XI. CLINICAL TRIALS
A. Meta-Analysis
A comprehensive meta-analysis involving 23 trials in 7739 patients demonstrated some superiority of primary PCI over thrombolytic therapy in reducing the individual end points of death, nonfatal infarction, and stroke. The risk of hemorrhagic stroke was significantly reduced by primary PCI.
The door-to-balloon time is the strongest predictor of outcome. A prospective registry of more than 27,000 patients undergoing primary PCI for acute myocardial infarction showed that in-hospital mortality significantly increased when the door-to-balloon time was delayed beyond two hours.
B. Danami-2, Andersen et al.
One of the first large randomized trials in assessing the benefits of primary PCI in patients with acute ST segment elevation infarction was done in Denmark.
Methods: Patients with acute myocardial infarction (1572) were randomized to treatment with angioplasty or accelerated treatment with intravenous alteplase.
Results: Among all patients the better outcome of angioplasty was driven primarily by a reduction in the rate of reinfarction (1.6% in the angioplasty group vs. 6.3% in the fibrinolysis group; p < 0.001). No significant differ¬ences were observed in the rate of death (6.6% vs. 7.8%; p ¼ 0.35). Also 96% of patients were transferred from referral hospitals to an invasive treatment center within two hours.