Safety of Tirofiban in Acute Ischemic Stroke

Siebler, Mario; Hennerici, Michael G.; Schneider, Dietmar; Reutern, G. M. von; Seitz, Rüdiger J.; Röther, Joachim; Witte, Otto W.; Hamann, Gerhard F.; Junghans, Ulrich; Villringer, Arno; Fiebach, Jochen B.

doi:10.1161/strokeaha.110.599662

Cited by 150 publications

(104 citation statements)

References 27 publications

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“…A SaTIS study comparing tirofiban with placebo on patients with NIHSS score of 4-18 has reported the average time length between the onset of symptoms and progression as 9.25 hours, whereas in our study, the mentioned average time length was determined as 27.85 hours (10). In the SaTIS study , the reliability and efficacy of tirofiban compared to placebo were assessed, but the early and long-term efficacy of the drug according to stroke subgroups were not evaluated (10).…”

Section: Discussioncontrasting

confidence: 73%

“…The SaTIS study reported symptomatic intracerebral hemorrhage in 1.6% of the cases. In our study, symptomatic intracerebral hemorrhage did not occur in any of our patients (10). The macroscopic hematuria seen in two patients in the first 24 hours of the therapy was associated with use of urinary catheter.…”

Section: Discussionsupporting

confidence: 41%

“…The progression occured on average 27.85 hours (6-72 hours) after the onset of stroke symptoms. The average NIHSS score at hour 1 of admission was 7.14 (2-6); the score at the time of progression occurence was 10.21 (5-21) with an average NIHSS increase of 3.07 (2-11); at 24 hours after administration of tirofiban, the score was 9.79 (3)(4)(5)(6)(7)(8)(9)(10)(11)(12)(13)(14)(15)(16)(17)(18)(19), and on discharge the score was 9.46 (1-18) (Figure 1). In the evaluation of the patient groups in terms of stroke subtypes, the NIHSS score was found to be highest in the cardioembolic stroke group and lowest in the small vessel disease group.…”

Section: Resultsmentioning

confidence: 99%

“…In the SaTIS study , the reliability and efficacy of tirofiban compared to placebo were assessed, but the early and long-term efficacy of the drug according to stroke subgroups were not evaluated (10). As result, the study reported that tirofiban was not very effective in the early stage of stroke, but the mortality rate in the 5-month follow-up was low with tirofiban therapy, when compared to other therapies (10).…”

Section: Discussionmentioning

confidence: 99%

“…The criteria for inclusion in the study were: presence of minor or medium-degree stroke on admission [with National Institute of Health Stroke Scale (NIHSS) score of [2][3][4][5][6][7][8][9][10][11][12][13][14][15][16][17][18], final diagnosis of PIS, age range of 18-80, contraindication for thrombolytic therapy, tirofiban use for therapy, and reachable control data at the end of the 3. month. The criteria for exclusion from the study were history of cerebral or extracerebral hemorrhage, known intracranial disease (such as arteriovenous malformation, neoplasm, aneurysm), liver disease, thrombocytopenia (platelet number <100.000), platelet dysfunction, major trauma, major surgery in the last 3 months, and past stroke; coagulopathy [prothrombin time (PT) >1.3 times of the normal and international normalized ratio (INR) >1.3].…”

Section: Methodsmentioning

confidence: 99%

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Progressive Ischemic Stroke: Clinical Features and Evaluation of Short-and Long- Term Tirofiban Therapy

