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Abstract TP185: Resolute Onyx Stent for Symptomatic Intracranial Stenosis: Short and Long-Term Results (R.O.S.S.I.S. Study) With 18-month Follow-Up
Stroke, Volume 55, Issue Suppl_1, Page ATP185-ATP185, February 1, 2024. Introduction:The Resolute Onyx stent has shown promise as an effective treatment for symptomatic intracranial atherosclerotic disease (sICAD), with positive clinical outcomes and low procedural complication rates. However, previous studies were limited by small sample sizes and lacked long-term follow-up.Methods:In this retrospective analysis, we examined patients who underwent Resolute Onyx stent placement for sICAD. Primary outcomes included stroke, intracerebral hemorrhage (ICH), and mortality rates at 1-, 6-, 12-, and 18-month follow-ups, and in-stent restenosis. Multivariable logistic regression identified predictors of stroke and mortality. Subgroup analyses assessed patients who underwent stenting at least 8 days after the qualifying event to ensure comparability with WEAVE registry data.Results:Our study included 77 patients with 84 procedures. The mean age was 61.9±13.0, with 35% being female. The median time from qualifying event to procedure was 5 days (IQR: 2-11). Among adherent patients, no disease-related deaths occurred after the first month. However, one ICH and two strokes occurred within 6 and 12 months, respectively. Comparison of WEAVE-matched and non-matched patients revealed no significant difference in complications during short- and long-term follow-up. Postprocedural complications within 72 hours were
Abstract TP214: In-Silico versus In-Vitro Evaluation of a New Stent-Retriever Design: A Novel Approach to Pre-Clinical Device Development
Stroke, Volume 55, Issue Suppl_1, Page ATP214-ATP214, February 1, 2024. Introduction:In-vitro evaluation (analysis in a bench top flow model) is the gold standard for pre-clinical investigation of devices being developed for endovascular thrombectomy (EVT). In-silico evaluation (computer simulated analysis in a virtual stroke model) has the potential to test and optimize large number of stent-retriever design variations in a relatively time and cost-effective manner. We aim to validate the utility of in-silico evaluation when compared with in-vitro evaluation for the SuperNova Stent-retriever.Methods:In-silico analysis was performed using a virtual thrombectomy model, built using data from a fine-grained finite-element model, to estimate the probability of successful recanalization. Neurovascular anatomy of the virtual model was built based on digital subtraction angiography of an in-vitro model (Sim Agility, Mentice, Inc). Gravity Medical Technology’s SuperNova Stent-retriever was the device under investigation. Multiple thrombectomy scenarios were defined and validation analysis was performed.Results:We defined multiple thrombectomy scenarios including 1 cm red blood clot in M1 artery, 2 cm bifurcation M1-M2 red blood clot (Y-shaped clot), 1 cm white blood clot in M1 artery, and 1 cm white blood clot in superior M2 artery. The figure below demonstrates a pictorial representation of the first scenario- 1 cm red blood clot in M1 artery followed by mechanical thrombectomy simulation using the SuperNova stent-retriever. Per our in-vitro analysis (10 thrombectomy experiments), the rate of first pass effect and the rate of complete recanalization after a maximum of 3 passes using SuperNova stent-retriever was 50% and 90%, respectively. Preliminary data suggests 97% concordance.Conclusion:In-silico analysis has the potential to improve and expedite pre-clinical thrombectomy device development. Further studies are required to better understand the scope and potential of this technology.
