Transcatheter Correction of Superior Venacaval Form of Sinus Venosus Defects Using Balloon-Mounted Covered STENTS.

Superior sinus venosus defects (SVD) are interatrial communications located above the confines of the oval fossa, where unroofing of the right upper pulmonary vein leads to its anomalous drainage to the superior venacava. Recent emergence of transcatheter closure of these defects using covered stents is an attractive alternative option especially in adults with additional comorbidities. This article focuses on various aspects of non-surgical closure of SVD, including patient selection, appropriate hardware options, step-by-step procedural details, evolution and modifications in the techniques over the last decade, protocols for follow-up evaluation, and potential complications associated with this intervention.

Transcatheter Pulmonary Valve in Congenital Heart Disease.

Over the last 2 decades, experience with transcatheter pulmonary valve replacement (TPVR) has grown significantly and has become an effective and reliable way of treating pulmonary valve regurgitation, right ventricular outflow (RVOT) obstruction, and dysfunctional bioprosthetic valves and conduits. With the introduction of self-expanding valves and prestents, dilated native RVOT can be addressed with the transcatheter approach. In this article, the authors review the current practices, technical challenges, and outcomes of TPVR.

Pulmonary Artery Stent Implantation.

Pulmonary artery stent implantation has become integral in the treatment of pulmonary artery stenosis and is probably the most efficacious therapy for these lesions. Advancements in technology involving stent design and the equipment used for stent delivery have made this procedure much safer and more effective. Strategies to mitigate and successfully treat adverse events related to pulmonary artery stent implantation are reasonably well-established. Pulmonary artery stent implantation remains one of the most complex and technically challenging of congenital cardiac interventions.

Robot-Assisted Correction of a Supra-Long Tracheal Stenosis Using C-Type Nickel-Titanium Alloy Exterior Stenting and Suspension Fixation Technique: A Case Report.

T-tubes and airway stents are commonly used but have limited effectiveness and frequent complications. A 50-year-old male patient presented with severe tracheal stenosis, affecting an 8.7 cm length of the airway. We employed an innovative approach known as external suspension fixation of tracheal stent using robotic assistance. This method involves surgically attaching the stent to the exterior of the trachea to provide support and stabilize the softened or collapsed tracheal segments. We designed a C-shaped nickel-titanium alloy exterior stent and successfully fixed it using robotic assistance. This intervention effectively restored tracheal function and led to a favorable postoperative recovery. The technique does not affect tracheal membrane function or airway mucociliary clearance. It could potentially be considered as a new option for treating long-segment benign tracheal softening or collapse.

Clinical Relevance of Posterior Osteophyte Formation in Ultra-congruent Total Knee Arthroplasty: Midterm Radiographic Rollback and Impingement Analysis.

Background: Posterior femoral condylar osteophytes were frequently observed in patients with the ultra-congruent (UC) deep-dish design prosthesis. Therefore, the purpose of the present study was to verify the clinical relevance of osteophyte formation in the UC design. Methods: From March 2014 to February 2018, a comparative study was conducted on 96 knees using the UC design. They were divided into 2 groups (group 1: osteophyte +, group 2: osteophyte -). Intraoperative findings, indirect femoral rollback assessment using 30° flexion and active full flexion lateral radiographs, serial change of the osteophyte, and outcomes were compared. Results: The mean follow-up period was 49.35 ± 3.47 months in group 1 and 47.52 ± 3.37 months in group 2. Posterior component coverage was significantly different between the groups: group 1 exhibited more underhang and group 2 exhibited more overhang (p = 0.022). On the indirect assessment of the femoral rollback, there was a statistically significant difference in deep flexion and change in distance (p < 0.001 and p < 0.001, respectively). There was no statistical difference between the 2 groups in the American Knee Society knee and function score, and group 2 showed significant improvement in pain compared to group 1 in Western Ontario and McMaster University Arthritis Index pain score (p = 0.029). Conclusions: Posterior condylar osteophyte formation was related to posterior impingement. It was more frequently observed in the underhang of the femoral component and insufficient femoral rollback. In addition, it changed with time and caused negative effects, including a gradual decrease in flexion and more pain.

