OBJECTIVES The aim of this was to analyse current outcomes in patients referred to coronary artery bypass grafting (CABG) for acute coronary syndromes (ACSs), including ST-elevation or non-ST-elevation ACS (non-ST-segment elevation myocardial infarction) or unstable angina. METHODS Patients (n = 2432) undergoing CABG for ACS between January 2010 and December 2017 were prospectively entered into a surgical myocardial infarction registry in North Rhine-Westphalia, Germany. Key end points were in-hospital all-cause mortality (IHM) and major adverse cardio-cerebral events (MACCE). Predictors for IHM and MACCE were analysed by multivariable logistic regression. RESULTS Patients (78% males) were referred for CABG for unstable angina (25%), non-ST-segment elevation myocardial infarction (50%), and ST-segment elevation myocardial infarction (25%). The mean patient age was 68 ± 11 years, logistic EuroSCORE was 19 ± 18% and three-vessel and left main stem diseases were diagnosed in 81% and 45% of patients, respectively. On-pump CABG with cardiac arrest or beating heart was performed in 92% and 2%, respectively, with only 6% off-pump surgery and 6% multiple arterial revascularization (3.1 ± 1.0 grafts, 93% left internal thoracic artery). Emergency CABG was performed in 23% of patients (42% in ST-segment elevation myocardial infarction; P < 0.001). The total IHM and MACCE rates were 8.1% and 17.5% and were highest in ST-segment elevation myocardial infarction patients with 12.6% and 28.5%, respectively (P < 0.001). Key predictors for IHM and MACCE were female gender, elevated troponin, left ventricular ejection fraction, inotropic support, logistic EuroSCORE, cardiopulmonary bypass and aortic clamp time and the need for emergency CABG. CONCLUSIONS Surgical myocardial revascularization in patients with ACS is still linked to substantial in-hospital mortality. Emergency CABG for patients with ACS was associated with poorer outcomes.
433 Background: Regorafenib improved OS versus placebo in patients with uHCC who progressed on prior sorafenib in the RESORCE trial (Bruix J, 2017). An interim analysis of the observational REFINE study supported the safety and effectiveness of regorafenib in patients with uHCC in real-world clinical practice (Lim HY, 2021). Here we present an exploratory analysis of OS in REFINE by prior treatment. Methods: REFINE is a multicenter study that enrolled patients with uHCC for whom a decision to treat with regorafenib is made by the treating physician prior to enrollment according to the local health authority approved label. The primary objective of this study is safety, including the incidences of treatment-emergent adverse events (TEAEs) and dose modifications due to TEAEs (NCI-CTCAE v4.03). The secondary endpoints include OS, progression-free survival, and treatment duration. Results: Of the 1,031 patients enrolled, 1,008 were evaluable for interim analysis. At baseline, median age was 66 years (range 21–94); 62% of patients were Barcelona Clinic Liver Cancer stage C; 62% had Child–Pugh A disease; and 83% had an Eastern Cooperative Oncology Group performance status of 0 or 1. In total, 99% of patients received prior treatment: 96% had prior sorafenib, 9% had ≥1 prior immunotherapy (most common: nivolumab [50%] and pembrolizumab [21%]), and 6% had a multikinase inhibitor other than sorafenib (lenvatinib [62%]). The majority of patients experienced TEAEs (91%) and drug-related TEAEs (73%). Median OS was 12.9 months (95% confidence interval [CI] 11.4, 14.6). Subgroup analyses of OS by prior treatment are shown (Table). Conclusions: REFINE reflects the changing treatment landscape and supports the safety and effectiveness of regorafenib in real-world patients with uHCC who had prior systemic treatment other than sorafenib, including immunotherapy. This interim analysis suggests that patients who received regorafenib in the second line had longer OS than patients who received regorafenib in the third line and beyond. Clinical trial information: NCT03289273. [Table: see text]
Background Left atrial appendix, as an essential source of systemic embolism and stroke in patients with atrial fibrillation, can be excluded during cardiac surgery, however the clinical benefit is as yet uncertain. Methods A total of 376 out of 3741 consecutive patients with atrial fibrillation presenting a high risk for stroke (CHA2DS2-VASc-Score ≥2 for men and ≥3 for women) who underwent heart surgery with cardiopulmonary bypass between 01/2012 and 12/2015 were analysed for mortality and stroke rate at 30 days, 12 and 24 months. Patients with concomitant LAA-closure alone (group1; n=107) were compared to patients with concomitant surgical ablation and LAA-closure (group2; n=85), and patients without surgical ablation and no LAA-closure (group3; n=184) as controls. To further adjust for pre- and intraoperative risk factors, a propensity score stratification analysis based on patients age, gender, EuroSCORE-2, CHA2DS2-VASc-Score and type of procedure was performed. Results Patients age was 72±8 years (mean±SD) and 33% were female. EuroSCORE-2 was 8.7±7.7%, 5.7±3.9%, and 5.4±8.4% and CHA2DS2-VASc-Score was 4.2±1.5, 3.9±1.4, and 4.1±1.4 on average for the respective groups. Mortality did not differ between groups at 30 days, 12 and 24 months. The incidence of stroke was 1.9% at 30 days, 4.8% at 12 and 6.7% at 24 months in group1. There was no stroke at 30 days and 12 months and 1.3% at 24 months in group2, and 1.8% at 30 days, 3.0% at 12 and 24 months in control group3. The overall mortality at 24 months was 27.1%, 20% and 24.6% respectively. After propensity score stratification, stroke rate showed significant benefit in group 2 (P=0.05) at 12 months and a hazard ratio of 0.17, 95% confidents limits 0.02–1.50, (P=0.08) at 24 months, whereas overall mortality did not significantly differ between the groups at 12 and 24 months follow-up. Conclusions In this propensity score stratification analysis, patients undergoing cardiac surgery with surgical ablation and concomitant LAA-closure had significant fewer strokes at 12 months follow-up compared to patients undergoing cardiac surgery with LAA-closure alone. Overall mortality did not significantly differ between the groups. Therefore, a concomitant LAA closure during heart surgery without additional surgical ablation does not show any clinical benefit in terms of reduced stroke rate or survival until 12 and 24 months follow-up.
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