13 results on '"Roosendaal, Stefan"'
Search Results
2. Type of intracranial hemorrhage after endovascular stroke treatment: association with functional outcome.
- Author
-
van der Steen W, van der Ende NAM, Luijten SPR, Rinkel LA, van Kranendonk KR, van Voorst H, Roosendaal SD, Beenen LFM, Coutinho JM, Emmer BJ, van Oostenbrugge RJ, Majoie CBLM, Lingsma HF, van der Lugt A, Dippel DWJ, and Roozenbeek B
- Subjects
- Adult, Humans, Thrombectomy adverse effects, Treatment Outcome, Intracranial Hemorrhages etiology, Intracranial Hemorrhages complications, Brain Ischemia complications, Brain Ischemia diagnostic imaging, Brain Ischemia surgery, Stroke diagnostic imaging, Stroke surgery, Endovascular Procedures adverse effects
- Abstract
Background: Intracranial hemorrhage (ICH) is a frequent complication after endovascular stroke treatment., Objective: To assess the association of the occurrence and type of ICH after endovascular treatment (EVT) with functional outcome., Methods: We analyzed data from the MR CLEAN-NO IV and MR CLEAN-MED trials. Both trials included adult patients with ischemic stroke with a large vessel occlusion in the anterior circulation, who were eligible for EVT. ICH was classified (1) as asymptomatic or symptomatic (concomitant neurological deterioration of ≥4 points on the NIHSS, or ≥2 points on 1 NIHSS item), and (2) according to the Heidelberg Bleeding Classification. We used multivariable ordinal logistic regression analyses to assess the association of the occurrence and type of ICH with the modified Rankin Scale score at 90 days., Results: Of 1017 included patients, 331 (33%) had an asymptomatic ICH, and 90 (9%) had a symptomatic ICH. Compared with no ICH, both asymptomatic (adjusted common OR (acOR)=0.76; 95% CI 0.58 to 0.98) and symptomatic (acOR=0.07; 95% CI 0.04 to 0.14) ICH were associated with worse functional outcome. In particular, isolated parenchymal hematoma type 2 (acOR=0.37; 95% CI 0.14 to 0.95), combined parenchymal hematoma with hemorrhage outside infarcted brain tissue (acOR=0.17; 95% CI 0.10 to 0.30), and combined hemorrhages outside infarcted brain tissue (acOR=0.14; 95% CI 0.03 to 0.74) were associated with worse functional outcome than no ICH.Strength of the association of ICH with functional outcome depends on the type of ICH. Although the association is stronger for symptomatic ICH, asymptomatic ICH after EVT is also associated with worse functional outcome., Competing Interests: Competing interests: DWJD and AvdL report unrestricted grants from Stryker, Penumbra, Medtronic, Cerenovus, Thrombolytic Science, LLC, Dutch Heart Foundation, Brain Foundation Netherlands, The Netherlands Organization for Health Research and Development, Health Holland Top Sector Life Sciences & Health, and Thrombolytic Science, LLC for research, paid to the institution. BR reports funding from the Dutch Heart Foundation and the Netherlands Organisation of Health Research and Development, paid to the institution. BJE reports unrestricted grants from The Netherlands Organization for Health Research and Development, Health Holland Top Sector Life Sciences & Health, and Nicolab b.v. all paid to the institution. CM received funds from, CVON/Dutch Heart Foundation and Stryker, (related to this project, paid to institution) and from the European Commission, Healthcare Evaluation Netherlands TWIN Foundation (unrelated to this project; all paid to the institution) and is a shareholder of Nicolab., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY. Published by BMJ.)
- Published
- 2023
- Full Text
- View/download PDF
3. Safety and Efficacy of Dual Thrombolytic Therapy With Mutant Prourokinase and Small Bolus Alteplase for Ischemic Stroke: A Randomized Clinical Trial.
- Author
-
van der Ende NAM, Roozenbeek B, Smagge LEM, Luijten SPR, Aerden LAM, Kraayeveld P, van den Wijngaard IR, Lycklama À Nijeholt GJ, den Hertog HM, Flach HZ, Postma AA, Roosendaal SD, Krietemeijer GM, Yo LSF, de Maat MPM, Nieboer D, Del Zoppo GJ, Meurer WJ, Lingsma HF, van der Lugt A, and Dippel DWJ
- Subjects
- Adult, Humans, Male, Aged, Female, Tissue Plasminogen Activator adverse effects, Fibrinolytic Agents, Thrombolytic Therapy, Intracranial Hemorrhages chemically induced, Treatment Outcome, Ischemic Stroke drug therapy, Brain Ischemia diagnostic imaging, Brain Ischemia drug therapy, Stroke diagnostic imaging, Stroke drug therapy
- Abstract
Importance: Dual thrombolytic treatment with small bolus alteplase and mutant prourokinase has the potential to be a safer and more efficacious treatment for ischemic stroke than alteplase alone because mutant prourokinase is designed to act only on degraded fibrin without affecting circulating fibrinogen., Objective: To assess the safety and efficacy of this dual thrombolytic treatment compared with alteplase., Design, Setting, and Participants: This controlled, open-label randomized clinical trial with a blinded end point was conducted from August 10, 2019, to March 26, 2022, with a total follow-up of 30 days. Adult patients with ischemic stroke from 4 stroke centers in the Netherlands were enrolled., Interventions: Patients were randomized (1:1) to receive a bolus of 5 mg of intravenous alteplase and 40 mg of an intravenous infusion of mutant prourokinase (intervention) or usual care with 0.9 mg/kg of intravenous alteplase (control)., Main Outcomes and Measures: The primary outcome was any intracranial hemorrhage (ICH) on neuroimaging at 24 hours. Secondary outcomes included functional outcome at 30 days, symptomatic ICH, and fibrinogen levels within 24 hours. Analyses were by intention to treat. Treatment effects were adjusted for baseline prognostic factors., Results: A total of 268 patients were randomized, and 238 (median [IQR] age, 69 [59-77] years; 147 [61.8%] male) provided deferred consent and were included in the intention-to-treat population (121 in the intervention group and 117 in the control group). The median baseline score on the National Institutes of Health Stroke Scale was 3 (IQR, 2-5). Any ICH occurred in 16 of 121 patients (13.2%) in the intervention group and 16 of 117 patients (13.7%) in the control group (adjusted odds ratio, 0.98; 95% CI, 0.46-2.12). Mutant prourokinase led to a nonsignificant shift toward better modified Rankin Scale scores (adjusted common odds ratio, 1.16; 95% CI, 0.74-1.84). Symptomatic ICH occurred in none of the patients in the intervention group and 3 of 117 patients (2.6%) in the control group. Plasma fibrinogen levels at 1 hour remained constant in the intervention group but decreased in the control group (β = 65 mg/dL; 95% CI, 26-105 mg/dL)., Conclusions and Relevance: In this trial, dual thrombolytic treatment with small bolus alteplase and mutant prourokinase was found to be safe and did not result in fibrinogen depletion. Further evaluation of thrombolytic treatment with mutant prourokinase in larger trials to improve outcomes in patients with larger ischemic strokes is needed. Overall, in patients with minor ischemic stroke who met indications for treatment with intravenous thrombolytics but were not eligible for treatment with endovascular therapy, dual thrombolytic therapy with intravenous mutant prourokinase was not superior to treatment with intravenous alteplase alone., Trial Registration: ClinicalTrials.gov Identifier: NCT04256473.
