Albert J Yoo1, Pooja Khatri2, J Mocco2, Osama O Zaidat2, Rishi Gupta2, Donald Frei2, Demetrius Lopes2, Harish Shownkeen2, Olvert A Berkhemer2, Denise Meyer2, Susana S Hak2, Sophia S Kuo2, Hope Buell2, Arani Bose2, Siu Po Sit2, Rüdiger von Kummer2. 1. From the Texas Stroke Institute, Dallas, (A.J.Y.); University of Cincinnati, OH (P.K.); Mount Sinai Health System, New York (J.M.); St. Vincent Mercy Medical Center, Toledo, OH (O.O.Z.); WellStar Health System, Marietta, GA (R.G.); Swedish Medical Center, Englewood, CO (D.F.); Rush University, Chicago, IL (D.L.); Central DuPage Hospital, Winfield, IL (H.S.); Amsterdam Medical Center, the Netherlands (O.A.B.); Academic Medical Center Amsterdam, Erasmus MC University Medical Center Rotterdam, the Netherlands (O.A.B.); Maastricht University Medical Center, the Netherlands (O.A.B.); Penumbra, Inc, Alameda, CA (D.M., S.S.H., S.S.K., H.B., A.B., S.P.S.); and Universitätsklinikum Carl Gustav Carus, Dresden, Germany (R.v.K.). ajyoo74@gmail.com. 2. From the Texas Stroke Institute, Dallas, (A.J.Y.); University of Cincinnati, OH (P.K.); Mount Sinai Health System, New York (J.M.); St. Vincent Mercy Medical Center, Toledo, OH (O.O.Z.); WellStar Health System, Marietta, GA (R.G.); Swedish Medical Center, Englewood, CO (D.F.); Rush University, Chicago, IL (D.L.); Central DuPage Hospital, Winfield, IL (H.S.); Amsterdam Medical Center, the Netherlands (O.A.B.); Academic Medical Center Amsterdam, Erasmus MC University Medical Center Rotterdam, the Netherlands (O.A.B.); Maastricht University Medical Center, the Netherlands (O.A.B.); Penumbra, Inc, Alameda, CA (D.M., S.S.H., S.S.K., H.B., A.B., S.P.S.); and Universitätsklinikum Carl Gustav Carus, Dresden, Germany (R.v.K.).
Abstract
BACKGROUND AND PURPOSE: Increasing thrombus length (TL) impedes recanalization after intravenous (IV) thrombolysis. We sought to determine whether the clinical benefit of aspiration thrombectomy relative to IV r-tPA (recombinant tissue-type plasminogen activator) may be greater at longer TL. METHODS:THERAPY was a randomized trial of aspiration thrombectomy plus IV r-tPA versus IV r-tPA alone in large-vessel stroke patients with prospective TL measurement ≥8 mm. In this post hoc study, we evaluated the association of TL with trial end points and potential endovascular treatment effect, using univariate, multivariable, and multiplicative interaction analyses. RESULTS: TL data were available for all 108 patients (28% internal carotid artery, 62% M1, and 10% M2). Median TL was 14.0 mm (interquartile range, 9.7-19.5 mm). Longer TL was associated with worse outcome (90-day modified Rankin Scale score: odds ratio, 1.24 per 5-mm TL increment; 95% confidence interval, 1.04-1.52; P=0.02), even after adjusting for key outcome predictors (adjusted P=0.004). Longer TL was also associated with more serious adverse events (adjusted P=0.01), more symptomatic hemorrhages (adjusted P=0.03), and increased mortality (adjusted P=0.01). No significant relationship was observed between TL and angiographic reperfusion (modified thrombolysis in cerebral ischemia 2b-3), but greater TL was associated with longer endovascular procedural times (ρ=0.36; P=0.045). Increasing TL was associated with greater aspiration thrombectomy treatment effect (interaction term P=0.03). This might be related to a potentially stronger adverse effect of increasing TL on 90-day modified Rankin Scale for patients treated with IV r-tPA (ρ=0.39; P=0.01) compared with intra-arterial therapy (ρ=0.20; P=0.165). CONCLUSIONS:Ischemic stroke patients with longer symptomatic thrombi have worse 90-day clinical outcomes but may have a greater relative benefit of aspiration thrombectomy over IV r-tPA alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01429350.
RCT Entities:
BACKGROUND AND PURPOSE: Increasing thrombus length (TL) impedes recanalization after intravenous (IV) thrombolysis. We sought to determine whether the clinical benefit of aspiration thrombectomy relative to IV r-tPA (recombinant tissue-type plasminogen activator) may be greater at longer TL. METHODS: THERAPY was a randomized trial of aspiration thrombectomy plus IV r-tPA versus IV r-tPA alone in large-vessel strokepatients with prospective TL measurement ≥8 mm. In this post hoc study, we evaluated the association of TL with trial end points and potential endovascular treatment effect, using univariate, multivariable, and multiplicative interaction analyses. RESULTS: TL data were available for all 108 patients (28% internal carotid artery, 62% M1, and 10% M2). Median TL was 14.0 mm (interquartile range, 9.7-19.5 mm). Longer TL was associated with worse outcome (90-day modified Rankin Scale score: odds ratio, 1.24 per 5-mm TL increment; 95% confidence interval, 1.04-1.52; P=0.02), even after adjusting for key outcome predictors (adjusted P=0.004). Longer TL was also associated with more serious adverse events (adjusted P=0.01), more symptomatic hemorrhages (adjusted P=0.03), and increased mortality (adjusted P=0.01). No significant relationship was observed between TL and angiographic reperfusion (modified thrombolysis in cerebral ischemia 2b-3), but greater TL was associated with longer endovascular procedural times (ρ=0.36; P=0.045). Increasing TL was associated with greater aspiration thrombectomy treatment effect (interaction term P=0.03). This might be related to a potentially stronger adverse effect of increasing TL on 90-day modified Rankin Scale for patients treated with IV r-tPA (ρ=0.39; P=0.01) compared with intra-arterial therapy (ρ=0.20; P=0.165). CONCLUSIONS:Ischemic strokepatients with longer symptomatic thrombi have worse 90-day clinical outcomes but may have a greater relative benefit of aspiration thrombectomy over IV r-tPA alone. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01429350.
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