2-year clinical outcomes after implantation of sirolimus-eluting, paclitaxel-eluting, and bare-metal coronary stents: results from the WDHR (Western Denmark Heart Registry).
OBJECTIVE
This registry study assessed the safety and efficacy of the 2 types of drug-eluting stents (DES), sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES), compared with bare-metal stents (BMS).


BACKGROUND
Drug-eluting stents may increase the risk of stent thrombosis (ST), myocardial infarction (MI), and death.


METHODS
A total of 12,395 consecutive patients with coronary intervention and stent implantation recorded in the Western Denmark Heart Registry from January 2002 through June 2005 were followed up for 2 years. Data on death and MI were ascertained from national medical databases. We used Cox regression analysis to control for confounding.


RESULTS
The 2-year incidence of definite ST was 0.64% in BMS patients, 0.79% in DES patients (adjusted relative risk [RR]: 1.09; 95% confidence interval [CI]: 0.72 to 1.65), 0.50% in SES patients (adjusted RR: 0.63, 95% CI: 0.35 to 1.15), and 1.30% in PES patients (adjusted RR: 1.82, 95% CI: 1.13 to 2.94). The incidence of MI was 3.8% in BMS-treated patients, 4.5% in DES-treated patients (adjusted RR: 1.24, 95% CI: 1.02 to 1.51), 4.1% in SES-treated patients (adjusted RR: 1.15, 95% CI: 0.91 to 1.47), and 5.3% in PES-treated patients (adjusted RR: 1.38, 95% CI: 1.06 to 1.81). Whereas overall 2-year adjusted mortality was similar in the BMS and the 2 DES stent groups, 12- to 24-month mortality was higher in patients treated with PES (RR 1.46, 95% CI: 1.02 to 2.09). Target lesion revascularization was reduced in both DES groups.


CONCLUSIONS
During 2 years of follow-up, patients treated with PES had an increased risk of ST and MI compared with those treated with BMS and SES. Mortality after 12 months was also increased in PES patients.
Kaltoft
Anne
A
Department of Cardiology, Aarhus University Hospital, Skejby, Brendstrupgaardsvej 100, 8200 Aarhus N, Denmark. annekaltoft@stofanet.dk
Jensen
Lisette Okkels
LO
Maeng
Michael
M
Tilsted
Hans Henrik
HH
Thayssen
Per
P
Bøttcher
Morten
M
Lassen
Jens Flensted
JF
Krusell
Lars Romer
LR
Rasmussen
Klaus
K
Hansen
Knud Nørregaard
KN
Pedersen
Lars
L
Johnsen
Søren Paaske
SP
Sørensen
Henrik Toft
HT
Thuesen
Leif
L
D000368:Aged; D015906:Angioplasty, Balloon, Coronary; D003327:Coronary Disease / Q000401:mortality / Q000628:therapy; D054855:Drug-Eluting Stents / Q000009:adverse effects; D005260:Female; D006801:Humans; D007166:Immunosuppressive Agents; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000209:etiology; D017239:Paclitaxel; D020123:Sirolimus; D015607:Stents / Q000009:adverse effects; D013927:Thrombosis / Q000209:etiology
D007166:Immunosuppressive Agents; D017239:Paclitaxel; D020123:Sirolimus