American heart journal
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American heart journal · Nov 2009
Randomized Controlled Trial Multicenter StudyDesign and rationale of the WOEST trial: What is the Optimal antiplatElet and anticoagulant therapy in patients with oral anticoagulation and coronary StenTing (WOEST).
Long-term oral anticoagulant treatment is obligatory in patients (class I) with mechanical heart valves and most patients with atrial fibrillation. When these patients undergo percutaneous coronary intervention with stenting, there is also an indication for treatment with aspirin and clopidogrel. However, triple therapy is known to increase the risk of bleeding complications. Unfortunately, there are no prospective data available to resolve this issue. Nevertheless, it all comes down to finding the ideal therapy in patients with indications of both chronic anticoagulation therapy and percutaneous intervention to prevent thrombotic complications (eg, stent thrombosis) without increasing the risk of bleeding. ⋯ No prospective randomized study has yet addressed the issue of optimal antiplatelet therapy in patients with chronic oral anticoagulant therapy undergoing coronary stenting. Therefore, the WOEST trial will help to define new guidelines for patients with indication for chronic anticoagulation who need coronary stenting.
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American heart journal · Oct 2009
Randomized Controlled Trial Comparative StudyBenefits of drug-eluting stents as compared to bare metal stent in ST-segment elevation myocardial infarction: four year results of the PaclitAxel or Sirolimus-Eluting stent vs bare metal stent in primary angiOplasty (PASEO) randomized trial.
Drug-eluting stent (DES) may offer benefits in terms of repeat revascularization, which may be counterbalanced by a potential higher risk of stent thrombosis, especially among patients with STEMI. No data have been reported so far on the long-term benefits and safety of DES in STEMI. The aim of the current study was to evaluate the short- and long-term benefits of sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) as compared to bare-metal stent (BMS) in patients undergoing primary angioplasty. ⋯ This study shows that among patients with STEMI undergoing primary angioplasty, both SES and PES are safe and associated with significant benefits in terms of TLR up to 4 years' follow-up, as compared to BMS. Thus, until the results of further large randomized trials with long-term follow-up become available, DES may be considered among patients with STEMI undergoing primary angioplasty.
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American heart journal · Oct 2009
Randomized Controlled Trial Multicenter Study Comparative StudyEarly abciximab administration before transfer for primary percutaneous coronary interventions for ST-elevation myocardial infarction reduces 1-year mortality in patients with high-risk profile. Results from EUROTRANSFER registry.
There are conflicting data on the clinical benefit from early administration of abciximab from a large randomized trial and a registry. However, both sources suggest that a benefit may depend on the baseline risk profile of the patients. We evaluated the role of early abciximab administration in patients with ST-segment-elevation myocardial infarction (STEMI) referred for primary percutaneous coronary intervention stratified by the STEMI Thrombolysis In Myocardial Infarction (TIMI) risk score. ⋯ Early abciximab administration before transfer for percutaneous coronary intervention in STEMI shows lower mortality at 1-year follow-up. This effect is confined to patients with higher risk profile as defined by TIMI risk score >or=3.
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American heart journal · Oct 2009
Randomized Controlled Trial Multicenter Study Comparative StudySPIRIT IV trial design: a large-scale randomized comparison of everolimus-eluting stents and paclitaxel-eluting stents in patients with coronary artery disease.
In the 300-patient SPIRIT II and 1002-patient SPIRIT III randomized trials, the everolimus-eluting stent (EES) compared to the paclitaxel-eluting stent (PES) resulted in reduced angiographic late loss (a primary end point in both trials), noninferior rates of 9-month target vessel failure (a primary end point in SPIRIT III), and reduced rates of target lesion revascularization and major adverse cardiac events (secondary end points). However, neither trial was powered for superiority for clinical end points, and the routine performance of angiographic follow-up may have artificially exaggerated the absolute benefits of EES. The relative efficacy of these 2 stents in patients with diabetes mellitus also remains controversial. We therefore designed a large-scale randomized trial without angiographic follow-up to further assess the differences between these 2 stent platforms. ⋯ SPIRIT IV is the largest randomized comparison of 2 DES with completed enrollment. The absence of routine angiographic follow-up will allow an accurate assessment of the absolute differences in the clinical safety and efficacy profile between these devices. The magnitude of the study will also permit significant insights to be gained into the relative performance of the 2 stents in important subgroups, including patients with diabetes mellitus.
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American heart journal · Sep 2009
Randomized Controlled Trial Multicenter StudyThe Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study design and rationale.
The protease-activated receptor 1 (PAR-1), the main platelet receptor for thrombin, represents a novel target for treatment of arterial thrombosis, and SCH 530348 is an orally active, selective, competitive PAR-1 antagonist. We designed TRA*CER to evaluate the efficacy and safety of SCH 530348 compared with placebo in addition to standard of care in patients with non-ST-segment elevation (NSTE) acute coronary syndromes (ACS) and high-risk features.