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Introduction: This physician-initiated study provides 5-year (i.e., long-term) treatment durability data from 3 top recruitment sites that participated in the prospective, multicenter, nonrandomized, single-arm VBX FLEX clinical study (ClinicalTrials.gov identifier: NCT02080871). It evaluates the long-term treatment durability of the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (VBX Stent-Graft) in the treatment of subjects with de novo or restenotic aortoiliac lesions. Materials and Methods: A total of 59 subjects with 94 treated lesions were enrolled at the 3 participating sites from the original 140 intent-to-treat subjects in the VBX FLEX study. The primary durability endpoint was long-term primary patency. Secondary long-term outcomes included freedom from target lesion revascularization (TLR), freedom from target vessel revascularization (TVR), as well as resting ankle-brachial index (ABI), Rutherford category, EuroQol 5 Dimensions, and Walking Impairment status. Results: Fifty-nine subjects participated and twenty-eight (47.5%) were available through the end of the study at 5-year follow-up (the median follow-up time was 6.6 years due to complications resulting from COVID-19 precautions). At 3 and 5 years, the Kaplan-Meier estimates for freedom from all-cause mortality were 94.5% and 81.7%, respectively. The Kaplan-Meier estimates for primary patency at 3 and 5 years were 94.0% and 89.5% (by lesion) and 91.7% and 84.4% (by subject). Primary assisted patency at 3 and 5 years were 93.3% and 93.3%. Kaplan-Meier estimate for freedom from TLR at 5 years was 89.1%. The majority of subjects were asymptomatic (Rutherford category 0) at 3 years (29/59; 72%), and at 5-year follow-up (18/28; 64%). The 5-year mean resting ankle-brachial index was 0.95±0.18, an improvement of 0.15±0.26 from the baseline (p<0.001). Quality of life measures also showed sustained improvement through long-term follow-up. Conclusion: The 5-year long-term follow-up data underscore the robustness and durability of the Viabahn Balloon-Expandable Endoprosthesis for treating aortoiliac occlusive disease. Clinical Impact: Durable improvement after endovascular treatment of iliac occlusive disease is clinically important because many of these patients are claudicants with significant life expectancy. This study is the first to evaluate the long-term outcomes in patients with iliac occlusive disease treated with the Viabahn VBX balloon-expandable endopirostheses. The study reports excellent long-term patency outcomes with prolonged clinical benefit. These durable results are likely to be an important consideration for clinicians undertaking iliac artery revascularization procedures. [ABSTRACT FROM AUTHOR]

Objective: To investigate the mid-term efficacy and patency rate of TurboHawk peripheral plaque excision system in the treatment of femoral popliteal artery lesions with different Global Limb Anatomic Staging System (GLASS) grades. Methods: The clinical data of 141 patients with femoral popliteal arteriosclerosis obliterans who were treated with TurboHawk from January 2018 to July 2022 in our institution were retrospectively analyzed. There were 109 male patients and 32 female patients. Recordings were made of the patient's symptoms of limb ischemia, technical success rate, primary patency rate of target vessels, ankle brachial index (ABI), GLASS grades, postoperative complications, and a statistical analysis with the patient's preoperative treatment was conducted. Results: All patients had improved limb ischemia symptoms to varying degrees after surgery, with a technical success rate of 100% (femoral artery puncture and superficial femoral artery recanalization) without bleeding, hematoma, pseudoaneurysm, arteriovenous fistula or other complications. The follow-up period was 1-24 months, during which the severity of claudication, resting pain, and toe ulcers significantly improved. The primary patency rate of the target vessel was 98.58% (139/141), and the ABI significantly increased on the second day, three months, and six months after surgery compared to before surgery. No major adverse events were found during follow-up. The patency rates at 1, 6, 12 and 24 months after intervention were 100%, 80%, 75% and 60% respectively. Conclusion: The mid-term efficacy and patency rate of TurboHawk in the treatment of femoral popliteal artery lesions with GLASS I patients have the best mid-term prognosis, the highest mid-term survival rate, and the highest vascular patency. The plaque removal system has proven to be an effective treatment for individual localized chronic total occlusion lesions. Additionally, the TurboHawk system provides a safe and minimally invasive treatment alternative for superficial femoral artery conditions, achieving significant therapeutic results within a brief period. [ABSTRACT FROM AUTHOR]

Objective To investigate the mid-term efficacy and patency rate of TurboHawk peripheral plaque excision system in the treatment of femoral popliteal artery lesions with different Global Limb Anatomic Staging System (GLASS) grades. Methods The clinical data of 141 patients with femoral popliteal arteriosclerosis obliterans who were treated with TurboHawk from January 2018 to July 2022 in our institution were retrospectively analyzed. There were 109 male patients and 32 female patients. Recordings were made of the patient’s symptoms of limb ischemia, technical success rate, primary patency rate of target vessels, ankle brachial index (ABI), GLASS grades, postoperative complications, and a statistical analysis with the patient’s preoperative treatment was conducted. Results All patients had improved limb ischemia symptoms to varying degrees after surgery, with a technical success rate of 100% (femoral artery puncture and superficial femoral artery recanalization) without bleeding, hematoma, pseudoaneurysm, arteriovenous fistula or other complications. The follow-up period was 1-24 months, during which the severity of claudication, resting pain, and toe ulcers significantly improved. The primary patency rate of the target vessel was 98.58% (139/141), and the ABI significantly increased on the second day, three months, and six months after surgery compared to before surgery. No major adverse events were found during follow-up. The patency rates at 1, 6, 12 and 24 months after intervention were 100%, 80%, 75% and 60% respectively. Conclusion The mid-term efficacy and patency rate of TurboHawk in the treatment of femoral popliteal artery lesions with GLASS I patients have the best mid-term prognosis, the highest mid-term survival rate, and the highest vascular patency. The plaque removal system has proven to be an effective treatment for individual localized chronic total occlusion lesions. Additionally, the TurboHawk system provides a safe and minimally invasive treatment alternative for superficial femoral artery conditions, achieving significant therapeutic results within a brief period.

