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Was ist neu? Aktueller Stand und Wahl der Revaskularisationsstrategie. Rezente Studien zeigen bei Patienten mit peripherer arterieller Verschlusskrankheit eine Inzidenz der akuten Extremitätenischämie von 0,8 pro 100 Patientenjahre. Aktuelle Leitlinien betonen die Notwendigkeit einer raschen Behandlung im Gefäßzentrum mit einer Option der offen-chirurgischen und interventionellen Revaskularisierung unter situativer Anpassung der Strategie. Im Vergleich zur offenen Operation zeigte sich in einer schwedischen Analyse mit Propensity score Matching ein Benefit für ein endovaskuläres Vorgehen bei ALI im Hinblick auf die Sterblichkeitsrate nach 30 Tagen und einem Jahr. Ähnliche Ergebnisse wurden in einer US-Analyse gezeigt, da hier die Sterblichkeitsrate während des stationären Aufenthalts bei endovaskulär behandelten Patienten ebenfalls geringer war. In manchen Fällen kann eine Kombination aus offenen und endovaskulären Techniken im Sinne eines Hybrideingriffes erforderlich sein. Endovaskuläre perkutane Interventionsoptionen bei ALI. Die endovaskulären Revaskularisierungsoptionen bei akuter Extremitätenischämie konzentrieren sich zunehmend auf ein breites Spektrum mechanischer Thrombektomiegeräte, basierend auf unterschiedlichen Funktionsprinzipien. Als Vorteil können mit manchen Systemen auch organisierte, subakute Thromben entfernt werden, die durch eine Lysetherapie häufig nicht ausreichend behandelt werden können. Eine lokale Thrombolyse kann so oft eingespart werden oder ist nur für kurze Zeit erforderlich, was das Blutungsrisiko deutlich reduziert. Akute Extremitätenischämie und COVID-19. Die bei Patienten mit COVID-19-Erkrankung gehäuft beobachteten Gerinnungsstörungen und damit verbundenen thrombotischen Komplikationen spielen auch eine Rolle für das Auftreten einer akuten Extremitätenischämie bei COVID-19. Zwar zeigen die meisten betroffenen Patienten typische Risikofaktoren für ALI, aber auch bislang weitgehend gesunde Patienten ohne typische Risikofaktoren oder Vorerkrankungen können betroffen sein. Vergleichende Analysen zeigen hohe Sterblichkeits- und niedrige technische Erfolgsraten bei Revaskularisation.

Purpose: To evaluate the use of the GoBack-catheter (Upstream Peripheral Technologies) in complex revascularizations in lower limb arteries. Materials and Methods: In this retrospective single-center study, the results of the first 100 consecutive patients including 101 limb-revascularizations, performed between May 2018 and July 2020 with the study device, were analyzed. In all cases, guidewire-crossing failed, and all lesions were chronic total occlusions (CTO), either de novo, reocclusions, or in-stent reocclusions. Successful crossing was defined as passing the CTO using the study device. Patency at discharge and after 30 days was defined as less than 50% restenosis on duplex sonography, without target lesion revascularization. Results: Median lesion length was 24 cm and 38 patients (37.6%) had a calcium grading according to the peripheral arterial calcium scoring system (PACSS) of 4 or 5. In 20.8% of patients, an occluded stent was treated. CTOs involved the femoropopliteal segment in 91.1%, iliac arteries in 5.9%, and tibial arteries in 7.9%. The GoBack-catheter was employed for entering into or crossing through parts or the full length of a CTO or an occluded stent as well as for re-entering into the true lumen after subintimal crossing. The device was used via contralateral and ipsilateral antegrade as well as retrograde access with an overall technical success rate of 92.1%. In 3 patients minor bleeding occurred at the crossing or re-entry site, which were managed conservatively. Thirty-day adverse limb events comprised minor amputations in 4 patients (4.0%), 1 major amputation (1.0%), and reocclusions in 7 limbs (6.9%). Conclusion: The new GoBack-catheter offers versatile endovascular applicability for complex CTO recanalization in a broad range of peripheral vascular interventions with a high technical success and low complication rate.

Zusammenfassung Hintergrund Die enge anatomische Beziehung zu den Viszeralgefäßen macht die Behandlung der komplexen thorakoabdominellen Aortenpathologien zu einer Herausforderung. Im Notfall stehen zu ihrer endovaskulären Behandlung Off-the-Shelf-Prothesen und parallele Techniken zur Verfügung, alternativ kann für komplexe Aortenanatomien die Modifizierung herkömmlicher Stentgrafts durch die behandelnden Chirurginnen und Chirurgen erfolgen, im Sinne eines Surgeon-modified Stentgrafts (SMSG). Ziel der vorliegenden Publikation ist die Darstellung der Möglichkeiten und Ergebnisse, die dieses Verfahren bietet. Ergebnisse Die Planung der Fenestrierungen des SMSG kann mittels manueller Messungen in Centerline of Flow-Rekonstruktionen der aortalen Computertomografie-Angiografie erfolgen. Vereinfacht und standardisiert wird die Planung des SMSG durch die Erstellung von personalisierten 3-D-Aortenmodellen und die Entwicklung von Algorithmen zur automatisierten Ermittlung der idealen Fenestrierungspositionen. Zur Herstellung des SMSG können die meisten zugelassenen Stentgrafts verwendet werden. Für die Anfertigung selbst sind unterschiedliche Techniken beschrieben. Außer der einfachen Fenestrierung ist auch die Erstellung von Mini-Cuffs, Directional Branches und Inner Branches beschrieben, weiterhin die Ergänzung von Diameter reducing Ties und das Vorladen von Führungsdrähten zur Erleichterung der Implantation. Die Behandlung mit SMSG zeigt gute Ergebnisse mit hohen technischen Erfolgsraten um 90–100% und niedriger 30-Tage-Mortalität, vor allem im Vergleich zur offen-chirurgischen Behandlung ähnlicher PatientInnen. Auch die Rate an Endoleaks ist mit 0–14% akzeptabel. Langzeitergebnisse zur Nachhaltigkeit der modifizierten Stentgrafts sind bislang noch nicht verfügbar. Schlussfolgerung Die Surgeon-modified Stentgrafts stellen eine sichere und machbare Ergänzung der Palette endovaskulärer Behandlungsoptionen für PatientInnen mit dringlichen komplexen thorakoabdominellen Aortenpathologien dar. Sie können im Rahmen eines individuellen Heilversuches eingesetzt werden und zeigen in der Literatur vielversprechende Ergebnisse.

