First-Line Sofia Aspiration Thrombectomy Approach within the Endovascular Treatment of Ischemic Stroke Multicentric Registry: Efficacy, Safety, and Predictive Factors of Success

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FIGURE.
Flowchart of the Sofia-Contact Aspiration, First-Line Technique Registry. AIS indicates acute ischemic stroke; LVO, large vessel occlusion; EVT, endovascular treatment; CA, contact aspiration.

Table 1:

Baseline characteristics (n = 296)^a

Characteristics	No.	Values
Baseline demographics and medical history
Age (mean) (yr)	296	69.5 ± 13.8
Men	296	150 (50.7)
Hypertension	288	158 (54.9)
Diabetes	285	50 (17.4)
Dyslipidemia	284	93 (32.7)
Current smoking	272	70 (25.7)
Previous stroke or TIA	286	43 (15.0)
Previous CAD	285	50 (17.5)
Antithrombotic medications	291	120 (41.2)
Antiplatelet	291	69 (23.7)
Anticoagulant	291	34 (11.7)
Current stroke event
Systolic BP (mean) (mm Hg)	245	148 ± 28
Diastolic BP (mean) (mm Hg)	245	82 ± 19
Blood glucose (median) (IQR) (mmol/L)	229	6.4 (5.7–8.0)
Admission NIHSS score (median) (IQR)	290	16 (11–21)
ASPECTS (median) (IQR)	278	7 (6–9)
Prestroke mRS ≥1	291	64 (22.0)
Site of occlusion
M1 MCA	296	124 (41.9)
M2 MCA		40 (13.5)
T-car		54 (18.2)
Tandem		39 (13.2)
Vertebrobasilar		39 (13.2)
Stroke etiology
Large-artery atherosclerosis	295	44 (14.9)
Cardioembolic		127 (43.1)
Dissection		11 (3.7)
Others		113 (38.3)
Intravenous rtPA	294	142 (48.3)
General anesthesia	291	71 (24.4)
Procedural times (median) (IQR) (min)
Onset to imaging	279	113 (84–180)
Admission to imaging	248	25 (16–41.5)
Imaging to groin puncture	262	107 (69–151)
Imaging to recanalization	279	157 (118–205)
Onset to puncture	276	242 (186–324)
Puncture to recanalization	287	40 (25–65.5)
Balloon-guide catheter	296	23 (7.8)
Mode of admission
Mothership	295	121 (41.0)
Drip and ship		174 (59.0)
Sofia catheter
5F	296	70 (23.7)
6F		226 (76.3)

Note:—BP indicates blood pressure; CAD, coronary artery disease; T-car, occlusion of carotid terminus; Mothership, comprehensive stroke centers with on-site interventional neuroradiologic services; Drip and ship, medical treatment (including intravenous thrombolysis) in a hospital before being transferred to a comprehensive stroke centers for thrombectomy.
↵a Values are expressed as No. (percentage) unless otherwise indicated.

Table 2:

Efficacy and safety outcomes in the overall population and population without rescue therapy (n = 296)^a

Outcomes	Overall		Patients without Rescue Therapy
Outcomes	Values	95% CI	Values	95% CI
Efficacy outcomes
Successful reperfusion (mTICI 2b/3)	255/296 (86.1)	81.7–89.9	191/208 (91.8)	87.2–95.2
Near-complete reperfusion (mTICI 2c/3)	157/296 (53.0)	47.4–58.7	128/208 (61.5)	54.6–68.2
Excellent reperfusion (mTICI 3)	122/296 (41.2)	35.5–47.1	104/208 (50.0)	43.0–57.0
FPE (mTICI 3 after first pass)	71/293 (24.2)	19.4–29.6	71/208 (34.1)	27.7–41.0
Early neurologic improvement^b	133/258 (51.6)	45.4–57.7	109/184 (59.2)	51.8–66.4
Favorable outcome	122/284 (43.0)	37.1–48.9	100/198 (50.5)	43.3–57.7
Groin puncture-to-recanalization time (median) (IQR)	40 (24–65)^c		30.0 (21.0–50.0)^d
No. of passes >2	117/293 (39.9)	34.3–45.8	46/208 (22.1)	16.7–28.4
Rescue therapy	88/296 (29.7)	24.6–35.3
Safety outcomes
Procedural complications	28/294 (9.5)	6.4–13.5	19/208 (9.1)	5.6–13.9
Any ICH	115/258 (44.6)	38.4–50.9	79/177 (44.6)	37.2–52.3
PH	31/258 (12.0)	8.3–16.6	22/177 (12.4)	8.0–18.2
sICH	16/258 (6.2)	3.5–9.8	10/177 (5.6)	2.7–10.1
All-cause death (90-day)	65/284 (22.9)	18.1–28.2	40/198 (20.2)	14.8–26.5

Note:—ICH indicates intracranial hemorrhage; sICH, symptomatic intracranial hemorrhage.
↵a Values expressed as No./total No. (%) unless otherwise indicated.
↵b Early neurologic improvement is defined as NIHSS score 0–1 at 24 hours or a decrease of ≥4 points in the NIHSS score at 24 hours. Favorable outcome is defined as a 90-day mRS ≤ 2.
↵c Twenty-six missing data.
↵d Fourteen missing data.

Table 3:

Independent predictors of favorable outcome; successful, excellent reperfusion; and first-pass effect^a

Note:—ref indicates reference; T-Car, occlusion of carotid terminus.
↵a Factors included in multivariate analysis of favorable outcome: age, hta, previous stroke or TIA, systolic BP, admission NIHSS score and ASPECTS, prestroke mRS ≥1, intravenous rtPA, general anesthesia, delay in imaging-to-groin puncture, site of occlusion, and the Sofia catheter. Factors included in multivariate model of successful reperfusion: age, current smoking, admission ASPECTS, site of occlusion, intravenous rtPA, etiology, delay in onset to imaging. Factors included in multivariate analysis of excellent reperfusion: age, sex, current smoking, antiplatelet use, glycemia, admission ASPECTS, site of occlusion, intravenous rtPA, and the Sofia catheter. Factors included in multivariate analysis of first-pass effect: age, current smoking, previous stroke or TIA, antiplatelet use, glycemia, admission NIHSS score and ASPECTS, prestroke mRS ≥1, site of occlusion. and intravenous rtPA.
↵b Per 10-year increase.
↵c Per 1-point increase.
↵d Per 1-hour increase.