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  • 1
    In: JAMA, American Medical Association (AMA), Vol. 327, No. 18 ( 2022-05-10), p. 1782-
    Abstract: In nonurban areas with limited access to thrombectomy-capable centers, optimal prehospital transport strategies in patients with suspected large-vessel occlusion stroke are unknown. Objective To determine whether, in nonurban areas, direct transport to a thrombectomy-capable center is beneficial compared with transport to the closest local stroke center. Design, Setting, and Participants Multicenter, population-based, cluster-randomized trial including 1401 patients with suspected acute large-vessel occlusion stroke attended by emergency medical services in areas where the closest local stroke center was not capable of performing thrombectomy in Catalonia, Spain, between March 2017 and June 2020. The date of final follow-up was September 2020. Interventions Transportation to a thrombectomy-capable center (n = 688) or the closest local stroke center (n = 713). Main Outcomes and Measures The primary outcome was disability at 90 days based on the modified Rankin Scale (mRS; scores range from 0 [no symptoms] to 6 [death] ) in the target population of patients with ischemic stroke. There were 11 secondary outcomes, including rate of intravenous tissue plasminogen activator administration and thrombectomy in the target population and 90-day mortality in the safety population of all randomized patients. Results Enrollment was halted for futility following a second interim analysis. The 1401 enrolled patients were included in the safety analysis, of whom 1369 (98%) consented to participate and were included in the as-randomized analysis (56% men; median age, 75 [IQR, 65-83] years; median National Institutes of Health Stroke Scale score, 17 [IQR, 11-21] ); 949 (69%) comprised the target ischemic stroke population included in the primary analysis. For the primary outcome in the target population, median mRS score was 3 (IQR, 2-5) vs 3 (IQR, 2-5) (adjusted common odds ratio [OR], 1.03; 95% CI, 0.82-1.29). Of 11 reported secondary outcomes, 8 showed no significant difference. Compared with patients first transported to local stroke centers, patients directly transported to thrombectomy-capable centers had significantly lower odds of receiving intravenous tissue plasminogen activator (in the target population, 229/482 [47.5%] vs 282/467 [60.4%]; OR, 0.59; 95% CI, 0.45-0.76) and significantly higher odds of receiving thrombectomy (in the target population, 235/482 [48.8%] vs 184/467 [39.4%]; OR, 1.46; 95% CI, 1.13-1.89). Mortality at 90 days in the safety population was not significantly different between groups (188/688 [27.3%] vs 194/713 [27.2%]; adjusted hazard ratio, 0.97; 95% CI, 0.79-1.18). Conclusions and Relevance In nonurban areas in Catalonia, Spain, there was no significant difference in 90-day neurological outcomes between transportation to a local stroke center vs a thrombectomy-capable referral center in patients with suspected large-vessel occlusion stroke. These findings require replication in other settings. Trial Registration ClinicalTrials.gov Identifier: NCT02795962
    Type of Medium: Online Resource
    ISSN: 0098-7484
    RVK:
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2022
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  • 2
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. 12 ( 2015-12), p. 3437-3442
    Abstract: Recent trials have shown the superiority of endovascular thrombectomy (EVT) over medical therapy alone in certain stroke patients with proximal arterial occlusion. Using data from the Randomized Trial of Revascularization With Solitaire FR Device Versus Best Medical Therapy in the Treatment of Acute Stroke due to Anterior Circulation Large Vessel Occlusion Presenting Within 8-Hours of Symptom Onset (REVASCAT) and a parallel reperfusion treatment registry, we sought to assess the utilization of EVT in a defined patient population, comparing the outcomes of patients treated in and outside the REVASCAT trial. Methods— SONIIA [Sistema Online d’Informació de l’Ictus Agut], a population-based, government-mandated, prospective registry of reperfusion therapies for stroke encompassing the entire population of Catalonia, was used as data source. The registry documents 5 key inclusion criteria of the REVASCAT trial: age, stroke severity, time to treatment, baseline