Visual and Refractive Outcomes After Bi-aspheric Trifocal Toric Diffractive Intraocular Lens Implantation.

PURPOSE: To assess clinical outcomes after cataract surgery with bilateral implantation of a new bi-aspheric diffractive intraocular lens (IOL). METHODS: Thirty patients underwent bilateral implantation of the Asqelio Trifocal Toric IOL (AST Products, Inc) and were evaluated 3 months postoperatively. Main outcomes included refractive error, photopic monocular and binocular uncorrected and corrected distance (UDVA, CDVA), intermediate (UIVA, CDIVA) at 60 cm, and near (UNVA, CDNVA) at 40 cm visual acuities. Mesopic monocular and binocular CDNVA were also measured. Defocus curves, binocular contrast sensitivity under photopic and mesopic conditions with and without glare and rotational stability were determined. Patients completed Catquest-9SF and visual symptoms questionnaires. RESULTS: Average values of binocular photopic CDVA, CDIVA, and CDNVA, and mesopic CDNVA were -0.04 ± 0.06, 0.02 ± 0.08, 0.02 ± 0.07, and 0.22 ± 0.11 logMAR, respectively. All patients achieved cumulative CDVA ⩾ 20/25, and CDIVA and CDNVA of 20/32 or better. Binocular depth of focus was approximately 3.25 diopters (D). Mean postoperative spherical equivalent was -0.08 ± 0.26 D, with 95% of eyes within ±0.50 D. Mean postoperative refractive cylinder was -0.22 ± 0.27 D, with 91.67% of eyes within 0.50 D or less, respectively. IOL rotation averaged 0.25 ± 0.65 degrees, all eyes having rotation of less than 5 degrees. Contrast sensitivity was within or above normal levels under photopic and mesopic conditions, with or without glare, except for 12 cpd under mesopic conditions with glare. Questionnaire responses indicated 96.67% of patients were satisfied or very satisfied with postoperative vision, and 80.00% to 96.67% reported no difficulty in different daily activities. CONCLUSIONS: The Asqelio Trifocal Toric IOL demonstrated favorable outcomes, providing excellent visual performance at all distances, precise refractive results, and remarkable rotational stability. Patients reported high satisfaction levels and minimal difficulty in daily activities. [J Refract Surg. 2024;40(6):e407-e419.].

Clinical Outcomes of a Toric Enhanced Depth-of-Focus Intraocular Lens Based on the Combination of 4th- and 6th-Order Spherical Aberration.

PURPOSE: To assess the visual and refractive outcomes of patients implanted with a toric extended depth-of-focus (EDOF) intraocular lens (IOL) following cataract surgery. METHODS: A total of 44 eyes implanted with the EDOF LuxSmart toric IOL were evaluated 4 to 6 months postoperatively. The main outcomes measurements evaluated were refractive error, rotational stability, distance, intermediate, and near visual acuities, defocus curve, photopic and mesopic contrast sensitivity, wavefront aberrations, and modulation transfer function, and the Catquest-9SF-questionnaire. RESULTS: The mean postoperative spherical equivalent and cylinder were -0.02 ± 0.26 and -0.17 ± 0.29 diopters (D), respectively. A total of 90.45% and 100% of the eyes had a postoperative spherical equivalent within ±0.50 and ±1.00 D, respectively (this being 93.18% and 100% for the refractive cylinder). The mean rotational stability was 0.61 ± 1.61 degrees. The mean binocular corrected distance visual acuity (CDVA), corrected distance intermediate visual acuity (CDIVA), and corrected distance near visual acuity (CDNVA) were -0.02 ± 0.06, 0.07 ± 0.08, and 0.26 ± 0.09 logMAR, respectively. The CDVA was 20/25 or better in 95.45% of patients, CDIVA was 20/25 or better in 72.73%, and CDNVA was 20/40 or better in 72.73%. The defocus curve showed good visual acuity at distance and intermediate vergences. The contrast sensitivity and optical quality outcomes were good with mean higher order, spherical, and coma aberration values of 0.161 ± 0.155, -0.019 ± 0.048, and 0.080 ± 0.065 µm, respectively. A total of 90.9% of patients were either fairly satisfied or very satisfied with their vision after the surgery, and 77.7% of patients reported no difficulties when reading text in newspapers. CONCLUSIONS: Implantation of the toric pure refractive EDOF technology IOL provides good refractive, optical, and visual quality at different distances, with high levels of patient satisfaction being reported. [J Refract Surg. 2024;40(6):e398-e406.].