Successful revascularization of patients with peripheral arterial disease (PAD) requires a comprehensive understanding of the risk population and the available treatment options. Even the urgency of revascularization varies widely depending on the clinical presentation. Patients with intermittent claudication should undergo a structured exercise program before revascularization may become necessary, whereas acute limb ischemia is a medical emergency and must be revascularized within a few hours. Endovascular treatment techniques have evolved rapidly over the past 20 years. New technologies and procedural techniques allow even complex lesions to be successfully treated with endovascular techniques, and most patients can now be treated minimally invasively in line with an "endovascular first" strategy. Bypass surgery remains an important option for patients with advanced disease. The techniques used vary depending on the clinical presentation, location, and complexity of the lesion. Although the evidence for different techniques is limited, a variety of clinical and lesion factors are known to be critical for acute technical success and long-term patency rates. The use of paclitaxel-coated balloons and stents has been shown to significantly reduce restenosis and reintervention rates after femoropopliteal interventions. However, a late mortality signal associated with the use of these devices continues to be debated. After successful intervention, appropriate drug therapy and standardized follow-up should be established to prevent adverse limb events and reduce the high rate of cardiovascular events.Eine erfolgreiche Revaskularisation von Patienten mit peripherer arterieller Verschlusskrankheit (PAVK) erfordert ein umfassendes Verständnis der Risikopopulation und der verfügbaren Behandlungsoptionen. Bereits die Dringlichkeit einer Revaskularisation ist je nach Krankheitsbild sehr unterschiedlich. Patienten mit Claudicatio intermittens sollen vor einer eventuell notwendigen Revaskularisation ein strukturiertes Trainingsprogramm durchlaufen, während eine akute Extremitätenischämie einen medizinischen Notfall darstellt und eine Revaskularisation innerhalb weniger Stunden erforderlich macht. Endovaskuläre Behandlungstechniken haben sich in den letzten 20 Jahren rasant weiterentwickelt. Neue Technologien und Verfahrenstechniken ermöglichen es, selbst komplexe Läsionen erfolgreich endovaskulär zu versorgen; die meisten Patienten können daher heute im Sinne einer „Endovascular-first-Strategie“ minimal-invasiv behandelt werden. Die Bypasschirurgie bleibt eine wichtige Option für Patienten mit fortgeschrittener Erkrankung. Die angewendeten Techniken variieren je nach klinischem Bild, Lage und Komplexität der Läsion. Zwar ist die Evidenz für verschiedene Techniken eingeschränkt, doch sind zahlreiche klinische und läsionsbezogene Faktoren bekannt, die entscheidend sind für den akuten technischen Erfolg und die Langzeitoffenheitsrate. Gerade die Verwendung von paclitaxelbeschichteten Ballons und Stents konnte die Restenose- und Wiedereingriffsrate nach femoropoplitealen Interventionen deutlich reduzieren. Allerdings wird ein spätes Mortalitätssignal in Zusammenhang mit der Verwendung dieser Devices weiterhin diskutiert. Nach erfolgreicher Intervention sollten eine entsprechende medikamentöse Therapie und standardisierte Nachkontrollen etabliert werden, um unerwünschte Extremitätenereignisse zu verhindern und die hohe kardiovaskuläre Ereignisrate zu vermindern.

Aim Since therapeutic hypothermia (TH) is known for its inhibitory effects on leucocyte migration and cytokine synthesis, our aim was to underline the necessity of early monitoring for potential immunomodulatory risks. Methods Using a 13‐year retrospective case‐control study at the paediatric intensive care unit (PICU) of the Medical University in Vienna, all newborn infants and children receiving TH were screened and compared with a diagnosis‐matched control group undergoing conventional normothermic treatment (NT). TH was accomplished by using a non‐invasive cooling device. Target temperature was 32‐34°C. Children with evident infections, a medical history of an immunodeficiency or undergoing immunosuppressive therapy, were excluded. Results During the observational period, 108 patients were screened, 27 of which underwent TH. Culture‐proven infections occurred in 22% of the TH group compared with 4% of the normothermic controls (P = .1). From the second day following PICU admission, median C‐reactive protein (CRP) values were higher in the TH group (day two P = .002, day three P = .0002, day six P = .008). Conclusion Children undergoing TH showed earlier and higher increases in CRP levels when compared to normothermic controls. These data underline the necessity of early and continuous monitoring for possible infectious complications.

Background This study evaluated the outcomes of endovascular repair of the thoracoabdominal aorta following the frozen elephant trunk (fET) procedure. Methods Between October 2014 and July 2018, 249 patients underwent thoracic or thoracoabdominal endovascular aortic repair in our institution. Of these, 10 patients (50% male) underwent second-stage endovascular repair after previous fET implantation. Feasibility and outcomes were evaluated. Results The mean interval between fET implantation and the second-stage endovascular repair was 136 days (range, 14-282 days). Indications for second-stage endovascular repair were thoracoabdominal aortic aneurysm Crawford type I (n = 3) or Crawford type II (n = 4) and complicated residual aortic dissection after fET (n = 3). We implanted 4 branched custom-made devices and 4 off-the-shelf thoracic stent grafts. Two patients were treated using the provisional extension to induce complete attachment (PETTICOAT) technique through a percutaneous access. The median intensive care unit stay was 1 day (range, 0-3 days), and median hospital stay was 7 days (range, 5-12 days). Spinal cord preconditioning was performed in 70% of our patients with zero paraplegia at 30 days. Computed tomographic scans at 8.5 ± 11.4 months of follow-up showed complete false lumen thrombosis of all type B aortic dissections and 1 type III endoleak with constant aneurysm diameter. Branch patency was 100%. Conclusions Second-stage endovascular repair after a previous fET is feasible with good midterm results. This staged hybrid procedure is extremely effective in patients whose aneurysms are confined both to the arch and thoracoabdominal aorta, leading to an excellent functional result. In case of favorable anatomy, endovascular repair in residual type B aortic dissection led to complete false lumen thrombosis.

