Long‐term outcomes of patients undergoing coronary sinus reducer implantation ‐ A multicenter study

BACKGROUND: Coronary sinus (CS) narrowing by reducer implantation has emerged as a safe and effective therapy for patients suffering from refractory angina. However, data regarding the clinical benefit of this treatment over time is lacking. METHODS: Patients undergoing successful reducer implantation were enrolled prospectively to clinical registries at three medical centers. Those with more than 2‐years of follow‐up were included in the present analysis. Peri‐procedural data, data regarding adverse events, and current evaluation of angina severity (Canadian Cardiovascular Society [CCS] class) were collected. RESULTS: Overall, 99 consecutive patients (77% males, mean age 69.8 ± 9.4) with severe angina were enrolled between September 2010 and October 2017 and included in the present analysis. No procedure‐related complications were recorded. During a median follow up time of 3.38 years (IQR 2.95–4.40), 15.1% of the patients died, 9% experienced myocardial infarction (MI) and 21% underwent percutaneous coronary intervention (PCI). Mean CCS class was 3.1 ± 0.5 at baseline, improved to 1.66 ± 0.8 at 1 year (p < .001), and remained low through 2‐years and at last follow up (1.72 ± 0.8 and 1.71 ± 0.8, p > 0.5 for both, in comparison to 1 year). At baseline 91% of patients reported severe disabling angina (CCS class 3–4), at 1 year only 17.9% suffered from disabling angina, p < .001, and this portion remained low overtime (19% at last follow up). CONCLUSION: Long‐term mortality of patients undergoing reducer implantation is similar to that reported for patients with stable coronary artery disease. The previously reported short‐term efficacy of the reducer, reflected by significant improvement of angina symptoms, is maintained over time.