Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised controlled trial.

BACKGROUND: Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke. METHODS: We did an open-label, multicentre, randomised controlled trial with a 2 × 3 factorial design in 15 centres in the Netherlands. We enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage. Randomisation was done using a web-based procedure with permuted blocks and stratified by centre. Patients were randomly assigned (1:1) to receive either periprocedural intravenous aspirin (300 mg bolus) or no aspirin, and randomly assigned (1:1:1) to receive moderate-dose unfractionated heparin (5000 IU bolus followed by 1250 IU/h for 6 h), low-dose unfractionated heparin (5000 IU bolus followed by 500 IU/h for 6 h), or no unfractionated heparin. The primary outcome was the score on the modified Rankin Scale at 90 days. Symptomatic intracranial haemorrhage was the main safety outcome. Analyses were based on intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. This trial is registered with the International Standard Randomised Controlled Trial Number, ISRCTN76741621. FINDINGS: Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population. On Feb 4, 2021, after unblinding and analysis of the data, the trial steering committee permanently stopped patient recruitment and the trial was stopped for safety concerns. The risk of symptomatic intracranial haemorrhage was higher in patients allocated to receive aspirin than in those not receiving aspirin (43 [14%] of 310 vs 23 [7%] of 318; adjusted OR 1·95 [95% CI 1·13-3·35]) as well as in patients allocated to receive unfractionated heparin than in those not receiving unfractionated heparin (44 [13%] of 332 vs 22 [7%] of 296; 1·98 [1·14-3·46]). Both aspirin (adjusted common OR 0·91 [95% CI 0·69-1·21]) and unfractionated heparin (0·81 [0·61-1·08]) led to a non-significant shift towards worse modified Rankin Scale scores. INTERPRETATION: Periprocedural intravenous aspirin and unfractionated heparin during endovascular stroke treatment are both associated with an increased risk of symptomatic intracranial haemorrhage without evidence for a beneficial effect on functional outcome. FUNDING: The Collaboration for New Treatments of Acute Stroke consortium, the Brain Foundation Netherlands, the Ministry of Economic Affairs, Stryker, Medtronic, Cerenovus, and the Dutch Heart Foundation.

[Neurological symptoms associated with aortoiliac occlusive disease: Leriche syndrome]. / Neurologische klachten door een aorta-iliacale occlusie.

Leriche syndrome was diagnosed in three patients aged 63, 71 and 73. They presented with a wide range of neurological symptoms such as impotence, pain or dysfunction of the lower extremities. Because a neurological diagnosis was initially suspected, there was a delay in two of the three patients before palpation for a distal pulse in the lower extremities was performed. A pulse was absent in all three patients. Duplex sonography, MR angiography and CT angiography revealed that a pulse was absent due to aortoiliac occlusive disease, also known as Leriche syndrome. They underwent treatment with covered endovascular reconstruction of the aortic bifurcation (CERAB), aortobifemoral bypass or intravenous thrombolysis. All patients significantly improved after treatment. Physicians should always consider aortoiliac occlusive disease in patients who present with neurological symptoms of the lower extremities and must check for a distal pulse in these patients.

Post-EVAR aneurysm sac shrinkage is prognostically favorable, but does not justify withholding follow-up.

BACKGROUND: One of the main drawbacks of endovascular aortic aneurysm repair (EVAR) compared to open aortic surgery is the possibility of developing endoleaks and secondary aneurysm rupture, requiring frequent imaging follow-up. This study aims to identify prognostic factors that could be incorporated in follow-up protocols, which might lead to better personalized, lower cost and safe EVAR follow-up. METHODS: A retrospective study was performed including all patients who underwent elective EVAR from January 2000 to December 2015. Follow-up data were gathered by reviewing medical files for radiographic imaging. Linear and logistic regressions were used to assess predictive factors for aneurysm shrinkage. RESULTS: In 361 patients, aneurysm sac shrinkage of 10 mm or more was measured in 152 (42.1%) patients. Patients with ≥10-mm aneurysm shrinkage had fewer endoleaks (4.3% vs. 24.6%, P<0.0001) and fewer re-interventions for endoleak (3.0% vs. 10.1%, P=0.007). Aneurysm sac shrinkage was correlated with the absence of endoleak development (OR 0.36, 95% CI 0.19-0.66, P=0.001). In patients who had achieved ≥10-mm shrinkage of the aneurysm sac, no further significant growth was seen, compared to 38 (15.3%) patients who did not attain size reduction (P<0.001). CONCLUSIONS: Once patients achieve ≥10-mm aneurysm sac shrinkage, they are less prone to developing subsequent aneurysm growth and have significantly lower risk of requiring surgery for endoleaks. However, a small number of patients remain at risk of requiring endoleak surgery after aneurysm shrinkage. Therefore, we would not recommend ceasing life-long imaging follow-up after significant aneurysm sac shrinkage, though it might be safe to increase the interval of follow-up.