Target Lesion Restenosis Research Articles

Rivaroxaban and Aspirin in Drug-Coated Balloon Angioplasty for Femoropopliteal In-Stent Restenosis: A Retrospective Cohort Study

BackgroundAfter drug-coated balloon (DCB) treatment of the femoropopliteal artery in-stent restenosis (ISR), a certain proportion of patients also experience target lesion restenosis. The purpose of this study was to explore the efficacy and safety of rivaroxaban combined with aspirin in the treatment of ISR after DCB intervention. MethodsPatients who underwent DCB treatment for ISR after femoropopliteal artery intervention at our center from March 2017 to February 2022 were included consecutively. According to the drug treatment after DCB intervention of ISR, the patients were divided into rivaroxaban and aspirin group (RA Group) and dual antiplatelet therapy (DAPT) group. The outcomes of two groups during the 12-month follow-up after DCB intervention were compared. ResultsA total of 92 patients were included in final analysis, with 43 in RA group and 49 in DAPT group. During 12-month follow-up, a total of 15 cases of recurrent ISR were detected, and the recurrence rate of ISR and clinically driven TLR in the RA group were lower than those in the DAPT group (P<0.05). The vascular patency rate in the RA group was higher than that in the DAPT group at 6 and 12 months of follow-up (P<0.05). During the follow-up, there were no adverse events such as death, myocardial infarction, stroke, amputation, or major bleeding, and only a total of 5 cases of minor bleeding occurred. ConclusionCompared with the standard DAPT regimen, rivaroxaban combined with aspirin can safely improve the follow-up outcome after DCB for femoropopliteal ISR.

Incidence of restenosis after drug-coated balloon percutaneous coronary intervention in patients with diabetes mellitus - a single-centre experience

Abstract Background and aim Diabetes mellitus (DM) is related to higher rates of complications after coronary revascularization.1 The efficiency of drug-coated balloon (DCB) percutaneous coronary intervention (PCI) has been shown for in-stent restenosis (ISR) and native small-vessel disease, however data on outcomes in DM is scarce. 2 The aim is to compare the incidence of target lesion restenosis at follow-up (FUP) coronary angiography in patients with and without DM receiving DCB PCI. Material and methods The registry included patients undergoing a DCB PCI at our university hospital centre from February 2011 to January 2022 (n=645). Patient demographics, comorbidities, pharmacotherapy, as well as data on the initial and FUP coronary angiography/PCI was collected. An FUP angiography was performed in 50% of patients (n=317), with a median FUP of 6 (interquartile range 3-17) months. Results Data is shown in Table 1. The cohort was 75% male, mean age 65 ± 10 years. DM was present in 35% (n=223) of patients, equally in both sexes, and was associated with a history of myocardial infarction, PCI, coronary artery bypass grafting, stroke; as well as arterial hypertension, and renal insufficiency. No age difference was noted between groups. At initial PCI, more DM patients had multivessel coronary disease and ISR as the indication for DCB (DM vs non-DM: 41% vs 31%, p=0.023). After DCB, no group difference was noted in regards to the need for a bail-out PCI. FUP was performed in an equal percentage of patients in both groups (54% vs 48%, p=0.181), with no differences seen in the incidence of restenosis (17% vs. 18%, p=0.879), the need for target lesion PCI (14% vs. 13%, p=0.863), or the use of anti-anginal drugs. Conclusion The findings of our single-centre analysis show that although DM is related to more advanced comorbidities it does not increase the risk of target lesion restenosis after DCB PCI. DCB PCI should be considered as a therapeutic option in candidate patients regardless of DM status.Comparison between diabetic and non diab

Bypass vs endovascular treatment for occluded femoro-popliteal stents in patients with critical limb-threatening ischemia

