Individual patient data network meta-analysis of mortality effects of implantable cardiac devices.
OBJECTIVE
Implantable cardioverter defibrillators (ICD), cardiac resynchronisation therapy pacemakers (CRT-P) and the combination therapy (CRT-D) have been shown to reduce all-cause mortality compared with medical therapy alone in patients with heart failure and reduced EF. Our aim was to synthesise data from major randomised controlled trials to estimate the comparative mortality effects of these devices and how these vary according to patients' characteristics.


METHODS
Data from 13 randomised trials (12 638 patients) were provided by medical technology companies. Individual patient data were synthesised using network meta-analysis.


RESULTS
Unadjusted analyses found CRT-D to be the most effective treatment (reduction in rate of death vs medical therapy: 42% (95% credible interval: 32-50%), followed by ICD (29% (20-37%)) and CRT-P (28% (15-40%)). CRT-D reduced mortality compared with CRT-P (19% (1-33%)) and ICD (18% (7-28%)). QRS duration, left bundle branch block (LBBB) morphology, age and gender were included as predictors of benefit in the final adjusted model. In this model, CRT-D reduced mortality in all subgroups (range: 53% (34-66%) to 28% (-1% to 49%)). Patients with QRS duration ≥150 ms, LBBB morphology and female gender benefited more from CRT-P and CRT-D. Men and those <60 years benefited more from ICD.


CONCLUSIONS
These data provide estimates for the mortality benefits of device therapy conditional upon multiple patient characteristics. They can be used to estimate an individual patient's expected relative benefit and thus inform shared decision making. Clinical guidelines should discuss age and gender as predictors of device benefits.
Centre for Health Economics, University of York, York, UK Department of Health Economics, ICON Clinical Research, Oxford, UK.
B
B
Woods
Department of Health Economics, ICON Clinical Research, Oxford, UK Department of Health Services Research and Policy, London School of Hygiene and Tropical Medicine, London, UK.
N
N
Hawkins
Department of Health Economics, ICON Clinical Research, Oxford, UK.
S
S
Mealing
Department of Health Sciences, University of Leicester, Leicester, UK.
A
A
Sutton
Ohio State University Medical Centre, Ohio, USA.
W T
WT
Abraham
Mayo Clinic, Phoenix, Arizona, USA.
J F
JF
Beshai
University of Rochester, New York, USA.
H
H
Klein
Centre for Health Economics, University of York, York, UK Department of Health Economics, ICON Clinical Research, Oxford, UK.
M
M
Sculpher
Freeman Hospital, Newcastle upon Tyne, UK.
C J
CJ
Plummer
Imperial College London (Royal Brompton Hospital), London, UK.
M R
MR
Cowie
D058406:Cardiac Resynchronization Therapy / Q000401:mortality; D058409:Cardiac Resynchronization Therapy Devices; D003131:Combined Modality Therapy / Q000401:mortality; D017147:Defibrillators, Implantable; D005260:Female; D006333:Heart Failure / Q000401:mortality* / Q000628:therapy; D006801:Humans; D008297:Male; D016032:Randomized Controlled Trials as Topic; D013318:Stroke Volume / Q000502:physiology