Demır¹,

Balal²,

Pak³

et al. 2016

Türk Beyin Damar Hast Derg

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OBJECTIVE: Progressive ischemic stroke is a disorder frequently seen in neurological intensive care unit and stroke units. The purpose of this retrospective study was to evaluate the clinical features of progressive ischemic stroke patients in neurological intensive care unit, the short-and long-term efficacy of tirofiban therapy, and the adverse events observed. METHODS: The study included patients with minor-moderate progressive ischemic stroke diagnosed in the period between January and December 2014. The National Institute of Health Stroke Scale scores at 24 hours after tirofiban therapy and on discharge, and the modified Rankin score and Barthel Index value at the end of the 3. month were recorded from the patients' files. RESULTS: The study included a total of 28 patients, 15 (53.6%) of whom were males. The mean age of the cases was 65.36±11.32 (39-80). According to the TOAST classification, 10 cases had large vessel atherosclerosis, 9 had cardioembolism, and 9 had small vessel disease. When the groups were evaluated in terms of stroke subtypes, the NIHSS score was highest in the cardioembolic group and lowest in the small vessel disease group. The cases in the small vessel disease group demonstrated the most marked fall in NIHSS score. CONCLUSION: Tirofiban may be an alternative therapy for progressive ischemic stroke in case of proper selection of patients and under proper monitorization to detect side effects. Keywords: Barthel index, progressive ischemic stroke, Tirofiban. PROGRESİF İSKEMİK İNME: KLİNİK ÖZELLİKLER VE TİROFİBAN TEDAVİSİNİN KISA VE UZUN DÖNEM ETKİNLİĞİNİN DEĞERLENDİRİLMESİÖZET AMAÇ: Progresif iskemik inme nörolojik yoğun bakım ve inme ünitelerinde sıklıkla karşılaşılan bir klinik durumdur. Retrospektif olarak planlanan bu çalışmanın amacı progresif iskemik inmenin klinik özelliklerinin, tirofiban tedavisinin kısa ve uzun dönem etkinliğinin ve komplikasyonların değerlendirilmesidir. GEREÇ ve YÖNTEM: Ocak 2014-Aralık 2014 tarihleri arasında hafif ve orta şiddetli progresif iskemik inme tanısı alan hastalar çalışmaya alınmıştır. Hastaların dosya bilgilerinden tirofiban tedavisi ve taburculuk esnasında NIHSS skoru, 3. ayda ise modifiye Rankin skoru ve Barthel indeksi değerleri hesaplanmıştır. BULGULAR: Yirmi sekiz hastadan oluşan çalışmada 15 hasta(% 53,6) kadın idi. Hastaların yaş ortalaması 65,36 ± 11,32 (39-80) idi. TOAST sınıflamasına göre inme etiyolojileri 10 hastada büyük arter aterosklerozu, 9 hastada kardiyoembolizm ve 9 hastada küçük damar hastalığı olarak belirlendi. İnme etiyolojilerine göre değerlendirildiğinde NIHSS skoru kardiyoembolizm grubunda en yüksek iken küçük damar hastalığı grubunda en düşük olarak hesaplandı. Etiyolojide küçük damar hastalığı olan olgularda tedavi sonrası NIHSS skorundaki düşme en fazla olarak belirlendi. SONUÇ: Progresif iskemik inme hastalarında uygun hasta ve yan etkilerin dikkatli takibi ile tirofiban iyi bir tedavi alternatifi olabilir. Anahtar Sözcükler: Barthel indeksi, progresif iskemik inme, Tirofiban.

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Section: Discussioncontrasting

confidence: 73%

Section: Discussionsupporting

confidence: 41%

Section: Resultsmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Progressive Ischemic Stroke: Clinical Features and Evaluation of Short-and Long- Term Tirofiban Therapy

Demır¹,

Balal²,

Pak³

et al. 2016

Türk Beyin Damar Hast Derg

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Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke

