Early Successful Recanalization After Intravenous Thrombolysis With Tenecteplase Versus Alteplase in Distal Vessel Occlusion Strokes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 319
- 试验地点
- 1
- 主要终点
- Early successful recanalization rate
研究概览
简要总结
The purpose of this monocentric retrospective study is to compare, in patients with acute distal vessel occlusion stroke, the early rates of successful recanalization in patients treated with Alteplase (ALT) versus Tenecteplase (TNK), based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.
详细描述
Early rates of successful recanalization (SR) of distal vessel occlusions (DVO) following intravenous thrombolysis (IVT) between alteplase (ALT) and tenecteplase (TNK) are poorly known.
From March 2016 to February 2020, consecutive stroke patients hospitalized in the stroke unit of the Sud-Francilien Hospital with DVO identified on baseline MRI and suitable for IVT but not for mechanical thrombectomy will be included. In our stroke unit, patients were treated with ALT, 0.9 mg/kg from March 2016 to February 2018 and then with TNK, 0.25 mg/kg from March 2018 to February 2020. MRI was controlled 1-2 hours within IVT (MRI-2). Early recanalization was assessed on an adapted Arterial Occlusion Lesion (AOL) scale, SR being defined as AOL 2/3 scores on MRI-2. The rate reduction of thrombus length (TL) when thrombus persisted, the IVT response threshold of TL and the infarct size evolution were also assessed. In the present study, the investigators sought to compare early rates of SR between the two lytics, based on a retrospective analysis of magnetic resonance imaging (MRI) performed early after IVT.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age≥ 18 years.
- •Acute ischemic stroke (visible on DWI, but not visible on FLAIR) on initial MRI associated with distal arterial occlusion as defined below:
- •A distal occlusion of the M2 segment of the middle cerebral artery (MCA)
- •Occlusion (regardless of location) of a non-dominant M2 branch of the MCA
- •Occlusion of the M3 segment of the MCA.
- •Occlusion of the A2 or A3 segment of the anterior cerebral artery (ACA)
- •Occlusion of the P2 or P3 branch of the posterior cerebral artery (PCA).
- •A proximal M2-MCA or proximal P1-PCA occlusion may also be included if not eligible for mechanical thrombectomy, especially if the initial NIHSS score is low (<5).
- •Distal arterial occlusion is identified by MRI either on the TOF (Time of Flight)-ARM sequence and/or on the presence of a thrombus (Susceptibility Vessel sign, SVS) on the SWAN sequence,
- •IVT by ALT or TNK within 4H30 after onset of symptoms,
- •Early brain MRI performed 1 to 2 hours after IVT (MRI n°2),
- •Good quality MRI (absence of motion artifact interfering with interpretation) with availability of DWI, FLAIR, TOF-MRA and SWAN sequences.
排除标准
- •Patients informed of the study who objected to the collection of their data.
研究组 & 干预措施
Alteplase (ALT)
Patients with distal vessel occlusion stroke treated with alteplase (from March 2016 to February 2018)
干预措施: Alteplase (0.9mg/kg) (Drug)
Tenecteplase (TNK)
Patients with distal vessel occlusion stroke treated with tenecteplase (from March 2018 to February 2020)
干预措施: Tenecteplase (0.25mg/kg) (Drug)
结局指标
主要结局
Early successful recanalization rate
时间窗: Between 1 and 2 hours after IVT
Early successful recanalization rate defined by an Arterial Occlusive Lesion (AOL) scale grade 2 or 3 on MRI-2 performed between 1 and 2 hours after IVT.
次要结局
- Evolution of cerebral infarct volume(Between 1 and 2 hours after IVT)
- Rates of early post-thrombolysis intracerebral hemorrhage(Between 1 and 2 hours after IVT)
- Thrombus length change(Between 1 and 2 hours after IVT)
- Very early clinical modification(Between 1 and 2 hours after IVT)
- Early complete recanalization rate(Between 1 and 2 hours after IVT)