Publications

2026

Caron, Elisa, Sai Divya Yadavalli, Mohit Manchella, Gabriel Jabbour, Jorge L Gomez-Mayorga, Roger B Davis, Virendra I Patel, David H Stone, Mark F Conrad, and Marc L Schermerhorn. (2026) 2026. “Impact of Chronic Kidney Disease on Outcomes Following Vascular Procedure in the Vascular Quality Initiative.”. Annals of Surgery 283 (2): 335-44. https://doi.org/10.1097/SLA.0000000000006520.

OBJECTIVE: To determine the optimal estimated glomerular filtration rate (eGFR) cutoff for use in risk stratification and prediction models.

BACKGROUND: Chronic kidney disease increases morbidity and mortality in most vascular procedures. However, a binary classification of eGFR <60 mL/min/1.73 m 2 , which is often used in both modeling and clinical trials, may not be optimal for predicting clinical outcomes.

METHODS: Vascular quality initiative data for nonemergent, first-time open aortic repair, endovascular aortic aneurysm repair, thoracic endovascular aortic repair, carotid endarterectomy, carotid artery stenting, peripheral vascular intervention, supra-inguinal bypass, and infra-inguinal bypass were analyzed from 2013 to 2023 and divided into cohorts based on eGFR (≥60, 45-59, 30-44, <30, and preoperative dialysis). χ 2 and logistic regression were used to evaluate perioperative outcomes.

RESULTS: Compared with patients with eGFR ≥60, those with eGFR 45 to 59 had similar odds of mortality following all procedures, except thoracic endovascular aortic repair. Driven by this group, the combined cohort showed a slight increase in the odds of mortality for eGFR 45 to 59 (0.6% vs 0.7%, adjusted odds ratio(aOR): 1.16, P = 0.002). Those in the 30 to 44 group demonstrated increased odds of mortality both overall and in the individual procedure groups (0.6% vs 1.2%, aOR: 1.78, P < 0.001). The odds of mortality continued to increase with worsening eGFR. The overall rate of new permanent dialysis was low for all eGFR cohorts, with a 0.02% difference between those with eGFR ≥60 and those in the 45 to 59 cohort (0.04% vs 0.06%; aOR: 1.65, P < 0.001). The odds of permanent dialysis likewise continued to increase with decreasing eGFR.

CONCLUSIONS: Rather than a binary eGFR cutoff of ≥60 and <60 to stratify patient risk, better risk stratification may be achieved by using 5 groups of ≥60, 45 to 59, 30 to 44, <30, and preoperative dialysis.

Darling, Jeremy D, Camila R Guetter, Leigh Friedman, Michael A Ciaramella, Isa F van Galen, Christina Marcaccio, Patric Liang, et al. (2026) 2026. “Outcomes Among Patients With Single-Vessel Tibial Runoff Undergoing Revascularization for Chronic Limb-Threatening Ischemia, and the Role of Peroneal Communicating Branch Quality.”. Journal of Vascular Surgery. https://doi.org/10.1016/j.jvs.2026.10.003.

OBJECTIVES: Data evaluating outcomes among patients with single-vessel tibial runoff are limited. Our aim was to compare outcomes across patients with sole anterior tibial (AT), peroneal, or posterior tibial (PT) runoff following revascularization for chronic limb-threatening ischemia (CLTI), and to evaluate whether the quality of peroneal communicating branches affects outcome risk within the peroneal runoff population.

METHODS: All patients undergoing first-time revascularization for CLTI were retrospectively reviewed (2005-2022) and stratified by sole runoff vessel (AT, peroneal, PT). Primary outcomes were wound healing, major amputation, major adverse limb events (MALE), and amputation/death, assessed by Kaplan-Meier analysis and multivariable Cox regression. A subset analysis stratified single-vessel peroneal runoff patients into a three-tiered, Peroneal Communicating Branch (PCB) Grade: Both branches present with at least one robust (PCB Grade 1), a single robust branch (PCB Grade 2), or no robust branch (PCB Grade 3), and compared each to the single-vessel AT/PT reference group.

