Pipeline Embolization Device with or without Adjunctive Coil Embolization: Analysis of Complications from the IntrePED Registry

Article Figures & Data

Table 1:

Patient details

Patient Characteristics	PED/Coils	PED Alone	P Value^{^a}
No. (%) of aneurysms	109 (12.0%)	797 (88.0%)
No. (%) of patients	104 (13.1%)	689 (86.9%)
Age (yr)			.279
Mean	57.6 ± 15.1	56.8 ± 14.0
Median, range	61.5; 3–81	57; 9–86
Sex (No., %)			.435
Male	24 (23.1%)	137 (19.9%)
Female	80 (76.9%)	552 (80.1%)
Follow-up duration (mo)			.718
Mean	21.1 ± 8.8	22.1 ± 8.8
Median, range	20.8; 0.1–45.0	21.0; 0.1–60.5
Procedure time (min)			<.0001
Mean	135.8 ± 63.9	96.7 ± 46.2
Median, range	120; 46–365	87; 10–376

↵a P values for age, duration of follow-up, and procedure time were calculated with Wilcoxon rank sum tests. P value for sex was calculated with the χ² test.

Table 2:

Aneurysm characteristics

Aneurysm Characteristics	PED/Coils	PED Alone	P Value^{^a}
No. of aneurysms	109	797
No. of patients	104	689
Aneurysm size (mm)^{^b}			<.0001
Mean	13.6 ± 7.8	10.3 ± 7.6
Median, range	12; 1.6–45.0	8; 1.0–55.0
Aneurysm neck (mm)			.017
Mean	6.4 ± 3.0	6.2 ± 5.1
Median, range	6; 0.8–16.0	5; 0.9–53.0
Aneurysm shape (No., %)			.3366
Fusiform	13 (11.9%)	103 (12.9%)
Saccular	85 (78.0%)	604 (75.8%)
Dissecting	3 (2.8%)	51 (6.4%)
Other	8 (7.3%)	39 (4.9%)
Aneurysm location (No., %)			<.0001
Internal carotid artery	70 (64.2%)	614 (77.0%)
Middle cerebral artery	8 (7.3%)	35 (4.4%)
Posterior cerebral artery	0 (0%)	15 (1.9%)
Basilar artery	16 (14.7%)	28 (3.5%)
Other	15 (13.8%)	105 (13.2%)
Aneurysm ruptured at initial presentation (No., %)	13 (11.9%)	63 (7.9%)	.155
Multiple PEDs used^{^c} (No., %)	34 (31.2%)	274 (34.5%)	.499

↵a P values for aneurysm size and neck size were calculated with Wilcoxon rank sum tests. P values for categoric variables were calculated with χ² tests.
↵b Of the 797 aneurysms treated with PEDs alone, size data were not available for 8 aneurysms. Of the 109 aneurysms treated with PED/coil, size data were not available for 2 aneurysms.
↵c Of the 797 aneurysms treated with PEDs alone, data regarding the number of PEDs used were not reported for 2 aneurysms.

Table 3:

Multiple PED use

Procedure	Aneurysm Size (%) (n/N)			P Value^{^a}	Total
Procedure	Small	Large	Giant	P Value^{^a}	Total
PED alone^{^b}	25.8% (113/438)	43.7% (129/295)	53.7% (29/54)	<.001	34.5% (274/795)
PED/coil^{^c}	18.2% (6/33)	32.3% (20/62)	66.7% (8/12)	.010	31.2% (34/109)
All subjects	25.3% (119/471)	41.7% (149/357)	56.1% (37/66)	<.001	34.1% (308/904)

↵a P values were calculated using Fisher exact tests.
↵b Of the 797 aneurysms treated with the PED alone, data regarding the number of PEDs used were not available for 2 aneurysms treated; thus, 795 is used as the total denominator. Of these 795 aneurysms, size data were not available for 8 aneurysms. All 795 are included in the total calculation, but only 787 are included in the aneurysm-size categories.
↵c Of the 109 aneurysms treated with PED/coil, size data were not available for 2 aneurysms. All 109 are included in the total calculation, but only 107 are included in the aneurysm-size categories.

Table 4:

Patient outcomes

Major Complications	PED/Coils (n, %) (Patients = 104; Aneurysms = 109)	PED Alone (n, %) (Patients = 689; Aneurysms = 797)	P Value^{^a}
Neurologic morbidity	11 (10.6%)	48 (7.0%)	.226
Spontaneous rupture	0 (0%)	5 (0.7%)	>.99
Ipsilateral intracranial hemorrhage	3 (2.9%)	17 (2.5%)	.738
Ischemic stroke	7 (6.7%)	29 (4.2%)	.307
Parent artery stenosis	0 (0%)	2 (0.3%)	>.99
Cranial neuropathy	1 (1.0%)	1 (0.1%)	.245
Neurologic mortality	7 (6.7%)	23 (3.3%)	.099
Neurologic morbidity and mortality	13 (12.5%)	54 (7.8%)	.128