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.
Comment In: J Am Coll Cardiol. 2009 Feb 24;53(8):665-619232898
The aim of this study was to examine outcomes subsequent to implantation of drug-eluting stents (DESs) and bare-metal stents (BMSs) in patients with diabetes. From January 2002 to June 2005, data from all percutaneous coronary interventions performed in Western Denmark were prospectively recorded. A total of 1,423 consecutive diabetic patients treated with stent implantation (2,094 lesions) were followed up for 15 months. Of these, 871 patients (1,180 lesions) were treated with a BMS, and 552 patients (914 lesions) were treated with a DES. Dual antiplatelet therapy was recommended for 12 months in both treatment groups. Data for death and myocardial infarction (MI) were ascertained from national health care databases. Use of DESs was not associated with increased risk of definite stent thrombosis (adjusted relative risk [RR] 0.76, 95% confidence interval [CI] 0.10 to 3.26) or MI (adjusted RR 0.90, 95% CI 0.53 to 1.52). In the DES group compared with the BMS group, adjusted RRs of target-lesion revascularization (adjusted RR 0.48, 95% CI 0.33 to 0.71), total mortality (adjusted RR 0.66, 95% CI 0.44 to 0.99), and cardiac mortality (adjusted RR 0.53, 95% CI 0.31 to 0.90) decreased by 52%, 34%, and 47%, respectively. In conclusion, use of DESs reduced target-lesion revascularization in diabetic patients receiving routine clinical care. This result was obtained without increased risk of death, stent thrombosis, or MI.
BACKGROUND: A high diagnostic performance of coronary computed tomographic angiography (CTA) in identifying coronary artery disease (CAD) has been shown in experienced high-volume centers. Whether this may be accomplished in centers with less CTA experience remains unknown. OBJECTIVES: We determined the diagnostic performance and interobserver reproducibility of CTA in detecting significant CAD in a center with limited experience. METHODS: In 209 patients, CTA was performed with 64-slice or dual-source CT technology, and analyses were performed independently by 2 inexperienced observers. Significant CAD by CTA was defined as >/=1 stenoses >/=50% or >/=1 nonevaluable segment, whereas significant CAD by invasive quantitative coronary angiography was defined as >/=1 stenoses >/=50%. We evaluated the influence of CAD pretest probability, Agatston score (AS), heart rate (HR), and observer experience on the diagnostic sensitivity, specificity, positive (PPV) and negative predictive values (NPV), interobserver reproducibility, and duration of CTA analysis. RESULTS: Per-patient (CAD prevalence, 35%) sensitivity was 88%-99%, specificity was 78%-82%, PPV was 68%-74%, and NPV was 92%-99%. Overall interobserver reproducibility was good (kappa = 0.65). A significant temporal improvement was observed in diagnostic specificity (observer A: 68%-89%, P = 0.007; observer B: 71%-89%, P = 0.02), and interobserver reproducibility (kappa = 0.35-0.89, P = 0.01) during the study period. Duration of analysis decreased during the study period and was positively associated with CAD pretest probability and AS. CONCLUSIONS: Suboptimal diagnostic performance and interobserver reproducibility must be anticipated during CTA implementation. A high diagnostic sensitivity, specificity, and interobserver reproducibility were achieved after a large number of studies performed with the state-of-the-art scanner technology.