RESULTS: Overall, 732 patients had single-vessel below-knee runoff: 225 AT, 315 peroneal, and 192 PT. Groups differed significantly in age, sex, and diabetes prevalence. Unadjusted two-year major amputation rates were significantly higher in the peroneal group (19% vs. 9.4% [AT] vs. 8.7% [PT]; P<.001), as were MALE rates (30% vs. 14% vs. 26%; P=.01). After adjustment, peroneal runoff was independently associated with higher risk of major amputation (HR 1.81 [1.04-3.13]) and MALE (HR 1.52 [1.03-2.25]) compared with AT/PT runoff. These associations persisted in the endovascular cohort (major amputation: HR 2.09 [1.06-4.13]; MALE: HR 1.59 [1.08-2.35]) but did not reach significance in the bypass cohort, which was limited by low event rates. When patients with single-vessel peroneal runoff were stratified by PCB Grades, unadjusted one-year major amputation rates followed a clear anatomically-driven pattern (6.9% (AT/PT) vs. 5.4% (PCB Grade 1) vs. 15% (PCB Grade 2) vs. 32% (PCB Grade 3); P<.001). After adjustment, when compared to AT/PT runoff, patients without any robust branch (PCB Grade 3) had significantly higher risk of major amputation (HR 3.21 [1.76-4.84]) and MALE (HR 2.41 [1.53-3.79]), while those with two branches with at least one being robust (PCB Grade 1) demonstrated higher rates of complete wound healing (HR 1.69 [1.09-2.62]) and no difference in major amputation or MALE.

CONCLUSIONS: Peroneal runoff is independently associated with worse limb outcomes following revascularization for CLTI, but this risk may be primarily driven by patients with absent or diminutive communicating branches. Those with robust branching demonstrate outcomes comparable to AT/PT runoff, underscoring the importance of further evaluation and pre-operative assessment of peroneal communicating branch quality - using the proposed PCB Grading system - in revascularization planning.

van Galen, Isa F, Jeremy D Darling, Camila R Guetter, Elisa Caron, Jemin Park, Roger B Davis, Douglas W Jones, et al. (2026) 2026. “The Effect of Aneurysm Diameter on Perioperative Outcomes Following Endovascular Thoracoabdominal Aortic Aneurysm Repair.”. Journal of Vascular Surgery 83 (4): 999-1009.e2. https://doi.org/10.1016/j.jvs.2025.10.010.

BACKGROUND: Endovascular repair of large diameter infrarenal and complex abdominal aortic aneurysms has been associated with worse outcomes. Whether these associations also apply to thoracoabdominal aortic aneurysms (TAAAs) remains unclear.

METHODS: We identified all patients who underwent endovascular repair for intact TAAAs between July 2010 and July 2024 in the Vascular Quality Initiative. A TAAA was defined as having a proximal aneurysm extent between zones 2 and 6, with at least one renal or visceral artery treated. Locally estimated scatterplot smoothing curves were used to visualize the relationship between preoperative aneurysm diameter and perioperative mortality, which informed the sex-specific definition of large aneurysms. Aneurysm size was categorized based on maximum diameter as follows (females/males): large (>60 mm/>65 mm), small (<50 mm/<55 mm), and medium (50-60 mm/55-65 mm). Perioperative outcomes were assessed using logistic regression models, and 5-year mortality was evaluated using adjusted Kaplan-Meier methods and Cox regression. Both large and small aneurysms were compared with medium-sized aneurysms.

RESULTS: A total of 1309 patients were included; of these, 54% underwent repair for medium-sized aneurysms, 37% for large aneurysms, and 9.1% for small aneurysms. The median follow-up was 345 days. After adjustment, compared with medium-sized aneurysms, large aneurysms were associated with 31% higher odds of any perioperative complication (adjusted odds ratio, 1.31; 95% confidence interval, 1.00-1.72; P = .046) and nearly twice the hazard of 5-year mortality (adjusted hazard ratio, 1.94; 95% confidence interval, 1.43-2.62; P < .01). The odds of perioperative mortality and in-hospital reintervention were similar between medium-sized and large aneurysms. No significant differences in perioperative outcomes or 5-year mortality were observed between patients with small and medium-sized aneurysms.

CONCLUSIONS: After endovascular repair for TAAAs, compared with medium-sized aneurysms, large aneurysms (>60 mm in females, >65 mm in males) were associated with higher odds of any complication and higher 5-year mortality. Patients with small aneurysms (<50 mm in females, <55 mm in males) demonstrated similar perioperative outcomes and 5-year mortality compared with those with medium-sized aneurysms. These findings highlight the need to optimize management strategies for patients with large TAAAs and emphasize the importance of improved screening programs to enable earlier detection.

