Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial.
Research article published in International journal of stroke : official journal of the International Stroke Society (2023)
Abstract
RATIONALE: Mechanical thrombectomy (MT) associated with the best medical treatment (BMT) has recently shown efficacy for the management of acute ischemic stroke (AIS) secondary to a large vessel occlusion. However, evidence is lacking regarding the benefit of MT for more distal occlusions. AIM: To evaluate the efficacy in terms of good clinical outcome at 3 months of MT associated with the BMT over the BMT alone in AIS related to a distal occlusion. METHODS: The DISCOUNT trial is a multicenter open-label randomized controlled trial involving French University hospitals. Adult patients (⩾18 years) with an AIS involving the anterior or posterior circulation secondary to a distal vessel occlusion within 6 h of symptom onset or within 24 h if no hyperintense signal on fluid attenuation inversion recovery acquisition will be randomized 1:1 to receive either MT associated with the BMT (experimental group) or BMT alone (control group). The number of patients to be included is 488. STUDY OUTCOMES: The primary outcome is the rate of good clinical outcome at 3 months defined as a modified Rankin scale (mRS) ⩽2 and evaluated by an independent assessor blinded to the intervention arm. Secondary outcomes include recanalization of the occluded vessel within 48 h, angiographic reperfusion in the experimental group, 3-month excellent clinical outcome (mRS ⩽ 1), all adverse events, and death. A cost utility analysis will estimate the incremental cost per quality-adjusted life year (QALY) gained. DISCUSSION: If positive, this study will open new insights in the management of AISs. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05030142 registered on 1 September 2021.
Abstract sourced from PubMed (NCBI) for the cited record. See the original publication for the authoritative version.
Summary
Mechanical thrombectomy (MT) associated with the best medical treatment (BMT) has recently shown efficacy for the management of acute ischemic stroke (AIS) secondary to a large vessel occlusion. However, evidence is lacking regarding the benefit of MT for more distal occlusions.
Why This Matters for Hirudotherapy
This is the rationale and design paper for the DISCOUNT trial, a multicenter open-label randomized controlled trial in French hospitals planning to enroll 488 patients to test whether mechanical thrombectomy plus best medical treatment outperforms best medical treatment alone for acute ischemic stroke caused by a distal (rather than large) vessel occlusion, with good clinical outcome (modified Rankin scale <=2 at 3 months) as the primary endpoint. For ASH it is peripheral, illustrating that even for established thrombo-occlusive emergencies the evidence base is built endpoint by endpoint through rigorous RCTs, the same standard against which any hirudotherapy claim should be measured. Caveat: this abstract describes a protocol only, reporting no results or efficacy data; the trial was registered (NCT05030142) but outcomes were pending, and the study concerns device-based thrombectomy, not leech therapy or the secretome.
Citation
Evaluation of mechanical thrombectomy in acute ischemic stroke related to a distal arterial occlusion: A randomized controlled trial.
Clarençon F et al. · International journal of stroke : official journal of the International Stroke Society, 2023
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