In: Health7 Jul 2010
Speaker: Ron Waksman, MD, Clinical Professor of Medicine (Cardiology), Georgetown University School of Medicine, and Associate Director of the Division of Cardiology, Washington Hospital Center, Washington, DC.
Data from a comparison of patient registries of two studies to assess the value of 12 months of therapy with clopidogrel (Sanofi Synthelabo/Bristol Myers Squibb) in patients treated with intracoronary radiation therapy for the prevention of recurrent in-stent restenosis post-brachytherapy is safe and is associated with a strong trend in the reduction of late total occlusion (LTO) and a significant decrease in revascularization rates compared to six months of clopidogrel, supporting the use of at least 12 months of clopidogrel after coronary brachytherapy for in-stent restenosis.
The aim of the study was to determine whether 12 months of clopidogrel therapy further reduces the rate of late thrombosis and late total occlusion over that demonstrated earlier with six months of clopidogrel canadian in patients with in-stent restenosis treated with intracoronary radiation therapy. The two patient registries compared were WRIST (Washington Radiation for the Stent Restenosis Trial) PLUS, a prior study of 120 patients with in-stent restenosis treated with gamma radiation and then given six months of clopidogrel and aspirin for the prevention of late thrombosis; and WRIST 12, a registry of 120 patients with entry criteria identical to WRIST PLUS, but with 12 months of aspirin and clopidogrel after intracoronary radiation therapy. The dose of clopidogrel administered in both studies was 75 mg once daily, with an angiographic follow-up at 15 months, in WRIST 12.
A comparison of clinical events of WRIST 12 patients and WRIST PLUS patients pointed out that the rate of reduction in late thrombosis in WRIST PLUS was 4.2%; this was reduced to 2.5% in WRIST 12. Major clinical events at 12 months showed no differences in the two patient groups in terms of death, Q-wave MI, and only a small difference in non-Q-wave MI, in favor of 12 months of clopidogrel. There were, however, significantly surprising findings with regard to reductions in the need for angioplasty, from 26% in WRIST PLUS to 14% in WRIST 12; in surgery, from 21% to 15%; in target lesion revascularization (TLR), from 33% to 18%; in target vessel revascularization (TVR), from 37% to 19%; and in overall major adverse cardiovascular events (MACE) from 38% to 20%; the reduction in risk of TLR, TVR, and MACE was highly statistically significant in favor of 12 months.
Endothelin Receptor Antagonist in Pulmonary Hypertension
Speaker: Nazzareno Galie, MD, Professor of Medicine, Institute of Cardiology, University of Bologna, Bologna, Italy.
The administration of bosentan (Tracleer, Actelion), an orally active dual endothelin receptor antagonist, has been shown to improve right ventricular (RV) systolic function and left ventricular (LV) early diastolic filling—improvements that lead to reverse ventricular modeling in patients with pulmonary arterial hypertension and help to explain previously reported improvements in exercise capacity and a delay in time to clinical worsening.
These conclusions were reached from a study of the effects of bosentan on echocardiographic and Doppler variables in a subgroup of 85 patients with World Health Organization (WHO) class III and IV pulmonary arterial hypertension who were enrolled in the prospective, double-blind, placebo-controlled BREATHE-1 (Bosentan: Randomized Trial of Endothelin Receptor Antagonist Therapy) study. In the BREATHE-1 trial, which included 213-patients, bosentan was administered twice daily at 125 or 250 mg, resulting in significant improvements in the primary endpoint of improvement in exercise capacity compared to placebo, as well as significant improvement in functional status in patients with pulmonary arterial hypertension. canadian antibiotics
In this sub-group analysis, 71 patients (84%) had primary pulmonary hypertension. In a 1:2 randomization procedure, 29 patients received placebo and 56 were given bosentan, with six-minute walk tests and echocardiograms performed at baseline and at 16 weeks. On baseline evaluations, Doppler and echocardiographic variables demonstrated marked abnormalities of RV and LV structure and function. At week 16, the treatment effect (the difference between treatment groups in mean change at 16 weeks) on the six-minute walking distance was 37 meters in favor of bosentan. Time velocity integrals of the LV outflow tract and of mitral inflow were improved in the bosen-tan group, resulting in an improvement of Doppler-derived cardiac index as well as marked treatment effects of bosentan on other echocardiographic and Doppler parameters, resulting in improved RV systolic function and LV early diastolic filling.
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