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Non-ST-elevation myocardial infarction (NSTEMI) and unstable angina pectoris are frequent causes of hospital admission in the elderly. However, clinical trials targeting this population are scarce, and these patients are less likely to receive treatment according to guidelines. We aimed to investigate whether this population would benefit from an early invasive strategy versus a conservative strategy. In this open-label randomised controlled multicentre trial, patients aged 80 years or older with NSTEMI or unstable angina admitted to 16 hospitals in the South-East Health Region of Norway were randomly assigned to an invasive strategy (including early coronary angiography with immediate assessment for percutaneous coronary intervention, coronary artery bypass graft, and optimum medical treatment) or to a conservative strategy (optimum medical treatment alone). A permuted block randomisation was generated by the Centre for Biostatistics and Epidemiology with stratification on the inclusion hospitals in opaque concealed envelopes, and sealed envelopes with consecutive inclusion numbers were made. The primary outcome was a composite of myocardial infarction, need for urgent revascularisation, stroke, and death and was assessed between Dec 10, 2010, and Nov 18, 2014. An intention-to-treat analysis was used. This study is registered with ClinicalTrials.gov, number NCT01255540. During a median follow-up of 1·53 years of participants recruited between Dec 10, 2010, and Feb 21, 2014, the primary outcome occurred in 93 (40·6%) of 229 patients assigned to the invasive group and 140 (61·4%) of 228 patients assigned to the conservative group (hazard ratio [HR] 0·53 [95% CI 0·41–0·69], p=0·0001). Five patients dropped out of the invasive group and one from the conservative group. HRs for the four components of the primary composite endpoint were 0·52 (0·35–0·76; p=0·0010) for myocardial infarction, 0·19 (0·07–0·52; p=0·0010) for the need for urgent revascularisation, 0·60 (0·25–1·46; p=0·2650) for stroke, and 0·89 (0·62–1·28; p=0·5340) for death from any cause. The invasive group had four (1·7%) major and 23 (10·0%) minor bleeding complications whereas the conservative group had four (1·8%) major and 16 (7·0%) minor bleeding complications. In patients aged 80 years or more with NSTEMI or unstable angina, an invasive strategy is superior to a conservative strategy in the reduction of composite events. Efficacy of the invasive strategy was diluted with increasing age (after adjustment for creatinine and effect modification). The two strategies did not differ in terms of bleeding complications. Norwegian Health Association (ExtraStiftelsen) and Inger and John Fredriksen Heart Foundation.

Abstract BACKGROUND The use of a subdural drain (SDD) after burr-hole drainage of chronic subdural hematoma (cSDH) reduces recurrence at 6 mo. Subperiosteal drains (SPDs) are considered safer, since they are not positioned in direct contact to cortical structures, bridging veins, or hematoma membranes. OBJECTIVE To investigate whether the recurrence rate after insertion of a SPD is noninferior to the insertion of a more commonly used SDD. METHODS Multicenter, prospective, randomized, controlled, noninferiority trial analyzing patients undergoing burr-hole drainage for cSDH aged 18 yr and older. After hematoma evacuation, patients were randomly assigned to receive either a SDD (SDD-group) or a SPD (SPD-group). The primary endpoint was recurrence indicating a reoperation within 12 mo, with a noninferiority margin of 3.5%. Secondary outcomes included clinical and radiological outcome, morbidity and mortality rates, and length of stay. RESULTS Of 220 randomized patients, all were included in the final analysis (120 SPD and 100 SDD). Recurrence rate was lower in the SPD group (8.33%, 95% confidence interval [CI] 4.28-14.72) than in the SDD group (12.00%, 95% CI 6.66-19.73), with the treatment difference (3.67%, 95% CI -12.6-5.3) not meeting predefined noninferiority criteria. The SPD group showed significantly lower rates of surgical infections (P = .0406) and iatrogenic morbidity through drain placement (P = .0184). Length of stay and mortality rates were comparable in both groups. CONCLUSION Although the noninferiority criteria were not met, SPD insertion led to lower recurrence rates, fewer surgical infections, and lower drain misplacement rates. These findings suggest that SPD may be warranted in routine clinical practice Graphical Abstract Graphical Abstract

