Balloon Guide Catheter in Endovascular Treatment for Acute Ischemic Stroke: Results from the MR CLEAN Registry

Introduction: Outcomes after endovascular treatment (EVT) for acute ischemic stroke are highly time dependent, but whether active reduction of time to treatment leads to better outcome has not been demonstrated. We compared data of the two subsequent MR CLEAN Registry cohorts, comprising all patients in the Netherlands who had EVT for acute ischemic stroke from 2014-2017, for a trend in time to treatment and its association with outcome. Methods: We compared workflow, successful reperfusion (eTICI 2B-3), NIHSS at 24h, functional outcome (mRS) at 90 days, occurrence of symptomatic intracranial hemorrhage (sICH) and mortality in patients with ischemic stroke and a proximal intracranial occlusion in the anterior circulation included in the second cohort of the Registry (June 2016-November 2017; n = 1779) to those in patients included in the first cohort (March 2014-June 2016; n = 1526) using logistic regression. Results: Baseline NIHSS was 16 in both cohorts. Times from onset-to-groin and onset-to-reperfusion were shorter in the second cohort than in the first (185 versus 210 minutes; p<0.01 and 238 versus 270 minutes; p<0.01, respectively) (Figure 1). Successful reperfusion was achieved more often in the second than in the first cohort (72% versus 58%; p<0.01). Rates of sICH and mortality did not differ (5.9% versus 5.7%; p=0.94 and 29% versus 29%; p=0.60). However, follow-up NIHSS was lower (median 10 versus 11; p<0.001) and more patients achieved functional independence at 90 days (42.6% versus 38.9%; p = 0.012) in the second cohort (Figure 1). In a logistic regression model, the difference in good outcome between the two cohorts (aOR 1.27; 95%CI 1.08-1.50) was reduced after additional adjustment for time to reperfusion (aOR 1.15; 95%CI 0.96-1.36) as well as successful reperfusion (aOR 1.16; 95%CI 0.95-1.41). Discussion: Our data show that outcomes after EVT in routine clinical practice are improving, likely attributable to improved workflow and experience.

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Response by Mulder et al to Letter Regarding Article, “Baseline Blood Pressure Effect on the Benefit and Safety of Intra-Arterial Treatment in MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment of Acute Ischemic Stroke in the Netherlands)”

Stroke ◽

10.1161/strokeaha.117.017996 ◽

2017 ◽

Vol 48 (8) ◽

Cited By ~ 2

Author(s):

Maxim J.H.L. Mulder ◽

Hester F. Lingsma ◽

Diederik W.J. Dippel

Keyword(s):

Blood Pressure ◽

Clinical Trial ◽

Ischemic Stroke ◽

The Netherlands ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Randomized Clinical Trial ◽

Pressure Effect ◽

Baseline Blood Pressure ◽

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Clinical and Imaging Determinants of Collateral Status in Patients With Acute Ischemic Stroke in MR CLEAN Trial and Registry

Stroke ◽

10.1161/strokeaha.119.027483 ◽

2020 ◽

Vol 51 (5) ◽

pp. 1493-1502

Author(s):

Eveline J.A. Wiegers ◽

Maxim J.H.L. Mulder ◽

Ivo G.H. Jansen ◽

Esmee Venema ◽

Kars C.J. Compagne ◽

...

Keyword(s):

Computed Tomography ◽

Ischemic Stroke ◽

Carotid Artery ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Computed Tomography Angiography ◽

