The impact of body mass index on the one year outcomes of patients treated by percutaneous coronary intervention with Biolimus- and Sirolimus-eluting stents (from the LEADERS Trial).
The aim of this analysis was to assess the effect of body mass index (BMI) on 1-year outcomes in patients enrolled in a contemporary percutaneous coronary intervention trial comparing a sirolimus-eluting stent with a durable polymer to a biolimus-eluting stent with a biodegradable polymer. A total of 1,707 patients who underwent percutaneous coronary intervention were randomized to treatment with either biolimus-eluting stents (n = 857) or sirolimus-eluting stents (n = 850). Patients were assigned to 1 of 3 groups according to BMI: normal (<25 kg/m(2)), overweight (25 to 30 kg/m(2)), or obese (>30 kg/m(2)). At 1 year, the incidence of the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was assessed. In addition, rates of clinically justified target lesion revascularization and stent thrombosis were assessed. Cox proportional-hazards analysis, adjusted for clinical differences, was used to develop models for 1-year mortality. Forty-five percent of the patients (n = 770) were overweight, 26% (n = 434) were obese, and 29% (n = 497) had normal BMIs. At 1-year follow-up, the cumulative rate of cardiac death, myocardial infarction, and clinically justified target vessel revascularization was significantly higher in the obese group (8.7% in normal-weight, 11.3% in overweight, and 14.5% in obese patients, p = 0.01). BMI (hazard ratio 1.47, 95% confidence interval 1.02 to 2.14, p = 0.04) was an independent predictor of stent thrombosis. Stent type had no impact on the composite of cardiac death, myocardial infarction, and clinically justified target vessel revascularization at 1 year in the 3 BMI groups (hazard ratio 1.08, 95% confidence interval 0.63 to 1.83, p = 0.73). In conclusion, BMI was an independent predictor of major adverse cardiac events at 1-year clinical follow-up. The higher incidence of stent thrombosis in the obese group may suggest the need for a weight-adjusted dose of clopidogrel.
Department of Interventional Cardiology, Erasmus Medical Center, Rotterdam, The Netherlands.
Giovanna
G
Sarno
Scot
S
Garg
Yoshinobu
Y
Onuma
Pawel
P
Buszman
Axel
A
Linke
Thomas
T
Ischinger
Volker
V
Klauss
Franz
F
Eberli
Roberto
R
Corti
William
W
Wijns
Marie-Claude
MC
Morice
Carlo
C
di Mario
Robert Jan
RJ
van Geuns
Pedro
P
Eerdmans
Hector M
HM
Garcia-Garcia
Gerrit-Anne
GA
van Es
Dick
D
Goedhart
Ton
T
de Vries
Peter
P
Jüni
Bernhard
B
Meier
Stephan
S
Windecker
Patrick
P
Serruys
D000368:Aged; D015906:Angioplasty, Balloon, Coronary / Q000401:mortality; D015992:Body Mass Index; D016001:Confidence Intervals; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007166:Immunosuppressive Agents / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000401:mortality / Q000628:therapy*; D009426:Netherlands; D009765:Obesity / Q000150:complications; D016017:Odds Ratio; D050177:Overweight / Q000150:complications; D011237:Predictive Value of Tests; D016016:Proportional Hazards Models; D012307:Risk Factors; D020123:Sirolimus / Q000008:administration & dosage* / Q000031:analogs & derivatives*; D016019:Survival Analysis; D016896:Treatment Outcome
D007166:Immunosuppressive Agents; C518022:umirolimus; D020123:Sirolimus