Hydrogel versus Bare Platinum Coils in Patients with Large or Recurrent Aneurysms Prone to Recurrence after Endovascular Treatment: A Randomized Controlled Trial

J. Raymond; R. Klink; M. Chagnon; S.L. Barnwell; A.J. Evans; J. Mocco; B.H. Hoh; A.S. Turk; R.D. Turner; H. Desal; D. Fiorella; S. Bracard; A. Weill; F. Guilbert; S. Lanthier; A.J. Fox; T.E. Darsaut; P.M. White; D. Roy

doi:10.3174/ajnr.A5101

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Fig 1.
Trial profile. Patients screened are not reported because no eligibility logs were required per protocol. Four hundred forty-seven patients in PRET included 250 in PRET-1 and 197 in PRET-2 groups.
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Fig 2.
Subgroup analysis of primary outcome in PRET groups.

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Table 1:

Baseline characteristics of patients and aneurysms

	PRET-1		PRET-2		PRET
	Platinum	Hydrogel	Platinum	Hydrogel	Platinum	Hydrogel
Total No. patients randomized	125	125	97	100	222	225
Male sex	35 (28.0%)	33 (26.4%)	33 (34%)	27 (27.0%)	68 (30.6%)	60 (26.7%)
Mean age (SD) (yr)	59 (11)	58 (11)	57 (12)	56 (10)	58 (12)	57 (11)
Multiple aneurysms	36 (28.8%)	36 (28.8%)	23 (23.7%)	22 (22.0%)	59 (26.6%)	58 (25.8%)
Ruptured aneurysms
No. (%) of treatment group	37 (29.6%)	35 (28%)	2 (2.1%)	5 (5.0%)	39 (17.6%)	40 (17.8%)
No. (%) WFNS > II	3 (8.1%)	8 (22.9%)	0	0	3 (7.7%)	8 (20.0%)
Unruptured aneurysms
mRS at baseline 0–2	85 (96.6%)	90 (100.0%)	94 (98.9%)	94 (98.9%)	179 (97.8%)	184 (99.5%)
mRS at baseline 3–5	3 (3.4%)	0	1 (1.1%)	1 (1.1%)	4 (2.2%)	1 (0.5%)
No. (%) symptomatic	24 (27.3%)	18 (20%)	8 (8.4%)	9 (9.5%)	32 (17.5%)	27 (14.6%)
Aneurysm size (maximal dimension)
Mean (SD) (mm)	13.3 (4.9)	12.7 (4.3)	8.6 (5.8)	8.3 (5.5)	11.3 (5.8)	10.7 (5.3)
≥10 mm	97 (77.6%)	96 (76.8%)	29 (29.9%)	25 (25.0%)	126 (56.8%)	121 (53.8%)
1.0–9.9 mm^{^a}	28 (22.4%)	29 (23.2%)	68 (70.1%)	75 (75.0%)	96 (43.2%)	104 (46.2%)
10.0–14.9 mm	59 (47.2%)	66 (52.8%)	16 (16.5%)	14 (14.0%)	75 (33.8%)	80 (35.6%)
15.0–19.9 mm	25 (20.0%)	24 (19.2%)	5 (5.2%)	7 (7.0%)	30 (13.5%)	31 (13.8%)
20.0–24.9 mm	8 (6.4%)	4 (3.2%)	6 (6.2%)	1 (1.0%)	14 (6.3%)	5 (2.2%)
≥25 mm	5 (4.0%)	2 (1.6%)	2 (2.1%)	3 (3.0%)	7 (3.2%)	5 (2.2%)
Aneurysm neck
Mean (SD) (mm)	5.0 (2.1)	4.8 (1.6)	4.5 (2.5)	4.6 (2.3)	4.8 (2.3)	4.7 (1.9)
Neck ≥4.0 (mm)	88 (70.4%)	94 (75.2%)	53 (54.6%)	58 (58.0%)	141 (63.5%)	152 (67.6%)
Aneurysm location, anterior	96 (76.8%)	104 (83.2%)	69 (71.1%)	70 (70.0%)	165 (74.3%)	174 (77.3%)
Internal carotid	58 (46.4%)	69 (55.2%)	43 (44.3%)	40 (40.0%)	101 (45.5%)	109 (48.4%)
Anterior cerebral	23 (18.4%)	18 (14.4%)	21 (21.6%)	24 (24.0%)	44 (19.8%)	42 (18.7%)
Middle cerebral	15 (12.0%)	17 (13.6%)	5 (5.2%)	6 (6.0%)	20 (9.0%)	23 (10.2%)
Aneurysm location, posterior	29 (23.2%)	21 (16.8%)	28 (28.9%)	30 (30.0%)	57 (25.7%)	51 (22.7%)
Basilar	23 (18.4%)	13 (10.4%)	21 (21.6%)	19 (19.0%)	44 (19.8%)	32 (14.2%)
Other posterior	6 (4.8%)	8 (6.4%)	7 (7.2%)	11 (11.0%)	13 (5.9%)	19 (8.4%)
Intended use of adjunct device	41 (32.8%)	42 (33.6%)	35 (36.1%)	38 (38.0%)	76 (34.2%)	80 (35.6%)