Yadavalli, Sai Divya, Elisa Caron, Daniel Colome, Lucas Souza-Mota, Winona W Wu, Carla Moreira, Jeffrey J Siracuse, Marc L Schermerhorn, and Lars Stangenberg. (2026) 2026. “Outcomes Following Unilateral Axillofemoral Bypass versus Crossover Femorofemoral Bypass in Chronic Limb-Threatening Ischemia Patients.”. Journal of Vascular Surgery 83 (3): 793-802.e1. https://doi.org/10.1016/j.jvs.2025.10.025.

OBJECTIVE: In patients with chronic limb-threatening ischemia (CLTI), extra-anatomical bypasses are viable options to establish inflow when aortic cross-clamping necessary for anatomical reconstruction cannot be tolerated or in those with a hostile abdomen. Given their infrequent use, direct comparisons between unilateral axillofemoral bypass (AxFB) vs cross-over femorofemoral bypass (FFB) for CLTI remain scarce. We evaluated postoperative and 5-year outcomes after AxFB vs FFB for CLTI.

METHODS: Patients undergoing nonemergent unilateral AxFB and FFB in the Vascular Quality Initiative linked to Medicare claims between 2014 and 2019 were identified, excluding procedures with other concomitant bypasses/interventions. We performed 1:2 (AxFB:FFB) propensity score matching for baseline demographics, comorbidities, urgency, ipsilateral presentation, and contralateral symptoms (rest pain vs ulcer/gangrene), and prior interventions/bypass procedures. Perioperative and 5-year outcomes were analyzed using logistic regression and Cox regression models.

RESULTS: We included 1185 patients (27% AxFB), of whom 224 AxFBs matched with 374 FFBs. After matching, perioperative mortality was comparable between the AxFB and FFB bypass groups (15% vs 10%; P = .12). However, AxFB patients had higher rates of any postoperative complication (30% vs 15%; P < .01) as well as ipsilateral major amputations (below knee, 1.8% vs 0.5%; above knee, 5.4% vs 2.4%; P = .05), in-hospital reintervention (13% vs 7.2%; P = .04), and surgical site infections (5.8% vs 1.6%; P = .01). Patency rates at discharge were similar between the two groups. Postoperative length of stay was higher in the AxFB patients (6.9 ± 5.3 vs 6.2 ± 20; P < .01), and rates for discharge to home were lower (57% vs 68%; P = .07). At 5 years, AxFB was associated with lower rates of 5-year overall survival (41% vs 46%; adjusted hazard ratio [aHR]. 1.3; 95% confidence interval [CI], 1.0-1.7; P = .046), and comparable reintervention free survival (49% vs 45%; aHR, 0.86; 95% CI, 0.59-1.2; P = .40). There was a suggestion of lower major amputation-free survival (69% vs 89%; aHR, 1.7; 95% CI, 0.92-3.1; P = .089), albeit not significantly.

CONCLUSIONS: Unilateral AxFB for CLTI was associated with lower 5-year survival rates and similar amputation-free survival and reintervention free-survival rates, alongside similar perioperative mortality and higher postoperative complication rates when compared with FFB. Our data confirm that, among the extra-anatomical bypass options, FFB remains first-line therapy and unilateral AxFB is an alternative option for the treatment of aortoiliac occlusive disease in select CLTI patients with acceptable outcomes.

Park, Jemin, Emily St John, Jeremy D Darling, and Marc L Schermerhorn. (2026) 2026. “Contemporary Outcomes of Carotid Revascularization Procedures.”. Seminars in Vascular Surgery 39 (1): 41-51. https://doi.org/10.1053/j.semvascsurg.2026.01.003.

Since the first carotid endarterectomy (CEA) in 1953 by Dr. Michael DeBakey, the management of carotid stenosis has evolved tremendously, with the introduction of transfemoral carotid artery stenting (tfCAS) in the 1990s and transcarotid artery revascularization (TCAR), introduced by Dr. Juan Parodi in 1998 and available commercially in 2015, as well as improved medical management. Society guidelines endorse revascularization for symptomatic patients with high-grade stenosis and acceptable procedural risk. Introduced as a minimally invasive alternative to CEA, tfCAS has been consistently associated with higher perioperative stroke risk compared with CEA. As such, guidelines recommend CEA for patients older than 70 years, although stenting may be considered for younger patients or those with high surgical risk. TCAR has increased in volume since its introduction in 2015, with continued growth after its coverage expansion in April 2022. Although no trials have directly compared TCAR with the other techniques, registry data have indicated its safety and equivocal outcomes compared with CEA, and guidelines show a preference for TCAR over tfCAS and CEA in patients with high surgical risk. Management of asymptomatic disease remains controversial, with advancements in medical therapy. The recent CREST-2 trial found a lower risk of perioperative stroke or death and ipsilateral stroke within 4 years after tfCAS and intensive medical therapy compared with intensive medical therapy alone; CEA and intensive medical therapy also had a lower risk but the difference did not reach statistical significance. As such, patient selection should continue to be individualized.

