The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection

Stefan T Engelter; Lukas S Enz; Flavia Ravanelli; Josefin E Kaufmann; Henrik Gensicke; Sabine Schaedelin; Andreas R Luft; Christoph Globas; Barbara Goeggel-Simonetti; Urs Fischer; Davide Strambo; Georg Kägi; Krassen Nedeltchev; Timo Kahles; Lars Kellert; Sverre Rosenbaum; Regina von Rennenberg; Alex Brehm; David Seiffge; Susanne Renaud; Tobias Brandt; Hakan Sarikaya; Annaelle Zietz; Johannes Wischmann; Alexandros A Polymeris; Sandro Fischer; Leo H Bonati; Gian Marco De Marchis; Nils Peters; Christian H Nolte; Hanne Christensen; Susanne Wegener; Marios-Nikos Psychogios; Marcel Arnold; Philippe Lyrer; Christopher Traenka

doi:10.1177/23969873251315362

The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection

Stefan T Engelter, Lukas S Enz, Flavia Ravanelli, Josefin E Kaufmann, Henrik Gensicke, Sabine Schaedelin, Andreas R Luft, Christoph Globas, Barbara Goeggel-Simonetti, Urs Fischer, Davide Strambo, Georg Kägi, Krassen Nedeltchev, Timo Kahles, Lars Kellert, Sverre Rosenbaum, Regina von Rennenberg, Alex Brehm, David Seiffge, Susanne RenaudTobias Brandt, Hakan Sarikaya, Annaelle Zietz, Johannes Wischmann, Alexandros A Polymeris, Sandro Fischer, Leo H Bonati, Gian Marco De Marchis, Nils Peters, Christian H Nolte, Hanne Christensen, Susanne Wegener, Marios-Nikos Psychogios, Marcel Arnold, Philippe Lyrer, Christopher Traenka

Department of Neurology

2 Citations (Scopus)

Abstract

INTRODUCTION: Cervical artery dissection is a major cause of stroke in the young. The optimal choice and duration of antithrombotic treatment for stroke prevention are debated, particularly beyond 3 months after symptom onset.

PATIENTS AND METHODS: TREAT-CAD (TREATment of Cervical Artery Dissection) was a randomized controlled trial with blinded outcome assessment comparing non-inferiority of aspirin to anticoagulation (Vitamin-K-antagonists) in participants with symptomatic, Magnetic-Resonance-(MR)-imaging-verified cervical artery dissection. TREAT-CAD could not establish non-inferiority of aspirin to anticoagulation at 3 months. Thereafter participants could continue antithrombotic medication and obtained a standardized assessment of clinical and MR-Imaging outcomes between 3 and 6 months. As crossover to the other treatment arm was possible, we performed an as-treated analysis as main analysis. The main outcomes were new clinical (ischemic stroke, intracranial/major extracranial bleeding, or death) and new MR-Imaging outcomes (ischemic or hemorrhagic brain lesions).

RESULTS: Among the 122 participants in the as-treated analysis, 3/93 (3.2%) aspirin-treated participants had new clinical (n = 1) and MRI-outcomes (n = 2) between 3 and 6 months while 1/29 (3.4%) anticoagulated participants had an MRI-outcome (n = 1). All outcome events were hemorrhagic while ischemic events were absent. No deaths occurred. This yields an absolute difference of 0.2% (95% CI -8.0% to 7.5%, p = 1.0).

DISCUSSION AND CONCLUSION: During the extended follow-up period of a controlled randomized trial comparing aspirin to anticoagulation in cervical artery dissection, outcomes between 3 and 6 months after randomization occurred rarely, similarly often in both groups and were exclusively hemorrhagic events. Thus, studies balancing benefits versus harms of antithrombotic treatment beyond 3 months are warranted. Registration: ClinicalTrials.gov: NCT02046460. https://clinicaltrials.gov/ct2/show/NCT02046460.

