Dataset Information

Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III.

ABSTRACT:

Background

Examination of linked data on patient outcomes and cost of care may help identify areas where stroke care can be improved. We report on the association between variations in stroke severity, patient outcomes, cost, and treatment patterns observed over the acute hospital stay and through the 12-month follow-up for subjects receiving endovascular therapy compared to intravenous tissue plasminogen activator alone in the IMS (Interventional Management of Stroke) III Trial.

Methods and results

Prospective data collected for a prespecified economic analysis of the trial were used. Data included hospital billing records for the initial stroke admission and subsequent detailed resource use after the acute hospitalization collected at 3, 6, 9, and 12 months. Cost of follow-up care varied 6-fold for patients in the lowest (0-1) and highest (20+) National Institutes of Health Stroke Scale category at 5 days, and by modified Rankin Scale at 3 months. The kind of resources used postdischarge also varied between treatment groups. Incremental short-term cost-effectiveness ratios varied greatly when treatments were compared for patient subgroups. Patient subgroups predefined by stroke severity had incremental cost-effectiveness ratios of $97 303/quality-adjusted life year (severe stroke) and $3 187 805/quality-adjusted life year (moderately severe stroke).

Conclusions

Detailed economic and resource utilization data from IMS III provide powerful evidence for the large effect that patient outcome has on the economic value of medical and endovascular reperfusion therapies. These data can be used to inform process improvements for stroke care and to estimate the cost-effectiveness of endovascular therapy in the US health system for stroke intervention trials.

Clinical trial registration

URL: http://www.clinicaltrials.gov. Registration number: NCT00359424.

SUBMITTER: Simpson KN

PROVIDER: S-EPMC5524059 | biostudies-literature | 2017 May

REPOSITORIES: biostudies-literature

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Publications

Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III.

Simpson Kit N KN Simpson Annie N AN Mauldin Patrick D PD Palesch Yuko Y YY Yeatts Sharon D SD Kleindorfer Dawn D Tomsick Thomas A TA Foster Lydia D LD Demchuk Andrew M AM Khatri Pooja P Hill Michael D MD Jauch Edward C EC Jovin Tudor G TG Yan Bernard B von Kummer Rüdiger R Molina Carlos A CA Goyal Mayank M Schonewille Wouter J WJ Mazighi Mikael M Engelter Stefan T ST Anderson Craig C Spilker Judith J Carrozzella Janice J Ryckborst Karla J KJ Janis L Scott LS Broderick Joseph P JP

Journal of the American Heart Association 20170508 5

<h4>Background</h4>Examination of linked data on patient outcomes and cost of care may help identify areas where stroke care can be improved. We report on the association between variations in stroke severity, patient outcomes, cost, and treatment patterns observed over the acute hospital stay and through the 12-month follow-up for subjects receiving endovascular therapy compared to intravenous tissue plasminogen activator alone in the IMS (Interventional Management of Stroke) III Trial.<h4>Meth ...[more]

