Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial.

BACKGROUND: We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. METHODS: Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. FINDINGS: PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. INTERPRETATION: No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. FUNDING: Medtronic, Inc.

Cardiac arrest survival after implementation of automated external defibrillator technology in the in-hospital setting.

BACKGROUND: Survival from ventricular tachycardia (VT) or ventricular fibrillation (VF) arrest is inversely related to delay to defibrillation. The automated external defibrillator (AED) has improved survival after out-of-hospital VT/VF arrest by decreasing time to defibrillation. The purpose of this study was to determine whether survival to discharge after in-hospital cardiac arrest caused by VT/VF could be improved via an institution-wide change from a standard monophasic defibrillator to a biphasic defibrillator with AED capability. METHODS AND RESULTS: After extensive staff education, all standard defibrillators were replaced by AEDs at a single institution. Outcomes were analyzed for 1 year before the change and 1 year after the change using a prospective database. In patients whose initial rhythm was VT/VF, AEDs were not associated with improvement in time to first shock (median 1 minute for both cohorts, p = 0.79) or survival to discharge (31% vs. 29%, p = 0.8) compared with standard defibrillators. In patients whose initial rhythm was asystole or pulseless electrical activity, AEDs were associated with a significant decrease in survival (15%) compared with standard defibrillators (23%, p = 0.04). The overall AED cohort showed no difference in survival to discharge compared with the standard cohort (18% vs. 23%, p = 0.09). CONCLUSIONS: Replacement of standard monophasic defibrillators with biphasic AEDs was associated with unchanged survival after in-hospital VT/VF arrest and decreased survival after in-hospital asystole or pulseless electrical activity arrest.

Mortality implications of primary percutaneous coronary intervention treatment delays: insights from the Assessment of Pexelizumab in Acute Myocardial Infarction trial.

BACKGROUND: Prior studies demonstrate a direct relationship between treatment delays to primary percutaneous intervention and mortality in patients with ST-segment elevation myocardial infarction (STEMI). This analysis compared the relationship of symptom onset-to-balloon time and door-to-balloon time on mortality in patients with STEMI. METHODS AND RESULTS: We analyzed different treatment delays (symptom onset-to-balloon time, door-to-balloon time) and mortality in 5745 STEMI patients. Baseline characteristics, flow grade, 90-day mortality, and clinical outcomes were compared in patients stratified by treatment delay. Multivariable logistic regression modeling was performed to assess the independent and relative effect of each treatment delay on 90-day mortality. Female sex, increased age, and worse thrombolysis in myocardial infarction flow grade were significantly associated with longer symptom onset-to-balloon times and door-to-balloon times. Longer symptom onset-to-balloon time was significantly associated with worse 90-day mortality (3.7%, 4.2%, and 6.5% for time delays <3 hours, 3 to 5 hours, and >5 hours, respectively, P<0.0001). Similarly, longer door-to-balloon times were significantly associated with worse 90-day mortality (3.2%, 4.0%, 4.6%, and 5.3% for delays <60 minutes, 60 to 90 minutes, 90 to 120 minutes, and ≥120 minutes respectively, P<0.0001). In a multivariate model of 90-day mortality, door-to-balloon time (χ(2) 6.0, P<0.014), and symptom onset-to-hospital arrival (χ(2) 9.8, P<0.007) remained independent determinants. CONCLUSIONS: Both symptom onset-to-balloon time and hospital door-to-balloon time are strongly associated with 90-day mortality following STEMI. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT00091637.