Long-Term Results of Endovascular Treatment with Nitinol Stents for Femoropopliteal TASC II C and D Lesions.

Background and Objectives: The feasibility of endovascular treatment (EVT) for Trans-Atlantic Inter-Society Consensus (TASC) II C and D femoropopliteal artery lesions has been described, but no prospective study has performed a long-term follow-up. The aim of this study was to report the long-term results of nitinol stents (NS) for the treatment of long femoropopliteal lesions. Materials and Methods: A single-center prospective, randomized controlled trial (RCT) comparing EVT with NS and vein bypass surgery was previously performed. The EVT group's follow-up was extended and separately analyzed with primary patency as the primary endpoint. The secondary endpoints were technical success, secondary patency, reinterventions, limb salvage, survival, complications, and clinical improvement. Results: Between 2016 and 2020, 109 limbs in 103 patients were included. A total of 48 TASC II C and 61 TASC II D lesions with a mean lesion length of 264 mm were reported. In 53% of limbs, the indication for treatment was chronic limb-threatening ischemia. The median follow-up was 45 months. Technical success was achieved in 88% of cases, despite 23% of the lesions being longer than 30 cm (retrograde popliteal access in 22%). At four-year follow-up, primary patency, secondary patency, and freedom from target lesion revascularizations were 35%, 48%, and 58%, respectively. Limb salvage and survival were 90% and 80% at 4 years. Clinical improvement of at least one Rutherford category at the end of follow-up was achieved in 83% of limbs. Conclusions: This study reports the longest follow-up of endovascular treatment with nitinol stents in femoropopliteal TASC II C and D lesions. The results emphasize the feasibility of an endovascular-first strategy, even in lesions beyond 30 cm in length, and clarify its acceptable long-term durability and good clinical outcomes. Large multicenter RCTs with mid- and long-term follow-up are needed to investigate the role of different endovascular techniques in long femoropopliteal lesions.

Revascularization Strategies for Patients With Femoropopliteal Peripheral Artery Disease.

BACKGROUND: No adequately powered studies exist to compare major clinical outcomes after endovascular therapy (EVT) with stent implantation vs bypass surgery (BSx) for symptomatic femoropopliteal peripheral artery disease. OBJECTIVES: This study sought to perform a pooled analysis of individual patient data from all randomized controlled trials comparing EVT vs BSx. METHODS: Principal investigators of 5 of 6 available randomized controlled trials agreed to pool individual patient data. The primary endpoint was major adverse limb events, a composite of all-cause death, major amputation, or target limb reintervention. Secondary endpoints included amputation-free survival, individual major adverse limb event components, and primary patency. Early complications were bleeding, infection, or all-cause death within 30 days. RESULTS: A total of 639 patients were analyzed with a mean age of 68.1 ± 9.1 years and 29.0% women. Baseline characteristics were comparable between groups. At 2 years, there were no significant differences between patients who received EVT and those who received BSx regarding major adverse limb events (40.1% vs 36.4%; log-rank P = 0.447; adjusted HR [aHR]: 1.04; 95% CI: 0.80-1.36), amputation-free survival (88.1% vs 90.0%; log-rank P = 0.455; aHR for death or amputation: 1.04; 95% CI: 0.63-1.71) and the other secondary endpoints except for primary patency, which was lower in patients who received EVT vs those who received BSx (51.2% vs 61.3%; log-rank P = 0.024; aHR for loss of primary patency: 1.31; 95% CI: 1.02-1.69). EVT was associated with significantly lower rates of early complications (6.8% vs 22.6%; P < 0.001) and shorter hospital stay (3.1 ± 4.2 days vs 7.4 ± 4.9 days; P < 0.001). CONCLUSIONS: These findings further support the efficacy and safety of EVT as an alternative to BSx in patients with symptomatic femoropopliteal peripheral artery disease.

Early and Sustained Changes in Bone Metabolism After Severe Burn Injury.

CONTEXT: Severe burn injury causes a massive stress response, consecutively heightened serum levels of acute phase proteins, cortisol, and catecholamines with accompanying disturbance in calcium metabolism. OBJECTIVE: Evaluation of early and prolonged changes of serum bone turnover markers (BTMs) and regulators of bone metabolism. DESIGN: Longitudinal observational design. SETTING: University clinic. PATIENTS: A total of 32 male patients with a median age of 40.5 years and a median burned total body surface area of 40% (83% patients with full thickness burn injury). INTERVENTIONS: None. MAIN OUTCOME MEASURES: Comparison of changes of BTM/regulators of bone metabolism in the early (d 2­7) and prolonged (d 7­56) phases after trauma. RESULTS: All investigated BTM/regulators significantly changed. During the early phase, pronounced increases were observed for serum type 1 collagen cross-linked C-telopeptide, intact N-terminal propeptide of type I procollagen, sclerostin, Dickkopf-1, bone-specific alkaline phosphatase, fibroblast growth factor 23, and intact parathyroid hormone levels, whereas 25-hydroxyvitamin D, albumin, serum, and ionized calcium levels decreased. Changes of osteoprotegerin, osteocalcin, and phosphate were less pronounced but remained significant. In the prolonged phase, changes of intact N-terminal propeptide of type I procollagen were most pronounced, followed by elevated sclerostin, osteocalcin, bone-specific alkaline phosphatase, and lesser changes for albumin levels. Calcium and ionized calcium levels tardily increased and remained within the limit of normal. In contrast, levels of intact parathyroid hormone, fibroblast growth factor 23, C-reactive protein, and to a lesser extent serum type 1 collagen cross-linked C-telopeptide and phosphate levels declined significantly during this phase of investigation. CONCLUSIONS: Ongoing changes of BTM and regulators of bone metabolism suggest alterations in bone metabolism with a likely adverse influence on bone quality and structure in male patients with severe burn injuries.

Effects of a single bout of walking exercise on blood coagulation parameters in obese women.

Obesity is associated with increased prevalence of thromboembolic events. We aimed to investigate whether obese women might benefit from vigorous aerobic exercise. Forty-two overweight and obese women performed a 30-min walking exercise test (treadmill ergometer) at an intensity of 70% of individual peak oxygen uptake. Blood samples were collected before and immediately after exercise. Thrombelastometry and platelet function measurements were performed on whole blood. Standard coagulation times, thrombin generation curves, markers of thrombin generation, fibrinolytic parameters, plasma levels of pro- and anticoagulatory factors, and microparticle procoagulant activity were determined in platelet-poor plasma samples. Thrombelastometry revealed a significant prolongation of clot formation time (P = 0.037) and a significant deceleration of fibrin build up (alpha angle, P = 0.034) after exercise. Calibrated automated thrombography revealed a significant exercise-induced decrease in endogenous thrombin potential (P = 0.039). Moreover, thrombin formation stopped earlier postexercise, reflected in shortened StartTail (P = 0.046). Significantly elevated tissue-plasminogen activator levels (P = 0.001) indicate an exercise-induced activation of the fibrinolytic system. White blood cell count increased significantly from pre- to postexercise (P = 0.045), indicating a mild exercise-induced leukocytosis. The results of this study demonstrate that vigorous aerobic exercise might be a suitable tool to protect obese women from thrombotic events. We show that a single bout of vigorous aerobic exercise is clearly associated with an activation of the fibrinolytic system and a decreased readiness of the postexercise samples to form a clot and to generate thrombin, the pivotal enzyme of hemostasis.