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Multicenter Study
. 2023 Oct;54(10):2522-2533.
doi: 10.1161/STROKEAHA.123.042966. Epub 2023 Aug 21.

Safety Outcomes of Mechanical Thrombectomy Versus Combined Thrombectomy and Intravenous Thrombolysis in Tandem Lesions

Aaron Rodriguez-Calienes  1   2 , Milagros Galecio-Castillo  1 , Mudassir Farooqui  1 , Ameer E Hassan  3 , Mouhammad A Jumaa  4 , Afshin A Divani  5 , Marc Ribo  6 , Michael Abraham  7 , Nils H Petersen  8 , Johanna Fifi  9 , Waldo R Guerrero  10 , Amer M Malik  11 , James E Siegler  12   13 , Thanh N Nguyen  14 , Albert J Yoo  15 , Guillermo Linares  16 , Nazli Janjua  17 , Darko Quispe-Orozco  1 , Wondwossen G Tekle  3 , Hisham Alhajala  4 , Asad Ikram  5 , Federica Rizzo  6 , Abid Qureshi  7 , Liza Begunova  9 , Stavros Matsouka  9 , Nicholas Vigilante  12 , Sergio Salazar-Marioni  18 , Mohamad Abdalkader  14 , Weston Gordon  16 , Jazba Soomro  15 , Charoskon Turabova  17 , Juan Vivanco-Suarez  1 , Maxim Mokin  10 , Dileep R Yavagal  11 , Tudor Jovin  12 , Sunil Sheth #  18 , Santiago Ortega-Gutierrez #  19
Affiliations
Multicenter Study

Safety Outcomes of Mechanical Thrombectomy Versus Combined Thrombectomy and Intravenous Thrombolysis in Tandem Lesions

Aaron Rodriguez-Calienes et al. Stroke. 2023 Oct.

Abstract

Background: We aimed to describe the safety and efficacy of mechanical thrombectomy (MT) with or without intravenous thrombolysis (IVT) for patients with tandem lesions and whether using intraprocedural antiplatelet therapy influences MT's safety with IVT treatment.

Methods: This is a subanalysis of a pooled, multicenter cohort of patients with acute anterior circulation tandem lesions treated with MT from 16 stroke centers between January 2015 and December 2020. Primary outcomes included symptomatic intracranial hemorrhage (sICH) and parenchymal hematoma type 2. Additional outcomes included hemorrhagic transformation, successful reperfusion (modified Thrombolysis in Cerebral Infarction score 2b-3), complete reperfusion (modified Thrombolysis in Cerebral Infarction score 3), favorable functional outcome (90-day modified Rankin Scale score 0-2), excellent functional outcome (90-day modified Rankin Scale score 0-1), in-hospital mortality, and 90-day mortality.

Results: Of 691 patients, 512 were included (218 underwent IVT+MT and 294 MT alone). There was no difference in the risk of sICH (adjusted odds ratio [aOR], 1.22 [95% CI, 0.60-2.51]; P=0.583), parenchymal hematoma type 2 (aOR, 0.99 [95% CI, 0.47-2.08]; P=0.985), and hemorrhagic transformation (aOR, 0.95 [95% CI, 0.62-1.46]; P=0.817) between the IVT+MT and MT alone groups after adjusting for confounders. Administration of IVT was associated with an increased risk of sICH in patients who received intravenous antiplatelet therapy (aOR, 3.04 [95% CI, 0.99-9.37]; P=0.05). The IVT+MT group had higher odds of a 90-day modified Rankin Scale score 0 to 2 (aOR, 1.72 [95% CI, 1.01-2.91]; P=0.04). The odds of successful reperfusion, complete reperfusion, 90-day modified Rankin Scale score 0 to 1, in-hospital mortality, or 90-day mortality did not differ between the IVT+MT versus MT alone groups.

Conclusions: Our study showed that the combination of IVT with MT for tandem lesions did not increase the overall risk of sICH, parenchymal hematoma type 2, or overall hemorrhagic transformation independently of the cervical revascularization technique used. However, intraprocedural intravenous antiplatelet therapy during acute stent implantation might be associated with an increased risk of sICH in patients who received IVT before MT. Importantly, IVT+MT treatment was associated with a higher rate of favorable functional outcomes at 90 days.

Keywords: intracranial hemorrhage; reperfusion; stroke; thrombectomy.

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Conflict of interest statement

