Endovascular stroke treatment in orally anticoagulated patients: an analysis from the German Stroke Registry-Endovascular Treatment

Clemens Küpper, Katharina Feil, Frank Arne Wollenweber, Steffen Tiedt, Moriz Herzberg, Franziska Dorn, Thomas Liebig, Marianne Dieterich, Lars Kellert, GSR investigators, Clemens Küpper, Katharina Feil, Frank Arne Wollenweber, Steffen Tiedt, Moriz Herzberg, Franziska Dorn, Thomas Liebig, Marianne Dieterich, Lars Kellert, GSR investigators

Abstract

Background: Endovascular treatment (ET) in orally anticoagulated (OAC) patients has not been evaluated in randomized clinical trials and data regarding this issue are sparse.

Methods: We analyzed data from the German Stroke Registry-Endovascular Treatment (GSR-ET; NCT03356392, date of registration: 22 Nov 2017). The primary outcomes were successful reperfusion defined as modified thrombolysis in cerebral infarction (mTICI 2b-3), good outcome at 3 months (modified Rankin scale [mRS] 0-2 or back to baseline), and intracranial hemorrhage (ICH) on follow-up imaging at 24 h analyzed by unadjusted univariate and adjusted binary logistic regression analysis. Additionally, we analyzed mortality at 3 months with adjusted binary logistic regression analysis.

Results: Out of 6173 patients, there were 1306 (21.2%) OAC patients, 479 (7.8%) with vitamin K antagonists (VKA) and 827 (13.4%) with non-vitamin K antagonist oral anticoagulation (NOAC). The control group consisted of 4867 (78.8%) non-OAC patients. ET efficacy with the rates of mTICI 2b-3 was similar among the three groups (85.6%, 85.3% vs 84.3%, p = 0.93 and 1). On day 90, good outcome was less frequent in OAC patients (27.8%, 27.9% vs 39.5%, p < 0.005 and < 0.005). OAC status was not associated with ICH at 24 h (NOAC: odd's ratio [OR] 0.89, 95% confidence interval [CI] 0.67-1.20; VKA: OR 1.04, CI 0.75-1.46). Binary logistic regression analysis revealed no influence of OAC status on good outcome at 3 months (NOAC: OR 1.25, CI 0.99-1.59; VKA: OR 1.18, CI 0.89-1.56) and mortality at 3 months (NOAC: OR 1.03, CI 0.81-1.30; VKA: OR 1.04, CI 0.78-1.1.37).

Conclusions: ET can be performed safely and successfully in LVO stroke patients treated with OAC. CLINICAL TRIAL REGISTRATION-URL: http://www.clinicaltrials.gov . Unique identifier: NCT03356392.

Keywords: Endovascular treatment; Ischemic stroke; Large vessel occlusion; Oral anticoagulation.

Conflict of interest statement

CK, KF, ST, MH, FD, and MD have nothing to disclose. FAW reports personal fees from Bayer, Pfizer-BMS, Portola, and Boehringer Ingelheim outside of this study. TL consults for Stryker Neurovascular GmbH and has received speaker honoraria by Pfizer, Covidien, Phenox, and Microvention outside this study. LK has received funding for travel or speaker honoraria from Bayer Vital, Boehringer Ingelheim, Bristol-Meyer-Squibb, Daiichi Sankyo, and Pfizer outside of this study.

Figures

Fig. 1
Fig. 1
Binary logistic regression analysis for good outcome (mRS 0–2 or back to baseline) at d90. mRS modified Rankin scale, IVT intravenous thrombolysis, NIHSS National Institute of Health Stroke Scale, pmRS premorbid modified Rankin scale, VKA vitamin K antagonist, NOAC non-vitamin K oral anticoagulation anticoagulant
Fig. 2
Fig. 2
Binary logistic regression analysis for mortality at d90. IVT intravenous thrombolysis, NIHSS National Institute of Health Stroke Scale, pmRS premorbid modified Rankin scale, VKA vitamin K antagonist, NOAC non-vitamin K oral anticoagulant
Fig. 3
Fig. 3
Binary logistic regression analysis for ICH at 24 h. ICH intracranial hemorrhage, IVT intravenous thrombolysis, NIHSS National Institute of Health Stroke Scale, pmRS premorbid modified Rankin scale, VKA vitamin K antagonist, NOAC non-vitamin K oral anticoagulant

