on behalf of the ARTS InvestigatorsBackground-Our aims were to compare coronary artery bypass grafting (CABG) and stenting for the treatment of diabetic patients with multivessel coronary disease enrolled in the Arterial Revascularization Therapy Study (ARTS) trial and to determine the costs of these 2 treatment strategies. Methods and Results-Patients (nϭ1205) were randomly assigned to stent implantation (nϭ600; diabetic, 112) or CABG (nϭ605; diabetic, 96). Costs per patient were calculated as the product of each patient's use of resources and the corresponding unit costs. Baseline characteristics were similar between the groups. At 1 year, diabetic patients treated with stenting had the lowest event-free survival rate (63.4%) because of a higher incidence of repeat revascularization compared with both diabetic patients treated with CABG (84.4%, PϽ0.001) and nondiabetic patients treated with stents (76.2%, Pϭ0.04). Conversely, diabetic and nondiabetic patients experienced similar 1-year event-free survival rates when treated with CABG (84.4% and 88.4%). The total 1-year costs for stenting and CABG in diabetic patients were $12 855 and $16 585 (PϽ0.001) and in the nondiabetic groups, $10 164 for stenting and $13 082 for surgery. Conclusions-Multivessel diabetic patients treated with stenting had a worse 1-year outcome than patients assigned to CABG or nondiabetics treated with stenting. The strategy of stenting was less costly than CABG, however, regardless of diabetic status. (Circulation. 2001;104:533-538.)
The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.
This pilot study evaluated the safety and efficacy of an intensified oral sirolimus regimen (15-mg loading dose 24 hr before PCI, followed by a daily dose of 5 mg for 4 weeks) in 15 patients subjected to elective bare metal coronary stent implantation for de novo lesions. Mean patient age was 59+/-9; 73% were male, and 13% were diabetic patients. The reference diameter was 3.04+/-0.38 mm, and the lesion length was 14+/-2 mm. Angiographic and volumetric intravascular ultrasound (IVUS) analyses were performed in all patients at 6.0+/-0.2 months. Two patients (13%) met the definition of in-segment binary restenosis; in-stent and in-segment angiographic late loss was 0.61+/-0.31 mm and 0.67+/-0.45 mm, respectively, and the percent neointimal volume was 28.5+/-15.8%. At adjacent reference segments, there was neither significant plaque increase nor constrictive vascular remodeling. At 24-month follow-up no deaths, myocardial infarctions, or target lesion revascularizations were detected. Mean sirolimus blood level was 13+/-7 ng/ml. No correlations were found between drug levels and late loss (r=0.15, P=0.59) or IVUS percent neointimal volume (r=0.23, P=0.47). Side effects were frequent (80%), leading to dose reductions in four and drug discontinuation in one patient. The results of this pilot study suggest that an intensified 5-mg oral sirolimus regimen resulted in no relevant improvements in the angiographic and IVUS parameters of restenosis after stent implantation in de novo lesions when compared with historic controls. Considering the efficacy/safety balance, our results do not encourage further trials evaluating the current protocol for the prevention of in-stent restenosis.
Since the mid-1990s, the dual antiplatelet therapy, consisting of the association between acetylsalicylic acid and a platelet P2Y12 receptor inhibitor, is the core of thrombosis prevention after coronary stent implantation, regardless of the models used. It is also used to prevent the occurrence of atherothrombotic events in the late phase after the intervention. The clinical presentation of coronary artery disease influences the duration of dual therapy, which tends to be longer in treated cases of acute coronary syndrome (usually for one year), when compared to cases of chronic coronary disease (often for up to 6 months). After this period, the P2Y12 inhibitor is usually discontinued, and monotherapy with aspirin is maintained. However, in the last two decades, it has been observed that prolonged use of two associated antiplatelet agents predisposes treated cases to bleeding complications, with potentially severe consequences – including increased mortality. Thus, alternatives that minimize this risk have been considered and evaluated, such as early discontinuation of acetylsalicylic acid (between 1 and 3 months after discharge), or the so-called monotherapy with P2Y12 inhibitors, aiming to reduce bleeding without compromising prevention of ischemic events. In the last decade, a series of randomized clinical trials evaluated this hypothesis, generally resulting in reduced bleeding complications, although not necessarily of those classified as major, with no significant increase in the most relevant cardiovascular events. This review discusses the main results of these clinical trials and their potential clinical implications for routine cardiology practice.
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