Abstract 4592: Geographic Enrollment Patterns Influence Outcome following ST Elevation Myocardial Infarction (STEMI): Observations from the FINESSE Trial
Introduction: Eastern European (EE) participation in pivotal cardiovascular clinical trials (CCT) has dramatically increased over the past decade. We sought to compare patient characteristics and outcomes following STEMI in EE compared to Western Europe (WE) in the background of a rigorous randomized CCT.
Methods: The Facilitated Intervention with Enhanced Reperfusion Speed to Stop Events (FINESSE) Study enrolled 2452 patient with STEMI and demonstrated a lack of benefit for a facilitated percutaneous coronary intervention (PCI) strategy for the primary outcome measure. Patient characteristics and outcomes for 1078 EE participants were compared to 1153 WE counterparts. Groups were compared with Chi-squared test for categorical variables and the Wilcoxon Rank-sum test for continuous variables. Death was analyzed using the log-rank test. Cox proportional hazards model was applied to control for baseline factors.
Results: Significant differences in baseline characteristics between EE and WE subjects are noted (Table 1⇓). No differences in unadjusted death (63(5.8%) vs 55(4.8%), p=NS) were noted at 90 days. Following adjustment, independent predictors of 90 mortality included increasing age, anterior MI, Killip Class, previous MI, statin therapy, and region of enrollment (Western vs Eastern Europe, HR 0.67, p<0.039).
Conclusions: Despite protocol-guided therapy, region of enrollment was an important independent determinant of 90-day mortality in European patients enrolled in FINESSE. Baseline Characteristics of STEMI patients enrolled in Europe in FINESSE