Finite element analysis of the effect of tibial osteotomy on the stress of polyethylene liner in total knee arthroplasty.

AIM: To explore the effects of tibial osteotomy varus angle combined with posterior tibial slope (PTS) on the stress of polyethylene liner in total knee arthroplasty (TKA) by building finite element model (FEM). METHODS: Established the FEM of standard TKA with tibial osteotomy varus angle 0° to 9° were established and divided into 10 groups. Next, each group was created 10 FEMs with 0° to 9° PTS separately. Calculated the stress on polyethylene liner in each group in Abaqus. Finally, the relevancy between tibial osteotomy angle and polyethylene liner stress was statistically analyzed using multiple regression analysis. RESULTS: As the varus angle increased, the area of maximum stress gradually shifted medially on the polyethylene liner. As the PTS increases, the percentage of surface contact forces on the medial and lateral compartmental of the polyethylene liner gradually converge to the same. When the varus angle is between 0° and 3°, the maximum stress of the medial compartmental surfaces of polyethylene liner rises smoothly with the increase of the PTS. When the varus angle is between 4° and 9°, as the increase of the PTS, the maximum stress of polyethylene liner rises first and then falls, forming a trough at PTS 5° and then rises again. Compared to the PTS, the varus angle has a large effect on the maximum stress of the polyethylene liner (p < .001). CONCLUSION: When the varus angle is 0° to 3°, PTS 0° is recommended, which will result in a more equalized stress distribution of the polyethylene liner in TKA.

A Magnetic Actuator Device for Fully Automated Blinking in Total Bidirectional Eyelid Paralysis: First Proof of Concept in a Human Participant.

Purpose: Currently, no solution exists to restore natural eyelid kinematics for patients with complete eyelid paralysis due to loss of function of both the levator palpebrae superioris and orbicularis oculi. These rare cases are prone to complications of chronic exposure keratopathy which may lead to corneal blindness. We hypothesized that magnetic force could be used to fully automate eyelid movement in these cases through the use of eyelid-attached magnets and a spectacle-mounted magnet driven by a programmable motor (motorized magnetic levator prosthesis [MMLP]). Methods: To test this hypothesis and establish proof of concept, we performed a finite element analysis (FEA) for a prototype MMLP to check the eyelid-opening force generated by the device and verified the results with experimental measurements in a volunteer with total bidirectional eyelid paralysis. The subject was then fitted with a prototype to check the performance of the device and its success. Results: With MMLP, eye opening was restored to near normal, and blinking was fully automated in close synchrony with the motor-driven polarity reversal, with full closure on the blink. The device was well tolerated, and the participant was pleased with the comfort and performance. Conclusions: FEA simulation results conformed to the experimentally observed trend, further supporting the proof of concept and design parameters. This is the first viable approach in human patients with proof of concept for complete reanimation of a bidirectionally paretic eyelid. Further study is warranted to refine the prototype and determine the feasibility and safety of prolonged use. Translational Relevance: This is first proof of concept for our device for total bidirectional eyelid paralysis.

Three-dimensional printed custom-made modular talus prosthesis in patients with talus malignant tumor resection.