Objective To observe and compare in-hospital and 1-year survival and prognosis of patients with 4b acute myocardial infarction (AMI) caused by early and late stent thrombosis (ST). Methods A total of 302 patients with 4b acute myocardial infarction caused by ST were enrolled in this study from January 2015 to February 2018. ST patients were confirmed by coronary angiography. These patients were divided into two groups: the early ST group (n=26) and the late ST group (n=276) according to the time of ST occurrence. Endpoint events during hospitalization and one year of follow up were compared between the two groups of patients. The primary endpoint events included cardiac death and recurrent AMI. The secondary endpoint events included target lesion revascularization (TLR), re-stent thrombosis, heart failure and stroke. The incidence of no endpoint events was compared between two groups of patients by Kaplan and Meier survival analysis. Cox regression analysis was used to analyze risk factors for endpoint events in patients with type 4b AMI. Results There was no significant difference in the incidence of the primary endpoint events during hospitalization between the two groups (7.7% vs. 3.3%，P=0.243). The incidence of heart failure was higher in the early ST group than that of the late ST group (11.5% vs.1.4%, P=0.016). There was no significant difference in the incidence rates of other secondary endpoint events between the two groups (P＞0.05). After a mean follow-up of 1 year, the incidence rates of primary endpoint events and the secondary eendpoint events were higher in the early ST group (20.0% vs. 5.9%，P＜0.05 and 36.0% vs. 11.5%，P＜0.01）than that of the late ST group. Kaplan and Meier survival analysis showed that the 1-year cumulative incidences of non-primary (P= 0.022) and non-secondary events (P＜0.001) were lower in the early ST group than those of the late ST group. Cox regression analysis showed that hypertension and history of coronary artery bypass grafting were independent risk factors for primary endpoint events in patients with 4b AMI, and intraoperative implantation of intraaortic balloon pump (IABP) and shortening the time from stent thrombosis to balloon dilation (ST to B) were independent protective factor. Conclusion Early ST patients have similar in-hospital outcomes and poor long-term prognosis compared with late ST induced 4b type AMI patients. Intraoperative implantation of IABP and shortening of ST to B time may improve the prognosis of 4b type AMI patients. [ABSTRACT FROM AUTHOR]

BackgroundConcerns regarding restenosis after treatment with drug-coated balloons (DCB) remain. We aimed to identify the incidence of target lesion revascularization (TLR) and explore clinical, procedural, and other factors influencing it.MethodsSingle-center retrospective analysis of a prospective cohort PCI registry study included 80 patients (100 lesions) who underwent successful DCB angioplasty between January 2020 and October 2023 and follow-up angiography within 2 years of either planned or unplanned reason. Incidence and factors associated with TLR were analyzed.ResultsAngiographic evaluation was conducted within a median of 151 days (interquartile range: 109 days). During index procedure, 54% were complex lesions. Intravascular imaging (IVI) was performed in 80% of lesions. TLR occurred in 11% of the lesions and was less frequent in the IVI group compared to the angiography-alone group [6.3 vs. 54.5%; odds ratio: 0.156, 95% confidence interval (CI): 0.042–0.580; p = 0.002]. No association was found between baseline and lesion characteristics, lesion complexity, plaque morphology, pre-dilatation procedure balloon type, maximal inflation pressure, or length of DCB between the groups (p > 0.05). Multivariate analysis revealed that IVI utilization was independently associated with a lower TLR rate (adjusted odds ratio: 0.116, 95% CI: 0.020–0.669; p = 0.016).ConclusionIn DCB angioplasty, only IVI use exhibited a significant difference in the TLR rate among baseline lesion characteristics and lesion preparation and was independently associated with a lower TLR rate.

Introduction: The authors analysed red cell distribution width (RDW), platelet distribution width (PDW), and the neutrophil-to-lymphocyte ratio (NLR) as potential predicting factors of adverse outcomes in patients after percutaneous coronary intervention (PCI) at 48 months follow-up. Material and methods: The authors gathered data on subjects who underwent PCI with a sirolimus-eluting Alex Plus stent (Balton, Poland). They characterized the rate of major adverse cardiovascular events (MACE) over a 4-year period, which encompassed cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR) depending on the RDW, PDW, and NLR values. Results: Included were 218 patients (256 stents), among which were also identified 77 complex, high-risk index procedure (CHIP) patients and 73 high bleeding risk (HBR) patients. The authors identified only RDW as having a significant impact on long-term outcomes and only in the total population and CHIP patients. The total population with RDW > 14.5% was characterized by higher age (67 ± 11 vs. 73 ± 10 years, p < 0.01) and higher incidence of chronic kidney disease (14% vs. 39%, p < 0.01) as well as chronic obstructive pulmonary disease (4% vs. 15%, p = 0.024). Interestingly, this group had a lower rate of ACS (42% vs. 34%, p = 0.049). At 48 months in the total population with RDW > 14.5% of patients, the rates of MACE, cardiac death, MI, and TLR were 26.8%, 19.5%, 9.8%, and 12.2%, respectively. Conclusions: RDW > 14.5% correlated with a higher risk of cardiac death in the total population and CHIP patients. [ABSTRACT FROM AUTHOR]

