Abstract
BACKGROUND AND PURPOSE: Patient selection for endovascular therapy remains a great challenge in clinic practice. We sought to determine the effect of baseline CT and angiography on outcomes in the Solitaire With the Intention for Thrombectomy as Primary Endovascular Treatment for Acute Ischemic Stroke (SWIFT PRIME) trial and to identify patients who would benefit from endovascular stroke therapy.
MATERIALS AND METHODS: The primary end point was a 90-day modified Rankin Scale score of 0–2. Subgroup and classification and regression tree analysis was performed on baseline ASPECTS, site of occlusion, clot length, collateral status, and onset-to-treatment time.
RESULTS: Smaller baseline infarct (n = 145) (ASPECTS 8–10) was associated with better outcomes in patients treated with thrombectomy versus IV tPA alone (66% versus 41%; rate ratio, 1.62) compared with patients with larger baseline infarcts (n = 44) (ASPECTS 6–7) (42% versus 21%; rate ratio, 1.98). The benefit of thrombectomy over IV tPA alone did not differ significantly by ASPECTS. Stratification by occlusion location also showed benefit with thrombectomy across all groups. Improved outcomes after thrombectomy occurred in patients with clot lengths of ≥8 mm (71% versus 43%; rate ratio, 1.67). Outcomes stratified by collateral status had a benefit with thrombectomy across all groups: none–fair collaterals (33% versus 0%), good collaterals (58% versus 44%), and excellent collaterals (82% versus 28%). Using a 3-level classification and regression tree analysis, we observed optimal outcomes in patients with favorable baseline ASPECTS, complete/near-complete recanalization (TICI 2b/3), and early treatment (mean mRS, 1.35 versus 3.73), while univariate and multivariate logistic regression showed significantly better results in patients with higher ASPECTS.
CONCLUSIONS: While benefit was seen with endovascular therapy across multiple subgroups, the greatest response was observed in patients with a small baseline core infarct, excellent collaterals, and early treatment.
Footnotes
Disclosures: Hans-Christoph Diener—OTHER RELATIONSHIPS: H.-C.D. received honoraria for participation in clinical trials, contribution to advisory boards, or oral presentations from the following: Abbott, Allergan, AstraZeneca, Bayer Vital, Bristol-Myers Squibb, Boehringer Ingelheim, CoAxia, Corimmun, Covidien, Daiichi Sankyo, D-Pharm, Fresenius, GlaxoSmithKline, Janssen-Cilag, Johnson & Johnson, Knoll, Eli Lilly, Merck Sharp & Dohme, Medtronic, Mindframe, Neurobiological Technologies, Novartis, Novo Nordisk, Paion, Parke-Davis, Pfizer, Sanofi-Aventis, Schering-Plough, Servier, Solvay, St. Jude, Syngis, Talecris Pharma Resources, Thrombogenics, WebMD Global, Wyeth and Yamanouchi. Financial support for research projects was provided by AstraZeneca, GlaxoSmithKline, Boehringer Ingelheim, Lundbeck, Novartis, Janssen-Cilag, Sanofi-Aventis, Syngis, and Talecris Pharma Resources. The Department of Neurology at the University Duisburg-Essen received research grants from the German Research Council, German Ministry of Education and Research, European Union, National Institutes of Health, the Bertelsmann Foundation, and the Heinz-Nixdorf Foundation. H.-C.D. has no ownership interest and does not own stocks in any pharmaceutical company. Alain Bonafe—UNRELATED: Consultancy: Medtronic, Stryker. Vitor Mendes Pereira—RELATED: Consulting Fee or Honorarium: Medtronic/Covidien, Comments: as EU Interventional Principal Investigator for the SWIFT PRIME trial*; UNRELATED: Consultancy: Medtronic, Stryker, Codman Neuro, Penumbra, Comments: proctoring and studies Advisory Board. Elad I. Levy—UNRELATED: Board Membership: Stryker, NeXtGen Biologics, MEDX, Cognition Medical Corp, Comments: serves on the Advisory Board; Consultancy: Pulsar Vascular; Expert Testimony, Comments: renders medical/legal opinion as an expert witness; Payment for Development of Educational Presentations: Covidien, Comments: honorarium for training and lectures; Stock/Stock Options: Intratech Medical, NeXtGen Biologics, Comments: shareholder/ownership interest; Other: Abbott Vascular, Comments: carotid training sessions for physicians. Blaise W. Baxter—UNRELATED: Consultancy: Penumbra, Comments: consulting fees for stroke therapy development; Payment for Lectures Including Service on