The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Coronary sinus narrowing for the treatment of refractory angina A multi-center prospective open-label clinical study (The REDUCER-I study)
Stefan Verheye1; Pierfrancesco Agostoni1; Francesco Giannini2; Jonathan Hill3; Christoph Jensen4; Steven Lindsay5; Pieter Stella6; Simon Redwood7; Shmuel Banai8; Maayan Konigstein8;
1. Cardiovascular Center, ZNA Middelheim Hospital, Lindendreef Antwerp Belgium, Belgium 2. GVM Care & Research Maria Cecilia Hospital Cotignola, Italy, Italy 3. King’s College Hospital, Denmark Hill, UK, United Kingdom 4. Elisabeth Hospital Essen, Germany, Germany 5. Bradford Teaching Hospitals NHS Foundation Trust, UK, United Kingdom 6. UMC Utrecht, Netherlands 7. St Thomas’ Hospital Cardiothoracic Centre, London, UK, United Kingdom 8. Tel Aviv Medical Center and Sackler School of Medicine, Tel Aviv University, Israel, Israel
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Aim: 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 and Results: Patients with refractory angina pectoris (n=228; 81% male, 68.3±9.6 years) were enrolled to this multi-center, non-randomized observational study , with up to 2 year follow-up. Patients with Canadian Cardiovascular Society (CCS) class 2-4 were treated with Reducer implantation in the CS. 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 2 years. Improvement in ≥1 CCS class was observed in 82%, and in ≥2 CCS classes in 31% of patients at 2 years. At baseline 70% of the cohort reported 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 out to 2 years.