Helsinki Area Acute Myocardial Infarction Treatment Re-Evaluation - Should the Patients Get a Drug-Eluting or Normal Stent - HAAMU-STENT - Presented at TCT 2006
The goal of the trial was to evaluate performance of percutaneous coronary intervention (PCI) using bare-metal stent or paclitaxel-eluting stent among patients with ST elevation myocardial infarction (MI).
Patients Screened: 213
Patients Enrolled: 164
Mean Follow Up: 1 year
Mean Patient Age: Mean age 63 years
Presentation with ST elevation MI within prior 12 hours
Left bundle branch block, contraindication for thrombolytic or GP IIb/IIIa inhibitor
Patients undergoing PCI were randomized to bare-metal stent (n = 82) or paclitaxel-eluting stent (n = 82). Patients were part of the larger HAAMU trial, which compared PCI with thrombolysis.
Aspirin (250 mg load, 100 mg/day), enoxaparin 30 mg IV, and post-PCI clopidogrel (300-600 mg load and 75 mg/day for 1 year)
The PCI was a primary PCI in 55% of patients and post-thrombolysis (i.e., facilitated PCI) in 45% of patients. Infarct-related artery was the left anterior descending in 44% of patients and right coronary artery in 45%. Mean percent stenosis at baseline was 78%.
At angiographic follow-up, in-stent percent diameter stenosis was larger in the bare-metal stent group compared with the paclitaxel-eluting stent group (34% vs. 24%, p < 0.001). Late lumen loss was also larger in the bare-metal stent group (0.73 mm vs. 0.26 mm, p < 0.001). Among the clinical events at 1 year, 4.9% of patients in the bare-metal stent group had died compared with 9.8% of the paclitaxel-eluting stent group (p = 0.23). There was no difference in the composite of death, MI, or target vessel revascularization (17% with bare-metal stent vs. 13% with paclitaxel-eluting stent, p = 0.52). Target vessel revascularization was performed in 11% of the bare-metal group and 3.7% of the paclitaxel group (p = 0.072). There were three cases of stent thrombosis in the bare-metal group and one in the paclitaxel-eluting stent group.
Among patients with ST elevation MI undergoing PCI, use of paclitaxel-eluting stents was associated with less late lumen loss compared with bare-metal stenting. Mortality at 1 year was directionally higher with paclitaxel-eluting stents while target vessel revascularization was directionally lower with paclitaxel-eluting stents, neither of which were statistically significant.
The present study was small and not adequately powered to fully evaluate clinical events. Late lumen loss and percent diameter stenosis was lower with paclitaxel-eluting stents at angiographic follow-up. However, longer follow-up and larger trials would be needed to fully evaluate safety and efficacy of paclitaxel-eluting stenting in this population. Patients in the trial were to be treated with clopidogrel for the full year of follow-up. The risk of events after clopidogrel discontinuation in the study is not known.
Presented by Dr. Ilkka Tierala at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2006), Washington, DC, October 2006.
Keywords: Paclitaxel, Myocardial Infarction, Coronary Restenosis, Metals, Thrombosis, Constriction, Pathologic, Coronary Vessels, Angioplasty, Balloon, Coronary, Stents
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