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RACECAT

Effect of Direct Transportation to Thrombectomy-Capable Center vs Local Stroke Center on Neurological Outcomes in Patients With Suspected Large-Vessel Occlusion Stroke in Nonurban Areas

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Year of Publication: 2022

Authors: Natalia Pérez de la Ossa, Sònia Abilleira, Tudor G. Jovin, ..., for the RACECAT Trial Investigators

Journal: JAMA

Citation: JAMA. 2022;327(18):1782-1794.

Link: https://doi.org/10.1001/jama.2022.4404

PDF: https://jamanetwork.com/journals/jama/fullarticle/2791844

Clinical Question

In nonurban areas, does direct transport to a thrombectomy-capable center result in better 90-day outcomes vs transport to the closest local stroke center in patients with suspected LVO?

Bottom Line

Direct transport did not improve 90-day outcomes vs local stroke center transport (adjusted OR 1.03; 95% CI 0.82-1.29). Direct transport increased thrombectomy rates (48.8% vs 39.4%) but reduced IV tPA rates (47.5% vs 60.4%), suggesting these effects offset each other. Stopped early for futility.

        Major Points
        No difference in 90-day mRS: adjusted OR 1.03 (0.82-1.29). Stopped for futility at 2nd interim analysis.
Direct transport increased thrombectomy: 48.8% vs 39.4% (OR 1.46; 1.13-1.89).
But reduced IV tPA: 47.5% vs 60.4% (OR 0.59; 0.45-0.76).
Time trade-off: tPA delayed by 35 min (155 vs 120 min) but groin puncture shortened by 56 min (214 vs 270 min).
Mortality identical: 27.3% vs 27.2% (HR 0.96; 0.78-1.18).
64.6% of local stroke center patients were emergently transferred for thrombectomy.
First RCT comparing mothership vs drip-and-ship in suspected LVO.
1,401 randomized (cluster, spatial-temporal); Catalonia, Spain; 6 thrombectomy + 22 local centers.
No subgroup benefited from direct transport (age, sex, tPA eligibility, RACE score — all NS interaction).
Results reflect a high-performance Catalan system — may not generalize to systems with longer transfer times or lower baseline thrombectomy rates.

      

Design

Study Type: Multicenter, population-based, spatial-temporal cluster-randomized trial with blinded endpoint assessment

Randomization: 1

Blinding: Open-label; blinded 90-day mRS assessment by certified telephone assessors. Cluster randomized by 12-hour time slots, stratified by territory and day of week.

Enrollment Period: March 2017 to June 2020

Follow-up Duration: 90 days

Centers: 28

Countries: Spain (Catalonia)

Sample Size: 1401

Analysis: ITT (as-randomized). Ordinal logistic regression. Stopped for futility at 70% enrollment.

Inclusion Criteria

Functionally independent (prestroke mRS 0-2).
Suspected LVO: RACE Scale score 5-9.
EMS evaluation in nonurban area where primary referral was a local stroke center without thrombectomy.
Estimated arrival at thrombectomy center <7 hours after onset.
Transport time to thrombectomy center 20-180 minutes.

Exclusion Criteria

Unstable clinical status or coma requiring emergent life support.
Prestroke mRS >2.
RACE Scale <4.
Estimated arrival at thrombectomy center >7 hours from onset.

Baseline Characteristics

Characteristic	Thrombectomy Center (N=482)	Local Stroke Center (N=467)
Age median (IQR)	77 (67-84)	76 (66-84)
Female	219 (45.4%)	209 (44.8%)
Hypertension	352 (73.5%)	331 (72.4%)
Diabetes	122 (25.5%)	105 (23.0%)
AF	120 (25.1%)	129 (28.2%)
RACE Scale median (IQR)	7 (6-8)	7 (6-8)
NIHSS at hospital median (IQR)	16 (9-20)	16 (11-21)
LVO confirmed	333 (69.1%)	303 (64.9%)
Time onset to first hospital median (IQR)	142 (100-231) min	88 (61-145) min
Travel time >60 min to thrombectomy center	270 (56.0%)	254 (54.4%)

Arms

Field	Direct to Thrombectomy Center (Mothership)	Control
Intervention	Direct ground ambulance transport to thrombectomy-capable center, bypassing local stroke center. Modification only for clinical deterioration.	Transport to closest local stroke center. If LVO confirmed or suspected (NIHSS ≥6), emergent transfer to thrombectomy center. 64.6% transferred; median door-in/door-out 78 min.
Duration	Single transport decision + 90-day follow-up	Single transport decision + 90-day follow-up

Outcomes

Outcome	Type	Control	Intervention	HR / OR / RR	P-value
Distribution of mRS at 90 days (ordinal shift, mRS 5+6 collapsed)	Primary	mRS median 3 (IQR 2-5)	mRS median 3 (IQR 2-5)		NS (futility stopped)
IV alteplase administered \| 95% CI: 0.45-0.76	Secondary	282/467 (60.4%)	229/482 (47.5%)	OR 0.59
Thrombectomy performed \| 95% CI: 1.13-1.89	Secondary	184/467 (39.4%)	235/482 (48.8%)	OR 1.46
Time onset to tPA median	Secondary	120 min	155 min	Diff +34.5 min
Time onset to groin puncture median	Secondary	270 min	214 min	Diff -56 min
Dramatic early response at 24h \| 95% CI: 0.55-1.02	Secondary	134/467 (28.7%)	115/482 (23.9%)	OR 0.76
90-day mortality	Adverse	194/713 (27.2%)	188/688 (27.3%)	HR 0.96
Clinical worsening requiring intubation	Adverse	5/713 (0.7%)	7/688 (1.0%)	OR 1.45

Subgroup Analysis

No significant interactions: age (<80/≥80), sex, tPA eligibility, prestroke mRS, RACE score (5-7/8-9). Transport time analysis: no effect modification by estimated travel time (P interaction=0.47).

Criticisms

Results apply only to nonurban patients in a high-performance Catalan system with efficient drip-and-ship.
44% of local stroke center patients had no vessel imaging at first hospital.
Stopped early for futility — may have been underpowered for subgroups.
Cluster randomization with inadvertent mismatch in first 350 patients.
Cannot establish transport time thresholds that might favor direct transport.
Workflow reflects European model with mandatory neurology contact — may not replicate elsewhere.

Funding

Fundació Ictus Malaltia Vascular via unrestricted grant from Medtronic (no role in trial).

Based on: RACECAT (JAMA, 2022)