We aimed to review the feasibility and safe use of the percutaneous axillary artery (AxA, 100 patients) approach for endovascular repair (ER) of thoraco-abdominal aortic aneurysms (TAAA, 90 patients) using fenestrated, branched, and chimney stent grafts and other complex endovascular procedures (10 patients) necessitating AxA access. Percutaneous puncture of the AxA in its third segment was performed using sheaths sized between 6 to 14F. For closing puncture sites greater than 8F, two Perclose ProGlide percutaneous vascular closure devices (PVCDs) (Abbott Vascular, Santa Clara, CA, USA) were deployed in the pre-close technique. The median maximum diameter of the AxA in the third segment was 7.27 mm (range 4.50–10.80). Device success, defined as successful hemostasis by PVCD, was reported in 92 patients (92.0%). As recently reported results in the first 40 patients suggested that adverse events, including vessel stenosis or occlusion, occurred only in cases with a diameter of the AxA < 5 mm, in all subsequent 60 cases AxA access was restricted to a vessel diameter ≥ 5 mm. In this late group, no hemodynamic impairment of the AxA occurred except in six early cases below this diameter threshold, all of which could be repaired by endovascular measures. Overall mortality at 30 days was 8%. In conclusion, percutaneous approach of the AxA in its third segment is feasible and represents a safe alternative access to open access for complex endovascular aorto-iliac procedures. Complications are rare, especially if the maximum diameter of the access vessel (AxA) is ≥5 mm.

The close anatomical relationship to the visceral vessels renders the treatment of complex throacoabdominal aortic pathologies challenging. In emergent cases, off-the-shelf stent grafts and parallel techniques are feasible treatment options. Alternatively, the treating surgeon can alter a conventional stent graft, creating a so-called surgeon-modified stent graft (SMSG) to adapt it to the complex aortic pathology. The aim of this publication is to present the possibilities and results of this method.The location of SMSG's fenestrations can be determined after manual measurements of the centerline of flow reconstructions of the aortic computed tomography-angiography. The planning of the SMSG can be simplified and standardized by creating personalized 3D aortic models, and by using algorithms for the automated determination of the ideal fenestration positions. Most approved stent grafts can be used as platforms for SMSG. Different manufacturing techniques have been described. In addition to simple fenestrations, mini-cuffs, directional branches, and inner branches are used. Furthermore, diameter reducing ties and preloaded catheters could facilitate the implantation. The treatment of complex aortic pathologies using SMSG has achieved good results, with high technical success rate of 90-100%, and low 30-day mortality, especially when compared to open surgical treatment of similar patients. The rate of endoleak of 0-14% was also acceptable. Long-term durability results after treatment with SMSG are not yet available.Surgeon-modified stent grafts are safe and feasible for the endovascular treatment of patients with urgent complex thoracoabdominal aortic pathologies. They represent compassionate use and show promising results in the published literature.Die enge anatomische Beziehung zu den Viszeralgefäßen macht die Behandlung der komplexen thorakoabdominellen Aortenpathologien zu einer Herausforderung. Im Notfall stehen zu ihrer endovaskulären Behandlung Off-the-Shelf-Prothesen und parallele Techniken zur Verfügung, alternativ kann für komplexe Aortenanatomien die Modifizierung herkömmlicher Stentgrafts durch die behandelnden Chirurginnen und Chirurgen erfolgen, im Sinne eines Surgeon-modified Stentgrafts (SMSG). Ziel der vorliegenden Publikation ist die Darstellung der Möglichkeiten und Ergebnisse, die dieses Verfahren bietet.Die Planung der Fenestrierungen des SMSG kann mittels manueller Messungen in Centerline of Flow-Rekonstruktionen der aortalen Computertomografie-Angiografie erfolgen. Vereinfacht und standardisiert wird die Planung des SMSG durch die Erstellung von personalisierten 3-D-Aortenmodellen und die Entwicklung von Algorithmen zur automatisierten Ermittlung der idealen Fenestrierungspositionen. Zur Herstellung des SMSG können die meisten zugelassenen Stentgrafts verwendet werden. Für die Anfertigung selbst sind unterschiedliche Techniken beschrieben. Außer der einfachen Fenestrierung ist auch die Erstellung von Mini-Cuffs, Directional Branches und Inner Branches beschrieben, weiterhin die Ergänzung von Diameter reducing Ties und das Vorladen von Führungsdrähten zur Erleichterung der Implantation. Die Behandlung mit SMSG zeigt gute Ergebnisse mit hohen technischen Erfolgsraten um 90–100% und niedriger 30-Tage-Mortalität, vor allem im Vergleich zur offen-chirurgischen Behandlung ähnlicher PatientInnen. Auch die Rate an Endoleaks ist mit 0–14% akzeptabel. Langzeitergebnisse zur Nachhaltigkeit der modifizierten Stentgrafts sind bislang noch nicht verfügbar.Die Surgeon-modified Stentgrafts stellen eine sichere und machbare Ergänzung der Palette endovaskulärer Behandlungsoptionen für PatientInnen mit dringlichen komplexen thorakoabdominellen Aortenpathologien dar. Sie können im Rahmen eines individuellen Heilversuches eingesetzt werden und zeigen in der Literatur vielversprechende Ergebnisse.

The aim of this systematic review was to summarise the comparative evidence on the risk of contrast-associated acute kidney injury (CA-AKI) with CO2 or iodinated contrast medium (ICM) for peripheral vascular interventions. We searched Ovid MEDLINE, Cochrane Library, Embase, Epistemonikos, PubMed-similar-articles, clinical trial registries, journal websites, and reference lists up to February 2022. We included studies comparing the risk of CA-AKI in patients who received CO2 or ICM for peripheral angiography with or without endovascular intervention. Two reviewers screened the references and assessed the risk of bias of the included studies. We extracted data on study population, interventions and outcomes. For the risk of CA-AKI as our primary outcome of interest, we calculated risk ratios (RRs) with a 95% confidence interval (CI) and performed random-effects meta-analyses. We identified three RCTs and five cohort studies that fully met our eligibility criteria. Based on a random-effects meta-analysis, the risk of CA-AKI was lower with CO2 compared to ICM (8.6% vs. 15.2%; RR, 0.59; 95% CI 0.33–1.04). Only limited results from a few studies were available on procedure and fluoroscopy time, radiation dose and CO2-related adverse events. The evidence suggests that the use of CO2 for peripheral vascular interventions reduces the risk of CA-AKI compared to ICM. However, due to the relevant residual risk of CA-AKI with the use of CO2, other AKI risk factors must be considered in patients undergoing peripheral vascular interventions.