BACKGROUND: Talar malignant tumor is extremely rare. Currently, there are several alternative management options for talus malignant tumor including below-knee amputation, tibio-calcaneal arthrodesis, and homogenous bone transplant while their shortcomings limited the clinical application. Three-dimensional (3D) printed total talus prosthesis in talus lesion was reported as a useful method to reconstruct talus, however, most researches are case reports and its clinical effect remains unclear. Therefore, the current study was to explore the application of 3D printed custom-made modular prosthesis in talus malignant tumor. METHODS: We retrospectively analyzed the patients who received the 3D printed custom-made modular prosthesis treatment due to talus malignant tumor in our hospital from February 2016 to December 2021. The patient's clinical data such as oncology outcome, operation time, and volume of blood loss were recorded. The limb function was evaluated with the Musculoskeletal Tumor Society 93 (MSTS-93) score, The American Orthopedic Foot and Ankle Society (AOFAS) score; the ankle joint ranges of motion as well as the leg length discrepancy were evaluated. Plain radiography and Tomosynthesis-Shimadzu Metal Artefact Reduction Technology (T-SMART) were used to evaluate the position of prosthesis and the osseointegration. Postoperative complications were recorded. RESULTS: The average patients' age and the follow-up period were respectively 31.5 ± 13.1 years; and 54.8 months (range 26-72). The medium operation time was 2.4 ± 0.5 h; the intraoperative blood loss was 131.7 ± 121.4 ml. The mean MSTS-93 and AOFAS score was 26.8 and 88.5 respectively. The average plantar flexion, dorsiflexion, varus, and valgus were 32.5, 9.2, 10.8, and 5.8 degree respectively. One patient had delayed postoperative wound healing. There was no leg length discrepancy observed in any patient and good osseointegration was observed on the interface between the bone and talus prosthesis in all subjects. CONCLUSION: The modular structure of the prosthesis developed in this study seems to be convenient for prosthesis implantation and screws distribution. And the combination of solid and porous structure improves the initial stability and promotes bone integration. Therefore, 3D printed custom-made modular talus prosthesis could be an alternative option for talus reconstruction in talus malignant tumor patients.

Metal-backed or all-poly tibial components: which are better for medial unicompartmental knee arthroplasty? A propensity-score-matching retrospective study at the 5-year follow-up.

BACKGROUND: This retrospective medium-term follow-up study compares the outcomes of medial fixed-bearing unicompartmental knee arthroplasty (mUKA) using a cemented metal-backed (MB) or an all-polyethylene (AP) tibial component. MATERIALS AND METHODS: The database of our institution was mined for primary mUKA patients implanted with an MB or an AP tibial component (the MB-UKA and AP-UKA groups, respectively) from 2015 to 2018. We compared patient demographics, patient-reported outcome measures (PROMs), and motion analysis data obtained with the Riablo™ system (CoRehab, Trento, Italy). We conducted propensity-score-matching (PSM) analysis (1:1) using multiple variables. RESULTS: PSM analysis yielded 77 pairs of MB-UKA and AP-UKA patients. At 5 years, the physical component summary (PCS) score was 52.4 ± 8.3 in MB-UKA and 48.2 ± 8.3 in AP-UKA patients (p < 0.001). The Forgotten Joint Score (FJS-12) was 82.9 ± 18.8 in MB-UKAs and 73.4 ± 22.5 in AP-UKAs (p = 0.015). Tibial pain was reported by 7.8% of the MB-UKA and 35.1% of the AP-UKA patients (p < 0.001). Static postural sway was, respectively, 3.9 ± 2.1 cm and 5.4 ± 2.3 (p = 0.0002), and gait symmetry was, respectively, 92.7% ± 3.7 cm and 90.4% ± 5.4 cm (p = 0.006). Patient satisfaction was 9.2 ± 0.8 in the MB-UKA and 8.3 ± 2.0 in the AP-UKA group (p < 0.003). CONCLUSIONS: MB-UKA patients experienced significantly better 5-year static sway and gait symmetry outcomes than AP-UKA patients. Although the PROMs of the two groups overlapped, MB-UKA patients had a lower incidence of tibial pain, better FJS-12 and PCS scores, and were more satisfied.

Use of Soft Penile Prosthesis in Grafting Surgery for Peyronie's Disease and Mild Erectile Dysfunction: Still an Option?