- Published
- 2023
- Full Text
- View/download PDF
4. Endovascular treatment versus no endovascular treatment after 6-24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands: a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial.
- Author
-
Olthuis SGH, Pirson FAV, Pinckaers FME, Hinsenveld WH, Nieboer D, Ceulemans A, Knapen RRMM, Robbe MMQ, Berkhemer OA, van Walderveen MAA, Lycklama À Nijeholt GJ, Uyttenboogaart M, Schonewille WJ, van der Sluijs PM, Wolff L, van Voorst H, Postma AA, Roosendaal SD, van der Hoorn A, Emmer BJ, Krietemeijer MGM, van Doormaal PJ, Roozenbeek B, Goldhoorn RB, Staals J, de Ridder IR, van der Leij C, Coutinho JM, van der Worp HB, Lo RTH, Bokkers RPH, van Dijk EI, Boogaarts HD, Wermer MJH, van Es ACGM, van Tuijl JH, Kortman HGJ, Gons RAR, Yo LSF, Vos JA, de Laat KF, van Dijk LC, van den Wijngaard IR, Hofmeijer J, Martens JM, Brouwers PJAM, Bulut T, Remmers MJM, de Jong TEAM, den Hertog HM, van Hasselt BAAM, Rozeman AD, Elgersma OEH, van der Veen B, Sudiono DR, Lingsma HF, Roos YBWEM, Majoie CBLM, van der Lugt A, Dippel DWJ, van Zwam WH, and van Oostenbrugge RJ
- Subjects
- Female, Humans, Male, Computed Tomography Angiography, Netherlands, Intracranial Hemorrhages etiology, Treatment Outcome, Stroke therapy, Stroke drug therapy, Brain Ischemia diagnostic imaging, Brain Ischemia surgery, Ischemic Stroke complications
- Abstract
Background: Endovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA)., Methods: MR CLEAN-LATE was a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial done in 18 stroke intervention centres in the Netherlands. Patients aged 18 years or older with ischaemic stroke, presenting in the late window with an anterior circulation large-vessel occlusion and collateral flow on CTA, and a neurological deficit score of at least 2 on the National Institutes of Health Stroke Scale were included. Patients who were eligible for late-window endovascular treatment were treated according to national guidelines (based on clinical and perfusion imaging criteria derived from the DAWN and DEFUSE-3 trials) and excluded from MR CLEAN-LATE enrolment. Patients were randomly assigned (1:1) to receive endovascular treatment or no endovascular treatment (control), in addition to best medical treatment. Randomisation was web based, with block sizes ranging from eight to 20, and stratified by centre. The primary outcome was the modified Rankin Scale (mRS) score at 90 days after randomisation. Safety outcomes included all-cause mortality at 90 days after randomisation and symptomatic intracranial haemorrhage. All randomly assigned patients who provided deferred consent or died before consent could be obtained comprised the modified intention-to-treat population, in which the primary and safety outcomes were assessed. Analyses were adjusted for predefined confounders. Treatment effect was estimated with ordinal logistic regression and reported as an adjusted common odds ratio (OR) with a 95% CI. This trial was registered with the ISRCTN, ISRCTN19922220., Findings: Between Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly assigned, and 502 (94%) patients provided deferred consent or died before consent was obtained (255 in the endovascular treatment group and 247 in the control group; 261 [52%] females). The median mRS score at 90 days was lower in the endovascular treatment group than in the control group (3 [IQR 2-5] vs 4 [2-6]), and we observed a shift towards better outcomes on the mRS for the endovascular treatment group (adjusted common OR 1·67 [95% CI 1·20-2·32]). All-cause mortality did not differ significantly between groups (62 [24%] of 255 patients vs 74 [30%] of 247 patients; adjusted OR 0·72 [95% CI 0·44-1·18]). Symptomatic intracranial haemorrhage occurred more often in the endovascular treatment group than in the control group (17 [7%] vs four [2%]; adjusted OR 4·59 [95% CI 1·49-14·10])., Interpretation: In this study, endovascular treatment was efficacious and safe for patients with ischaemic stroke caused by an anterior circulation large-vessel occlusion who presented 6-24 h from onset or last seen well, and who were selected on the basis of the presence of collateral flow on CTA. Selection of patients for endovascular treatment in the late window could be primarily based on the presence of collateral flow., Funding: Collaboration for New Treatments of Acute Stroke consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Top Sector Life Sciences & Health, and the Netherlands Brain Foundation., Competing Interests: Declaration of interests RJvO and WHvZ report financial support for the current manuscript from the Collaboration for New Treatments of Acute Stroke (CONTRAST) consortium (which was financed for the current study by the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation, the Netherlands Brain Foundation, Stryker, Medtronic, and Cerenovus), all paid to their institution. WHvZ reports speaker fees from Stryker, Cerenovus, and Nicolab, and consulting fees from Philips, all paid to institution; participated in the advisory boards of WeTrust (Philips) and ANAIS (Anaconda), all paid to institution; and participated in the advisory boards of InEcxtremis (CHU Montpellier, Montpellier, France) and DISTAL (University Hospital Basel, Basel, Switzerland), studies for which no payments were received. AvdL reports financial support for this study by grants from