Abstract WMP88: Intraarterial Tirofiban Through Deployed Stent-Retriever Bailout: A Potential Alternative to Angioplasty and Stenting
Stroke, Volume 55, Issue Suppl_1, Page AWMP88-AWMP88, February 1, 2024. Background:In stroke patients undergoing EVT, angioplasty and stenting (A&S) has been described as a bailout technique when thrombectomy fails or intracranial stenosis is suspected. We aim to investigate effects of the administration of intraarterial (IA) tirofiban through a deployed stent-retriever over the occluding lesion prior to A&S.Methods:Patients with LVO in the anterior circulation undergoing EVT were reviewed. We include patients in which stent-retriever/direct aspiration failed (TICI 0-2a) or underlying intracranial stenosis was suspected and received the loading dose of tirofiban prior to intended A&S bailout. A stent-retriever was deployed over the lesion to create a by-pass channel and 8 to 12 ml of tirofiban were locally infused during 10 minutes through a distal access catheter proximally positioned. The stent-retriever was re-sheathed into the microcatheter before retrieval. Additionally, 10-15 ml of tirofiban were administered intravenously. An angiogram was performed to determine recanalization grade and indicate potential A&S.Results:From 546 consecutive EVT patients, 14 (2.6%) were considered potential candidates for A&S bailout and received the study protocol: mean age 76 years, median admission NIHSS 17 (IQR 11-21). The occlusion locations were: ICA (3, 21,4%), M1-MCA (9, 64.3%), M2-MCA (2, 14.3%), Mean IA tirofiban dose was 10mg. Post-infusion angiogram showed succesful reperfusion (TICI2b-3) in 11 patients (78.6%). In 4 cases (28.6%) A&S was finally performed. At 24 hours median NIHSS was 14 (IQR 9-20) and the rates of reocclusion (follow-up imaging in 8/12) and SICH were 0%.Conclusion:In stroke patients undergoing EVT in which A&S is considered as bailout, IA administration of tirofiban through a deployed stentretriever may safely achieve sustained recanalization in a substantial number of patients, ultimately avoiding definitive stenting. Further prospective data is warranted.
Abstract 48: Early Carotid Endarterectomy and Carotid Artery Stent Placement in Symptomatic Patients With Internal Carotid Artery Stenosis
Stroke, Volume 55, Issue Suppl_1, Page A48-A48, February 1, 2024. Background:The American Heart Association/American Stroke Association (AHA/ASA) 2021 guidelines state that in patients in whom revascularization is planned within 1 week of the index stroke, it is reasonable to choose carotid endarterectomy (CEA) over carotid artery stent placement (CAS) to reduce the periprocedural stroke rate (level of evidence 2A, weak evidence, [B-R] moderate quality data).Objective:To compare the 1-month stroke, myocardial infarction (MI), and/or death rates among symptomatic patients undergoing either CAS or CEA according to the timing of the procedure in Carotid Revascularization Endarterectomy versus Stenting Trial (CREST).Methods:We analyzed the effect of CAS and CEA on the rates of 1-month stroke, MI, and/or death after adjusting age, gender, presenting symptom (transient ischemic attack [TIA], retinal ischemia, or minor ischemic stroke), severity of stenosis (50-69% and 70-99%), and timing of procedure (≤7 days and >7 days post qualifying event) using multivariate analysis.Results:The rate of 1-month stroke, MI, and/or death was higher (non-significant) in patients who underwent CAS compared with those who underwent CEA within ≤7 days post-qualifying event (8 of 157 [5.1%] versus 3 of 124 [2.4%], p=0.251). In the multivariate analysis, there was no difference in the odds of 1-month stroke, MI, and/or death in patients who underwent CEA compared with those who underwent CAS (odds ratio [OR] 0.57, 95% CI 0.26-1.20, p=0.15). There was no effect of the timing of the procedure (OR 1.19,95% CI 0.48-3.47, p=0.72). The interaction term between CEA versus CAS and the timing of the procedure was not significant (OR 1.69, 95% 0.21-36.31 CI p=0.66). The only significant factors associated with decreased odds of 1-month stroke, MI, and/or death were the qualifying event of TIA (OR 0.13, 95% CI 0.02-0.57, p=0.02) and retinal ischemic event (OR 0.13, 95% CI 0.01-0.63, p=0.02).Conclusions:In our analysis, we did not identify any increase in odds of a 1-month stroke, MI, and/or death rate with CAS compared with CEA according to the timing of the procedure. Qualifying event characteristics rather than the timing of procedure appeared to be the most determinant, highlighting the need to revisit the recommendations in the AHA/ASA guidelines.
