Coronary sinus narrowing safe for treating refractory angina: Interim data from REDUCER-I study
Belgium: In patients with refractory angina, the coronary sinus (CS) Reducer demonstrated a high safety profile, as confirmed by results from the ongoing REDUCER-I study. The results, published in EuroIntervention, showed a sustained improvement in the quality of life and angina severity for up to two years.
The increased pressure of coronary sinus (CS) can reduce myocardial ischemia by blood redistribution from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish the narrowing of the coronary sinus and increase CS pressure. In preclinical studies, Reducer implantation was safe and linked to improved ischemic parameters.
The REDUCER-I study is an open-label, international, prospective, multi-center, post-market study that collects data from refractory angina patients treated with the Reducer. In the study, Stefan Verheye, Cardiovascular Center, ZNA Middelheim Hospital, Lindendreef Antwerp, Belgium, and colleagues presented the overall clinical outcomes of the first 228 enrollees of the trial.
They conducted the study to determine the efficacy and safety of the coronary sinus Reducer in improving quality of life and angina severity in patients with angina pectoris, refractory to medical and interventional therapies.
REDUCER-I is a multicentre, non-randomized observational study. The participants had refractory angina pectoris Canadian Cardiovascular Society (CCS) class II-IV and were treated with Reducer implantation.
The study demonstrated the following findings:
- 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 seen in 82%, and≥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.
- An improvement in additional measured parameters of functional class and quality of life was also observed.
The safety profile of therapy was confirmed in patients with refractory angina, as established in the interim results from the ongoing REDUCER-I study.
"The results also showed a sustained improvement in angina severity and quality of life for up to two years," the researchers wrote.
Reference:
The study titled "Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study (the REDUCER-I study)" was published in the journal EuroIntervention. DOI: 10.4244/EIJ-D-20-00873