the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation, the Netherlands Brain Foundation, Medtronic, and Cerenovus, all paid to institution; reports grants from Stryker, Thrombolytic Science, Penumbra, GE Healthcare, Philips Healthcare, and Siemens Healthineers, all paid to institution; reports payments from Siemens Healthineers, all paid to institution; participates in the advisory board of ESCAPE-MEVO; and is a research leader of the CONTRAST consortium. CBLMM reports grants from the Netherlands Cardiovascular Research Initiative, an initiative of the Dutch Heart Foundation, TWIN Foundation, European Commission, Healthcare Evaluation Netherlands, and Stryker (all paid to institution); and is a (minority interest) shareholder of Nicolab. MU reports research grants from the Dutch Heart Foundation, the Netherlands Organisation for Health Research and Development, and Belgian Health Care Knowledge Centre, all paid to institution; and support to attend the Stroke Symposium Johnson & Johnson 2022. BR reports being the chair of the Writing Committee of the Dutch Stroke Guideline. DWJD reports funding from the Dutch Heart Foundation, Netherlands Brain Foundation, the Netherlands Organisation for Health Research and Development, Health Holland Top Sector Life Sciences & Health, Penumbra, Stryker, Medtronic, Thrombolytic Science, and Cerenovus (all unrestricted grants for research), paid to institution. JMC reports receiving research support from Bayer, AstraZeneca, and Medtronic for research, all paid to institution; and is a co-founder and shareholder of TrianecT. HDB reports consulting fees from Stryker Neurovascular, all paid to institution. AAP reports institutional grants from Siemens Healthcare and Bayer Healthcare, paid to institution. BJE reports funding from the Netherlands Organisation for Health Research and Development and Health Holland Top Sector Life Sciences & Health, and unrestricted grants from Nicolab, all paid to institution. HBvdW reports research grants from the Dutch Heart Foundation, European Commission, and Stryker; consultancy fees from Bayer and TargED, all paid to institution; and stocks in Philips. RPHB reports research grants from the Netherlands Organisation for Health Research and Developmen and the Dutch Ministry of Economic Affairs and Climate Policy, an unrestricted grant from Siemens Healthineers, and consulting fees from Guerbet, all paid to institution. P-JvD reports consulting fees from Stryker and Philips, all paid to institution. YBWEMR reports being a minor shareholder of Nicolab. IRvdW reports consulting fees from Philips (paid to IRvdW) and is a stockholder and inventor of a patent owned by Neurophyxia. All other authors declare no competing interests., (Copyright © 2023 Elsevier Ltd. All rights reserved.)
- Published
- 2023
- Full Text
- View/download PDF
5. Validity of Early Outcomes as Indicators for Comparing Hospitals on Quality of Stroke Care.
- Author
-
Amini M, Eijkenaar F, Lingsma HF, den Hartog SJ, Olthuis SGH, Martens J, van der Worp B, van Zwam W, van der Hoorn A, Roosendaal SD, Roozenbeek B, Dippel D, and van Leeuwen N
- Subjects
- Humans, Prospective Studies, Cerebral Infarction etiology, Treatment Outcome, Thrombectomy adverse effects, Brain Ischemia therapy, Ischemic Stroke etiology, Stroke diagnosis, Stroke therapy, Stroke etiology, Endovascular Procedures adverse effects
- Abstract
Background Insight into outcome variation between hospitals could help to improve quality of care. We aimed to assess the validity of early outcomes as quality indicators for acute ischemic stroke care for patients treated with endovascular therapy (EVT). Methods and Results We used data from the MR CLEAN (Multicenter Randomized Controlled Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry, a large multicenter prospective cohort study including 3279 patients with acute ischemic stroke undergoing EVT. Random effect linear and proportional odds regression were used to analyze the effect of case mix on between-hospital differences in 2 early outcomes: the National Institutes of Health Stroke Scale (NIHSS) score at 24 to 48 hours and the expanded thrombolysis in cerebral infarction score. Between-hospital variation in outcomes was assessed using the variance of random hospital effects (tau
2 ). In addition, we estimated the correlation between hospitals' EVT-patient volume and (case-mix-adjusted) outcomes. Both early outcomes and case-mix characteristics varied significantly across hospitals. Between-hospital variation in the expanded thrombolysis in cerebral infarction score was not influenced by case-mix adjustment (tau2 =0.17 in both models). In contrast, for the NIHSS score at 24 to 48 hours, case-mix adjustment led to a decrease in variation between hospitals (tau2 decreases from 0.19 to 0.17). Hospitals' EVT-patient volume was strongly correlated with higher expanded thrombolysis in cerebral infarction scores ( r =0.48) and weakly with lower NIHSS score at 24 to 48 hours ( r =0.15). Conclusions Between-hospital variation in NIHSS score at 24 to 48 hours is significantly influenced by case-mix but not by patient volume. In contrast, between-hospital variation in expanded thrombolysis in cerebral infarction score is strongly influenced by EVT-patient volume but not by case-mix. Both outcomes may be suitable for comparing hospitals on quality of care, provided that adequate adjustment for case-mix is applied for NIHSS score.- Published