BACKGROUND: Plaque incision and grafting (PEG) is a primary surgical therapy for severe penile curvature in Peyronie's disease (PD); However, it can increase the risk of erectile dysfunction (ED), particularly in patients with pre-operative mild ED. Soft penile prosthesis (SPP) implantation is a viable treatment option in such cases. This study aims to compare the outcomes of PEG-only approach to PEG plus SPP implantation. METHODS: Between 2010 and 2019, 32 patients with PD and mild ED (5-item version of the International Index of Erectile Function scores: 17-21) underwent PEG surgery. Two groups were defined based on the surgery type: PEG-only and PEG plus SPP. The long-term outcomes included correction of penile bending, erection quality, intercourse ability, penile length and sensitivity. The overall satisfaction and impact of surgery on sexual activity and quality of life were also assessed. RESULTS: Of the 32 patients, 13 (40.6%) underwent PEG-only surgery, whereas 19 (59.4%) underwent PEG plus SPP. No significant differences were noted between the groups regarding pre-operative characteristics (all p > 0.1) or intra- and post-operative complication rates (all p > 0.2). The median patch area was larger in the PEG-only group (28 cm2 vs. 16.2 cm2; p = 0.001), whereas patients in the PEG plus SPP group were more likely to receive a single patch implant (100% vs. 53.8%; p < 0.001). The penile length increased in 18 patients (61.6%), with significant differences between the two groups (30% vs. 81.2%; p = 0.03). Overall, 14 patients (53.8%) reported greater satisfaction with their sexual life post-operatively, with comparable rates between the groups (p = 0.2). No significant differences were found in the post-operative 5-item version of the International Index of Erectile Function scores or severe post-operative ED (all p > 0.5). CONCLUSIONS: SPP placement during corporoplasty in patients with mild ED is safe and feasible, and it may be a suitable option for patients uncertain about inflatable prosthesis placement. The use of SPP resulted in longer penile lengths and necessitated smaller grafts. However, further data are required to understand the long-term clinical implications of this approach.

[Outcomes of extended depth of focus intraocular lenses implantation]. / Rezul'tat implantatsii intraokulyarnykh linz s rasshirennoi glubinoi fokusa.

Extended depth of focus (EDOF) intraocular lenses (IOLs) are the latest IOL designs. In recent years, several models of EDOF IOLs have become available in Russia, two of which (Tecnis Symfony and Acrysof IQ Vivity) are implanted in our clinic. Comparative studies devoted to the results of implantation of the new EDOF IOLs are rare in the available literature. PURPOSE: This article compares the outcomes of implantation of two EDOF IOLs in patients with presbyopia and/or cataract. MATERIAL AND METHODS: The prospective study included 60 patients (81 eyes) after implantation of EDOF IOL Tecnis Symfony (32 patients, 45 eyes; group 1) or EDOF IOL AcrySof IQ Vivity (28 patients, 36 eyes; group 2). The mean follow-up period was 3.9±1.3 months. RESULTS: All groups showed a significant (p<0.05) increase in uncorrected near visual acuity (UCNVA), intermediate visual acuity (UCIVA), and distance visual acuity (UCDVA) at the maximum follow-up time compared to preoperative values. In group 1, the best corrected near visual acuity (BCNVA) increased from 0.61±0.10 to 0.82±0.16 at the maximum follow-up time, and in group 2 - from 0.58±0.08 to 0.67±0.12 (p>0.05). Both groups showed a significant increase in best corrected intermediate and distance visual acuity (BCIVA and BCDVA) at the maximum follow-up time. The increase in the indicator compared to the preoperative period was not significant in both groups (p>0.05). The frequency of side optical phenomena was low in both groups. No significant differences were found between the groups (p>0.05). CONCLUSION: This study presents a comparative analysis of the results of implantation of two different EDOF IOLs. Both lenses were comparable in most of the studied parameters, including providing good distance and intermediate vision, functional near vision, as well as a low frequency of side optical phenomena. In all cases the patients were satisfied with the results of the surgical intervention.

Three-Dimensional Printed Total Talus Replacement with a Concurrent Total Ankle Arthroplasty as a Personalized Approach for Advanced Ankle Osteoarthritis A Case Repor.