Abstract 16952: Comparative Outcomes of Below-the-Knee Stent Deployment Interventions: A Report From the XLPAD Registry
Circulation, Volume 148, Issue Suppl_1, Page A16952-A16952, November 6, 2023. Background:Stent use in the below-the-knee (BTK) peripheral arteries remains controversial, with scarce data on real world outcomes.Methods:We examined 1572 patients from the XLPAD Registry (NCT01904851) from 2006-2021 that underwent BTK endovascular intervention and stratified them based on stent vs non-stent interventions. The primary outcome was the incidence of major adverse limb events (MALE), which includes death, clinically driven revascularization, amputation, non-fatal myocardial infarction, and stroke.Results:517 (33%) patients received a stent and 1055 did not. Mean age 68 years, predominantly male (72%). White race was more frequent in stent group (64% vs. 55%, p
Abstract 17745: Impact of Acute Limb Ischemia Caused by Femoropopliteal Stent Thrombosis on Clinical Outcomes in Patients With Lower Extremity Artery Disease
Circulation, Volume 148, Issue Suppl_1, Page A17745-A17745, November 6, 2023. Introduction:Although contemporary femoropopliteal (FP)-specific stents have shown durable patency in endovascular therapy (EVT), acute limb ischemia (ALI) caused by stent thrombosis (ST) are substantially experienced in clinical setting. The current study investigated that impact of ALI caused by FP-ST on clinical outcomes in patients with lower extremity artery disease (LEAD).Methods:The current study was multicenter and retrospective study enrolling 498 ALI patients (mean age: 76 years, male: 59%, diabetes mellitus [DM]: 34%, hemodialysis [HD]: 19%). We compared clinical outcomes of 105 ALI caused by FP-ST (ST-ALI) with 347 ALI caused by de novo thrombosis or embolus (de novo-ALI) presenting Rutherford category I or II. Outcome measure was 12-month amputation free survival (AFS), and predictors of AFS were also investigated using multivariate Cox proportional hazard analysis.Results:Frequency of DM (63% vs. 26%) and HD (51% vs. 10%) was higher in ST-ALI, while average age was older (74 years vs. 77 years) and frequency of atrial fibrillation (Af) (18% vs. 49%) was higher in de novo-ALI. In patients presenting with Rutherford category I or II ALI, The 12-month AFS was significantly lower in ST-ALI than in de novo-ALI (52.2±5.1% vs. 75.6±2.5%, p<0.001). Multivariate analysis revealed that ST-ALI (hazard ratio [HR]: 1.77, 95% confidential interval [CI] 1.18-2.65, p=0.006) as well as age (HR: 1.03, 95%CI 1.01-1.05, p=0.008), HD (HR: 2.58, 95%CI 1.64-4.04, p<0.001), Af (HR: 1.77, 95%CI 1.18-2.65, p=0.006), presence of wound (HR: 1.78, 95%CI 1.10-2.88, p=0.018), peak CRP value (HR: 1.05, 95%CI 1.03-1.07, p<0.001) and non-ambulatory status (HR: 2.17, 95%CI 1.41-3.31, p<0.001) were significantly associated with low 12-month AFS.Conclusions:In patients presenting with Rutherford category I or II ALI, ST-ALI, age, hemodialysis, presence of wound, atrial fibrillation, peak CRP value and non-ambulatory status adversely impact on 12-month AFS.
