Among high-risk patients who had a myocardial infarction with ST-segment elevation and who were treated with fibrinolysis, transfer for PCI within 6 hours after fibrinolysis was associated with significantly fewer ischemic complications than was standard treatment. (ClinicalTrials.gov number, NCT00164190.)
Drug-eluting stents are effective in reducing the need for target-vessel revascularization in patients at highest risk for restenosis, without a significantly increased rate of death or myocardial infarction.
Background-Despite the current standard antiplatelet regimen of aspirin and clopidogrel (with or without glycoprotein IIb/IIIa inhibitors) in percutaneous coronary intervention patients, periprocedural and postprocedural ischemic events continue to occur. Prasugrel (CS-747, LY640315), a novel potent thienopyridine P2Y 12 receptor antagonist, has the potential to achieve higher levels of inhibition of ADP-induced platelet aggregation than currently approved doses of clopidogrel. Methods and Results-Joint Utilization of Medications to Block Platelets Optimally-Thrombolysis In MyocardialInfarction 26 (JUMBO-TIMI 26) was a phase 2, randomized, dose-ranging, double-blind safety trial of prasugrel versus clopidogrel in 904 patients undergoing elective or urgent percutaneous coronary intervention. Patients were randomized to either standard dosing with clopidogrel or 1 of 3 prasugrel regimens. Subjects were monitored for 30 days for bleeding and clinical events. The primary end point of the trial was clinically significant (TIMI major plus minor) non-CABG-related bleeding events in prasugrel-versus clopidogrel-treated patients. Hemorrhagic complications were infrequent, with no significant difference between patients treated with prasugrel or clopidogrel in the rate of significant bleeding (1.7% versus 1.2%; hazard ratio, 1.42; 95% CI, 0.40, 5.08). In prasugrel-treated patients, there were numerically lower incidences of the primary efficacy composite end point (30-day major adverse cardiac events) and of the secondary end points myocardial infarction, recurrent ischemia, and clinical target vessel thrombosis. Conclusions-In this phase 2 study, which was designed to assess safety when administered at the time of percutaneous coronary intervention, prasugrel and clopidogrel both resulted in low rates of bleeding. The results of this trial serve as a foundation for the large phase 3 clinical trial designed to assess both efficacy and safety. (Circulation. 2005;111:3366-3373.)
Objectives-To test the hypothesis that endovascular stents used with dilation of coarctation of the aorta (CoA) improve late outcomes. Balloon dilation for CoA has been limited by concerns over the risk for acute dissection, late restenosis, or aneurysm formation. Design-All patients seen with CoA between November 1994 and September 1997 underwent attempted stent implantation. Follow up was obtained for all patients and a subgroup (n = 18) had repeat catheterisation at a mean (SD) of 1.3 (0.5) years to assess residual gradient and stentCoA morphology. Results-Stents were placed in 27 patients (15 male and 12 female patients, mean age 30.1 (13.1) years), of whom seven had prior surgical coarctectomy and one had a prior balloon dilation. Hypertension was present in 26 patients (mean pressure 164 (26)/86 (13) mm Hg), of whom 16 were on antihypertension drugs. CoA gradients were 46 (20) mm Hg (range 18-106 mm Hg) at baseline and 3 (5) mm Hg after the procedure. One patient had a stroke following the procedure; another patient had incomplete dilation and underwent a second procedure. At 1.8 (1) years after the procedure the mean pressure was 130 (14)/74 (11) mm Hg with seven patients on antihypertension treatment. The clinical gradient was 4 (8) mm Hg (range 0-32 mm Hg). At follow up angiography, the mean gradient was 4(6) mm Hg, and two patients had a gradient over 10 mm Hg. Aneurysms formed in three patients at the dilation site; one patient was referred for surgery. Conclusion-In this age group stent management for CoA appears to be an eVective technique and results in sustained reduction in CoA gradients at early term follow up, but aortic aneurysm was detected in 17% of patients who had repeat angiography. (Heart 2001;85:561-566)
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