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Postconditioning with Lactate-enriched Blood for Cardioprotection in ST-segment Elevation Myocardial Infarction
Published on: May 28, 2019
ST-elevation myocardial infarction patients can be enrolled in randomized trials before emergent coronary
James C Blankenship1, Kimberly A Skelding, Thomas D Scott
1Department of Cardiology, Geisinger Medical Center, Danville, PA 17822, USA. jblankenship@geisinger.edu
Insights
Enrolling ST-elevation myocardial infarction (STEMI) patients in clinical trials does not significantly delay reperfusion therapy. Door-to-balloon times remain similar for research and nonresearch patients, ensuring timely treatment for STEMI care.
Area of Science:
- Cardiology
- Clinical Trials
- Interventional Cardiology
Background:
- Multicenter trials are crucial for evaluating new treatments in ST-elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI).
- Enrollment in clinical trials could potentially delay critical reperfusion therapy for STEMI patients.
Purpose of the Study:
- To assess whether STEMI patients undergoing PCI can be enrolled in clinical trials without compromising door-to-balloon times.
- To determine the impact of clinical trial enrollment on the timeliness of reperfusion therapy in STEMI patients.
Main Methods:
- A single PCI center prospectively enrolled STEMI patients in clinical trials between October 2004 and December 2007.
- Door-to-balloon times were compared between patients enrolled in trials and those not enrolled, considering direct presentations and transfers.
Main Results:
- Of 581 STEMI patients, 123 were enrolled in clinical trials.
- Door-to-balloon times were similar for research and nonresearch patients, both for transferred (104 vs. 108 minutes) and directly presenting patients (55 vs. 44 minutes).
Conclusions:
- STEMI patients can be enrolled in clinical trials without significant delays in reperfusion.
- Door-to-balloon times under 90 minutes are achievable even with clinical trial enrollment for directly presenting STEMI patients.
Background:
Multicenter trials are necessary to compare the effectiveness of new drugs and devices for patients with ST-elevation myocardial infarction (STEMI) percutaneous coronary intervention (PCI). However, enrollment of STEMI patients in clinical trials could be detrimental to patients if it significantly delayed reperfusion therapy. We sought to determine whether STEMI patients treated with PCI could be enrolled in clinical trials without prolonging door-to-balloon times.
Methods:
At a single PCI center between October 17, 2004, and December 31, 2007, patients were enrolled in 1 of 4 trials requiring central enrollment and informed consent if (1) a study was actively enrolling, (2) the patient met inclusion/exclusion criteria, (3) and a study nurse was available. Median door-to-balloon times were compared for patients enrolled in clinical trials compared to those not enrolled.
Results:
Of 581 STEMI patients treated with PCI, 123 were enrolled in clinical trials and 458 were not. For patients transferred for PCI, community hospital door-to-balloon times were similar for research and nonresearch patients (104 vs 108 minutes, P = .4). For patients presenting directly to the PCI center, median door-to-balloon times were similar for research (55 minutes) and nonresearch patients (44 minutes, P = .5) after adjustment for age, culprit artery, and operator.
Conclusions:
Patients with STEMI may be enrolled in clinical trials with no significant delay in achieving reperfusion. For patients presenting directly to the PCI center, median door-to-balloon times well under 90 minutes can be achieved even with enrollment into clinical trials.
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