ObjectiveThe aim of the study was to compare the early and medium-term outcomes of bypass vs endovascular treatment of occluded femoro-popliteal stents in patients with chronic limb-threatening ischemia (the OUT-STEPP multicentric registry). MethodsBetween January 2016 and December 2021, 317 patients in 14 centers underwent treatment for a symptomatic occlusion of femoro-popliteal stent/stents. One hundred sixty-one patients were included into the present study: 46 (28.6%) underwent open bypass surgery (Group OPEN), and 115 (71.4%) underwent endovascular revascularization (Group ENDO). Early (30 days) results were assessed and compared between the two groups. Estimated 5-year outcomes were evaluated and compared with the log rank test. ResultsAt 30 days, no differences were found in terms of major adverse cardiovascular events, acute kidney injury, reinterventions, major amputation, and all-cause mortality between the two groups. The need for blood transfusions was higher for patients in Group OPEN (17; 36.9% vs 13; 11.3%; P < .001). The mean length of intensive care unit stay and the mean hospital stay were higher for patients in Group OPEN ([0.3 ± 0.9 vs 0 days; P < .001] and [9.7 ± 5.8 vs 3.3 ± 1.4 days; P < .001], respectively). The overall median duration of follow-up was 33.1 months (interquartile range, 14-49.5 months). At 5 years, there were no differences between the two groups in terms of survival (68.7% Group OPEN vs 68.8% Group ENDO; P = .27; log-rank, 1.21), primary patency (56.3% Group OPEN vs 67.8% Group ENDO; P = .39; log-rank, 0.75), secondary patency (59.1% Group OPEN vs 77.8% Group ENDO; P = .24; log-rank, 1.40), absence of target lesion restenosis (56.8% Group OPEN vs 62.7% Group ENDO; P = .42; log-rank, 0.65), and limb salvage (77.2% Group OPEN vs 90.4% Group ENDO; P = .17; log-rank, 1.87). ConclusionsBoth bypass and endovascular treatment provided safe and effective restoration of patency for femoro-popliteal in-stent occlusion in patients with chronic limb-threatening ischemia. Open surgery was associated with longer stay in hospital and increased use of blood transfusions. At 5 years, no significant differences were found in the rates of overall patency or limb salvage between bypass and endovascular treatment.

A multicenter, randomized, open-labelled, non-inferiority trial of sustained-release sarpogrelate versus clopidogrel after femoropopliteal artery intervention

Optimal antiplatelet therapy after endovascular therapy (EVT) for peripheral artery disease is controversial. This trial aimed to evaluate whether sarpogrelate plus aspirin was non-inferior for preventing early restenosis after femoropopliteal (FP) EVT compared to clopidogrel plus aspirin. In this open-label, prospective randomized trial, 272 patients were enrolled after successful EVT for FP lesions. Patients in each group received aspirin 100 mg and clopidogrel 75 mg or sarpogrelate 300 mg orally once per day for 6 months. The primary outcome was target lesion restenosis at 6 months, tested for noninferiority. Patient characteristics and EVT patterns were similar, except for increased inflow procedures in the sarpogrelate group and increased outflow procedures in the clopidogrel group. The sarpogrelate group showed a tendency of less restenosis at 6 months than the clopidogrel group (13.0% vs. 19.1%, difference 6.1 percentage points, 95% CI for noninferiority − 0.047 to 0.169). Secondary endpoints related to safety outcomes were rare in both groups. Risks of target lesion restenosis of the two intervention arm were uniform across most major subgroups except for those with coronary artery disease. In conclusion, Sarpogrelate plus aspirin is non-inferior to clopidogrel plus aspirin in preventing early restenosis after FP EVT. Larger multi-ethnic trials are required to generalize these findings. Trial registration: National Institutes of Health Clinical Trials Registry (ClinicalTrials.gov identifier: NCT02959606; 09/11/2016).

Neutrophil-to-Lymphocyte Ratio Predicts Restenosis After Drug-Coated Balloon Therapy for Femoropopliteal Artery Lesions: A Retrospective Study.

BackgroundPeripheral artery disease (PAD) is a common atherosclerotic vascular disease. The use of drug-coated balloon (DCB) for the treatment of femoropopliteal artery disease has gradually increased. A certain percentage of patients developed target lesion restenosis after DCB treatment of the femoral popliteal artery. The neutrophil-to-lymphocyte ratio (NLR) is closely related to the level of inflammatory activity and has predictive value for atherosclerotic vascular disease. This study aimed to analyze the relationship between NLR and 1-year restenosis after DCB for femoropopliteal artery disease.MethodsPatients with femoropopliteal artery disease who were treated with DCBs at our hospital from May 2016 to December 2020 were retrospectively included. Baseline data during the patient’s first hospital stay and data during follow-up were collected. Demographic data, laboratory test results, lesion examination results, and major adverse events during the follow-up period were collected. Logistic regression was used to analyze the factors associated with restenosis after DCB.ResultsA total of 117 patients were included. During 1-year follow-up, 19 cases (16.2%) of restenosis were detected. Five of these patients (4.3% of total included patients) were readmitted for symptomatic ischemia. No deaths or amputations occurred. Baseline NLR in patients with restenosis was higher than that in patients without restenosis (2.4 (2.1, 3.4) vs. 1.8 (1.3, 2.3), P < 0.001). Logistic univariate and multivariate analysis showed that baseline hs-CRP level (OR = 1.10, 95%CI: 1.05–1.34), lesion length (OR = 1.04, 95%CI: 1.02–1.27), use of rivaroxaban (OR = 1.08, 95%CI: 1.05–1.39), NLR (OR = 1.47, 95%CI: 1.13–2.48), LDL-C level (OR = 1.25, 95%CI: 1.05–1.52), and diabetes (OR = 1.25, 95%CI: 1.05–1.52) = 1.18, 95%CI: 1.06–1.66) were predictors of restenosis.ConclusionBaseline NLR before DCB can predict the risk of restenosis after surgery.

