Management of peripheral arterial interventions with mono or dual antiplatelet therapy—the MIRROR study: a randomised and double-blinded clinical trial

Objectives

To investigate the influence of dual antiplatelet therapy vs. aspirin alone on local platelet activation and clinical endpoints in patients with PAD treated with endovascular therapy.

Methods

Patients received either 500?mg aspirin and 300?mg clopidogrel before intervention followed by a daily dose of 100?mg aspirin and 75?mg clopidogrel for 6 months, or the same doses of aspirin plus placebo instead of clopidogrel. Primary endpoints were local concentrations of platelet activation markers β-thromboglobulin and CD40L, and the rate of patient’s resistant to clopidogrel. Secondary endpoints included the clinical development 6?months after the intervention.

Results

Eighty patients, 40 in each group, were enrolled. The median peri-interventional concentration of β-TG was 224.5 vs. 365.5 (P?=?0.03) in the clopidogrel and placebo group. The concentration of CD40L was 127 and 206.5 (P?=?0.05). Thirty per cent of patients who had received clopidogrel were resistant. Two clopidogrel and eight placebo patients required TLR (P?=?0.04). The clopidogrel patients who needed revascularisation were both resistant to clopidogrel. Minor bleeding complications occurred in one clopidogrel and two placebo patients.

Conclusion

Dual antiplatetet therapy reduces peri-interventional platelet activation and improves functional outcome without higher bleeding complications. An individual tailored dual antiplatelet therapy seems desirable for endovascularly treated patients with PAD.

Key Points

? The role of clopidogrel and aspirin following endovascular therapy was investigated. ? Dual antiplatelet therapy reduces peri-interventional platelet activation more than aspirin alone. ? Dual antiplatelet therapy improves the outcome of endovascularly treated patients. ? Clopidogrel resistance is important when treating peripheral arterial disease endovascularly.     

Drug-Coated Balloon Treatment of Femoropopliteal Lesions for Patients With Intermittent Claudication and Ischemic Rest Pain: 2-Year Results From the IN.PACT Global Study

Objectives

The IN.PACT Global Study is the largest prospective, multicenter, independently adjudicated trial to evaluate a paclitaxel drug-coated balloon in patients with lifestyle-limiting claudication and/or ischemic rest pain due to atherosclerotic disease of the femoropopliteal artery and includes complex lesions beyond what are typically included in randomized controlled trials.

Drug-Coated Balloon Treatment for Femoropopliteal Artery Disease: The Chronic Total Occlusion Cohort in the IN.PACT Global Study

Objectives

This study evaluated the 12-month safety and effectiveness of a paclitaxel drug-coated balloon for treatment of intermittent claudication or rest pain in subjects with femoropopliteal chronic total occlusions (CTO).

BCNU stability as a function of ethanol concentration and temperature

Summary BCNU is increasingly used in low ethanol (ETOH) concentrations, 5% dextrose-water (D5W), or normal saline (NS) solutions, especially for intra-arterial and prolonged (e.g., 3 day) intravenous (IV) infusions. Little work, however, has been done to evaluate BCNU decomposition rates in concentrations, diluents, and temperatures similar to those employed clinically. This study examined BCNU solutions in ETOH, NS, and D5W to evaluate, conclusively, initial recovery and decomposition rates in these three diluents. Initial BCNU recovery rates were: 95.6 ± 0.3% (100% D5W), 89.6 ± 0.5% (15% ETON), and 85.2 ± 0.5% (NS) (P < 0.001). Study of all solutions revealed no measurable BCNU decomposition over 24 hrs (0° C) and no significant difference in decomposition rates between any of the diluents (19.5° C). At 37° C, the solutions showed different half-lives: 14.3 ± 0.19 hrs (15% ETOH), 10.6 ± 0.02 hrs (10% ETON), 8.2 ± 0.21 hrs (5% ETOH), 7.3 ± 0.06 hrs (NS), and 6.8 ± 0.07 hrs (D5W) (P < 0.001). Decomposition rates between all three temperatures (19.5° C, 37° C, and 50° C) were significantly different (P < 0.01) for each diluent. Dissolving BCNU powder into either D5W or NS required only 5 min when hand-shaken at body temperature. This study of initial recovery and decomposition rates suggests that, although BCNU decomposition rates were significantly increased at body temperature (37° C), it was quite low and essentially unaffected by different diluents at room temperature (i.e., 19.5°C). D5W as a diluent for BCNU appeared to provide significantly higher recovery than NS or 15% ETON with no significant difference in half-life at room temperature and thus appeared a practical alternative diluent to ETOH for infusions.     

