Journal of thrombosis and thrombolysis
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J. Thromb. Thrombolysis · Dec 2005
Randomized Controlled Trial Multicenter Study Comparative StudyA randomized, double-blind, placebo-controlled study of the safety and efficacy of intravenous MCC-135 as an adjunct to primary percutaneous coronary intervention in patients with acute myocardial infarction: rationale and design of the evaluation of MCC-135 for left ventricular salvage in acute MI (EVOLVE) study.
As a consequence of acute ischemia and reperfusion in patients with acute ST elevation myocardial infarction, calcium overload inside myocytes not only affects myocardial contraction, relaxation, and myocyte recovery following reperfusion, but also may be related to myocyte necrosis and fatal arrhythmia. MCC-135 is the first in a new class of agents that reduce intracellular calcium overload. Pre-clinical and early clinical studies yielded promising results for patients with ST elevation myocardial infarction. ⋯ The rationale, design, and methods of the EVOLVE study are described in this paper, along with 2 sub-studies, involving a comparison of pre- and post-PCI measurements with either SPECT or echocardiography, to examine myocardial salvage and the time course of changes in myocardial infarction size and left ventricular function. MINIABSTRACT: The Evaluation of MCC-135 for Left Ventricular Salvage in Acute MI (EVOLVE) study is a Phase 2, multicenter, randomized, double-blind, placebo-controlled clinical trial of two doses of MCC-135, first in a new class of agents that reduce intracellular calcium overload, as adjunct therapy for preservation of left ventricular function and reduction of infarct size in patients with moderate-large STEMI undergoing primary PCI. The rationale, design, and methods of the EVOLVE study, along with two sub-studies, are described in this paper.
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J. Thromb. Thrombolysis · Jun 2005
Randomized Controlled Trial Clinical TrialMini-dose pump-prime aprotinin inhibited enhanced fibrinolytic activity and reduced blood loss and transfusion requirements after coronary artery bypass surgery.
Low-dose aprotinin in the pump during cardiopulmonary bypass (CPB) has been shown to improve postoperative hemostasis and platelet preservation. This investigation was undertaken to evaluate the effects of mini-dose pump prime only aprotinin (70 mg) on the hemostatic parameters and blood transfusion requirements in patients undergoing on-pump coronary artery bypass surgery (CABG). ⋯ Mini dose pump-prime aprotinin reduces postoperative blood loss, transfusion requirements and yet confers hemostatic improvement through reduced fibrinolysis in patients undergoing routine coronary artery bypass grafting.
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J. Thromb. Thrombolysis · Jun 2005
Randomized Controlled Trial Multicenter Study Clinical TrialThe role of gender and other factors as predictors of not receiving reperfusion therapy and of outcome in ST-segment elevation myocardial infarction.
The standard of care for ST-segment elevation myocardial infarction (STEMI) is prompt coronary reperfusion with thrombolysis or percutaneous coronary intervention. Women have higher mortality rates than men following STEMI and fewer women are considered eligible for reperfusion therapy. We analyzed the impact of gender, and other factors, on the outcome and treatment of STEMI in the TETAMI trial and registry. ⋯ Female gender was not an independent predictor of outcome or underutilization of reperfusion therapy. Factors more common in female STEMI patients (advanced age and delayed presentation) were associated with not receiving reperfusion therapy and adverse outcome. Increased awareness is needed to reduce delayed presentation after symptom onset, especially among women. Abbreviated abstract. In this analysis of 2741 ST-segment elevation myocardial infarction patients in the TETAMI trial and registry, a trend was observed for women being less likely to receive reperfusion therapy and more likely to have an adverse outcome than men. This was related to factors more common in female patients (advanced age and delayed presentation), and showed that an increased awareness is needed to reduce delayed presentation after symptom onset, especially among women.
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J. Thromb. Thrombolysis · Feb 2005
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialThrombolysis and counterpulsation to improve survival in myocardial infarction complicated by hypotension and suspected cardiogenic shock or heart failure: results of the TACTICS Trial.
Sustained hypotension, cardiogenic shock, and heart failure all imply a poor prognosis in acute myocardial infarction (MI). We assessed the benefit of adding 48 hours of intra-aortic balloon counterpulsation (IABP) to standard treatment for MI, in an international trial among hospitals without primary angioplasty capabilities. ⋯ While early IABP use was not associated with a definitive survival benefit when added to fibrinolysis for patients with MI and hemodynamic compromise in this small trial, its use suggested a possible benefit for patients with the most severe heart failure or hypotension. ABBREVIATED ABSTRACT: We assessed the benefit of adding 48 hours of intra-aortic balloon counterpulsation to fibrinolytic therapy among 57 patients with acute myocardial infarction complicated by sustained hypotension, possible cardiogenic shock, or possible heart failure. The primary end point, mortality at 6 months, did not differ between groups (34% for combined treatment versus 43% for fibrinolysis alone [n = 27]; adjusted P = 0.23), although patients with Killip class III or IV did show a trend toward greater benefit from IABP (39% for combined therapy versus 80% for fibrinolysis; P = 0.05).
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J. Thromb. Thrombolysis · Jun 2004
Randomized Controlled Trial Multicenter Study Clinical TrialMyocardial salvage after reduced-dose thrombolysis combined with glycoprotein IIb/IIIa blockade versus thrombolysis alone in patients with acute myocardial infarction.
The aim of study was to examine the efficacy of reduced-dose alteplase plus abciximab versus alteplase alone by quantifying the amount of myocardium salvaged using myocardial scintigraphy. ⋯ When used as a general strategy in patients with acute myocardial infarction, adding abciximab to alteplase does not increase significantly the amount of salvaged myocardium as compared with alteplase alone. Combination therapy may offer advantages over thrombolytic agents alone if such therapy is applied within 2 hours from symptom onset; however these data need to be proven by studies of adequate power.