functional status, and occlusion site. We compared procedural, safety, and functional outcomes in patients treated inside and outside the trial. Results— From November 2012 to December 2014, out of 17596 ischemic stroke patients in Catalonia (population 7.5 million), 2576 patients received reperfusion therapies (17/100000 inhabitants-year), mainly intravenous thrombolysis only (2036). From the remaining 540 treated with EVT, 103 patients (out of 206 randomized) were treated within REVASCAT and 437 outside the trial. Of these, 399 did not fulfill some of the study criteria, and 38 were trial candidates (8 treated at REVASCAT centers and 30 at 2 non-REVASCAT centers). The majority of procedural, safety, and functional outcomes were similar in patients treated with EVT within and outside REVASCAT. Conclusions— REVASCAT enrolled nearly all eligible patients representing one third of all patients treated with EVT. Patients treated with EVT within and outside REVASCAT had similar outcomes, reinforcing the therapeutic value of EVT. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT01692379.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
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  • 3
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. 4 ( 2014-04), p. 1046-1052
    Abstract: We sought to assess outcomes after endovascular treatment/therapy of acute ischemic stroke, overall and by subgroups, and looked for predictors of outcome. Methods— We used data from a mandatory, population-based registry that includes external monitoring of completeness, which assesses reperfusion therapies for consecutive patients with acute ischemic stroke since 2011. We described outcomes overall and by subgroups (age ≤ or 〉 80 years; onset-to-groin puncture ≤ or 〉 6 hours; anterior or posterior strokes; previous IV recombinant tissue-type plasminogen activator or isolated endovascular treatment/therapy; revascularization or no revascularization), and determined independent predictors of good outcome (modified Rankin Scale score ≤2) and mortality at 3 months by multivariate modeling. Results— We analyzed 536 patients, of whom 285 received previous IV recombinant tissue-type plasminogen activator. Overall, revascularization (modified Thrombolysis In Cerebral Infarction scores, 2b and 3) occurred in 73.9%, 5.6% developed symptomatic intracerebral hemorrhages, 43.3% achieved good functional outcome, and 22.2% were dead at 90 days. Adjusted comparisons by subgroups systematically favored revascularization (lower proportion of symptomatic intracerebral hemorrhages and death rates and higher proportion of good outcome). Multivariate analyses confirmed the independent protective effect of revascularization. Additionally, age 〉 80 years, stroke severity, hypertension (deleterious), atrial fibrillation, and onset-to-groin puncture ≤6 hours (protective) also predicted good outcome, whereas lack of previous disability and anterior circulation strokes (protective) as well as and hypertension (deleterious) independently predicted mortality. Conclusions— This study reinforces the role of revascularization and time to treatment to achieve enhanced functional outcomes and identifies other clinical features that independently predict good/fatal outcome after endovascular treatment/therapy.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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  • 4
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. suppl_1 ( 2014-02)
    Abstract: Background: Evidence clearly supports intravenous thrombolysis (IVT) as first-line therapy for AIS. Yet, endovascular treatment (EVT) might be an alternative for patients with IVT contraindications. Our aim was to study whether patients treated with primary EVT in daily practice did as well as those treated with IVT alone in terms of functional outcome. Methods: Observational, population-based study of consecutive AIS patients treated with either isolated EVT or IVT within 2011 and 2012 in Catalonia. Patients were prospectively included in a health-administration based registry with external monitoring of completeness. Inclusion criteria: EVT or IVT delivered under routine conditions. Exclusion criteria: combined IVT+EVT therapy, pre-stroke mRS 〉 2, lacunar stroke subtype, unusual stroke etiology, baseline NIHSS 〉 25 and onset-to-treatment (OTT) 〉 400 minutes. We determined the risk-adjusted