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.
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.
Authors: Neal W Dickert; David Wendler; Chandan M Devireddy; Sara F Goldkind; Yi-An Ko; Candace D Speight; Scott Yh Kim Journal: Clin Trials Date: 2018-10-03 Impact factor: 2.486