Patients prone to recurrence after endovascular treatment: Periprocedural results of the PRET randomized trial on large and recurrent aneurysms

Jean Raymond, R. Klink, M. Chagnon, S. L. Barnwell, A. J. Evans, J. Mocco, B. L. Hoh, A. S. Turk, R. D. Turner, H. Desal, D. Fiorella, S. Bracard, A. Weill, F. Guilbert, D. Roy

Research output: Contribution to journalArticle

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Abstract

BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n = 2, unrelated to treatment) and morbidity (defined as mRS >2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS ≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

Original languageEnglish (US)
Pages (from-to)1667-1676
Number of pages10
JournalAmerican Journal of Neuroradiology
Volume35
Issue number9
DOIs
StatePublished - Sep 1 2014
Externally publishedYes

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Aneurysm
Recurrence
Hydrogel
Platinum
Therapeutics
Neck
Safety
Stents
Arm
Randomized Controlled Trials

ASJC Scopus subject areas

  • Clinical Neurology
  • Radiology Nuclear Medicine and imaging

Cite this

Patients prone to recurrence after endovascular treatment : Periprocedural results of the PRET randomized trial on large and recurrent aneurysms. / Raymond, Jean; Klink, R.; Chagnon, M.; Barnwell, S. L.; Evans, A. J.; Mocco, J.; Hoh, B. L.; Turk, A. S.; Turner, R. D.; Desal, H.; Fiorella, D.; Bracard, S.; Weill, A.; Guilbert, F.; Roy, D.

In: American Journal of Neuroradiology, Vol. 35, No. 9, 01.09.2014, p. 1667-1676.

Research output: Contribution to journalArticle

Raymond, J, Klink, R, Chagnon, M, Barnwell, SL, Evans, AJ, Mocco, J, Hoh, BL, Turk, AS, Turner, RD, Desal, H, Fiorella, D, Bracard, S, Weill, A, Guilbert, F & Roy, D 2014, 'Patients prone to recurrence after endovascular treatment: Periprocedural results of the PRET randomized trial on large and recurrent aneurysms', American Journal of Neuroradiology, vol. 35, no. 9, pp. 1667-1676. https://doi.org/10.3174/ajnr.A4035
Raymond, Jean ; Klink, R. ; Chagnon, M. ; Barnwell, S. L. ; Evans, A. J. ; Mocco, J. ; Hoh, B. L. ; Turk, A. S. ; Turner, R. D. ; Desal, H. ; Fiorella, D. ; Bracard, S. ; Weill, A. ; Guilbert, F. ; Roy, D. / Patients prone to recurrence after endovascular treatment : Periprocedural results of the PRET randomized trial on large and recurrent aneurysms. In: American Journal of Neuroradiology. 2014 ; Vol. 35, No. 9. pp. 1667-1676.
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abstract = "BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29{\%} of PRET-1 and 4{\%} of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50{\%} of PRET-2 patients. They were wide-neck (≥4 mm) in 70{\%} and in the posterior circulation in 24{\%} of patients. Stents were used in 28{\%} of patients (35{\%} in PRET-2). Coiling was successful in 98{\%}. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n = 2, unrelated to treatment) and morbidity (defined as mRS >2 at 1 month) occurred in 25 patients (5.6{\%}; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3{\%} of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95{\%} of patients were home with a good outcome (mRS ≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4{\%} of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.",
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T2 - Periprocedural results of the PRET randomized trial on large and recurrent aneurysms

AU - Raymond, Jean

AU - Klink, R.

AU - Chagnon, M.

AU - Barnwell, S. L.

AU - Evans, A. J.

AU - Mocco, J.

AU - Hoh, B. L.

AU - Turk, A. S.

AU - Turner, R. D.

AU - Desal, H.

AU - Fiorella, D.

AU - Bracard, S.

AU - Weill, A.

AU - Guilbert, F.

AU - Roy, D.

PY - 2014/9/1

Y1 - 2014/9/1

N2 - BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n = 2, unrelated to treatment) and morbidity (defined as mRS >2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS ≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

AB - BACKGROUND AND PURPOSE: Some patients with large or recurrent aneurysms may be at increased risk of recurrence postcoiling. The Patients Prone to Recurrence after Endovascular Treatment (PRET) trial was designed to assess whether hydrogel coils were superior to platinum coils in these high-risk patients. This article reports periprocedural safety and operator-assessed angiographic results from the PRET trial. MATERIALS AND METHODS: PRET was a pragmatic, multicenter, randomized controlled trial. Patients had ≥10-mm aneurysms (PRET-1) or a major recurrence after coiling of an aneurysm of any size (PRET-2). Patients were randomly allocated to hydrogel or control arms (any platinum coil) by using concealed allocation with minimization. Assist devices could be used as clinically required. Aneurysms could be unruptured or recently ruptured. Analyses were on an intent-to-treat basis. RESULTS: Four hundred forty-seven patients were recruited (250 PRET-1; 197 PRET-2). Aneurysms were recently ruptured in 29% of PRET-1 and 4% of PRET-2 patients. Aneurysms were ≥10 mm in all PRET-1 and in 50% of PRET-2 patients. They were wide-neck (≥4 mm) in 70% and in the posterior circulation in 24% of patients. Stents were used in 28% of patients (35% in PRET-2). Coiling was successful in 98%. Adverse events occurred in 28 patients with hydrogel and 23 with platinum coils. Mortality (n = 2, unrelated to treatment) and morbidity (defined as mRS >2 at 1 month) occurred in 25 patients (5.6%; 12 hydrogel, 13 platinum), related to treatment in 10 (4 hydrogel; 6 platinum) (or 2.3% of 444 treated patients). No difference was seen between hydrogel and platinum for any of the indices used to assess safety up to at least 30 days after treatment. At 1 month, 95% of patients were home with a good outcome (mRS ≤2 or unchanged). Operator-assessed angiographic outcomes were satisfactory (complete occlusion or residual neck) in 339 of 447 or 76.4% of patients, with no significant difference between groups. CONCLUSIONS: Endovascular treatment of large and recurrent aneurysms can be performed safely with platinum or hydrogel coils.

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