• Douglas P Zipes, Nelson Svorkdal, Daniel Berman, Richard Boortz-Marx, Timothy Henry, Amir Lerman, Edgar Ross, Michael Turner, and Christopher Irwin.
• Indiana University School of Medicine, Indianapolis, IN 46202-4800, USA. dzipes@iupui.edu
• Neuromodulation. 2012 Nov 1;15(6):550-8; discussion 558-9.

Objectives  The aim of this study was to evaluate the safety and efficacy of spinal cord stimulation (SCS) for refractory angina.Materials And Methods  This multicenter, randomized, single-blind, controlled trial evaluated SCS in two patient groups: high stimulation (HS) (treatment) and low stimulation (LS) (control). The HS group controlled SCS with a programmer for a minimum of two hours four times daily. The LS group received SCS therapy above the paresthesia threshold for one min once daily. The primary efficacy endpoint was number of angina attacks recorded by patients at six months. The primary safety endpoint was the major adverse cardiac event (MACE) rate at six months.Results  Due to slow enrollment, a futility analysis was performed, resulting in early termination of the study. Sixty-eight patients were randomized after implantation. Mean change in angina attacks per day from baseline to six months was -1.19 ± 2.13 (HS) and -1.29 ± 1.66 (LS). The difference from baseline was significant within each group (both p < 0.001) but not between groups (p = 0.45). Total exercise time and time to angina onset increased significantly from baseline to six months within each group (both p = 0.02 and 0.002) but not between groups (p = 0.52 and 0.51). MACE was similar between groups.Conclusion  Although this study was terminated early, the results obtained at six months suggest that SCS (HS) is not more effective than the control (LS) in patients with refractory angina.© 2012 International Neuromodulation Society.

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