The aim of the study was to assess 24-month efficacy and safety of a novel drug-eluting stent (DES) for femoropopliteal interventions with an innovative stent design and abluminal reservoir technology releasing the amphilimus formulation (sirolimus plus fatty acid) for efficient drug transfer and optimized release kinetics.DES releasing paclitaxel exhibited good patency rates after femoropopliteal interventions. No benefit has been reported when sirolimus or everolimus were used for antiproliferative stent coating.Within a multicenter, first-in-man, single-arm study, 100 patients with symptomatic femoropopliteal disease (Rutherford category 2-4, mean lesion length 5.8 ± 3.9 cm, 35.0% total occlusions) were treated with the NiTiDES stent (Alvimedica). Two-year follow-up included assessment of primary patency (defined as absence of clinically driven target lesion revascularization or binary restenosis with a peak systolic velocity ratio2.4 by duplex ultrasound), safety, functional, and clinical outcomes.At 24 months, Kaplan-Meier estimates of primary patency and freedom from clinically driven target lesion revascularization were 83.4% (95% CI: 73.9%-89.6%) and 93.1% (95% CI: 85.3%-96.9%), respectively. Over the study period, 3 deaths were reported with no major limb amputation. Functional and clinical benefits were sustained, as 82.1% of patients fell into Rutherford category 0 or 1 at 24 months, which was associated with preserved improvements in all walking disability questionnaire scores.The 2-year results of the ILLUMINA (Innovative siroLimus seLf expanding drUg-eluting stent for the treatMent of perIpheral disease: evaluation of safety aNd efficAcy) study demonstrate a sustained treatment benefit with a novel sirolimus-eluting stent that also compares favorably to other femoropopliteal intervention trials. Head-to-head comparisons of NiTiDES with a paclitaxel-based DES are warranted. (The ILLUMINA Study [ILLUMINA]; NCT03510676).

Background and aims Muscle-related symptoms with or without creatine kinase (CK) elevation are common adverse effects associated with statin use. Symptoms are ranging from benign myalgia to myositis and in rare cases to rhabdomyolysis. The aim was to characterize and describe muscular side effects and create an anatomical frequency mapping. Methods The prospective observational study was performed at a large lipidology outpatient unit in Vienna. 1111 consecutively admitted patients with muscular side effects on statin monotherapy were included during a 4-year period. Anatomical mapping of the affected muscles, signs and symptoms, the onset of symptoms after starting statin therapy and disappearance after cessation of treatment was assessed. Results In 96.5% of the patients with muscle symptoms, there was no elevation of CK. The anatomical mapping revealed exercised muscles as being mainly affected in 84%. In the upper extremity, symptoms were mainly described at the dominating side. Mostly affected muscles were the pectoral (61.4%), followed by the quadriceps femoris (59.8%), the biceps brachii (54.3%) and the deltoid (22.5%) muscles. The majority of symptoms (76.9%, n = 854) appeared within 29 days. Symptoms disappeared after discontinuation of statin therapy at a mean of 5.4 days. Conclusions Physical activity seems to be a key trigger for onset of statin-induced muscular side effects. The appearance of symptoms can be symmetrical, asymmetrical, generalized or in isolated muscle groups only. Different statins usually produce similar symptoms, but often some patients tolerate one statin better than another.

Objectives This study sought to report short- and long-term efficacy and safety outcomes of retrograde tibioperoneal access for endovascular treatment of chronic total occlusions (CTOs). Background Antegrade recanalization of peripheral CTO is associated with a high failure rate and retrograde puncture of tibioperoneal arteries has been adopted to overcome this limitation. Methods Within a retrospective single center cohort study, data of 554 infrainguinal occlusions were acquired in which a retrograde puncture of at least 1 infrapopliteal artery became necessary. Techniques used for access, retrograde lesion crossing, and antegrade treatment modalities were recorded. Next to short-term outcomes, long-term results through 4 years were described using survival analysis. Results The majority of patients (71.5%) had critical limb ischemia (CLI) and occlusion locations were the femoropopliteal segment (35.9%), infrapopliteal segment (42.6%), or both segments (21.5%). Retrograde access was most commonly performed via the proximal (28%) or distal (34%) anterior tibial artery. Retrograde access could be established in 98.6% and subsequent lesion crossing was successful in 95.1%. Complications due to distal puncture were rare (3.3%). At 1 year, freedom from target lesion revascularization and restenosis were 74.6 ± 3.7% and 67.5 ± 4.4% in claudicants and 62.2 ± 2.8% and 36.0 ± 4.4% in CLI patients, respectively. Late complications at the distal puncture site after a median follow-up time of 234 days comprised 1 stenosis, 7 occlusions, and 3 clinically nonrelevant arteriovenous fistula occurring only in CLI patients. Conclusions Retrograde tibioperoneal access is a safe option for recanalization of complex CTOs after a failed antegrade approach. Complications at the puncture site were rare.

As only limited evidence is available for potential benefits of n-3 PUFA supplementation in patients with peripheral arterial disease (PAD), we studied the effects of 4 g n-3 PUFA on endothelial function and inflammatory markers. Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors were randomised to receive either 4 g n-3 PUFA or placebo daily for 3 months in a double-blind fashion. Primary endpoint was endothelial function assessed by flow-mediated vasodilation (FMD). In addition, ankle–brachial index, maximum and pain-free walking distances were determined. Lipid parameters including the omega-3 index reflecting n-3 PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers were measured over the same time interval. After 3 months of treatment with 4 g n-3 PUFA daily, a significant improvement of FMD was observed compared with placebo (n-3 PUFA, median Δ 3·7 (interquartile range (IQR) –1·8, 7·1) % v. placebo, Δ –0·5 (IQR –6·5, 3·0) %, P = 0·01 between the groups). After a 3-month washout period, this benefit was not sustained (n-3 PUFA, median Δ 0·6 (IQR –2·2, 5·6) % v. placebo, Δ –0·9 (IQR –6·6, 6·7) %, P = 0·20). In response to n-3 PUFA, an improvement of lipid parameters with a pronounced increase in the omega-3 index was seen. No changes were found for other parameters. In conclusion, in patients with PAD, 4 g/d n-3 PUFA improved cardiovascular risk in PAD patients, which needs testing in large-scale trials.

