Treatment of Angina Pectoris- Preliminary Results of the REDUCER-I trial (A Multi-Center Prospective Observational Open-Label Clinical Trial)

Background: Refractory angina is a common disabling clinical condition, and a major public health problem, which affects patients` quality of life, and has a significant impact upon health care resources. The coronary sinus (CS) Reducer is a novel technology designed to reduce disabling symptoms and improve quality of life of patients suffering from refractory angina.

Methods: The REDUCER-I is an open label post market multicenter study which collects long term data of subjects with refractory angina pectoris treated with the Reducer. Patient with refractory angina (CCS class 2-4) underwent Reducer implantation. Baseline, and follow-up evaluation consisted of clinical assessment including the completion of Seattle angina Questionnaire (SAQ) and CCS class evaluation, and objective assessment by treadmill ergometry, and 6-minute walk test (6MWT).

Results: 188 patients (78% male, 67.9±9.5 years) were enrolled. No procedure or device related adverse events were recorded at up to 5 years. Angina severity score (CCS class) diminished from a mean of 2.8 ±0.6 at baseline to 1.8±0.7 at both 6 and 24 months (p<0.001). All domains of Seattle Angina Questionnaire improved significantly 6 and 12 months after Reducer implantation. 6MWT distance increased from 324.2±124.8 m. at baseline to 375.6±108.8 m (p<0.001) following Reducer implantation, and there was a trend towards longer exercise duration in treadmill ergometry (356.1±154.2 sec vs. 377.5±157.2 sec, p=0.055)

Conclusions: Reducer implantation for the treatment of severe refractory angina is a safe procedure, which significantly alleviates symptoms of angina and improves quality of life and indices of physical function.