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Updated: Nov 25, 2025
Interventional Diagnostic Procedure: A Practical Guide for the Assessment of Coronary Vascular Function
Published on: March 15, 2022
Coronary sinus narrowing for the treatment of refractory angina: a multicentre prospective open-label clinical study
Stefan Verheye1, Pierfrancesco Agostoni, Francesco Giannini
1Cardiovascular Center, ZNA Middelheim Hospital, Lindendreef Antwerp, Belgium.
Insights
The coronary sinus Reducer effectively and safely treats refractory angina, significantly improving patient quality of life and reducing symptom severity for up to two years.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Device Technology
Background:
- The REDUCER-I study is an international, post-market study collecting long-term data on patients with refractory angina treated with the Reducer device.
- This analysis presents the initial clinical outcomes from the first 228 patients enrolled in the study.
Purpose of the Study:
- To evaluate the safety and efficacy of the coronary sinus (CS) Reducer.
- To assess improvements in angina severity and quality of life for patients with refractory angina pectoris.
Main Methods:
- A multicentre, non-randomised, observational study design.
- Inclusion of patients with refractory angina pectoris (Canadian Cardiovascular Society class II-IV).
- Treatment involved Reducer implantation.
Main Results:
- High procedural success rate (99%) with low rates of major adverse events.
- Significant reduction in Canadian Cardiovascular Society (CCS) class from baseline (2.8) to two years (1.8).
- Sustained improvements in angina severity and quality of life observed up to two years.
Conclusions:
- Interim results from the REDUCER-I study confirm the high safety profile of the Reducer therapy.
- The device demonstrates sustained efficacy in improving angina severity and quality of life in refractory angina patients up to two years.
Background:
The REDUCER-I study is a prospective (with a retrospective component), open-label, multi-centre, international, post-market study, which collects long-term data of patients with refractory angina treated with the Reducer. Here we present the overall clinical outcomes of the first 228 patients enrolled.
Aims:
The aim of this study is 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:
REDUCER-I is a multicentre, non-randomised observational study. Enrolled patients had refractory angina pectoris Canadian Cardiovascular Society (CCS) class II-IV and were treated with Reducer implantation.
Results:
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 observed in 82%, and in ≥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. 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 up to two years.
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