Drug-Eluting Resorbable Scaffold versus Angioplasty for Infrapopliteal Artery Disease.

BACKGROUND: Among patients with chronic limb-threatening ischemia (CLTI) and infrapopliteal artery disease, angioplasty has been associated with frequent reintervention and adverse limb outcomes from restenosis. The effect of the use of drug-eluting resorbable scaffolds on these outcomes remains unknown. METHODS: In this multicenter, randomized, controlled trial, 261 patients with CLTI and infrapopliteal artery disease were randomly assigned in a 2:1 ratio to receive treatment with an everolimus-eluting resorbable scaffold or angioplasty. The primary efficacy end point was freedom from the following events at 1 year: amputation above the ankle of the target limb, occlusion of the target vessel, clinically driven revascularization of the target lesion, and binary restenosis of the target lesion. The primary safety end point was freedom from major adverse limb events at 6 months and from perioperative death. RESULTS: The primary efficacy end point was observed (i.e., no events occurred) in 135 of 173 patients in the scaffold group and 48 of 88 patients in the angioplasty group (Kaplan-Meier estimate, 74% vs. 44%; absolute difference, 30 percentage points; 95% confidence interval [CI], 15 to 46; one-sided P<0.001 for superiority). The primary safety end point was observed in 165 of 170 patients in the scaffold group and 90 of 90 patients in the angioplasty group (absolute difference, -3 percentage points; 95% CI, -6 to 0; one-sided P<0.001 for noninferiority). Serious adverse events related to the index procedure occurred in 2% of the patients in the scaffold group and 3% of those in the angioplasty group. CONCLUSIONS: Among patients with CLTI due to infrapopliteal artery disease, the use of an everolimus-eluting resorbable scaffold was superior to angioplasty with respect to the primary efficacy end point. (Funded by Abbott; LIFE-BTK ClinicalTrials.gov number, NCT04227899.).

Outcomes of early transcarotid artery revascularization versus carotid endarterectomy after acute neurologic events.

OBJECTIVE: Carotid revascularization within 14 days of a neurologic event has been recommended by society guidelines. Transcarotid artery revascularization (TCAR) carries the lowest overall stroke rate for any carotid artery stenting technique. However, the outcomes of TCAR within 14 days of a neurologic event have not been directly compared with those after carotid endarterectomy (CEA). METHODS: We compared the 30-day outcomes of symptomatic patients who had undergone TCAR and CEA within 14 days of a stroke or transient ischemic attack (TIA) from January 2016 to February 2020 using the Society for Vascular Surgery Vascular Quality Initiative carotid artery stenting and CEA databases. Propensity score matching was used to adjust for patient risk factors. The primary outcome was a composite of postoperative ipsilateral stroke, death, and myocardial infarction (MI). RESULTS: A total of 1281 symptomatic patients had undergone TCAR and 13,429 patients had undergone CEA within 14 days of a neurologic event. After 1:1 propensity matching, 728 matched pairs were included for analysis. The primary composite outcome of stroke, death, or MI was more frequent in the TCAR group (4.7% vs 2.6%; P = .04). This was driven by a higher rate of postoperative ipsilateral stroke in the TCAR group (3.8% vs 1.8%; P = .005). No differences were found between TCAR and CEA in terms of death (0.7% vs 0.8%; P = .8) or MI (0.8% vs 1%; P = .7). Although TCAR procedures were shorter (median, 69 minutes [interquartile range, 53-85 minutes]; vs median, 120 minutes [interquartile range, 93-150 minutes]; P < .001) and the postoperative length of stay was similar (2 days; P = .3) compared with CEA, the TCAR patients were more likely to be discharged to a facility other than home (26% vs 19%; P < .01). Performing TCAR within 48 hours of a stroke was an independent predictor of postoperative stoke or TIA (odds ratio, 5.4; 95% confidence interval, 1.8-16). This increased risk of postoperative stroke or TIA was not found when performing TCAR within 48 hours of a TIA. CONCLUSIONS: TCAR within 14 days of a neurologic event resulted in higher ipsilateral postoperative stroke rates compared with CEA, especially when performed within 48 hours after a stroke.

Evaluation of an Infrapopliteal Drug-Eluting Resorbable Scaffold: Design Methodology for the LIFE-BTK Randomized Controlled Trial.

