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Current treatment of ischaemic stroke with thrombolytic therapy is restricted to 3–4·5 h after symptom onset. We aimed to assess the safety and efficacy of desmoteplase, a fibrin-dependent plasminogen activator, given between 3 h and 9 h after symptom onset in patients with occlusion or high-grade stenosis in major cerebral arteries. In a prospective, double-blind, multicentre, parallel-group, randomised trial, we enrolled patients from 77 hospitals in 17 countries who had ischaemic stroke and occlusion or high-grade stenosis in major cerebral arteries. We randomly assigned patients in a 1:1 ratio, using computer-generated randomisation lists with stratification for baseline National Institutes of Health Stroke Scale and age, to treatment with desmoteplase (90 μg/kg) given 3–9 h after symptom onset or to placebo. Patients, investigators, staff, and the funder were masked to treatment assignment. The primary outcome was a favourable modified Rankin Scale score (0–2) at day 90 in all treated patients who had at least one postbaseline measurement of the modified Rankin Scale. Safety was assessed in all randomly assigned patients who received study drugs. This trial is registered with ClinicalTrials.gov, number NCT00790920. Between Feb 6, 2009, and Nov 27, 2013, we enrolled 492 patients and randomly assigned 247 to desmoteplase and 245 to placebo (236 in the desmoteplase group and 237 in the placebo group were included in the analysis of the primary endpoint). Median time from stroke onset to treatment was 6·9 h (IQR 5·7–8·0) for placebo and 7·0 h (6·0–7·9) for desmoteplase. Modified Rankin Scale score (0–2) at day 90 occurred in 121 (51%) patients given desmoteplase and 118 (50%) patients given placebo (adjusted odds ratio 1·20, 95% CI 0·79–1·81, p=0·40). 24 (10%) of 240 patients given desmoteplase died compared with 23 (10%) of 238 patients given placebo. Serious adverse events occurred in 64 (27%) of 240 patients receiving desmoteplase compared with 69 (29%) of 238 patients receiving placebo; frequency of symptomatic intracranial haemorrhage (six [3%] patients in the desmoteplase group vs five [2%] in the placebo group), symptomatic cerebral oedema (five [2%] vs four [2%]), and major haemorrhage (ten [4%] vs 15 [6%]) was much the same between treatment groups. Treatment with desmoteplase did not cause safety concerns and did not improve functional outcome when given to patients who had ischaemic stroke and major cerebral artery occlusion beyond 3 h of symptom onset. H Lundbeck A/S.

Software platform technology solutions now enable artificial intelligence guided and quantitative cardiac computed tomography angiography (CCTA) for coronary artery plaque quantification and characterization and vascular morphology assessment. As most patients referred for invasive coronary angiography (ICA) are found not to have actionable coronary artery disease, artificial intelligence guided CCTA measures of vascular morphology may allow for improved referral management to ICA in a manner that is safe and lower in costs.

ObjectiveMany patients presenting with suspected acute coronary syndrome (ACS) have high-sensitivity cardiac troponin (hs-cTn) concentrations between rule-in and rule-out thresholds and hence need serial testing, which is time consuming. The Prospective RandOmised Trial of Emergency Cardiac Computerised Tomography (PROTECCT) assessed the utility of coronary CT angiography (CCTA) in patients with suspected ACS, non-ischaemic ECG and intermediate initial hs-cTn concentration.MethodsPatients were randomised to CCTA-guided management versus standard of care (SOC). The primary outcome was hospital length of stay (LOS). Secondary outcomes included cost of in-hospital stay and major adverse cardiac events (MACE) at 12 months of follow-up. Data are mean (SD); for LOS harmonic means, IQRs are shown.Results250 (aged 55 (14) years, 25% women) patients were randomised. Harmonic mean (IQR) LOS was 7.53 (6.0–9.6) hours in the CCTA arm and 8.14 (6.3–9.8) hours in the SOC arm (p=0.13). Inpatient cost was £1285 (£2216) and £1108 (£3573), respectively, p=0.68. LOS was shorter in the CCTA group in patients with <25% stenosis, compared with SOC; 6.6 (5.6–7.8) hours vs 7.5 (6.1–9.4) hours, respectively; p=0.021. More referrals for cardiology outpatient clinic review and cardiac CT-related outpatient referrals occurred in the SOC arm (p=0.01). 12-month MACE rates were similar between the two arms (7 (5.6%) in the CCTA arm and 8 (6.5%) in the SOC arm—log-rank p=0.78).ConclusionsCCTA did not lead to reduced hospital LOS or cost, largely because these outcomes were influenced by the detection of ≥25% grade stenosis in a proportion of patients.Trial registration number NCT03583320.

