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Association Of Escalating Antithrombotic Therapy On Bleeding And Survival After Lower Extremity Revascularization For CLTI
Jeremy D. Darling, Jacqueline A. Schermerhorn, Camila R. Guetter, MD, MPH, Isa F. van Galen, MD, Michael Ciaramella, MD, Patric Liang, MD, Lars Stangenberg, MD, PhD, Mark C. Wyers, MD, Allen D. Hamdan, MD, Marc L. Schermerhorn, MD, Christina Marcaccio, MD, MPH.
Beth Israel Deaconess Medical Center, Boston, MA, USA.
OBJECTIVES: VOYAGER PAD demonstrated the benefit of low-dose dual pathway inhibition (LD-DPI) in select populations, yet the balance between bleeding and limb-related outcomes in real-world practice remains unclear. We aimed to compare outcomes among patients on differing antithrombotic regimens.
METHODS: All patients with available medication data undergoing first-time lower extremity revascularization for CLTI between 2005-2022 were included. Patients were stratified by discharge medication regimen: single antiplatelet therapy (SAPT), prolonged (
>90days) dual antiplatelet therapy (DAPT), LD-DPI, standard DPI, and triple therapy (TT). Primary outcomes included gastrointestinal bleeding (GIB), any bleeding complication (bleeding necessitating transfusion
>2 units within 48 hours), stroke, MI, acute limb ischemia (ALI), major adverse limb events (MALE), and survival. Outcomes were analyzed with Kaplan-Meier and Cox regression analyses.
RESULTS: Overall, 1,342 patients were included: 487 SAPT, 359 DAPT, 35 LD-DPI, 257 DPI, and 154 TT. Baseline demographics varied, with SAPT and TT having the lowest and highest rates of CAD (47% vs. 59%), hypertension (85% vs. 94%), and dialysis-dependence (14% vs. 25%) (all
P<.05). Kaplan-Meier estimates showed significant differences in three-year rates of GIB (2.0% (SAPT) vs. 8.2% (DAPT) vs. 10% (LD-DPI) vs. 10% (DPI) vs. 14% (TT)), any bleeding complication (2.4% vs. 5.8% vs. 6.5% vs. 12% vs. 19%), and survival (63% vs. 62% vs. 55% vs. 58% vs. 44%) (all
P<.001)(
Figure I). No differences were noted in rates of MI, stroke, or MALE (all
P>.05). After adjustment, compared to SAPT, DAPT, DPI, and TT were associated with increasingly higher hazard of GIB (HR 3.84, 95% CI [1.71-8.64], HR 5.99[2.33-15.4], and HR 8.58[2.94-24.9], respectively) and any bleeding complication (HR 2.24[1.04-4.80], HR 6.00[2.61-13.7], and HR 11.5[4.52-29.1], respectively). Compared to SAPT, TT had 31% lower hazard of survival (HR 0.69[0.49-0.98]).
CONCLUSIONS: Escalation of antithrombotic therapy beyond SAPT after first-time lower extremity revascularization for CLTI is associated with increased bleeding risk, and triple therapy with reduced survival, likely reflecting the vulnerability of frailer patients less able to tolerate bleeding complications. No differences were observed in MALE, underscoring the challenge of balancing limb-related outcomes with bleeding risk. Careful monitoring, individualized risk stratification, and shared decision-making remain essential in managing this complex and high-risk patient population.
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