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.
AIMS: Stent thrombosis is a serious complication of percutaneous coronary intervention (PCI). We examined the incidence of stent thrombosis and other outcomes in patients treated with PCI and paclitaxeleluting stents (PES), sirolimus-eluting stents (SES) or bare-metal stents (BMS). METHODS AND RESULTS: All patients who underwent PES, SES or BMS implantation from January 2002 to June 2005 were identified in the population-based Western Denmark Heart Registry. All were followed for 36 months. Cox regression analysis was used to estimate relative risk (RR), controlling for covariates. A total of 12,374 patients were treated with stents: 1,298 with PES, 2,202 with SES and 8,847 with BMS. The three-year incidence of definite stent thrombosis was similar in the DES group (1.1%) and in the BMS group (0.7%) (adjusted relative risk [RR]: 1.24; 95% confidence interval [CI]: 0.85-1.81). Very late definite stent thrombosis occurred more frequently in DES-treated patients (adjusted RR: 2.89, 95% CI: 1.48- 5.65). The three-year mortality rate did not differ significantly between the two groups. Target lesion revascularisation (TLR) was lower in DES-treated patients than in BMS-treated patients (adjusted RR: 0.71, 95% CI: 0.63-0.81). CONCLUSIONS: An increased risk of very late definite stent thrombosis was observed in DES-treated patients compared with BMS-treated patients, but a similar mortality was detected. TLR continued to be lower among patients receiving DES.
BACKGROUND: The optimal stenting strategy in coronary artery bifurcation lesions is unknown. In the present study, a strategy of stenting both the main vessel and the side branch (MV+SB) was compared with a strategy of stenting the main vessel only, with optional stenting of the side branch (MV), with sirolimus-eluting stents. METHODS AND RESULTS: A total of 413 patients with a bifurcation lesion were randomized. The primary end point was a major adverse cardiac event: cardiac death, myocardial infarction, target-vessel revascularization, or stent thrombosis after 6 months. At 6 months, there were no significant differences in rates of major adverse cardiac events between the groups (MV+SB 3.4%, MV 2.9%; P=NS). In the MV+SB group, there were significantly longer procedure and fluoroscopy times, higher contrast volumes, and higher rates of procedure-related increases in biomarkers of myocardial injury. A total of 307 patients had a quantitative coronary assessment at the index procedure and after 8 months. The combined angiographic end point of diameter stenosis >50% of main vessel and occlusion of the side branch after 8 months was found in 5.3% in the MV group and 5.1% in the MV+SB group (P=NS). CONCLUSIONS: Independent of stenting strategy, excellent clinical and angiographic results were obtained with percutaneous treatment of de novo coronary artery bifurcation lesions with sirolimus-eluting stents. The simple stenting strategy used in the MV group was associated with reduced procedure and fluoroscopy times and lower rates of procedure-related biomarker elevation. Therefore, this strategy can be recommended as the routine bifurcation stenting technique.
OBJECTIVE: To identify risk factors for clinical-driven target lesion revascularisation (TLR) in patients treated with sirolimus-eluting (Cypher) or paclitaxel-eluting (Taxus) stents in a real-world scenario. DESIGN: From 1 January 2003 to 18 May 2005, all patients treated with a Cypher or Taxus stent were consecutively registered and followed for 9 months. Re-intervention was driven by clinical symptoms. SETTING: Western Denmark Heart Registry. PATIENTS: 4432 patients with 6102 lesions treated with a Cypher (n = 3791 lesions) or Taxus (n = 2311 lesions) stent. INTERVENTIONS: Percutaneous coronary intervention. MAIN OUTCOME MEASURES: TLR, defined as either new percutaneous coronary intervention or coronary artery bypass graft operation of the target lesion, within 9 months from the index procedure. RESULTS: TLR within 9 months was performed in 2.5% of lesions treated with the Cypher stent and in 3.3% of lesions treated with the Taxus stent (OR 1.36, 95% CI 1.00 to 1.84). After adjustment by multivariate logistic regression, Taxus stent implantation was an independent predictor of TLR (OR 1.43, 95% CI 1.05 to 1.95). Implantation of >1 stent per lesion (OR 1.62, 95% CI 1.13 to 2.33) and reference diameter
Timing, causes, and predictors of death after three years' follow-up in the Danish Multicenter Randomized Study of Fibrinolysis versus Primary Angioplasty in Acute Myocardial Infarction (DANAMI-2) trial.
This study evaluated the timing, causes, and predictors of death during long-term follow-up after primary angioplasty with stent implantation versus in-hospital fibrinolysis with a tissue plasminogen activator (alteplase). We randomized 1,572 patients with ST-elevation myocardial infarction to primary angioplasty or alteplase and followed them for 3 years. The causes of death were prospectively assessed by an end point committee unaware of the study treatment. A total of 225 patients (14.3%) died, 113 within the first 30 days and 112 between 31 days and 3 years. The mortality and causes of death did not differ between the 2 treatments. The causes of death were cardiogenic shock/congestive heart failure (41%), sudden death (17%), other cardiac death (10%), cancer (12%), and other noncardiac death (20%). Cardiac death was predominant during the first month only (86% of early deaths), and noncardiac death and cardiac death were equally frequent after 30 days (49% and 51% of late deaths, respectively). Independent predictors of death after discharge were age, left ventricular ejection fraction, diabetes, Killip class, and a lack of treatment with a beta blocker or statin. In conclusion, the causes of death did not differ between alteplase treatment and primary angioplasty with stent implantation. One half of the deaths within 3 years after ST-elevation myocardial infarction occurred during the first 30 days, and cardiac death was predominant during the first 30 days only.