probability [adjustment variables: age, NIHSS, OTT, pre-morbid mRS, hypertension, dyslipidemia, diabetes, AF, OCSP classification and etiology] of achieving functional independence at 3 months (mRS 〈 =2) and performed subgroup analyses. Results: 1149 patients underwent IVT and 129 (10.1%) EVT. Patients in the EVT arm were younger (71.2+/-11.5 vs. 74.3+/-11.9), had higher NIHSS scores (18 [12-20] vs. 11 [7-18]), were treated later (198 [150-270] vs. 140 [105-190]) and more frequently had concomitant AF (55% vs. 21.9%), heart failure (12.4% vs. 4.9%), and were on anticoagulants (49.6% vs. 5.4%). Dyslipidemia (45.4% vs. 36.4%) and antiplatelets (42.7% vs. 26.4%) were more frequent in the IVT arm. Overall, the risk-adjusted likelihood of good functional outcome was better for EVT (OR: 1.56; 95% CI: 0.97-2.52). Subgroup analyses showed that patients with NIHSS = 〉 14 (OR: 1.92; 95% CI: 1.10-3.46) and those treated within 180-270 minutes post-stroke (OR: 3.44; 95% CI: 1.41-8.39) benefited more from EVT. Conclusions: In a population-based study of reperfusion therapies for AIS, patients undergoing isolated EVT were more likely to achieve functional independence at 3 months as compared to patients treated with IVT, particularly those with severe strokes or those treated within 3-4.5 hours post-stroke. These findings need to be confirmed in a RCT.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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  • 5
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. 5 ( 2016-05), p. 1381-1384
    Abstract: Since demonstration of the benefit of endovascular treatment (EVT) in acute ischemic stroke patients with proximal arterial occlusion, stroke care systems need to be reorganized to deliver EVT in a timely and equitable way. We analyzed differences in the access to EVT by geographical areas in Catalonia, a territory with a highly decentralized stroke model. Methods— We studied 965 patients treated with EVT from a prospective multicenter population-based registry of stroke patients treated with reperfusion therapies in Catalonia, Spain (SONIIA). Three different areas were defined: (A) health areas primarily covered by Comprehensive Stroke Centers, (B) areas primarily covered by local stroke centers located less than hour away from a Comprehensive Stroke Center, and (C) areas primarily covered by local stroke centers located more than hour away from a Comprehensive Stroke Center. We compared the number of EVT×100 000 inhabitants/year and time from stroke onset to groin puncture between groups. Results— Baseline characteristics were similar between groups. Throughout the study period, there were significant differences in the population rates of EVT across geographical areas. EVT rates by 100 000 in 2015 were 10.5 in A area, 3.7 in B, and 2.7 in C. Time from symptom onset to groin puncture was 82 minutes longer in group B (312 minutes [245–435]) and 120 minutes longer in group C (350 minutes [284–408] ) compared with group A (230 minutes [160–407]; P 〈 0.001). Conclusions— Accessibility to EVT from remote areas is hampered by lower rate and longer time to treatment compared with areas covered directly by Comprehensive Stroke Centers.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
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    detail.hit.zdb_id: 1467823-8
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  • 6
    In: International Journal of Stroke, SAGE Publications, Vol. 14, No. 7 ( 2019-10), p. 734-744
    Abstract: Optimal pre-hospital delivery pathways for acute stroke patients suspected to harbor a large vessel occlusion have not been assessed in randomized trials. Aim To establish whether stroke subjects with rapid arterial occlusion evaluation scale based suspicion of large vessel occlusion evaluated by emergency medical services in the field have higher rates of favorable outcome when transferred directly to an endovascular center (endovascular treatment stroke center), as compared to the standard transfer to the closest local stroke center (local-SC). Design Multicenter, superiority, cluster randomized within a cohort trial with blinded endpoint assessment. Procedure Eligible patients must be 18 or older, have acute stroke symptoms and not have an immediate life threatening condition requiring emergent medical intervention. They must be suspected to have intracranial large vessel occlusion based on