Real-World Cost-Effectiveness of Late Time Window Thrombectomy for Patients With Ischemic Stroke.
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ABSTRACT:
SUBMITTER: Gao L
PROVIDER: S-EPMC8712752 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:Background and purposeMechanical thrombectomy (MT) has been recommended for the treatment of nonminor ischemic stroke by national and international guidelines, but cost-effectiveness evidence has been generated for only a few countries using heterogeneous evaluation methods. We estimate the cost-effectiveness of MT across 32 European countries.MethodsA Markov model was developed to estimate the cost-effectiveness of MT compared with standard care over a 5-year time horizon. Patients with ischemic stroke eligible for MT were identified from 2017 country-specific incidence data. A societal perspective was adopted, including health, social, and informal care costs, and productivity losses. Model outcomes were expressed as quality-adjusted life years. Sensitivity analyses were conducted to test the robustness of findings.ResultsWe identified 267 514 ischemic stroke cases that were eligible for MT treatment across 32 European countries. MT was found to be more effective and cheaper than standard care in two-thirds of the countries (21/32) and cost-effective in all but one country (Bulgaria). Across Europe, the intervention was estimated to produce over 101 327 additional quality-adjusted life years (95% uncertainty interval, 65 180-149 085) and cost savings of $981 million (€868 million, 95% uncertainty interval, -1544 to 2564) and of $1.7 billion (€1.5 billion, 95% uncertainty interval, -1.2 to 3.6) in health and social care and societal costs, respectively.ConclusionsMT is highly likely to be cost-effective compared with standard care across Europe as a whole and in the vast majority of European countries.
| S-EPMC7834665 | biostudies-literature
Project description:BackgroundRecent randomized trials have suggested that endovascular thrombectomy (EVT) alone may provide similar functional outcomes as the current standard of care, EVT combined with intravenous alteplase treatment, for acute ischemic stroke secondary to large vessel occlusion. We conducted an economic evaluation of these 2 therapeutic options.MethodsWe constructed a decision analytic model with a hypothetical cohort of 1000 patients to assess the cost-effectiveness of EVT with intravenous alteplase treatment versus EVT alone for acute ischemic stroke secondary to large vessel occlusion from both the societal and public health care payer perspectives. We used studies and data published in 2009-2021 for model inputs, and acquired cost data for Canada and China, representing high- and middle-income countries, respectively. We calculated incremental cost-effectiveness ratios (ICERs) using a lifetime horizon and accounted for uncertainty using 1-way and probabilistic sensitivity analyses. All costs are reported in 2021 Canadian dollars.ResultsIn Canada, the difference in quality-adjusted life-years (QALYs) gained between EVT with alteplase and EVT alone was 0.10 from both the societal and health care payer perspectives. The difference in cost was $2847 from a societal perspective and $2767 from the payer perspective. In China, the difference in QALYs gained was 0.07 from both perspectives, and the difference in cost was $1550 from the societal perspective and $1607 from the payer perspective. One-way sensitivity analyses showed that the distributions of modified Rankin Scale scores at 90 days after stroke were the most influential factor on ICERs. For Canada, compared to EVT alone, the probability that EVT with alteplase would be cost-effective at a willingness-to-pay threshold of $50 000 per QALY gained was 58.7% from a societal perspective and 58.4% from a payer perspective. The corresponding values for at a willingness-to-pay threshold of $47 185 (3 times the Chinese gross domestic product per capita in 2021) were 65.2% and 67.4%.InterpretationFor patients with acute ischemic stroke due to large vessel occlusion eligible for immediate treatment with both EVT alone and EVT with intravenous alteplase treatment, it is uncertain whether EVT with alteplase is cost-effective compared to EVT alone in Canada and China.
