TY - JOUR
T1 - Clinical course and outcome of patients enrolled in US and non-US centres in MADIT-CRT
AU - Buber, Jonathan
AU - Klein, Helmut
AU - Moss, Arthur J.
AU - McNitt, Scott
AU - Eldar, Michael
AU - Padeletti, Luigi
AU - Vogt, Juergen
AU - Meine, Mathias
AU - Brown, Mary W.
AU - Barsheshet, Alon
AU - Zareba, Wojciech
AU - Goldenberg, Ilan
N1 - Funding Information:
MADIT-CRT was supported by an unrestricted research grant from Boston Scientific Corp., St. Paul, Minnesota, to the University of Rochester School of Medicine and Dentistry. The present study was not funded by Boston Scientific Corp.
PY - 2011/11
Y1 - 2011/11
N2 - Aims We aimed to evaluate within the MADIT-CRT database whether different enrollment characteristics between US and non-US centres affected the clinical course of study patients. Methods and results We evaluated differences in baseline characteristics, procedure-associated complications, clinical as well as echocardiographic response to cardiac resynchronization therapy with a defibrillator (CRT-D), between patients enrolled in 87 US centres (n= 1271) and 23 non-US centres (n= 549) in MADIT-CRT. Non-US patients displayed significant differences in baseline characteristics from US patients, including a higher frequency of left bundle branch block, a more advanced heart failure (HF) functional class >3 months prior to enrolment, and larger baseline cardiac volumes. Procedure-related complications occurred at a significantly higher frequency among patients enrolled in non-US centres (17) than among those enrolled in US centres (10; P < 0.001). During follow-up, CRT-D was associated with 42 (P = 0.003) and 38 (P < 0.001) reductions in the risk of HF or death in the two respective groups (P for the difference = 0.80), and with similar reductions in cardiac volumes (all P > 0.10). Subgroup analysis showed a more pronounced effect of CRT-D among women in the US group, including a significant 71 (P = 0.02) reduction in the risk of death, whereas CRT-D therapy was associated with a significant clinical benefit in men only in the non-US group. Conclusion Patients enrolled in US and non-US centres in MADIT-CRT displayed significant differences in baseline clinical and echocardiographic characteristics and in the frequency of procedure-related complications, but experienced an overall similar clinical and echocardiographic response to CRT-D.
AB - Aims We aimed to evaluate within the MADIT-CRT database whether different enrollment characteristics between US and non-US centres affected the clinical course of study patients. Methods and results We evaluated differences in baseline characteristics, procedure-associated complications, clinical as well as echocardiographic response to cardiac resynchronization therapy with a defibrillator (CRT-D), between patients enrolled in 87 US centres (n= 1271) and 23 non-US centres (n= 549) in MADIT-CRT. Non-US patients displayed significant differences in baseline characteristics from US patients, including a higher frequency of left bundle branch block, a more advanced heart failure (HF) functional class >3 months prior to enrolment, and larger baseline cardiac volumes. Procedure-related complications occurred at a significantly higher frequency among patients enrolled in non-US centres (17) than among those enrolled in US centres (10; P < 0.001). During follow-up, CRT-D was associated with 42 (P = 0.003) and 38 (P < 0.001) reductions in the risk of HF or death in the two respective groups (P for the difference = 0.80), and with similar reductions in cardiac volumes (all P > 0.10). Subgroup analysis showed a more pronounced effect of CRT-D among women in the US group, including a significant 71 (P = 0.02) reduction in the risk of death, whereas CRT-D therapy was associated with a significant clinical benefit in men only in the non-US group. Conclusion Patients enrolled in US and non-US centres in MADIT-CRT displayed significant differences in baseline clinical and echocardiographic characteristics and in the frequency of procedure-related complications, but experienced an overall similar clinical and echocardiographic response to CRT-D.
KW - Cardiac resynchronization therapy
KW - Complications
KW - Death
KW - Heart failure
UR - http://www.scopus.com/inward/record.url?scp=80755172643&partnerID=8YFLogxK
U2 - 10.1093/eurheartj/ehr149
DO - 10.1093/eurheartj/ehr149
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AN - SCOPUS:80755172643
SN - 0195-668X
VL - 32
SP - 2697
EP - 2704
JO - European Heart Journal
JF - European Heart Journal
IS - 21
ER -