Patients Prone to Recurrence after Endovascular Treatment: Periprocedural Results of the PRET Randomized Trial on Large and Recurrent Aneurysms

J. 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

doi:10.3174/ajnr.A4035

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Fig 1.
Recruitment. Notice how recruitment decreased progressively from December 2010 to December 2013, a possible sign of case selection.
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Fig 2.
Flow chart. Diagram shows patient flow from randomization to periprocedural safety end points.

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Table 1:

Morbidity and mortality adjudicated per patient

	PRET-1		PRET-2		PRET
	Platinum	Hydrogel	Platinum	Hydrogel	Platinum	Hydrogel
Death
Total	0	2 (1.6%)	0	0	0	2 (0.9%)
Treatment-related	0	0	0	0	0	0
Morbidity (mRS > 2)
Total	11 (8.8%)	5 (4.0%)	2 (2.1%)	5 (5.0%)	13 (5.9%)	10 (4.4%)
Treatment-related	5 (4.0%)	2 (1.6%)	1 (1.0%)	2 (2.0%)	6 (2.7%)	4 (1.8%)
Any stroke	11 (8.8%)	5 (4.0%)	8 (8.2%)	9 (9.0%)	19 (8.6%)	14 (6.2%)
Any complication	8 (6.4%)	4 (3.2%)	1 (1.0%)	2 (2.0%)	9 (4.1%)	6 (2.7%)
No complication	95 (76.0%)	107 (85.6%)	86 (88.7%)	83 (83.0%)	181 (81.5%)	190 (84.4%)
Withdrawn	0	2 (1.6%)	0	1 (1.0%)	0	3 (1.3%)
Fisher exact test P value	.052		.612		.174

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Table 2:

Safety indices reported at time of the procedure and during follow-up

	PRET-1		PRET-2		PRET
	Platinum	Hydrogel	Platinum	Hydrogel	Platinum	Hydrogel
Procedural complications
Thromboembolic	10 (8.0%)	6 (4.9%)	1 (1.0%)	3 (3.0%)	11 (5.0%)	9 (4.1%)
Hemorrhagic	2 (1.6%)	1 (0.8%)	1 (1.0%)	1 (1.0%)	3 (1.4%)	2 (0.9%)
Other	4 (3.2%)	6 (4.9%)	4 (4.1%)	3 (3.0%)	8 (3.6%)	9 (4.1%)
Anti-GP IIb/IIIa used during embolization	8 (6.4%)	11 (8.9%)	7 (7.2%)	4 (4.0%)	15 (6.8%)	15 (6.8%)
Clinical deterioration at end of procedure	5 (4.0%)	1 (0.8%)	2 (2.1%)	3 (3.0%)	7 (3.2%)	4 (1.9%)
Hospitalization
Days (median) (min) (max)	2 (1) (94)	1 (0) (70)	1 (0) (51)	1 (0) (30)	1 (0) (94)	1 (0) (70)
Days >5 for unruptured aneurysms	9 (7.2%)	7 (5.7%)	5 (5.2%)	5 (5.1%)	14 (6.3%)	12 (5.4%)
Days >15 for ruptured aneurysms	10 (8.0%)	10 (8.1%)	1 (1.0%)	0	11 (5.0%)	10 (4.5%)
New imaging findings at discharge	17 (13.6)	11 (8.9%)	7 (7.2%)	9 (9.1%)	24 (10.8%)	20 (9.0%)
mRS >2 at discharge	17 (13.6%)	9 (7.3%)	1 (1.0%)	5 (5.1%)	18 (8.1%)	14 (6.3%)
Discharge destination
Home	107 (85.6%)	108 (87.8%)	95 (97.9%)	92 (92.9%)	202 (91.0%)	200 (90.1%)
Other than home	18 (14.4%)	15 (12.2%)	2 (2.1%)	7 (7.1%)	20 (9.0%)	22 (9.2%)
mRS >2 at 1 month	11 (8.8%)	6 (4.9%)	3 (3.1%)	5 (5.1%)	14 (6.3%)	11 (5%)
Location at 1 month
Home	117 (93.6%)	116 (94.3%)	95 (97.9%)	95 (96.0%)	212 (95.5%)	211 (95.0%)
Other than home	8 (6.4%)	7 (5.7%)	2 (2.1%)	4 (4.0%)	10 (4.5%)	11 (5%)
AE
No. reported	16	18	7	10	23	28
No. (%) serious	10 (62%)	8 (44.4%)	3 (42.9%)	6 (60%)	13 (56.5%)	14 (50%)
AE attribution (No.) (% of total No. reported)
Related to treatment	14 (87.5%)	14 (77.8%)	7 (100%)	10 (100%)	21 (91.3%)	24 (85.7%)
Related to aneurysm	2 (12.5%)	3 (16.7%)	0	0	2 (8.7%)	3 (10.7%)
Unrelated	0	1 (5.5%)	0	0	0	1 (3.6%)

Note:—Anti-GP IIb/IIIa indicates antiglycoprotein IIb/IIIa; AE, adverse events; min, minimum; max, maximum.

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Table 3:

Operator-assessed immediate angiographic results

	PRET-1		PRET-2		PRET
	Platinum	Hydrogel	Platinum	Hydrogel	Platinum	Hydrogel
No coiling, for any reason	3 (2.4%)	3 (2.4%)	0	5 (5.0%)	3 (1.4%)	8 (3.6%)
Residual aneurysm	32 (25.6%)	39 (31.2%)	12 (12.4%)	14 (14.0%)	44 (19.8%)	53 (23.6%)
Residual neck	48 (38.4%)	48 (38.4%)	40 (41.2%)	40 (40.0%)	88 (39.6%)	88 (39.1%)
Complete obliteration	42 (33.6%)	35 (28.0%)	45 (46.4%)	41 (41.0%)	87 (39.2%)	76 (33.8%)
Fisher exact test P value	.723		.151		.280