| S-EPMC10205869 | biostudies-literature
Project description:Although initial studies of neuroendovascular intervention did not review benefit over intravenous thrombolytics (iv r-tPA), recent studies have suggested otherwise. Elderly patients (age ?80 years) are typically excluded from clinical trials.To examine the utility of mechanical thrombectomy based on patient outcomes.All stroke-alert activations at our health system from January 2011 to June 2014 were examined. All patients aged ?80 years who had undergone mechanical thrombectomy were identified. Clinical characteristics included physiologic imaging findings, use of intravenous thrombolytics, baseline and postoperative National Institute of Health Stroke Scale (NIHSS), thrombolysis in cerebral infarction scores (TICI), and discharge destination.Mean NIHSS on presentation was 18.2 (range, 6-31), and 13.3 (range, 3-30) post thrombectomy. Three (16.6%) patients received iv r-tPA, two (11.1%) had symptomatic intracranial hemorrhage. Eight (44.4%) died, eight (44.4%) were discharged to nursing homes, and two (11.7%) were discharged to inpatient rehab and subsequently home. Favorable outcome was achieved in five (27.7%) patients. Fourteen (77.7%) patients had physiologic imaging prior to intervention. Three (75%) of four patients who did not have physiologic imaging prior to thrombectomy died. Thirteen (66.6%) patients had TICI 3 recanalization.Our study showed that although there remains a role of mechanical thrombectomy in the treatment of acute ischemic stroke in very elderly patients, it is associated with significant higher morbidity and mortality compared to younger patients, but should remain a very viable treatment option when quality of life is the most important consideration.
| S-EPMC4580118 | biostudies-other
Project description:Importance:Although thrombectomy benefit was maintained in transfer patients with ischemic stroke in early-window trials, overall functional independence rates were lower in thrombectomy and medical management-only groups. Objective:To evaluate whether the imaging-based selection criteria used in the Endovascular Therapy Following Imaging Evaluation for Ischemic Stroke 3 (DEFUSE 3) trial would lead to comparable outcome rates and treatment benefits in transfer vs direct-admission patients. Design, Setting, and Participants:Subgroup analysis of DEFUSE 3, a prospective, randomized, multicenter, blinded-end point trial. Patients were enrolled between May 2016 and May 2017 and were followed up for 90 days. The trial comprised 38 stroke centers in the United States and 182 patients with stroke with a large-vessel anterior circulation occlusion and initial infarct volume of less than 70 mL, mismatch ratio of at least 1.8, and mismatch volume of at least 15 mL, treated within 6 to 16 hours from last known well. Patients were stratified based on whether they presented directly to the study site or were transferred from a primary center. Data were analyzed between July 2018 and October 2018. Interventions or Exposures:Endovascular thrombectomy plus standard medical therapy vs standard medical therapy alone. Main Outcomes and Measures:The primary outcome was the distribution of 90-day modified Rankin Scale scores. Results:Of the 296 patients who consented, 182 patients were randomized (66% were transfer patients and 34% directly presented to a study site). Median age was 71 years (interquartile range [IQR], 60-79 years) vs 70 years (IQR, 59-80 years); 69 transfer patients were women (57%) and 23 of the direct group were women (37%). Transfer patients had longer median times from last known well to study site arrival (9.43 vs 9 hours) and more favorable collateral profiles (based on hypoperfusion intensity ratio): median for transfer, 0.35 (IQR, 0.18-0.47) vs 0.42 (IQR, 0.25-0.56) for direct (P = .05). The primary outcome (90-day modified Rankin Scale score shift) did not differ in the direct vs transfer groups (direct OR, 2.9; 95% CI, 1.2-7.2; P = .01; transfer OR, 2.6; 95% CI, 1.3-4.8; P = .009). The overall functional independence rate (90-day modified Rankin Scale score 0-2) in the thrombectomy group did not differ (direct 44% vs transfer 45%) nor did the treatment effect (direct OR, 2.0; 95% CI, 0.9-4.4 vs transfer OR, 3.1; 95% CI, 1.6-6.1). Thrombectomy reperfusion rates, mortality, and symptomatic intracranial hemorrhage rates did not differ. Conclusions and Relevance:In late-window patients selected by penumbral mismatch criteria, both the favorable outcome rate and treatment effect did not decline in transfer patients. These results have health care implications indicating transferring potential candidates for late-window thrombectomy is associated with substantial clinical benefits and should be encouraged. Trial Registration:ClinicalTrials.gov identifier: NCT02586415.