Note:—WFNS indicates World Federation of Neurological Societies.
↵a PRET-1 aneurysms recruited as ≥10 mm on noninvasive imaging have been measured using fiducials as <10 mm by the core laboratory; median size was 8.6 mm (mean, 8.3 ± 1.3 mm).

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Table 2:

Primary outcome in all patients in PRET^{^a}

	PRET-1		PRET-2		PRET
	Platinum (n = 124)	Hydrogel (n = 120)	Platinum (n = 96)	Hydrogel (n = 95)	Platinum (n = 220)	Hydrogel (n = 215)
Primary outcome	55 (44.4%)	63 (52.5%)	47 (49.0%)	40 (42.1%)	102 (46.4%)	103 (47.9%)
Major recurrence	33 (26.6%)	35 (29.2%)	33 (34.4%)	25 (26.3%)	66 (30.0%)	60 (27.9%)
Retreatment	11 (8.9%)	19 (15.8%)	10 (10.4%)	6 (6.3%)	21 (9.5%)	25 (11.6%)
Initial treatment failure	3 (2.4%)	1 (0.8%)	0 (0.0%)	4 (4.2%)	3 (1.4%)	5 (2.3%)
SAH	1 (0.8%)	1 (0.8%)	1 (1.0%)	1 (1.1%)	2 (0.9%)	2 (0.9%)
Mass effect	0 (0.0%)	1 (0.8%)	3 (3.1%)	0 (0.0%)	3 (1.4%)	1 (0.5%)
Related mortality	1 (0.8%)	3 (2.5%)	0 (0.0%)	0 (0.0%)	1 (0.5%)	3 (1.4%)
Related morbidity	2 (1.6%)	1 (0.8%)	0 (0.0%)	1 (1.1%)	2 (0.9%)	2 (0.9%)
Last observation carried forward^{^b}	4 (3.2%)	2 (1.7%)	0 (0.0%)	3 (3.2%)	4 (1.8%)	5 (2.3%)

↵a Data are numbers.
↵b Residual aneurysm at initial treatment and no angiographic follow-up.

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Table 3:

Packing density versus primary outcome

Packing Density^{^a}	Platinum Primary Outcome (Angiographic Outcome Only)		Hydrogel Primary Outcome (Angiographic Outcome Only)		Total Primary Outcome (Angiographic Outcome Only)
Packing Density^{^a}	No	Yes	No	Yes	No	Yes
PRET-1
Valid No.	69	51	57	61	126	112
Percentile 25	14.72	11.92	33.91	18.55	18.28	13.79
Median	22.18	17.13	50.92	36.93	29.60	23.47
Median	35.52	27.61	89.26	58.88	53.60	46.90
PRET-2
Valid No.	49	47	55	37	104	84
Percentile 25	18.15	6.02	34.62	11.64	24.46	7.37
Median	34.05	19.66	84.80	40.38	51.49	29.12
Percentile 75	60.15	43.21	172.95	94.72	111.77	65.92
PRET
Valid No.	118	98	112	98	230	196
Percentile 25	15.23	7.65	34.27	17.91	21.81	12.55
Median	24.14	17.66	62.47	38.50	37.94	25.58
Percentile 75	43.72	35.71	114.34	71.66	74.87	50.58

↵a Packing density is coil volume (V) divided by aneurysm volume (VA). V = π(c/2)² L, where c is coil caliber and L is coil length. VA = 4/3 π ab (a + b)/2, where a and b are half the long and short axes of the aneurysm.