- 2023
- Full Text
- View/download PDF
6. Prognostic Value of Thrombus Volume and Interaction With First-Line Endovascular Treatment Device Choice.
- Author
-
van Voorst H, Bruggeman AAE, Andriessen J, Hoving JW, Konduri PR, Yang W, Kappelhof M, Arrarte Terreros N, Roos YBWEM, van Zwam WH, van der Lugt A, van der Hoorn A, Boiten J, Roosendaal S, Jenniskens S, Caan MWA, Marquering HA, Emmer BJ, and Majoie CBLM
- Subjects
- Humans, Prognosis, Thrombectomy methods, Retrospective Studies, Treatment Outcome, Stroke diagnostic imaging, Stroke surgery, Stroke complications, Ischemic Stroke complications, Thrombosis diagnostic imaging, Thrombosis surgery, Thrombosis complications, Endovascular Procedures methods, Brain Ischemia diagnostic imaging, Brain Ischemia surgery
- Abstract
Background: A larger thrombus in patients with acute ischemic stroke might result in more complex endovascular treatment procedures, resulting in poorer patient outcomes. Current evidence on thrombus volume and length related to procedural and functional outcomes remains contradicting. This study aimed to assess the prognostic value of thrombus volume and thrombus length and whether this relationship differs between first-line stent retrievers and aspiration devices for endovascular treatment., Methods: In this multicenter retrospective cohort study, 670 of 3279 patients from the MR CLEAN Registry (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) for endovascularly treated large vessel occlusions were included. Thrombus volume (0.1 mL) and length (0.1 mm) based on manual segmentations and measurements were related to reperfusion grade (expanded Treatment in Cerebral Infarction score) after endovascular treatment, the number of retrieval attempts, symptomatic intracranial hemorrhage, and a shift for functional outcome at 90 days measured with the reverted ordinal modified Rankin Scale (odds ratio >1 implies a favorable outcome). Univariable and multivariable linear and logistic regression were used to report common odds ratios (cORs)/adjusted cOR and regression coefficients (B/aB) with 95% CIs. Furthermore, a multiplicative interaction term was used to analyze the relationship between first-line device choice, stent retrievers versus aspiration device, thrombus volume, and outcomes., Results: Thrombus volume was associated with functional outcome (adjusted cOR, 0.83 [95% CI, 0.71-0.97]) and number of retrieval attempts (aB, 0.16 [95% CI, 0.16-0.28]) but not with the other outcome measures. Thrombus length was only associated with functional independence (adjusted cOR, 0.45 [95% CI, 0.24-0.85]). Patients with more voluminous thrombi had worse functional outcomes if endovascular treatment was based on first-line stent retrievers (interaction cOR, 0.67 [95% CI, 0.50-0.89]; P =0.005; adjusted cOR, 0.74 [95% CI, 0.55-1.0]; P =0.04)., Conclusions: In this study, patients with a more voluminous thrombus required more endovascular thrombus retrieval attempts and had a worse functional outcome. Patients with a lengthier thrombus were less likely to achieve functional independence at 90 days. For more voluminous thrombi, first-line stent retrieval compared with first-line aspiration might be associated with worse functional outcome.
- Published
- 2023
- Full Text
- View/download PDF
7. Author Response: Clinical Outcome After Endovascular Treatment in Patients With Active Cancer and Ischemic Stroke: A MR CLEAN Registry Substudy.
- Author
-
Verschoof MA, Groot AE, de Bruijn SFTM, Roozenbeek B, van der Worp HB, Dippel DWJ, Emmer BJ, Roosendaal SD, Majoie CBLM, Roos YBWM, and Coutinho JM
- Subjects
- Humans, Netherlands, Registries, Treatment Outcome, Brain Ischemia drug therapy, Brain Ischemia surgery, Endovascular Procedures adverse effects, Ischemic Stroke surgery, Neoplasms etiology, Stroke drug therapy, Stroke surgery
- Published
- 2022
- Full Text
- View/download PDF
8. Improvements in Endovascular Treatment for Acute Ischemic Stroke: A Longitudinal Study in the MR CLEAN Registry.
- Author
-
Compagne KCJ, Kappelhof M, Hinsenveld WH, Brouwer J, Goldhoorn RB, Uyttenboogaart M, Bokkers RPH, Schonewille WJ, Martens JM, Hofmeijer J, van der Worp HB, Lo RTH, Keizer K, Yo LSF, Lycklama À Nijeholt GJ, den Hertog HM, Sturm EJC, Brouwers PJAM, van Walderveen MAA, Wermer MJH, de Bruijn SF, van Dijk LC, Boogaarts HD, van Dijk EJ, van Tuijl JH, Peluso JPP, de Kort PLM, van Hasselt BAAM, Fransen PS, Schreuder THCML, Heijboer RJJ, Jenniskens SFM, Sprengers MES, Ghariq E, van den Wijngaard IR, Roosendaal SD, Meijer AFJA, Beenen LFM, Postma AA, van den Berg R, Yoo AJ, van Doormaal PJ, van Proosdij MP, Krietemeijer MGM, Gerrits DG, Hammer S, Vos JA, Boiten J, Coutinho JM, Emmer BJ, van Es ACGM, Roozenbeek B, Roos YBWEM, van Zwam WH, van Oostenbrugge RJ, Majoie CBLM, Dippel DWJ, and van der Lugt A
- Subjects
- Humans, Longitudinal Studies, Registries, Thrombectomy methods, Treatment Outcome, Brain Ischemia diagnostic imaging, Brain Ischemia surgery, Endovascular Procedures methods, Ischemic Stroke, Stroke diagnostic imaging, Stroke surgery
- Abstract
Background: We evaluated data from all patients in the Netherlands who underwent endovascular treatment for acute ischemic stroke in the past 3.5 years, to identify nationwide trends in time to treatment and procedural success, and assess their effect on clinical outcomes., Methods: We included patients with proximal occlusions of the anterior circulation from the second and first cohorts of the MR CLEAN (Multicenter Randomized Clinical trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands) Registry (March 2014 to June 2016; June 2016 to November 2017, respectively). We compared workflow times and rates of successful reperfusion (defined as an extended Thrombolysis in Cerebral Infarction score of 2B-3) between cohorts and chronological quartiles (all included patients stratified in chronological quartiles of intervention dates to create equally sized groups over the study period). Multivariable ordinal logistic regression was used to assess differences in the primary outcome (ordinal modified Rankin Scale at 90 days)., Results: Baseline characteristics were similar between cohorts (second cohort n=1692, first cohort n=1488) except for higher age, poorer collaterals, and less signs of early ischemia on computed tomography in the second cohort. Time from stroke onset to groin puncture and reperfusion were shorter in the second cohort (median 185 versus 210 minutes; P <0.001 and 236 versus 270 minutes; P <0.001, respectively). Successful reperfusion was achieved more often in the second than in the first cohort (72% versus 66%; P <0.001). Functional outcome significantly improved (adjusted common odds ratio 1.23 [95% CI, 1.07-1.40]). This effect was attenuated by adjustment for time from onset to reperfusion (adjusted common odds ratio, 1.12 [95% CI, 0.98-1.28]) and successful reperfusion (adjusted common odds ratio, 1.13 [95% CI, 0.99-1.30]). Outcomes were consistent in the analysis per chronological quartile., Conclusions: Clinical outcomes after endovascular treatment for acute ischemic stroke in routine clinical practice have improved over the past years, likely resulting from improved workflow times and higher successful reperfusion rates.