An Overview of In Vitro Drug Release Methods for Drug-Eluting Stents.

The drug release profile of drug-eluting stents (DESs) is affected by a number of factors, including the formulation, design, and physicochemical properties of the utilized material. DES has been around for twenty years and despite its widespread clinical use, and efficacy in lowering the rate of target lesion restenosis, it still requires additional development to reduce side effects and provide long-term clinical stability. Unfortunately, for analyzing these implants, there is still no globally accepted in vitro test method. This is owing to the stent’s complexity as well as the dynamic arterial compartments of the blood and vascular wall. The former is the source of numerous biological, chemical, and physical mechanisms that are more commonly observed in tissue, lumen, and DES. As a result, universalizing bio-relevant apparatus, suitable for liberation testing of such complex implants is difficult. This article aims to provide a comprehensive review of the methods used for in vitro release testing of DESs. Aspects related to the correlation of the release profiles in the cases of in vitro and in vivo are also addressed.

Application of mechanical debulking in arteriosclerosis occlusive disease of lower extremity

Objective: To evaluate the effect of mechanical debulking in treating arteriosclerosis occlusive disease of lower extremity. Methods: The clinical data of 52 arteriosclerosis occlusive disease of lower extremity cases treated with Rotarex mechanical debulking system from June 2017 to June 2020 at Department of Intervention Vascular Surgery,Peking University Third Hospital were retrospectively analyzed. There were 37 males and 15 females,aged(69.4±10.1)years(range:47 to 89 years).Lesion length was (21.6±12.9)cm(range:4 to 45 cm),occlusion length was (18.5±11.8)cm(range:4 to 45 cm).The lesion was located in iliac artery(IA) in 6 cases,femoral-popliteal artery(FPA) in 42 cases,and both IA and FPA in 4 cases. All the cases were treated with Rotarex mechanical debulking system. Residual stenosis more than 50% were treated with percutaneous transluminal angioplasty(PTA).Drug coated balloon was used in part of them,and stent was used only when it was necessary. The patient's operation, complications, postoperative target vessel restenosis and reoperation were collected. The paired sample t test and rank sum test was used for data comparison and the postoperative target vessel patency rate was analyzed by Kaplan-Meier survival curve. Results: All the 52 cases obtained technical success. Percutaneous transluminal angioplasty was used in all cases,and drug coated balloon were used in 11 cases. Twenty-six stents were implanted in 24 cases (2 cases implanted 2 stents).Nine stents were implanted in IA and 15 in FPA. The length of stents was (11.3±3.3)cm(range:6 to 23 cm).There were 3 procedure related complications: one of them was acute occlusion in an iliac lesion,and thrombectomy was applied urgently,and the result was good. And the other two were distal embolism. The thrombus were took out with guiding catheter. The hospital stay was (4.8±1.9)days. The ankle brachial index increased from 0.34±0.16 to 0.81±0.16 after treatment(t=-25.160,P<0.01).The Rutherford stages decreased from (M(IQR)) 3(1) to 1(1(Z=-6.825,P<0.01).The median followed up time was 19 months(range:6 to 42 months).Two cases stopped antiplatelet agents during follow-up and which result in acute thrombosis 2 weeks and 2 months later respectively. One of them was treated with percutaneous mechanical thrombectomy and the other one was not for gastrointestinal hemorrhage. Four cases died during follow-up,one case died of lung cancer,one died of abdominal infection,and the other 2 cases died of cardiovascular disease,and no amputation was observed. Target lesion restenosis(TLR) more than 50% occurred in 13 cases during the follow-up. All TLR were observed in FPA,and target lesion revascularization was taken in 3 of them. According to Kaplan-Meier survival curve analysis,half-year,1-year and 2-year cumulative patency rates of target vessels in this group was 94.2%,87.4% and 51.4%, respectively. And half-year and 1-year cumulative patency rates just in FPA cases was 92.9% and 84.3%, respectively. Conclusions: Percutaneous mechanical debulking using Rotarex catheter combining PTA can reduce the use of stents in femoral-popliteal artery. It is safe and effective in treating with arteriosclerosis obliterans of lower extremity.