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Table 4:

Adverse events^{^a}

	PRET-1		PRET-2		PRET
	Platinum (n = 125)	Hydrogel (n = 123)	Platinum (n = 97)	Hydrogel (n = 99)	Platinum (n = 222)	Hydrogel (n = 222)
Total	24 (19.2%)	26 (21.1%)	13 (13.4%)	15 (15.2%)	37 (16.7%)	41 (18.5%)
SAH during follow-up	1 (0.8%)	0 (0.0%)	1 (1.0%)	2 (2.0%)	2 (0.9%)	2 (0.9%)
Mass effect	0 (0.0%)	1 (0.8%)	2 (2.1%)	0 (0.0%)	2 (0.9%)	1 (0.5%)
Stroke	1 (0.8%)	2 (1.6%)	1 (1.0%)	0 (0.0%)	2 (0.9%)	2 (0.9%)
TIA	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.5%)
Inflammatory	2 (1.6%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	2 (0.9%)	0 (0.0%)
Subdural hematoma	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.0%)	0 (0.0%)	1 (0.5%)
Non-neurologic	3 (2.4%)	1 (0.8%)	0 (0.0%)	0 (0.0%)	3 (1.4%)	1 (0.5%)
Retreatment-related	1 (0.8%)	4 (3.3%)	2 (2.1%)	1 (1.0%)	3 (1.4%)	5 (2.3%)
Periprocedural event	16 (12.8%)	18 (14.6%)	7 (7.2%)	10 (10.1%)	23 (10.4%)	28 (12.6%)
Serious	15 (12.0%)	15 (12.2%)	5 (5.2%)	10 (10.1%)	20 (9.0%)	25 (11.3%)
Delayed	5 (4.0%)	7 (5.7%)	2 (2.1%)	4 (4.0%)	7 (3.2%)	11 (5.0%)
Periprocedure	10 (8.0%)	8 (6.5%)	3 (3.1%)	6 (6.1%)	13 (5.9%)	14 (6.3%)

↵a Adverse events were recorded during the trial. Periprocedural events (within 1 month of procedure) are lumped together. Data are numbers.

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Table 5:

Morbidity and mortality according to mRS at last follow-up^{^a}

mRS	PRET-1		PRET-2		PRET
mRS	Platinum (n = 125)	Hydrogel (n = 123)	Platinum (n = 97)	Hydrogel (n = 99)	Platinum (n = 222)	Hydrogel (n = 222)
0	88 (70.4%)	77 (62.6%)	60 (61.9%)	67 (67.7%)	148 (66.7%)	144 (64.9%)
1	19 (15.2%)	25 (20.3%)	23 (23.7%)	16 (16.2%)	42 (18.9%)	41 (18.5%)
2	7 (5.6%)	7 (5.7%)	10 (10.3%)	9 (9.1%)	17 (7.7%)	16 (7.2%)
3	1 (0.8%)	3 (2.4%)	3 (3.1%)	0 (0.0%)	4 (1.8%)	3 (1.4%)
4	5 (4.0%)	1 (0.8%)	1 (1.0%)	3 (3.0%)	6 (2.7%)	4 (1.8%)
5	2 (1.6%)	0 (0.0%)	0 (0.0%)	1 (1.0%)	2 (0.9%)	1 (0.5%)
6	3 (2.4%)	10 (8.1%)	0 (0.0%)	3 (3.0%)	3 (1.4%)	13 (5.9%)

↵a Data are numbers.

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