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Published on: March 15, 2022
Coronary Sinus Narrowing for Treating Refractory Angina: REDUCER-I Multicenter "Real-World" Observational Study
Stefan Verheye1, Tim P van de Hoef2, Ranil de Silva3
1Cardiovascular Center, ZAS Middelheim Hospital, Antwerp, Belgium.
Insights
The coronary sinus (CS) Reducer safely and effectively treats refractory angina, improving patient quality of life. These benefits, including reduced angina symptoms, are sustained for at least three years.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina significantly impairs quality of life in patients ineligible for revascularization.
- Optimal medical therapy often fails to alleviate symptoms in these patients.
- The coronary sinus (CS) Reducer has shown promise in treating refractory angina.
Purpose of the Study:
- To analyze the primary effectiveness and safety endpoints of the REDUCER-I study.
- To evaluate the real-world performance of the CS Reducer in refractory angina patients.
- To assess the durability of treatment effects up to three years.
Main Methods:
- A nonrandomized, real-world study involving 400 patients across 25 European centers.
- Primary effectiveness endpoint: improvement in Canadian Cardiovascular Society (CCS) class at 6 months.
- Primary safety endpoints: major adverse cardiac events and serious adverse events within 30 days.
Main Results:
- Low rates of major adverse cardiac events (1.6%) and serious adverse events (1.1%) within 30 days.
- Significant improvement in CCS class for 69.8% of patients at 6 months.
- Sustained improvements in CCS class and quality of life observed at the 3-year interim analysis.
Conclusions:
- The CS Reducer provides a safe and effective treatment option for patients with refractory angina.
- Significant improvements in angina symptoms and quality of life are achieved.
- Treatment benefits are sustained over a three-year period.
Background:
Patients with refractory angina are often ineligible for revascularization and have poor quality of life despite optimal medical therapy. The coronary sinus (CS) Reducer (Shockwave Medical Inc) was safe and effective in the treatment of refractory angina in the COSIRA (Coronary Sinus Reducer for Treatment of Refractory Angina) randomized sham-controlled trial.
Objectives:
This study sought to perform the primary endpoint analysis of the complete REDUCER-I (An Observational Study of the Neovasc Reducer System) study cohort.
Methods:
REDUCER-I is a nonrandomized, "real-world" study of patients with refractory angina treated with the CS Reducer conducted at 25 centers from 9 European countries. The primary effectiveness endpoint was an improvement in Canadian Cardiovascular Society (CCS) class at 6 months. The primary safety endpoints were major adverse cardiac events and device- or procedure-related serious adverse events through 30 days. Study follow-up is planned through 5 years with some interim 3-year analyses included here.
Results:
From 2016 to 2023, 400 patients were enrolled, including 78.0% (312/400) male patients, 54.3% (216/398) with previous myocardial infarction, 73.6% (293/398) with previous revascularization, and 72.0% (280/389) CCS class III/IV. Major adverse cardiac event and serious adverse event rates were 1.6% (95% CI: 0.7-3.6) and 1.1% (4/371), respectively, with no deaths within 30 days. At 6 months, 69.8% (240/344) of patients improved by ≥1 CCS class. Six-minute walk distances improved by 34.1 ± 85.8 m at 6 months (P < 0.0001). Interim 3-year results showed CCS class and Seattle Angina Questionnaire quality of life improvements were sustained (P < 0.0001).
Conclusions:
The complete primary endpoint analysis of the REDUCER-I study shows patients with refractory angina were safely and effectively treated with the CS Reducer. Improvements in angina and quality of life appear sustained through 3 years.
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