Baseline characteristics of patients enrolled in the Exenatide Study of Cardiovascular Event Lowering (EXSCEL).

BACKGROUND: EXSCEL is a randomized, double-blind, placebo-controlled trial examining the effect of exenatide once-weekly (EQW) versus placebo on time to the primary composite outcome (cardiovascular death, nonfatal myocardial infarction or nonfatal stroke) in patients with type 2 diabetes mellitus (DM) and a wide range of cardiovascular (CV) risk. METHODS: Patients were enrolled at 688 sites in 35 countries. We describe their baseline characteristics according to prior CV event status and compare patients with those enrolled in prior glucagon-like peptide-1 receptor agonist (GLP-1RA) outcomes trials. RESULTS: Of a total of 14,752 participants randomized between June 2010 and September 2015, 6,788 (46.0%) patients were enrolled in Europe; 3,708 (25.1%), North America; 2,727 (18.5%), Latin America; and 1,529 (10.4%), Asia Pacific. Overall, 73% had at least one prior CV event (70% coronary artery disease, 24% peripheral arterial disease, 22% cerebrovascular disease). The median (IQR) age was 63 years (56, 69), 38% were female, median baseline HbA1c was 8.0% (7.3, 8.9) and 16% had a prior history of heart failure. Those without a prior CV event were younger with a shorter duration of diabetes and better renal function than those with at least one prior CV event. Compared with prior GLP-1RA trials, EXSCEL has a larger percentage of patients without a prior CV event and a notable percentage who were taking a dipeptidyl peptidase-4 inhibitor at baseline (15%). CONCLUSIONS: EXSCEL is one of the largest global GLP-1RA trials, evaluating the safety and efficacy of EQW with a broad patient population that may extend generalizability compared to prior GLP-1RA trials (ClinicalTrials.gov number, NCT01144338).

An invasive strategy is associated with decreased mortality in patients with unstable angina and non-ST-elevation myocardial infarction: GUSTO IIb trial.

There has been much debate concerning an invasive versus a conservative strategy for patients with acute coronary syndromes. The purpose of this study was to determine whether early in-hospital catheterization reduced mortality in patients with unstable angina and non-ST-elevation myocardial infarction. We performed a retrospective analysis of data collected in the Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) IIb trial, which compared hirudin and heparin in patients with acute coronary syndromes. We identified 8011 patients with non-ST-segment elevation myocardial infarction and unstable angina who were enrolled in the trial. The primary endpoints were all-cause mortality at 30 days and 1 year. Data were analyzed with multivariate hazards models and propensity scores.After accounting for inception time bias, there were 7897 patients identified, of whom 4536 patients (57%) underwent invasive therapy and 3361 (43%) underwent conservative therapy. Adjusting for propensity scores, the adjusted 30-day mortality for the invasive group was 2.5% compared with 2.7% in the conservative group (P = 0.92); at 1 year, the invasive group had a 6.2% mortality, versus 8.6% in the conservative group (P = 0.005). In a multivariate analysis that adjusted for other clinical factors, an invasive strategy was associated with lower 1-year mortality (hazard ratio = 0.46; 95% confidence interval: 0.10 to 0.84). In patients presenting with acute coronary syndromes, an invasive strategy is associated with improved survival at 1 year even after adjusting for baseline differences.