CHAMPION PHOENIX: Does Timing of PCI Impact Efficacy or Safety Outcomes?
In contrast to findings from several prior studies, time of percutaneous coronary intervention (PCI) may not affect efficacy or safety outcomes of ST-segment elevation myocardial infarction (STEMI), according to findings from the CHAMPION PHOENIX Trial presented Aug. 30 during ESC Congress 2016 in Rome and simultaneously published in the Journal of the American College of Cardiology.
According to Senthil Selvaraj, MD, Deepak L. Bhatt, MD, MPH, FACC, et al., several previous studies have indicated worse outcomes for patients presenting with STEMI during off-hours as compared to the work day. In this newest study, a subgroup of 1,992 patients with recent STEMI from CHAMPION PHOENIX was dichotomized according to time of presentation, with off-hour PCI defined as an intervention performed on weekends, holidays and from 7 p.m. to 7 a.m. on weekdays. The primary efficacy outcome was a combined endpoint of all-cause death, myocardial infarction, stent thrombosis, or ischemia-driven revascularization at 48 hours. The primary safety outcome was GUSTO-defined moderate or severe bleeding, with ACUITY-defined major or minor bleeding also examined.
Results showed most participants (70 percent) underwent angiography through femoral access (79). On-hours participants were more likely to be enrolled from the U.S., have diabetes mellitus, have a prior PCI, and receive a higher dose clopidogrel load, low molecular weight heparin, bivalirudin, or a drug-eluting stent (p <0.05 for all comparisons). Off-hours participants underwent PCI more rapidly from symptom onset (median: 5.00 vs. 5.98 hours, P <0.0001). Bailout therapy with GP IIb/IIIa inhibitors was similar across both groups, as was the risk of the primary efficacy outcome for on-hours presentation. There was also no significant difference in risk of ST with on-hours PCI (adjusted RR 0.57 [95 percent CI 0.27, 1.21], p = 0.15) or in the primary safety outcome (p = 0.22). Investigators did note that cangrelor showed consistent benefits regardless of time of PCI for all outcomes (p >0.05 for interaction).
“Previous hazards identified with off-hours presentation in STEMI were not seen in a large, international, contemporary trial with prospective data collection and adjudication of efficacy outcomes,” the study authors said. “Such data are reassuring and may reflect global quality improvement measures in STEMI care.”
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