The development of new technologies and techniques has significantly advanced the field of endovascular peripheral interventions for chronic and acute limb ischemia over the last 20 years. Nowadays, the majority of patients with symptomatic peripheral arterial occlusive disease can be treated percutaneously using an endovascular first approach as a minimally invasive alternative to classical bypass surgery. Balloon angioplasty and stent implantation are the mainstays of endovascular interventions. For reconstruction of complex aortoiliac occlusions covered stents are frequently used. Patency rates after femoropopliteal interventions have been improved by the introduction of drug-eluting balloon and stent technologies. Advances in material and access techniques now enable the successful endovascular treatment of more complex infrapopliteal stenoses and occlusions.

INTRODUCTION Owing to the ageing of the population and rising rates of diabetes, more patients suffering from chronic limb threatening ischemia (CLTI) need revascularization for often complex, multilevel peripheral arterial occlusive disease. Below the knee (BTK) lesions are common in CLTI and short-term outcomes of BTK endovascular revascularizations have improved substantially over the last decade as a consequence of improved techniques and dedicated low profile devices. EVIDENCE ACQUISITION The manuscript summarized the information identified through a limited literature review conducted on key resources including MEDLINE and EMBASE databases as well as conference proceedings. The keywords were "angioplasty," "endovascular intervention," "infrapopliteal," "tibial arteries" and "below the knee." The search was limited to contemporary English-language documents published between 2000 and 2020. EVIDENCE SYNTHESIS Rates of re-stenosis and re-occlusion are high after infrapopliteal interventions limiting long-term success and necessitating frequent repeat procedures. CONCLUSIONS In this article we aimed to summarize current knowledge regarding the need, options and outcome of repeat BTK interventions through a limited literature review and presentation of own data.

Summary: Background: Our aim was to determine the rate of ischemic stroke following thoracic endovascular aortic repair (TEVAR) after reducing gas volume released during stentgraft deployment by de-airing of thoracic stentgrafts with high-volume of 0.9% heparinized saline solution. Patients and methods: A single center retrospective analysis of all consecutive patients undergoing TEVAR from 2014 to 2019 was performed. All thoracic stentgrafts were flushed with 120 ml 0.9% heparinized saline solution before implantation, according to our institutional protocol. Endpoints were in-hospital rates of ischemic stroke and spinal cord ischemia (SCI), and all-cause mortality. Results: One hundred and fifty-four patients (mean age: 66.8 ± 13.6 years, 64.9% males) were treated with TEVAR during the study period. Indications for treatment were thoracic aortic aneurysms (n = 75, 48.7%), acute type B aortic dissections (n = 46, 29.9%), aortic arch aneurysms and penetrating aortic ulcers (n = 28, 18.2%), and blunt traumatic aortic injuries (n = 5, 3.2%). Timing of procedure was urgent in 75 patients (48.7%). Proximal landing zone were zone 0–1–2 (n = 75, 48.7%), zone 3 (n = 66, 42.9%) and zone 4 (n = 13, 8.4%). Supra-aortic vessels were revascularized with custom-made fenestrated stentgrafts in 9 patients (5.8%), using chimney technique in 4 patients (2.6%), and with debranching procedures in 19 patients (12.3%). Left subclavian artery was covered without revascularization in 46 patients (29.9%). In-hospital stroke occurred in two patients (1.3%) and SCI in another two patients (1.3%). In-hospital mortality rate was 0.6%. No further in-hospital events were noted. Conclusions: De-airing of stentgrafts with high-volume of 0.9% heparinized saline solution seems to be safe and can be used as an adjunct to keep occurrence of neurological events after TEVAR as low as possible.

Purpose: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. Methods: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. Results: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). Conclusion: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

The authors sought to evaluate the performance of the Ranger paclitaxel-coated balloon versus uncoated balloon angioplasty for femoropopliteal lesions at 12 months.Drug-coated balloons (DCBs) are a promising endovascular treatment option for peripheral artery disease of the femoropopliteal segment, and each unique device requires dedicated clinical study.The prospective, randomized RANGER SFA (Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries) study (NCT02013193) enrolled 105 patients with symptomatic lower limb ischemia (Rutherford category 2 to 4) and stenotic lesions in the nonstented femoropopliteal segment at 10 European centers. Seventy-one patients (mean age 68 ± 8 years, n = 53 men) were enrolled in the Ranger DCB arm, and 34 patients (mean age 67 ± 9 years, n = 23 men) were assigned to the control group. Twelve-month analysis included patency, safety, and clinical outcomes and quality-of-life assessments.The DCB group had a greater primary patency rate at 12 months (Kaplan-Meier estimate 86.4% vs. 56.5%), with a significantly longer time to patency failure (log-rank p 0.001). The estimated freedom from target lesion revascularization rate was 91.2% in the DCB group and 69.9% in the control group at 12 months, with a significantly longer time to reintervention (p = 0.010). No target limb amputations or device-related deaths occurred in either group.Twelve-month results show that patency was maintained longer after Ranger DCB treatment than after conventional balloon angioplasty, and this result was associated with a low revascularization rate and good clinical outcomes.

Background Lipoprotein(LP)-apheresis is the treatment of choice in patients suffering from severe familial hypercholesterolemia. A wide range of mechanisms has been claimed to be responsible for the known clinical benefit. Methods Patients suffering from heterozygous familial hypercholesterolemia undergoing LP-apheresis either with direct adsorption of lipoproteins (DALI) or dextran sulfate (DS) were examined. A total volume of 10 l blood was exchanged. Non-lipid effects, mainly concerning endothelial function (circulating endothelial cells, circulating endothelial progenitor cells, flow-mediated vasodilation, microalbuminuria) as well as left ventricular ejection fraction and homocysteine were assessed. Results A single LP-apheresis session improves paradox contractile response in statin intolerant patients, but not in those on regular statin therapy. In contrast, over a 6-months follow-up after treatment initiation, all the examined parameters (circulating endothelial cells, circulating endothelial progenitor cells, flow mediated vasodilatation, homocysteine, microalbuminuria and left ventricular ejection fraction) improved. When available, a comparison between DS vs. DALI was performed. In none of the subgroups a significant difference was noted. Discussion These findings indicate that beyond the well known lipid/lipoprotein lowering action the broad spectrum of functional tests examined reflecting mainly endothelial function is significantly improved by LP-apheresis treatment on the long-term and seems to be a key underlying reason for the clinical improvement seen in these patients.

