Randomized trial of ticagrelor vs. aspirin in patients after coronary artery bypass grafting: the TiCAB trial.

AIMS: The antiplatelet treatment strategy providing optimal balance between thrombotic and bleeding risks in patients undergoing coronary artery bypass grafting (CABG) is unclear. We prospectively compared the efficacy of ticagrelor and aspirin after CABG. METHODS AND RESULTS: We randomly assigned in double-blind fashion patients scheduled for CABG to either ticagrelor 90 mg twice daily or 100 mg aspirin (1:1) once daily. The primary outcome was the composite of cardiovascular death, myocardial infarction (MI), repeat revascularization, and stroke 12 months after CABG. The main safety endpoint was based on the Bleeding Academic Research Consortium classification, defined as BARC ≥4 for periprocedural and hospital stay-related bleedings and BARC ≥3 for post-discharge bleedings. The study was prematurely halted after recruitment of 1859 out of 3850 planned patients. Twelve months after CABG, the primary endpoint occurred in 86 out of 931 patients (9.7%) in the ticagrelor group and in 73 out of 928 patients (8.2%) in the aspirin group [hazard ratio 1.19; 95% confidence interval (CI) 0.87-1.62; P = 0.28]. All-cause mortality (ticagrelor 2.5% vs. aspirin 2.6%, hazard ratio 0.96, CI 0.53-1.72; P = 0.89), cardiovascular death (ticagrelor 1.2% vs. aspirin 1.4%, hazard ratio 0.85, CI 0.38-1.89; P = 0.68), MI (ticagrelor 2.1% vs. aspirin 3.4%, hazard ratio 0.63, CI 0.36-1.12, P = 0.12), and stroke (ticagrelor 3.1% vs. 2.6%, hazard ratio 1.21, CI 0.70-2.08; P = 0.49), showed no significant difference between the ticagrelor and aspirin group. The main safety endpoint was also not significantly different (ticagrelor 3.7% vs. aspirin 3.2%, hazard ratio 1.17, CI 0.71-1.92; P = 0.53). CONCLUSION: In this prematurely terminated and thus underpowered randomized trial of ticagrelor vs. aspirin in patients after CABG no significant differences in major cardiovascular events or major bleeding could be demonstrated. CLINICALTRIALS.GOV IDENTIFIER: NCT01755520.

The prognostic relevance of oxygen uptake in inoperable chronic thromboembolic pulmonary hypertension.

BACKGROUND: Patients with chronic thromboembolic pulmonary hypertension (CTEPH) present with a decreased oxygen uptake, however, the prognostic relevance of oxygen uptake (VO2 ) in inoperable CTEPH is unknown. METHODS: Patients with inoperable CTEPH were retrospectively analyzed. All patients were assessed by means of right heart catheterisation and cardio pulmonary exercise testing in semisupine position with a 30 Watt increment step-protocol. RESULTS: One-hundred and fifty-one patients (82 female (54.3%), mean age 61 ± 12.4 years) presented with a mean pulmonary arterial pressure of 40.2 ± 14.2 mmHg and pulmonary vascular resistance (PVR) of 641.9 ± 374.8 dyne∗s/cm5 . The peak VO2 (mean 13.1 ± 4.5 mL∗kg-1 ∗min-1 ) was measured at initial referral. Over a follow-up of up to 10 years (mean 4.41 ± 2.57 years), 31 patients had died. Patients with a baseline peak VO2 ≥ 10.7 mL∗kg-1 ∗min-1 [area under the receiver-operating characteristic curve (AUC) = 0.728, P = 0.001] had better survival than those with a peak VO2 ≤ 10.7 mL∗kg-1 ∗min-1 using Kaplan-Meier analysis (88.8% vs 60.1%; log rank P = 0.001). Adjusting for age, gender and PVR, multivariate analysis identified peak VO2 as a predictor of mortality [hazard ratio (HR): 2.78, 95% CI 1.01-7.63, P = 0.047]. In addition, peak VO2 failed as an independent prognostic factor in a stepwise multivariate model including all variables significant in the univariate analysis. CONCLUSIONS: In patients with inoperable CTEPH the peak VO2 is a significant predictor of survival, when adjusting for age, gender and PVR. However, peak VO2 failed as an independent prognostic factor when correcting for all significant baseline variables, which is limiting the clinical usability.