Outcome after revascularization with paclitaxel-coated devices in patients with chronic limb-threatening ischemia.

OBJECTIVE: Data regarding the safety and efficacy of paclitaxel (PTX)-coated peripheral arterial devices for femoropopliteal artery (FPA) atherosclerotic disease is derived from studies that mainly evaluated patients with claudication. Outcomes of PTX treatment for patients with chronic limb-threatening ischemia (CLTI) is incompletely defined. This study compares outcome in patients with CLTI treated with and without PTX. METHODS: We retrospectively studied patients who underwent FPA intervention for an indication of CLTI in the Vascular Quality Initiative peripheral vascular intervention database from 2016 to 2020. Patients who had concomitant iliac or tibial interventions were included. One limb per patient was studied. Propensity score matching based on demographics, comorbidities, indication, and pharmacological therapy was performed to generate balanced cohorts. Kaplan-Meier survival analysis and multivariate Cox regression compared limb salvage, overall survival, primary patency, and major adverse limb events (MALE) between patients treated with and without PTX. RESULTS: Demographics, comorbidities, indications, and procedural details were similar between 14,065 PTX and 14,065 non-PTX propensity-matched patients. Kaplan-Meier analysis at 18-month follow-up demonstrated that the PTX group compared with the non-PTX group had a significantly higher rates of limb salvage (89.2% vs 86.5%; P < .001), primary patency (80.3% vs 76.9%; P < .001), and freedom from MALE (72.6% vs 67.9%; P < .001). Multivariate analysis also showed that PTX treatment was associated with a lower risk of major amputation (hazard ratio [HR], 0.74; 95% confidence interval [CI], 0.67-0.82; P < .001), loss of primary patency (HR, 0.80; 95% CI, 0.74-0.87; P < .001), and MALE (HR, 0.77; 95% CI, 0.72-0.82; P < .001). Overall, 21% of patients had a prior ipsilateral peripheral vascular intervention. Removing these patients from the analysis yielded similar results at 18 months. Overall survival at 54 months was not statistically different between the PTX and non-PTX groups in the overall cohort (73.5 vs 71.3%; P = .07), but significant in the de-novo treated patients (73.9% vs 70.7%; P = .02).Multivariate analyses showed a lower mortality risk in the PTX patients (HR, 0.93; 95% CI, 0.87-0.98; P = .02). CONCLUSIONS: FPA intervention with a PTX-coated device is associated with improved limb salvage, primary patency, and freedom from MALE at the 18-month follow-up compared with uncoated devices. This benefit was not associated with an increase in all-cause mortality out to 4.5 years. Further study is necessary to determine the optimal role for PTX in the treatment of the FPA for patients with CLTI and to understand its long-term outcome.

One-year outcomes after transcarotid artery revascularization (TCAR) in the ROADSTER 2 trial.

OBJECTIVES: Transcarotid artery revascularization (TCAR) is a carotid stenting technique that utilizes reversal of cerebral arterial flow to confer cerebral protection. Although carotid endarterectomy (CEA) remains the standard for treatment of symptomatic and asymptomatic carotid stenosis, the search for the optimal minimally invasive option for the high-risk surgical patient continues. The goal of the current study is to evaluate the 1-year safety and efficacy of TCAR in a prospective clinical trial. METHODS: ROADSTER 2 is a prospective, open-label, single-arm, multicenter, post-approval registry for patients undergoing TCAR. All patients were considered high risk for CEA and underwent independent neurological assessments preoperatively, postoperatively, and had long-term clinical follow-up. The primary end point was incidence of ipsilateral stroke after treatment with the ENROUTE Transcarotid Stent System. Secondary end points included individual/composite rates of stroke, death, and perioperative myocardial infarction. RESULTS: Between June 2016 and November 2018, 155 patients at 21 centers in the United States and one in the European Union were enrolled and represented a subset of the overall trial. Asymptomatic (n = 119; 77%) and symptomatic patients (n = 36; 23%) with high-risk anatomic (ie, high lesion, restenosis, radiation injury; 43%), physiologic (32%), or combined factors (25%) were enrolled. No patient suffered a perioperative myocardial infarction or stroke. Over the year, no patient had an ipsilateral stroke, but four patients died (2.6%), all from non-neurological causes. Additionally, a technical success rate of 98.7% with a low cranial nerve deficit rate of 1.3% was achieved. CONCLUSIONS: In patients with high risk factors, TCAR yields high technical success with a low stroke and death rate at 1 year. Further comparative studies with CEA are warranted.

Optimal conduit choice for open lower extremity bypass in chronic limb-threatening ischemia.

Open bypass surgery remains a major tool for limb salvage in chronic limb-threatening ischemia (CLTI). Although rest pain and tissue loss both fall into the category of CLTI, goals of revascularization are markedly different for each context. Rest pain mandates long-term patency considerations. Tissue loss, however, requires consideration of infection risks and patency enough to heal the wound. Of the major conduit options, autologous saphenous vein graft continues to be the conduit of choice, given both superior patency and low risk of infection. When saphenous vein graft is not available or not available in appropriate length, arm vein, small saphenous vein, and spliced combinations of these have acceptable patency rates. Heparin-bonded polytetrafluoroethylene and Dacron grafts are prosthetic conduits with excellent patency rates when vein is not available. For infected wounds without other options, cryovein continues to provide acceptable patency for limb salvage. Creation of a bypass is only part of CLTI management. Appropriate postoperative surveillance with noninvasive studies, including ankle-brachial index and duplex ultrasound, can alert to impending graft failure, with a drop in ankle-brachial index of 0.15 and velocity ratios of 3 or more suggestive of significant stenoses. Anticoagulation has only been found in limited contexts (such as poor conduit or poor outflow) to offer some patency benefit, however, findings from the VOYAGER PAD (Vascular Outcomes Study of ASA [Acetylsalicylic Acid] Along With Rivaroxaban in Endovascular or Surgical Limb Revascularization for PAD) trial were a major breakthrough, showing a reduction in the composite outcome of major adverse limb, cardiac, and cerebrovascular events in revascularized patients taking low-dose rivaroxaban in conjunction with aspirin, without a substantial increase in bleeding risk.