Abstract 16244: Oncologic Disease and In-Stent Restenosis: A Nationwide Analysis
Circulation, Volume 148, Issue Suppl_1, Page A16244-A16244, November 6, 2023. Introduction:Recent studies have shown that Ischemic Heart Disease (IHD) is leading cause of cardiovascular mortality in cancer patients. There is little information about In-Stent Restenosis (ISR), one complication of IHD treatment. ISR has been associated with the presence of underlying risk factors but there is no clear association between cancer and ISR.Methods:A retrospective cohort study was made selecting a sample of adult patients using the National Inpatient Sample (NIS) database from January 2017 to December 2019. Patients with cancer were identified and stratified by 5 main sites: lung, breast, gastrointestinal, prostate, and hematological tissue. Main outcome was odds of ISR in the oncologic population. Secondary outcomes were Major Adverse Cardiovascular Events (MACE) and mortality in patients with ISR, stratified by presence or absence of cancer. Univariate and multivariate analysis were done, adjusting for possible confounders.Results:A total of 90,900,000 adults were identified, of which 4,888,734 had cancer. From the adult population, 197350 patients with ISR were identified. Primary analysis revealed that cancer is not associated with increased odds of ISR but rather decreased, adjusted for other comorbidities, with an OR=0.181(IC95%=0.167-0.198, p=0.001). Paradoxically, secondary analysis of the ISR subpopulation showed statistically significant differences between cancer and non-cancer patients in the rate of composite MACE, and other cardiovascular outcomes such as Heart Failure, Atrial Fibrillation, and other arrhythmias (Table 1).Conclusions:The present study shows that cancer is associated with decreased odds for ISR, but in with patients with ISR cancer was associated with higher prevalence of composite MACE, mainly due to arrhythmias and heart failure. Further studies are needed to explain the dynamic relationship between cancer and endothelial dysfunction.
Abstract 12711: Stent Length as a Predictor of Target Vessel Revascularization in Patients Treated With Drug-Eluting Stents
Circulation, Volume 148, Issue Suppl_1, Page A12711-A12711, November 6, 2023. Background:While several factors have been shown to increase the risk of stent thrombosis, most cases of target vessel revascularization (TVR) are due to in-stent restenosis (ISR) and have not been fully evaluated. Objectives: Our aims were to identify predictors of early and late TVR after drug-eluting stents (DES) implantation in a large prospective registry, focusing on stent length.Methods and Results:We analyzed rates of TVR according to stent length in a prospective registry of 14,447 all-comers treated with angioplasty and DES implantation in our institution. Patients were divided into quartiles according to stent length – mean 21mm – percentile 25 (Q1) 15mm, 50 (Q2) 18mm, 75 (Q3) 26mm and 100 (Q4) 32mm. At baseline patients had similar rates of diabetes mellitus, congestive heart failure and left ventricular ejection fraction. Patients in the first quartile tend to be older, more commonly of female gender, with higher rates of GFR
Abstract 13212: Prevention of Delayed Coronary Obstruction Following Transcatheter Aortic Valve Replacement Using Intravascular Ultrasound and “Modified” Snorkeling Stent Technique
Circulation, Volume 148, Issue Suppl_1, Page A13212-A13212, November 6, 2023. Introduction:Coronary obstruction (CO) is a potentially fatal complication that can occur after transcatheter aortic valve replacement (TAVR). Here we report a successful management of a TAVR patient at risk of delayed CO using intravascular ultrasound (IVUS) and a “modified” snorkeling stent technique.Case presentation:An 88-year-old woman presented with severe symptomatic aortic stenosis. Despite the left coronary artery (LCA) being not low, a Multidetector Computed Tomography scan identified a relatively long leaflet of the left coronary cusp (LCC) and a calcified nodule on the cusp (Figure 1A), indicating a high CO risk. A transfemoral TAVR was conducted using a 26mm Evolut FX (Medtronic, IL, USA) protecting the LCA with a 6-F Judkins left (JL) 4.0 guiding catheter, a 0.014 inch coronary guide wire, and a guide-extension catheter. Upon reaching the point of no recapture, LCA blood flow was maintained, and hemodynamics was stable. However, IVUS revealed the calcified nodule on the LCC was close to the left main (LM) ostium (Figure 1B), indicating a high risk of delayed CO.We continued and completed the prosthesis deployment protecting the LCA. Following the deployment, We introduced another guiding catheter (6-F JL3.5) into the prosthesis and engaged it with the LCA via the prosthesis frame, utilizing a double-guiding catheter technique. Subsequently, we placed a coronary stent from the LM to the prosthesis (Figure 1C). After the TAVR procedure, we verified that a JL3.5 catheter could easily engage the implanted coronary stent (Figure 1F). This “modified” snorkeling stent technique appears feasible and provides easier coronary access compared to the “Chimney” snorkeling stent technique.
