Intra-aortic balloon counterpulsation and infarct size in patients with acute anterior myocardial infarction without shock: the CRISP AMI randomized trial.
Abstract | CONTEXT: OBJECTIVE: DESIGN, SETTING, AND PATIENTS: INTERVENTION: MAIN OUTCOME MEASURES:
Infarct size expressed as a percentage of left ventricular (LV) mass and measured by cardiac magnetic resonance imaging performed 3 to 5 days after PCI. Secondary end points included all-cause death at 6 months and vascular complications and major bleeding at 30 days. Multiple imputations were performed for missing infarct size data. RESULTS: The median time from first contact to first coronary device was 77 minutes (interquartile range, 53 to 114 minutes) for the IABC plus PCI group vs 68 minutes (interquartile range, 40 to 100 minutes) for the PCI alone group (P = .04). The mean infarct size was not significantly different between the patients in the IABC plus PCI group and in the PCI alone group (42.1% [95% CI, 38.7% to 45.6%] vs 37.5% [95% CI, 34.3% to 40.8%], respectively; difference of 4.6% [95% CI, -0.2% to 9.4%], P = .06; imputed difference of 4.5% [95% CI, -0.3% to 9.3%], P = .07) and in patients with proximal left anterior descending Thrombolysis in Myocardial Infarction flow scores of 0 or 1 (46.7% [95% CI, 42.8% to 50.6%] vs 42.3% [95% CI, 38.6% to 45.9%], respectively; difference of 4.4% [95% CI, -1.0% to 9.7%], P = .11; imputed difference of 4.8% [95% CI, -0.6% to 10.1%], P = .08). At 30 days, there were no significant differences between the IABC plus PCI group and the PCI alone group for major vascular complications (n = 7 [4.3%; 95% CI, 1.8% to 8.8%] vs n = 2 [1.1%; 95% CI, 0.1% to 4.0%], respectively; P = .09) and major bleeding or transfusions (n = 5 [3.1%; 95% CI, 1.0% to 7.1%] vs n = 3 [1.7%; 95% CI, 0.4% to 4.9%]; P = .49). By 6 months, 3 patients (1.9%; 95% CI, 0.6% to 5.7%) in the IABC plus PCI group and 9 patients (5.2%; 95% CI, 2.7% to 9.7%) in the PCI alone group had died (P = .12). CONCLUSION: Among patients with acute anterior STEMI without shock, IABC plus primary PCI compared with PCI alone did not result in reduced infarct size. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00833612.
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Authors | Manesh R Patel, Richard W Smalling, Holger Thiele, Huiman X Barnhart, Yi Zhou, Praveen Chandra, Derek Chew, Marc Cohen, John French, Divaka Perera, E Magnus Ohman |
Journal | JAMA
(JAMA)
Vol. 306
Issue 12
Pg. 1329-37
(Sep 28 2011)
ISSN: 1538-3598 [Electronic] United States |
PMID | 21878431
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Topics |
- Aged
- Angioplasty, Balloon
- Female
- Heart Ventricles
- Humans
- Intra-Aortic Balloon Pumping
(methods)
- Magnetic Resonance Imaging
- Male
- Middle Aged
- Myocardial Infarction
(classification, pathology, therapy)
- Myocardial Reperfusion
- Shock, Cardiogenic
- Treatment Outcome
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