References

    1. Alegiani AC, Dorn F, Herzberg M, Wollenweber FA, Kellert L, Siebert E, Nolte CH, von Rennenberg R, Hattingen E, Petzold GC, Bode FJ, Pfeilschifter W, Schafer JH, Wagner M, Rother J, Eckert B, Kraft P, Pham M, Boeckh-Behrens T, Wunderlich S, Bernkopf K, Reich A, Wiesmann M, Mpotsaris A, Psychogios M, Liman J, Maier I, Berrouschot J, Bormann A, Limmroth V, Spreer J, Petersen M, Krause L, Lowens S, Kraemer C, Zweynert S, Lange KS, Thonke S, Kastrup A, Papanagiotou P, Alber B, Braun M, Fiehler J, Gerloff C, Dichgans M, Thomalla G. Systematic evaluation of stroke thrombectomy in clinical practice: The German Stroke Registry Endovascular Treatment. Int J Stroke. 2019;14:372–380. doi: 10.1177/1747493018806199.
    1. Benavente L, Larrosa D, Garcia-Cabo C, Perez AI, Rico M, Vega P, Murias E, Calleja S. Safety and efficacy of mechanical thrombectomy in acute ischemic stroke of anticoagulated patients—a prospective observational study. J Stroke Cerebrovasc Dis. 2016;25:2093–2098. doi: 10.1016/j.jstrokecerebrovasdis.2016.06.006.
    1. Berkhemer OA, Fransen PS, Beumer D, van den Berg LA, Lingsma HF, Yoo AJ, Schonewille WJ, Vos JA, Nederkoorn PJ, Wermer MJ, van Walderveen MA, Staals J, Hofmeijer J, van Oostayen JA, Lycklama a Nijeholt GJ, Boiten J, Brouwer PA, Emmer BJ, de Bruijn SF, van Dijk LC, Kappelle LJ, Lo RH, van Dijk EJ, de Vries J, de Kort PL, van Rooij WJ, van den Berg JS, van Hasselt BA, Aerden LA, Dallinga RJ, Visser MC, Bot JC, Vroomen PC, Eshghi O, Schreuder TH, Heijboer RJ, Keizer K, Tielbeek AV, den Hertog HM, Gerrits DG, van den Berg-Vos RM, Karas GB, Steyerberg EW, Flach HZ, Marquering HA, Sprengers ME, Jenniskens SF, Beenen LF, van den Berg R, Koudstaal PJ, van Zwam WH, Roos YB, van der Lugt A, van Oostenbrugge RJ, Majoie CB, Dippel DW, Investigators MC A randomized trial of intraarterial treatment for acute ischemic stroke. N Engl J Med. 2015;372:11–20. doi: 10.1056/NEJMoa1411587.
    1. Campbell BC, Mitchell PJ, Kleinig TJ, Dewey HM, Churilov L, Yassi N, Yan B, Dowling RJ, Parsons MW, Oxley TJ, Wu TY, Brooks M, Simpson MA, Miteff F, Levi CR, Krause M, Harrington TJ, Faulder KC, Steinfort BS, Priglinger M, Ang T, Scroop R, Barber PA, McGuinness B, Wijeratne T, Phan TG, Chong W, Chandra RV, Bladin CF, Badve M, Rice H, de Villiers L, Ma H, Desmond PM, Donnan GA, Davis SM, Investigators E-I Endovascular therapy for ischemic stroke with perfusion-imaging selection. N Engl J Med. 2015;372:1009–1018. doi: 10.1056/NEJMoa1414792.
    1. Cernik D, Sanak D, Divisova P, Kocher M, Cihlar F, Zapletalova J, Veverka T, Prcuchova A, Ospalik D, Cerna M, Janousova P, Kral M, Dornak T, Prasil V, Franc D, Kanovsky P. Mechanical thrombectomy in patients with acute ischemic stroke on anticoagulation therapy. Cardiovasc Intervent Radiol. 2018;41:706–711. doi: 10.1007/s00270-018-1902-7.
    1. Goyal M, Demchuk AM, Menon BK, Eesa M, Rempel JL, Thornton J, Roy D, Jovin TG, Willinsky RA, Sapkota BL, Dowlatshahi D, Frei DF, Kamal NR, Montanera WJ, Poppe AY, Ryckborst KJ, Silver FL, Shuaib A, Tampieri D, Williams D, Bang OY, Baxter BW, Burns PA, Choe H, Heo JH, Holmstedt CA, Jankowitz B, Kelly M, Linares G, Mandzia JL, Shankar J, Sohn SI, Swartz RH, Barber PA, Coutts SB, Smith EE, Morrish WF, Weill A, Subramaniam S, Mitha AP, Wong JH, Lowerison MW, Sajobi TT, Hill MD, Investigators ET Randomized assessment of rapid endovascular treatment of ischemic stroke. N Engl J Med. 2015;372:1019–1030. doi: 10.1056/NEJMoa1414905.