Abstract 13699: Comparing Patency Benefits of Pulmonary Stent Implantation and Balloon Angioplasty in Pulmonary Vein Stenosis: A Systematic Review and Meta-Analysis
Circulation, Volume 148, Issue Suppl_1, Page A13699-A13699, November 6, 2023. Introduction:Pulmonary vein stenosis (PVS) may arise from various conditions and result in significant morbidity and mortality. Transcatheter approaches, including pulmonary stent implantation (PSI) and pulmonary balloon angioplasty (PBA) are associated with restenosis risks. We conducted a meta-analysis comparing PSI and PBA to understand restenosis risk and complications rate.Methods:We conducted a comprehensive search of PubMed, Google Scholar, Scopus, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases from inception until May 2023. A total of 1233 studies were screened, and 11 studies were included in our analysis. Our primary outcomes of interest were the risk of restenosis requiring reintervention, 5-year freedom from restenosis, and the risk of procedure-related complications. We calculated odds ratios (ORs) with corresponding 95% confidence intervals (CIs) using a random-effects model and performed a meta-regression analysis.Results:We included a total of eleven observational studies in our meta-analysis, comprising 780 patients with PVS, 335 of whom underwent PBA and 445 underwent PSI. Our analysis showed that PSI was associated with a lower risk of restenosis requiring reintervention compared to PBA (OR 0.34, 95% CI 0.13, 0.87, P= 0.02). PSI was also associated with a significantly higher 5-year freedom from restenosis (OR 4.42, 95% CI 1.11, 17.62, P= 0.04) than PBA. There was no significant difference in the risk of procedure-related complications between PSI and PBA. Our meta-regression analysis revealed that age of patient and stent size did not significantly affect the risk of restenosis requiring intervention.Conclusions:PSI offers superior patency benefits compared to PBA for PVS. PSI was associated with a lower risk of restenosis requiring reintervention and a higher 5-year freedom from restenosis. Bases on these findings, PSI is the preferred strategy for the treatment of pulmonary vein stenosis.
