Day or Night, STEMI Patients Receive Similar Levels of Quality Care
STEMI patients treated as part of the 10,000-patient CHAMPION PHOENIX trial who presented to the hospital during off times such as nights, weekends, and holidays were just as likely to survive and to have good clinical outcomes as those who presented during regular daytime hours, new data suggest.
Although prior studies have indicated that off-hours presentation is associated with worse outcomes, the analysis of this particular trial found this not to be the case.
“In our international study of contemporary primary PCI practice, we found that outcomes off-hours were as good as on-hours,” co-author Deepak L. Bhatt, MD, MPH(Brigham and Women’s Hospital, Boston, MA), told TCTMD in an email. “Potentially, this improvement in practice over time is due to quality improvement efforts in primary PCI,” such as those by the American College of Cardiology and American Heart Association, he suggested.
Bhatt presented the findings during a poster session at the European Society of Cardiology Congress 2016 in Rome, and they were simultaneously published in the Journal of the American College of Cardiology.
In the main CHAMPION PHOENIX trial, rates of the primary efficacy endpoint (all-cause death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours), the secondary efficacy endpoint (stent thrombosis at 48 hours), and MI were lower in those who received cangrelor (Kengreal, The Medicines Company) compared with clopidogrel.
For the new analysis, Bhatt and colleagues led by Senthil Selvaraj, MD (Brigham and Women’s Hospital),categorized patients by presentation times into either regular weekday hours or off hours, defined as weekdays from 7 PM to 7 AM, weekends, and holidays. Patients enrolled in the trial underwent urgent or elective PCI at 153 centers worldwide and were randomly assigned to either cangrelor or clopidogrel.
After multivariate propensity-score adjustment, there were no differences in rates of all-cause death, MI, ischemia-driven revascularization, or stent thrombosis at 48 hours or 30 days when patients who presented on weekday versus off hours were compared. There also was no difference in risk of the individual endpoint of stent thrombosis for on-hours compared with off-hours PCI, or in the rate of GUSTO-defined moderate or severe bleeding.
The researchers say the data “are reassuring and may reflect global quality improvement measures in STEMI care.”
Interesting, but Verification Needed
However, they also urge caution in interpreting the results and in completely ruling out potential harm associated with off-hours presentation, pointing out that the trial’s population may not be generalizable to all STEMI patients. Not only did the cohort have a lower rate of prior coronary procedures than what has been documented in registry patients, their times to treatment also were shorter for off-hours participants.
Furthermore, Bhatt noted that the sites in CHAMPION PHOENIX were all experienced high-volume hospitals, “so further research is necessary to see whether our results can be generalized to other types of hospitals,” he said.
Commenting on the study for TCTMD, Harlan M. Krumholz, MD, SM (Yale-New Haven Hospital, New Haven, CT), said while it is interesting, “unfortunately it is hard to know whether the trial population is truly representative of care in the countries that enrolled patients—and whether the representativeness was consistent by time of presentation.”
Importantly, Krumholz said, the confidence intervals are wide, making it difficult to exclude the possibility of important differences.
“Thus, we really should look to registry data with larger and more representative samples to see if we can verify what is being reported here,” he concluded.
Note: Co-author Gregg W. Stone, MD,is a faculty member of the Cardiovascular Research Foundation, the publisher of TCTMD.
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Selvaraj S, Bhatt DL, Stone GW, et al. “Off-hours” versus “on-hours” presentation in ST-segment elevation myocardial infarction: findings from CHAMPION PHOENIX. J Am Coll Cardiol. 2016;Epub ahead of print.
- The CHAMPION PHOENIX trial was sponsored by The Medicines Company.
- Krumholz reports no relevant conflicts of interest.
- Bhatt reports serving on the advisory boards of Cardax, Elsevier Practice Update Cardiology, Medscape Cardiology, and Regado Biosciences; on the board of directors of Boston VA Research Institute, Society of Cardiovascular Patient Care; as chair of the AHA Quality Oversight Committee; on the data monitoring committees of Duke Clinical Research Institute, Harvard Clinical Research Institute, Mayo Clinic, and Population Health Research Institute; as site co-investigator of Biotronik, Boston Scientific, and St. Jude Medical; and as a trustee of the American College of Cardiology (ACC). He also reports receiving honoraria from the ACC (Senior Associate Editor, Clinical Trials and News, ACC.org), Belvoir Publications (Editor in Chief, Harvard Heart Letter), Duke Clinical Research Institute (clinical trial steering committees), Harvard Clinical Research Institute (clinical trial steering committee), HMP Communications (Editor in Chief, Journal of Invasive Cardiology), Journal of the American College of Cardiology (Guest Editor; Associate Editor), Population Health Research Institute (clinical trial steering committee), Slack Publications (Chief Medical Editor, Cardiology Today’s Intervention), Society of Cardiovascular Patient Care (Secretary/Treasurer), and WebMD (CME steering committees); research funding from Amarin, Amgen, AstraZeneca, Bristol-Myers Squibb, Eisai, Ethicon, Forest Laboratories, Ischemix, Medtronic, Pfizer, Roche, Sanofi Aventis, and The Medicines Company; and royalties from Elsevier (Editor, Cardiovascular Intervention: A Companion to Braunwald’s Heart Disease). He additionally reports being involved in unfunded research with FlowCo, PLx Pharma, and Takeda.