Original language	English
Journal	European Stroke Journal
Volume	10
Issue number	3
Pages (from-to)	871-881
Number of pages	11
ISSN	2396-9873
DOIs	https://doi.org/10.1177/23969873251315362
Publication status	Published - Sept 2025

Keywords

Adult
Anticoagulants/therapeutic use
Aspirin/therapeutic use
Female
Fibrinolytic Agents/therapeutic use
Follow-Up Studies
Humans
Magnetic Resonance Imaging
Male
Middle Aged
Platelet Aggregation Inhibitors/therapeutic use
Stroke/prevention & control
Treatment Outcome
Vertebral Artery Dissection/drug therapy

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Engelter, S. T., Enz, L. S., Ravanelli, F., Kaufmann, J. E., Gensicke, H., Schaedelin, S., Luft, A. R., Globas, C., Goeggel-Simonetti, B., Fischer, U., Strambo, D., Kägi, G., Nedeltchev, K., Kahles, T., Kellert, L., Rosenbaum, S., von Rennenberg, R., Brehm, A., Seiffge, D., ... Traenka, C. (2025). The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection. European Stroke Journal, 10(3), 871-881. https://doi.org/10.1177/23969873251315362

Engelter, ST, Enz, LS, Ravanelli, F, Kaufmann, JE, Gensicke, H, Schaedelin, S, Luft, AR, Globas, C, Goeggel-Simonetti, B, Fischer, U, Strambo, D, Kägi, G, Nedeltchev, K, Kahles, T, Kellert, L, Rosenbaum, S, von Rennenberg, R, Brehm, A, Seiffge, D, Renaud, S, Brandt, T, Sarikaya, H, Zietz, A, Wischmann, J, Polymeris, AA, Fischer, S, Bonati, LH, De Marchis, GM, Peters, N, Nolte, CH, Christensen, H, Wegener, S, Psychogios, M-N, Arnold, M, Lyrer, P & Traenka, C 2025, 'The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection', European Stroke Journal, vol. 10, no. 3, pp. 871-881. https://doi.org/10.1177/23969873251315362

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title = "The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection",

abstract = "INTRODUCTION: Cervical artery dissection is a major cause of stroke in the young. The optimal choice and duration of antithrombotic treatment for stroke prevention are debated, particularly beyond 3 months after symptom onset.PATIENTS AND METHODS: TREAT-CAD (TREATment of Cervical Artery Dissection) was a randomized controlled trial with blinded outcome assessment comparing non-inferiority of aspirin to anticoagulation (Vitamin-K-antagonists) in participants with symptomatic, Magnetic-Resonance-(MR)-imaging-verified cervical artery dissection. TREAT-CAD could not establish non-inferiority of aspirin to anticoagulation at 3 months. Thereafter participants could continue antithrombotic medication and obtained a standardized assessment of clinical and MR-Imaging outcomes between 3 and 6 months. As crossover to the other treatment arm was possible, we performed an as-treated analysis as main analysis. The main outcomes were new clinical (ischemic stroke, intracranial/major extracranial bleeding, or death) and new MR-Imaging outcomes (ischemic or hemorrhagic brain lesions).RESULTS: Among the 122 participants in the as-treated analysis, 3/93 (3.2\%) aspirin-treated participants had new clinical (n = 1) and MRI-outcomes (n = 2) between 3 and 6 months while 1/29 (3.4\%) anticoagulated participants had an MRI-outcome (n = 1). All outcome events were hemorrhagic while ischemic events were absent. No deaths occurred. This yields an absolute difference of 0.2\% (95\% CI -8.0\% to 7.5\%, p = 1.0).DISCUSSION AND CONCLUSION: During the extended follow-up period of a controlled randomized trial comparing aspirin to anticoagulation in cervical artery dissection, outcomes between 3 and 6 months after randomization occurred rarely, similarly often in both groups and were exclusively hemorrhagic events. Thus, studies balancing benefits versus harms of antithrombotic treatment beyond 3 months are warranted. Registration: ClinicalTrials.gov: NCT02046460. https://clinicaltrials.gov/ct2/show/NCT02046460.",

