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Research ArticleNeurointervention
Open Access

A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms

T.E. Darsaut, J.M. Findlay, M.W. Bojanowski, C. Chalaala, D. Iancu, D. Roy, A. Weill, W. Boisseau, A. Diouf, E. Magro, M. Kotowski, M.B. Keough, L. Estrade, N. Bricout, J.-P. Lejeune, M.M.C. Chow, C.J. O’Kelly, J.L. Rempel, R.A. Ashforth, H. Lesiuk, J. Sinclair, U.-E. Erdenebold, J.H. Wong, F. Scholtes, D. Martin, B. Otto, A. Bilocq, E. Truffer, K. Butcher, A.J. Fox, A.S. Arthur, L. Létourneau-Guillon, F. Guilbert, M. Chagnon, J. Zehr, B. Farzin, G. Gevry and J. Raymond
American Journal of Neuroradiology May 2023, DOI: https://doi.org/10.3174/ajnr.A7865

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  • Table 1:

    Patient and index aneurysm characteristics

    CharacteristicsSurgical (n = 143)Endovascular (n = 148)
    Patient
     Age at treatment (mean) (SD) (yr)56.1 (10)56.9 (10)
     Female sex (No.) (%)98 (69%)105 (71%)
    Pretreatment mRS score (No.) (%)
     0120 (84)114 (77)
     122 (15)29 (20)
     21 (1)5 (3)
    Patients with multiple aneurysms (No.) (%)26 (18)38 (26)
    Index aneurysm location (No.) (%)
     Anterior circulation (No.) (%)139 (97)143 (97)
      ICA
       Ophthalmic/paraophthalmic17 (12)18 (12)
       Posterior communicating/anterior choroidal16 (11)29 (20)
       Carotid terminus13 (9)12 (8)
      MCA
       MCA bifurcation/M143 (30)48 (32)
      ACA
       Anterior communicating43 (30)31 (21)
       Pericallosal5 (3)5 (3)
       Other2 (1)0
    Posterior circulation (No.) (%)4 (3)5 (3)
     PCA01 (1)
     SCA02 (1)
     PICA4 (3)2 (1)
    Index aneurysm size (mean) (range) (mm)7.7 (3–20)7.9 (3–24)
     3–9 mm (%)112 (78)115 (78)
     10–15 mm (%)26 (18)28 (19)
     >15 mm (%)5 (3)5 (3)
    Aneurysm neck ≥4 mm56 (39)56 (38)
    Recurrent, previously treated index aneurysm7 (5)3 (2)
    Medical history
     Pain/headache15 (10)19 (13)
     Cranial nerve palsy4 (3)4 (3)
     Stroke/TIA5 (3)3 (2)
     History of previous SAH from another aneurysm19 (13)18 (12)
     Hypertension73 (51)71 (48)
     Current smoker56 (39)62 (42)
     Excessive alcohol14 (10)9 (6)
     Positive family history27 (19)26 (18)
    Treatment
     Time from randomization to treatment (mean) (SD) (wk)17.8 (22)9.4 (18)
     Adherence to assigned treatment (No.) (%)138 (97)142 (96)
     Index aneurysm rupture after randomization, before  treatment1 (1)0
     Additional nonindex aneurysms treated at same time14 (10)15 (10)
     Stent-assisted coiling (non-flow-diverting stent) (No.) (%)NA29 (19)
     Flow-diverting stent (No.) (%)NA9 (6)

    • Note:—NA indicates not applicable.

  • Table 2:

    Primary and secondary outcomes

    Surgical (n = 142)Endovascular (n = 148)
    Primary outcomea (composite)b (No.) (%)13 (9)28 (19)
     Failure to occlude aneurysm with allocated technique1 (1)5 (3)
     Intracranial hemorrhage during FU2 (2)1 (1)
     Saccular residual aneurysm10 (7)22 (15)
     Missing primary outcome1 (1)0
    Secondary outcomesn = 143n = 148
     No. of days hospitalized per treatment (mean) (median) (range)6.7 (5) (1–25)3.8 (1) (0–122)
     No. of patients hospitalized for >5 days (No.) (%)69 (48)12 (8)
     Patients with postoperative morbidity (discharge mRS > 2) (No.) (%)3 (2)4 (3)
     Patients with new neurologic deficits following treatment (No.) (%)32 (22)19 (12)
    Discharge location
     Home (No.) (%)135 (94)142 (96)
     Other hospital (No.) (%)4 (3)2 (1)
     Rehabilitation center (No.) (%)3 (2)3 (2)
     Death (No.) (%)1 (1)1 (1)
    1-year mRS (No.) (%)
     079 (55)93 (63)
     155 (38)41 (28)
     26 (4)11 (7)
     31 (1)1 (1)
     41 (1)1 (1)
     500
     61 (1)1 (1)
    Death and dependency (mRS >2) at 1 year (No.) (%)3 (2)3 (2)
    Mean (SD) time of 1-year mRS assessment (mo)15.1 (9.4)15.4 (6.4)
    Retreatment of index aneurysm during follow-up (No.) (%)3 (2)8 (5)
    Angiographic outcome at 1 year
     Complete aneurysm occlusion (No.) (%)114 (80)84 (57)
     Residual aneurysm neck (No.) (%)16 (11)40 (27)
     Saccular residual aneurysm (No.) (%)11 (8)23 (16)
     1-year imaging not available (No.) (%)c2 (1)1 (1)
     CTA/MRA/catheter angiographic determinations (No.) (%)116 (81), 14 (10), 11 (8)14 (10), 106 (72), 27 (18)
     Mean (SD) time of 1-year imaging assessment (mo)15.7 (10.0)15.2 (8.2)

    • Note:—FU indicates follow-up.

    • ↵a RR for the primary outcome: 2.07; 95% CI, 1.12–3.83; P = .021.

    • ↵b One primary outcome was assigned per patient. When a patient had >1 primary outcome, it was assigned on the basis of the following hierarchy: intracranial hemorrhage > failure of technique > residual aneurysm.

    • ↵c There was 1 death in each group.

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A Pragmatic Randomized Trial Comparing Surgical Clipping and Endovascular Treatment of Unruptured Intracranial Aneurysms
T.E. Darsaut, J.M. Findlay, M.W. Bojanowski, C. Chalaala, D. Iancu, D. Roy, A. Weill, W. Boisseau, A. Diouf, E. Magro, M. Kotowski, M.B. Keough, L. Estrade, N. Bricout, J.-P. Lejeune, M.M.C. Chow, C.J. O’Kelly, J.L. Rempel, R.A. Ashforth, H. Lesiuk, J. Sinclair, U.-E. Erdenebold, J.H. Wong, F. Scholtes, D. Martin, B. Otto, A. Bilocq, E. Truffer, K. Butcher, A.J. Fox, A.S. Arthur, L. Létourneau-Guillon, F. Guilbert, M. Chagnon, J. Zehr, B. Farzin, G. Gevry, J. Raymond
American Journal of Neuroradiology May 2023, DOI: 10.3174/ajnr.A7865
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