Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms: A Randomized Controlled Trial

TY - JOUR

T1 - Second-Generation Hydrogel Coils for the Endovascular Treatment of Intracranial Aneurysms: A Randomized Controlled Trial

AU - Taschner, Christian A

AU - Chapot, René

AU - Costalat, Vincent

AU - Machi, Paolo

AU - Courthéoux, Patrick

AU - Barreau, Xavier

AU - Berge, Jérôme

AU - Pierot, Laurent

AU - Kadziolka, Krzysztof

AU - Jean, Betty

AU - Blanc, Raphaël

AU - Biondi, Alessandra

AU - Brunel, Hervé

AU - Gallas, Sophie

AU - Berlis, Ansgar

AU - Herbreteau, Denis

AU - Berkefeld, Joachim

AU - Urbach, Horst

AU - Elsheikh, Samer

AU - Fiehler, Jens

AU - Desal, Hubert

AU - Graf, Erika

AU - Bonafé, Alain

N1 - © 2018 The Authors.

PY - 2018/3

Y1 - 2018/3

N2 - BACKGROUND AND PURPOSE: Endovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils.METHODS: A randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized.RESULTS: Randomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils-adjusted for rupture status-of 8.4% (95% confidence interval, 0.5-16.2; P=0.036). Adverse and serious adverse events were evenly distributed between groups.CONCLUSIONS: Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms.CLINICAL TRIAL REGISTRATION: URL: https://www.drks.de/drks_web/. Unique identifier: DRKS00003132.

AB - BACKGROUND AND PURPOSE: Endovascular embolization of intracranial aneurysms with hydrogel-coated coils lowers the risk of major recurrence, but technical limitations (coil stiffness and time restriction for placement) have prevented their wider clinical use. We aimed to assess the efficacy of softer, second-generation hydrogel coils.METHODS: A randomized controlled trial was conducted at 22 centers in France and Germany. Patients aged 18 to 75 years with untreated ruptured or unruptured intracranial aneurysms measuring 4 to 12 mm in diameter were eligible and randomized (1:1 using a web-based system, stratified by rupture status) to coiling with either second-generation hydrogel coils or bare platinum coils. Assist devices were allowed as clinically required. Independent imaging core laboratory was masked to allocation. Primary end point was a composite outcome measure including major aneurysm recurrence, aneurysm retreatment, morbidity that prevented angiographic controls, and any death during treatment and follow-up. Data were analyzed as randomized.RESULTS: Randomization began on October 15, 2009, and stopped on January 31, 2014, after 513 patients (hydrogel, n=256; bare platinum, n=257); 20 patients were excluded for missing informed consent and 9 for treatment-related criteria. Four hundred eighty-four patients (hydrogel, n=243; bare platinum, n=241) were included in the analysis; 208 (43%) were treated for ruptured aneurysms. Final end point data were available for 456 patients. Forty-five out of 226 (19.9%) patients in the hydrogel group and 66/230 (28.7%) in the control group had an unfavorable composite primary outcome, giving a statistically significant reduction in the proportion of an unfavorable composite primary outcome with hydrogel coils-adjusted for rupture status-of 8.4% (95% confidence interval, 0.5-16.2; P=0.036). Adverse and serious adverse events were evenly distributed between groups.CONCLUSIONS: Our results suggest that endovascular coil embolization with second-generation hydrogel coils may reduce the rate of unfavorable outcome events in patients with small- and medium-sized intracranial aneurysms.CLINICAL TRIAL REGISTRATION: URL: https://www.drks.de/drks_web/. Unique identifier: DRKS00003132.

KW - Adolescent

KW - Adult

KW - Aged

KW - Cerebral Angiography

KW - Coated Materials, Biocompatible/administration & dosage

KW - Embolization, Therapeutic

KW - Female

KW - Humans

KW - Hydrogels/administration & dosage

KW - Intracranial Aneurysm/diagnostic imaging

KW - Male

KW - Middle Aged

KW - Stents

U2 - 10.1161/STROKEAHA.117.018707

DO - 10.1161/STROKEAHA.117.018707

M3 - SCORING: Journal article

C2 - 29437981

VL - 49

SP - 667

EP - 674

JO - STROKE

JF - STROKE

SN - 0039-2499

IS - 3

ER -