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Patients with refractory angina not amenable to revascularization have few options. To test a new device designed to improve symptoms in such patients, investigators conducted a manufacturer-sponsored, phase II, randomized, sham-controlled trial of an hourglass-shaped, metal-mesh “Reducer” that is inserted in the coronary sinus to create a pressure gradient that theoretically redistributes blood toward ischemic myocardium.
The study involved 104 patients (mean age, 68; 81% men) with Canadian Cardiovascular Society (CCS) class III or IV angina despite maximal medical therapy; the patients had evidence of reversible ischemia and were not eligible for coronary revascularization. Patients were randomized to undergo implantation of the device or …