| S-EPMC6563543 | biostudies-literature
Project description:Background and purpose Futile recanalization (FR), defined as functional dependence despite successful reperfusion, is common in patients who experience an acute stroke after thrombectomy. We aimed to determine the predictors of FR in patients who underwent thrombectomy in late time windows (6 h or more after symptom onset). Methods This retrospective review included patients who underwent thrombectomy for acute anterior circulation large vessel occlusion from October 2019 to June 2021. Successful reperfusion was defined as a modified Thrombolysis in Cerebral Infarction (mTICI) score of 2b/3. Functional dependence at 90 days was defined as a modified Rankin scale score of 3–6. Multivariate analysis and a receiver operating characteristic (ROC) curve were used to identify the predictors of FR in patients treated in delayed time windows. Results Of the 99 patients included, FR was observed in 51 (51.5%). In the multivariate analysis, older age (OR, 1.12; 95% CI, 1.04–1.22; P = 0.005), female sex (OR, 3.79; 95% CI, 1.08–13.40; P = 0.038), a higher National Institutes of Health Stroke Score (NIHSS) score upon admission (OR, 1.11; 95% CI, 1.02–1.22; P = 0.023), and an increased number of passes per procedure (OR, 2.07; 95% CI, 1.11–3.86; P = 0.023) were independently associated with FR after thrombectomy. The ROC curve indicated that the model that combined age, female sex, baseline NIHSS score, and the number of passes per procedure (area under the curve, 0.84; 95% CI, 0.75–0.90, P < 0.001) was able to predict FR accurately. Conclusions Older age, female sex, higher NIHSS score upon admission, and an increased number of passes per procedure were independent predictors of FR in patients who experienced acute ischemic strokes after thrombectomy in late time windows.
| S-EPMC9519892 | biostudies-literature
Project description:Clinical trials have demonstrated improved 90-day outcomes for patients with acute ischemic stroke treated with stent retriever thrombectomy plus tissue-type plasminogen activator (SST+tPA) compared with tPA. Previous studies suggested that this strategy may be cost-effective, but models were derived from pooled data and older assumptions.In this prospective economic substudy conducted alongside the SWIFT-PRIME trial (Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke), in-trial costs were measured for patients using detailed medical resource utilization and hospital billing data. Utility weights were assessed at 30 and 90 days using the EuroQol-5 dimension questionnaire. Post-trial costs and life-expectancy were estimated for each surviving patient using a model based on trial data and inputs derived from a contemporary cohort of ischemic stroke survivors.Index hospitalization costs were $17?183 per patient higher for SST+tPA than for tPA ($45?761 versus $28?578; P<0.001), driven by initial procedure costs. Between discharge and 90 days, costs were $4904 per patient lower for SST+tPA than for tPA ($11?270 versus $16?174; P=0.014); total 90-day costs remained higher with SST+tPA ($57?031 versus $44?752; P<0.001). Higher utility values for SST+tPA led to higher in-trial quality-adjusted life years (0.131 versus 0.105; P=0.005). In lifetime projections, SST+tPA was associated with substantial gains in quality-adjusted life years (6.79 versus 5.05), cost savings of $23?203 per patient and was economically dominant when compared with tPA in 90% of bootstrap replicates.Among patients with acute ischemic stroke enrolled in the SWIFT-PRIME trial, SST increased initial treatment costs, but was projected to improve quality-adjusted life-expectancy and reduce healthcare costs over a lifetime horizon compared with tPA.URL: http://www.clinicaltrials.gov. Unique identifier: NCT01657461.