Periprocedural and 30-day outcomes of robotic-assisted percutaneous coronary intervention used in the intravascular imaging guidance

In recent years, there have been several reports on robotic-assisted percutaneous coronary intervention (R-PCI), but few studies have been conducted on R-PCI performed under intravascular imaging guidance. To elucidate the periprocedural and postoperative 30-day outcomes of intravascular imaging-guided R-PCI, we performed a retrospective observational study on all patients in 102 consecutive cases who underwent R-PCI under intravascular imaging guidance at a single center in Japan from June 12, 2019 to February 18, 2021. The primary end point was 30-day survival, and the secondary end point was the incidence of complications. Intravascular imaging-guided R-PCI was performed 110 times in total on 125 lesions. The medians of procedural time, fluoroscopy time, contrast volume, patient entrance skin dose, and radiation exposure to the main operator were 49 min, 16 min, 67 mL, 0.62 Gy, and 0 μSv, respectively. Furthermore, 60.0% of target lesion branches were American College of Cardiology Foundation/American Heart Association classification type B2 or type C. However, in all cases, lesion dilatation was successful, and the final Thrombolysis in Myocardial Infarction flow grade was 3. The combination of manual operation was required in 12.7% of all cases, but 30-day survival was confirmed in all cases. There were two problems at the puncture site. One small distal branch artery dissection occurred due to manual operation, but no cardiovascular events (myocardial infarction, stroke) occurred and no target lesion restenosis was observed within 30 days of R-PCI. Hence, R-PCI using intravascular imaging demonstrated highly satisfactory treatment outcomes, and no complication caused by robotic operation was observed.

SIroliMus coated angioPlasty versus plain balloon angioplasty in the tREatment of dialySis acceSs dysfunctION (IMPRESSION): study protocol for a randomized controlled trial

BackgroundPercutaneous transluminal angioplasty is the current standard treatment for arteriovenous fistula (AVF) stenosis. The mid- and long-term patency with plain balloon angioplasty (PBA) is however far from satisfactory. While paclitaxel-coated balloon angioplasty has been shown to be superior to PBA, concern over its safety profile has recently arisen after a reported possible increased mortality risk with a meta-analysis of large lower limb studies. An angioplasty balloon with a new type of drug coating, the sirolimus-coated balloon (SCB), has been proven to improve patency in the coronary arteries. However, its effect on AV access has yet to be studied.Methods/designThis is an investigator-initiated, prospective, multicenter, double-blinded, randomized controlled clinical trial to assess the effectiveness of SCB compared to PBA in improving the patency of AVF after angioplasty. A total of 170 patients with mature AVF that requires PTA due to AVF dysfunction will be randomly assigned to treatment with a SCB or PBA at a 1:1 ratio, stratified by location of AVF and followed up for up to 1 year. The inclusion criteria include [1] adult patient aged 21 to 85 years who requires balloon angioplasty for dysfunctional arteriovenous fistula [2]; matured AVF, defined as being in use for at least 1 month prior to the angioplasty; and [3] successful angioplasty of the underlying stenosis with PBA, defined as less than 30% residual stenosis on digital subtraction angiography (DSA) and restoration of thrill in the AVF on clinical examination. The exclusion criteria include thrombosed or partially thrombosed access circuit at the time of treatment, presence of symptomatic or angiographically significant central vein stenosis that requires treatment with more than 30% residual stenosis post angioplasty, and existing stent placement within the AVF circuit. The primary endpoint of the study is access circuit primary patency at 6 months. The secondary endpoints are target lesion primary patency; access circuit-assisted primary patency; access circuit secondary patency at 3, 6, and 12 months; target lesion restenosis rate at 6 months; total number of interventions; complication rate; and cost-effectiveness. The trial is supported by Concept Medical.DiscussionThis study will evaluate the clinical efficacy and safety of SCB compared to PBA in the treatment of AVF stenosis in hemodialysis patients.Trial registrationClinicalTrials.govNCT04409912. Registered on 1 June 2020

