51. Effect of Mechanical Thrombectomy Without vs With Intravenous Thrombolysis on Functional Outcome Among Patients With Acute Ischemic Stroke
- Author
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Tomoji Takigawa, Skip Study Investigators, Toshihiro Ueda, Masato Inoue, Yasuhiro Nishiyama, Mitsuhiro Iwasaki, Yuki Kamiya, Tetsuhiro Higashida, Yasuyuki Iguchi, Seiji Okubo, Kazunori Akaji, Masataka Takeuchi, Kentaro Suzuki, Shigeru Fujimoto, Hiromichi Naito, Ryuzaburo Kanazawa, Mikito Hayakawa, Yorio Koguchi, Yuji Matsumaru, Junya Aoki, Teruyuki Hirano, Keigo Shigeta, Norihiro Ishii, Yohei Takayama, Wataro Tsuruta, Kazunori Miki, Masafumi Morimoto, Kazumi Kimura, Noriyuki Kato, Takahiro Ota, and Toshiaki Otsuka
- Subjects
Male ,medicine.medical_treatment ,Severity of Illness Index ,01 natural sciences ,law.invention ,03 medical and health sciences ,0302 clinical medicine ,Fibrinolytic Agents ,Randomized controlled trial ,Modified Rankin Scale ,law ,Severity of illness ,Confidence Intervals ,Humans ,Medicine ,030212 general & internal medicine ,0101 mathematics ,Infusions, Intravenous ,Stroke ,Aged ,Cerebral Hemorrhage ,Ischemic Stroke ,Thrombectomy ,Aged, 80 and over ,Intracerebral hemorrhage ,business.industry ,010102 general mathematics ,General Medicine ,Thrombolysis ,Odds ratio ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Confidence interval ,Functional Status ,Treatment Outcome ,Tissue Plasminogen Activator ,Anesthesia ,Acute Disease ,Female ,business - Abstract
Importance Whether intravenous thrombolysis is needed in combination with mechanical thrombectomy in patients with acute large vessel occlusion stroke is unclear. Objective To examine whether mechanical thrombectomy alone is noninferior to combined intravenous thrombolysis plus mechanical thrombectomy for favorable poststroke outcome. Design, Setting, and Participants Investigator-initiated, multicenter, randomized, open-label, noninferiority clinical trial in 204 patients with acute ischemic stroke due to large vessel occlusion enrolled at 23 hospital networks in Japan from January 1, 2017, to July 31, 2019, with final follow-up on October 31, 2019. Interventions Patients were randomly assigned to mechanical thrombectomy alone (n = 101) or combined intravenous thrombolysis (alteplase at a 0.6-mg/kg dose) plus mechanical thrombectomy (n = 103). Main Outcomes and Measures The primary efficacy end point was a favorable outcome defined as a modified Rankin Scale score (range, 0 [no symptoms] to 6 [death]) of 0 to 2 at 90 days, with a noninferiority margin odds ratio of 0.74, assessed using a 1-sided significance threshold of .025 (97.5% CI). There were 7 prespecified secondary efficacy end points, including mortality by day 90. There were 4 prespecified safety end points, including any intracerebral hemorrhage and symptomatic intracerebral hemorrhage within 36 hours. Results Among 204 patients (median age, 74 years; 62.7% men; median National Institutes of Health Stroke Scale score, 18), all patients completed the trial. Favorable outcome occurred in 60 patients (59.4%) in the mechanical thrombectomy alone group and 59 patients (57.3%) in the combined intravenous thrombolysis plus mechanical thrombectomy group, with no significant between-group difference (difference, 2.1% [1-sided 97.5% CI, −11.4% to ∞]; odds ratio, 1.09 [1-sided 97.5% CI, 0.63 to ∞];P = .18 for noninferiority). Among the 7 secondary efficacy end points and 4 safety end points, 10 were not significantly different, including mortality at 90 days (8 [7.9%] vs 9 [8.7%]; difference, –0.8% [95% CI, –9.5% to 7.8%]; odds ratio, 0.90 [95% CI, 0.33 to 2.43];P > .99). Any intracerebral hemorrhage was observed less frequently in the mechanical thrombectomy alone group than in the combined group (34 [33.7%] vs 52 [50.5%]; difference, –16.8% [95% CI, –32.1% to –1.6%]; odds ratio, 0.50 [95% CI, 0.28 to 0.88];P = .02). Symptomatic intracerebral hemorrhage was not significantly different between groups (6 [5.9%] vs 8 [7.7%]; difference, –1.8% [95% CI, –9.7% to 6.1%]; odds ratio, 0.75 [95% CI, 0.25 to 2.24];P = .78). Conclusions and Relevance Among patients with acute large vessel occlusion stroke, mechanical thrombectomy alone, compared with combined intravenous thrombolysis plus mechanical thrombectomy, failed to demonstrate noninferiority regarding favorable functional outcome. However, the wide confidence intervals around the effect estimate also did not allow a conclusion of inferiority. Trial Registration umin.ac.jp/ctr Identifier:UMIN000021488
- Published
- 2021
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