Drug-coated balloon (DCB) technology was developed as an alternative treatment for obstructive coronary artery disease (CAD) and in-stent restenosis (ISR). Management of coronary ISR is clinically challenging and frequently encountered in practice. The Agent DCB uses an inactive excipient to effectively deliver a targeted, therapeutic dose of paclitaxel to the vessel wall. AGENT IDE is a prospective, multicenter, randomized controlled trial to evaluate superiority of the Agent DCB to balloon angioplasty in treating patients with ISR. A total of 480 patients with ISR of a previously treated lesion length <26 mm and reference vessel diameter >2.0 mm to ≤4.0 mm will be initially randomized. Subjects presenting with recent myocardial infarction (MI), complex lesions, or thrombus in the target vessel will be excluded. An adaptive group sequential design with one formal interim analysis for sample size re-estimation will be conducted, and the sample size may be increased to a maximum of 600 subjects. The primary endpoint is the rate of 12-month target lesion failure (TLF; composite of any ischemia-driven revascularization of the target lesion (TLR), target vessel related MI, or cardiac death) and will be tested for superiority in the test arm against the control. Functional status and general health-related quality of life will be measured by changes in the EQ-5D scores. Subjects will be followed for 5 years following the index procedure. This study will prospectively evaluate the safety and efficacy of Agent DCB in patients treated for coronary ISR.

Patients with advanced heart failure were randomly assigned to receive a centrifugal-flow or an axial-flow LVAD. At 2 years, the centrifugal-flow LVAD was associated with less pump replacement and with longer survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

In a randomized trial conducted in Norway, decompression surgery alone was noninferior to decompression with instrumented fusion with respect to the percentage of patients who had a 30% reduction on a scale of pain and disability over a period of 2 years, with a noninferiority margin of −15 percentage points.

Patients who were 50 years of age or older and had a displaced femoral neck fracture were randomly assigned to total hip arthroplasty or hemiarthroplasty. Total hip arthroplasty did not differ significantly from hemiarthroplasty with regard to the incidence of secondary procedures and led to clinically unimportant improvement over hemiarthroplasty in function over 24 months.

Among patients with spondylolisthesis and lumbar spinal stenosis, laminectomy with fusion was associated with modestly greater improvement in physical health–related quality of life than laminectomy alone but not with significantly greater reduction in disability related to back pain. The increased use of the lumbar spinal fusion procedure in the United States, along with the wide variation in practice, is attracting interest from multiple stakeholders, including patients, physicians, payers, and policymakers. In a report published in 2014, spinal fusion (465,000 hospital-based procedures in 2011) accounted for the highest aggregate hospital costs ($12.8 billion in 2011) of any surgical procedure performed in U.S. hospitals. 1 The randomized, controlled Spine Patient Outcomes Research Trial (SPORT) showed that surgery was superior to nonoperative care for the management of lumbar degenerative spondylolisthesis. 2 In SPORT, most patients in the surgical group were treated by means . . .

In a randomized trial, 366 patients with advanced heart failure received a centrifugal- or axial-flow LVAD. At 2 years, the centrifugal-flow LVAD was superior with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.

In this randomized, controlled trial comparing decompression surgery alone with decompression surgery plus fusion surgery for patients with lumbar spinal stenosis, there was no significant between-group difference in clinical outcomes at 2 and 5 years. Lumbar spinal stenosis is caused by a gradual narrowing of the spinal canal. Patients with lumbar spinal stenosis typically present with low back pain and leg pain, which occur especially when they are walking. This degenerative condition severely restricts function, walking ability, and quality of life. Lumbar spinal stenosis has become the most common indication for spinal surgery, 1 – 4 and studies have shown that surgical treatment in selected patients is more successful than conservative alternatives. 5 – 7 As the use of surgery to treat lumbar spinal stenosis has increased during the past decades, so has the complexity of the surgical procedures. . . .

In patients with subdural hematoma and an indication for surgical evacuation, middle meningeal artery embolization plus surgery led to a lower risk of reoperation for recurrence or progression within 90 days than surgery alone.