Shaw, Brian L, Sai Divya Yadavalli, Marc L Schermerhorn, Mark C Wyers, and Lars Stangenberg. (2026) 2026. “Vascular Complications After Anterior Lumbar Interbody Fusion or Oblique Lumbar Interbody Fusion.”. Journal of Vascular Surgery 83 (4): 1234-40. https://doi.org/10.1016/j.jvs.2025.11.037.

OBJECTIVE: Adequate exposure of the anterior and lateral spinal columns, requiring mobilization of major vascular structures, is critical to instrumented lumbar spine surgery. Anterior lumbar interbody fusion (ALIF) has traditionally been the primary approach, but oblique lumbar interbody fusion (OLIF) is increasingly used. We aimed to compare intraoperative and postoperative vascular outcomes between ALIF and OLIF approaches.

METHODS: A retrospective chart review identified all patients who underwent ALIF or OLIF for lumbar spine surgery between January 2017 and July 2023 at a single tertiary care center. Primary outcomes included frequency and level of vascular injury, as well as estimated blood loss. Secondary outcomes included operative times and other intra- and perioperative parameters. Adjusted analyses were performed using inverse probability of treatment weighting based on propensity scores.

RESULTS: A total of 292 procedures were included (222 ALIF, 70 OLIF). Rates of vascular injury were similar between ALIF and OLIF after inverse probability of treatment weighting (ALIF vs OLIF: 9.5% vs 9.4%, P = .98) as well as similar blood loss overall (155 [28] cc vs 323 [178] cc, P = .16). Injuries at L4-L5 were more frequent in ALIF (5.3% vs 0%), and L5-S1 injuries were higher during OLIF (2.6% vs 7.7%, P = .015). Procedure duration was longer for OLIF than for ALIF (132 [6] minutes vs 260 [14] minutes, P < .001). No differences were observed in other postoperative outcomes, including injuries to surrounding structures, surgical site infections, and length of hospital stay.

CONCLUSIONS: In this cohort, ALIF and OLIF approaches demonstrated comparable rates of vascular injury and estimated blood loss overall; however, the level of injury differed between the procedures, with more distal injuries at L5-S1 during OLIF. OLIF procedures were also associated with longer procedure times. Both approaches remain safe and effective options for lumbar spine access when performed in high-volume centers.

Allievi, Sara, Vinamr Rastogi, Sai Divya Yadavalli, Sharjeel A Chaudhry, Douglas W Jones, Kristina A Giles, Salvatore T Scali, Hence J M Verhagen, Santi Trimarchi, and Marc L Schermerhorn. (2026) 2026. “The Effect of Early Reintervention on Late Outcomes Following Infrarenal and Fenestrated Endovascular Aneurysm Repair.”. Journal of Vascular Surgery 83 (4): 1034-46. https://doi.org/10.1016/j.jvs.2025.10.096.

OBJECTIVE: In this study, we examined the association between early reintervention and 5-year outcomes following endovascular aneurysm repair (EVAR) and fenestrated EVAR (FEVAR), and assessed factors associated with higher risk of early reintervention.

METHODS: We identified all patients undergoing elective infrarenal EVAR and juxtarenal FEVAR (custom-made devices [CMDs] and physician-modified endografts [PMEGs]) in the Vascular Implant Surveillance and International Outcomes Network dataset (2014-2019). Patients with <6 months of follow-up were excluded to address potential survival bias. We stratified the population by the occurrence of an early reintervention within the first postoperative year (early reintervention), and assessed association with 5-year all-cause mortality, reintervention, and rupture, using Kaplan-Meier methods and multivariable Cox regression analysis. Second, we assessed factors associated with early reintervention with multivariable logistic regression and performed a sensitivity analysis by restricting the definition of early reintervention to the first 6-months postoperatively.