- Published
- 2022
- Full Text
- View/download PDF
9. Safety and efficacy of aspirin, unfractionated heparin, both, or neither during endovascular stroke treatment (MR CLEAN-MED): an open-label, multicentre, randomised controlled trial.
- Author
-
van der Steen W, van de Graaf RA, Chalos V, Lingsma HF, van Doormaal PJ, Coutinho JM, Emmer BJ, de Ridder I, van Zwam W, van der Worp HB, van der Schaaf I, Gons RAR, Yo LSF, Boiten J, van den Wijngaard I, Hofmeijer J, Martens J, Schonewille W, Vos JA, Tuladhar AM, de Laat KF, van Hasselt B, Remmers M, Vos D, Rozeman A, Elgersma O, Uyttenboogaart M, Bokkers RPH, van Tuijl J, Boukrab I, van den Berg R, Beenen LFM, Roosendaal SD, Postma AA, Krietemeijer M, Lycklama G, Meijer FJA, Hammer S, van der Hoorn A, Yoo AJ, Gerrits D, Truijman MTB, Zinkstok S, Koudstaal PJ, Manschot S, Kerkhoff H, Nieboer D, Berkhemer O, Wolff L, van der Sluijs PM, van Voorst H, Tolhuisen M, Roos YBWEM, Majoie CBLM, Staals J, van Oostenbrugge RJ, Jenniskens SFM, van Dijk LC, den Hertog HM, van Es ACGM, van der Lugt A, Dippel DWJ, and Roozenbeek B
- Subjects
- Adult, Aspirin therapeutic use, Heparin adverse effects, Humans, Magnetic Resonance Imaging, Treatment Outcome, Brain Ischemia therapy, Stroke etiology
- Abstract
Background: Aspirin and unfractionated heparin are often used during endovascular stroke treatment to improve reperfusion and outcomes. However, the effects and risks of anti-thrombotics for this indication are unknown. We therefore aimed to assess the safety and efficacy of intravenous aspirin, unfractionated heparin, both, or neither started during endovascular treatment in patients with ischaemic stroke., Methods: We did an open-label, multicentre, randomised controlled trial with a 2 × 3 factorial design in 15 centres in the Netherlands. We enrolled adult patients (ie, ≥18 years) with ischaemic stroke due to an intracranial large-vessel occlusion in the anterior circulation in whom endovascular treatment could be initiated within 6 h of symptom onset. Eligible patients had a score of 2 or more on the National Institutes of Health Stroke Scale, and a CT or MRI ruling out intracranial haemorrhage. Randomisation was done using a web-based procedure with permuted blocks and stratified by centre. Patients were randomly assigned (1:1) to receive either periprocedural intravenous aspirin (300 mg bolus) or no aspirin, and randomly assigned (1:1:1) to receive moderate-dose unfractionated heparin (5000 IU bolus followed by 1250 IU/h for 6 h), low-dose unfractionated heparin (5000 IU bolus followed by 500 IU/h for 6 h), or no unfractionated heparin. The primary outcome was the score on the modified Rankin Scale at 90 days. Symptomatic intracranial haemorrhage was the main safety outcome. Analyses were based on intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. This trial is registered with the International Standard Randomised Controlled Trial Number, ISRCTN76741621., Findings: Between Jan 22, 2018, and Jan 27, 2021, we randomly assigned 663 patients; of whom, 628 (95%) provided deferred consent or died before consent could be asked and were included in the modified intention-to-treat population. On Feb 4, 2021, after unblinding and analysis of the data, the trial steering committee permanently stopped patient recruitment and the trial was stopped for safety concerns. The risk of symptomatic intracranial haemorrhage was higher in patients allocated to receive aspirin than in those not receiving aspirin (43 [14%] of 310 vs 23 [7%] of 318; adjusted OR 1·95 [95% CI 1·13-3·35]) as well as in patients allocated to receive unfractionated heparin than in those not receiving unfractionated heparin (44 [13%] of 332 vs 22 [7%] of 296; 1·98 [1·14-3·46]). Both aspirin (adjusted common OR 0·91 [95% CI 0·69-1·21]) and unfractionated heparin (0·81 [0·61-1·08]) led to a non-significant shift towards worse modified Rankin Scale scores., Interpretation: Periprocedural intravenous aspirin and unfractionated heparin during endovascular stroke treatment are both associated with an increased risk of symptomatic intracranial haemorrhage without evidence for a beneficial effect on functional outcome., Funding: The Collaboration for New Treatments of Acute Stroke consortium, the Brain Foundation Netherlands, the Ministry of Economic Affairs, Stryker, Medtronic, Cerenovus, and the Dutch Heart Foundation., Competing Interests: Declaration of interests BR and DWJD report financial support for the current manuscript from the CONTRAST consortium, all paid to their institution. AvdL, BR, HBvdW, CBLMM, DWJD, and MU report funding from the Dutch Heart Foundation, all paid to their institution. AvdL and DWJD report funding from the Dutch Brain foundation paid to their institution. AvdL, BJE, DWJD, and MU report funding from Health Holland Top Sector Life Sciences & Health, all paid to their institution. AvdH, BJE, BR, DWJD, JAV, JMC, and RvdB report grants from the Netherlands Organisation for Health Research and Development, all paid to their institution. AvdL, AJY, HBvdW, CBLMM, and DWJD report funding from Stryker, all paid to their institution. AvdL, AJY, DWJD, and RPHB report funding from Cerenovus, all paid to their institution. AvdL, AJY, DWJD, and JMC