Speakers Bureaus: Penumbra, Comments: Speakers Bureau expenses paid for talks; Patents (Planned, Pending or Issued): Advanced Catheter Therapies, Comments: devices and methods for perfusion therapy; Patent No. US 8622992 B2; Stock/Stock Options: Penumbra, Comments: hold stock in the company. Tudor G. Jovin—UNRELATED: Consultancy: Codman Neurovascular, Neuravi; Stock/Stock Options: Silk Road, Anaconda, Blockade Medical; Travel/Accommodations/Meeting Expenses Unrelated to Activities Listed: Stryker, Fundació Ictus. Raul G. Nogueira—RELATED: Consulting Fee or Honorarium: Stryker Neurovascular (TREVO-2 Trial, Principal Investigator, modest; DAWN Trial, Principal Investigator, no compensation; TREVO Registry Steering Committee, no compensation); Medtronic (SWIFT Trial Steering Committee, modest; SWIFT-PRIME Trial Steering Committee, no compensation; STAR Trial Angiographic Core Lab, significant), Penumbra (3D Separator Trial Executive Committee, no compensation), Neuravi (ARISE-2 Steering Committee, no compensation), Genentech (Physician Advisory Board, modest), Allm Inc (Physician Advisory Board, no compensation), Editor-In-Chief Interventional Neurology (no compensation). Dileep R. Yavagal—RELATED: Grant: Medtronic, Comments: University of Miami was a site for the SWIFT-PRIME study*; Consulting Fee or Honorarium: Medtronic, Comments: Steering Committee member for this trial; Support for Travel to Meetings for the Study or Other Purposes: Medtronic; UNRELATED: Consultancy: Medtronic; Payment for Lectures Including Service on Speakers Bureaus: Penumbra, Medtronic, Comments: consultant to Medtronic; Travel/Accommodations/Meeting Expenses Unrelated to Activities Listed: Medtronic; Other: Medtronic. Christophe Cognard—UNRELATED: Consultancy: MicroVention, Stryker, Medtronic. Derk D. Purcell—RELATED: Other: BioClinica, Comments: I was a central reader, paid by the imaging clinical research organization (BioClinica); UNRELATED: Consultancy: BioClinica, Comments: central reader for imaging clinical research organization. Reza Jahan—RELATED: Fees for Participation in Review Activities such as Data Monitoring Boards, Statistical Analysis, Endpoint Committees, and the Like: Medtronic, Comments: on Executive Steering Committee of SWIFT PRIME; UNRELATED: Consultancy: Medtronic. Jeffrey L. Saver—RELATED: Grant: Medtronic, Comments: The University of California Regents received payments on the basis of clinical trial contracts for the number of subjects enrolled*; Consulting Fee or Honorarium: Medtronic, Comments: Dr Saver received funding for services as a scientific consultant regarding the SWIFT PRIME trial design and conduct to Medtronic; Support for Travel to Meetings for the Study or Other Purposes: Medtronic, Comments: Dr Saver received funding for travel as a scientific consultant regarding the SWIFT PRIME trial design and conduct to Medtronic; UNRELATED: Consultancy: Stryker, Neuravi, BrainsGate, Pfizer, Squibb, Boehringer Ingelheim (prevention only), ZZ Biotech, and St. Jude Medical, Comments: Dr Saver has received funding for services as a scientific consultant regarding trial design and conduct to Stryker, Neuravi, BrainsGate, Pfizer, Squibb, Boehringer Ingelheim (prevention only), ZZ Biotech, and St. Jude Medical; Royalties: University of California, Comments: The University of California has patent rights for retrieval devices for stroke.* Mayank Goyal—RELATED: Grant: Medtronic, Comments: HERMES collaboration, part funding for the ESCAPE trial*; Consulting Fee or Honorarium: Medtronic, Comments: For the design and conduct of the SWIFT PRIME trial; Other: Stryker, MicroVention, Ablynx, Comments: For advice and teaching on acute stroke; UNRELATED: Patents (Planned, Pending or Issued): GE Healthcare, Comments: licensing agreement regarding systems of stroke diagnosis. *Money paid to the institution.
An academic steering committee supervised the trial design and operations. The sponsor of the study (Covidien) was responsible for site management, data management, and safety reporting. The study data were independently monitored. The statistical analyses were prepared by an independent external statistician (S. Brown; Altair Biostatistics, St. Louis Park, Minnesota).
This work was supported by the SWIFT PRIME study, funded by Covidien.
- © 2017 by American Journal of Neuroradiology
