High-speed rotational atherectomy before paclitaxel-eluting stent implantation in complex calcified coronary lesions: the randomized ROTAXUS (Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease) trial

OBJECTIVES This study sought to determine the effect of rotational atherectomy (RA) on drug-eluting stent (DES) effectiveness. BACKGROUND DES are frequently used in complex lesions, including calcified stenoses, which may challenge DES delivery, expansion, and effectiveness. RA can adequately modify calcified plaques and facilitate stent delivery and expansion. Its impact on DES effectiveness is widely unknown. METHODS The ROTAXUS (Rotational Atherectomy Prior to TAXUS Stent Treatment for Complex Native Coronary Artery Disease) study randomly assigned 240 patients with complex calcified native coronary lesions to RA followed by stenting (n = 120) or stenting without RA (n = 120, standard therapy group). Stenting was performed using a polymer-based slow-release paclitaxel-eluting stent. The primary endpoint was in-stent late lumen loss at 9 months. Secondary endpoints included angiographic and strategy success, binary restenosis, definite stent thrombosis, and major adverse cardiac events at 9 months. RESULTS Despite similar baseline characteristics, significantly more patients in the standard therapy group were crossed over (12.5% vs. 4.2%, p = 0.02), resulting in higher strategy success in the rotablation group (92.5% vs. 83.3%, p = 0.03). At 9 months, in-stent late lumen loss was higher in the rotablation group (0.44 ± 0.58 vs. 0.31 ± 0.52, p = 0.04), despite an initially higher acute lumen gain (1.56 ± 0.43 vs. 1.44 ± 0.49 mm, p = 0.01). In-stent binary restenosis (11.4% vs. 10.6%, p = 0.71), target lesion revascularization (11.7% vs. 12.5%, p = 0.84), definite stent thrombosis (0.8% vs. 0%, p = 1.0), and major adverse cardiac events (24.2% vs. 28.3%, p = 0.46) were similar in both groups. CONCLUSIONS Routine lesion preparation using RA did not reduce late lumen loss of DES at 9 months. Balloon dilation with only provisional rotablation remains the default strategy for complex calcified lesions before DES implantation.

Effect of ticagrelor on the outcomes of patients with prior coronary artery bypass graft surgery: insights from the PLATelet inhibition and patient outcomes (PLATO) trial

BACKGROUND Patients with prior coronary artery bypass graft surgery (CABG) who present with an acute coronary syndrome have a high risk for recurrent events. Whether intensive antiplatelet therapy with ticagrelor might be beneficial compared with clopidogrel is unknown. In this substudy of the PLATO trial, we studied the effects of randomized treatment dependent on history of CABG. METHODS Patients participating in PLATO were classified according to whether they had undergone prior CABG. The trial's primary and secondary end points were compared using Cox proportional hazards regression. RESULTS Of the 18,613 study patients, 1,133 (6.1%) had prior CABG. Prior-CABG patients had more high-risk characteristics at study entry and a 2-fold increase in clinical events during follow-up, but less major bleeding. The primary end point (composite of cardiovascular death, myocardial infarction, and stroke) was reduced to a similar extent by ticagrelor among patients with (19.6% vs 21.4%; adjusted hazard ratio [HR], 0.91 [0.67, 1.24]) and without (9.2% vs 11.0%; adjusted HR, 0.86 [0.77, 0.96]; P(interaction) = .73) prior CABG. Major bleeding was similar with ticagrelor versus clopidogrel among patients with (8.1% vs 8.7%; adjusted HR, 0.89 [0.55, 1.47]) and without (11.8% vs 11.4%; HR, 1.08 [0.98, 1.20]; P(interaction) = .46) prior CABG. CONCLUSIONS Prior-CABG patients presenting with acute coronary syndrome are a high-risk cohort for death and recurrent cardiovascular events but have a lower risk for major bleeding. Similar to the results in no-prior-CABG patients, ticagrelor was associated with a reduction in ischemic events without an increase in major bleeding.

The relations between Arabs and Israelites prior to the rise of Islam

D. S. Margoliouth

Horizontal ridge augmentation in conjunction with or prior to implant placement in the anterior maxilla: a systematic review.