Clinical outcome of the patients with femoropopliteal artery disease after endovascular therapy: focused on drug-coated-balloon-related distal embolism detected by laser doppler flowmetry

Several trials have shown that paclitaxel drug-coated balloons (DCBs) significantly reduce restenosis rates. However, some reports have shown distal embolisms occurring after DCBs. No study has analyzed the clinical outcomes of patients with DCB-induced distal embolism. This study aimed to investigate the clinical outcomes of DCB-induced distal embolism in patients with femoropopliteal artery disease. Between February 2018 and April 2019, consecutive patients (n = 32) who presented with de novo femoropopliteal artery disease and underwent endovascular therapy using DCB were retrospectively reviewed in a single-center study. Patients were divided into two groups based on whether distal embolism was detected using laser doppler flowmetry (DEL group) or not (non-DEL group). Baseline characteristics and 1-year clinical outcomes were compared between the groups. DEL was found in 44% of limbs (DEL group: n = 15, non-DEL group: n = 19). Below-the-knee arterial runoff ≤ 1 (p = 0.033), popliteal lesion (p = 0.044), ambulation difficulty (p = 0.021), and previous history of coronary artery disease (p = 0.013) were identified as predictive factors of DEL. Procedural factors, reference vessel diameter, lesion length, and total drug amount were not predictive of DEL. The overall target lesion restenosis (TLR) rate was 17.4% (n = 5). The TLR rate was not significantly different between the DEL and non-DEL groups (13.3% vs. 15.8%, p = 0.55). Severe calcification was the only significant factor for TLR (4.2% vs. 40.0%, p = 0.02). Among patients with femoropopliteal disease, there was no difference in 1-year clinical outcome between patients who underwent DEL and those who did not.

The efficacy of paclitaxel drug-eluting balloon angioplasty versus standard balloon angioplasty in stenosis of native hemodialysis arteriovenous fistulas

Abstract Background End stage renal disease is on increasing trend and haemodialysis is the main dialysis modality among these patients. Thus, a functioning dialysis vascular access is critical to the delivery of life-saving haemodialysis treatment to these patients. Conventional angioplasty is the first line of treatment; with a 50% of permeability rate (6 months). For this reason, new alternatives are necessary to maintain the access permeability.Hypothesis: Paclitaxel coated balloon is superior to conventional plain balloon angioplasty with decreased re-stenosis of target lesion, improved access circuit and target lesion patency, and decreased number of interventions needed to maintain patency. Methods A total of 39 patients were randomized to receive a paclitaxel-coated balloon (n=15) or plain angioplasty balloon (n=24) after satisfactory angioplasty with a high-pressure balloon. The inclusion criteria were clinical signs of vascular dysfunction confirmed by Doppler Ultrasound and/or angiography. The primary endpoint was target lesion patency defined as time elapsed between the completion of effective and the appearance of restenosis at 3, 6 and 12 months after angioplasty. Secondary endpoints included the relationship between the location of the stenosis, previous angioplasty, demographic variables and survival. Results We recruited 39 patients with dysfunctional vascular accesses; 24 were assigned to the conventional balloon angioplasty group and 15 drug-eluting balloon angioplasty (paclitaxel). With demographic characteristics in Table I. In group A, all were autologous acces. Group B 16% (4) of the accesses were prosthetic and 84% (20) autologous. In relation to the type and length of stenosis, group A was more frequent at the level and longer, whereas in group B it predominated in the central type and less than 20 mm.In our study, we also observed a high rate of total occlusions, frequently in central vessels in group B, while in group A, where peripheral vessels were predominant, total occlusion was less frequent. Table II. We had no complications in either group, and dialysis was immediate at the end of the procedure. Group A did not present restenosis. Table III. Table III shows DEB group (15p) with 100% of permeability according to follow-up and only one (1/15) of patients died due to myocardial infarction and cerebrovascular accident and this patient kept lasted 9 months without restenosis In Table IV. Group B had 2 (8%) patients with restenosis so it was necessary to reoperate using a drug eluting balloon and until now there is no restenosis. From this group we do not have mortality. One patient 1 (24%) had a recovered infarction. Conclusions Paclitaxel-coated balloon angioplasty resulted in superior survival of dysfunctional peripheral vascular access at 12 meses. Both arms show equivalent complications and similar mortality Funding Acknowledgement Type of funding sources: Public hospital(s). Main funding source(s): Enrique Garcés Hospital

