Presentation csrd
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This document summarizes a clinical trial testing a coronary sinus reducing device for the treatment of refractory angina. The trial involved 104 patients randomized to receive the hourglass-shaped device, which creates pressure in the coronary sinus to redistribute blood flow, or a sham procedure. At 6-month follow-up, the device led to reduced angina symptoms and improved quality of life compared to the sham group, as measured by the Seattle Angina Questionnaire and Canadian Cardiovascular Society class. The results provide preliminary evidence that increasing coronary sinus pressure may help relieve angina by recruiting collateral blood flow.
Presentation csrd
- 2. BACKGROUND • Refractory angina • The balloon expandable, stainless steel, hourglass-shaped, coronary-sinus reducing device creates a focal narrowing and increases pressure in the coronary sinus, thus redistributing blood into ischemic myocardium
- 3. METHODS • Phase 2, multicenter, randomized, double- blind, sham-controlled clinical trial to test the safety and efficacy of the coronary sinus reducing device • Conducted at 11 clinical centers and was sponsored by Neovasc
- 7. • The physiological rationale for a beneficial effect of increased coronary sinus pressure in angina pectoris remains unclear. • In 1954, Beck and Leighninger described a surgical procedure for partial occlusion of the coronary sinus, which was associated with relief of angina, an improvement in functional class, and a reduction in mortality. • The most commonly proposed mechanism of benefit is recruitment of coronary collateral flow, with redistribution from the less-ischemic epicardium to the ischemic endocardium
- 8. RESULTS • From April 2010 through April 2013, a total of 104 patients were enrolled in the trial; 52 patients were assigned to the treatment group and 52 to the control group. • The device was successfully implanted in 50 of the 52 patients (96%) randomly assigned to the treatment group. In 2 patients, the implantation failed owing to a venous valve in the coronary sinus that could not be crossed with the device
- 9. Outcomes: • At baseline all participants underwent 1) a clinical interview to determine the CCS class, 2) physical examination, 3) symptom limited stress test, 4) dobutamine stress echocardiogram, and 5) Seattle Angina Questionnaire (SAQ). • CCS Class: Participants were assessed for CCS grade at discharge, 30 days, 3 and 6months. To maintain blinding, clinical followup was done by investigators blinded to the treatment allocation.
- 20. In conclusion • This small, double-blind, randomized, sham- controlled trial showed that the coronary-sinus reducing device led to a reduction in symptoms and improved quality of life in patients with disabling angina pectori