    1. Hacke W, Kaste M, Fieschi C, von Kummer R, Davalos A, Meier D, Larrue V, Bluhmki E, Davis S, Donnan G, Schneider D, Diez-Tejedor E, Trouillas P. Randomised double-blind placebo-controlled trial of thrombolytic therapy with intravenous alteplase in acute ischaemic stroke (ECASS II). Second European-Australasian Acute Stroke Study Investigators. Lancet. 1998;352:1245–1251. doi: 10.1016/S0140-6736(98)08020-9.
    1. Jovin TG, Chamorro A, Cobo E, de Miquel MA, Molina CA, Rovira A, San Roman L, Serena J, Abilleira S, Ribo M, Millan M, Urra X, Cardona P, Lopez-Cancio E, Tomasello A, Castano C, Blasco J, Aja L, Dorado L, Quesada H, Rubiera M, Hernandez-Perez M, Goyal M, Demchuk AM, von Kummer R, Gallofre M, Davalos A, Investigators RT Thrombectomy within 8 hours after symptom onset in ischemic stroke. N Engl J Med. 2015;372:2296–2306. doi: 10.1056/NEJMoa1503780.
    1. Krajickova D, Krajina A, Herzig R, Vitkova E, Haluskova S, Vysata O, Cabelkova P, Valis M. Safety and efficacy of mechanical thrombectomy with stent-retrievers in anticoagulated patients with anterior circulation stroke. Clin Radiol. 2019;74:165111–165116. doi: 10.1016/j.crad.2018.10.009.
    1. Kurowski D, Jonczak K, Shah Q, Yaghi S, Marshall RS, Ahmad H, McKinney J, Torres J, Ishida K, Cucchiara B. Safety of endovascular intervention for stroke on therapeutic anticoagulation: multicenter cohort study and meta-analysis. J Stroke Cerebrovasc Dis. 2017;26:1104–1109. doi: 10.1016/j.jstrokecerebrovasdis.2016.12.027.
    1. L'Allinec V, Ernst M, Sevin-Allouet M, Testard N, Delasalle-Guyomarch B, Guillon B, Mazighi M, Desal H, Bourcier R, Investigators NTF Safety and efficacy of mechanical thrombectomy in acute ischemic stroke of anticoagulated patients. J Neurointerv Surg. 2018;10:e29. doi: 10.1136/neurintsurg-2017-013714.
    1. L'Allinec V, Sibon I, Mazighi M, Labreuche J, Kyheng M, Boissier E, Roy M, Gory B, Dargazanli C, Desal H, Lapergue B, Bourcier R, Treatment E, Endovascular Treatment in Ischemic Stroke I MT in anticoagulated patients: direct oral anticoagulants versus vitamin K antagonists. Neurology. 2020;94:e842–e850. doi: 10.1212/WNL.0000000000008873.
    1. Meinel TR, Kniepert JU, Seiffge DJ, Gralla J, Jung S, Auer E, Frey S, Goeldlin M, Mordasini P, Mosimann PJ, Nogueira RG, Haussen DC, Rodrigues GM, Uphaus T, L'Allinec V, Krajickova D, Alonso A, Costalat V, Hajdu SD, Olive-Gadea M, Maegerlein C, Pierot L, Schaafsma J, Suzuki K, Arnold M, Heldner MR, Fischer U, Kaesmacher J. Endovascular stroke treatment and risk of intracranial hemorrhage in anticoagulated patients. Stroke. 2020;51:892–898. doi: 10.1161/STROKEAHA.119.026606.
    1. Mundiyanapurath S, Tillmann A, Mohlenbruch MA, Bendszus M, Ringleb PA. Endovascular stroke therapy may be safe in patients with elevated international normalized ratio. J Neurointerv Surg. 2017;9:1187–1190. doi: 10.1136/neurintsurg-2016-012757.
