Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial. Issue 1 (18th October 2016)

• Record Type: Journal Article
• Authors: Muir, Keith W; Ford, Gary A; Messow, Claudia-Martina; Ford, Ian; Murray, Alicia; Clifton, Andrew; Brown, Martin M; Madigan, Jeremy; Lenthall, Rob; Robertson, Fergus; Dixit, Anand; Cloud, Geoffrey C; Wardlaw, Joanna; Freeman, Janet; White, Philip
• Other Names: author non-byline.; Clifton Andy author non-byline.; Markus Hugh author non-byline.; Lees Kennedy author non-byline.; Molyneux Andy author non-byline.; Lewis Steff author non-byline.; Robinson Tom author non-byline.; Molyneux Andy author non-byline.; Norrie John author non-byline.; Perry Richard author non-byline.; Brown Martin M author non-byline.; Roffe Christine author non-byline.; Nayak Sanjeev author non-byline.; Lobotesis Kyriakos author non-byline.; Smith Craig author non-byline.; Herwadkar Amit author non-byline.; Kandasamy Naga author non-byline.; Goddard Tony author non-byline.; Bamford John author non-byline.; Subramanian Ganesh author non-byline.; Littleton Edward author non-byline.; Lamin Sal author non-byline.; Storey Kelley author non-byline.; Ghatala Rita author non-byline.; Banaras Azra author non-byline.; Aeron-Thomas John author non-byline.; Hazel Bath author non-byline.; Maguire Holly author non-byline.; Veraque Emelda author non-byline.; Harrison Louise author non-byline.; Keshvara Rekha author non-byline.; Cunningham James author non-byline.;
• Is Part Of: Journal of neurology, neurosurgery and psychiatry. Volume 88:Issue 1(2017)
• Page Start: 38
• Page End: 44
• Publication Date: 2016-10-18
• Subjects: Neurology -- Periodicals; Nervous system -- Surgery -- Periodicals; Psychiatry -- Periodicals; 616.8
• DOI: 10.1136/jnnp-2016-314117
• Languages: English
• ISSNs: 0022-3050

Abstract

Abstract : Objective: The Pragmatic Ischaemic Thrombectomy Evaluation (PISTE) trial was a multicentre, randomised, controlled clinical trial comparing intravenous thrombolysis (IVT) alone with IVT and adjunctive intra-arterial mechanical thrombectomy (MT) in patients who had acute ischaemic stroke with large artery occlusive anterior circulation stroke confirmed on CT angiography (CTA). Design: Eligible patients had IVT started within 4.5 hours of stroke symptom onset. Those randomised to additional MT underwent thrombectomy using any Conformité Européene (CE)-marked device, with target interval times for IVT start to arterial puncture of <90 min. The primary outcome was the proportion of patients achieving independence defined by a modified Rankin Scale (mRS) score of 0–2 at day 90. Results: Ten UK centres enrolled 65 patients between April 2013 and April 2015. Median National Institutes of Health Stroke Scale score was 16 (IQR 13–21). Median stroke onset to IVT start was 120 min. In the intention-to-treat analysis, there was no significant difference in disability-free survival at day 90 with MT (absolute difference 11%, adjusted OR 2.12, 95% CI 0.65 to 6.94, p=0.20). Secondary analyses showed significantly greater likelihood of full neurological recovery (mRS 0–1) at day 90 (OR 7.6, 95% CI 1.6 to 37.2, p=0.010). In the per-protocol population (n=58), the primary and most secondary clinical outcomes significantly favoured MT (absolute difference in mRS 0–2 of 22% and adjusted OR 4.9, 95% CI 1.2 to 19.7, p=0.021). Conclusions: The trial did not find a significant difference between treatment groups for the primary end point. However, the effect size was consistent with published data and across primary and secondary end points. Proceeding as fast as possible to MT after CTA confirmation of large artery occlusion on a background of intravenous alteplase is safe, improves excellent clinical outcomes and, in the per-protocol population, improves disability-free survival. Trial registration number: NCT01745692; Results.