Abstract 17002: Platelet-Derived Purified Exosome Product to Treat In-Stent Restenosis Porcine Model
Circulation, Volume 148, Issue Suppl_1, Page A17002-A17002, November 6, 2023. Introduction:Patients with coronary artery disease (CAD) not amenable to revascularization are reported to have a 3-year mortality >14%. Advances in treatment modalities including medical management, rotational atherectomy, balloon lithotripsy, and drug-eluting stents work for focal disease but poorly treat diffuse CAD. In a porcine model of in-stent restenosis, we here evaluated whether a pro-angiogenic platelet-derived exosome product (PEP) could be delivered into the perivascular space to foster collateral vessel formation.Methods/Results:Cobalt chromium stents were placed and were oversized by 1 mm in the left anterior descending (LAD) and posterior descending arteries (PDA) of sus scrofa domesticus pigs. In-stent restenosis was angiographically visualized at the 2-month timepoint, with hemodynamic significance documented with fractional flow reserve (FFR) of
Abstract 15318: A Dene- and Drug-Eluting Peripheral Stent Using a Baculovirus-Eluting PVA Hydrogel Coating
Circulation, Volume 148, Issue Suppl_1, Page A15318-A15318, November 6, 2023. Introduction:Over 20 % of people over 60 have peripheral artery disease (PAD), the narrowing of peripheral arteries due to atherosclerosis. More recent data suggests a surge in PAD in younger people (affecting up to 4 % of people). Atherosclerosis is complex, initially involving fat deposition and endothelial cell dysfunction, leading to inflammation, hyperproliferation of cells, plaque development, and calcification. This can lead to significant pain, discomfort, limb ischemia, stroke, and increases the risk of major cardiovascular events such as myocardial infarction and coronary artery disease. Often a bare-metal or drug-eluting stent will force the artery open. These stents are highly effective but come with complications such as restenosis, thrombosis, and enhanced endothelial dysfunction leading to patency as low as 60 % one-year post-implantation.Hypothesis:A gene- and drug-eluting hydrogel stent coating can promote endothelial recovery while the long-term drug elution prevents restenosis and inflammation, improving the clinical outcome of PAD (Figure 1).Methods & results:The gene encoding nitric oxide had been cloned into a baculovirus, a highly efficient and safe gene delivery vector to arterial cells. Nitric oxide inhibits smooth muscle cell proliferation, promotes endothelial cell proliferation, promotes angiogenesis, and prevents reactive oxygen species production within the diseased artery. The 10-day gene elution has the potential to leave behind a healthy endothelial lining, and the 100-day Everolimus drug elution can prevent restenosis and inflammation. Moreover, the gene- and drug-eluting stent is stable during crimping and expansion, has a high tensile strength, is non-cytotoxic, and is anti-thrombotic by preventing platelet adhesion.Conclusion:Overall, the novel stent exhibits beneficial mechanical and cellular properties with the potential to mitigate current stenting complications using dual gene and drug therapy.
Abstract 19047: Comparison of Drug-Eluting Stent With Bare-Metal Stent Implantation in Femoropopliteal Artery Disease: A Systematic Review and Meta-Analysis
Circulation, Volume 148, Issue Suppl_1, Page A19047-A19047, November 6, 2023. Introduction:Trials comparing drug eluting stent (DES) versus bare metal stents (BMS) in patients undergoing endovascular therapy for femoropopliteal artery disease (FPAD) have shown variable results. Data indicating clear patency benefit of DES has not been definitively demonstrated.Methods:Medline, Embase, & Cochrane Central databases were searched to identify previous studies comparing efficacy of drug eluting stent versus bare metal stents in treatment of FPAD. The primary outcome of interest was risk of restenosis. Secondary outcomes included all-cause mortality, stent fracture, target vessel revascularization and primary patency. Odds ratios (OR) were pooled using a random-effect model while heterogeneity among studies was assessed using the Higgins I2value.Results:A total of 7 studies (5 RCTs and 2 retrospective cohorts) with 1786 patients were included in our analyses. The risk of target vessel revascularization was significantly reduced with the use of DES (OR: 0.69, 95% CI: 0.49-0.98, I2= 0) as compared with BMS. However, there was no significant difference observed in risk of restenosis (OR: 0.83, 95% CI 0.59-1.16), primary patency (OR: 1.09, 95% CI 0.91-1.29), stent fracture (OR: 0.84, 95% CI 0.27-2.67) and all-cause mortality (OR: 1.65, 95% CI 0.71-3.85).Conclusion:The risk of target vessel revascularization was significantly reduced with the use of DES implantation in patients with FPAD. However, DES does not seem to provide much benefit in terms of clinical outcomes. Further larger RCTs are needed to provide more evidence in the comparison between DES and BMS for FPAD.
