Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA

Johnston, S. Claiborne; Amarenco, Pierre; Denison, Hans; Evans, Scott; Himmelmänn, Anders; James, Stefan; Knutsson, Mikael; Ladenvall, Per; Molina, Carlos A.; Wang, Yongjun

doi:10.1056/nejmoa1916870

Cited by 389 publications

(395 citation statements)

References 18 publications

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“…THALES was a randomized, double-blind, placebo-controlled, multicenter, international, parallel-group trial conducted at 414 sites in 28 countries. 4 The Executive Committee designed and oversaw the conduct and analysis of the trial in collaboration with the sponsor, AstraZeneca. Details of the study rationale, design, and methods have been described previously.…”

Section: Methodsmentioning

confidence: 99%

“… 5 After the trial start, given the results of the POINT trial (Platelet Oriented Inhibition in New TIA and Minor Ischemic Stroke) and CHANCE trial (Clopidogrel in High-Risk Patients With Acute Nondisabling Cerebrovascular Events), 6 , 7 the study assumptions were adjusted to a lower hazard ratio requiring less primary end points and smaller sample size. 4 …”

Section: Methodsmentioning

confidence: 99%

“…In THALES, ticagrelor added to aspirin reduced the 30-day risk of stroke or death by 17% relative to placebo and aspirin. 4 In a prespecified analysis of the THALES trial, we aimed to evaluate the efficacy and safety of ticagrelor added to aspirin in the first 30 days following a TIA or minor ischemic stroke in patients with or without ipsilateral, potentially causal, ≥30% atherosclerotic stenosis of cervicocranial vasculature.…”

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confidence: 99%

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Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin

Amarenco

Denison

Evans

et al. 2020

Stroke

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Background and Purpose: Among patients with a transient ischemic attack or minor ischemic strokes, those with ipsilateral atherosclerotic stenosis of cervicocranial vasculature have the highest risk of recurrent vascular events. Methods: In the double-blind THALES (The Acute Stroke or Transient Ischemic Attack Treated With Ticagrelor and ASA for Prevention of Stroke and Death) trial, we randomized patients with a noncardioembolic, nonsevere ischemic stroke, or high-risk transient ischemic attack to ticagrelor (180 mg loading dose on day 1 followed by 90 mg twice daily for days 2–30) or placebo added to aspirin (300–325 mg on day 1 followed by 75–100 mg daily for days 2–30) within 24 hours of symptom onset. The present paper reports a prespecified analysis in patients with and without ipsilateral, potentially causal atherosclerotic stenosis ≥30% of cervicocranial vasculature. The primary end point was time to the occurrence of stroke or death within 30 days. Results: Of 11 016 randomized patients, 2351 (21.3%) patients had an ipsilateral atherosclerotic stenosis. After 30 days, a primary end point occurred in 92/1136 (8.1%) patients with ipsilateral stenosis randomized to ticagrelor and in 132/1215 (10.9%) randomized to placebo (hazard ratio 0.73 [95% CI, 0.56–0.96], P =0.023) resulting in a number needed to treat of 34 (95% CI, 19–171). In patients without ipsilateral stenosis, the corresponding event rate was 211/4387 (4.8%) and 230/4278 (5.4%), respectively (hazard ratio, 0.89 [95% CI, 0.74–1.08]; P =0.23, P interaction =0.245). Severe bleeding occurred in 4 (0.4%) and 3 (0.2%) patients with ipsilateral atherosclerotic stenosis on ticagrelor and on placebo, respectively ( P =NS), and in 24 (0.5%) and 4 (0.1%), respectively, in 8665 patients without ipsilateral stenosis (hazard ratio=5.87 [95% CI, 2.04–16.9], P =0.001). Conclusions: In this exploratory analysis comparing ticagrelor added to aspirin to aspirin alone, we found no treatment by ipsilateral atherosclerosis stenosis subgroup interaction but did identify a higher absolute risk and a greater absolute risk reduction of stroke or death at 30 days in patients with ipsilateral atherosclerosis stenosis than in those without. In this easily identified population, ticagrelor added to aspirin provided a clinically meaningful benefit with a number needed to treat of 34 (95% CI, 19–171). Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03354429.

