TY - JOUR
T1 - Subcutaneous or Transvenous Defibrillator Therapy
AU - PRAETORIAN Investigators
AU - Knops, Reinoud E.
AU - Olde Nordkamp, Louise R. A.
AU - Delnoy, Peter-Paul H. M.
AU - Boersma, Lucas V. A.
AU - Kuschyk, J. rgen
AU - el-Chami, Mikhael F.
AU - Bonnemeier, Hendrik
AU - Behr, Elijah R.
AU - Brouwer, Tom F.
AU - Kääb, Stefan
AU - Mittal, Suneet
AU - Quast, Anne-Floor B. E.
AU - Smeding, Lonneke
AU - van der Stuijt, Willeke
AU - de Weger, Anouk
AU - de Wilde, Koen C.
AU - Bijsterveld, Nick R.
AU - Richter, Sergio
AU - Brouwer, Marc A.
AU - de Groot, Joris R.
AU - Kooiman, Kirsten M.
AU - Lambiase, Pier D.
AU - Neuzil, Petr
AU - Vernooy, Kevin
AU - Alings, Marco
AU - Betts, Tim R.
AU - Bracke, Frank A. L. E.
AU - Burke, Martin C.
AU - de Jong, Jonas S. S. G.
AU - Wright, David J.
AU - Tijssen, Jan G. P.
AU - Wilde, Arthur A. M.
N1 - Copyright © 2020 Massachusetts Medical Society.
PY - 2020/8/6
Y1 - 2020/8/6
N2 - BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).
AB - BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies.METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks.RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12).CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).
KW - Aged
KW - Arrhythmias, Cardiac/therapy
KW - Cardiomyopathies/therapy
KW - Death, Sudden, Cardiac/epidemiology
KW - Defibrillators, Implantable/adverse effects
KW - Electrodes, Implanted/adverse effects
KW - Equipment Failure
KW - Female
KW - Follow-Up Studies
KW - Heart Diseases/therapy
KW - Humans
KW - Incidence
KW - Kaplan-Meier Estimate
KW - Male
KW - Middle Aged
KW - Prosthesis Design
UR - http://www.scopus.com/inward/record.url?scp=85089170129&partnerID=8YFLogxK
U2 - https://doi.org/10.1056/NEJMoa1915932
DO - https://doi.org/10.1056/NEJMoa1915932
M3 - Article
C2 - 32757521
SN - 0028-4793
VL - 383
SP - 526
EP - 536
JO - New England journal of medicine
JF - New England journal of medicine
IS - 6
ER -