RESULTS: We identified 10,348 EVARs and 1154 FEVARs (456 PMEGs, 698 CMDs), of which 3.1% and 7.2% (3.1% CMD, 4.0% PMEG) underwent early reintervention, respectively. Among EVARs, compared with no early reintervention, early reintervention patients were younger, and more frequently had chronic obstructive pulmonary disease, anemia, prior abdominal aortic surgery, and more distal sealing zone (all P < .05). Compared with no early reintervention, early reintervention was associated with higher 5-year mortality (42% vs 33%; hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.29-2.02; P < .001), reintervention (34% vs 13%; HR, 4.96; 95% CI, 3.77-6.52; P < .001), and rupture (5.3% vs 0.5%; HR, 20.2; 95% CI, 9.97-40.8; P < .001). At the sensitivity analysis, the 5-year outcomes remained similar. Factors associated with a higher risk of early reintervention were anemia, chronic obstructive pulmonary disease, renal dysfunction, and prior aortic surgery. Among FEVARs, compared with no early reintervention, early reintervention patients were more frequently treated by a high-volume physician (≥21 complex [EVAR] cEVAR/year) and in high-volume centers (≥22 cEVAR/year; both P < .005). Compared with no early reintervention, early reintervention was associated with similar 5-year mortality (41% vs 38%; HR, 0.96; 95% CI, 0.60-1.54; P = .87), but greater reintervention rates (38% vs 26%; HR, 3.02; 95% CI, 1.88-4.86; P < .001) and rupture rates (6.8% vs 2.2%; HR, 6.52; 95% CI, 1.98-21.5; P < .001). At the sensitivity analysis, the 5-year outcomes remained similar. Factors associated with higher early reintervention risk were female sex, larger diameter, and PMEG.

CONCLUSIONS: Because early reintervention after EVAR and FEVAR proved to be a marker of increase risk for 5-year reintervention and rupture, these patients have a uniquely high-risk phenotype that warrants vigilant surveillance and underscores the need for rigorous preoperative risk stratification and planning. Understanding factors associated with early reintervention allows health care professionals to identify high-risk patients, leading to informed counseling and more personalized follow-up care.

van Galen, Isa F, Camila R Guetter, Jeremy D Darling, Elisa Caron, Roger B Davis, Virendra I Patel, Thomas F X O’Donnell, Constantijn E B Hazenberg V, Joost A van Herwaarden, and Marc L Schermerhorn. (2026) 2026. “Association Between Pre-Operative Aneurysm Diameter and One Year Sac Behaviour Following Endovascular Aneurysm Repair.”. European Journal of Vascular and Endovascular Surgery : The Official Journal of the European Society for Vascular Surgery. https://doi.org/10.1016/j.ejvs.2026.04.004.

OBJECTIVE: This retrospective cohort study assessed the association between aneurysm diameter and one year sac behaviour.

METHODS: All endovascular aortic repairs (EVARs) with one year imaging follow up in the Vascular Quality Initiative (2003 - 2024) were included. Sac behaviour was defined as expansion (≥ 5 mm enlargement), regression (≥ 5 mm shrinkage), or stable (< 5 mm change). Aneurysm diameter was categorised by sex specific thresholds (women/men): < 45/< 50 mm, 45 - 50/50 - 55 mm, 50 - 55/55 - 60 mm, 55 - 60/60 - 65 mm, 60 - 65/65 - 70 mm, and > 65/> 70 mm. Sac behaviour was estimated using multinomial logistic regression, with sac stability and 50 - 55/55 - 60 mm as reference categories. Restricted cubic splines (RCS) were incorporated to explore the continuous relationship.

RESULTS: A total of 28 275 patients were included. At one year, 48.5% had sac regression, 45.4% stability, and 6.1% expansion. Using 50 - 55/55 - 60 mm as the diameter reference and sac stability as the outcome reference, adjusted odds ratios (95% confidence interval) for sac regression were 0.40 (0.37 - 0.43) for < 45/< 50 mm, 0.82 (0.77 - 0.86) for 45 - 50/50 - 55 mm, 1.25 (1.17 - 1.33) for 55 - 60/60 - 65 mm, 1.38 (1.29 - 1.48) for 60 - 65/65 - 70 mm, and 1.46 (1.37 - 1.57) for > 65/> 70 mm. Corresponding odds ratios for expansion were 1.92 (1.88 - 1.95), 1.03 (1.02 - 1.04), 1.20 (1.18 - 1.21), 1.43 (1.41 - 1.45), and 1.67 (1.64 - 1.69), respectively. RCS demonstrated that regression increased steeply with diameter up to ∼55 mm, while stability declined progressively. Expansion was most common in small aneurysms and least likely near 55 mm.