We characterized the performance as well as safety of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), deployed in the acute coronary syndrome (ACS) setting. We enrolled patients who were subjected to percutaneous coronary intervention (PCI) between July 2015 and March 2016 and took into consideration demographics, clinical and laboratory data, and clinical outcomes. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12-, 24-, 36-, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 88 ACS and 144 chronic coronary syndrome (CCS) patients. The mean age of the ACS population was 67 ± 13 years old, and 32% of it consisted of females. Patients with ACS were characterized by lower rates of arterial hypertension (85.2% vs. 95.8%, p = 0.004), dyslipidemia (67% vs. 81.9%, p = 0.01), prior MI (34.1% vs. 57.6%, p < 0.001), and prior PCI (35.2% vs. 68.8%, p < 0.001). At 48 months, among the ACS patients, the rates of MACE, death, cardiac death, MI, and TLR were 23.9%, 11.4%, 7.9%, 9.1%, and 10.2%, respectively. No stent thrombosis cases were reported. Multivariable Cox regression revealed that the statistically significant MACE predictors were massive calcifications in coronary arteries (HR 9.0, 95% CI 1.75–46.3, p = 0.009), post-dilatation (HR 3.78, 95% CI 1.28–11.2, p = 0.016), prior CABG (HR 6.64, 95% CI 1.62–27.1, p = 0.008), vitamin K antagonist use (HR 5.99, 95% CI 1.29–27.8, p = 0.022), and rivaroxaban use (HR 51.7, 95% CI 4.48–596, p = 0.002). The study findings show that Alex Plus was effective and safe in a contemporary cohort of real-world ACS patients undergoing primary PCI. The outcomes were comparable between the ACS and chronic coronary syndrome patients, with a trend of lower TLR in ACS patients at 4 years. [ABSTRACT FROM AUTHOR]

We characterized the performance, as well as the safety, of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), implanted in patients with type 2 diabetes (DM) with a 4-year follow-up. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12, 24, 36, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 97 DM and 135 non-DM patients. The mean age of the DM patients was 69.5 ± 10.1 years and females accounted for 30% of the patients. DM patients had higher rates of arterial hypertension (97% vs. 88%, p = 0.016), dyslipidemia (86% vs. 70%, p = 0.005), prior MI (61% vs. 40%, p = 0.002), prior PCI (65% vs. 50%, p = 0.020), and prior CABG (14% vs. 5.9%, p = 0.029). We recorded statistically significant differences for MACE (HR 1.85, 95% CI 1.01–3.41, p = 0.046), cardiac death (HR 4.46, 95% CI 1.44–13.8, p = 0.010), and MI (HR 3.17, 95% CI 1.10–9.12, p = 0.033), but not for TLR, between DM and non-DM patients in terms of the analyzed endpoints at 4 years. Our study showed that Alex Plus was efficient and safe in a contemporary cohort of real-world DM patients undergoing percutaneous revascularization.

Purpose: This study aimed to evaluate the benefits and risks of patients with peripheral artery disease (PAD) treated with Absorb everolimus-eluting bioresorbable vascular scaffold (BVS) by analyzing all the published studies on the clinical characteristics of patients with PAD. Materials and Methods: PubMed, Embase, and the Cochrane Library were searched for relevant studies. Efficacy, safety, and basic characteristics were analyzed. Results: Four studies were included in meta-analysis, including a total number of 155 patients with PAD. The pooled overall primary patency, freedom from target lesion revascularization (TLR), symptom resolution, and wound healing were 90%, 96%, 94%, and 86%, respectively. The pooled perioperative complication and all-cause mortality were 4% and 9%, respectively. Preoperative total occlusion was detected in 43 of 192 lesions (22%). The mean lesion length was 27.26 mm. In terms of comorbidities, the pooled percentage of hypertension, hyperlipidemia, diabetes mellitus, coronary artery disease, chronic kidney disease history, and smoking were 65%, 74%, 49%, 43%, 20%, and 57%, respectively. Conclusion: Among these studies, hypertension, hyperlipidemia, and diabetes mellitus were the most common comorbidities in patients with PAD. The Absorb everolimus-eluting BVS was safe and showed the favorable clinical outcomes in both patency and TLR, especially in infrapopliteal disease with heavy calcification. The conclusions of this meta-analysis still needed to be verified by more relevant studies with more careful design, more rigorous execution, and larger sample size. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to assess the association between high on-aspirin treatment platelet reactivity (HAPR) and the subsequent risk of restenosis after percutaneous coronary intervention (PCI) with predominantly drug-eluting stents. Background: The association between HAPR and subsequent risk of restenosis after PCI is unclear. Methods: This study included 4839 patients undergoing PCI (02/2007–12/2011) in the setting of the Intracoronary Stenting and Antithrombotic Regimen-ASpirin and Platelet Inhibition (ISAR-ASPI) registry. Platelet function was assessed with impedance aggregometry using the multi-plate analyzer immediately before PCI and after intravenous administration of aspirin (500 mg). The primary outcome was clinical restenosis, defined as target lesion revascularization at 1 year. Secondary outcomes included binary angiographic restenosis and late lumen loss at 6- to 8-month angiography. Results: The upper quintile cut-off of platelet reactivity measurements (191 AU × min) was used to categorize patients into a group with HAPR (platelet reactivity > 191 AU × min; n = 952) and a group without HAPR (platelet reactivity ≤ 191 AU × min; n = 3887). The primary outcome occurred in 94 patients in the HAPR group and 405 patients without HAPR (cumulative incidence, 9.9% and 10.4%; HR = 0.96, 95% CI 0.77–1.19; P = 0.70). Follow-up angiography was performed in 73.2% of patients. There was no difference in binary restenosis (15.2% vs. 14.9%; P = 0.79) or late lumen loss (0.32 ± 0.57 vs. 0.32 ± 0.59 mm; P = 0.93) between patients with HAPR versus those without HAPR. Conclusions: This study did not find an association between HAPR, measured at the time of PCI, and clinical restenosis at 1 year after PCI. [ABSTRACT FROM AUTHOR]

