Key result
Paclitaxel-eluting stents were associated with an increased 2-year risk of definite stent thrombosis compared to bare-metal stents (1.30% vs 0.64%; adjusted RR 1.82, 95% CI 1.13-2.94).
Why the study?
Do sirolimus-eluting or paclitaxel-eluting stents compared to bare-metal stents affect the risk of stent thrombosis, myocardial infarction, and death in patients undergoing coronary intervention?
Cohort (n=12,395)
Do sirolimus-eluting or paclitaxel-eluting stents compared to bare-metal stents affect the risk of stent thrombosis, myocardial infarction, and death in patients undergoing coronary intervention?
Relative Risk: 1.09 (95% CI 0.72–1.65)
Absolute Event Rate: 0.79% vs 0.64%
In a large registry cohort, paclitaxel-eluting stents, but not sirolimus-eluting stents, were associated with an increased risk of stent thrombosis, myocardial infarction, and late mortality compared to bare-metal stents at 2 years.
Paclitaxel-eluting stents may raise thrombosis risk; leaves open causal effects versus sirolimus-eluting stents and need for randomized confirmation.
OBJECTIVES: 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.
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Kaltoft et al. (2009) conducted a cohort in Coronary intervention and stent implantation (n=12,395). Drug-eluting stents (sirolimus-eluting and paclitaxel-eluting) vs. Bare-metal stents was evaluated on Definite stent thrombosis (RR 1.09, 95% CI 0.72 to 1.65). Paclitaxel-eluting stents were associated with an increased 2-year risk of definite stent thrombosis compared to bare-metal stents (1.30% vs 0.64%; adjusted RR 1.82, 95% CI 1.13-2.94).
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