Ankle arthritis is becoming more common and can be pain-ful and debilitating. As the disease progresses, degenera-tive cystic changes may be found in the distal fibula, distal tibia, and talus. After failure of non-operative modalities, arthrodesis is often considered the surgical intervention of choice, but this leaves the patient with reduced range of motion, altered gait, and can negatively impact adjacent joints of the foot. Total ankle arthroplasty has been found to be an effective surgical option for ankle arthritis but is contraindicated in patients with talar collapse. When this is the case, a more personalized approach for preserving ankle motion is necessary. We present the case of a 65-year-old male with severe right ankle arthritis and talar collapse treated with a custom three-dimensionally printed talus and concurrent total ankle replacement with 2-year follow-up.

BK Viremia and Viruria Does Not Depend on the Type of Double-J Stent Used During Kidney Transplantation.

OBJECTIVES: BK virus is a major cause of chronic renal allograft failure.Transplant ureteral stent use has been reported as a risk factorfor BK virus infection. Recently, the use of a new type of ureteral stent (Magnetic Black Star) was reported in kidney transplant recipients. The aim ofthis preliminary report was to compare BK virus viremia and viruria occurrence depending on the type of double-J stent (standard versus Magnetic Black Star). MATERIALS AND METHODS: We included all kidney transplants performed in our center from January to December 2022. Each case had double-J stent placement. Indwelling stents were either a 6- or 7-Fr standard double-J stent or a 6-Fr Magnetic Black Star double-J stent. The type of double-J stent was chosen according to the surgeon's preference. A standard BK virus screening protocol was followed during the study period, which consisted of routine polymerase chain reaction examination of plasma and urine samples during monthly follow-ups. RESULTS: We assessed 120 patients without missing data: 92 patients received standard double-J stents and 28 patients received Magnetic Black Star stents. Patients were mostly male in the standard group (70.7%) versus the Magnetic Black Star group (42.9%) (P = .01). ABO- and HLA-incompatible transplant rates were similar in both groups. BK viremia occurrence and BK viruria occurrence were similar between groups at 1 month, 3 months, and 6 months. CONCLUSIONS: This preliminary study showed no differences concerning BKvirus infection depending on the type of double-J stents used during kidney transplant.

Unintended Deformation of Stents During Bifurcation PCI: An OCTOBER Trial Substudy.

BACKGROUND: Unintended deformation of implanted coronary stents can lead to loss of coronary access, stent thrombosis and coronary events during follow-up. The incidence, mechanisms and clinical outcomes of unintended stent deformations (USD) during complex bifurcation stenting are not well characterized. OBJECTIVES: In a prespecified analysis of the OCTOBER (European Trial on Optical Coherence Tomography Optimized Bifurcation Event Reduction) trial, we aimed to: 1) determine the incidence and characterize mechanisms of USD identified by optical coherence tomography (OCT); and 2) evaluate physician's detection and correction of accidental abluminal rewiring and USD. METHODS: OCT scans were analyzed for accidental abluminal rewiring and USD. When USD was identified, the plausible mechanism was determined by analysis of all procedural OCT scans and the corresponding angiograms. RESULTS: USD was identified by the core lab in 9.3% (55/589) of OCT-guided cases. Accidental abluminal rewiring was the cause in 44% (24/55), and guide catheter collision was the cause in 40% (22/55) of cases. USD was found in 18.5% of all cases with left main bifurcation percutaneous coronary intervention. The total incidence of abluminal rewiring was 33 in 32 OCT-guided cases (5.4%) and was corrected by physicians in 18 of 33 appearances (54.5%). The 2-year major adverse cardiac event rate for patients with untreated USD (n = 30) was 23.3%, whereas patients with confirmed or possibly corrected USD (n = 25) had no events during follow-up. CONCLUSIONS: USD was associated with adverse procedural complications and cardiac events during follow-up when not identified and corrected. The predominant mechanisms were undetected abluminal rewiring and guide catheter collision. Left main bifurcation percutaneous coronary intervention was a particular risk with USD detected in 18.5% of cases.