Nicolas W Shammas, Gail Shammas, Lori Christensen, Sue Jones-Miller On behalf of the JET-RANGER InvestigatorsMidwest Cardiovascular Research Foundation, Davenport, IA, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 E 4th Street, Suite A, Davenport, IA, 52801, USA, Email shammas@mchsi.comBackground: The JET-RANGER study (NCT03206762) was a multicenter (11 US centers) randomized trial, core lab adjudicated, designed to demonstrate the superiority of Jetstream + Paclitaxel coated balloon (JET+PCB) versus angioplasty (PTA) + PCB in treating femoropopliteal (FP) arterial disease. The one-year primary endpoint of JET-RANGER has been recently published. The 2-year outcome data are presented in this report.Methods: There were 43 patients who completed the 1-year follow-up. Two were lost to follow-up and one died prior to the 2-year follow-up, resulting in 40 patients. Fifteen patients were randomized to PTA+PCB and 25 patients to JET +PCB. Kaplan Meier Survival analysis was performed to estimate the freedom from TLR. Bailout stenting was not considered a TLR in this analysis. Statistical significance was determined by a p-value < 0.05.Results: Freedom from TLR was similar between the 2 groups at 2 years. There was also no significant difference in the change of ABI between the PTA + PCB and JET + PCB from baseline at 6-months, (p-value = 0.7890), 1-year (p-value = 0.4070), and 2-year (p-value=0.7410). There was also no statistical difference between the JET + PCB and PTA + PCB arms for RCC improvement by one or more category, (p-value= 1.000). There were no minor or major amputations for either arm throughout the 2-year follow up. One JET + PCB patient died before the 2-year specified window.Conclusion: JET + PCB had similar freedom from TLR and improvement in ABI and RCC at 2-year follow-up when compared to PTA + PCB with no difference in amputation or mortality between the 2 arms.Clinical Trial Registration: NCT03206762.Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting

Whether an eruptive or noneruptive target lesion calcified nodule (CN) portends worse acute and long-term clinical outcomes after stenting has not been established. The authors sought to compare acute and long-term clinical outcomes in eruptive CN vs noneruptive CN morphology. Using optical coherence tomography, an eruptive CN was defined as an accumulation of small calcium fragments protruding and disrupting the overlying fibrous cap, typically with small amount of thrombus. A noneruptive CN was defined as an accumulation of small calcium fragments with a smooth intact fibrous cap without an overlying thrombus. The primary endpoint was target lesion failure (TLF) including cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization in patients with ≥6-month follow-up. Among 3,231 patients with evaluable pre- and postintervention OCT, 236 patients had lesions with CNs (7.3%). After eliminating 4 secondary lesions and 6 patients without ≥6-month follow-up, 126 (54.8%) lesions with eruptive CNs and 104 (45.2%) lesions with noneruptive CNs formed the current report. Compared with noneruptive CNs, eruptive CNs were independently associated with greater stent expansion (89.2% ± 18.7% vs. 81.5% ± 18.9%; P = 0.003) after adjusting for morphologic and procedural factors. At 2 years, eruptive CNs trended toward more TLF compared with noneruptive CNs (Kaplan-Meier estimates, 19.8% vs 12.5%; P = 0.11) and significantly more target lesion revascularization (18.3% vs 9.6%; P = 0.04). In the adjusted model, eruptive CNs were independently associated with 2-year TLF (HR: 2.07; 95% CI: 1.01-4.50; P = 0.048). Compared with noneruptive CN morphology, lesions with an eruptive CN appearance on optical coherence tomography had a worse poststent long-term clinical outcome despite better acute stent expansion. [Display omitted] [ABSTRACT FROM AUTHOR]

Nicolas W Shammas,1 Bhaskar Purushottam,2 W John Shammas,1 Lori Christensen,1 Gail Shammas,1 Desyree Weakley,1 Sue Jones-Miller1 On behalf of the JET-RANGER Investigators1Midwest Cardiovascular Research Foundation, Davenport, IA, USA; 2Regional Health CR, Cardiovascular Medicine, Monument Health, Rapid City, SD, USACorrespondence: Nicolas W Shammas, Research Director, Midwest Cardiovascular Research Foundation, 630 East 4th Street, Suite A, Davenport, IA, USA, Email shammas@mchsi.comBackground: It is unknown at this time whether Jetstream atherectomy (JET) and paclitaxel-coated balloon (PCB) provides a superior outcome to balloon angioplasty (PTA) followed by PCB in treating femoropopliteal (FP) arterial disease.Methods: The JET-RANGER study was a multicenter (eleven US centers) randomized trial, core lab–adjudicated, designed to demonstrate the superiority of JET + PCB versus PTA + PCB in treating FP arterial disease. The study intended to enroll 255 patients, but was stopped early because of poor enrollment due to COVID-19 and concerns about the association of paclitaxel with mortality. The data are thus considered exploratory. A total of 47 patients (48 lesions) with claudication (80.9%) or rest pain/ulcerations (19.2%) were randomly assigned 2:1 to JET + PCB (n=31) or PTA + PCB (n=16). The In.PACT (Medtronic) and Ranger (Boston Scientific) PCBs were used. Freedom from target-lesion revascularization (TLR) was evaluated at 1 year. Analysis was performed on intention to treat.Results: Mean lesion length was 10.8± 4.3 cm for JET + PCB and 11.2± 7.6 cm for PTA + PCB (P=0.858). There were no other differences in demographic or angiographic variables between the two groups. Procedural success was superior with JET + PCB (87.1%) vs PTA + PCB alone (52.9%; P=0.0147). Overall bailout stenting rate was 17% (0 JET + DCB versus 50% PCB, P< 0.0001). There was no distal embolization requiring treatment. There was no amputation or death in either group. Using KM analysis, the primary end point of freedom from TLR (bailout stent considered a TLR) at 1 year was 100% and 43.8% (P< 0.0001) for JET + PCB versus PTA + PCB, respectively. When bailout stent was not considered a TLR, freedom from TLR was 100% and 93.7%, respectively (P=0.327).Conclusion: A high rate of freedom from TLR was seen in the JET + PCB arm and the PTA + DCB arm at 1-year follow-up, with a significant reduction in bailout stenting following vessel prepping with the Jetstream.Keywords: Jetstream, atherectomy, femoropopliteal, vessel prepping, drug-coated balloons, Ranger, In.PACT, randomized trial, dissections, bailout stenting

