Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study)

Abstract

Background: The REDUCER-I study is a prospective (with a retrospective component), open-label, multi-centre, international, post-market study, which collects long-term data of patients with refractory angina treated with the Reducer. Here we present the overall clinical outcomes of the first 228 patients enrolled.

Aims: The aim of this study is to examine the safety and efficacy of the coronary sinus (CS) Reducer in improving angina severity and quality of life in patients suffering from angina pectoris, refractory to medical and interventional therapies.

Methods: REDUCER-I is a multicentre, non-randomised observational study. Enrolled patients had refractory angina pectoris Canadian Cardiovascular Society (CCS) class II-IV and were treated with Reducer implantation.

Results: In the first 228 patients (81% male, 68.3±9.6 years), the procedural success rate was 99%, with only one adjudicated possible procedural or device-related MACE. Mean CCS class decreased from 2.8±0.6 at baseline, to 1.8±0.7 at two years. Improvement in ≥1 CCS class was observed in 82%, and in ≥2 CCS classes in 31% of patients at two years. At baseline, 70% of the cohort were reported to be in CCS class III-IV; this portion was reduced to 15% at follow-up. Additional measured parameters of functional class and quality of life were also improved.

Conclusions: Interim results from the ongoing REDUCER-I study confirm the high safety profile of this therapy in patients suffering from refractory angina. The results also demonstrate sustained improvement in angina severity and in quality of life up to two years.

Conflict of interest statement

S. Verheye, P. Agostoni and F. Giannini serve as proctors for Neovasc Inc. S. Banai is the Medical Director of Neovasc Inc. The other authors have no conflicts of interest to declare.

Figures

Figure 1

Improvement in CCS class at 6, 12 and 24 months following Reducer implantation.

Figure 2

CCS class over time for the overall study population (A) and for Arm 1 (B).

Figure 3

Percentage of patients with severe angina (CCS class III-IV) over time.