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

mentioning

confidence: 99%

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Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin

Amarenco

Denison

Evans

et al. 2020

Stroke

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“…Nevertheless, the SOCRATES clinical trial demonstrated that ticagrelor is not superior to aspirin in reducing the rate of stroke, myocardial infarction, or death at 90 days after acute ischemic stroke or TIA ( 191 ). However, current results of the THALES trial have demonstrated that the risk of the composite of stroke or death within 30 days in patients with a mild-to-moderate acute noncardioembolic ischemic stroke or TIA was lower with ticagrelor and aspirin than with aspirin alone, while severe bleeding was more frequent with ticagrelor ( 192 ).…”

Section: Potential Translational and Clinical Applicationsmentioning

confidence: 99%

Platelets as Mediators of Neuroinflammation and Thrombosis

et al. 2020

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Beyond platelets function in hemostasis, there is emerging evidence to suggest that platelets contribute crucially to inflammation and immune responses. Therefore, considering the detrimental role of inflammatory conditions in severe neurological disorders such as multiple sclerosis or stroke, this review outlines platelets involvement in neuroinflammation. For this, distinct mechanisms of platelet-mediated thrombosis and inflammation are portrayed, focusing on the interaction of platelet receptors with other immune cells as well as brain endothelial cells. Furthermore, we draw attention to the intimate interplay between platelets and the complement system as well as between platelets and plasmatic coagulation factors in the course of neuroinflammation. Following the thorough exposition of preclinical approaches which aim at ameliorating disease severity after inducing experimental autoimmune encephalomyelitis (a counterpart of multiple sclerosis in mice) or brain ischemia-reperfusion injury, the clinical relevance of platelet-mediated neuroinflammation is addressed. Thus, current as well as future propitious translational and clinical strategies for the treatment of neuro-inflammatory diseases by affecting platelet function are illustrated, emphasizing that targeting platelet-mediated neuroinflammation could become an efficient adjunct therapy to mitigate disease severity of multiple sclerosis or stroke associated brain injury.

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“…Vorteil für die Ticagrelor-Behandlung zur Reduktion primärer Endpunktereignisse (6,7 % vs. 9,6 %; HR 0,68; 95 %CI 0,53-0,88)[22]. Kürzlich wurde die THALES-Studie zur frühzeitigen Kombinationstherapie von Ticagrelor und ASS veröffentlicht[23]. In dieser Studie wurde die Kombination von Ticagrelor in der kardiologischen Standarddosis (erster Tag 2x180 mg, danach 2x90 mg/ Therapie überwiegend im Zielbereich ist, gibt es keinen signifikanten Vorteil bezüglich der Embolieratenreduktion.…”

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Sekundärprophylaxe der zerebralen Ischämie

Reiff¹,

Ringleb²

2020

Nervenheilkunde

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ZUSAMMENFASSUNGDie Sekundärprävention von Hirninfarkt und TIA umfasst neben wichtigen Maßnahmen der Lebensstiländerung zur Risikofaktorenmodifikation verschiedene medikamentöse und interventionelle Verfahren. Durch Behandlung von arterieller Hypertonie und Hyperlipidämie können erneute vaskuläre Ereignisse, Schlaganfall wie Herzinfarkt, verhindert werden. Eine große Bedeutung hat auch die antithrombotische Sekundärprävention durch Thrombozytenaggregationshemmer und orale Antikoagulantien sowie deren Kombination. Bei Vorliegen symptomatischer intra- oder extrakranieller arteriosklerotischer Stenosen können auch gefäßchirurgische oder neuroradiologisch interventionelle Verfahren der Verhinderung weiterer Schlaganfälle dienen.

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Ticagrelor and Aspirin or Aspirin Alone in Acute Ischemic Stroke or TIA

Cited by 389 publications

References 18 publications

Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin

Ticagrelor Added to Aspirin in Acute Nonsevere Ischemic Stroke or Transient Ischemic Attack of Atherosclerotic Origin

Platelets as Mediators of Neuroinflammation and Thrombosis

Sekundärprophylaxe der zerebralen Ischämie

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