Odds Ratio ◽

Internal Carotid ◽

Common Odds Ratio ◽

Mr Clean

Background and Purpose— Collateral circulation status at baseline is associated with functional outcome after ischemic stroke and effect of endovascular treatment. We aimed to identify clinical and imaging determinants that are associated with collateral grade on baseline computed tomography angiography in patients with acute ischemic stroke due to an anterior circulation large vessel occlusion. Methods— Patients included in the MR CLEAN trial (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; n=500) and MR CLEAN Registry (n=1488) were studied. Collateral status on baseline computed tomography angiography was scored from 0 (absent) to 3 (good). Multivariable ordinal logistic regression analyses were used to test the association of selected determinants with collateral status. Results— In total, 1988 patients were analyzed. Distribution of the collateral status was as follows: absent (7%, n=123), poor (32%, n=596), moderate (39%, n=735), and good (23%, n=422). Associations for a poor collateral status in a multivariable model existed for age (adjusted common odds ratio, 0.92 per 10 years [95% CI, 0.886–0.98]), male (adjusted common odds ratio, 0.64 [95% CI, 0.53–0.76]), blood glucose level (adjusted common odds ratio, 0.97 [95% CI, 0.95–1.00]), and occlusion of the intracranial segment of the internal carotid artery with occlusion of the terminus (adjusted common odds ratio 0.50 [95% CI, 0.41–0.61]). In contrast to previous studies, we did not find an association between cardiovascular risk factors and collateral status. Conclusions— Older age, male sex, high glucose levels, and intracranial internal carotid artery with occlusion of the terminus occlusions are associated with poor computed tomography angiography collateral grades in patients with acute ischemic stroke eligible for endovascular treatment.

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MR CLEAN, a multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke in the Netherlands: study protocol for a randomized controlled trial

Trials ◽

10.1186/1745-6215-15-343 ◽

2014 ◽

Vol 15 (1) ◽

Cited By ~ 133

Author(s):

Puck SS Fransen ◽

◽

Debbie Beumer ◽

Olvert A Berkhemer ◽

Lucie A van den Berg ◽

...

Keyword(s):

Clinical Trial ◽

Randomized Controlled Trial ◽

Ischemic Stroke ◽

The Netherlands ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Randomized Clinical Trial ◽

Controlled Trial ◽

Randomized Controlled ◽

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Endovascular treatment for calcified cerebral emboli in patients with acute ischemic stroke

Journal of Neurosurgery ◽

10.3171/2020.9.jns201798 ◽

2021 ◽

pp. 1-11

Author(s):

Agnetha A. E. Bruggeman ◽

Manon Kappelhof ◽

Nerea Arrarte Terreros ◽

Manon L. Tolhuisen ◽

Praneeta R. Konduri ◽

...

Keyword(s):

Ischemic Stroke ◽

The Netherlands ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Functional Outcome ◽

Functional Independence ◽

First Line ◽

Multicenter Randomized Controlled Trial ◽

Intravenous Alteplase ◽

Mr Clean

OBJECTIVE Calcified cerebral emboli (CCE) are a rare cause of acute ischemic stroke. The authors aimed to assess the association of CCE with functional outcome, successful reperfusion, and mortality. Furthermore, they aimed to assess the effectiveness of intravenous alteplase treatment and endovascular treatment (EVT), as well as the best first-line EVT approach in patients with CCE. METHODS The Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry is a prospective, observational multicenter registry of patients treated with EVT for acute ischemic stroke in 16 intervention hospitals in the Netherlands. The association of CCE with functional outcome, reperfusion, and mortality was evaluated using logistic regression models. Univariable comparisons were made to determine the effectiveness of intravenous alteplase treatment and the best first-line EVT approach in CCE patients. RESULTS The study included 3077 patients from the MR CLEAN Registry. Fifty-five patients (1.8%) had CCE. CCE were not significantly associated with worse functional outcome (adjusted common OR 0.71, 95% CI 0.44–1.15), and 29% of CCE patients achieved functional independence. An extended Thrombolysis in Cerebral Infarction score ≥ 2B was significantly less often achieved in CCE patients compared to non-CCE patients (adjusted OR [aOR] 0.52, 95% CI 0.28–0.97). Symptomatic intracranial hemorrhage occurred in 8 CCE patients (15%) vs 171 of 3022 non-CCE patients (6%; p = 0.01). The median improvement on the National Institutes of Health Stroke Scale (NIHSS) was 2 in CCE patients versus 4 in non-CCE patients (p = 0.008). CCE were not significantly associated with mortality (aOR 1.16, 95% CI 0.64–2.12). Intravenous alteplase use in CCE patients was not associated with functional outcome or reperfusion. In CCE patients with successful reperfusion, stent retrievers were more often used as the primary treatment device (p = 0.04). CONCLUSIONS While patients with CCE had significantly lower reperfusion rates and less improvement on the NIHSS after EVT, CCE were not significantly associated with worse functional outcome or higher mortality rates. Therefore, EVT should still be considered in this specific group of patients.

