Objectives The ENDEAVOR IV (Randomized Comparison of Zotarolimus-Eluting and Paclitaxel-Eluting Stents in Patients with Coronary Artery Disease) trial evaluated the safety and efficacy of the ...zotarolimus-eluting stent (ZES) compared with the paclitaxel-eluting stent (PES). Background First-generation drug-eluting stents have reduced angiographic and clinical restenosis, but long-term safety remains controversial. A second-generation drug-eluting stent, which delivers zotarolimus, a potent antiproliferative agent, via a biocompatible phosphorylcholine polymer on a cobalt alloy thin-strut stent has shown promising experimental and early clinical results. Methods This is a prospective, randomized (1:1), single-blind, controlled trial comparing outcomes of patients with single de novo coronary lesions treated with ZES or PES. The primary end point was noninferiority of 9-month target vessel failure defined as cardiac death, myocardial infarction, or target vessel revascularization. Results Among a total of 1,548 patients assigned to ZES (n = 773) or PES (n = 775), at 9 months, ZES was noninferior to PES with rates of target vessel failure 6.6% versus 7.1%, respectively (pnoninferiority ≤ 0.001). There were fewer periprocedural myocardial infarctions with ZES (0.5% vs. 2.2%; p = 0.007), whereas at 12 months, there were no significant differences between groups in rates of cardiac death, myocardial infarction, target vessel revascularization, or stent thrombosis. Although incidence of 8-month binary angiographic in-segment restenosis was higher in patients treated with ZES versus PES (15.3% vs. 10.4%; p = 0.284), rates of 12-month target lesion revascularization were similar (4.5% vs. 3.2%; p = 0.228), especially in patients without planned angiographic follow-up (3.6% vs. 3.2%; p = 0.756). Conclusions These findings demonstrate that ZES has similar clinical safety and efficacy compared with PES in simple and medium complexity single de novo coronary lesions. (ENDEAVOR IV Clinical Trial; NCT00217269 )
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
Objective.—Dizziness is a symptom of acute mountain sickness (AMS). This study tested whether immediate fall in systolic blood pressure (BP) on standing was more severe at altitude and whether this ...was associated with symptoms of dizziness. Methods.—Eighty-five lowlanders flew into La Paz, Bolivia (3650 m), and after 4 to 5 days of acclimatization ascended in 90 minutes to the Chacaltaya Laboratory (5200 m) by road. Blood pressure was measured on 5 occasions, 3 times at 5200 m and twice at sea level, before and after the expedition using a mercury sphygmomanometer. Both a supine and an erect (within 15 seconds of standing) BP measurement were recorded. Participants recorded whether they felt dizzy on standing. A mixed-effect model was used to test for a difference in the change in BP for time and altitude. Results.—The immediate fall in systolic BP observed on standing was significantly greater (P < .001) on all 3 altitude study days (18.2, 23.4, and 20.7 mm Hg) than at sea level (12.2 and 12.4 mm Hg). There was no significant difference in the change in diastolic BP or change in mean arterial BP between sea level and altitude. Conclusions.—The immediate drop in systolic BP observed on standing was greater at altitude. However, mean arterial pressure was maintained, and we found no association between the degree of immediate fall in BP and dizziness or AMS.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Background Literature guiding the management of early-onset scoliosis consists primarily of studies with a low level of evidence. Evaluation of clinical equipoise (i.e., when there is no known ...superiority among treatment modalities) allows for prioritization of research efforts. The objective of this study was to evaluate areas of clinical uncertainty among pediatric spine surgeons regarding the treatment of early-onset scoliosis. Methods Fourteen experienced pediatric spine surgeons participated in semistructured interviews to identify clinical variables that influence decision making in the treatment of early-onset scoliosis. A series of case scenarios of 315 patients with idiopathic and neuromuscular early-onset scoliosis was then developed to be representative of those encountered in clinical practice. Using an online survey, eleven surgeons selected their choice of eight treatment options for each case scenario. Associations between case characteristics and treatment choices were assessed with chi-square and logistic regression analysis. Participants then reviewed the areas of treatment uncertainty identified in the survey, nominated additional research questions of interest, and ranked their interest to further explore the identified research questions. Results Collective equipoise was identified in numerous scenarios in the survey spanning a range of ages and magnitudes of scoliosis, and additional questions were identified during the nominal group technique. Areas that had the greatest clinical uncertainty included the management of patients who have finished treatment with a growing-rod, timing of rod-lengthening intervals, and indications for spine-based and rib-based proximal instrumentation anchors. The use of rib anchors compared with spine-based anchors was ranked highly for consideration in future clinical trials. Conclusions Variability in decision making with regard to the optimum treatment of certain subsets of patients with early-onset scoliosis reflects gaps in the available evidence. Structured consensus methods identified priorities for higher levels of research in this area of scoliosis. Higher-level studies, including randomized trials, should focus on answering the questions highlighted in this report.
Background Although the risk of thromboembolism after total hip arthroplasty continues beyond hospital discharge, the cost-effectiveness of extending prophylaxis beyond hospitalization is unclear. We ...compared the cost-effectiveness of an extended duration of antithrombotic prophylaxis following total hip arthroplasty, with use of low-molecular-weight heparin or warfarin administered for twenty-eight days beyond hospital discharge, in terms of incremental cost per quality-adjusted life year gained. Methods The economic analysis was structured around a decision tree characterizing the consequences of extended prophylaxis choices following total hip arthroplasty. The health benefits of extended antithrombotic prophylaxis, measured as the reduction in symptomatic venous thromboembolic events and deaths for each treatment alternative, were determined through a systematic review of the literature. Gains in quality-adjusted life years were based on the distribution of life years remaining for all patients undergoing total hip arthroplasty in Canada in 2003, weighted by utilities derived from the literature. The cost analysis, in 2006 Canadian dollars, took a direct payer perspective with a ninety-day time horizon. Results There was a net gain in quality-adjusted life years in both cohorts that received extended prophylaxis relative to the cohort that received no extended prophylaxis (7.5 quality-adjusted life years per 1000 patients treated with low-molecular-weight heparin and 5.5 quality-adjusted life years per 1000 patients treated with warfarin), although these gains were not significant. The net treatment costs per 1000 patients treated were $799,104 with low-molecular-weight heparin and $72,236 with warfarin. In comparison with the cohort that received no extended prophylaxis, the cost-effectiveness of low-molecular-weight heparin was $106,454 per quality-adjusted life year gained and the cost-effectiveness of warfarin was $13,115 per quality-adjusted life year gained. Conclusions There is insufficient economic evidence to support extended thromboprophylaxis with low-molecular-weight heparin following total hip arthroplasty. Although the cost-effectiveness of warfarin was potentially quite favorable, this finding was based on limited clinical evidence. Further research is required to clarify the benefits of extended prophylaxis, particularly with warfarin. Level of Evidence Economic and decision analysis, Level I . See Instructions to Authors for a complete description of levels of evidence.
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