PMID: 28483774

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Project description:Background and purposeEndovascular strategies provide unique opportunity to correlate angiographic measures of collateral circulation at the time of endovascular therapy. We conducted systematic analyses of collaterals at conventional angiography on recanalization, reperfusion, and clinical outcomes in the endovascular treatment arm of the Interventional Management of Stroke (IMS) III trial.MethodsProspective evaluation of angiographic collaterals was conducted via central review of subjects treated with endovascular therapy in IMS III (n=331). Collateral grade before endovascular therapy was assessed with the American Society of Interventional and Therapeutic Neuroradiology/Society of Interventional Radiology scale, blinded to all other data. Statistical analyses investigated the association between collaterals with baseline clinical variables, angiographic measures of recanalization, reperfusion and clinical outcomes.ResultsAdequate views of collateral circulation to the ischemic territory were available in 276 of 331 (83%) subjects. Collateral grade was strongly related to both recanalization of the occluded arterial segment (P=0.0016) and downstream reperfusion (P<0.0001). Multivariable analyses confirmed that robust angiographic collateral grade was a significant predictor of good clinical outcome (modified Rankin Scale score≤2) at 90 days (P=0.0353), adjusted for age, history of diabetes mellitus, National Institutes of Health Stroke Scale strata, and Alberta Stroke Program Early CT Score. The relationship between collateral flow and clinical outcome may depend on the degree of reperfusion.ConclusionsMore robust collateral grade was associated with better recanalization, reperfusion, and subsequent better clinical outcomes. These data, from the largest endovascular trial to date, suggest that collaterals are an important consideration in future trial design.Clinical trial registration urlhttp://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Project description:Background and purposeThe Interventional Management of Stroke (IMS)-III trial randomized patients with acute ischemic stroke to intravenous tissue-type plasminogen activator (tPA) plus endovascular therapy versus intravenous tPA therapy alone within 3 hours from symptom onset. A predefined secondary hypothesis was that subjects with significant early ischemic change on the baseline scan would not respond to endovascular therapy.MethodsThe primary outcome was 90-day modified Rankin Scale score 0 to 2. The baseline and follow-up computed tomographic (CT) scan images were reviewed centrally and blinded to any clinical information. We assessed whether the baseline Alberta Stroke Program Early CT Score (ASPECTS) predicted outcome and interacted with study treatment. We analyzed subgroups defined by time from onset to intravenous tPA initiation and baseline occlusion status at a prespecified α=0.01.ResultsBaseline demographic and clinical characteristics of 656 randomized patients were similar between subjects with a baseline ASPECTS 8 to 10 (58% of the study sample) versus 0 to 7. Subjects with ASPECTS 8 to 10 were almost twice as likely (relative risk, 1.8; 99% confidence interval, 1.4-2.4) to achieve a favorable outcome. There was insufficient evidence of a treatment-by-ASPECTS interaction. In those treated with onset to intravenous tPA <120 minutes, in CT angiography-proven internal carotid artery or middle cerebral artery occlusion, and in both, results were similar. The probability of achieving recanalization (arterial occlusion lesion, 2-3) of the primary arterial occlusive lesion (relative risk, 1.3; 99% confidence interval, 1.0-1.8) or achieving thrombolysis in cerebral ischemia score 2b/3 reperfusion (relative risk 2.0; 99% confidence interval, 1.2-3.2) was higher among subjects with higher ASPECTS.ConclusionsASPECTS is a strong predictor of outcome and a predictor of reperfusion. ASPECTS did not identify a subpopulation of subjects that particularly benefitted from endovascular therapy immediately after routine intravenous tPA.Clinical trial registration urlhttp://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Project description:The Fast Assessment of Stroke and Transient Ischemic Attack to Prevent Early Recurrence trial raised concern that loading doses of clopidogrel may increase hemorrhagic complications. We investigated if similar rates of hemorrhage occur in patients with acute ischemic stroke (AIS) of varying severity.Patients meeting inclusion criteria were divided into 2 groups: the LOAD group and non-LOAD group. The LOAD group was defined as patients who were administered a loading dose of 300 mg or more of clopidogrel with or without aspirin within 24 hours of admission. The non-LOAD group was devised using propensity score (PS): 55 patients who received a loading dose of clopidogrel of 300 mg or more were matched on PS to 55 patients who did not receive loading doses. These patients were taken from a pool of 341 consecutive ischemic patients ineligible for intravenous or intra-arterial fibrinolysis, 162 of whom received a clopidogrel loading dose and the remainder of whom did not. The frequency of hemorrhage was compared between the 2 groups using Student t test and chi-square. Logistic regression was used to assess the relationship between loading dose and serious bleeding events (symptomatic intracerebral hemorrhage [sICH] or transfusion for systemic bleeding).AIS patients (N = 596) were screened during the 31-month period of this retrospective study. Of this sample, 170 patients were excluded: 149 patients were excluded because they were treated with intravenous tissue plasminogen activator (IV t-PA) alone, 11 were excluded because they were treated with IV t-PA combined with intra-arterial therapy (IAT), and 10 were excluded for treatment with IAT alone. An additional 85 patients were excluded because they were not admitted to the stroke service or because they had an in-hospital stroke. Baseline characteristics of the groups were well matched. There were no significant differences in the rates of sICH, transfusion, hemorrhagic transformation, or systemic bleeding. Clopidogrel loading was not associated with increased odds of serious bleeding events in the crude model (odds ratio [OR] .92, 95% confidence interval [CI] .27-3.13) or after adjusting for covariates and confounders of interest (OR 1.06, 95% CI .28-4.04).Contrary to our original hypothesis, patients with AIS receiving clopidogrel loading doses within 24 hours of symptom onset did not appear to experience a higher rate of new serious bleeding events during acute hospitalization when compared with patients who did not receive loading doses. The Platelet-Oriented Inhibition in New TIA and Minor Ischemic Stroke trial is expected to provide insight into the safety of clopidogrel loading as an acute intervention after cerebral ischemia.

