PMID- 25090172
OWN - NLM
STAT- MEDLINE
DCOM- 20141203
LR  - 20220409
IS  - 2168-6114 (Electronic)
IS  - 2168-6106 (Linking)
VI  - 174
IP  - 8
DP  - 2014 Aug
TI  - Cardiac resynchronization therapy in women: US Food and Drug Administration 
      meta-analysis of patient-level data.
PG  - 1340-8
LID - 10.1001/jamainternmed.2014.2717 [doi]
AB  - IMPORTANCE: Women were underrepresented in cardiac resynchronization therapy 
      (CRT) trials for heart failure (making up about 20% of enrollees). Combining 
      individual patient data from multiple clinical trials would enable assessment of 
      CRT benefit in women. OBJECTIVE: To evaluate whether women with left bundle 
      branch block (LBBB) benefit from CRT-defibrillators (CRT-D) at a shorter QRS 
      duration than men with LBBB do. DESIGN, SETTING, AND PARTICIPANTS: Individual 
      patient data were pooled from 3 CRT-D vs implantable cardioverter defibrillator 
      (ICD) trials (4076 patients) enrolling predominantly patients with New York Heart 
      Association (NYHA) class II heart failure and follow-up to 3 years. The effect of 
      CRT-D compared with ICD on outcomes was assessed using random effects Cox 
      proportional hazards. MAIN OUTCOMES AND MEASURES: Time to heart failure event or 
      death (primary) and death alone (secondary). RESULTS: Women benefited from CRT-D 
      more than men. The main difference occurred in patients with LBBB and a QRS of 
      130 to 149 milliseconds. In this group, women had a 76% reduction in heart 
      failure or death (absolute CRT-D to ICD difference, 23%; hazard ratio [HR], 0.24, 
      [95% CI, 0.11-0.53]; P < .001) and a 76% reduction in death alone (absolute 
      difference 9%; HR, 0.24, [95% CI, 0.06-0.89]; P = .03), while there was no 
      significant benefit in men for heart failure or death (absolute difference 4%; 
      HR, 0.85 [95% CI, 0.60-1.21]; P = .38) or death alone (absolute difference 2%; 
      HR, 0.86 [95% CI, 0.49-1.52]; P = .60). Neither women nor men with LBBB benefited 
      from CRT-D at QRS shorter than 130 milliseconds, while both sexes with LBBB 
      benefited at QRS of 150 milliseconds or longer. CONCLUSIONS AND RELEVANCE: In 
      this population of patients with primarily mild heart failure, women with LBBB 
      benefited from CRT-D at a shorter QRS duration than men with LBBB. This is 
      important because recent guidelines limit the class I indication for CRT-D to 
      patients with LBBB and QRS of 150 milliseconds or longer. While guidelines do 
      give a class IIa indication to patients with LBBB and a QRS of 120 to 149 
      milliseconds, the present findings are important to communicate because women are 
      less likely to receive CRT-D than men are. This study exemplifies the potential 
      public health and regulatory science value of combining data from multiple 
      clinical trials submitted to the FDA.
FAU - Zusterzeel, Robbert
AU  - Zusterzeel R
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Selzman, Kimberly A
AU  - Selzman KA
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Sanders, William E
AU  - Sanders WE
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Canos, Daniel A
AU  - Canos DA
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - O'Callaghan, Kathryn M
AU  - O'Callaghan KM
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Carpenter, Jamie L
AU  - Carpenter JL
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Pina, Ileana L
AU  - Pina IL
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
FAU - Strauss, David G
AU  - Strauss DG
AD  - Center for Devices and Radiological Health, US Food and Drug Administration, 
      Silver Spring, Maryland.
LA  - eng
PT  - Comparative Study
PT  - Journal Article
PT  - Meta-Analysis
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PT  - Research Support, U.S. Gov't, P.H.S.
PL  - United States
TA  - JAMA Intern Med
JT  - JAMA internal medicine
JID - 101589534
SB  - IM
CIN - JAMA Intern Med. 2014 Aug;174(8):1348-9. PMID: 24957916
CIN - Nat Rev Cardiol. 2014 Sep;11(9):501-2. PMID: 25072912
CIN - Int J Cardiol. 2015 Mar 1;182:454-6. PMID: 25602298
MH  - Aged
MH  - Bundle-Branch Block/mortality/*therapy
MH  - Cardiac Resynchronization Therapy/*methods
MH  - Cardiac Resynchronization Therapy Devices
MH  - Defibrillators, Implantable
MH  - Female
MH  - Heart Failure/mortality/*therapy
MH  - Humans
MH  - Middle Aged
MH  - Proportional Hazards Models
MH  - Treatment Outcome
MH  - United States
MH  - United States Food and Drug Administration
EDAT- 2014/08/05 06:00
MHDA- 2014/12/15 06:00
CRDT- 2014/08/05 06:00
PHST- 2014/08/05 06:00 [entrez]
PHST- 2014/08/05 06:00 [pubmed]
PHST- 2014/12/15 06:00 [medline]
AID - 1881932 [pii]
AID - 10.1001/jamainternmed.2014.2717 [doi]
PST - ppublish
SO  - JAMA Intern Med. 2014 Aug;174(8):1340-8. doi: 10.1001/jamainternmed.2014.2717.