a pre-hospital rapid arterial occlusion evaluation scale of ≥5, be located in geographical areas where the default health authority assigned referral stroke center is a non-thrombectomy capable hospital, and estimated arrival at a thrombectomy capable stroke hospital in less than 7 h from time last seen well. Cluster randomization is performed according to a pre-established temporal sequence (temporal cluster design) with three strata: day/night, distance to the endovascular treatment stroke center, and week/week-end day. Study outcome The primary endpoint is the modified Rankin Scale score at 90 days. The primary safety outcome is mortality at 90 days. Analysis The primary endpoint based on the modified intention-to-treat population is the distribution of modified Rankin Scale scores at 90 days analyzed under a sequential triangular design. The maximum sample size is 1754 patients, with two planned interim analyses when 701 (40%) and 1227 patients have completed follow-up. Hypothesized common odds ratio is 1.35.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
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  • 7
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 47, No. suppl_1 ( 2016-02)
    Abstract: Background: Benefit of endovascular treatment (EVT) for acute stroke has been demonstrated recently in several randomized clinical trials. This benefit is time-dependent and revascularization achieved at later times is associated with a poor risk-benefit ratio. Hypothesis: Stroke Code systems based on a drip-and-ship model have been implemented worldwide to accelerate iv-tPA treatment. However, access to EVT in remote areas is hampered due to long distances and delays related to inter-hospital transfers. Methods: We studied patients treated with EVT from a prospective multicenter population-based registry of acute stroke patients treated with reperfusion therapies (SONIIA) initiated in January 2011. Three groups were defined: (1) patients directly evaluated in comprehensive stroke centers (CSC) (n=895), (2) patients transferred from a remote hospital located less than 1 hour away from a CSC (n=191) and (3) patients transferred from a remote hospital located more than 1 hour away from a CSC (n=153). We compared population EVT rates (number of EVT/100000 inhabitants/year) and time from stroke onset to groin puncture between groups. The benefit of helicopter over ground transfer was evaluated in group 3. Results: We found no differences between the three groups in baseline characteristics (age, vascular risk factors and stroke severity). 48% of patients in group 1, 60% in group 2 and 62% in group 3 received iv-tPA previously to EVT, with time from symptom onset to iv-tPA of 120 min, 110 min and 137 min respectively. Population EVT rates were 4-fold higher in group 1 (6.69 in group 1, 2.07 in group 2 and 1.68 in group 3). Time from symptom onset to EVT was longer in group 2 (322 min [255-445]) and group 3 (365 min [312-450] ) compared to group 1 (243 min [175-404]) (p 〈 0.001). Helicopter transfer was used in 24% of patients in group 3 and reduced the time to groin puncture in 35 minutes. Conclusions: Accessibility to EVT in remote areas is hampered in comparison to areas depending directly on CSC. Time from symptom onset to EVT is 90-120 minutes longer in patients transferred from remote hospitals compared to patients directly evaluated in CSC. Based on these results, strategies to shorten inter-hospital transfer time or alternative mother-ship models should be considered.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2016
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  • 8
    In: Cerebrovascular Diseases, S. Karger AG, Vol. 38, No. 5 ( 2014), p. 328-336
    Abstract: 〈 b 〉 〈 i 〉 Background: 〈 /i 〉 〈 /b 〉 Among the acute ischemic stroke patients with large vessel occlusions and contraindications for the use of IV thrombolysis, mainly on oral anticoagulation or presenting too late, primary endovascular therapy is often performed as an alternative to the standard therapy even though evidence supporting the use of endovascular reperfusion therapies is not yet established. Using different statistical approaches, we compared the functional independence rates at 3 months among patients undergoing primary endovascular therapy and patients treated only with IV thrombolysis. 