    1. Purrucker JC, Wolf M, Haas K, Rizos T, Khan S, Dziewas R, Kleinschnitz C, Binder A, Groschel K, Hennerici MG, Lobotesis K, Poli S, Seidel G, Neumann-Haefelin T, Ringleb PA, Heuschmann PU, Veltkamp R. Safety of endovascular thrombectomy in patients receiving non-vitamin K antagonist oral anticoagulants. Stroke. 2016;47:1127–1130. doi: 10.1161/STROKEAHA.116.012684.
    1. Rebello LC, Haussen DC, Belagaje S, Anderson A, Frankel M, Nogueira RG. Endovascular treatment for acute ischemic stroke in the setting of anticoagulation. Stroke. 2015;46:3536–3539. doi: 10.1161/STROKEAHA.115.011285.
    1. Rozeman AD, Wermer MJ, Lycklama a Nijeholt GJ, Dippel DW, Schonewille WJ, Boiten J, Algra A, group MCp-ts Safety of intra-arterial treatment in acute ischaemic stroke patients on oral anticoagulants. A cohort study and systematic review. Eur J Neurol. 2016;23:290–296. doi: 10.1111/ene.12734.
    1. Saver JL, Goyal M, Bonafe A, Diener HC, Levy EI, Pereira VM, Albers GW, Cognard C, Cohen DJ, Hacke W, Jansen O, Jovin TG, Mattle HP, Nogueira RG, Siddiqui AH, Yavagal DR, Baxter BW, Devlin TG, Lopes DK, Reddy VK, du Mesnil de Rochemont R, Singer OC, Jahan R, Investigators SP Stent-retriever thrombectomy after intravenous t-PA vs. t-PA alone in stroke. N Engl J Med. 2015;372:2285–2295. doi: 10.1056/NEJMoa1415061.
    1. Uphaus T, Singer OC, Berkefeld J, Nolte CH, Bohner G, Niederkorn K, Deutschmann H, Haring HP, Trenkler J, Neumann-Haefelin T, Hofmann E, Stoll A, Bormann A, Bussmeyer M, Mpotsaris A, Reich A, Wiesmann M, Petzold GC, Urbach H, Jander S, Turowski B, Weimar C, Schlamann M, Liebeskind DS, Groschel S, Boor S, Groschel K. Safety of endovascular treatment in acute stroke patients taking oral anticoagulants. Int J Stroke. 2017;12:412–415. doi: 10.1177/1747493016677986.
    1. Wollenweber FA, Tiedt S, Alegiani A, Alber B, Bangard C, Berrouschot J, Bode FJ, Boeckh-Behrens T, Bohner G, Bormann A, Braun M, Dorn F, Eckert B, Flottmann F, Hamann GF, Henn KH, Herzberg M, Kastrup A, Kellert L, Kraemer C, Krause L, Lehm M, Liman J, Lowens S, Mpotsaris A, Papanagiotou P, Petersen M, Petzold GC, Pfeilschifter W, Psychogios MN, Reich A, von Rennenberg R, Rother J, Schafer JH, Siebert E, Siedow A, Solymosi L, Thonke S, Wagner M, Wunderlich S, Zweynert S, Nolte CH, Gerloff C, Thomalla G, Dichgans M, Fiehler J. Functional outcome following stroke thrombectomy in clinical practice. Stroke. 2019;50:2500–2506. doi: 10.1161/STROKEAHA.119.026005.
    1. Wong JWP, Churilov L, Dowling R, Mitchell P, Bush S, Kanesan L, Yan B. Safety of endovascular thrombectomy for acute ischaemic stroke in anticoagulated patients ineligible for intravenous thrombolysis. Cerebrovasc Dis. 2018;46:193–199. doi: 10.1159/000493801.
    1. Zapata-Wainberg G, Ximenez-Carrillo A, Trillo S, Fuentes B, Cruz-Culebras A, Aguirre C, Alonso de Lecinana M, Vera R, Barcena E, Fernandez-Prieto A, Mendez-Cendon JC, Caniego JL, Diez-Tejedor E, Masjuan J, Vivancos J, Madrid Stroke N. Mechanical thrombectomy in orally anticoagulated patients with acute ischemic stroke. J Neurointerv Surg. 2018;10:834–838. doi: 10.1136/neurintsurg-2017-013504.

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