Operation for acute postinfarction mitral insufficiency and cardiogenic shock

Since 1973, 11 patients have had emergency valve replacement for severe mitral insufficiency and cardiogenic shock within 1 month (mean 10.0 days) of acute myocardial infarction. Mean age was 60 years (range 44 to 71 years). Nine infarcts affected the inferior wall, one patient had a prior myocardial infarction, and only two patients had a history of cardiac symptoms. Ten patients had pulmonary edema, five were oliguric (less than 0.5 ml/kg/hr for 12 hours), four required endotracheal intubation, nine required preoperative intra-aortic balloon support, and three had had a cardiac arrest. Preoperative cardiac index averaged 1.7 L/m2/min even with pharmacologic and circulatory support. Eight patients had cardiac catheterization and nine had echocardiograms. Left ventricular ejection fraction varied from 23% to 83% (mean 51%) and was not prognostic. Five patients had papillary muscle rupture and six patients had papillary muscle dysfunction. The mitral valve was replaced with a mechanical prosthesis in all patients. Five had simultaneous coronary artery bypass grafts. Three of five patients with papillary muscle rupture and two of six with papillary muscle dysfunction survived hospitalization. Two patients could not be weaned from cardiopulmonary bypass, two patients died within 24 hours of low cardiac output, and two patients died 3 weeks postoperatively of acute tubular necrosis and sepsis following prolonged preoperative cardiogenic shock. The interval from onset of shock to operative therapy averaged 1.7 days for survivors versus 9.3 days for nonsurvivors. Although the amount of viable left ventricular mass cannot be measured preoperatively, we recommend early operation, before other organ systems fail, for patients having severe mitral insufficiency and cardiogenic shock within 30 days of acute myocardial infarction.     

Intentional replantation for periodontally involved hopeless teeth

Abstract –  The aim of this study was to evaluate the clinical and radiographic results of intentional replantation of periodontally involved teeth after conditioning of root surfaces with tetracycline–HCl. Thirteen patients (seven female, six male; age range: 35–52 years) with 15 periodontally involved hopeless teeth were included in this study. During the replantation procedure, the affected teeth were gently extracted, then the granulation tissues, calculus, remaining periodontal ligament and necrotic cementum on the root surfaces were removed. Tetracycline–HCl, at a concentration of 100 mg ml⁻¹, was applied for 5 min to the root surfaces. The teeth were then replaced into the socket and splinted. Patients were clinically and radiographically evaluated at baseline (time of surgery) and 6 months after the surgery. The following measurements were recorded: probing depth (PD), gingival recession (R), the amount of bone loss (BL) and bone gain (BG). Results indicated a reduction in PD and in the amount of bone loss and healthy gingiva. Mean PD was decreased from 5.25 to 2.36 mm, gingival recession was increased from 3.73 to 4.0 mm, and BL was reduced from 73.20 to 56.86%. At the end of 6 months, no root resorption or ankylosis was observed radiographically. Even during the short period of evaluation, it may be suggested that intentional replantation can be an alternative approach to extraction in cases where advanced periodontal destruction is present and no other treatments could be considered.     

