SIR 2024
Arterial Interventions and Peripheral Arterial Disease (PAD)
Jayer Chung, MD (he/him/his)
Associate Professor of Surgery
Baylor College of Medicine
Financial relationships: Full list of relationships is listed on the CME information page.
Thomas Maldonado, MD
Professor of Surgery
NYU Langone Medical Center
Disclosure information not submitted.
Heiko Wendorff, MD
Managing Senior Physician
Klinikum rechts der Isar, Germany
Disclosure information not submitted.
Khanjan H. Nagarsheth, MD
Associate Professor
University of Maryland
Disclosure information not submitted.
This sub-analysis of the STRIDE study evaluates safety and efficacy outcomes for patients treated without tissue plasminogen activator (tPA) during and after aspiration mechanical thrombectomy (MT) for lower extremity-acute limb ischemia (LE-ALI).
Materials and Methods:
STRIDE is an international, prospective, single-arm, multicenter, observational study enrolling LE-ALI patients treated firstline with MT using the Indigo System at 16 sites across the US and EU. Patients with pre-procedural tPA were excluded; peri- and post-procedural tPA use was left to physician discretion.
Results:
STRIDE enrolled 119 participants (46.2% female, mean age 66.3 years), 72 (60.5%) of whom received MT without the use of tPA. Patients who received tPA (overnight or single session) were more likely to have popliteal aneurysm (14.9% with vs 0.0% without, p=0.001) or thrombus in a bypass graft (31.9% vs 5.6%, p< 0.001). Both populations had similar rates of multisegmental infrainguinal disease (65.7% vs 69.1%, p=0.819) and baseline Rutherford Class IIb (31.9% vs 36.1%, p=0.109).
No significant differences were detected between patients treated with or without tPA for target limb salvage rate at 30 days (100.0% vs 97.1%, p=0.521), technical success (92.9% vs 98.5%, p=0.296), improvement in modified SVS runoff score (4.5 vs 7.3, p=0.3486), or patency at 30 days (93.0% vs 87.1%, p=0.531). Device-related serious adverse events (2.1% vs 0.0%, p=0.395), periprocedural major bleeds (6.4% vs 2.8%, p=0.382), and 30-day mortality (2.1% vs 4.2%, p >0.999) also did not differ significantly. Median aspiration time was 22 minutes, time of procedure (arterial puncture to sheath removal) was longer for patients who received tPA (966.0 vs 88.0 minutes, p< 0.001).
Conclusion:
While the STRIDE study did not limit use of peri- or post-procedural tPA, most patients in this challenging real-world cohort were treated without tPA. This sub-analysis demonstrates that MT with Indigo system yields high procedural success, low complication rates and high target limb salvage rates in LE-ALI without use of thrombolytics.