Endovascular therapy for acute ischaemic stroke: the Pragmatic Ischaemic Stroke Thrombectomy Evaluation (PISTE) randomised, controlled trial

Abstract

ObjectiveThe 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).DesignEligible 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.ResultsTen 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).ConclusionsThe 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 numberNCT01745692; Results.

Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands)

“…[11][12][13][14][15][16][17] The average increase in likelihood of good functional outcome at 90 days after IAT is 19.5%. 18 Three studies suggest that high BP is a risk factor for poor outcome and SICH in patients treated with IAT.…”

Rates and Quality of Preinterventional Reperfusion in Patients With Direct Access to Endovascular Treatment

“…[1][2][3][4][5][6][7][8][9] Because tPA favors recanalization in large vessel occlusions, 10 preinterventional reperfusion obviating the need for thrombectomy is one important conceivable benefit of the bridging approach. 11 According to a recently published meta-analysis, preinterventional reperfusion occurs in about every tenth patient with an intention to bridge.…”

An historical and contemporary review of endovascular therapy for acute ischemic stroke

“…THERAPY, using the Penumbra aspiration system rather than a retrievable stent, presented in 2015 and published in September 2016 and PISTE, a pragmatic trial conducted in the UK only, have both reported a trend to improved outcome that did not reach statistical significance [22,23]. In an attempt to identify the poorest prognosis patients the THERAPY trial targeted patients with a thrombus length of 8mm or longer but failed to show any significant difference in the primary outcome of functional independnece (mRS 0-2) at 90 days, 38% IAT v 30% IVT groups (p=0.52).…”