CONCLUSION: Pre-operative aneurysm diameter showed a non-linear association with one year sac behaviour. Sac regression increased up to ∼55 mm, where the predicted probability of expansion was lowest. Small aneurysms had nearly twofold higher odds of expansion relative to stability. In larger aneurysms, higher odds of expansion reflected lower stability rather than a meaningful rise in absolute expansion risk. Further investigation is needed to clarify the mechanisms underlying sac expansion in small aneurysms. These findings suggest that patients treated at small diameters may require closer surveillance.

Darling, Jeremy D, Jacqueline A Schermerhorn, Camila R Guetter, Michael A Ciaramella, Isa F van Galen, Jemin Park, Patric Liang, et al. (2026) 2026. “Safety and Efficacy of Escalating Antithrombotic Therapy After Lower Extremity Revascularization for Chronic Limb-Threatening Ischemia.”. Journal of Vascular Surgery 84 (1): 167-177.e2. https://doi.org/10.1016/j.jvs.2026.03.439.

OBJECTIVE: The VOYAGER PAD trial demonstrated the benefit of low-dose dual pathway inhibition (LD-DPI) with aspirin and low-dose rivaroxaban 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 after lower extremity revascularization for chronic limb-threatening ischemia (CLTI).

METHODS: All patients with available medication data undergoing first-time lower extremity revascularization for CLTI between 2005 and 2022 at a single institution were included. Patients were stratified by discharge medication regimen, including single antiplatelet therapy (SAPT; further stratified into aspirin monotherapy [SAPTasa] and P2y12 inhibitor monotherapy [SAPTp2y]), prolonged (>90 days) dual antiplatelet therapy (DAPT), LD-DPI, standard DPI (SAPT + full-dose anticoagulation), and triple therapy (TT; DAPT + anticoagulation at any dose). Primary outcomes included gastrointestinal bleeding (GIB), any bleeding complication (bleeding necessitating transfusion of ≥2 units within 48 hours, bleeding leading to surgical intervention, or intracranial hemorrhage), stroke, myocardial infarction (MI), acute limb ischemia, primary patency, major adverse limb events (MALE), and mortality. Outcomes were analyzed with Kaplan-Meier and Cox regression analyses.

RESULTS: Overall, 1286 patients were included: 402 SAPTasa, 85 SAPTp2y, 359 DAPT, 35 LD-DPI, 257 DPI, and 148 TT. Baseline demographics varied, with SAPTasa and TT having the lowest and highest respective rates of coronary artery disease (49% vs 60%), hypertension (84% vs 95%), and atrial fibrillation (11% vs 60%) (all P < .05). Kaplan-Meier estimates showed significant differences between groups in 3-year rates of GIB (1.5% [SAPTasa] vs 2.6% [SAPTp2y] vs 8.8% [DAPT] vs 10% [LD-DPI] vs 10% [DPI] vs 15% [TT]), any bleeding complication (3.2% vs 2.6% vs 5.8% vs 7.8% vs 14% vs 21%), and death (37% vs 38% vs 38% vs 44% vs 43% vs 57%) (all P ≤ .001). No differences were noted in rates of MI, stroke, primary patency, or MALE. After adjustment, compared with SAPTasa, DAPT, DPI, and TT were associated with increasingly higher hazard of GIB (DAPT: hazard ratio [HR], 3.75; 95% confidence interval [CI], 1.60-8.76; DPI: HR, 5.48; 95% CI, 2.11-14.2; and TT: HR, 8.65; 95% CI, 3.07-24.3) and DPI and TT with higher hazard of any bleeding complication (HR, 5.07; 95% CI, 2.22-11.6; and HR, 9.65; 95% CI, 3.99-23.3). Compared with SAPTasa, TT had 40% higher hazard of mortality (HR, 1.40; 95% CI, 1.01-1.95).

CONCLUSIONS: Escalation of antithrombotic therapy beyond SAPT after first-time lower extremity revascularization for CLTI is associated with higher bleeding risk, and TT with lower survival, possibly reflecting the vulnerability of frailer patients less able to tolerate bleeding complications. No differences were observed in MI, stroke, patency, or MALE, underscoring the challenge of balancing limb-related outcomes with bleeding risk. Careful monitoring, individualized risk stratification, and shared decision-making remain essential. Larger studies are needed to further define the relative efficacy and safety of intensified antithrombotic regimens.