WEAVE Trial: Final Results in 152 On-Label Patients
Michael J Alexander, Alois Zauner, John C Chaloupka, Blaise Baxter, Richard C Callison, Rishi Gupta, Shlee S Song, Wengui Yu, WEAVE Trial Sites and Interventionalists, Lei Feng, David Bonovich, Gabor Toth, Brian Kott, Erol Veznedaroglu, Andrew Ringer, Philip Meyers, John Agola, Basavaraj Ghodke, Abdulnasser Alhajeri, Justin Fraser, Curtis Given 2nd, Eric Lopez de Valle, Qaisar Shah, Gary Nesbit, Ameer Hassan, Thomas Grobelny, Richard Fessler 2nd, Harish Shownkeen, Michael J Alexander, Alois Zauner, John C Chaloupka, Blaise Baxter, Richard C Callison, Rishi Gupta, Shlee S Song, Wengui Yu, WEAVE Trial Sites and Interventionalists, Lei Feng, David Bonovich, Gabor Toth, Brian Kott, Erol Veznedaroglu, Andrew Ringer, Philip Meyers, John Agola, Basavaraj Ghodke, Abdulnasser Alhajeri, Justin Fraser, Curtis Given 2nd, Eric Lopez de Valle, Qaisar Shah, Gary Nesbit, Ameer Hassan, Thomas Grobelny, Richard Fessler 2nd, Harish Shownkeen
Abstract
Background and Purpose- The WEAVE trial (Wingspan Stent System Post Market Surveillance) is a postmarket surveillance trial mandated by the Food and Drug Administration to assess the periprocedural safety of the Wingspan Stent system in the treatment of symptomatic intracranial atherosclerotic disease. Methods- A total of 152 consecutive patients who met the Food and Drug Administration on-label usage criteria were enrolled at 24 hospitals and underwent angioplasty and stenting with the Wingspan stent. On-label criteria included age 22 to 80 years, symptomatic intracranial atherosclerotic stenosis of 70% to 99%, baseline modified Rankin Scale score ≤3, ≥2 strokes in the vascular territory of the stenotic lesion with at least 1 stroke while on medical therapy, and stenting of the lesion ≥8 days after the last stroke. The primary analysis assessed the periprocedural stroke, bleed, and death rate within 72 hours of the procedure with adjudication by a core study Stroke Neurologist. Results- The trial was stopped early after interim analysis of 152 consecutive patients demonstrated a lower than expected 2.6% (4/152 patients) periprocedural stroke, bleed, and death rate. This was lower than the 4% periprocedural primary event safety benchmark set for the interim analysis in the study. A total of 97.4% (148/152) patients were event-free at 72 hours, 1.3% (2/152) had nonfatal strokes, and 1.3% (2/152) of patients died. Conclusions- With experienced interventionalists, and proper patient selection following the on-label usage guidelines, the use of the Wingspan stent for intracranial atherosclerotic disease demonstrated a low periprocedural complication rate and excellent safety profile. This is the largest on-label, multicenter, prospective trial of the Wingspan stent system to date with the lowest reported complication rate. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT02034058.
Keywords: angioplasty; antiplatelet therapy; atherosclerosis; patient selection; stents.
Source: PubMed