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
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
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U2 - 10.1093/eurheartj/ehr149
DO - 10.1093/eurheartj/ehr149
M3 - Article
C2 - 21642283
AN - SCOPUS:80755172643
VL - 32
SP - 2697
EP - 2704
JO - European Heart Journal
JF - European Heart Journal
SN - 0195-668X
IS - 21
ER -