Background: Critical limb-threatening ischemia (CLTI) is a severe condition characterized by rest pain and ischemic tissue loss that affects 5% to 10% of people with peripheral artery disease. In the United States, there are few Food and Drug Administration-approved devices for the primary treatment of arteries below-the-knee (BTK). Unfortunately, all suffer from high restenosis rates due to intimal hyperplasia, elastic recoil, and untreated dissection because of a lack of scaffolding. The Esprit BTK system is a resorbable, drug-eluting scaffold device with the potential to address an unmet need in people suffering from CLTI because of infrapopliteal atherosclerosis. The LIFE-BTK (pivotaL Investigation of saFety and Efficacy of drug-eluting resorbable scaffold treatment-Below The Knee) randomized controlled trial (RCT) is a prospectively designed premarket evaluation of the Esprit BTK drug-eluting resorbable scaffold used in the treatment of those patients. Methods: The LIFE-BTK trial enrolled 261 subjects with CLTI for the RCT and a further 7 subjects for a pharmacokinetic substudy. The objective of the RCT was to evaluate the safety and efficacy of the Esprit BTK scaffold compared to percutaneous transluminal angioplasty. The primary efficacy end point was a composite of limb salvage and primary patency at 12 months. The primary safety end point is freedom from major adverse limb events and peri-operative death at 6 months and 30 days, respectively. Clinical follow-up care is planned for 5 years. Conclusions: Novel devices must be tested in RCTs to evaluate their safety and efficacy compared to the standard of care if we are to improve outcomes for this challenging group of patients.

Postintervention monitoring of peripheral arterial disease wound healing using dynamic vascular optical spectroscopy.

Significance: Due to the persistence of chronic wounds, a second surgical intervention is often necessary for patients with peripheral arterial disease (PAD) within a year of the first intervention. The dynamic vascular optical spectroscopy system (DVOS) may assist physicians in determining patient prognosis only a month after the first surgical intervention. Aim: We aim to assess the DVOS utility in characterizing wound healing in PAD patients after endovascular intervention. Approach: The DVOS used near-infrared light ( 670 < λ < 850 nm ) to record hemodynamic response to a cuff inflation in 14 PAD patients with lower limb ulcers immediately before, immediately after, and at a first follow-up 3 to 4 weeks after intervention. Ankle-brachial index (ABI) and arterial duplex ultrasound (A-DUS) measurements were obtained when possible. Results: The total hemoglobin plateau time differed significantly between patients with ulcers that reduced in size ( N = 9 ) and patients with ulcers that did not ( N = 5 ) 3 to 4 weeks after intervention ( p value < 0.001 ). Data correlated strongly (89% sensitivity, 100% specificity, and AUC = 0.96 ) with long-term wound healing. ABI and A-DUS measurements were not statistically associated with wound healing. Conclusions: This pilot study demonstrates the potential of the DVOS to aid physicians in giving accurate long-term wound healing prognoses 1 month after intervention.

Injectable Therapeutic Organoids Using Sacrificial Hydrogels.

Organoids are becoming widespread in drug-screening technologies but have been used sparingly for cell therapy as current approaches for producing self-organized cell clusters lack scalability or reproducibility in size and cellular organization. We introduce a method of using hydrogels as sacrificial scaffolds, which allow cells to form self-organized clusters followed by gentle release, resulting in highly reproducible multicellular structures on a large scale. We demonstrated this strategy for endothelial cells and mesenchymal stem cells to self-organize into blood-vessel units, which were injected into mice, and rapidly formed perfusing vasculature. Moreover, in a mouse model of peripheral artery disease, intramuscular injections of blood-vessel units resulted in rapid restoration of vascular perfusion within seven days. As cell therapy transforms into a new class of therapeutic modality, this simple method-by making use of the dynamic nature of hydrogels-could offer high yields of self-organized multicellular aggregates with reproducible sizes and cellular architectures.

Power-pulse spray thrombectomy for treatment of Paget-Schroetter syndrome.

OBJECTIVE: This initial single-center study describes three cases of axillary-subclavian vein thrombosis (Paget-Schroetter syndrome) treated with a rapid, novel thrombectomy technique, termed "power-pulse spray thrombectomy," in which a thrombolytic agent is directly infused into the clot via a catheter, followed by intravascular mechanical clot fracture and removal. CONCLUSION: All patients in this series were treated in a single session. Complete clot removal was successfully achieved without the development of any complications. This is the first description of the application of this technique in the treatment of Paget-Schroetter syndrome to our knowledge.