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Coronary-sinus reducing device appears to benefit patients with angina
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New data from the phase 2 COSIRA trial demonstrate that implantation of a coronary-sinus reducing device was associated with significant improvement in symptoms and quality of life in patients with refractory angina ineligible for coronary revascularization.
Researchers assigned 104 patients with Canadian Cardiovascular Society (CCS) class III or IV angina and myocardial ischemia ineligible for revascularization to the balloon-expandable coronary-sinus reducing device (Reducer, Neovasc) or a sham procedure.
The diameter of the coronary-sinus reducing device, which is made of stainless steel, expands with the inflation of the semicompliant balloon, which has an hourglass shape, and conforms to the anatomy of the coronary sinus. After implantation via a catheter, the central orifice of the device becomes the sole path for blood flow through the coronary sinus, resulting in redistribution of blood from the less ischemic epicardium to the ischemic endocardium, according to information in the study.
The primary endpoint was the proportion of patients with improvement of at least two CCS angina classes at 6 months. Secondary endpoints included the proportion of patients with improvement of at least one CCS angina class at 6 months and exercise tolerance as measured by a symptom-limited stress test.
Symptoms improved
Compared with the control group, the treatment group had a greater rate of improvement of at least two CCS angina classes at 6 months (35% vs. 15%; P = .02), and of at least one class at 6 months (71% vs. 42%; P = .003).
Researchers assessed quality of life via the Seattle Angina Questionnaire. They found that the treatment group improved 17.6 points on a 100-point scale vs. 7.6 points for controls (P = .03).
According to the researchers, there was no difference between the groups in improvement in exercise time (treatment group, 13%; control group, 1%; P = .07) or mean change in wall-motion index as assessed by means of dobutamine echocardiography (treatment group, 14%; control group, 8%; P = .2).
During the study period, there was one MI in the treatment group and one death and three MIs in the control group.
Christopher B. Granger
“Our study was not statistically powered to detect an improvement in ischemia by means of objective measures such as stress testing or wall-motion index,” Stefan Verheye, MD, PhD, from Antwerp Cardiovascular Center, Ziekenhuis Network Antwerpen Middelheim, Antwerp, Belgium, and colleagues wrote. “A larger trial would be necessary to show such a benefit. Since the planning of this study, tools with better fidelity to detect improvement in myocardial ischemia … have become more commonplace and would be attractive methods to use in phase 3 studies of the coronary-sinus reducing device.”
Alternatives needed
Bernard J. Gersh
In a related editorial, Christopher B. Granger, MD, and Bernard J. Gersh, MB, ChB, DPhil, noted that, “if confirmed in subsequent trials, coronary-sinus reducing therapy may be a welcome and needed addition to the options to improve the quality of life of patients with refractory angina.”
Although the mortality rate for patients with refractory angina is low, “the effect of persistent, recurrent and frequent symptoms on quality of life is substantial and emphasizes the need for alternative therapeutic options,” wrote Granger, from Duke Clinical Research Institute, and Gersh, from the department of cardiovascular diseases at the Mayo Clinic College of Medicine and Cardiology Today Editorial Board member. – by Erik Swain
Disclosure: The study was funded by Neovasc. Gersh and Verheye reports no relevant financial disclosures; four researchers report receiving personal fees from Neovasc and one research reports financial ties with Abbott, Boston Scientific, Eli Lilly, Novo Nordisk and Zealand Pharma. Granger reports financial ties with AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Daiichi-Sankyo, Eli Lilly, Gilead Sciences, GlaxoSmithKline, Hoffmann-La Roche, Janssen Pharmaceuticals, Medtronic Foundation, Merck & Co., Pfizer, Ross Medical Corp., Salix Pharmaceuticals, Sanofi-Aventis, Takeda, and The Medicines Company.
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