Treatment in patients who are not eligible for intravenous alteplase: MR CLEAN subgroup analysis

Maxim Jhl Mulder; Olvert A. Berkhemer; Puck Ss Fransen; Debbie Beumer; Lucie A. van den Berg; Hester F. Lingsma; Yvo Bwem Roos; Robert J. van Oostenbrugge; Wim H. van Zwam; Charles Blm Majoie; Aad van der Lugt; Diederik Wj Dippel

doi:https://doi.org/10.1177/1747493016641969

Treatment in patients who are not eligible for intravenous alteplase: MR CLEAN subgroup analysis

Maxim Jhl Mulder, Olvert A. Berkhemer, Puck Ss Fransen, Debbie Beumer, Lucie A. van den Berg, Hester F. Lingsma, Yvo Bwem Roos, Robert J. van Oostenbrugge, Wim H. van Zwam, Charles Blm Majoie, Aad van der Lugt, Diederik Wj Dippel

Research output: Contribution to journal › Article › Academic › peer-review

26 Citations (Scopus)

Abstract

Patients with acute ischemic stroke due to intracranial large vessel occlusion benefit from intra-arterial therapy. Uncertainty exists about the effect of intra-arterial therapy in patients with contraindications for treatment with intravenous alteplase treatment. Our aim was to describe the clinical characteristics of this subgroup of patients and whether intra-arterial therapy is as safe and effective as it is after intravenous alteplase treatment. All 500 MR CLEAN patients were included and we distinguished between patients who were and were not treated with intravenous alteplase treatment. We estimated the effect of intra-arterial therapy on the shift on the modified Rankin Scale score with ordinal logistic regression analysis and tested for interaction of intravenous alteplase treatment with intra-arterial therapy on outcome. Furthermore, safety parameters and serious adverse events were analyzed. Fifty-five patients (11%) were not treated with intravenous alteplase treatment, mostly because of prolonged coagulation time tests or recent surgery. These patients were older and more often had atrial fibrillation or other vascular comorbidity. There was no interaction between intravenous alteplase treatment and intervention effect (p = 0.927). Intra-arterial therapy effect size in patients without intravenous alteplase treatment was 2.06 [95% CI: 0.69-6.13] and in patients with intravenous alteplase treatment 1.71 [95% CI: 1.22-2.40]. There were no safety issues. For patients with acute ischemic anterior circulation stroke caused by intracranial large vessel occlusion, who have contraindications for intravenous alteplase, intra-arterial treatment is not less effective or less safe than in patients who receive the treatment after intravenous alteplase. Clinical trial registration-URL: http://www.trialregister.nl. Unique identifier: (NTR)1804.Clinical trial registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758

Original language	English
Pages (from-to)	637-645
Journal	International journal of stroke
Volume	11
Issue number	6
DOIs	https://doi.org/10.1177/1747493016641969
Publication status	Published - 2016

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Mulder, M. J., Berkhemer, O. A., Fransen, P. S., Beumer, D., van den Berg, L. A., Lingsma, H. F., Roos, Y. B., van Oostenbrugge, R. J., van Zwam, W. H., Majoie, C. B., van der Lugt, A., & Dippel, D. W. (2016). Treatment in patients who are not eligible for intravenous alteplase: MR CLEAN subgroup analysis. International journal of stroke, 11(6), 637-645. https://doi.org/10.1177/1747493016641969

@article{b1fc2758e609454e9db7862fa8450991,

title = "Treatment in patients who are not eligible for intravenous alteplase: MR CLEAN subgroup analysis",

abstract = "Patients with acute ischemic stroke due to intracranial large vessel occlusion benefit from intra-arterial therapy. Uncertainty exists about the effect of intra-arterial therapy in patients with contraindications for treatment with intravenous alteplase treatment. Our aim was to describe the clinical characteristics of this subgroup of patients and whether intra-arterial therapy is as safe and effective as it is after intravenous alteplase treatment. All 500 MR CLEAN patients were included and we distinguished between patients who were and were not treated with intravenous alteplase treatment. We estimated the effect of intra-arterial therapy on the shift on the modified Rankin Scale score with ordinal logistic regression analysis and tested for interaction of intravenous alteplase treatment with intra-arterial therapy on outcome. Furthermore, safety parameters and serious adverse events were analyzed. Fifty-five patients (11%) were not treated with intravenous alteplase treatment, mostly because of prolonged coagulation time tests or recent surgery. These patients were older and more often had atrial fibrillation or other vascular comorbidity. There was no interaction between intravenous alteplase treatment and intervention effect (p = 0.927). Intra-arterial therapy effect size in patients without intravenous alteplase treatment was 2.06 [95% CI: 0.69-6.13] and in patients with intravenous alteplase treatment 1.71 [95% CI: 1.22-2.40]. There were no safety issues. For patients with acute ischemic anterior circulation stroke caused by intracranial large vessel occlusion, who have contraindications for intravenous alteplase, intra-arterial treatment is not less effective or less safe than in patients who receive the treatment after intravenous alteplase. Clinical trial registration-URL: http://www.trialregister.nl. Unique identifier: (NTR)1804.Clinical trial registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758",