Die Gefasmedizin und mit ihr die Behandlung der symptomatischen arteriellen Verschlusskrankheit (pAVK) haben im letzten Jahrzehnt einen starken Wandel hin zur endovaskularen Therapie erfahren. Attraktiv v. a. durch die geringe Invasivitat der Behandlung, konnen nun auch komplexe Gefaspathologien technisch endovaskular gelost werden. Fur die Beckenarterien haben Stents vergleichbare Ergebnisse zur aortofemoralen Bypasschirurgie gebracht. Femoropopliteal erzielten medikamentenbeschichtete Stents und Ballonkatheter verbesserte Langzeitergebnisse nach endovaskularer Intervention. Im kruralen Stromgebiet haben die wenig invasiven Rekanalisationstechniken der endovaskularen Therapie zum Durchbruch verholfen. Seit dem Jahr 2000 wurden fachgesellschaftsubergreifend internationale Behandlungsempfehlungen (TASC[Trans-Atlantic Inter-Society Consensus] I + II) herausgegeben, die letztmals 2015 fur das krurale Gefasgebiet erganzt wurden. Fur Deutschland wurden 2016 interdisziplinar neue Leitlinien zur Behandlung der pAVK publiziert, die der endovaskularen Therapie erstmals einen so hohen Stellenwert einraumen, dass sie in der taglichen Praxis zunehmend „first line“ eingesetzt werden kann.

Aims Drug-coated balloons (DCBs) for femoropopliteal interventions have not been tested against each other. We aimed to directly compare efficacy and safety of a high-dose (In.Pact™) vs. low-dose (Ranger™) DCB with nominal paclitaxel densities of 3.5 vs. 2.0 μg/mm2. Methods and results Within a prospective, multicentre, non-inferiority, clinical trial 414 patients with symptomatic femoropopliteal lesions (Rutherford classification 2–4) were randomly assigned in a 1:1 ratio to endovascular treatment with either high- or low-dose DCB after stratification for lesion length. Primary efficacy and safety endpoints comprised primary patency and freedom from major adverse events (i.e. device and procedure-related deaths through 1 month, major amputations, and clinically driven target lesion revascularization through 12 months). We set a non-inferiority margin of −10% at 12 months. Total occlusions were observed frequently (>40%) and provisional stenting was performed in every fourth intervention. Non-inferiority was determined for both primary efficacy and safety endpoints at 12 months. Primary patency was 81.5% in the high-dose and 83.0% in low-dose DCB group {difference: 1.5% [lower bound of the 90% two-sided confidence interval (CI) −5.2%]; P non-inferiority < 0.01}. Freedom from major adverse events was determined in 92.6% in high-dose and in 91.0% in low-dose DCB group [difference −1.6% (lower bound of the 90% two-sided CI −6.5%); P non-inferiority < 0.01]. Overall death rate was low (2.0%) and no major amputation occurred. Conclusion Two DCBs with different coating characteristics exhibited comparable results with excellent effectiveness and safety through 12 months for femoropopliteal interventions including a wide range of lesion lengths. Clinical trial registration The trial is registered with ClinicalTrials.gov (NCT02701543).

As only limited evidence is available for potential benefits of n-3 PUFA supplementation in patients with peripheral arterial disease (PAD), we studied the effects of 4 g n-3 PUFA on endothelial function and inflammatory markers. Seventy patients with stable PAD classified as Rutherford stage 2 or 3 and good control of cardiovascular factors were randomised to receive either 4 g n-3 PUFA or placebo daily for 3 months in a double-blind fashion. Primary endpoint was endothelial function assessed by flow-mediated vasodilation (FMD). In addition, ankle-brachial index, maximum and pain-free walking distances were determined. Lipid parameters including the omega-3 index reflecting n-3 PUFA intake as well as pro-inflammatory, endothelial and platelet activation markers were measured over the same time interval. After 3 months of treatment with 4 g n-3 PUFA daily, a significant improvement of FMD was observed compared with placebo (n-3 PUFA, median Δ 3·7 (interquartile range (IQR) -1·8, 7·1) % v. placebo, Δ -0·5 (IQR -6·5, 3·0) %, P = 0·01 between the groups). After a 3-month washout period, this benefit was not sustained (n-3 PUFA, median Δ 0·6 (IQR -2·2, 5·6) % v. placebo, Δ -0·9 (IQR -6·6, 6·7) %, P = 0·20). In response to n-3 PUFA, an improvement of lipid parameters with a pronounced increase in the omega-3 index was seen. No changes were found for other parameters. In conclusion, in patients with PAD, 4 g/d n-3 PUFA improved cardiovascular risk in PAD patients, which needs testing in large-scale trials.

Abstract. Chronic critical lower limb ischemia (CLI) has been defined as ischemia that endangers the leg. An attempt was made to give a precise definition of CLI, based on clinical and hemodynamic data (Second European Consensus). CLI may be easily defined from a clinical point of view as rest pain of the distal foot or gangrene or ulceration. It is probably useful to add leg ulcers of other origin which do not heal because of severe ischemia, and to consider the impact of frailty on adverse outcome. From a hemodynamic viewpoint there is no consensus and most of the existing classifications are not based upon evidence. We should thus propose a definition and then validate it in a prospective cohort in order to define the patients at major risk of amputation, and also to define the categories of patients whose prognosis is improved by revascularisation. From today’s available data, it seems clear that the patients with a systolic toe pressure (STP) below 30 mmHg must be revascularised whenever possible. However other patients with clinically suspected CLI and STP above 30 mmHg must be evaluated and treated in specialised vascular units and revascularisation has to be discussed on a case by case basis, taking into account other data such as the WiFi classification for ulcers.In conclusion, many useful but at times contradictory definitions of CLI have been suggested. Only a few have taken into account evidence, and none have been validated prospectively. This paper aims to address this and to give notice that a CLI registry within Europe will be set up to prospectively validate, or not, the previous and suggested definitions of CLI.