There are scarce data about the incidence and impact on clinical outcomes of target lesion revascularization (TLR) after percutaneous coronary intervention (PCI) for unprotected left main distal bifurcation lesions (ULMD) in current generation drug eluting stent (cDES) era. We evaluated the incidence and impact on clinical outcomes of TLR after PCI using cDES for ULMD. We identified 720 patients treated with cDES for ULMD at New Tokyo Hospital (Matsudo, Japan), San Raffaele Scientific Institute and EMO-GVM Centro Cuore Columbus (Milan, Italy) between January 2005 and December 2015. We divided those patients in 2 groups; TLR group (n = 107), no TLR group (n = 613). The TLR group was comprised patients undergoing a repeat revascularization by PCI or coronary artery bypass grafting of the target lesion. Analysis using propensity score adjustment was also performed. The primary endpoint was cardiac mortality. Additionally, we analyzed the impact of TLR for each main branch (MB) or side branch on cardiac mortality using multivariate Cox regression analysis. Cardiac mortality was significantly higher in TLR group than in no TLR group (adjusted HR 1.96; 95 % CI, 1.50–3.62; p = 0.032). Cardiac mortality was also significantly higher in TLR group after propensity score adjustment. TLR for MB was identified as an independent predictor of cardiac death on multivariate Cox regression analysis. The TLR, especially the TLR for MB, after PCI even with cDES for ULMD, was strongly associated with worse cardiac mortality. [Display omitted] [ABSTRACT FROM AUTHOR]

Despite the excellent long-term results of internal mammary artery (IMA)–left anterior descending (LAD) bypass, percutaneous revascularization of IMA is sometimes required for IMA-LAD bypass failure. However, its clinical outcomes have not been fully elucidated. The aim of this study was to investigate the long-term clinical outcomes, including target lesion revascularization (TLR) following contemporary percutaneous revascularization of failed IMA bypass graft. We examined data of 59 patients who had undergone percutaneous revascularization of IMA due to IMA-LAD bypass failure at nine hospitals. Patients with IMA graft used for Y-composite graft or sequential bypass graft were excluded. The incidence of TLR was primarily examined, whereas other clinical outcomes including cardiac death, myocardial infarction, and target vessel revascularization were also evaluated. Mean age of the enrolled patients was 67.4 ± 11.3 years, and 74.6% were men. Forty patients (67.8%) had anastomotic lesions, and 17 (28.8%) underwent revascularization within three months after bypass surgery. Procedural success was achieved in 55 (93.2%) patients. Stent implantation was performed in 13 patients (22.0%). During a median follow-up of 1401 days (interquartile range, 282–2521 days), TLR was required in six patients (8.5% at 1, 3, and 5 years). Patients who underwent percutaneous revascularization within 3 months after surgery tended to have a higher incidence of TLR. Clinical outcomes of IMA revascularization for IMA-LAD bypass failure were acceptable. [ABSTRACT FROM AUTHOR]

Percutaneous coronary intervention (PCI) is increasingly performed for symptom relief and survival benefit, particularly in patients presenting with acute coronary syndromes. It remains controversial whether prior PCI, and specifically when index PCI is performed on previously treated lesion(s), affects peri-procedural and in-hospital mortality. We queried an institutional PCI registry for all unique patients undergoing PCI during a 4-year period and classified them as having had or not prior PCI. If prior PCI had occurred, we further defined index PCI as a target lesion (TLR) PCI or non-TLR PCI, according to lesion(s) treated during the prior PCI. Multivariable analysis was performed to identify predictors of in-hospital mortality. Prior PCI was an independent predictor of in-hospital survival or lower mortality (HR 0.41 [0.22–0.76], P = 0.004), together with lower age (per 5 years, HR 0.73 [0.66–0.82], P < 0.001) and elective PCI (HR 0.63 [0.58–0.70], P < 0.0001). Among prior PCI patients, TLR PCI was associated with higher mortality (HR 3.03 [1.05–8.33]. P = 0.045), while elective PCI status was associated with lower mortality (HR 0.10 [0.01–0.80], P = 0.03). This excess mortality was only present in non-elective PCI cases (P INT = 0.02). We conclude that PCI mortality risk is decreased in patients with prior PCI, particularly when index PCI is performed electively on a lesion not previously treated. • In-hospital mortality of patients undergoing PCI is affected predominantly by age and clinical presentation. • Prior PCI is associated with lower in-hospital mortality during index PCI TLR-PCI is associated with increased in-hospital mortality when performed in ACS setting. [ABSTRACT FROM AUTHOR]

Although various devices and strategies were introduced into endovascular therapy, factors associated with chronic outcomes remain unclear. Therefore, this study aimed to build preliminary data of Japanese femoropopliteal lesions in a period of transition from non-drug to drug technology. This research was a multicenter, prospective, and observational study. A total of 1003 consecutive patients with a mean age of 73.6 ± 8.3 years from 67 institutes were registered from February 2017 to June 2018 in Japan. In addition to the baseline data, angiographic findings affecting primary patency were studied. Lesion length was 16.4 ± 9.6 cm, and chronic total occlusion was found in 42%. Calcified lesions were found in 75% of patients. The 1-year and 2-year freedom from target lesion revascularization were 81% and 75%, respectively, and maximum walking distance showed improvement over the two years (pre; 234 m ± 211 m, 1-year; 402 m ± 241 m, 2-year; 428 m ± 231 m). The independent predictors for primary patency were pre-procedure ankle-brachial index, history of minor amputation, ostium lesion, and drug-coated balloon use. Angiographic analysis revealed that only lesion length and full cover stent were related to primary patency. Two-year freedom from target vessel revascularization was 75% in the Japanese transitional period of drug-eluting devices. Maximum walking distance was improved and well maintained for up to 2-year. [ABSTRACT FROM AUTHOR]