Abstract 15324: Biodegradable Polymer Ultrathin Sirolimus-Eluting Stent is Associated With Better Outcomes Compared With Polymer-Free Ultrathin Sirulimus-Eluting Stent in Complex Percutaneous Coronary Intervention: A Post Hoc Analysis of the HOST-IDEA Randomized Clinical Trial
Circulation, Volume 148, Issue Suppl_1, Page A15324-A15324, November 6, 2023. Introduction:Third generation drug-eluting stents with ultrathin struts and advanced polymer technology have been introduced. However, their safety and efficacy have not been fully elucidated, particularly in complex percutaneous intervention (PCI).AimTo investigate the clinical outcomes of complex PCI using the Coroflex ISAR polymer-free sirolimus-eluting stent (SES) or Orsiro biodegradable polymer SES.Methods:This study was a post-hoc analysis of the HOST-IDEA trial that randomly assigned 2,013 patients undergoing PCI with Orsiro or Coroflex ISAR into either 3-month dual antiplatelet therapy (DAPT) or 12-month DAPT arms from January 2016 to May 2021 at 37 centers in South Korea. We compared a 1:1 propensity score (PS)–matched cohort balanced by patient and procedural characteristics. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically-driven target lesion revascularization at 1 year. Complex PCI was defined as any of the following features: ≥3 stents implanted, ≥3 lesions treated, bifurcation PCI, total stent length ≥ 60 mm, left main PCI, or heavy calcification.Results:After PS matching, baseline patient and procedural characteristics were balanced between Coroflex ISAR and Orsiro groups (n=542 in each). Complex PCI was significantly associated with a higher rate of TLF compared with non-complex PCI (5.3% vs. 1.1%, hazard ratio (HR) 5.12 [95% confidence interval (CI) 2.21-11.86], P
Abstract 16581: Impact of Drug Eluting Stent Deployment and Calcification on Worsening Target Lesion Failure in Femoropopliteal Lesions
Circulation, Volume 148, Issue Suppl_1, Page A16581-A16581, November 6, 2023. Introduction:Endovascular therapy (EVT) with drug coated balloon (DCB) has been proven superior to balloon angioplasty only in the patency rate. EVT with drug eluting stent (DES) also has shown to be superior to balloon angioplasty only or implantation of bare metal stents. Primary patency of EVT in femoropopliteal lesions (FP-EVT) for DES and DCB is around 80%-90% at 12 months respectively. Therefore, the use of drug technology for FP-EVT is reasonable and generally accepted. However, in daily clinical practice, some target lesion failure (TLF) cases show worse clinical and/or angiographic conditions than the original before the intervention, and many of those cases have bad outcomes. There are no reports on predictors of the worse condition.Methods:A total of 292 consecutive FP lesions of 194 patients who visited our hospital from April 2017 to March 2021 and underwent FP-EVT with drug technologies (DES: 104, DCB: 188) were retrospectively reviewed. “Worsening target lesion failure (WTLF)” was defined as TLF with acute limb ischemia symptom or occlusion of the lesion which had been stenosis at the initial treatment. We investigated the predictor of WTLF.Results:The mean age of all study patients was 72.5±9.3 years and 68% were male. During the follow-up period (median: 568 days), 13 WTLFs were observed. 9 (8.7%) cases were treated with DES and 4 (2.1%) were with DCB at the initial treatment (p=0.01). Cases with WTLF had severer and longer calcification (bilateral calcification: 84.6% vs. 47.7%, p=0.007; calcium length: 162±74mm vs. 85±11mm, p=0.005). Multivariate Cox regression analysis indicated that DES use (Hazard ratio (HR)=4.66, 95% confidence interval [1.28-16.92], p=0.046) and bilateral calcification (HR=7.21, [1.04-50.14], p=0.020) were independently associated with the occurrence of the WTLF. The prevalence of composite outcome, major amputations and all cause deaths, was 54% in the group with WTLF, which was higher than the group without WTLF (p=0.02).Conclusions:Patients with WTLF had bad outcomes. Bilateral calcification and DES deployment were associated with an increased risk for WTLF. For stenotic lesions with bilateral calcification, it may be better to avoid DES deployment.