Abstract No. 106 Procedural Success with Thrombolytic Free, Single-Session Aspiration Mechanical Thrombectomy: STRIDE Study Sub-analysis

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). STRIDE is an international, prospective, single-arm, multicenter, observational study enrolling LE-ALI patients treated first line 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. 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). 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.