The optimal endpoint after balloon angioplasty remains poorly defined. This study aimed to characterize post-balloon angioplasty anatomical and physiological indexes by quantitative flow ratio (QFR) and to compare their prognostic impacts on long-term clinical outcomes. This retrospective study included 106 lesions from 106 patients who underwent percutaneous coronary interventions with drug-coated-balloon (n = 69) or plain-old-balloon-angioplasty (n = 37). Analyses measured minimum lumen diameter (MLD) and percent diameter stenosis (%DS) as anatomical indexes; QFR of target vessel (QFR-vessel) and QFR-gradient (ΔQFR between proximal and distal segments of the lesion) as physiological indexes. Primary endpoint was target lesion revascularization (TLR) after the index procedure. TLR occurred in 21 (20 %) lesions. TLR group showed significantly smaller QFR-vessel (0.79 ± 0.12 vs. 0.85 ± 0.12, p = 0.03), as well as greater QFR-gradient (0.12 ± 0.07 vs. 0.04 ± 0.03, p < 0.0001) at post-procedure compared with non-TLR group. The percentage of angiographically significant dissection was also more frequently observed in TLR group compared with non-TLR group (47.6 % vs. 14.1 %, p < 0.0001 for log-rank). In the multivariate analysis, angiographically significant dissection and QFR-gradient at post-procedure was significantly associated with TLR. In the receiver-operating characteristics curve analysis, the area under the curve for predicting post-procedural TLR was significantly greater for QFR-gradient than for MLD and residual %DS (p < 0.0001 for MLD and p = 0.0003 for residual %DS at post-procedure). The best cut-off value of post-procedural QFR-gradient for predicting TLR was 0.08. Post-procedural QFR-gradient across the lesion was a statistically independent and stronger predictor of TLR, compared with anatomical indexes. [Display omitted] • Post-procedural QFR after POBA or DCB was a predictor of subsequent TLR. • Per-lesion QFR analysis was a stronger predictor, compared with per-vessel analysis. • The best cut-off value of post QFR-gradient for predicting TLR was 0.08. • QFR analysis may help identify the optimal endpoint of balloon angioplasty. [ABSTRACT FROM AUTHOR]

Symptomatic central venous obstruction (CVO) is sometimes observed in patients undergoing hemodialysis. Angioplasty is generally performed for salvage purposes, and stent implantation is performed as a last resort to prevent permanent venous occlusion. However, published reports about the clinical outcomes of stenting for CVO have been limited by the small number of included patients and the relatively old generation of analyzed stents. This study aimed to clarify the safety and efficacy of endovascular therapy (EVT) using stents for symptomatic CVO in contemporary practice. This retrospective review was performed between May 2012 and August 2021. We retrospectively analyzed consecutive 31 lesions (31 patients, 64 ± 10.7 years old) treated with a vascular stent for elastic recoil after balloon angioplasty or recurrent stenosis <3 months after angioplasty. The primary outcome was primary patency, defined as freedom from target lesion revascularization. The secondary outcome was assisted primary patency, defined as freedom from permanent occlusion of the target stents. In all cases, stents were successfully deployed on the target lesions. No EVT-related complications were observed. Self-expandable and balloon-expandable stents were used in 26 and 5 lesions, respectively. The median follow-up period was 18 months (interquartile range, 7–40). Kaplan-Meier analysis revealed that the primary patency rates were 66.1 % at 6 months, 61.7 % at 12 months, and 38.4 % at 24 months after EVT. The assisted primary patency rate was 70.3 % 24 months after EVT. In the multivariate analysis, younger age was the only independent predictor of target lesion revascularization (hazard ratio: 0.92, 95 % CI: 0.85–0.99, p = 0.04). Stent implantation for CVO that is resistant to standard angioplasty seems safe and effective. [Display omitted] • Endovascular therapy with stents for central venous obstruction in patients receiving hemodialysis is safe. • Midterm patency rates seem acceptable in contemporary practice. • Young age is a predictor of clinically driven, target lesion revascularization. [ABSTRACT FROM AUTHOR]

In-stent restenosis (ISR) still occurs after percutaneous coronary intervention (PCI). Few studies have compared the outcomes of PCI for de novo stenosis with those of PCI for ISR, and the results are conflicting. The present study aimed to conduct this comparison. Using patient-level data from the randomized all-comer SORT OUT studies III to X, we included all patients with previous PCI and either an ISR or a de novo lesion as the study target lesion. Outcomes of interest were major adverse cardiac events (MACE) and target lesion revascularization (TLR) after 5 years. Of the 2,928 patients with a previous PCI included in the SORT OUT studies, 491 (17%) were treated for ISR and 2,437 (83%) for a de novo stenosis. Baseline characteristics did not differ significantly. At 5 years, MACE occurred in 148 patients (32%) in the ISR group and 654 patients (28%) in the de novo stenosis group (crude and adjusted hazard ratio 1.16 [95% confidence interval (CI) 0.97 to 1.38] and 1.16 [95% CI 0.97 to 1.38]). The risk of TLR was higher in the ISR group compared with the de novo stenosis group (crude and adjusted hazard ratio 1.64 [95% CI 1.24 to 2.17] and 1.71 [95% CI 1.27 to 2.30]). In conclusion, the risk of MACE was similar between PCI for ISR and PCI for de novo lesions after 5 years. However, the risk of TLR was higher in the ISR group compared with the de novo stenosis group., Competing Interests: Declaration of competing interest The authors have no competing interests to declare., (Copyright © 2024 The Author(s). Published by Elsevier Inc. All rights reserved.)