PURPOSE To systematically review clinical studies examining the survival and success rates of implants in horizontal ridge augmentation, either prior to or in conjunction with implant placement in the anterior maxilla. MATERIALS AND METHODS A literature search was undertaken up to September 2012 including clinical studies in English with ≥ 10 consecutively treated patients and a mean follow-up of at least 12 months. Two reviewers screened the pertinent articles and extracted the data. Key words focused on the outcome parameters (implant success, implant survival, horizontal bone gain, and intra- and postoperative complications) in studies utilizing either a simultaneous approach (ridge augmentation performed at the time of implant placement) or a staged approach (ridge augmentation performed prior to implant placement) were analyzed. RESULTS A total of 13 studies met the inclusion criteria, with 2 studies in the simultaneous group and 11 studies in the staged group. In the simultaneous group, survival rates of implants were 100% in both studies, with one study also reporting a 100% implant success rate. No data on horizontal bone gain were available. In the staged group, success rates of implants placed in horizontally augmented ridges ranged from 96.8% to 100% (two studies), and survival rates ranged from 93.5% to 100% (five studies). However, follow-up periods differed widely (up to 4.1 years). Mean horizontal bone gain determined at reentry (implant placement) ranged from 3.4 to 5.0 mm with large overall variations (0 to 9.8 mm, five studies). Intraoperative complications were not reported. Postsurgical complications included mainly mucosal dehiscences (five studies), and, occasionally, complete failures of block grafts were described in one study. CONCLUSIONS Staged and simultaneous augmentation procedures in the anterior maxilla are both associated with high implant success and survival rates. The level of evidence, however, is better for the staged approach than for the simultaneous one.

Thrombolysis in patients with prior stroke within the last 3 months

BACKGROUND AND PURPOSE Patients with prior stroke within 3 months have been mostly excluded from randomized thrombolysis trials mainly because of the fear of an increased rate of symptomatic intracerebral hemorrhage (sICH). The aim of this study was to compare baseline characteristics and clinical outcome of thrombolyzed patients who had a previous stroke within the last 3 months with those not fulfilling this criterion (comparison group). METHODS In all, 1217 patients were included in our analysis (42.2% women, mean age 68.8 ± 14.4 years). RESULTS Patients with previous stroke within the last 3 months (17/1.4%) had more often a basilar artery occlusion (41.2% vs. 10.8%) and less frequently a modified Rankin scale (mRS) score 0-1 prior to index stroke (88.2% vs. 97.3%) and a higher mean time lapse from symptom onset to thrombolysis (321 min vs. 262 min) than those in the comparison group. Stroke severity was not different between the two groups. Rates of sICH were 11.8% vs. 6%. None of the sICHs and only one asymptomatic intracerebral hemorrhage occurred in the region of the former infarct. At 3 months, favorable outcome (mRS ≤ 2) in patients with previous stroke within 3 months was 29.4% (vs. 48.9%) and mortality 41.2% (vs. 22.7%). CONCLUSIONS In patients with prior stroke within the last 3 months, none of the sICHs and only one asymptomatic intracerebral hemorrhage occurred in the region of the former infarct. The high mortality was influenced by four patients, who died until discharge due to acute major index stroke. It is reasonable to include these patients in randomized clinical trials and registries to assess further their thrombolysis benefit-risk ratio.

Gan Meʼir Georgii Weiganmeiri, in Academia Tubingensi Professoris : continens Institutionum hebraeae linguae per tabulas digestarum libros duos: quorum prior vocum absolutarum formationes; posterior earundem mutationes, solide & perfecte explicat, quibus cognitis, lector industrius de tota re grammatica & oratione hebræa facilime iudicare poterit

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Zevalin and BEAM (Z-BEAM) versus rituximab and BEAM (R-BEAM) conditioning chemotherapy prior to autologous stem cell transplantation in patients with mantle cell lymphoma.

Early relapse is common in patients with mantle cell lymphoma (MCL) highlighting the unmet need for further improvement of therapeutic options for these patients. CD20 inhibition combined with induction chemotherapy as well as consolidation with high-dose chemotherapy (HDCT) is increasingly considered cornerstones within current therapy algorithms of MCL whereas the role of radioimmunotherapy is unclear. This retrospective single center study compared 46 consecutive MCL patients receiving HDCT in first or second remission. Thirty-five patients had rituximab and BEAM (R-BEAM), and 11 patients received ibritumomab tiuxetan (Zevalin®), an Yttrium-90 labeled CD20 targeting antibody, prior to BEAM (Z-BEAM) followed by autologous stem cell transplantation (ASCT). We observed that the 5-year overall survival (OS) in the R-BEAM and Z-BEAM groups was 55% and 71% (p = 0.288), and the 4-year progression free survival (PFS) was 32% and 41%, respectively (p = 0.300). There were no treatment related deaths in both groups, and we observed no differences in toxicities, infection rates or engraftment. Our data suggest that the Z-BEAM conditioning regimen followed by ASCT is well tolerated, but was not associated with significantly improved survival compared to R-BEAM. Copyright © 2015 John Wiley & Sons, Ltd.

