Why the study?
Does the use of drug-eluting stents compared to bare-metal stents affect the risk of stent thrombosis, myocardial infarction, and death in patients undergoing percutaneous coronary interventions?
Does the use of drug-eluting stents compared to bare-metal stents affect the risk of stent thrombosis, myocardial infarction, and death in patients undergoing percutaneous coronary interventions?
Although DES are associated with an increased risk of very late stent thrombosis and MI between 12 and 15 months, the overall minor risk does not outweigh the significant reduction in target lesion revascularization compared to BMS.
DES may raise very late stent thrombosis and MI risk after 12 months; leaves open net benefit of DES versus BMS in real-world PCI.
OBJECTIVES: The aim of the study was to examine outcomes subsequent to implantation of drug-eluting stents (DES) and bare-metal stents (BMS). BACKGROUND: Use of DES might be associated with increased risk of stent thrombosis (ST), myocardial infarction (MI), and death. METHODS: From January 2002 through June 2005, data from all percutaneous coronary interventions in western Denmark were prospectively recorded in the Western Denmark Heart Registry; 12,395 consecutive patients (17,152 lesions) treated with stent implantation were followed for 15 months. Data on death and MI were ascertained from the national databases. The Academic Research Consortium definition of ST was used. RESULTS: The DES were implanted in 3,548 patients (5,422 lesions) and BMS were implanted in 8,847 patients (11,730 lesions). Definite, probable, or possible ST was found in 190 (2.15%) patients in the BMS group and in 64 (1.80%) patients in the DES. The risk of definite ST was similar in the 2 groups (DES: 0.65%; BMS: 0.61%). Very late definite ST (between 12 and 15 months after implantation) occurred more frequently in patients receiving DES (hazard ratio [HR] 10.93, 95% confidence interval [CI] 1.27 to 93.76). Also, the risk of MI between 12 and 15 months after implantation was higher in the DES group (HR 4.00, 95% CI 2.06 to 7.79). Mortality was similar in the 2 groups. Target lesion revascularization was reduced by 43% in patients treated with DES (HR 0.57, 95% CI 0.48 to 0.67). CONCLUSIONS: The minor risk of ST and MI within 15 months after implantation of DES seems unlikely to outweigh the benefit of these stents.
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Jensen et al. (2007) studied this question.
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