Association of Soluble Suppression of Tumorigenesis 2 (sST2) With Platelet Activation, Monocyte Tissue Factor and Ischemic Outcomes Following Angioplasty and Stenting

Background: Peripheral artery disease (PAD) patients undergoing infrainguinal angioplasty with stenting suffer high rates of target lesion restenosis and ischemic events. Blood-based prognostic markers in these patients are currently limited. The IL-33/ST2-system is involved in atherothrombosis. Soluble ST2 has been proposed as a biomarker in patients with cardiovascular disease.Aim: To investigate the association of sST2 with platelet activation and monocyte tissue factor (TF) in 316 patients undergoing elective angioplasty and stenting for cardiovascular disease, and its predictive value for ischemic outcomes following infrainguinal angioplasty with stent implantation in 104 PAD patients within this cohort.Methods and Results: Circulating levels of sST2, platelet surface P-selectin, monocyte TF expression as well as soluble P-selectin were determined in 316 consecutive patients on dual antiplatelet therapy following angioplasty and stenting. sST2 was independently associated with soluble P-selectin (B = 6.4, 95% CI 2.0–10.7, p = 0.004) and TF expression (B = 0.56, 95% CI 0.02–1.1, p = 0.041) but not with platelet surface P-selectin (B = 0.1, 95% CI −0.1–0.3, p = 0.307) after adjustment for age, sex, clinical risk factors and inflammatory parameters. During the follow-up of 24 months, the primary endpoint occurred in 41 of 104 PAD patients (39.4%). However, circulating levels of sST2 did not predict the primary endpoint in PAD patients (HR 1.1, 95% CI 0.76–1.71, p = 0.527).Conclusion: sST2 is associated with soluble P-selectin and monocyte TF expression in atherosclerosis but not with ischemic outcomes following infrainguinal angioplasty with stent implantation for PAD.

PCI complexity and risk of adverse events in relation to high bleeding risk among patients receiving drug-eluting stents

Abstract Background The relation between complex percutaneous coronary intervention (PCI), high bleeding risk (HBR), and adverse events after coronary artery implantation of drug-eluting stents has been incompletely characterized. This study sought to investigate the ischemic and bleeding events after complex PCI including a stratification according to HBR estimated by PARIS bleeding risk score. Methods Between January 2013 and December 2013, 10,167 consecutive patients undergoing PCI were prospectively enrolled in Fuwai PCI Registry. Complex PCI was defined when having at least one of the following characteristics: 3 vessels treated, ≥3 stents implanted, ≥3 lesions treated, bifurcation with 2 stents implanted, total stent length &amp;gt;60 mm, treatment of chronic total occlusion, unprotected left main PCI, in-stent restenosis target lesion, and severely calcified lesion. The primary ischemic endpoint was major adverse cardiovascular events (MACE) [composite of cardiac death, myocardial infarction, and definite/probable stent thrombosis], and primary bleeding endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding. Results The median duration of follow-up was 29 months. In adjusted Cox regression analysis, patients having complex PCI procedures experienced higher risks of MACE (hazard ratio [HR]: 1.63, 95% confidence interval [CI]: 1.38–1.92; P&amp;lt;0.001), compared with non-complex PCI. In contrast, the risk of clinically relevant bleeding was statistically similar between the 2 groups (HR: 0.86 [0.66–1.11]; P=0.238). There was no statistical interaction between HBR (PARIS bleeding score ≥8 or &amp;lt;8) and complex PCI in regard to MACE (adjusted Pinteraction=0.388) and clinically relevant bleeding (adjusted Pinteraction=0.279). Conclusions Patients who had undergone complex PCI resulted in substantially more ischemic events, without an increase in clinically relevant bleeding risk; and these associations did not seem to be modified by HBR status. More intensified antiplatelet therapy may be beneficial for patients with complex percutaneous coronary revascularization procedures. Funding Acknowledgement Type of funding source: Foundation. Main funding source(s): Chinese Academy of Medical Sciences Innovation Fund for Medical Sciences

The Influence of Diabetes Mellitus on the Outcome of Superficial Femoral Artery Recanalization is Debatable.