Disclosures A.E. Hassan is a consultant/speaker at Medtronic, Microvention, Stryker, Penumbra, Cerenovus, Genentech, GE Healthcare, Scientia, Balt, vizai, Insera therapeutics, Proximie, NeuroVasc, NovaSignal, Vesalio, Rapid Medical, Imperative Care and Galaxy Therapeutics; principal investigator for COMPLETE study—Penumbra, LVO SYNCHRONISE—vizai, Millipede Stroke Trial—Perfuze, RESCUE—ICAD, Medtronic; steering committee/publication committee member for SELECT, DAWN, SELECT 2, EXPEDITE II, EMBOLISE, CLEAR, ENVI, DELPHI, DISTALS. Dr Divani performed fundings at the University of New Mexico Center for Brain Recovery and Repair Center of Biomedical Research Excellence through Grant Number (NIH P20GM109089, Pilot PI), W81XWH-17-2-0053 (PI), 1R21NS130423-01 (PI). Dr Ribo is consultant at aptaTargets, Anaconda Biomed, Philips, Medtronic, Cerenovus, Vesalio, and Rapid Pulse outside the submitted work. Dr Abraham is a consultant at Penumbra Inc, Qapel, Stryker Corporation. Dr Fifi is a consultant at Cerenovus, Stryker Corporation, Microvention Inc; received stock from Cerebrotech, Imperative Care, Sime&Cure; and received grants from viz AI. Data and Safety Monitoring: MIVI. Dr Yoo is a consultant for Johnson & Johnson Medical Devices & Diagnostics Group—Latin America, LLC, Nicolab, Penumbra Inc, Philips, Vesalio, ZOLL Circulation Inc; received grants from Genetech, USA Inc, Johnson & Johnson Medical Devices & Diagnostics Group—Latin America, LLC, Medtronic, Penumbra Inc, Stryker; Employment at HCA Healthcare; received stock from Insera, Nicolab; performed data and safety monitoring at National Institutes of Health. Dr Mokin is a consultant at Johnson & Johnson Medical Devices & Diagnostics Group—Latin America, LLC, Medtronic, MicroVention Inc, received stock from Bendit Technology, BrainQ, Serenity medical, Synchrone. Dr Yavagal is a consultant at Athersys, Gravity Medical Technology, Johnson & Johnson Health Care Systems Inc, Medtronic USA Inc, Poseydon, Stryker Corporation, Vascular Dynamics; received stock from Athersys, Poseydon, Rapid Medical. Dr Jovin is a consultant at Contego Medical Inc received stock from Anaconda, Freeox Biotech, Galaxy, Kandu, Methinks, Route92, vizai. Grant: Medtronicm, USA, Inc, Stryker Corporation; performed data and safety monitoring at Johnson & Johnson, Cerenovus. Dr Sheth is a consultant at vizAI, Penumbra, Imperative Care; received grants from NIH, vizAI; and took ownership for Motif Neuroscience (not related to this article). Dr Ortega-Gutierrez received grants from NIH-NINDS (R01NS127114-01, R03NS126804), Stryker, Medtronics, Microvention, Penumbra, IschemiaView, vizai, and Siemens; he is a consultant at Medtronic and Stryker Neurovascular. The other authors report no conflicts.

Figures

Figure 1.
Figure 1.. Flow diagram of patients included in the study.
ICA indicates internal carotid artery; IVT, intravenous thrombolysis; LKW, last known well; MT, mechanical thrombectomy; and UK, unknown.
Figure 2.
Figure 2.. Symptomatic intracranial hemorrhage (sICH) and parenchymal hematoma type 2 (PH2) in patients treated with mechanical thrombectomy (MT) alone and intravenous thrombolysis (IVT)+MT.
Bar chart illustrating the results for the primary analysis (A) and the sensitivity analysis for the early window (0–6 hours; B). *Adjusted for internal carotid artery (ICA) stenting, number of passes, modified Thrombolysis in Cerebral Infarction 2b-3. **Adjusted for ICA stenting, age, hypertension, Alberta Stroke Program Early Computed Tomography Score.
Figure 3.
Figure 3.. Comparisons in symptomatic intracranial hemorrhage according to the use of intravenous thrombolysis (IVT) in prespecified subgroups.
Adjusted for number of passes, modified Thrombolysis in Cerebral Infarction. p-het: P value for test of interactions. ASPECTS indicates Alberta Stroke Program Early Computed Tomography Score; ICA, internal carotid artery; MT, mechanical thrombectomy; OR, odds ratio for sICH; and p-het, P value of heterogeneity.
Figure 4.
Figure 4.. Shift analysis of modified Rankin Scale (mRS) at 90 days in patients treated with mechanical thrombectomy (MT) alone and intravenous thrombolysis (IVT)+MT.
Bar chart depicting the results of the entire cohort (A) and the sensitivity analysis for the early window (0–6 hours; B). aOR indicates adjusted odds ratio; IVT, intravenous thrombolysis; MT, mechanical thrombectomy; and OR, odds ratio. *Categorized mRS score 0 to 2 vs 3 to 6. Adjusted for age, National Institutes of Health Stroke Scale (NIHSS), type of anesthesia, successful reperfusion, internal carotid artery stenting, symptomatic intracranial hemorrhage, and postprocedural antiplatelet therapy. **Multinomial model. Adjusted for age, NIHSS, type of anesthesia, successful reperfusion, internal carotid artery stenting, symptomatic intracranial hemorrhage, and postprocedural antiplatelet therapy.
Figure 5.
Figure 5.. Comparisons of favorable outcomes at 90 days according to the use of intravenous thrombolysis (IVT) in prespecified subgroups.
ASPECTS indicates Alberta Stroke Program Early Computed Tomography Score; ICA, internal carotid artery; MT, mechanical thrombectomy; OR, odds ratio of favorable outcome at 90 days; and p-het, P value of heterogeneity.
See this image and copyright information in PMC

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