Safety and efficacy of Coronary Sinus Reducer implantation at 2-year follow-up

Abstract

Introduction: Coronary Sinus Reducer emerged as promising therapeutic option for patients with refractory angina. While recent literature reports short-term benefits of Reducer implantation, there is paucity of evidence regarding its safety and efficacy at longer follow-up.

Methods: In the original cohort of 50 refractory angina patients treated with Reducer at San Raffaele Hospital (Milan, Italy) between March 2015 and August 2016, we reassessed angina symptoms, quality of life and recorded adverse events at 2-year (mean ± SD: 748 ± 84 days) follow-up.

Results: Canadian Cardiovascular Society (CCS) score improved of ≥1 class in 34 patients (75.6%), and of ≥2 classes in 16 patients (35.6%), translating into a significant mean CCS score reduction at 2-year follow-up (1.74 ± 0.86 vs. 2.98 ± 0.52; p < 0.001). Four out of five Seattle Angina Questionnaire items improved significantly (p < 0.001 for all). Ten patients (22%) underwent percutaneous coronary intervention (PCI) during follow-up, three for acute coronary syndromes. Five patients died, two for cardiovascular causes (stroke and cardiac arrest).

Conclusions: Safety and efficacy observed in the short follow-up period after Reducer implantation are maintained at two years. Ten patients underwent PCI during follow-up, underlining that Reducer does not affect coronary artery disease progression.

Keywords: Chronic refractory angina; Coronary Sinus Reducer; Optimal medical therapy.