P6363Real world experience with Reducer implantation for refractory angina treatment

Abstract

Background: Refractory angina is defined as chronic chest pain, due to severe coronary artery disease (CAD) despite optimal medical therapy and with no option for interventional or surgical revascularization. Coronary sinus (CS) Reducer (Neovasc Inc., Richmond B.C., Canada) implantation emerged as a novel therapeutic treatment to improve quality of life and to relieve symptoms in these patients. To date, only a single randomized clinical trial and three observational studies demonstrating safety and efficacy are available. Purpose: Aim of this study is to assess clinical efficacy of the Reducer device in a real-world setting. Methods: This is a multicentre, observational retrospective registry involving Italy, Israel, The Netherlands, and Belgium. Patients’ baseline clinical characteristics, Canadian Cardiovascular Society (CCS) angina severity class, and Seattle Angina Questionnaire (SAQ) scores at baseline and follow-up were recorded. Results: Between March 2010 and December 2017, a total of 207 patients underwent Reducer implantation procedure. In two patients the procedure was aborted due to unsuitable CS anatomy. No cases of periprocedural serious adverse events were reported. Patients were 67.6±10.5 years old, 140 (68.3%) were male, with a high prevalence of CAD risk factors, 34 (20.1%) had chronic kidney disease. A total of 113 (55.1%) had a previous myocardial infarction, 152 (74.1%) a previous CABG, 172 (83.9%) a previous PCI. All suffered from severe refractory angina (CCS class 3.15±0.58) with low scores at the baseline SAQ. Mean number of anti-ischemic drugs prescribed was 2.3±0.9. A median of 11 (range: 0–73) months of follow-up was available for the 205 implanted patients. A significant reduction in mean CCS was observed at follow-up: 1.89±1.10 vs. 3.17±0.56 (p<0.001), with 160 (78.0%) patients showing at least 1 CCS class reduction. This translated in improvement in all of the SAQ domains scores at follow-up: 61.8±20.8 vs 43.2±17.8 for physical limitation, 66.6±26.9 vs 36.3±20.5 for angina stability, 67.0±20.9 vs 45.2±22.1 for angina frequency, 69.0±17.8 vs 52.3±21.8 for treatment satisfaction, 52.1±20.4 vs 25.8±16.7 for quality of life (p<0.001 for all). These benefits allowed a significant reduction in the number of anti-ischemic drugs prescribed: 2.17±0.95 vs 2.33±0.93 (p=0.004). Twenty (9.8%) deaths occurred at follow-up, with 4 (2%) ascertained cardiacrelated, and 38 (18.5%) patients were subsequently hospitalized due to angina. There were no device-related deaths. Conclusion(s): In our multicentre, real-world experience (the largest reported to date), Reducer implantation in patients with refractory angina was safe and effective in terms of reduction of symptoms and improvement of quality of life at mid-term follow-up. Interestingly, the rate of responder patients reported was around 80%, confirming the findings of previous studies.