| S-EPMC5461963 | biostudies-literature
Project description:ImportanceTwo 2018 randomized controlled trials (DAWN and DEFUSE 3) demonstrated the clinical benefit of mechanical thrombectomy (MT) more than 6 hours after onset in acute ischemic stroke (AIS). Health-economic evidence is needed to determine whether the short-term health benefits of late MT translate to a cost-effective option during a lifetime in the United States.ObjectiveTo compare the cost-effectiveness of 2 strategies (MT added to standard medical care [SMC] vs SMC alone) for various subgroups of patients with AIS receiving care more than 6 hours after symptom onset.Design, setting, and participantsThis economic evaluation study used the results of the DAWN and DEFUSE 3 trials to populate a cost-effectiveness model from a US health care perspective combining a decision tree and Markov trace. The DAWN and DEFUSE 3 trials enrolled 206 international patients from 2014 to 2017 and 182 US patients from 2016 to 2017, respectively. Patients were followed until 3 months after stroke. The clinical outcome at 3 months was available for 29 subgroups of patients with AIS and anterior circulation large vessel occlusions. Data analysis was conducted from July 2018 to October 2019.ExposuresMT with SMC in the extended treatment window vs SMC alone.Main outcomes and measuresExpected costs and quality-adjusted life-years (QALYs) during lifetime were estimated. Deterministic results (incremental costs and effectiveness, incremental cost-effectiveness ratios, and net monetary benefit) were presented, and probabilistic analyses were performed for the total populations and 27 patient subgroups.ResultsIn the DAWN study, the MT group had a mean (SD) age of 69.4 (14.1) years and 42 of 107 (39.3%) were men, and the control group had a mean (SD) age of 70.7 (13.2) years and 51 of 99 (51.5%) were men. In the DEFUSE 3 study, the MT group had a median (interquartile range) age of 70 (59-79) years, and 46 of 92 (50.0%) were men, and the control group had a median (interquartile range) age of 71 (59-80) years, and 44 of 90 (48.9%) were men. For the total trial population, incremental cost-effectiveness ratios were $662/QALY and $13 877/QALY based on the DAWN and DEFUSE 3 trials, respectively. MT with SMC beyond 6 hours had a probability greater than 99.9% of being cost-effective vs SMC alone at a willingness-to-pay threshold of $100 000/QALY. Subgroup analyses showed a wide range of probabilities for MT with SMC to be cost-effective at a willingness-to-pay threshold of $50 000/QALY, with the greatest uncertainty observed for patients with a National Institute of Health Stroke Scale score of at least 16 and for those aged 80 years or older.Conclusions and relevanceThe results of this study suggest that late MT added to SMC is cost-effective in all subgroups evaluated in the DAWN and DEFUSE 3 trials, with most results being robust in probabilistic sensitivity analyses. Future MT evidence-gathering could focus on older patients and those with National Institute of Health Stroke Scale scores of 16 and greater.
| S-EPMC7448828 | biostudies-literature
Project description:BackgroundThe beneficial effects of endovascular treatment with new-generation mechanical thrombectomy devices compared with intravenous thrombolysis alone to treat acute large-artery ischemic stroke have been shown in randomized controlled trials (RCTs). This study aimed to estimate the cost utility of mechanical thrombectomy compared with the established standard of care.MethodsWe developed a Markov decision process analytic model to assess the cost-effectiveness of treatment with mechanical thrombectomy plus intravenous thrombolysis versus treatment with intravenous thrombolysis alone from the public payer perspective in Canada. We conducted comprehensive literature searches to populate model inputs. We estimated the efficacy of mechanical thrombectomy plus intravenous thrombolysis from a meta-analysis of 5 RCTs, and we used data from the Oxford Vascular Study to model long-term clinical outcomes. We calculated incremental cost-effectiveness ratios (ICER) using a 5-year time horizon.ResultsThe base case analysis showed the cost and effectiveness of treatment with mechanical thrombectomy plus intravenous thrombolysis to be $126?939 and 1.484 quality-adjusted life-years (QALYs), respectively, and the cost and effectiveness of treatment with intravenous thrombolysis alone to be $124?419 and 1.273 QALYs, respectively. The mechanical thrombectomy plus intravenous thrombolysis strategy was associated with an ICER of $11?990 per QALY gained. Probabilistic sensitivity analysis showed that the probability of treatment with mechanical thrombectomy plus intravenous thrombolysis being cost-effective was 57.5%, 89.7% and 99.6% at thresholds of $20?000, $50?000 and $100?000 per QALY gained, respectively. The main factors influencing the ICER were time horizon, extra cost of mechanical thrombectomy treatment and age of the patient.InterpretationMechanical thrombectomy as an adjunct therapy to intravenous thrombolysis is cost-effective compared with treatment with intravenous thrombolysis alone for patients with acute large-artery ischemic stroke.
