Safety and outcome after thrombolytic treatment in ischemic stroke patients with high-risk cardioembolic sources and prior subtherapeutic warfarin use

Lee, Jung Hwan; Jung, Yo Han; Choi, Hye Yeon; Nam, Chung Mo; Yang, Jae Hyuk; Cho, Han Jin; Nam, Hyo Suk; Lee, Ki Young; Heo, Ji Hoe

doi:10.1016/j.jns.2010.07.025

Cited by 25 publications

(20 citation statements)

References 26 publications

(25 reference statements)

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“…Two relatively small multicenter registries and several single-center case series have shown widely varied rates of sICH (0%-36%) in patients taking warfarin with subtherapeutic INR at the time of thrombolysis. 157,177,[179][180][181][182][183][184][185][186] In 2 meta-analyses, the larger of which included 284 patients, the OR for sICH was increased for warfarin-treated patients (OR, 2.6; 95% CI, 1.1-5.9; and aOR, 4.1; 95% CI, 1-16.1), but both of these analyses were not adjusted for potential confounders. 184,187 Data from 2 large registries (GWTG and Safe Implementation of Thrombolysis in Stroke-International Stroke Thrombolysis Register [SITS-ISTR]) indicate that although patients on warfarin do have higher crude rates of sICH than those not taking warfarin, when confounders such as stroke severity, older age, and comorbidities are considered, warfarin treatment with subtherapeutic INR does not independently increase the risk of sICH.…”

Section: Warfarinmentioning

confidence: 99%

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke

Demaerschalk¹,

Kleindorfer²,

Adeoye³

et al. 2016

Stroke

566

237

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Purpose-To critically review and evaluate the science behind individual eligibility criteria (indication/inclusion and contraindications/exclusion criteria) for intravenous recombinant tissue-type plasminogen activator (alteplase) treatment in acute ischemic stroke. This will allow us to better inform stroke providers of quantitative and qualitative risks associated with alteplase administration under selected commonly and uncommonly encountered clinical circumstances and to identify future research priorities concerning these eligibility criteria, which could potentially expand the safe and judicious use of alteplase and improve outcomes after stroke. Methods-Writing group members were nominated by the committee chair on the basis of their previous work in relevant topic areas and were approved by the American Heart Association Stroke Council's Scientific Statement Oversight Committee and the American Heart Association's Manuscript Oversight Committee. The writers used systematic literature reviews, references to published clinical and epidemiology studies, morbidity and mortality reports, clinical and public health guidelines, authoritative statements, personal files, and expert opinion to summarize existing evidence and to indicate gaps in current knowledge and, when appropriate, formulated recommendations using standard American Heart Association criteria. All members of the writing group had the opportunity to comment on and approved the final version of this document. The document underwent extensive American Heart Association internal peer review, Stroke The American Heart Association makes every effort to avoid any actual or potential conflicts of interest that may arise as a result of an outside relationship or a personal, professional, or business interest of a member of the writing panel. Specifically, all members of the writing group are required to complete and submit a Disclosure Questionnaire showing all such relationships that might be perceived as real or potential conflicts of interest.This statement was approved by the American Heart Association Science Advisory and Coordinating Committee on September 24, 2015, and the American Heart Association Executive Committee on October 5, 2015. A copy of the document is available at http://my.americanheart.org/statements by selecting either the "By Topic" link or the "By Publication Date" link. To purchase additional reprints, call 843-216-2533 or e-mail kelle.ramsay@ wolterskluwer.com.The online-only Data Supplement, which contains literature search strategies and Figures A, B, and C, is available with this article at http://circ. ahajournals.org/lookup/suppl/doi:10.1161/STR.0000000000000086/-/DC1.The American Heart Association requests that this document be cited as follows: Demaerschalk BM, Kleindorfer DO, Adeoye OM, Demchuk AM, Fugate JE, Grotta JC, Khalessi AA, Levy EI, Palesch YY, Prabhakaran S, Saposnik G, Saver JL, Smith EE; on behalf of the American Heart Association Stroke Council and Council on Epidemiology and Prevention. Scientific rational...