et al. 2021

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IMPORTANCEThe underenrollment of women in randomized clinical trials represents a threat to the validity of the evidence supporting clinical guidelines and potential disparities in access to novel treatments. OBJECTIVE To determine whether women were underenrolled in contemporary randomized clinical trials of acute stroke therapies published in 9 major journals after accounting for their representation in underlying stroke populations.DATA SOURCES MEDLINE was searched for acute stroke therapeutic trials published between January 1, 2010, and June 11, 2020.STUDY SELECTION Eligible articles reported the results of a phase 2 or 3 randomized clinical trial that enrolled patients with stroke and/or transient ischemic attack and examined a therapeutic intervention initiated within 1 month of onset.DATA EXTRACTION Data extraction was performed by 2 independent authors in duplicate. Individual trials were matched to estimates of the proportion of women in underlying stroke populations using the Global Burden of Disease database. MAIN OUTCOMES AND MEASURESThe primary outcome was the enrollment disparity difference (EDD), the absolute difference between the proportion of trial participants who were women and the proportion of strokes in the underlying disease populations that occurred in women. Random-effects meta-analyses of the EDD were performed, and multivariable metaregression was used to explore the associations of trial eligibility criteria with disparity estimates. RESULTSThe search returned 1529 results, and 115 trials (7.5%) met inclusion criteria. Of 121 105 randomized patients for whom sex was reported, 52 522 (43.4%) were women. The random-effects summary EDD was −0.053 (95% CI, −0.065 to −0.040), indicating that women were underenrolled by 5.3 percentage points. This disparity persisted across virtually all geographic regions, intervention types, and stroke types, apart from subarachnoid hemorrhage (0.117 [95% CI, 0.084 to 0.150]). When subarachnoid hemorrhage trials were excluded, the summary EDD was −0.067 (95% CI, −0.078 to −0.057). In the multivariable metaregression analysis, an upper age limit of 80 years as an eligibility criterion was associated with a 6-percentage point decrease in the enrollment of women.CONCLUSIONS AND RELEVANCE Further research is needed to understand the causes of the underenrollment of women in acute stroke trials. However, to maximize representation, investigators should avoid imposing age limits on enrollment.

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Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke

Zhao,

Li,

et al. 2024

JAMA Neurol

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ImportanceEvidence supports using antiplatelet therapy in patients with acute ischemic stroke. However, neurological deterioration remains common under the currently recommended antiplatelet regimen, leading to poor clinical outcomes.ObjectiveTo determine whether intravenous tirofiban administered within 24 hours of stroke onset prevents early neurological deterioration in patients with acute noncardioembolic stroke compared with oral aspirin.Design, Setting, and ParticipantsThis investigator-initiated, multicenter, open-label, randomized clinical trial with blinded end-point assessment was conducted at 10 comprehensive stroke centers in China between September 2020 and March 2023. Eligible patients were aged 18 to 80 years with acute noncardioembolic stroke within 24 hours of onset and had a National Institutes of Health Stroke Scale (NIHSS) score of 4 to 20.InterventionPatients were assigned randomly (1:1) to receive intravenous tirofiban or oral aspirin for 72 hours using a central, web-based, computer-generated randomization schedule; all patients then received oral aspirin.Main OutcomeThe primary efficacy outcome was early neurological deterioration (increase in NIHSS score ≥4 points) within 72 hours after randomization. The primary safety outcome was symptomatic intracerebral hemorrhage within 72 hours after randomization.ResultsA total of 425 patients were included in the intravenous tirofiban (n = 213) or oral aspirin (n = 212) groups. Median (IQR) age was 64.0 years (56.0-71.0); 124 patients (29.2%) were female, and 301 (70.8%) were male. Early neurological deterioration occurred in 9 patients (4.2%) in the tirofiban group and 28 patients (13.2%) in the aspirin group (adjusted relative risk, 0.32; 95% CI, 0.16-0.65; P = .002). No patients in the tirofiban group experienced intracerebral hemorrhage. At 90-day follow-up, 3 patients (1.3%) in the tirofiban group and 3 (1.5%) in the aspirin group died (adjusted RR, 1.15; 95% CI, 0.27-8.54; P = .63), and the median (IQR) modified Rankin scale scores were 1.0 (0-1.25) and 1.0 (0-2), respectively (adjusted odds ratio, 1.28; 95% CI, 0.90-1.83; P = .17).Conclusions and RelevanceIn patients with noncardioembolic stroke who were seen within 24 hours of symptom onset, tirofiban decreased the risk of early neurological deterioration but did not increase the risk of symptomatic intracerebral hemorrhage or systematic bleeding.Trial RegistrationClinicalTrials.gov Identifier: NCT04491695

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Safety of Tirofiban in Acute Ischemic Stroke

Cited by 150 publications

References 27 publications

Progressive Ischemic Stroke: Clinical Features and Evaluation of Short-and Long- Term Tirofiban Therapy

Progressive Ischemic Stroke: Clinical Features and Evaluation of Short-and Long- Term Tirofiban Therapy

Sex Disparities in Enrollment in Recent Randomized Clinical Trials of Acute Stroke

Effects of Tirofiban on Neurological Deterioration in Patients With Acute Ischemic Stroke

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