A retrospective analysis was carried out on 110 patients who had undergone endovascular treatment of the SFA from 2010 to 2017 comparing outcomes in diabetic (DM) vs non-diabetic patients (nDM). 56 (50.9%) of the patients were diabetic and 54 were non-diabetic (49.1%). 52.7% (62.7% DM vs 35.2% nDM, p = 0.0003) were patients with critical limb ischemia. SFA occlusion was present in 65.5% (60.7% DM vs 70.4% nDM, p = 0.29) of all patients. All had undergone PTA of the SFA and 40.9% had received adjunctive stenting (44.6% DM vs 37.0% nDM, p = 0.41). A multilevel treatment was executed in 39.1% (51.8% DM vs 25.9% nDM) of the cases whereas an infra-popliteal procedure was associated in 27.3% (37.5% DM vs 16.7% nDM). In both groups the presence of diabetes was significantly associated (p = 0.005 e p = 0.014, respectively). Reintervention rate was 22.7%; 13 in the diabetic group (23.2%) and 12 in the non-diabetic group (22.2%). Of those who had had reintervention (p = 0.77); 9 patients (8.2%) had undergone an open surgical operation, 6 of whom had diabetes (p = 0.32). 5 patients (4.5%) had had major amputation, 4 of whom were diabetic (p = 0.20). Curves assessing freedom from target lesion restenosis were substantially overlapping between the two groups. No statistical associations between diabetes and reintervention or amputation rates were found. Indication to treat the SFA were not influenced by the presence of diabetes but further investigation is required to verify our hypothesis.

Primary Patency of Long-Segment Femoropopliteal Artery Lesions in Patients with Peripheral Arterial Occlusive Disease Treated with Paclitaxel-Eluting Technology

The aim of this study is to evaluate the performance and predictors of failure of paclitaxel drug-eluting stents and paclitaxel-coated balloons in the treatment of long-segment femoropopliteal disease. We report a retrospective cohort analysis of patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in lesions >100mm, which were not included in any of the pivotal trials. Ninety-seven patients with peripheral vascular disease (Rutherford III-VI) underwent long-segment (≥100mm) femoropopliteal drug-eluting stent (DES) implantation or angioplasty with drug-coated balloons (DCB). Patients were followed after their initial procedure for target lesion restenosis, defined as a reduction in lumen diameter by greater than 50% as measured by duplex ultrasonography (ratio >2). The median length of the affected arterial segments was 110mm (interquartile range [IQR] 100-150, absolute range 100-260) using up to 4 overlapping stents. During the median 13-month follow-up (IQR 7-16), no early thrombotic occlusions occurred within 30days, but 28 (29%) patients developed a target lesion restenosis after 1year. Cumulative primary patency at 6 and 12months was 87% and 71% overall, respectively. The cumulative patency during the same follow-up periods varied between patients treated with different paclitaxel modalities with 88% and 80% primary patency in patients treated with DES (n=63) versus 81% and 49% in patients treated with DCB (n=21) (adjusted hazard ratio 2.46, P=0.03). Lesion length, concurrent tibial intervention, and recurrent target lesions were not associated with restenosis. Short-term outcomes in patients treated with paclitaxel-eluting stents and paclitaxel-coated balloons in long lesions, mirror results from the clinical trials. The primary patency observed in patients treated with DES was significantly higher than in patients treated with DCB.

Drug-coated Balloons for Small Coronary Vessel Interventions: A Literature Review.

Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed.

Is There a Safety Concern for Drug-Coated Balloons in Peripheral Arterial Disease?

Drug-coated balloons (DEB) and drug-eluting stents (DES) emerged as a tool to aid in lowering the rates of neointimal hyperplasia and target lesion restenosis following endovascular peripheral arterial disease (PAD) interventions. Although the initial trials comparing these devices with non-drug balloons and stents showed favorable results, more recent data raised concerns regarding the mid to long-term safety of these devices. In this review, we will discuss the evolution of endovascular therapy for PAD, with highlights regarding the recent debates on the long-term safety of the drug-coated devices for treatment of PAD.

Interwoven Nitinol Stents versus Drug Eluting Stents in the Femoro-Popliteal Segment: A Propensity Matched Analysis

