STRIDE Suggests Race, Not Sex, Associated With Outcomes in ALI Treated With Mechanical Aspiration Thrombectomy

November 5, 2024—Data from the STRIDE study suggest that race, not sex, is associated with outcomes in acute limb ischemia (ALI) treated with mechanical aspiration thrombectomy.

Alex Powell, MD, presented the STRIDE findings in the fourth and final late-breaking clinical trials session at VIVA24, the 22nd annual Vascular InterVentional Advances annual vascular education symposium held by The VIVA Foundation on November 3-6 in Las Vegas, Nevada.

STRIDE assessed safety, efficacy, and quality of life (QoL) outcomes through 365 days for lower extremity ALI (LE-ALI) patients treated first line with mechanical aspiration thrombectomy using the Indigo Aspiration System (Penumbra, Inc.). STRIDE was a prospective, single-arm study that enrolled 119 patients across 16 sites (United States and Europe).

As summarized in the VIVA24 press release, the primary outcome was target limb salvage (TLS) at 30 days postprocedure. Secondary outcomes included device-related serious adverse events, technical success (postprocedure thrombolysis in myocardial infarction flow grades 2/3), mortality, and 30-day patency.

In these subgroup analyses, sex differences were analyzed, and a multivariate Cox proportional hazards model was developed to identify predictors of time to primary and secondary outcomes.

Dr. Powell reported that for all patients (mean age, 66.3 years; 46.2% female; 20.2% African American), TLS and patency at 30 days were 98.2% (109/111) and 89.4% (101/113), respectively. No sex differences were observed for 30-day TLS (P > .999), 30-day patency (P = .220), 365-day mortality (P = .223), or change in QoL (P = .372).

Periprocedural major bleeding (not device related) occurred at a higher rate in females (9.1% vs 0%; P = .019), but all had below-normal range of preprocedural hemoglobin and hematocrit levels or a chronic history of anemia. In the multivariate model, race and sex were not associated with 30-day patency or 365-day mortality. However, African American patients had increased risk of limb loss (hazard ratio, 13.2; 95% CI, 2.5-68.6) and a reduced QoL improvement at 365 days (∆ –3.1; 95% CI, –6.7 to 0.4).

Data from STRIDE continue to support Indigo as a safe and effective option for first-line treatment of LE-ALI in a diverse patient population. Male and female patients experienced good efficacy, safety, and improved QoL outcomes, despite literature reporting women having a history of poorer outcomes than men.

Multivariate analyses identified increased risks for African American patients, underscoring the need for continued research into underlying baseline risk factors and efforts to achieve equity in LE-ALI treatment, concluded the STRIDE findings in the VIVA24 press release.