Five years of thrombolysis in a Chilean hospital: leading a local initiative towards a national public health policy
T. Ernesto FigueroaDaniel Martinez SaezE. MansillaM. AlvaradoJoyce BarraCristian GonzálezJ GonzálezPablo J. Martín RodríguezOscar TrujilloPatricia LilloIris Delgado
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Thrombolysis with administration of intravenous (IV) recombinant tissue plasminogen activator (rtPA) has been performed in some tertiary care hospitals in Iran in recent decade. Mininstery of Health and Medical Education of Iran approved a new management strategy which covers the cost of Alteplase since 2015. This is a great advance in increasing chance for Iranian stroke patients to get the treatment. Delay in performing triage and CT and laboratory tests is another limiting factor which can be decreased by defining special team members for thrombolysis. Most of the Iranian neurologists are not expert for performing the management. This limitation can be managed by continous thrombolysis work shops. However many of the Neurologists may not be interested to do the thrombolysis due to its risks and lack of financial benefits for responsible doctor. Most of the contraindications for thrombolysis with tPA originated as exclusion criteria in famous clinical trials. These were derived from expert consensus for the National Institute of Neurological Disorders and Stroke (NINDS) trial. Despite the fact that the safety and efficacy of IV rtPA has been repeatedly confirmed in large international observational studies over the past 20 years, most patients with acute ischemic stroke still do not receive thrombolytic treatment. Some of the original exclusion criteria have proven to be unnecessarily restrictive in real-world clinical practice. It has been suggested that application of relaxed exclusion criteria might increase the IV thrombolysis rate up to 20% with comparable outcomes to thrombolysis with more conventional criteria. We review the absolute and relative contraindications to IV rtPA for acute ischemic stroke, discussing the underlying rationale and evidence supporting these exclusion criteria. There are two therapeutic strategies for selecting the contraindications and exclusion criteria. Flexible method is ignoring some absolute or partial exclusion critera as illustrated above. This method will increase the probability of symptomatic intracerebral hemorrhage and death and may increase numbers of legal condemnations for treating physician. Rigid method is prohibition of violations from standard protocols of thrombolysis which decreases both numbers of managed patients and thrombolysis contraindications. Physicians who prefer the first therapeutic strategy refer to data of published articles and guidelines of American and European stroke societies. There are two points of view; first, the Iranian neurologists do not have thrombolysis experience as well as western neurologusts. For instance very limited number of Iranian neurologists have enough experience for detection of ASPECT score. Second, due to some social factors number of legal condemnations due to medical malpractice has been hugely increased in recent two decades in Iran. Based on these points second strategy is more wise for Iranian neurologists. The speaker has made a standard protocol of thrombolysis based on international gudelines and his experience. This standard protocol which is designed according to the rigid method is available by search in Google engine and is provided in Persian language.
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Introduction: The encouraging efficacy and safety data on intravenous thrombolysis with tenecteplase in ischemic stroke and its practical advantages motivated our centers to switch from alteplase to tenecteplase. We report its impact on treatment times and clinical outcomes. Methods: We retrospectively analyzed clinical and procedural data of patients treated with alteplase or tenecteplase in a comprehensive (CSC) and a primary stroke center (PSC), which transitioned respectively in 2019 and 2018. Tenecteplase enabled in-imaging thrombolysis in the CSC. The main outcomes were the imaging-to-thrombolysis and thrombolysis-to-puncture times. We assessed the association of tenecteplase with 3-month functional independence and parenchymal hemorrhage (PH) with multivariable logistic models. Results: We included 795 patients, 387 (48.7%) received alteplase and 408 (51.3%) tenecteplase. Both groups (tenecteplase vs alteplase) were similar in terms of age (75 vs 76 years), baseline NIHSS score (7 vs 7.5) and proportion of patients treated with mechanical thrombectomy (24.1% vs 27.5%). Tenecteplase patients had shorter imaging-to-thrombolysis times (27 vs 36 min, p < 0.0001) mainly driven by patients treated in the CSC (22 vs 38 min, p < 0.001). In the PSC, tenecteplase patients had shorter thrombolysis-to-puncture times (84 vs 95 min, p = 0.02), reflecting faster interhospital transfer for MT. 3-month functional independence rate was higher in the tenecteplase group (62.8% vs 53.4%, p < 0.01). In the multivariable analysis, tenecteplase was significantly associated with functional independence (OR a 1.68, 95% CI 1.15–2.48, p < 0.01), but not with PH (OR a 0.68, 95% CI 0.41–1.12, p = 0.13). Conclusion: Switch from alteplase to tenecteplase reduced process times and may improve functional outcome, with similar safety profile.