author = "Mulder, {Maxim Jhl} and Berkhemer, {Olvert A.} and Fransen, {Puck Ss} and Debbie Beumer and {van den Berg}, {Lucie A.} and Lingsma, {Hester F.} and Roos, {Yvo Bwem} and {van Oostenbrugge}, {Robert J.} and {van Zwam}, {Wim H.} and Majoie, {Charles Blm} and {van der Lugt}, Aad and Dippel, {Diederik Wj}",

year = "2016",

doi = "https://doi.org/10.1177/1747493016641969",

language = "English",

volume = "11",

pages = "637--645",

journal = "International journal of stroke",

issn = "1747-4930",

publisher = "Wiley-Blackwell",

number = "6",

}

Mulder, MJ, Berkhemer, OA, Fransen, PS, Beumer, D, van den Berg, LA, Lingsma, HF, Roos, YB, van Oostenbrugge, RJ, van Zwam, WH, Majoie, CB, van der Lugt, A & Dippel, DW 2016, 'Treatment in patients who are not eligible for intravenous alteplase: MR CLEAN subgroup analysis', International journal of stroke, vol. 11, no. 6, pp. 637-645. https://doi.org/10.1177/1747493016641969

TY - JOUR

T1 - Treatment in patients who are not eligible for intravenous alteplase: MR CLEAN subgroup analysis

AU - Mulder, Maxim Jhl

AU - Berkhemer, Olvert A.

AU - Fransen, Puck Ss

AU - Beumer, Debbie

AU - van den Berg, Lucie A.

AU - Lingsma, Hester F.

AU - Roos, Yvo Bwem

AU - van Oostenbrugge, Robert J.

AU - van Zwam, Wim H.

AU - Majoie, Charles Blm

AU - van der Lugt, Aad

AU - Dippel, Diederik Wj

PY - 2016

Y1 - 2016

N2 - Patients with acute ischemic stroke due to intracranial large vessel occlusion benefit from intra-arterial therapy. Uncertainty exists about the effect of intra-arterial therapy in patients with contraindications for treatment with intravenous alteplase treatment. Our aim was to describe the clinical characteristics of this subgroup of patients and whether intra-arterial therapy is as safe and effective as it is after intravenous alteplase treatment. All 500 MR CLEAN patients were included and we distinguished between patients who were and were not treated with intravenous alteplase treatment. We estimated the effect of intra-arterial therapy on the shift on the modified Rankin Scale score with ordinal logistic regression analysis and tested for interaction of intravenous alteplase treatment with intra-arterial therapy on outcome. Furthermore, safety parameters and serious adverse events were analyzed. Fifty-five patients (11%) were not treated with intravenous alteplase treatment, mostly because of prolonged coagulation time tests or recent surgery. These patients were older and more often had atrial fibrillation or other vascular comorbidity. There was no interaction between intravenous alteplase treatment and intervention effect (p = 0.927). Intra-arterial therapy effect size in patients without intravenous alteplase treatment was 2.06 [95% CI: 0.69-6.13] and in patients with intravenous alteplase treatment 1.71 [95% CI: 1.22-2.40]. There were no safety issues. For patients with acute ischemic anterior circulation stroke caused by intracranial large vessel occlusion, who have contraindications for intravenous alteplase, intra-arterial treatment is not less effective or less safe than in patients who receive the treatment after intravenous alteplase. Clinical trial registration-URL: http://www.trialregister.nl. Unique identifier: (NTR)1804.Clinical trial registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758

AB - Patients with acute ischemic stroke due to intracranial large vessel occlusion benefit from intra-arterial therapy. Uncertainty exists about the effect of intra-arterial therapy in patients with contraindications for treatment with intravenous alteplase treatment. Our aim was to describe the clinical characteristics of this subgroup of patients and whether intra-arterial therapy is as safe and effective as it is after intravenous alteplase treatment. All 500 MR CLEAN patients were included and we distinguished between patients who were and were not treated with intravenous alteplase treatment. We estimated the effect of intra-arterial therapy on the shift on the modified Rankin Scale score with ordinal logistic regression analysis and tested for interaction of intravenous alteplase treatment with intra-arterial therapy on outcome. Furthermore, safety parameters and serious adverse events were analyzed. Fifty-five patients (11%) were not treated with intravenous alteplase treatment, mostly because of prolonged coagulation time tests or recent surgery. These patients were older and more often had atrial fibrillation or other vascular comorbidity. There was no interaction between intravenous alteplase treatment and intervention effect (p = 0.927). Intra-arterial therapy effect size in patients without intravenous alteplase treatment was 2.06 [95% CI: 0.69-6.13] and in patients with intravenous alteplase treatment 1.71 [95% CI: 1.22-2.40]. There were no safety issues. For patients with acute ischemic anterior circulation stroke caused by intracranial large vessel occlusion, who have contraindications for intravenous alteplase, intra-arterial treatment is not less effective or less safe than in patients who receive the treatment after intravenous alteplase. Clinical trial registration-URL: http://www.trialregister.nl. Unique identifier: (NTR)1804.Clinical trial registration-URL: http://www.controlled-trials.com. Unique identifier: ISRCTN10888758

U2 - https://doi.org/10.1177/1747493016641969

DO - https://doi.org/10.1177/1747493016641969

M3 - Article

C2 - 27048692

SN - 1747-4930

VL - 11

SP - 637

EP - 645

JO - International journal of stroke

JF - International journal of stroke

IS - 6

ER -