report funding from Medtronic, all paid to their institution. AvdL, AJY, and DWJD report funding from Penumbra, all paid to their institution. AvdL and DWJD report funding from Thrombolytic Science paid to their institution. AJY, CBLMM and YBWEMR are minor shareholders of Nicolab. AJY reports funding from Genentech paid to his institution; consulting fees from Penumbra, Cerenovus, Philips, and Vesalio paid to himself; participates in an advisory board of Philips, Nicolab, XCath, and HCA; is part of the endovascular safety monitor of the NIH MOST trial; is an associate editor of the Stroke: Vascular and Interventional Neurology journal; and is a stock owner of Insera. AAP reports institutional grants from Siemens Healthineers and Bayer Healthcare. FJAM reports reimbursements for lectures for Speaker Bureau and Canon Medical Systems. AMT reports being a junior staff member of the Dutch Heart Foundation. BJE reports being a delegate of the Netherlands in the European Union of Medical Specialists Neuroradiology. HBvdW reports grants from the European Union, and participation in an advisory board of Bayer Healthcare and LivaNova, all paid to their institution. CBLMM received funds from the European Commission, TWIN foundation, and Health Evaluation Netherlands, all paid to their institution. JMC reports funding from the Dutch Thrombosis Society and the Dr CJ Vaillant Foundation; consulting fees from Bayer Healthcare, Boehringer, and Portola, all paid to their institution; a fellowship from the European Stroke Organisation; and is a member of the writing committee of the European Stroke Organisation guideline on cerebral venous thrombosis, both unpaid. WvZ reports consulting and speaker fees from Philips, Stryker, Cerenovus, and NicoLab, all paid to their institution; and participation in advisory boards of WeTrust (Philips), Solonda (Anaconda), and InExtremis (CHU Montpellier). All other authors declare no competing interests., (Copyright © 2022 Elsevier Ltd. All rights reserved.)
- Published
- 2022
- Full Text
- View/download PDF
10. Clinical Outcome After Endovascular Treatment in Patients With Active Cancer and Ischemic Stroke: A MR CLEAN Registry Substudy.
- Author
-
Verschoof MA, Groot AE, de Bruijn SFTM, Roozenbeek B, van der Worp HB, Dippel DWJ, Emmer BJ, Roosendaal SD, Majoie CBLM, Roos YBWEM, and Coutinho JM
- Subjects
- Humans, Registries, Thrombectomy adverse effects, Treatment Outcome, Brain Ischemia diagnosis, Brain Ischemia surgery, Endovascular Procedures adverse effects, Ischemic Stroke, Neoplasms complications, Stroke etiology, Stroke surgery
- Abstract
Background and Objectives: To explore clinical and safety outcomes of patients with acute ischemic stroke (AIS) and active cancer after endovascular treatment (EVT)., Methods: Using data from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry, we compared patients with active cancer (defined as cancer diagnosed within 12 months before stroke, metastatic disease, or current cancer treatment) to patients without cancer. Outcomes were 90-day modified Rankin Scale (mRS) score, mortality, successful reperfusion (expanded Treatment in Cerebral Infarction score ≥2b), symptomatic intracranial hemorrhage (sICH), and recurrent stroke. Subgroup analyses were performed in patients with a prestroke mRS score of 0 or 1 and according to treatment setting (curative or palliative). Analyses were adjusted for prognostic variables., Results: Of 2,583 patients who underwent EVT, 124 (4.8%) had active cancer. They more often had prestroke disability (mRS score ≥2: 34.1% vs 16.6%). The treatment setting was palliative in 25.3% of the patients. There was a shift toward worse functional outcome at 90 days in patients with active cancer (adjusted common odds ratio [acOR] 2.2, 95% confidence interval [CI] 1.5-3.2). At 90 days, patients with active cancer were less often independent (mRS score 0-2: 22.6% vs 42.0%, adjusted OR [aOR] 0.5, 95% CI 0.3-0.8) and more often dead (52.2% vs 26.5%, aOR 3.2, 95% CI 2.1-4.9). Successful reperfusion (67.8% vs 60.5%, aOR 1.4, 95% CI 1.0-2.1) and sICH rates (6.5% vs 5.9%, aOR 1.1, 95% CI 0.5-2.3) did not differ. Recurrent stroke within 90 days was more common in patients with active cancer (4.0% vs 1.3%, aOR 3.1, 95% CI 1.2-8.1). The sensitivity analysis of patients with a prestroke mRS score of 0 or 1 showed that patients with active cancer still had a worse outcome at 90 days (acOR 1.9, 95% CI 1.2-3.0). Patients with active cancer in a palliative treatment setting regained functional independence less often compared to patients in a curative setting (18.2% vs 32.1%), and mortality was higher (81.8% vs 39.3%)., Discussion: Despite similar technical success, patients with active cancer had significantly worse outcomes after EVT for AIS. Moreover, they had an increased risk of recurrent stroke. Nevertheless, about a quarter of the patients regained functional independence, and the risk of other complications, most notably sICH, was not increased., Classification of Evidence: This study provides Class I evidence that patients with active cancer undergoing EVT for AIS have worse functional outcomes at 90 days compared to those without active cancer., (© 2022 American Academy of Neurology.)