keywords = "Adult, Anticoagulants/therapeutic use, Aspirin/therapeutic use, Female, Fibrinolytic Agents/therapeutic use, Follow-Up Studies, Humans, Magnetic Resonance Imaging, Male, Middle Aged, Platelet Aggregation Inhibitors/therapeutic use, Stroke/prevention \& control, Treatment Outcome, Vertebral Artery Dissection/drug therapy",

author = "Engelter, \{Stefan T\} and Enz, \{Lukas S\} and Flavia Ravanelli and Kaufmann, \{Josefin E\} and Henrik Gensicke and Sabine Schaedelin and Luft, \{Andreas R\} and Christoph Globas and Barbara Goeggel-Simonetti and Urs Fischer and Davide Strambo and Georg K{\"a}gi and Krassen Nedeltchev and Timo Kahles and Lars Kellert and Sverre Rosenbaum and \{von Rennenberg\}, Regina and Alex Brehm and David Seiffge and Susanne Renaud and Tobias Brandt and Hakan Sarikaya and Annaelle Zietz and Johannes Wischmann and Polymeris, \{Alexandros A\} and Sandro Fischer and Bonati, \{Leo H\} and \{De Marchis\}, \{Gian Marco\} and Nils Peters and Nolte, \{Christian H\} and Hanne Christensen and Susanne Wegener and Marios-Nikos Psychogios and Marcel Arnold and Philippe Lyrer and Christopher Traenka",

