Using a narrowing device in the coronary sinus may provide relief of symptoms and improve angina by at least one class, according to a study published Feb. 5 in the New England Journal of Medicine.
The phase II trial randomized 104 patients between device treatment and sham procedure. Patients had Canadian Cardiovascular Society (CCS) class III or IV angina and MI and were enrolled at 11 clinical centers. The Reducer (Neovasc) implant was delivered via catheter. Sham procedure patients also underwent catheterization, but received no further treatment. Procedures occurred between 2010 and 2013.
Lead author of the Coronary Sinus Reducer for Treatment of Refractory Angina (COSIRA) trial, Stefan Verheye, MD, PhD, of the Antwerp Cardiovascular Center at Ziekenhuis Netwerk Antwerpen Middelheim in Belgium, and colleagues followed patients for six months to determine short-term outcomes.
Implantation was successful in 96 percent of patients assigned to treatment. Thirty-five percent of patients in the treatment group and 15 percent of patients in the sham-control group had improvement of at least two CCS classes at six months. However, 71 percent of patients in the treatment group and 42 percent of patients in the sham-control group had improvement of at least one CSS class at six months. Greater improvements were also noted among the treatment group as opposed to the control group in responses to quality of life measurements.
Mean exercise duration also improved by 13 percent in the treatment group as opposed to 1 percent among control patients. Wall motion index and ST-segment depression of 1 mm also saw improvements; within the treatment group, wall motion improved by 14 percent and ST-segment depression was prolonged by 49 seconds (13 percent). In the control group, ST-segment depression prolonged by 18 seconds (4 percent) and wall-motion improved by 8 percent.
The treatment group reported 76 adverse events. The control group reported 93. Between the treatment and sham, one and three MIs, respectively, were reported. Only one death was reported and was part of the sham-control group.
Verheye et al noted as the prevalence of refractory angina increases, more interventions were needed to provide relief for patients. While the present trial was too underpowered to make broad statements about general utility of the device, significant improvement was seen in some, but not all endpoints.
The trial was sponsored by Neovasc.