- Published
- 2022
- Full Text
- View/download PDF
11. Prediction of Outcome and Endovascular Treatment Benefit
- Author
-
Venema, Esmee, Roozenbeek, Bob, Mulder, Maxim JHL, Brown, Scott, Majoie, Charles BLM, Steyerberg, Ewout W, Demchuk, Andrew M, Muir, Keith W, Dávalos, Antoni, Mitchell, Peter J, Bracard, Serge, Berkhemer, Olvert A, Lycklama à Nijeholt, Geert J, van Oostenbrugge, Robert J, Roos, Yvo BWEM, van Zwam, Wim H, van der Lugt, Aad, Hill, Michael D, White, Philip, Campbell, Bruce CV, Guillemin, Francis, Saver, Jeffrey L, Jovin, Tudor G, Goyal, Mayank, Dippel, Diederik WJ, Lingsma, Hester F, der Lugt, Aad van, Boiten, Jelis, Vos, Jan Albert, Jansen, Ivo GH, Goldhoorn, Robert-Jan B, Compagne, Kars CJ, Kappelhof, Manon, Brouwer, Josje, den Hartog, Sanne J, Hinsenveld, Wouter H, van Es, Adriaan CGM, Emmer, Bart J, Coutinho, Jonathan M, Schonewille, Wouter J, Wermer, Marieke JH, van Walderveen, Marianne AA, Staals, Julie, Hofmeijer, Jeannette, Martens, Jasper M, de Bruijn, Sebastiaan F, van Dijk, Lukas C, van der Worp, H Bart, Lo, Rob H, van Dijk, Ewoud J, Boogaarts, Hieronymus D, Vries, J de, de Kort, Paul LM, van Tuijl, Julia, Peluso, Jo P, Fransen, Puck, van den Berg, Jan SP, van Hasselt, Boudewijn AAM, Aerden, Leo AM, Dallinga, René J, Uyttenboogaart, Maarten, Eschgi, Omid, Bokkers, Reinoud PH, Schreuder, Tobien HCML, Heijboer, Roel JJ, Keizer, Koos, Yo, Lonneke SF, den Hertog, Heleen M, Bulut, Tomas, Brouwers, Paul JAM, Sprengers, Marieke ES, Jenniskens, Sjoerd FM, van den Berg, René, Yoo, Albert J, Beenen, Ludo FM, Postma, Alida A, Roosendaal, Stefan D, van der Kallen, Bas FW, van den Wijngaard, Ido R, Bot, Joost, van Doormaal, Pieter-Jan, Meijer, Anton, Ghariq, Elyas, van Proosdij, Marc P, Krietemeijer, G Menno, Lo, Rob, Gerrits, Dick, Dinkelaar, Wouter, and Appelman, Auke PA
- Subjects
Clinical Trials and Supportive Activities ,Clinical Research ,Stroke ,Brain Disorders ,Neurosciences ,Aged ,Aged ,80 and over ,Brain Ischemia ,Endovascular Procedures ,Humans ,Ischemic Stroke ,Male ,Middle Aged ,Registries ,Thrombectomy ,Treatment Outcome ,ischemic stroke ,registry ,reperfusion ,thrombectomy ,uncertainty ,HERMES collaborators and MR CLEAN Registry Investigators* ,Cardiorespiratory Medicine and Haematology ,Clinical Sciences ,Neurology & Neurosurgery - Abstract
Background and purposeBenefit of early endovascular treatment (EVT) for ischemic stroke varies considerably among patients. The MR PREDICTS decision tool, derived from MR CLEAN (Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands), predicts outcome and treatment benefit based on baseline characteristics. Our aim was to externally validate and update MR PREDICTS with data from international trials and daily clinical practice.MethodsWe used individual patient data from 6 randomized controlled trials within the HERMES (Highly Effective Reperfusion Evaluated in Multiple Endovascular Stroke Trials) collaboration to validate the original model. Then, we updated the model and performed a second validation with data from the observational MR CLEAN Registry. Primary outcome was functional independence (defined as modified Rankin Scale score 0–2) 3 months after stroke. Treatment benefit was defined as the difference between the probability of functional independence with and without EVT. Discriminative performance was evaluated using a concordance (C) statistic.ResultsWe included 1242 patients from HERMES (633 assigned to EVT, 609 assigned to control) and 3156 patients from the MR CLEAN Registry (all of whom underwent EVT within 6.5 hours). The C-statistic for functional independence was 0.74 (95% CI, 0.72–0.77) in HERMES and, after model updating, 0.80 (0.78–0.82) in the Registry. Median predicted treatment benefit of routinely treated patients (Registry) was 10.3% (interquartile range, 5.8%–14.4%). Patients with low (
- Published
- 2021
12. Estimation of treatment effects in observational stroke care data: comparison of statistical approaches
- Author
-
Amini, Marzyeh, van Leeuwen, Nikki, Eijkenaar, Frank, van de Graaf, Rob, Samuels, Noor, van Doormaal, Pieter Jan, Roozenbeek, Bob, Dippel, Diederik W.J., Lingsma, Hester F., van der Lugt, Aad, Vos, Jan Albert, Brouwer, Josje, den Hartog, Sanne J., Hinsenveld, Wouter H., Kappelhof, Manon, Compagne, Kars C.J., Goldhoorn, Robert Jan B., Mulder, Maxim J.H.L., Jansen, Ivo G.H., Emmer, Bart J., de Bruijn, Sebastiaan F., de Vries, J., Fransen, Puck, den Hertog, Heleen M., Brouwers, Paul, Jenniskens, Sjoerd F.M., Roosendaal, Stefan D., Ghariq, Elyas, Dinkelaar, Wouter, el Ghannouti, Naziha, Sterrenberg, Martin, Sprengers, Rita, Verheesen, Sabrina, Khalilzada, Mostafa, Venema, Esmee, Chalos, Vicky, Ergezen, Saliha, Harmsma, Roger R.M., Muijres, Daan, de Jong, Anouk, Berkhemer, Olvert A., Treurniet, Kilian M., LeCouffe, Natalie E., Radiology and nuclear medicine, ACS - Atherosclerosis & ischemic syndromes, Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Damage and Repair in Cancer Development and Cancer Treatment (DARE), MUMC+: MA Neurologie (3), Klinische Neurowetenschappen, MUMC+: Hersen en Zenuw Centrum (3), RS: Carim - B05 Cerebral small vessel disease, Clinical Neurophysiology, TechMed Centre, Public Health, Health Systems and Insurance (HSI), Radiology & Nuclear Medicine, Neurology, Neurosciences, Erasmus School of Law, General Practice, Emergency Medicine, Intensive Care, Erasmus MC other, Medical Oncology, Amsterdam Neuroscience - Neurovascular Disorders, Radiology and Nuclear Medicine, and ACS - Microcirculation