〈 b 〉 〈 i 〉 Methods: 〈 /i 〉 〈 /b 〉 We used data from a prospective, government-mandated and externally audited registry of reperfusion therapies for ischemic stroke (January 2011 to November 2012). Patients were selected if treated with either IV thrombolysis alone (n = 1,582) or primary endovascular thrombectomy (n = 250). A series of exclusions were made to homogenize the clinical characteristics among the two groups. We then carried out multivariate logistic regression and propensity score matching analyses on the final study sample (n = 1,179) to compare functional independence at 3 months, as measured by the modified Rankin scale scores 0-2, between the two groups. 〈 b 〉 〈 i 〉 Results: 〈 /i 〉 〈 /b 〉 The unadjusted likelihood of good outcome was poorer among the endovascular group (OR: 0.69; 95% CI: 0.47-1.0). After adjustment, no differences by treatment modality were seen (OR: 1.51; 95% CI: 0.93-2.43 for primary endovascular therapy). Patients undergoing endovascular thrombectomy within 180-270 min (OR: 2.89; 95% CI: 1.17-7.15) and patients with severe strokes (OR: 1.84; 95% CI: 1.02-3.35) did better than their intravenous thrombolysis counterparts. The propensity score-matched analyses with and without adjustment by additional covariates showed that endovascular thrombectomy was as effective as intravenous thrombolysis alone in achieving functional independence (OR for unadjusted propensity score matched: 1.35; 95% CI: 0.9-2.02, OR for adjusted propensity score matched: 1.45; 95% CI: 0.91-2.32). 〈 b 〉 〈 i 〉 Conclusion: 〈 /i 〉 〈 /b 〉 This comparative effectiveness study shows that in ischemic stroke patients with contraindications for IV thrombolysis, primary endovascular treatment might be an alternative therapy at least as effective as IV thrombolysis alone. Randomized controlled trials are urgently needed.
    Type of Medium: Online Resource
    ISSN: 1015-9770 , 1421-9786
    Language: English
    Publisher: S. Karger AG
    Publication Date: 2014
    detail.hit.zdb_id: 1482069-9
    detail.hit.zdb_id: 1069462-6
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  • 9
    In: Journal of the American Geriatrics Society, Wiley, Vol. 65, No. 9 ( 2017-09)
    Abstract: The aim of the study was to confirm the safety and effectiveness of using intravenous thrombolysis ( IVT ) with individuals aged 80 and older in routine practice in different hospital settings. Design Observasional registry. Setting Prospective multicenter population‐based registry of acute stroke patients treated with reperfusion therapies in Catalonia, Spain (Sistema Online d'Informació de l'Ictus Agut). Participants Individuals treated only with IVT (N = 3,231; 1,189 (36.8%) aged ≥80). Measurements Symptomatic intracranial hemorrhage, mortality, and favorable outcome (modified Rankin Scale ( mRS ) score = 0–2) at 3 months were evaluated according to hospital characteristics. Treating hospitals were classified in three categories: comprehensive stroke centers ( CSC s), primary stroke centers ( PSC s), and community hospitals operating a telestroke system ( TS ). First individuals aged 80 and older were compared with those younger than 80, and then participants aged 80 and older were focused on. Results Participants aged 80 and older had significantly higher baseline National Institute of Health Stroke Scale ( NIHSS ) scores, longer onset to treatment times, and worse outcomes than younger participants. For participants aged 80 and older, 90‐day mortality was 23.2%, with 38.7% having favorable outcomes at 3 months. Symptomatic intracranial hemorrhage ( SICH ; Safe Implementation of Thrombolysis in Stroke‐ MO nitoring ST udy definition) was observed in 4.7% of subjects. None of the risk factors differed significantly between participants treated in different types of hospitals. Basal stroke severity measured according to NIHSS score was not significantly different either. The three different types of hospitals achieved similar outcomes, although the TS and PSC hospitals had significantly higher proportions of SICH (6.3% and 6.3%, respectively) than the CSC (3.2%). Conclusion Older adults with acute stroke treated with IVT had similar outcomes regardless of hospital characteristics.
    Type of Medium: Online Resource
    ISSN: 0002-8614 , 1532-5415
    URL: Issue
    Language: English
    Publisher: Wiley
    Publication Date: 2017
    detail.hit.zdb_id: 2040494-3
    detail.hit.zdb_id: 80363-7
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