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Effect of Intravenous Thrombolysis on MRI Parameters and Functional Outcome in Acute Stroke <6 Hours
Background and Purpose— The goals of this study were to examine MRI baseline characteristics of patients with acute ischemic stroke (AIS) and to study the influence of intravenous tissue plasminogen activator (tPA) on MR parameters and functional outcome using a multicenter approach. Methods— In this open-label, nonrandomized study of AIS patients with suspected anterior circulation stroke, subjects received a multiparametric stroke MRI protocol (diffusion- and perfusion-weighted imaging and MR angiography) within 6 hours after symptom onset and on follow-up. Patients were treated either with tPA (thrombolysis group) or conservatively (no thrombolysis group). Functional outcome was assessed on day 90 (modified Rankin Score; mRS). Results— We enrolled 139 AIS patients (no thrombolysis group, n=63; thrombolysis group, n=76). Patients treated with tPA were more severely affected (National Institutes of Health Stroke Scale score, 10 versus 13; P =0.002). Recanalization rates were higher in the thrombolysis group (Thrombolysis in Myocardial Infarction criteria 1 through 3 on day 1; 66.2% versus 32.7%; P <0.001). Proximal vessel occlusions resulted in larger infarct volumes and worse outcome ( P =0.02). Thrombolysis was associated with a better outcome regardless of the time point of tPA treatment (≤3 hours or 3 to 6 hours) (univariate analysis: mRS ≤2, P =0.017; mRS ≤1, P =0.023). Age ( P =0.003), thrombolytic therapy at 0 to 6 hours ( P =0.01), recanalization ( P =0.016), lesion volume on day 7 ( P =0.001), and initial National Institutes of Health Stroke Scale score ( P =0.001) affected functional outcome (mRS on day 90) positively (multivariate analysis). The time point of tPA therapy affected the recanalization rate ( P =0.024) but not final infarct volume. Conclusions— In this pilot study, tPA therapy had a beneficial effect on vessel recanalization and functional outcome. Multiparametric MRI delineates tissue at risk of infarction in AIS patients, which may be helpful for the selection of patients for tPA therapy. tPA therapy appeared safe and effective beyond a 3-hour time window. This study delivers the rationale for a randomized, MR-based tPA trial.
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Although 8 yr have passed since the Food and Drug Administration (FDA) released tissue plasminogen activator (t-PA) for use in the United States to treat patients with acute ischemic stroke, thrombolysis is still very controversial. Clearly, thrombolysis is a step forward but there remain problems with its use, and with the guidelines and policies that direct its application.
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Tenecteplase is a modied tissue plasminogen activator and newer thrombolytic agent. It has a longer half life ,which is more brin specic, produces less systemic depletion of circulating brinogen, and is more resistant to plasminogen activator inhibitor. Because of its pharmacodynamic properties which results in rapid reperfusion and lower intracranial hemorrhages. Hence the objective is to study the efcacy of tenectaplase in acute ischemic stroke including, neurological and functional outcome at 3 months which is assessed by mRS scale and also to know the complications arising out of thrombolysis with tenectaplase. This is Methods- prospective observational study of 40 cases of acute ischemic stroke undergoing thrombolysis with tenecteplase within 4.5 hours of onset. Dose of 0.2 mg /kg of tenecteplase was used for thrombolysis and outcome was evaluated with improvement in NIHSS score at arrival , 24 hrs, 1 week and at discharge, 1 and 3 month and mRS scale at 1 and 3 months. In our study, 67.5% (27 out of 40) patients met the primary clinical efcacy outc Result- ome by achieving an improvement in NIHSS score of 4 or more points at 24 h and 67% (27out of 40 patients) met the secondary clinical efcacy outcome by having an mRS scale of 0 or 1 at 3 months. Adverse events were noted in 7 patients (17.5%) of which 4 developed ICH and 3 patients showed poor clinical outcome. ConclusionTenecteplase appears to be a safe and effective agent for acute ischemic stroke because of signicant improvement in NIHSS , low disability rates were observed in the present study
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This article reports the first case of a patient presenting with acute myocardial infarction in whom a repeated dose of tissue plasminogen activator (t-PA) was able to achieve successful thrombolysis after a first dose of t-PA itself failed to do so. This case report presents an alternative approach for the treatment of patients who fail thrombolysis after an initial dose of t-PA, an approach that might be particularly useful in hospitals that do not have immediate access to advanced interventional services.
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