Chiropractic adjustive manipulation on subjects with acute low back pain: visual analog pain scores and plasma beta-endorphin levels

The purpose of this study was to evaluate pain scores and plasma beta-endorphin levels following a single spinal adjustive manipulation in subjects with acute low back pain. Eighteen subjects were randomly assigned to either a control group, which received no treatment; a sham group, which received only light physical contact (touch); or an experimental group, which received an adjustive manipulation at a specific lumbar segment. Following a standard protocol, all subjects were administered visual analog pain scales and venous blood was drawn 5 min prior to, 5 min after, and 30 min after intervention. Analysis of the pain scores indicated that there was a slight, but significant, reduction of pain in the experimental group, but no similar reduction in the control or sham groups. Furthermore, this reduction of pain in the experimental group was not accompanied any significant change in the plasma beta-endorphin concentration.     

Radiologische „report turnaround times“ und Untersuchungszeitpunkte bei Patienten auf Intensivstationen

Aims

The radiological examinations performed in intensive care units (ICUs) were analyzed for the purpose of internal quality control. Data included the type of examination performed, the time of day the examination was performed and the differences in radiologist report turnaround times.

Material and methods

A retrospective analysis of the radiology information system (RIS) database of all radiological examinations performed in the ICU of a large German hospital from 2009 through 2011 was carried out. The search retrieved 75,169 examinations performed in ICU patients which were included in the analysis. The records were analyzed for type of radiological examination performed, i.e. conventional X-ray, ultrasound, computed tomography (CT), magnetic resonance imaging (MRI), angiography and nuclear medicine examinations, time of day the examination was performed and the interval between examination and time of reporting and release of the final report.

Results

Cross-modality it took on average 52 min until a report was written and approximately 7 h before the final report was released. Turnaround times were shortest for ultrasound, conventional X-ray and CT. Over the 3-year observation period there was an overall tendency toward shorter turnaround times whereby improvement in time until reporting was most marked for conventional X-ray, MRI and ultrasound (reduction of 24, 17, and 15 min, respectively). The time until release of the final report improved most markedly for CT, conventional X-ray and angiography (improvement of approximately 6.67, 5.08 and 0.78 h, respectively).

Conclusions

During the 3-year observation period a reduction in turnaround times for reporting results and release of finalized reports could be observed, despite an increase in the total number of cases.     

Effect of black mulberry (Morus nigra) extract treatment on cognitive impairment and oxidative stress status of d-galactose-induced aging mice

Context: Morus nigra L. (Moraceae) has various uses in traditional medicine. However, the effect of M. nigra on cognitive impairment has not been investigated yet.

Objective: The objective of this study is to determine the phenolic acid content and DNA damage protection potential of M. nigra leaf extract and to investigate the extract effect on cognitive impairment and oxidative stress in aging mice.

Materials and methods: Phenolic acid content was determined by quantitative chromatographic analysis. DNA damage protection potential was evaluated on pBR322 plasmid DNA. Thirty-two Balb-C mice were randomly divided into four groups (control, d-galactose, d-galactose?+?M. nigra 50, and d-galactose?+?M. nigra 100). Mice were administered d-galactose (100?mg/kg, subcutaneous) and M. nigra (50 or 100?mg/kg, orally) daily for 8 weeks. Behavioral responses were evaluated with Morris water maze. Activities of antioxidant enzymes and levels of malondialdehyde (MDA) were assayed in serum, brain, and liver.

Results: In extract, vanillic (632.093?μg/g) and chlorogenic acids (555.0?μg/g) were determined. The extract between 0.02 and 0.05?mg/mL effectively protected all DNA bands against the hazardous effect of UV and H₂O₂. Morus nigra significantly improved learning dysfunctions (p <?0.01), increased memory retention (p?<?0.01), reduced MDA levels (p?<?0.05), and elevated SOD, GPx, and CAT activities (p?<?0.05) compared with the d-galactose group.

Discussion and conclusion: These results show that M. nigra has the potential in improving cognitive deficits in mice and that M. nigra may be useful to suppress aging, partially due to its scavenging activity of free radicals and high antioxidant capacity.