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.
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.
Authors: Nathaniel Katz; Robert H Dworkin; Richard North; Simon Thomson; Sam Eldabe; Salim M Hayek; Brian H Kopell; John Markman; Ali Rezai; Rod S Taylor; Dennis C Turk; Eric Buchser; Howard Fields; Gregory Fiore; McKenzie Ferguson; Jennifer Gewandter; Chris Hilker; Roshini Jain; Angela Leitner; John Loeser; Ewan McNicol; Turo Nurmikko; Jane Shipley; Rahul Singh; Andrea Trescot; Robert van Dongen; Lalit Venkatesan Journal: Pain Date: 2021-07-01 Impact factor: 6.961
Authors: Sam Eldabe; Simon Thomson; Rui Duarte; Morag Brookes; Mark deBelder; Jon Raphael; Ed Davies; Rod Taylor Journal: Neuromodulation Date: 2015-09-21
Authors: Emil Isagulyan; Konstantin Slavin; Nikolay Konovalov; Eugeny Dorochov; Alexey Tomsky; Andrey Dekopov; Elizaveta Makashova; David Isagulyan; Pavel Genov Journal: Korean J Pain Date: 2020-04-01