Background
Non–ST-segment myocardial infarction (NSTEMI) can be complicated by high-degree atrioventricular (AV) block, asystole, or electromechanical dissociation (EMD), but these events are not well characterized in the contemporary era. This analysis assesses the incidence of and factors associated with these dysrhythmias in acute NSTEMIs.
Methods
Patients with NSTEMI in the EARLY ACS, PLATO, and TRACER trials were included in the pooled cohort (N = 29,677). Logistic regression was used to identify factors associated with in-hospital high-degree AV block and asystole or EMD, and Kaplan-Meier methods were used to assess mortality.
Results
High-degree AV block occurred in 112 (0.4%) patients, asystole in 157 (0.5%), and EMD in 38 (0.1%). Pacemakers were inserted in 241 patients (0.8%) during the index hospitalization: 30 (12%) for AV block. Among patients with high-degree AV block, we observed more frequent right coronary artery lesions (47% vs 29%). Age, diabetes, lower heart rate, and lower blood pressure were associated with high-degree AV block. Higher Killip class, ST-segment depression, prior myocardial infarction, and peripheral vascular disease were most strongly associated with asystole or EMD. Ten-day unadjusted survival was 90% for patients with high-degree AV block and 43% for those with asystole or EMD.
Conclusions
Although high-degree AV block, asystole, and EMD were infrequent complications of NSTEMI, they were associated with substantial short-term mortality. Only 1 in 8 pacemakers placed in NSTEMI patients during the acute hospitalization was for high-degree AV block.
Probabilistic sensitivity analysis indicated robustness in the Conclusionsof dominance/highly cost-effective approach for SEC vs. UST. ConClusions: Applying stricter criteria for response (i.e., PASI≥ 75 instead of PASI≥ 50) for treatment dis/ continuation for highly efficacious PSO therapy (SEC) Resultsin overall greater QALYs and cost savings for the health-care system.
667 Background: CONCUR (NCT01584830) showed that regorafenib (REG) significantly improves overall survival (OS) and progression-free survival (PFS) vs. placebo (PBO) in Asian patients with mCRC who progressed after standard therapy (J Li, et al. WCGI 2014). Post hoc exploratory analyses were conducted to assess the effect of treatment on HRQoL. Methods: Patients were randomly assigned 2:1 to treatment with either REG (n=136) or PBO (n=68). The HRQoL analyses included all 204 patients and were selected a priori based on clinical relevance; the global health status/QoL (QL) and the physical functioning (PF) scales of the EORTC QLQ-C30 questionnaire were used. A linear mixed-effects model (LMM) was used to examine the treatment effect on HRQoL and trends over time, assuming that data were missing at random. A pattern-mixture model (PMM) was applied to assess the treatment effect while accounting for potentially informative missing data. Time-to-deterioration (TTD) of HRQoL and responder analyses were conducted to determine the treatment effect based on timing and proportion of patients reaching a minimal important difference (MID) change in QL/PF (≥10 points). Results: The QL and PF changes over time were numerically similar between REG and PBO based on the LMM. The PMM grouped patients based on timing of last HRQoL assessment (<3 or ≥3 cycles) and had results similar to the LMM, demonstrating little impact of informative missing data. For the TTD analysis, when an event was defined as the earliest MID decrease in QL/PF, disease progression, or death, REG showed significantly different TTD curves from PBO (QL: median 8.0 vs. 7.0 weeks, hazard ratio (HR)=0.54; PF: median 7.9 vs. 7.0 weeks, HR=0.59, respectively; all p<0.01). Median TTD was comparable between treatments after removing progression/death from the definition. The responder analyses showed that a similar proportion of patients achieved an improvement in MID in REG vs. PBO (QL: 27.2% vs. 29.4%; PF: 14.0% vs.16.2%, respectively). Conclusions: The findings of this exploratory analysis demonstrate that HRQoL is similar for the REG and PBO groups, indicating that REG prolongs OS and PFS vs. PBO while maintaining a comparable HRQoL. Clinical trial information: NCT01584830.
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