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Multicenter randomized clinical trial of endovascular treatment for acute ischemic stroke. The effect of periprocedural medication: acetylsalicylic acid, unfractionated heparin, both, or neither (MR CLEAN-MED). Rationale and study design

Trials ◽

10.1186/s13063-020-04514-9 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Vicky Chalos ◽

◽

Rob A. van de Graaf ◽

Bob Roozenbeek ◽

Adriaan C. G. M. van Es ◽

...

Keyword(s):

Clinical Trial ◽

Ischemic Stroke ◽

Acetylsalicylic Acid ◽

Endovascular Treatment ◽

Unfractionated Heparin ◽

Acute Ischemic Stroke ◽

Randomized Clinical Trial ◽

Study Design ◽

Mr Clean

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Combined Effect of Age and Baseline Alberta Stroke Program Early Computed Tomography Score on Post-Thrombectomy Clinical Outcomes in the MR CLEAN Registry

Stroke ◽

10.1161/strokeaha.120.031773 ◽

2020 ◽

Vol 51 (12) ◽

pp. 3742-3745

Author(s):

Johanna Ospel ◽

Manon Kappelhof ◽

Adrien E. Groot ◽

Natalie E. LeCouffe ◽

Jonathan M. Coutinho ◽

...

Keyword(s):

Ischemic Stroke ◽

Endovascular Treatment ◽

Acute Ischemic Stroke ◽

Functional Outcome ◽

Odds Ratio ◽

Modified Rankin Scale ◽

Common Odds Ratio ◽

Significant Difference ◽

Main Effect ◽

Mr Clean

Background and Purpose: Ischemic brain tissue damage in patients with acute ischemic stroke, as measured by the Alberta Stroke Program Early CT Score (ASPECTS) may be more impactful in older than in younger patients, although this has not been studied. We aimed to investigate a possible interaction effect between age and ASPECTS on functional outcome in acute ischemic stroke patients undergoing endovascular treatment, and compared reperfusion benefit across age and ASPECTS subgroups. Methods: Patients with ischemic stroke from the MR CLEAN Registry (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands; March 2014–November 2017) were included. Multivariable ordinal logistic regression was performed to obtain effect size estimates (adjusted common odds ratio) on functional outcome (modified Rankin Scale score) for continuous age and granular ASPECTS, with a 2-way multiplicative interaction term (age×ASPECTS). Outcomes in four patient subgroups based on age (< versus ≥ median age [71.8 years]) and baseline ASPECTS (6–10 versus 0–5) were assessed. Results: We included 3279 patients. There was no interaction between age and ASPECTS on modified Rankin Scale ( P =0.925). The highest proportion of modified Rankin Scale 5 to 6 was observed in patients >71.8 years with baseline ASPECTS 0 to 5 (68/107, 63.6%). There was benefit of reperfusion in all age-ASPECTS subgroups. Although the adjusted common odds ratio was lower in patients >71.8 years with ASPECTS 0 to 5 (adjusted common odds ratio, 1.60 [95% CI, 0.66–3.88], n=110), there was no significant difference from the main effect ( P =0.299). Conclusions: Although the proportion of poor outcomes following endovascular treatment was highest in older patients with low baseline ASPECTS, outcomes did not significantly differ from the main effect. These results do not support withholding endovascular treatment based n a combination of high age and low ASPECTS.

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