Background Lumbosacral canal stenosis is known as the most common cause of back surgery with several complications. Selecting a minimally invasive treatment with high efficacy in such patients is necessary. This study was designed to evaluate the effectiveness of ozone therapy in combination with caudal epidural steroid in patients with lumbar spinal stenosis. Methods A double-blind randomized clinical trial was conducted on 50 patients with lumbar spinal stenosis allocated into two study groups. Under ultrasound guidance, the first group received 80 mg of triamcinolone hexavalent with 4 mL of Marcaine 0.5% and 6 mL of distilled water to the caudal epidural space. The second group received an injection similar to the first group, combined with 10 mL of ozone (O2-O3) gas at a concentration of 10 µg/cc. The patients were followed at baseline, one, and six months after injection with clinical outcomes measures using Visual Analog Scale (VAS), Walking Distance (WD) and Oswestry Disability Index (ODI). Results The mean age of subjects, 30 males (60%) and 20 females (40%), was reported as 64.51 ± 7.19 years old. Reduction of pain intensity based on VAS score was statistically significant in both groups at follow-up periods (P < 0.001). The VAS changes in the first month and sixth months showed no significant difference between the two groups (P = 0.28 and P = 0.33, respectively). The improvement in disability index (ODI) in both types of treatment during follow-up was significant (P < 0.0001), and there was no difference between the two treatment groups in one month and six months (P = 0.48 and P = 0.88, respectively). As for walking distance, the improvement process with both types of treatment during follow-up periods was significant (P < 0.001). However, after one and six months of treatment, the rate of improvement in patients’ walking distance in the caudal epidural steroid injection plus ozone group was significantly higher than in the epidural steroid group (p = 0.026 and p = 0.017, respectively). Conclusions In this study, the results of VAS and ODI outcomes showed that caudal epidural steroid injection combined with ozone has no advantage over caudal epidural steroid injection alone. Interestingly, our results demonstrated that the group receiving caudal epidural steroid injection plus ozone scored significantly higher on the walking distance index than the group receiving caudal epidural steroid alone. Trial Registration IRCT IRCT20090704002117N2 (registration date: 07/08/2019).

Lumbar transforaminal epidural injection (TFEI) effectively decreases low back pain and radicular pain in herniated intervertebral disc (HIVD) and spinal stenosis (SS). The precise delivery of drugs to the target is important for pain control and minimizing complications. We aimed to evaluate the efficacy and complications of the subpedicular (SP) and retrodiscal (RD) approaches by analysis of contrast spread patterns into the pathologic target on the basis of a newly established specific criterion. We also investigated whether the severity of patients' spinal disease influenced this pattern. A prospective, randomized, observational study. Interventional pain management center at a university-affiliated hospital. Among patients who showed lumbar spinal stenosis or HIVD at the L4/5 level, participants were randomly assigned to undergo TFEI with the SP approach (SP group) or RD approach (RD group). Pain relief in terms of the visual analog scale (VAS) score and complications such as intravascular or intradiscal uptake were also analyzed. The contrast image was analyzed as the contrast media was injected, starting from 0.5 mL up to 3.0 mL. The spread patterns of contrast media were graded into 4 categories, which were newly defined in this study. Both groups demonstrated a significant decrease in pain relief (P value < 0.01) at 2 and 4 weeks after the procedures, but no significant difference was found between the 2 groups. In the intergroup analysis between the RD and SP groups, with a 1.5-mL contrast media injection, more patients in the RD group (17.2%) showed a grade 3 spread than those in the SP group (8.2%). In the subgroup analysis, the RD group showed superior spread (more grade 3 and 4) with 1.5-, 2-, and 2.5-mL contrast media injections (P values = 0.02, 0.03, and 0.04) in severe central stenosis, and 1.5- and 2-mL contrast media injections (P values = 0.01, 0.02) in severe foraminal stenosis. The follow-up period was only 4 weeks after TFESI, and higher contrast injection was used for procedures. The RD approach for TFEI showed a better contrast spreading pattern than the SP approach, especially in patients with severe central and foraminal spinal stenosis. The RD approach might be more beneficial for patients with severe central and foraminal spinal stenosis in the short-term follow-up.

BackgroundCoronary computed tomography angiography (CCTA) enables improved diagnosis of subclinical, coronary artery disease (CAD). This retrospective cohort study investigated the association between different treatment modalities guided by CCTA and the prevention of major adverse cardiovascular events (MACEs) in patients with stable CAD.MethodsFrom 2005 to 2013, a total of 9338 patients, including both asymptomatic individuals with risk factors and symptomatic patients with suspected CAD, who underwent CCTA were analyzed. The patients were categorized into one of three groups based on results of CCTA: obstructive CAD (≥ 50% stenosis in at least one vessel), non-obstructive CAD (1–49% stenosis in at least one vessel), and no observed CAD (0% stenosis). They were subsequently followed up to assess the treatment they received and the occurrence of MACEs (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, or late revascularization).ResultsDuring an average follow-up period of 9.9 ± 2.4 years, patients with obstructive CAD had the highest incidence of MACEs (19.8%), followed by those with non-obstructive CAD and no coronary artery stenosis (10.3 and 5.5%, respectively). After adjusting for confounding variables, it was found that patients treated with statins alone were the least likely to develop MACEs in all three groups, compared to those receiving no treatment, with hazard ratios (95% CI) of 0.43 (0.32, 0.58), 0.47 (0.34, 0.64), and 0.46 (0.31, 0.69), respectively. In patients with obstructive CAD, treatment with a combination of statin and aspirin, or early revascularization was associated with a lower likelihood of experiencing MACEs compared to no treatment with hazard ratios of 0.43 (0.33, 0.58) and 0.64 (0.43, 0.97), respectively.ConclusionCCTA offers useful guidance for the treatment of patients with stable CAD and shows potential for prevention of CV events. However, the full validation of a given strategy utilizing CCTA will require a prospective longitudinal study, utilizing a randomized clinical trial design.