Dictionum Hebraicarum, quae universo sefer tehilim continentur, Syllabus geminus : Quorum prior radices & quae inde formantur, cum singulorum interpretatione ... ordine alphabetico complectitur; In usum eorum, qui ad linguae sanctae studium primum accedunt, contextus

a Paulo Tossano

Outcomes in Advanced Head and Neck Cancer Treated with Up-front Neck Dissection prior to (Chemo)Radiotherapy.

OBJECTIVE Our aim was to compare outcomes with and without up-front neck dissection prior to (chemo)radiotherapy in head and neck squamous cell carcinoma. STUDY DESIGN Case series with chart review. SETTING Tertiary referral center. SUBJECTS AND METHODS Outcomes of oropharyngeal, laryngeal, and hypopharyngeal squamous cell carcinoma cases with neck lymph node metastases treated from January 2001 to March 2012 were analyzed. Due to imbalances in baseline characteristics between groups treated with (n = 129) and without (n = 95) up-front neck dissection, propensity score matching was performed. RESULTS Median follow-up was 48 months (range, 12-148). With up-front neck dissection, the hazard ratio for the primary end point, disease-free survival, was 0.63 (95% confidence interval: 0.37-1.06, P = .08). Up-front neck dissection reduced acute grade ≥3 toxicity significantly when xerostomia was excluded (odds ratio: 0.40, 95% confidence interval: 0.20-0.82, P = .012). CONCLUSION Our results indicate less acute treatment toxicity without any significant difference in terms of oncologic outcome with up-front neck dissection prior to (chemo)radiotherapy as compared with (chemo)radiotherapy alone. Well-designed randomized trials are required to verify this result and further investigate the impact of this strategy on late toxicity and oncologic outcome.

Lavage prior to vertebral augmentation reduces the risk for cement leakage

PURPOSE This study aimed at assessing the cement leakage rate and the filling pattern in patients treated with vertebroplasty, kyphoplasty and stentoplasty with and without a newly developed lavage technique. STUDY DESIGN Retrospective clinical case-control study. METHODS A newly developed bipedicular lavage technique prior to cement application was applied in 64 patients (45.1 %) with 116 vertebrae, ("lavage" group). A conventional bipedicular cement injection technique was used in 78 patients (54.9 %) with 99 levels ("controls"). The outcome measures were filling patterns and leakage rates. RESULTS The overall leakage rate (venous, cortical defect, intradiscal) was 37.9 % in the lavage and 83.8 % in the control group (p < 0.001). Venous leakage (lavage 12.9 % vs. controls 31.3 %; p = 0.001) and cortical defect leakage (lavage 17.2 % vs. controls 63.3 %; p < 0.001) were significantly lower in the lavage group compared to "controls," whereas intradiscal leakages were similar in both groups (lavage 12.1 % vs. controls 15.2 %; p = 0.51). For venous leakage multivariate logistic regression analysis showed lavage to be the only independent predictor. Lavage was associated with 0.33-times (95 % CI 0.16-0.65; p = 0.001) lower likelihood for leakage in compared to controls. CONCLUSIONS Vertebral body lavage prior to cement augmentation is a safe technique to reduce cement leakage in a clinical setting and has the potential to prevent pulmonary fat embolism. Moreover, a better filling pattern can be achieved.

The influence of students' prior clinical skills and context characteristics on mini-CEX scores in clerkships - a multilevel analysis.

BACKGROUND In contrast to objective structured clinical examinations (OSCEs), mini-clinical evaluation exercises (mini-CEXs) take place at the clinical workplace. As both mini-CEXs and OSCEs assess clinical skills, but within different contexts, this study aims at analyzing to which degree students' mini-CEX scores can be predicted by their recent OSCE scores and/or context characteristics. METHODS Medical students participated in an end of Year 3 OSCE and in 11 mini-CEXs during 5 different clerkships of Year 4. The students' mean scores of 9 clinical skills OSCE stations and mean 'overall' and 'domain' mini-CEX scores, averaged over all mini-CEXs of each student were computed. Linear regression analyses including random effects were used to predict mini-CEX scores by OSCE performance and characteristics of clinics, trainers, students and assessments. RESULTS A total of 512 trainers in 45 clinics provided 1783 mini-CEX ratings for 165 students; OSCE results were available for 144 students (87 %). Most influential for the prediction of 'overall' mini-CEX scores was the trainers' clinical position with a regression coefficient of 0.55 (95 %-CI: 0.26-0.84; p < .001) for residents compared to heads of department. Highly complex tasks and assessments taking place in large clinics significantly enhanced 'overall' mini-CEX scores, too. In contrast, high OSCE performance did not significantly increase 'overall' mini-CEX scores. CONCLUSION In our study, Mini-CEX scores depended rather on context characteristics than on students' clinical skills as demonstrated in an OSCE. Ways are discussed which focus on either to enhance the scores' validity or to use narrative comments only.