Berkhemer Olvert A, Jansen Ivo G H, Beumer Debbie, Fransen Puck S S, van den Berg Lucie A, Yoo Albert J, Lingsma Hester F, Sprengers Marieke E S, Jenniskens Sjoerd F M, Lycklama À Nijeholt Geert J, van Walderveen Marianne A A, van den Berg René, Bot Joseph C J, Beenen Ludo F M, Boers Anna M M, Slump Cornelis H, Roos Yvo B W E M, van Oostenbrugge Robert J, Dippel Diederik W J, van der Lugt Aad, van Zwam Wim H, Marquering Henk A, Majoie Charles B L M
From the Departments of Radiology (O.A.B., I.G.H.J., M.E.S.S., R.v.d.B., L.F.M.B., A.M.M.B., C.B.L.M.M.), Neurology (L.A.v.d.B., Y.B.W.E.M.R.), and Biomedical Engineering and Physics (A.M.M.B., H.A.M.), Academic Medical Center, Amsterdam, The Netherlands; Departments of Neurology (O.A.B., P.S.S.F., D.W.J.D.), Radiology (P.S.S.F., A.v.d.L.), and Public Health (H.F.L.), Erasmus MC University Medical Center Rotterdam, The Netherlands; Departments of Neurology (D.B., R.J.v.O.), and Radiology (W.H.v.Z.), Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center, The Netherlands; Texas Stroke Institute, TX (A.J.Y.); Department of Radiology, Radboud University Medical Center, Nijmegen, The Netherlands (S.F.M.J.); Department of Radiology, MC Haaglanden, The Hague, The Netherlands (G.J.L.à.N.); Department of Radiology, Leiden University Medical Center, The Netherlands (M.A.A.v.W.); Department of Radiology, VU Medical Center, Amsterdam, The Netherlands (J.C.J.B.); and Department of Robotics & Mechatronics, University of Twente, Enschede, The Netherlands (A.M.M.B., C.H.S.).
Stroke. 2016 Mar;47(3):768-76. doi: 10.1161/STROKEAHA.115.011788. Epub 2016 Jan 28.
Recent randomized trials have proven the benefit of intra-arterial treatment (IAT) with retrievable stents in acute ischemic stroke. Patients with poor or absent collaterals (preexistent anastomoses to maintain blood flow in case of a primary vessel occlusion) may gain less clinical benefit from IAT. In this post hoc analysis, we aimed to assess whether the effect of IAT was modified by collateral status on baseline computed tomographic angiography in the Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands (MR CLEAN).
MR CLEAN was a multicenter, randomized trial of IAT versus no IAT. Primary outcome was the modified Rankin Scale at 90 days. The primary effect parameter was the adjusted common odds ratio for a shift in direction of a better outcome on the modified Rankin Scale. Collaterals were graded from 0 (absent) to 3 (good). We used multivariable ordinal logistic regression analysis with interaction terms to estimate treatment effect modification by collateral status.
We found a significant modification of treatment effect by collaterals (P=0.038). The strongest benefit (adjusted common odds ratio 3.2 [95% confidence intervals 1.7-6.2]) was found in patients with good collaterals (grade 3). The adjusted common odds ratio was 1.6 [95% confidence intervals 1.0-2.7] for moderate collaterals (grade 2), 1.2 [95% confidence intervals 0.7-2.3] for poor collaterals (grade 1), and 1.0 [95% confidence intervals 0.1-8.7] for patients with absent collaterals (grade 0).
In MR CLEAN, baseline computed tomographic angiography collateral status modified the treatment effect. The benefit of IAT was greatest in patients with good collaterals on baseline computed tomographic angiography. Treatment benefit appeared less and may be absent in patients with absent or poor collaterals.
URL: http://www.trialregister.nl and http://www.controlled-trials.com. Unique identifier: (NTR)1804 and ISRCTN10888758, respectively.
近期的随机试验已证实,在急性缺血性卒中中,使用可回收支架进行动脉内治疗(IAT)具有益处。侧支循环不良或缺失(即预先存在的吻合支,在主要血管闭塞时维持血流)的患者可能从IAT中获得较少的临床益处。在这项事后分析中,我们旨在评估在荷兰急性缺血性卒中血管内治疗多中心随机临床试验(MR CLEAN)中,IAT的效果是否因基线计算机断层血管造影的侧支循环状态而改变。
MR CLEAN是一项IAT与非IAT的多中心随机试验。主要结局是90天时的改良Rankin量表。主要效应参数是改良Rankin量表上向更好结局方向转变的调整后共同比值比。侧支循环从0级(缺失)到3级(良好)进行分级。我们使用带有交互项的多变量有序逻辑回归分析来估计侧支循环状态对治疗效果的修正。
我们发现侧支循环对治疗效果有显著修正(P = 0.038)。在侧支循环良好(3级)的患者中发现了最强的益处(调整后共同比值比为3.2 [95%置信区间1.7 - 6.2])。中度侧支循环(2级)的调整后共同比值比为1.6 [95%置信区间1.0 - 2.7],侧支循环不良(1级)的为1.2 [95%置信区间0.7 - 2.3],侧支循环缺失(0级)的患者为1.0 [95%置信区间0.1 - 8.7]。
在MR CLEAN中,基线计算机断层血管造影的侧支循环状态改变了治疗效果。在基线计算机断层血管造影侧支循环良好的患者中,IAT的益处最大。在侧支循环缺失或不良的患者中,治疗益处似乎较少甚至可能不存在。
网址:http://www.trialregister.nl和http://www.controlled-trials.com。唯一标识符:分别为(NTR)1804和ISRCTN10888758。