STEMI-PCI at Off Hours: Outcomes Didn't Suffer in Modern Cohort

September 01, 2016

ROME, ITALY — Patients presenting with STEMI and receiving PCI "off-hours"—at night and on weekends—did not show worse outcomes compared with those arriving during regular daytime working hours in a new analysis of the randomized CHAMPION PHOENIX trial[1].

Presenting the data at a poster at the European Society of Cardiology (ESC) 2016 Congress, Dr Senthil Selvaraj (Brigham and Women's Hospital, Boston, MA) explained to heartwire from Medscape that several previous studies have suggested worse outcomes in patients presenting off-hours, but these have mostly been based on registry data. "Our results come from a large, contemporary, international randomized trial so may be more reliable," he suggested.

Dr Senthil Selvaraj

"These reassuring results suggest that recent efforts toward quality improvement such as the Missions Lifeline Initiative appear to be having good effects," Selvaraj said.

The analysis was also published online as a letter in the Journal of the American College of Cardiology on August 30, 2016.

For the current study, the 1992 STEMI patients enrolled into the CHAMPION PHOENIX study were analyzed by time of presentation. Off-hours PCI was defined by intervention performed during weekdays from 7 pm to 7 am, weekends, and holidays.

Because time of PCI was not randomized in the trial, logistic multivariate regression with propensity-score analysis was used to determine the risk of all outcomes. Propensity scores were constructed using age, randomization arm, enrollment site (US vs non-US), previous MI, previous PCI, history of diabetes, clopidogrel loading dose, type of anticoagulant, and type of stent.

The primary efficacy outcome was a composite of all-cause death, MI, stent thrombosis, or ischemia-driven revascularization at 48 hours. The primary safety outcome for this analysis was GUSTO-defined moderate or severe bleeding, while ACUITY-defined major or minor bleeding was also examined.

Results showed that the primary efficacy outcome was not significantly different for on-hours vs off-hours presentation on unadjusted analysis (RR 1.11, 95% CI 0.68–1.83; P=0.67) or after multivariate propensity score adjustment (RR 1.00, 95% CI 0.57–1.74; P=0.99).

The primary safety outcome and the incidence of stent thrombosis were also not statistically different in the two groups.

On-hours participants were more likely to be enrolled from the US, 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). Bailout therapy with GP IIb/IIIa inhibitors was similar in the groups.

One observation that might be surprising was that off-hours participants actually underwent PCI more rapidly from symptom onset (median: 5.00 vs. 5.98 hours, P<0.0001). They also had slightly shorter admission to PCI times.

"Sometimes, we can see shorter treatment times during off-hours as the cath lab is not busy, and there are fewer traffic delays," Selvaraj commented.

The authors note: "These findings are reassuring and suggest that outcomes for STEMI revascularization are not dependent upon time of presentation. Such information is important given that previous studies suggesting a difference in efficacy were retrospective with unadjudicated outcomes. The additional collection of stent thrombosis and ischemia-driven revascularization are important end points in PCI that are not widely available in previous studies."

CHAMPION PHOENIX was sponsored by the Medicines Company. Selvaraj reports no relevant financial relationships; disclosures for the coauthors are listed in the letter.

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