Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial

CONTEXT: Compared with bare metal stents, sirolimus-eluting and paclitaxel-eluting stents have been shown to markedly improve angiographic and clinical outcomes after percutaneous coronary revascularization, but their performance in the treatment of de novo coronary lesions has not been compared in a prospective multicenter study. OBJECTIVE: To compare the safety and efficacy of sirolimus-eluting vs paclitaxel-eluting coronary stents. DESIGN: Prospective, randomized comparative trial (the REALITY trial) conducted between August 2003 and February 2004, with angiographic follow-up at 8 months and clinical follow-up at 12 months. SETTING: Ninety hospitals in Europe, Latin America, and Asia. PATIENTS: A total of 1386 patients (mean age, 62.6 years; 73.1% men; 28.0% with diabetes) with angina pectoris and 1 or 2 de novo lesions (2.25-3.00 mm in diameter) in native coronary arteries. INTERVENTION: Patients were randomly assigned in a 1:1 ratio to receive a sirolimus-eluting stent (n = 701) or a paclitaxel-eluting stent (n = 685). MAIN OUTCOME MEASURES: The primary end point was in-lesion binary restenosis (presence of a more than 50% luminal-diameter stenosis) at 8 months. Secondary end points included 1-year rates of target lesion and vessel revascularization and a composite end point of cardiac death, Q-wave or non-Q-wave myocardial infarction, coronary artery bypass graft surgery, or repeat target lesion revascularization. RESULTS: In-lesion binary restenosis at 8 months occurred in 86 patients (9.6%) with a sirolimus-eluting stent vs 95 (11.1%) with a paclitaxel-eluting stent (relative risk [RR], 0.84; 95% confidence interval [CI], 0.61-1.17; P = .31). For sirolimus- vs paclitaxel-eluting stents, respectively, the mean (SD) in-stent late loss was 0.09 (0.43) mm vs 0.31 (0.44) mm (difference, -0.22 mm; 95% CI, -0.26 to -0.18 mm; P<.001), mean (SD) in-stent diameter stenosis was 23.1% (16.6%) vs 26.7% (15.8%) (difference, -3.60%; 95% CI, -5.12% to -2.08%; P<.001), and the number of major adverse cardiac events at 1 year was 73 (10.7%) vs 76 (11.4%) (RR, 0.94; 95% CI, 0.69-1.27; P = .73). CONCLUSION: In this trial comparing sirolimus- and paclitaxel-eluting coronary stents, there were no differences in the rates of binary restenosis or major adverse cardiac events. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00235092.

Performance of vertebral cancellous bone augmented with compliant PMMA under dynamic loads

Increased fracture risk has been reported for the adjacent vertebral bodies after vertebroplasty. This increase has been partly attributed to the high Young's modulus of commonly used polymethylmethacrylate (PMMA). Therefore, a compliant bone cement of PMMA with a bulk modulus closer to the apparent modulus of cancellous bone has been produced. This compliant bone cement was achieved by introducing pores in the cement. Due to the reduced failure strength of that porous PMMA cement, cancellous bone augmented with such cement could deteriorate under dynamic loading. The aim of the present study was to assess the potential of acute failure, particle generation and mechanical properties of cancellous bone augmented with this compliant cement in comparison to regular cement. For this purpose, vertebral biopsies were augmented with porous- and regular PMMA bone cement, submitted to dynamic tests and compression to failure. Changes in Young's modulus and height due to dynamic loading were determined. Afterwards, yield strength and Young's modulus were determined by compressive tests to failure and compared to the individual composite materials. No failure occurred and no particle generation could be observed during dynamical testing for both groups. Height loss was significantly higher for the porous cement composite (0.53+/-0.21%) in comparison to the biopsies augmented with regular cement (0.16+/-0.1%). Young's modulus of biopsies augmented with porous PMMA was comparable to cancellous bone or porous cement alone (200-700 MPa). The yield strength of those biopsies (21.1+/-4.1 MPa) was around two times higher than for porous cement alone (11.6+/-3.3 MPa).

Simple virtual reality display of fetal volume ultrasound

Three-dimensional (3D) ultrasound volume acquisition, analysis and display of fetal structures have enhanced their visualization and greatly improved the general understanding of their anatomy and pathology. The dynamic display of volume data generally depends on proprietary software, usually supplied with the ultrasound system, and on the operator's ability to maneuver the dataset digitally. We have used relatively simple tools and an established storage, display and manipulation format to generate non-linear virtual reality object movies of prenatal images (including moving sequences and 3D-rendered views) that can be navigated easily and interactively on any current computer. This approach permits a viewing or learning experience that is superior to watching a linear movie passively.

Dopamine inhibition and the adaptation of behavior to ongoing reality

Spontaneous confabulation is a rare memory disorder resulting from orbitofrontal damage or disconnection. Patients act on the basis of memories that do not pertain to the current situation, and are disoriented. No medical treatment is known. Recent studies suggest that subcortical dopaminergic structures are involved in the selection of currently relevant memories. We present a patient who regained the ability to adapt thought and behavior to ongoing reality when treated with risperidone, a dopamine antagonist.