This study sought to report short- and long-term efficacy and safety outcomes of retrograde tibioperoneal access for endovascular treatment of chronic total occlusions (CTOs).Antegrade recanalization of peripheral CTO is associated with a high failure rate and retrograde puncture of tibioperoneal arteries has been adopted to overcome this limitation.Within a retrospective single center cohort study, data of 554 infrainguinal occlusions were acquired in which a retrograde puncture of at least 1 infrapopliteal artery became necessary. Techniques used for access, retrograde lesion crossing, and antegrade treatment modalities were recorded. Next to short-term outcomes, long-term results through 4 years were described using survival analysis.The majority of patients (71.5%) had critical limb ischemia (CLI) and occlusion locations were the femoropopliteal segment (35.9%), infrapopliteal segment (42.6%), or both segments (21.5%). Retrograde access was most commonly performed via the proximal (28%) or distal (34%) anterior tibial artery. Retrograde access could be established in 98.6% and subsequent lesion crossing was successful in 95.1%. Complications due to distal puncture were rare (3.3%). At 1 year, freedom from target lesion revascularization and restenosis were 74.6 ± 3.7% and 67.5 ± 4.4% in claudicants and 62.2 ± 2.8% and 36.0 ± 4.4% in CLI patients, respectively. Late complications at the distal puncture site after a median follow-up time of 234 days comprised 1 stenosis, 7 occlusions, and 3 clinically nonrelevant arteriovenous fistula occurring only in CLI patients.Retrograde tibioperoneal access is a safe option for recanalization of complex CTOs after a failed antegrade approach. Complications at the puncture site were rare.

Background Transcatheter aortic valve replacement (TAVI) is an alternative treatment for patients with symptomatic severe aortic stenosis ineligible for surgical aortic valve replacement (SAVR) or at increased perioperative risk. Due to continually emerging evidence, we performed a systematic review and meta-analysis comparing benefits and harms of TAVI, SAVR, medical therapy, and balloon aortic valvuloplasty. Methods We searched MEDLINE, Embase, and Cochrane CENTRAL from 2002 to June 6, 2017. We dually screened abstracts and full-text articles for randomized controlled trials (RCTs) and propensity score-matched observational studies. Two investigators independently rated the risk of bias of included studies and determined the certainty of evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). If data permitted, we performed meta-analyses using random- and fixed-effects models. Results Out of 7755 citations, we included six RCTs (5862 patients) and 13 observational studies (6376 patients). In meta-analyses, patients treated with SAVR or TAVI had similar risks for mortality at 30 days (relative risk [RR] 1.05; 95% confidence interval [CI] 0.82 to 1.33) and 1 year (RR 1.02; 95% CI 0.93 to 1.13). TAVI had significantly lower risks for major bleeding but increased risks for major vascular complications, moderate or severe paravalvular aortic regurgitation, and new pacemaker implantation compared to SAVR. Comparing TAVI to medical therapy, mortality did not differ at 30 days but was significantly reduced at 1 year (RR 0.51; 95% CI 0.34 to 0.77). Conclusions Given similar mortality risks but different patterns of adverse events, the choice between TAVI and SAVR remains an individual one. Electronic supplementary material The online version of this article (10.1186/s13643-019-0954-3) contains supplementary material, which is available to authorized users.

The development of new technologies and techniques has significantly advanced the field of endovascular peripheral interventions for chronic and acute limb ischemia over the last 20 years. Nowadays, the majority of patients with symptomatic peripheral arterial occlusive disease can be treated percutaneously using an endovascular first approach as a minimally invasive alternative to classical bypass surgery. Balloon angioplasty and stent implantation are the mainstays of endovascular interventions. For reconstruction of complex aortoiliac occlusions covered stents are frequently used. Patency rates after femoropopliteal interventions have been improved by the introduction of drug-eluting balloon and stent technologies. Advances in material and access techniques now enable the successful endovascular treatment of more complex infrapopliteal stenoses and occlusions.

Type II endoleak (T2EL) is the most common endoleak after endovascular aneurysm repair (EVAR). Its optimal management has been controversially discussed. Thus, preliminary selective embolization of aneurysm sac side branches (ASSBs) has been adopted to prevent T2EL. Our goal was to determine the rate of T2EL and the diameter decrease of abdominal aortic aneurysms (AAAs) after EVAR performed after preemptive embolization of ASSBs.From September 2014 to September 2019, 139 patients with AAAs underwent percutaneous ASSB embolization before EVAR. Follow-up imaging studies were performed at 1 and 6 months and annually thereafter. The end points included freedom from T2EL, AAA sac shrinkage, T2EL-related reinterventions, and all-cause mortality.The mean follow-up was 23 ± 16 months (range, 1-61 months). The patients had had a median of five (range, one to eight) patent ASSBs found on preoperative imaging studies. After completion of embolization, 76.4% of the initially patent ASSBs were occluded, with no major procedure-related complications. Follow-up imaging studies showed T2ELs in seven patients (5%), with an aneurysm sac increase seen in six of these patients. The number of ASSBs remaining patent after embolization was the only discriminative factor in patients with and without T2EL. Six T2EL-related reinterventions were performed during follow-up. Most patients (n = 91; 86.7%) had experienced aneurysm sac shrinkage, and the mean diameter reduction was 9.2 ± 7.7 mm (P .001) in all patients with follow-up data available. One aneurysm-related death occurred within 30 days after EVAR.Preemptive embolization of ASSBs for patients with AAAs is safe and effective in preventing T2ELs after EVAR. Aneurysm sac shrinkage was observed in a high proportion of patients.