Project description:Background and purposeGeneral anesthesia (GA) for endovascular therapy (EVT) of acute ischemic stroke may be associated with worse outcomes.MethodsThe Interventional Management of Stroke III trial randomized patients within 3 hours of acute ischemic stroke onset to intravenous tissue-type plasminogen activator±EVT. GA use within 7 hours of stroke onset was recorded per protocol. Good outcome was defined as 90-day modified Rankin Scale ≤2. A multivariable analysis adjusting for dichotomized National Institutes of Health Stroke Scale (NIHSS; 8-19 versus ≥20), age, and time from onset to groin puncture was performed.ResultsFour hundred thirty-four patients were randomized to EVT, 269 (62%) were treated under local anesthesia and 147 (33.9%) under GA; 18 (4%) were undetermined. The 2 groups were comparable except for median baseline NIHSS (16 local anesthesia versus 18 GA; P<0.0001). The GA group was less likely to achieve a good outcome (adjusted relative risk, 0.68; confidence interval, 0.52-0.90; P=0.0056) and had increased in-hospital mortality (adjusted relative risk, 2.84; confidence interval, 1.65-4.91; P=0.0002). Those with medically indicated GA had worse outcomes (adjusted relative risk, 0.49; confidence interval, 0.30-0.81; P=0.005) and increased mortality (relative risk, 3.93; confidence interval, 2.18-7.10; P<0.0001) with a trend for higher mortality with routine GA. There was no significant difference in the adjusted risks of subarachnoid hemorrhage (P=0.32) or symptomatic intracerebral hemorrhage (P=0.37).ConclusionsGA was associated with worse neurological outcomes and increased mortality in the EVT arm; this was primarily true among patients with medical indications for GA. Relative risk estimates, though not statistically significant, suggest reduced risk for subarachnoid hemorrhage and symptomatic intracerebral hemorrhage under local anesthesia. Although the reasons for these associations are not clear, these data support the use of local anesthesia when possible during EVT.Clinical trial registrationURL: http://www.clinicaltrials.gov. Unique identifier: NCT00359424.

Project description:PurposeNational guidelines recommend prompt identification of candidates for acute ischemic stroke (AIS) treatment, requiring timely neuroimaging with CT and/or MRI. CT is often preferred because of its widespread availability and rapid acquisition. Despite higher diagnostic accuracy of MRI, it commonly involves complex workflows that could potentially cause treatment time delays. The purpose of this study was to analyze the impact on outcomes of imaging utilization before treatment decisions at comprehensive stroke centers for patients presenting with suspected AIS in the anterior circulation with last-known-well-to-arrival time 0 to 24 hours.MethodsA decision simulation model based on the American Heart Association's recommendations for AIS care pathways was developed from a health care perspective to compare initial imaging strategies: (1) stepwise-CT: noncontrast CT (NCCT) at the time of presentation, with CT angiography (CTA) ± CT perfusion (CTP) only in select patients (initial imaging to exclude hemorrhage and extensive ischemia) for mechanical thrombectomy (MT) evaluation; (2) stepwise-hybrid: NCCT at the time of presentation, with MR angiography (MRA) ± MR perfusion (MRP) only for MT evaluation; (3) stepwise-advanced: NCCT + CTA at presentation, with MR diffusion-weighted imaging (MR DWI) + MRP only for MT evaluation; (4) comprehensive-CT: NCCT + CTA + CTP at the time of presentation; and (5) comprehensive-MR: MR DWI + MRA + MRP at the time of presentation. Model parameters were defined using evidence-based data. Cost-effectiveness and sensitivity analyses were performed.ResultsThe cost-effectiveness analyses revealed that comprehensive-CT and comprehensive-MR yield the highest lifetime quality-adjusted life-years (QALYs) (4.81 and 4.82, respectively). However, the incremental cost-effectiveness ratio of comprehensive-MR is $233,000/QALY compared with comprehensive-CT. Stepwise-CT, stepwise-hybrid, and stepwise-advanced strategies are dominated, yielding lower QALYs and higher costs compared with comprehensive-CT.ConclusionsPerforming comprehensive-CT at presentation is the most cost-effective initial imaging strategy at comprehensive stroke centers.

Dataset Information

Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III.

Background

Methods and results

Conclusions

Clinical trial registration

Publications

Observed Cost and Variations in Short Term Cost-Effectiveness of Therapy for Ischemic Stroke in Interventional Management of Stroke (IMS) III.

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