An Aspirin-Free Strategy for Immediate Treatment Following Complex Percutaneous Coronary Intervention.

BACKGROUND: There was no study evaluating the effects of an aspirin-free strategy in patients undergoing complex percutaneous coronary intervention (PCI). OBJECTIVES: The authors aimed to evaluate the efficacy and safety of an aspirin-free strategy in patients undergoing complex PCI. METHODS: We conducted the prespecified subgroup analysis based on complex PCI in the STOPDAPT-3 (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3), which randomly compared low-dose prasugrel (3.75 mg/d) monotherapy to dual antiplatelet therapy (DAPT) with low-dose prasugrel and aspirin in patients with acute coronary syndrome or high bleeding risk. Complex PCI was defined as any of the following 6 criteria: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length >60 mm, or a target of chronic total occlusion. The coprimary endpoints were major bleeding events (Bleeding Academic Research Consortium 3 or 5) and cardiovascular events (a composite of cardiovascular death, myocardial infarction, definite stent thrombosis, or ischemic stroke) at 1 month. RESULTS: Of the 5,966 study patients, there were 1,230 patients (20.6%) with complex PCI. Regardless of complex PCI, the effects of no aspirin relative to DAPT were not significant for the coprimary bleeding (complex PCI: 5.30% vs 3.70%; HR: 1.44; 95% CI: 0.84-2.47; P = 0.18 and noncomplex PCI: 4.26% vs 4.97%; HR: 0.85; 95% CI: 0.65-1.11; P = 0.24; P for interaction = 0.08) and cardiovascular (complex PCI: 5.78% vs 5.93%; HR: 0.98; 95% CI: 0.62-1.55; P = 0.92 and noncomplex PCI: 3.70% vs 3.10%; HR: 1.20; 95% CI: 0.88-1.63; P = 0.25; P for interaction = 0.48) endpoints without significant interactions. CONCLUSIONS: The effects of the aspirin-free strategy relative to standard DAPT for the cardiovascular and major bleeding events were not different regardless of complex PCI. (ShorT and OPtimal duration of Dual AntiPlatelet Therapy after everolimus-eluting cobalt-chromium stent-3 [STOPDAPT-3]; NCT04609111).

Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions.

BACKGROUND: Limited comparative data exist on different interventional strategies for endovascular revascularization of complex femoropopliteal interventions. OBJECTIVES: In this study, the authors aimed to compare a stent-avoiding (SA) vs a stent-preferred (SP) strategy, promoting optimal lesion preparation and the use of drug-eluting technologies in both arms. METHODS: Within a prospective, multicenter, pilot study, 120 patients with symptomatic complex femoropopliteal lesions (Rutherford classification 2-4, mean lesion length 187.7 ± 78.3 mm, 79.2% total occlusions) were randomly assigned in a 1:1 fashion to endovascular treatment with either paclitaxel-coated balloons or polymer-coated, paclitaxel-eluting stents. Lesion preparation including the use of devices for plaque modification and/or removal was at the operators' discretion in both treatment arms. RESULTS: In the SA group, lesion preparation was more frequently performed (71.7% SA [43/60] vs 51.7% [31/60] SP; P = 0.038) with a high provisional stenting rate (48.3% [29/60]). At the 12-month follow-up, primary patency was 78.2% (43/55) in the SA group and 78.6% (44/56) in the SP group (P = 1.0; relative risk: 0.995; 95% CI: 0.818-1.210). Freedom from major adverse events was determined in 93.1% (54/58) in the SA group and in 94.9% (56/59) in the SP group (P = 0.717; relative risk: 0.981; 95% CI: 0.895-1.075), with all adverse events attributable to clinically driven target lesion revascularization. CONCLUSIONS: Both endovascular strategies promoting lesion preparation before the use of drug-eluting devices suggest promising efficacy and safety results in complex femoropopliteal procedures with a high proportion of total occlusions through 12 months. Ongoing follow-up will show whether different results emerge over time. (Best Endovascular Strategy for Complex Lesions of the Superficial Femoral Artery [BEST-SFA]; NCT03776799).