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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

Coronary Sinus Reducer Stent for the Treatment of Chronic Refractory Angina Pectoris

A Prospective, Open-Label, Multicenter, Safety Feasibility First-in-Man Study

Shmuel Banai, MD^_*,1,_*, Shmuel Ben Muvhar^,1, Keyur H. Parikh, MD, Aharon Medina, MD, Horst Sievert, MD^||, Ashok Seth, MD^¶, Jonathan Tsehori, MD^_*, Yoav Paz, MD^_*, Ami Sheinfeld, MD^# and Gad Keren, MD^_*,1

^_* Cardiology Department, Tel Aviv Medical Center, Tel Aviv, Israel
Neovasc Medical, Inc., Or Yehuda, Israel
The Heart Care Clinic/SAL Hospital, Ahmedabad, India
Bikur Cholim Hospital, Jerusalem, Israel
^|| Cardio Vascular Center Frankfurt, Sankt Katharinen, Frankfurt, Germany
^¶ Max Devki Devi Heart and Vascular Institute, New Delhi, India
^# Sheba Medical Center, Ramat Gan, Israel.

Manuscript received September 22, 2006; revised manuscript received January 2, 2007, accepted January 2, 2007.

^_* Reprint requests and correspondence: Dr. Shmuel Banai, Interventional Cardiology, Tel Aviv Medical Center, 6 Weizman Street, Tel Aviv, Israel. (Email: banais{at}netvision.net.il).

Objectives: This study sought to evaluate the safety of the Coronary Sinus Reducer (Neovasc Medical, Inc., Or Yehuda, Israel) as a potential alternate therapy for patients with refractory angina who are not candidates for conventional revascularization procedures.

Background: Increased coronary sinus (CS) pressure can reduce myocardial ischemia by redistribution of blood from nonischemic to ischemic territories. The Coronary Sinus Reducer is a percutaneous implantable device designed to establish CS narrowing and to elevate CS pressure. In preclinical experiments, implantation of the Reducer was safe and was associated with improved ischemic parameters. In the present study, the safety and feasibility of the Coronary Sinus Reducer was evaluated in patients with refractory angina who were not candidates for revascularization.

Methods: Fifteen coronary artery disease patients with severe angina and reversible ischemia were electively treated with the Reducer. Clinical evaluation, dobutamine echocardiography, thallium single-photon emission computed tomography, and administration of an angina questionnaire were performed before and 6 months after implantation. Cardiac computed tomography was performed 2 days and 6 months after implantation.

Results: All procedures were completed successfully. No procedure-related adverse events occurred during the periprocedural and the follow-up periods. Angina score improved in 12 of 14 patients. Average Canadian Cardiovascular Society score was 3.07 at baseline and 1.64 at follow-up (n = 14, p < 0.0001). Stress-induced ST-segment depression was reduced in 6 of 9 patients and was eliminated in 2 of these 6 (p = 0.047). The extent and severity of myocardial ischemia by dobutamine echocardiography and by thallium single-photon emission computed tomography was reduced (p = 0.004 [n = 13] and p = 0.042 [n = 10], respectively).

Conclusions: Implantation of the Coronary Sinus Reducer is feasible and safe. These findings, along with the clinical improvement observed, support further evaluation of the Reducer as an alternative treatment for patients with chronic refractory angina who are not candidates for coronary revascularization.

Abbreviations and Acronyms   CABG = coronary artery bypass graft   CAD = coronary artery disease   CCS = Canadian Cardiovascular Society   CS = coronary sinus   CT = computed tomography   PCI = percutaneous coronary intervention   SPECT = single-photon emission computed tomography