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Section: Warfarinmentioning

confidence: 99%

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke

Demaerschalk¹,

Kleindorfer²,

Adeoye³

et al. 2016

Stroke

566

237

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“…However, the differences were not statistically significant. It is of note that in these 2 studies [10,12] the rate of symptomatic hemorrhage was very high (31 and 15%, respectively) in the anticoagulated patients compared to 3 and 8%, respectively, in those not anticoagulated. In our series of patients, the rate of hemorrhage was much lower despite the levels of INR being higher; and this cannot be explained by differences in the clinical characteristics of the patients since these were very similar.…”

Section: Discussionmentioning

confidence: 98%

“…Neither did we encounter a greater risk of bleeding associated with the higher levels of INR, albeit the numbers of patients treated with INR >1.5, and more especially >1.7, are very low and, as such, these findings need to be interpreted with caution. The few previous studies that evaluated this risk had contradictory findings, or were inconclusive because of small patient samples that can lead to type I and type II errors [10,11,12,13,14,15]. Three retrospective studies with small sample size suggested that systemic thrombolysis was safe in patients previously anticoagulated [11,13,14,20].…”

Section: Discussionmentioning

confidence: 99%

“…Only 1 study demonstrated a significant increase in the risk of SICH even with values of INR <1.7 (range: 1.04-1.61) [10]. Another study [12] showed an almost 2-fold increase in the number of SICH among the patients receiving warfarin with low levels of INR (median: 1.14; interquartile range: 1.02-1.42). However, the differences were not statistically significant.…”

Section: Discussionmentioning

confidence: 99%

“…Hence it is important to define the safety profile of systemic thrombolysis in these clinical situations. However, the literature on this aspect is scant [10,11,12,13,14,15]. We conducted the present study to evaluate the efficacy and safety of intravenous thrombolysis in patients under prior oral anticoagulant (OA) treatment with acenocoumarol, and in patients who had previously received LMWH.…”

Section: Introductionmentioning

confidence: 99%

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Safety and Outcomes following Thrombolytic Treatment in Stroke Patients Who Had Received Prior Treatment with Anticoagulants

Matute¹,

Masjuán²,

Egido³

et al. 2012

Cerebrovasc Dis

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Background: Information is scare regarding the safety of intravenous thrombolysis in patients under anticoagulant treatment, given that this is an exclusion criterion in clinical trials. We analyzed the risk of hemorrhagic complications following thrombolysis in patients under treatment with low-molecular-weight heparins (LMWH) and oral anticoagulants (OA). Methods: In a multicentered prospective study of consecutive acute stroke patients treated with intravenous alteplase we recorded age, gender, baseline NIHSS score, treatment delay, risk factors, etiology and previous therapy. The neurological progress (National Institutes of Health Stroke Scale at 7 days) and functional evolution at 3 months (modified Rankin Scale score), mortality and symptomatic intracerebral hemorrhage (SICH) were compared between patients with LMWH or OA and those without prior anticoagulant therapy. Results: Of the 1,482 patients, 21 (1.4%) had received LMWH and 70 (4.7%) OA (international normalized ratio, INR, 0.9-2.0). Patients on OA were older, presented higher basal glucose levels, had been treated later and had a higher prevalence of hypertension, dyslipidemia, prior stroke, atrial fibrillation and cardioembolic pathologies. The severity of stroke on admission was similar in the different groups. The percentages of patients achieving independence (mRS 0-2) at 3 months were 33, 44 and 58 (LMWH, OA and no prior anticoagulant treatment, respectively; p = 0.02 for both comparisons of LMWH vs. no treatment and OA vs. no treatment); the mortality rates were 30, 25 and 12% (p = 0.010, p = 0.001, respectively) and the SICH were 14, 3 and 2% (p < 0.0001 for comparison of LMWH vs. no treatment). In the case of treatment with OA, the outcomes were independent of the INR value. Following adjustment for confounding variables, the prior use of OA was associated with higher mortality (OR: 2.15, 95% CI: 1.1-4.2; p = 0.026) but not with SICH transformation or lower probability of independence. The use of LMWH was associated with higher mortality (OR: 5.3, 95% CI: 1.8-15.5; p = 0.002), risk of SICH (OR: 8.4, 95% CI: 2.2-32.2; p = 0.002) and lower probability of achieving independence (OR: 0.3, 95% CI: 0.1-0.97; p = 0.043). Conclusions: The use of intravenous thrombolysis appears to be safe in patients previously treated with OA with INR levels <2 since there is no increase in SICH. The prior use of LMWH appears to increase the risk of SICH, death and dependence and, as such, the decision for systemic treatment with thrombolytic agents needs to be taken with caution in these cases. Larger case series are necessary to confirm these findings.

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Risks of Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Receiving Warfarin and Treated With Intravenous Tissue Plasminogen Activator

Xian¹,

Li²,

Smith³

et al. 2012

JAMA

147

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Safety and outcome after thrombolytic treatment in ischemic stroke patients with high-risk cardioembolic sources and prior subtherapeutic warfarin use

Cited by 25 publications

References 26 publications

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke

Scientific Rationale for the Inclusion and Exclusion Criteria for Intravenous Alteplase in Acute Ischemic Stroke

Safety and Outcomes following Thrombolytic Treatment in Stroke Patients Who Had Received Prior Treatment with Anticoagulants

Risks of Intracranial Hemorrhage Among Patients With Acute Ischemic Stroke Receiving Warfarin and Treated With Intravenous Tissue Plasminogen Activator

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