Background: Evidence regarding drug-coated balloon (DCB)-only angioplasty in de novo lesions of large vessels is still limited and mainly focused on paclitaxel-coated balloon. We aimed to analyze the safety and efficacy of sirolimus-coated balloon (SCB)-only angioplasty in de novo lesions in large vessels compared to drug-eluting stent (DES)., Methods: In this retrospective, dual-center, case-control study, we enrolled all consecutive patients treated between January 2022 and January 2024 with SCB-only angioplasty in de novo lesion in large vessel (> 2.75 mm) compared to a propensity-score matched contemporary population treated with DES. The primary endpoint was the rate of target lesion revascularization (TLR), while secondary endpoints were cardiac death (CD), target vessel revascularization (TVR), myocardial infarction (MI), and target lesion failure (TLF), defined as a composite of them., Results: The mean age was 70.1 ± 9.8 years in the SCB group (n = 92) and 67.9 ± 9.6 years in the DES group (n = 92) (p = 0.76). The median follow-up was 19.5 ± 12 months in the SCB group and 20.1 ± 13.1 months in the DES group (p = 0.47). TLR occurred in 6.7% of patients in the SCB group and 5.6% in the DES group (p = 0.75). The incidence of MI, TVR, and TLF were similar between the two groups (4.3% vs 3.3%, p = 0.7, 2.2% vs 3.4%, p = 0.65% and 9.8% vs 8.7%, p = 0.79). CD occurred in 4.3% in the SCB group, compared to 3.3% in the DES group (p = 0.70)., Conclusion: Our study suggests that SCB angioplasty is both safe and effective in the treatment of de novo lesions of large vessels compared with DES., (© 2025 Wiley Periodicals LLC.)

Introduction: Ostial coronary lesions are a subset of proximal coronary lesions, which are relatively more difficult to treat and were associated with worse clinical outcomes in the early percutaneous coronary intervention (PCI) era. Data regarding the outcomes of ostial lesions' PCI in the contemporary era are lacking. Methods: We conducted a single-center, all-comer, prospective registry study, enrolling patients undergoing PCI with the use of contemporary drug-eluting stents (DES) between July 2016 and February 2018. Included in the present analysis were only patients treated for proximal lesions. Clinical outcomes were compared between patients undergoing PCI of ostial versus proximal nonostial lesions. The primary endpoint was target vessel revascularization (TVR). Secondary endpoints included target lesion revascularization (TLR) and major cardiovascular adverse events (MACE) at 12 months. Results: A total of 334 (84.7% male, 67.3 ± 10.7 years) patients were included, of which 91 patients were treated for ostial lesions and 243 were treated for proximal nonostial lesions. Baseline and procedural characteristics were similar between the two groups. At 12 months, TVR and TLR were numerically higher among patients undergoing PCI of ostial versus nonostial lesions without reaching statistical significance (5.5% vs. 3.3%; p = 0.35 and 4.4% vs. 2.5%; p = 0.47, respectively). The rate of MACE was similar between the two groups. Conclusion: In patients undergoing PCI with the use of contemporary DES, clinical outcomes were similar among patients treated for ostial compared to proximal nonostial lesions. Larger studies are required to further evaluate the performance of contemporary DES in this subset of lesions. [ABSTRACT FROM AUTHOR]

Purpose: Data on the long-term safety and effectiveness of drug-coated balloons (DCBs) for the treatment of long femoropopliteal atherosclerotic lesions in the real-world setting are rare. This study reports 3 year and 5 year outcomes of the pre-specified 150 mm balloon sub-cohort of the IN.PACT Global Study.Methods: The IN.PACT Global Study was a prospective, multicentre, international, single-arm study evaluating the performance of the IN.PACT Admiral DCB in real-world patients with femoropopliteal atherosclerotic disease. This pre-specified 150 mm DCB cohort analysis comprised 107 participants (111 lesions) with all target lesions treated with at least one 150 mm DCB.Results: Mean lesion length was 20.3 ± 9.2 cm; 18.0% had in-stent restenosis, 58.6% were totally occluded, and 17.1% were severely calcified. Through 60 months, the Kaplan-Meier estimate of freedom from clinically driven target lesion revascularization (CD-TLR) was 72.7% [95% confidence interval (CI):62.4%-80.5%]. The safety composite endpoint (freedom from device/procedure-related death through 30 days; freedom from target limb major amputation and clinically driven target vessel revascularization through 5 years) was 70.5%. The cumulative incidence of major amputation was 1.0% and all-cause mortality was 18.4% through 60 months. Freedom from CD-TLR rates in the provisional stented and non-stented subgroups through 36 months were 64.0% [95% CI: 46.1%-77.3%] and 81.9% [95% CI: 69.7%-89.6%] (log-rank p = 0.074), respectively.Conclusions: The results demonstrate sustained long-term safety of the 150 mm IN.PACT Admiral DCB for long femoropopliteal atherosclerotic lesions in real-world patients. In particular, the results show that DCB angioplasty is an effective revascularization modality in long complex lesions.Clinicaltrials: gov identifier: NCT01609296.Level Of Evidence: Level 3, Cohort Study. [ABSTRACT FROM AUTHOR]

