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Published on: February 18, 2020
[Coronary Sinus Reducer implantation: a new treatment for chronic refractory angina]
Francesco Giannini1, Andrea Aurelio2, Alaide Chieffo2
1U.O. Cardiologia Interventistica, Ospedale San Raffaele, Milano - EMO-GVM Centro Cuore Columbus, Milano.
Insights
Refractory angina patients may find symptom relief with the coronary sinus Reducer. This implantable device improves myocardial ischemia and reduces symptoms in patients unresponsive to standard treatments.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Refractory angina presents disabling symptoms from severe coronary artery disease.
- Optimal medical therapy and revascularization often fail to improve symptoms.
- There is a clinical need for novel therapies addressing symptoms and healthcare costs.
Purpose of the Study:
- To evaluate the efficacy of the coronary sinus Reducer in patients with refractory angina.
- To assess the device's impact on symptoms and myocardial ischemia.
- To determine if the coronary sinus Reducer offers a new therapeutic option.
Main Methods:
- A randomized, double-blind, multicenter clinical trial was conducted.
- 104 patients with refractory angina were included.
- The study compared the coronary sinus Reducer implantation against a placebo.
Main Results:
- Coronary sinus Reducer implantation demonstrated a significant improvement in symptoms.
- The device was associated with a reduction in myocardial ischemia.
- Clinical studies, including this trial, show promising results for the device.
Conclusions:
- The coronary sinus Reducer is a potential therapeutic option for refractory angina.
- The device alleviates symptoms by improving coronary blood flow redistribution.
- This therapy addresses the unmet need for effective treatments in refractory angina.
Abstract:
Refractory angina is a chronic condition characterized by the presence of disabling symptoms due to severe obstructive coronary artery disease not improved by either optimal medical therapy and/or percutaneous or surgical revascularization. Mortality rates associated with this condition are quite low in clinically stable patients on optimal medical therapy. However, rehospitalization rates are high. In this subgroup of patients there is thus a clinical need for new therapies targeting an improvement of symptoms but taking into account the potential impact in terms of healthcare and costs. A considerable number of innovative therapeutic modalities for the treatment of refractory angina have been investigated over the years. However, none of them has become a standard of care. Devices implanted in coronary sinus are a possible therapeutic option in these patients that may alleviate myocardial ischemia by forcing redistribution of coronary blood flow from less ischemic subepicardium to the more ischemic subendocardium, potentially relieving symptoms of ischemia. The coronary sinus Reducer (Neovasc Inc., Richmond B.C., Canada) is a percutaneous implantable device designed to achieve controlled narrowing of the coronary sinus and to increase its upstream pressure. Coronary sinus Reducer implantation was associated with improvement in symptoms and reduction of myocardial ischemia in pre-clinical and clinical studies. Recently, a randomized, double-blind, multicenter clinical trial demonstrated, in 104 patients with refractory angina, its benefit in improving symptoms, when compared to placebo.
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