Percutaneous transluminal angioplasty (PTA) is a common procedure in patients with peripheral arterial disease (PAD) affecting the femoropopliteal segment (F-P). Biomimetic nitinol stents (Supera peripheral stent, SPS) and drug eluting stents (DES) were designed to improve the longevity of F-P PTA; however, their performance has not been compared in a pragmatic setting, taking atherosclerotic plaque characteristics into account. Overall, 296 consecutive patients (mean age: 73y, SD: 11y, 65% male, 68% with chronic limb threatening ischaemia) who underwent F-P PTA using SPS or DES between 2013 and 2018 were identified from a prospectively maintained institutional database. Patient and plaque characteristics, including F-P plaque characterisation based on computed tomography, were collected; 121 case matched pairs were created using a propensity score based on patient and plaque data. During the median two year follow up, 28% of the cohort (32% SPS vs. 24% DES, p=.07) developed target lesion restenosis (TLR)>50%. Among the 121 case matched pairs of patients, those with SPS vs. DES were not significantly more likely to develop TLR >50% (31% vs. 27%, p=.34), or stent occlusion (13% vs. 12%, p=.85 - secondary patency rate 87% vs. 88%), have a major amputation (10% vs. 6%, p=.16), require re-intervention (14% vs. 9%, p=.12), or die (7% vs.4%, p=.31). Plaque calcification did not predict restenosis or occlusion in either stent group, both in the matched and non matched populations. Multivariable analysis adjusted for patient and plaque characteristics revealed that the main predictors of restenosis >50% at two years were female sex [odds ratio (OR): 2.05, p=.01], hypertension (OR: 2.10, p=.04) and previous F-P occlusion (OR: 1.35, p=.04). Medium term results following F-P PTA with either SPS or DES are comparable, regardless of plaque calcification and patient characteristics.

Drug-Eluting Balloon Versus Drug-Eluting Stent for Complex Femoropopliteal Arterial Lesions: The DRASTICO Study

BackgroundDrug-eluting technologies improve 12-month angiographic results of femoropopliteal (FP) interventions, but few data on the comparison between drug-coated balloons (DCBs) and drug-eluting stents (DES) are available. ObjectivesThe aim of this study was to compare, after balloon pre-dilation, a strategy of DCB followed by provisional self-expanding nitinol bare-metal stent implantation with a strategy of systematic DES implantation in patients at high risk for FP restenosis. MethodsPatients presenting with either intermittent claudication or critical limb ischemia undergoing FP intervention were randomly assigned 1:1 to DCB or DES after successful target lesion pre-dilation. The primary endpoint was 12-month target lesion binary restenosis, assessed using Doppler ultrasound. Secondary endpoints were freedom from target lesion revascularization and from major amputation. ResultsA total of 192 patients, 96 in the DCB group and 96 in the DES group, with 240 lesions in 225 limbs, were included. Diabetes and critical limb ischemia were present in >50% in both groups. Mean lesion length was 14 cm, and baseline target lesion occlusion reached about 60% of cases in both groups. The systematic DES strategy yielded larger post-procedural minimal luminal diameter and a lower incidence of residual dissection compared to DCB, in which nitinol stents were used in only 21% of the lesions. Twelve-month target lesion restenosis was observed in 22% of DCB-treated versus 21% of DES-treated patients (p = 0.90). Clinically driven target lesion revascularization was necessary in 14% of DCB patients versus 17% of DES patients (p = 0.50). ConclusionsDCB was not superior to DES in the treatment of complex FP lesions in a high-risk population, yielding similar rate of restenosis and clinically driven target lesion revascularization. (Paclitaxel-Eluting Balloon Angioplasty With Provisional Use of Nitinol Stent Versus Systematic Implantation of Paclitaxel-Eluting Stent for the Treatment of Femoropopliteal De Novo Lesions; NCT01969630)

Is vessel prep necessary before treating the superficial femoral artery?

The standard of care for treating symptomatic peripheral arterial disease has been percutaneous transluminal angioplasty with or without stenting over the last couple of years. This endovascular treatment of claudicants or patients with critical limb ischemia has increased in numbers and has even surpassed open surgery. Our daily practice has evolved to an endovascular-first approach, especially in the femoropopliteal region, being the most frequently treated vessel. However, neointimal hyperplasia and elastic recoil leading to target lesion restenosis or occlusion after initial successful treatment is not uncommon. In recent years, drug-eluting technologies on balloons or stents have been investigated as a potential solution for this problem with excellent results compared to plain-old balloon angioplasty. Nonetheless in the majority of those trials, the bailout stenting rate increased with lesion complexity, albeit it in long or heavily calcified lesions due to flow-limiting dissections, elastic recoil or the calcium barrier preventing adequate drug uptake. There is a need for vessel preparation in order to ameliorate drug delivery, especially in complex lesions. Multiple devices are available to prepare even the most challenging lesions for drug uptake or stenting, by achieving maximal luminal gain and by minimizing dissections. This review aims to give an overview of the most common modalities for vessel preparation in the superficial femoral artery beside plain old balloon angioplasty together with an overview of the current literature of each device in the superficial femoral artery.