| S-EPMC4933608 | biostudies-literature
Project description:BackgroundEmergent large vessel occlusion (ELVO) strokes are devastating ischemic vascular events for which novel treatment options are needed. Using vascular cell adhesion molecule 1 (VCAM1) as a prototype, the objective of this study was to identify proteomic biomarkers and network signaling functions that are potential therapeutic targets for adjuvant treatment for mechanical thrombectomy.MethodsThe blood and clot thrombectomy and collaboration (BACTRAC) study is a continually enrolling tissue bank and registry from stroke patients undergoing mechanical thrombectomy. Plasma proteins from intracranial (distal to clot) and systemic arterial blood (carotid) were analyzed by Olink Proteomics for N=42 subjects. Statistical analysis of plasma proteomics used independent sample t tests, correlations, linear regression, and robust regression models to determine network signaling and predictors of clinical outcomes. Data and network analyses were performed using IBM SPSS Statistics, SAS v 9.4, and STRING V11.ResultsIncreased systemic (p<0.001) and intracranial (p=0.013) levels of VCAM1 were associated with the presence of hypertension. Intracranial VCAM1 was positively correlated to both infarct volume (p=0.032; r=0.34) and edema volume (p=0.026; r=0.35). The %∆ in NIHSS from admittance to discharge was found to be significantly correlated to both systemic (p=0.013; r = -0.409) and intracranial (p=0.011; r = -0.421) VCAM1 levels indicating elevated levels of systemic and intracranial VCAM1 are associated with reduced improvement of stroke severity based on NIHSS from admittance to discharge. STRING-generated analyses identified biologic functional descriptions as well as function-associated proteins from the predictive models of infarct and edema volume.ConclusionsThe current study provides novel data on systemic and intracranial VCAM1 in relation to stroke comorbidities, stroke severity, functional outcomes, and the role VCAM1 plays in complex protein-protein signaling pathways. These data will allow future studies to develop predictive biomarkers and proteomic targets for drug development to improve our ability to treat a devastating pathology.
| S-EPMC8111916 | biostudies-literature
Project description:ObjectivesTo investigate the relationship between the initiation time of anticoagulation after endovascular treatment (EVT) and the outcomes in atrial fibrillation (AF)-related acute ischemic stroke (AIS) patients.MethodsIn this prospective registry study, from March 2013 to June 2022, patients with anterior circulation territories AF-related AIS who underwent EVT within 24 h were included. The primary outcome was favorable [modified Rankin Scale (mRS) 0-1) at ninety days and the secondary outcome was hemorrhage events after anticoagulants. Factors affecting the outcomes were pooled into multivariate regression and ROC curve analysis.ResultsOf 234 eligible patients, there were 63 (26.9%) patients achieved a favorable outcome. The symptomatic intracranial hemorrhage (sICH), ICH, and systemic hemorrhage events after anticoagulants occurred in 8 (3.4%), 28 (12.0%), and 39 (16.7%) patients, severally. A longer EVT to anticoagulation time (p = 0.033) was associated with an unfavorable outcome (mRS 3-6). An earlier EVT to anticoagulation time was the independent risk factor of sICH (p = 0.043), ICH (p = 0.005), and systemic hemorrhage (p = 0.005). There was no significant difference in recurrent AIS/ transient ischemic attack (TIA) or mortality among patients who started anticoagulation at ≤ 4 days, ≥ 15 days, or 4 to 15 days. The optimum cut-off for initiating anticoagulants to predict a favorable outcome and hemorrhage events was 4.5 days and 3.5 days after EVT, respectively.ConclusionsIn AF-related AIS, the time of EVT to anticoagulation is an independent factor of the functional outcome and hemorrhage events after anticoagulation. The optimal initiate time of anticoagulant after EVT is 4.5 days.ClinicaltrialregisterNCT03754738.
| S-EPMC10025205 | biostudies-literature