Journal of cardiovascular medicine
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J Cardiovasc Med (Hagerstown) · Feb 2009
Randomized Controlled Trial Comparative StudyClinical and biomaterial evaluation of hyaluronan-based heparin-bonded extracorporeal circuits with reduced versus full systemic anticoagulation in reoperation for coronary revascularization.
This prospective randomized study compares full and reduced heparinization on novel hyaluronan-based heparin-bonded circuits vs. uncoated controls under challenging clinical setting including biomaterial evaluation. ⋯ Hyaluronan-based heparin-bonded circuits provided better clinical outcome and less inflammatory response compared with uncoated surfaces. Reduced systemic heparinization combined with hyaluronan-based heparin-bonded circuits is feasible and clinically well tolerated.
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J Cardiovasc Med (Hagerstown) · Feb 2009
Randomized Controlled Trial Multicenter Study Comparative StudyA multicenter, randomized study to test immunosuppressive therapy with oral prednisone for the prevention of restenosis after percutaneous coronary interventions: cortisone plus BMS or DES versus BMS alone to eliminate restenosis (CEREA-DES) - study design and rationale.
Several randomized trials and registries have shown a reduction of restenosis after coronary angioplasty with drug-eluting stents (DESs) compared with bare metal stents (BMSs). However, cost-efficacy analysis and long-term outcome of DESs compared to BMSs deserve further assessment. Moreover, concern has been raised regarding adverse clinical events occurring late after DES implantation, in particular, late stent thrombosis related to the suspension of dual antiplatelet therapy. The use of a short-cycle oral treatment with prednisone at immunosuppressive dose after BMS implantation has shown remarkable efficacy in reducing restenosis in nondiabetic patients, with very low additional cost and without the need for long-term dual antiplatelet therapy. Such results are however limited by small sample size. ⋯ This study will provide a magnitude of the net clinical and economic benefits of DES and of the safety and efficacy of BMS and cortisone compared to the standard use of BMS alone in nondiabetic patients with coronary artery disease.
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J Cardiovasc Med (Hagerstown) · Sep 2008
Randomized Controlled Trial Multicenter StudyA randomized trial comparing eptifibatide vs. placebo in patients with diffuse coronary artery disease undergoing drug-eluting stent implantation: design of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial.
Despite the availability of several potent antithrombotic agents, the optimal antiplatelet regimen in elective patients undergoing complex percutaneous coronary interventions is still debated. Aim of the INtegrilin plus STenting to Avoid myocardial Necrosis Trial will be to assess the safety and efficacy of routine usage of the glycoprotein IIb/IIIa inhibitor eptifibatide in patients already treated with aspirin and clopidogrel and undergoing implantation of at least two drug-eluting stents in the same lesion, thus identifying a clinically stable but anatomically complex patient subset. ⋯ The INtegrilin plus STenting to Avoid myocardial Necrosis Trial study will test for the first time the beneficial impact of routine glycoprotein IIb/IIIa inhibition on top of dual oral antiplatelet treatment in clinically stable yet anatomically complex patients undergoing drug-eluting stents implantation. Results of this single-blind randomized trial will provide important insights to improve the management strategy of patients and outcomes in the current drug-eluting stents era.
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J Cardiovasc Med (Hagerstown) · Dec 2007
Randomized Controlled Trial Multicenter StudyPost-cardioversion transesophageal echocardiography (POSTEC) strategy with the use of enoxaparin for brief anticoagulation in atrial fibrillation patients: the multicenter POSTEC trial (a pilot study).
In patients with atrial fibrillation (AF), we sought to evaluate the feasibility and safety of a new transesophageal echocardiography (TEE)-guided strategy, aimed at selecting, 7 days post-cardioversion, those patients who are at low risk (i.e. who can terminate anticoagulation after a second TEE) and those at high risk (i.e. who have to continue it). ⋯ The pre/post-cardioversion TEE strategy with enoxaparin in AF may constitute a feasible and safe approach in selecting patients at low thromboembolic risk who can benefit from precocious termination of anticoagulation (7 days after cardioversion). It may be also useful to identify those patients in whom a life-lasting anticoagulation could be beneficial. A larger trial to confirm these findings is under way.
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J Cardiovasc Med (Hagerstown) · Aug 2007
Randomized Controlled Trial Multicenter StudyInvestigation on Colchicine for Acute Pericarditis: a multicenter randomized placebo-controlled trial evaluating the clinical benefits of colchicine as adjunct to conventional therapy in the treatment and prevention of pericarditis; study design amd rationale.
Colchicine is safe and effective in the treatment and prevention of recurrent pericarditis after failure of conventional treatment. The recent guidelines of the European Society of Cardiology suggest that colchicine might be useful even in the treatment of the first episode. However, the use of the drug is not based on any strong evidence obtained from clinical trials, and no randomized placebo-controlled trial is available to guide the management of acute pericarditis. ⋯ The ICAP trial will be the first randomized placebo-controlled trial in this area. This trial will provide important evidence regarding the possible benefit of the early use of colchicine in the treatment of acute pericarditis and the primary prevention of recurrences, the most troublesome and commonest complication of pericarditis.