WEDNESDAY, Aug. 5, 2020 (HealthDay News) -- For patients with an indication for an implantable cardioverter defibrillator (ICD) but no indication for pacing, subcutaneous ICD is noninferior to transvenous ICD, according to a study published in the Aug. 6 issue of the New England Journal of Medicine.
Reinoud E. Knops, M.D., Ph.D., from the University of Amsterdam, and colleagues conducted a noninferiority trial involving patients with an indication for an ICD but not for pacing who were randomly assigned to receive either a subcutaneous ICD or transvenous ICD (426 and 423 patients, respectively). The composite of device-related complications and inappropriate shocks was examined as the primary end point.
The researchers found that a primary end point event occurred in 68 patients in the subcutaneous ICD group and 68 in the transvenous ICD group at a median follow-up of 49.1 months (48-month Kaplan-Meier estimated cumulative incidence, 15.1 and 15.7 percent, respectively; hazard ratio, 0.99; 95 percent confidence interval, 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 and 44 patients in the subcutaneous and transvenous ICD groups, respectively (hazard ratio, 0.69; 95 percent confidence interval, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95 percent confidence interval, 0.89 to 2.30).
"The trial provides data to aid patients and providers in their shared decision making regarding ICD selection," write the authors of an accompanying editorial.
Several authors disclosed ties to pharmaceutical companies, including Boston Scientific, which supported the study.