Spinal cord stimulation therapy for patients with refractory angina who are not candidates for revascularization

Douglas P. Zipes, Nelson Svorkdal, Daniel Berman, Richard Boortz-Marx, Timothy Henry, Amir Lerman, Edgar Ross, Michael Turner, Christopher Irwin

Research output: Contribution to journalArticle

34 Scopus citations

Abstract

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.

Original languageEnglish (US)
Pages (from-to)550-559
Number of pages10
JournalNeuromodulation
Volume15
Issue number6
DOIs
StatePublished - Jan 1 2012

Keywords

  • Angina pectoris
  • electric stimulation therapy
  • spinal cord stimulation

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine
  • Neurology
  • Clinical Neurology

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