Background Drug-coated balloon (DCB) is a novel and effective device for coronary artery disease patients with in-stent restenosis (ISR). However, the incidence and possible influencing factors associated with binary restenosis have not yet been adequately assessed. Methods The data are extracted from a prospective, multicenter, randomized controlled trial. A total of 211 patients with ISR were enrolled at 13 centers from August 2017 to October 2018 and treated with DCB. At the 9-month coronary angiographic follow-up, patients were divided into restenosis and non-restenosis groups, and demographic data, lesion features, and laboratory tests were retrospectively reviewed. Furthermore, logistic regression analysis was used to identify possible influencing factors. Results All patients successfully underwent treatment, and 166 patients with 190 lesions took part in angiography follow-ups at 9 months. Of these, 41 patients with 44 target lesions developed restenosis following treatment, and the incidence of ISR was 24.7%. There were significant differences in the average length of target lesions and the number of multivessel lesions and fasting plasma glucose (FBG) between the two groups ( p  < 0.05). Demographic data, cardiac risk factors, left ventricular ejection fractions (LVEF), blood routine tests, biochemical tests, and other features of devices and lesions showed no difference. Logistic regression analyses showed that FBG > 6.1 mmol/L (OR: 7.185 95% CI: 2.939–17.567 P  < 0.001) and length of lesion (OR:1.046 95% CI: 1.001–1.093 P  = 0.046) were associated risk factors. Conclusions The longer length of lesions, more target lesions and FBG > 6.1 mmol/L per individual may be characteristics of patients showing ISR following treatment. Studies with larger sample size, and more complete follow-up data are needed in the future to expend on these findings. Trial registration No.: NCT04213378, first posted date (30/12/2019).

Background Despite the simplicity of male circumcision, complications occur frequently. Post-circumcision meatal stenosis is a concerning complication that might require several interventions. Aim This study aims to evaluate the incidence of meatal stenosis in long-term follow-up, following three common circumcision methods: frenular artery preservation, frenular ligation, and the Plastibell device. Methods This study is the continuation of the previous randomized clinical trial, the preliminary abstract of which has been accepted in the annual meeting of the American Urological Association in 2011. However, in this paper, we only included the patients with results of long-term follow-up. Patients were followed for a median of 11 years (range, 7–17). Follow-ups were recorded by evaluation of meatus and signs and symptoms of meatal stenosis. Results Two hundred six boys (80 neonates and 126 non-neonates) at the time of procedure were included in this study. The circumcision was conducted on 23.3% (48/206) of boys with the Plastibell device (PD) and 39.3% (81/206) of cases with frenular artery preservation (FAP) and 37.4% (77/206) of cases with frenular artery ligation (FAL). Meatal stenosis presented in 13 children during follow-up. Considering the three methods of circumcision, a significant difference in the incidence of meatal stenosis among the types of circumcisions was observed (6.3% in PD and 1.2% in FAP, 11.7% in FAL, P  = 0.026). Conclusion The present study revealed that the technique preserving the frenular artery is associated with a significantly lower incidence of meatal stenosis. Hence, the FAP is the recommended technique for circumcision as compared to two other methods.

Purpose To evaluate the treatments of a short-segment atherosclerotic stenosis in the superficial femoral arteries with the cutting balloon angioplasty (CBA) versus conventional balloon angioplasty [percutaneous transluminal angioplasty (PTA)] in a randomized controlled trial. Material and Methods The study group comprised 60 patients (33 men, 27 women; average age 64 years) with a short (≤5 cm) focal SFA de novo atherosclerotic stenosis associated with a history of intermittent claudication or rest pain. The primary end point of this study was the rate of binary restenosis in the treated segment 12 months after the intervention. All patients were evenly randomized to either the PTA or CBA treatment arms. Follow-up angiograms and ankle–brachial index (ABI) measurements were performed after 12 months. The evaluation of the restenosis rates and factors influencing its occurrence were calculated by logistic regression analysis. Results In the intention-to-treat analysis, restenosis rates after 2-month follow-up were 9 of 30 (30 %) in the PTA group and 4 of 30 (13 %) in the CBA group ( p  = 0.117). In the actual treatment analysis, after exclusion of patients who required nitinol stent placement for a suboptimal result after angioplasty alone (5 patients in the PTA group and none in the CBA group), restenosis rates were 9 of 25 (36 %) and 4 of 30 (13 %), respectively ( p  = 0.049). In the intention-to-treat analysis there were also significant differences in ABI values between the PTA and CBA groups at 0.77 ± 0.11 versus 0.82 ± 0.12, respectively ( p  = 0.039), at 12 months. Conclusion Based on the presented results of the trial, CBA seems to be a safer and more effective than PTA for treatment of short atherosclerotic lesions in the superior femoral artery.