year = "2025",

month = sep,

doi = "10.1177/23969873251315362",

language = "English",

volume = "10",

pages = "871--881",

journal = "European Stroke Journal",

issn = "2396-9873",

publisher = "Oxford University Press",

number = "3",

}

TY - JOUR

T1 - The 6-months follow-up of the TREAT-CAD trial

T2 - Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection

AU - Engelter, Stefan T

AU - Enz, Lukas S

AU - Ravanelli, Flavia

AU - Kaufmann, Josefin E

AU - Gensicke, Henrik

AU - Schaedelin, Sabine

AU - Luft, Andreas R

AU - Globas, Christoph

AU - Goeggel-Simonetti, Barbara

AU - Fischer, Urs

AU - Strambo, Davide

AU - Kägi, Georg

AU - Nedeltchev, Krassen

AU - Kahles, Timo

AU - Kellert, Lars

AU - Rosenbaum, Sverre

AU - von Rennenberg, Regina

AU - Brehm, Alex

AU - Seiffge, David

AU - Renaud, Susanne

AU - Brandt, Tobias

AU - Sarikaya, Hakan

AU - Zietz, Annaelle

AU - Wischmann, Johannes

AU - Polymeris, Alexandros A

AU - Fischer, Sandro

AU - Bonati, Leo H

AU - De Marchis, Gian Marco

AU - Peters, Nils

AU - Nolte, Christian H

AU - Christensen, Hanne

AU - Wegener, Susanne

AU - Psychogios, Marios-Nikos

AU - Arnold, Marcel

AU - Lyrer, Philippe

AU - Traenka, Christopher

PY - 2025/9

Y1 - 2025/9

N2 - INTRODUCTION: Cervical artery dissection is a major cause of stroke in the young. The optimal choice and duration of antithrombotic treatment for stroke prevention are debated, particularly beyond 3 months after symptom onset.PATIENTS AND METHODS: TREAT-CAD (TREATment of Cervical Artery Dissection) was a randomized controlled trial with blinded outcome assessment comparing non-inferiority of aspirin to anticoagulation (Vitamin-K-antagonists) in participants with symptomatic, Magnetic-Resonance-(MR)-imaging-verified cervical artery dissection. TREAT-CAD could not establish non-inferiority of aspirin to anticoagulation at 3 months. Thereafter participants could continue antithrombotic medication and obtained a standardized assessment of clinical and MR-Imaging outcomes between 3 and 6 months. As crossover to the other treatment arm was possible, we performed an as-treated analysis as main analysis. The main outcomes were new clinical (ischemic stroke, intracranial/major extracranial bleeding, or death) and new MR-Imaging outcomes (ischemic or hemorrhagic brain lesions).RESULTS: Among the 122 participants in the as-treated analysis, 3/93 (3.2%) aspirin-treated participants had new clinical (n = 1) and MRI-outcomes (n = 2) between 3 and 6 months while 1/29 (3.4%) anticoagulated participants had an MRI-outcome (n = 1). All outcome events were hemorrhagic while ischemic events were absent. No deaths occurred. This yields an absolute difference of 0.2% (95% CI -8.0% to 7.5%, p = 1.0).DISCUSSION AND CONCLUSION: During the extended follow-up period of a controlled randomized trial comparing aspirin to anticoagulation in cervical artery dissection, outcomes between 3 and 6 months after randomization occurred rarely, similarly often in both groups and were exclusively hemorrhagic events. Thus, studies balancing benefits versus harms of antithrombotic treatment beyond 3 months are warranted. Registration: ClinicalTrials.gov: NCT02046460. https://clinicaltrials.gov/ct2/show/NCT02046460.

AB - INTRODUCTION: Cervical artery dissection is a major cause of stroke in the young. The optimal choice and duration of antithrombotic treatment for stroke prevention are debated, particularly beyond 3 months after symptom onset.PATIENTS AND METHODS: TREAT-CAD (TREATment of Cervical Artery Dissection) was a randomized controlled trial with blinded outcome assessment comparing non-inferiority of aspirin to anticoagulation (Vitamin-K-antagonists) in participants with symptomatic, Magnetic-Resonance-(MR)-imaging-verified cervical artery dissection. TREAT-CAD could not establish non-inferiority of aspirin to anticoagulation at 3 months. Thereafter participants could continue antithrombotic medication and obtained a standardized assessment of clinical and MR-Imaging outcomes between 3 and 6 months. As crossover to the other treatment arm was possible, we performed an as-treated analysis as main analysis. The main outcomes were new clinical (ischemic stroke, intracranial/major extracranial bleeding, or death) and new MR-Imaging outcomes (ischemic or hemorrhagic brain lesions).RESULTS: Among the 122 participants in the as-treated analysis, 3/93 (3.2%) aspirin-treated participants had new clinical (n = 1) and MRI-outcomes (n = 2) between 3 and 6 months while 1/29 (3.4%) anticoagulated participants had an MRI-outcome (n = 1). All outcome events were hemorrhagic while ischemic events were absent. No deaths occurred. This yields an absolute difference of 0.2% (95% CI -8.0% to 7.5%, p = 1.0).DISCUSSION AND CONCLUSION: During the extended follow-up period of a controlled randomized trial comparing aspirin to anticoagulation in cervical artery dissection, outcomes between 3 and 6 months after randomization occurred rarely, similarly often in both groups and were exclusively hemorrhagic events. Thus, studies balancing benefits versus harms of antithrombotic treatment beyond 3 months are warranted. Registration: ClinicalTrials.gov: NCT02046460. https://clinicaltrials.gov/ct2/show/NCT02046460.

KW - Adult

KW - Anticoagulants/therapeutic use

KW - Aspirin/therapeutic use

KW - Female

KW - Fibrinolytic Agents/therapeutic use

KW - Follow-Up Studies

KW - Humans

KW - Magnetic Resonance Imaging

KW - Male

KW - Middle Aged

KW - Platelet Aggregation Inhibitors/therapeutic use

KW - Stroke/prevention & control

KW - Treatment Outcome

KW - Vertebral Artery Dissection/drug therapy

UR - https://www.scopus.com/pages/publications/85217185442

U2 - 10.1177/23969873251315362

DO - 10.1177/23969873251315362

M3 - Journal article

C2 - 39910883

SN - 2396-9873

VL - 10

SP - 871

EP - 881

JO - European Stroke Journal

JF - European Stroke Journal

IS - 3

ER -

The 6-months follow-up of the TREAT-CAD trial: Aspirin versus anticoagulation for stroke prevention in patients with cervical artery dissection

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Keywords

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