- Subjects
Epidemiology ,Acute ischemic stroke ,General anesthesia ,Health Informatics ,ADJUSTMENT ,Intravenous thrombolysis ,GENERAL-ANESTHESIA ,Fibrinolytic Agents ,CONSCIOUS SEDATION ,Humans ,Thrombolytic Therapy ,ACUTE ISCHEMIC-STROKE ,Unmeasured confounding ,OUTCOMES ,Confounding by indication ,BINARY DATA ,Fibrinolytic Agents/therapeutic use ,Endovascular Procedures ,Other Research Radboud Institute for Health Sciences [Radboudumc 0] ,THROMBECTOMY ,INSTRUMENTAL VARIABLE METHODS ,Stroke ,Endovascular Procedures/methods ,PROPENSITY SCORE ,Instrumental variable ,Treatment Outcome ,ENDOVASCULAR TREATMENT ,Statistical approaches ,Ecological-analysis ,Stroke/drug therapy - Abstract
Introduction Various statistical approaches can be used to deal with unmeasured confounding when estimating treatment effects in observational studies, each with its own pros and cons. This study aimed to compare treatment effects as estimated by different statistical approaches for two interventions in observational stroke care data. Patients and methods We used prospectively collected data from the MR CLEAN registry including all patients (n = 3279) with ischemic stroke who underwent endovascular treatment (EVT) from 2014 to 2017 in 17 Dutch hospitals. Treatment effects of two interventions – i.e., receiving an intravenous thrombolytic (IVT) and undergoing general anesthesia (GA) before EVT – on good functional outcome (modified Rankin Scale ≤2) were estimated. We used three statistical regression-based approaches that vary in assumptions regarding the source of unmeasured confounding: individual-level (two subtypes), ecological, and instrumental variable analyses. In the latter, the preference for using the interventions in each hospital was used as an instrument. Results Use of IVT (range 66–87%) and GA (range 0–93%) varied substantially between hospitals. For IVT, the individual-level (OR ~ 1.33) resulted in significant positive effect estimates whereas in instrumental variable analysis no significant treatment effect was found (OR 1.11; 95% CI 0.58–1.56). The ecological analysis indicated no statistically significant different likelihood (β = − 0.002%; P = 0.99) of good functional outcome at hospitals using IVT 1% more frequently. For GA, we found non-significant opposite directions of points estimates the treatment effect in the individual-level (ORs ~ 0.60) versus the instrumental variable approach (OR = 1.04). The ecological analysis also resulted in a non-significant negative association (0.03% lower probability). Discussion and conclusion Both magnitude and direction of the estimated treatment effects for both interventions depend strongly on the statistical approach and thus on the source of (unmeasured) confounding. These issues should be understood concerning the specific characteristics of data, before applying an approach and interpreting the results. Instrumental variable analysis might be considered when unobserved confounding and practice variation is expected in observational multicenter studies.
- Published
- 2022
- Full Text
- View/download PDF
13. Carotid web: an occult mechanism of embolic stroke.
- Author
-
Grory, Brian Mac, Emmer, Bart J., Roosendaal, Stefan D., Zagzag, David, Yaghi, Shadi, Nossek, Erez, and Mac Grory, Brian
- Subjects
INTERNAL carotid artery ,STAGNATION flow ,STROKE ,ARTERIAL dissections ,CAROTID endarterectomy - Abstract
The carotid web is a proposed stroke mechanism that may underlie cryptogenic stroke, particularly in younger patients without vascular risk factors. The web appears as a shelf-like projection into the lumen of the proximal cervical internal carotid artery without evidence of calcification. It is pathologically defined as intimal fibromuscular dysplasia. Altered haemodynamics distal to the web cause flow stagnation and remote embolisation of fibrin-based clots. It is best demonstrated and diagnosed on CT angiography (CTA) of the neck because of its ability to resolve calcium and create multiplanar reconstructions. Although they can be readily visualised on CTA, carotid webs may be missed or misinterpreted because they do not typically cause haemodynamically significant stenosis and can mimic arterial dissection, non-calcified atherosclerotic plaque and intraluminal thrombus. Options for management include antiplatelet therapy, carotid endarterectomy and carotid artery stenting. Modern management strategies for cryptogenic stroke include long-term cardiac monitoring, further investigation for structural cardiac disease and a diagnostic workup for arterial hypercoagulability, however, these strategies are not likely to capture the possibility of a carotid web. Carotid webs should be suspected in a young patient presenting with recurrent unihemispheric strokes particularly when conventional vascular risk factors are not present. [ABSTRACT FROM AUTHOR]
- Published
- 2020
- Full Text
- View/download PDF
Catalog
Discovery Service for Jio Institute Digital Library
For full access to our library's resources, please sign in.