Randomization and Data Collection
arrhythmia, heart failure, Thomas’ NHS, ventricular arrythmias
HEART FAILURE, SUDDEN DEATH, ARRHYTHMIA
Participants were randomized in a 1:1 manner to either PCI plus OMT (PCI group) or OMT alone (OMT group). Randomization was stratified by center using randomly permuted blocks of varying size. Those randomized to the PCI group had revascularization attempted on all proximally diseased vessels subtending viable myocardium. All patients were initiated on OMT before enrollment, with subsequent uptitration of therapy supervised by a heart failure specialist at each recruiting site. Implantation of ICDs (and/or CRT) was an integral component of OMT in all patients, but the decision to implant a device was at the discretion of heart teams at recruiting centers. Device programming was carried out by implanting centers as per usual clinical care.Clinical follow-up was carried out for a minimum of 24 months, with the last follow-up visit conducted within 3 months of the end of the overall trial follow-up period. Transthoracic echocardiography was performed at 6 and 12 months and analyzed by an echocardiography core laboratory at Guy’s and St Thomas’ NHS Foundation Trust, with readers blinded to treatment allocation and the temporal sequence of echocardiograms. Data relating to indication and timing of ICD and CRT insertion, aborted sudden death, and sustained ventricular arrythmias were collected from a dedicated arrhythmia case report form after completion of main trial follow-up using physical and electronic health records at the participating centers, including all scheduled and unscheduled device checks. ICD therapies were classified as appropriate or inappropriate by recruiting centers, as documented in the clinical device interrogation reports; these are the reports used for clinical and governance purposes in the National Health Service of the United Kingdom.