Introduction: Data regarding the effectiveness and safety of percutaneous mechanical thrombectomy (PMT) in contemporary routine care are scarce. Materials and Methods: Consecutive patients undergoing PMT of native lower limb acutely/subacutely occluded arteries were included. Results: In all, 525 consecutive patients were available for analysis with a mean age of 66.7 ± 10.7 years. Almost two-third (n = 324; 61.7%) were men with acutely (n = 211; 40.2%) or subacutely (n = 314; 59.8%) occluded lesions presenting mostly in Rutherford-Becker category (RBC): 3 (30.3%) and 4 (47.6%). Mean lesion length was 159 mm (range 22-279 mm), with moderate and severe calcification in 119 (23.3%) lesions. PMT was performed solely in 161(27.2%), PMT + balloon angioplasty in 232 (39.1%), provisional stenting in 169 (28.4%), and thrombolysis in 77 (13.9%) interventions. Procedural technical success rate was 97.7%, with improvement in RBC persisting in 74.1% of patients after 12 ± 2.4 months mean time follow-up. Overall 30 days major adverse events (MAEs) was 6.9% with a mortality rate of 1.1%. No death was directly related to the device. After 12 months, a promising overall target lesion revascularization (TLR; 10.1%), non-TLR (6.6%), and major amputation rates (2.3%) were found. One-year mortality was 8%. Conclusion: Treatment with PMT resulted in clinic and hemodynamic improvement in the majority of patients, thereby reducing the need for thrombolysis in a significant proportion of patients. Prospective studies in this issue are recommended.

Purpose: To report a subanalysis of the German centers enrolling patients in the prospective, global, multicenter, randomized LEVANT 2 pivotal trial ( ClinicalTrials.gov identifier NCT01412541) of the Lutonix drug-coated balloon (DCB) for the treatment of femoropopliteal occlusive disease. Methods: Among the 476 patients in LEVANT 2, 126 patients (mean age 67.1±9.6 years; 79 men) were enrolled at the 8 participating German sites between August 2011 and July 2012 and were randomized 2:1 to treatment with the Lutonix DCB (n=83) vs an uncoated balloon during percutaneous transluminal angioplasty (PTA, n=43). All patients had intermittent claudication or rest pain (Rutherford categories 2–4). Average lesion length was 58 mm and average treated length was 100 mm. Severe calcification was present in 11% of lesions, and 23% were total occlusions. The efficacy outcome was primary patency at 12 months, and the safety outcome was 12-month freedom from a composite of perioperative death, index limb–related death, amputation (below or above the ankle), and index limb revascularization. Secondary endpoints included target lesion revascularization (TLR), major adverse events, and functional outcomes. Results: Demographic, clinical, and lesion characteristics were matched between Lutonix DCB and PTA groups, as were the final percent diameter stenosis (19%) and procedure success (91%). By Kaplan-Meier analysis, the 12-month primary patency rate was 80% vs 58% (p=0.015) and the composite safety endpoint rate was 94% vs 72% (p=0.001), respectively. Freedom from TLR was higher for DCBs (96%) vs PTA (82%, p=0.012). Major adverse events were similar for both groups. The benefit favoring DCB over PTA was observed in German men and women. Compared to the non-German LEVANT 2 cohort, there was a shorter time between insertion and inflation of treatment balloons (21.8 vs 39.5 seconds, p

Objectives The authors sought to investigate the efficacy of a drug-coated balloon (DCB) for treatment of complex femoropopliteal lesions. Background Superiority of DCBs compared with uncoated balloon angioplasty for femoropopliteal interventions has been demonstrated in randomized trials for short lesions. Their performance in complex lesions with higher restenosis rates is unclear. Methods Patency, target lesion revascularization (TLR) rate, clinical improvement, and safety endpoints of femoropopliteal lesions in 288 limbs (n = 260) treated with the In.Pact Pacific or Admiral DCB (Medtronic, Minneapolis, Minnesota) were retrospectively analyzed for up to 2 years of follow-up. Predictors of restenosis were identified by logistic regression. Results Lesions were de novo in 51.7%, restenosis in 11.1%, and in-stent restenosis in 37.2%. Mean lesion length was 24.0 ± 10.2 cm, and 65.3% were occluded. Stent implantation was performed in 23.3%. Kaplan Meier estimates of primary patency were 79.2% and 53.7% for all lesions at 1 and 2 years, respectively, whereas freedom from TLR was 85.4% and 68.6%. Primary patency for in-stent restenosis treatment was 76.6% and 48.6%, and freedom from TLR was 83.0% and 58.7% at 1 and 2 years, respectively. Rutherford category improved from a median 3.3 to 1.2 at 1 year, and to 1.1 at 2 years. Major amputation rate was 2.1% at 2 years. No adverse events were thought to be attributable to the coating of the balloon. Conclusions These results suggest that DCB are safe and effective in delaying rather than preventing restenosis in long, complex lesions and restenosis of the femoropopliteal tract. Further studies are recommended to confirm these results.

Background Randomized trials of drug-eluting stents (DES) and drug-coated balloons (DCB) for femoropopliteal interventions reported superior patency rates for both strategies compared to standard balloon angioplasty. To date, head-to-head comparisons are missing. Objectives The authors sought to compare DES versus DCB for femoropopliteal lesions through 36 months. Methods Within a multicenter, randomized trial, 150 patients with symptomatic femoropopliteal disease were randomly assigned to primary DES implantation or DCB angioplasty with bailout stenting after stratification for lesion length (≤10 cm, >10 cm to ≤20 cm, and >20 cm to ≤30 cm). The primary effectiveness endpoint was primary patency at 12 months assessed by Kaplan-Meier. Secondary endpoints comprised major adverse events including death, major amputations, and clinically driven target lesion revascularization, and clinical outcomes. Results More than one-half of lesions were total occlusions, and the stenting rate was 25.3% in the DCB group. Kaplan-Meier estimates of primary patency were 79% and 80% for DES and DCB at 12 months (p = 0.96) but decreased to 54% and 38% through 36 months (p = 0.17), respectively. Freedom from clinically driven target lesion revascularization was >90% at 12 months but dropped to around 70% at 36 months in both groups. Overall, the mortality rate through 36 months was 7.3%, with 1 procedure-related death in the DCB group. Improvement of clinical outcomes was sustained through 36 months. Conclusions Patency rates at 12 months suggest comparable effectiveness and safety of DES versus DCB plus bailout stenting in femoropopliteal interventions; a trend in favor of the DES was observed up to 36 months. (Randomized Evaluation of the Zilver PTX Stent vs. Paclitaxel-Eluting Balloons for Treatment of Symptomatic Peripheral Artery Disease of the Femoropopliteal Artery [REAL PTX]; NCT01728441)