In-stent restenosis (ISR) remains a significant challenge in interventional cardiology despite advancements in stent technology. Drug-coated balloons (DCBs), which deliver antiproliferative agents directly to the vessel wall, have emerged as a promising alternative to plain balloon angioplasty for ISR treatment. This meta-analysis evaluates the efficacy of DCBs compared to plain balloon angioplasty in patients with coronary ISR. A comprehensive search of PubMed and Embase was conducted on June 27, 2024. The search identified randomized controlled trials comparing DCBs and plain balloon angioplasty for ISR treatment. Six trials involving 1,322 patients met the inclusion criteria. Quality was assessed with the Cochrane Risk of Bias tool. Data extraction and statistical analysis were performed using RevMan software, assessing heterogeneity with the I2 statistic and publication bias using funnel plots. The analysis showed that DCBs significantly reduced late in-stent and in-segment luminal loss (P < 0.001) and target lesion revascularization (P = 0.02) compared to plain balloon angioplasty. Major adverse cardiovascular events and the combined endpoint of target lesion revascularization, myocardial infarction, and death also showed highly significant improvements with DCB treatment (P < 0.00001 and P = 0.0002, respectively). However, no significant effect was observed on myocardial infarction and mortality rates. DCBs significantly reduce in-stent late luminal loss, target lesion revascularization, and major adverse cardiovascular events compared to plain balloon angioplasty. [ABSTRACT FROM AUTHOR]

The impact of metabolic syndrome (MS) on stent performance and outcomes of patients underwent percutaneous coronary intervention (PCI), including stent implantation, had not yet been fully established. The aim of the present study was to investigate long-term safety and efficacy of 2nd generation DES vs. other stent types in MS patients underwent successful PCI for an acute coronary event. Descriptive epidemiology, angiographic characteristics and one-year clinical outcomes, including major adverse cardiovascular events (MACE) and target lesion revascularization (TLR) procedures were evaluated according to the stent type inserted for 204 patients. The occurrence of TLR (6.62% vs. 9.43%, p = 0.50) and the composite outcomes (20.52% vs. 24.52%, p = 0.54) did not differ significantly between patients having 2nd generation drug eluting stents (DES) or other stent types implanted at the index procedure. It seems that the PCI in acute coronary syndrome (ACS) is similarly efficient regardless of the stent type, suggesting that for the treatment of ACS in MS patients, all stent types show similar results, in terms of TLR or MACE. [ABSTRACT FROM AUTHOR]

Abstract Background Diabetes mellitus is a risk for increased incidence of adverse clinical events after percutaneous coronary intervention. However, the difference in the incidence of adverse clinical events according to stent type in patients with diabetes remains to be elucidated. In the present study, we aimed to compare the clinical outcomes between patients treated with the biodegradable polymer sirolimus-eluting stents (BP-SES) and the durable polymer everolimus-eluting stents (DP-EES) among patients with diabetes. Methods Among 631 lesions in 510 consecutive patients treated with either BP-SES or DP-EES, 165 lesions in 141 patients with diabetes mellitus and stable angina pectoris were identified and classified into the BP-SES group (48 lesions in 44 patients) and the DP-EES group (117 lesions in 100 patients). The incidence of adverse clinical events after stent implantation was compared between the 2 groups. Results There was no significant difference in the prevalence of conventional risk factors, lesion characteristics, and procedural characteristics between the 2 groups. During median 386 [334–472] days follow-up, the incidence of target lesion revascularization (11.4 vs. 2.0%, p = 0.003) and device-oriented clinical endpoint (13.6 vs. 6.0%, p = 0.035) in the BP-SES group was significantly greater than that in the DP-EES group. A univariate model demonstrated that the BP-SES usage was significantly associated with the higher incidence of target lesion revascularization (odds ratio, 6.686; 95% confidence interval, 1.234–36.217; p = 0.028). Conclusion BP-SES was associated with the greater incidence of TLR than the DP-EES in patients with diabetes mellitus. Further studies with larger cohorts and longer follow-up are required to confirm the present results.

Objectives: Current thin-strut 2 nd generation drug eluting stents (DES) are considered as optimal standard of care for revascularization of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI). Ultrathin (≤ 70 μm strut thickness) strut DES have recently been shown to reduce target lesion failure (TLF) compared to thin-strut DES. Therefore, in order to assess the validity of improved outcomes associated with ultrathin-strut DES, we conducted an updated meta-analysis that includes recently published follow-ups of previously conducted randomized controlled trials (RCTs)., Methods: MEDLINE and Scopus were queried from their inception to May 2024 to identify studies comparing outcomes between ultrathin and current thin-strut 2 nd generation DES groups. A random-effects meta-analysis was conducted to derive risk ratios (RR) from dichotomous data. The primary endpoint was long-term TLF defined as a composite of cardiac death, target vessel myocardial infarction (TV-MI) and clinically driven target lesion revascularization (CD-TLR). The secondary outcome was target-vessel failure (TVF) defined as a composite of cardiac death, TV-MI and clinically driven target-vessel revascularization (CD-TVR)., Results: A total of 17 RCTs (n=22141) with a mean follow-up of 34 months were included. The risk of TLF was significantly lowered in the ultrathin DES group in comparison to thin-strut DES. A significant decrease was also noted in rates of TVF, CD-TLR and CD-TVR in the ultrathin DES vs thin-strut DES group., Conclusion: The results of our analysis demonstrate a significantly reduced risk of TLF in the ultrathin DES group in comparison with thin-strut DES. Ultrathin DES was also associated with a significantly decreased risk of TVF, CD-TLR and CD-TVR., Competing Interests: None., (AJCD Copyright © 2024.)

Although outcomes have improved with new-generation drug-eluting stents, few reports have analyzed the risk factors associated with chronic outcomes of chronic total occlusion (CTO)-percutaneous coronary intervention (PCI). This study aimed to investigate the independent risk factors for target lesion revascularization (TLR) and major adverse cardiac and cerebrovascular events (MACCEs) after CTO-PCI using Japanese multicenter data. A total of 3,666 patients, who underwent CTO-PCI and completed a 1-year follow-up, registered at the Japanese CTO-PCI Expert Registry from 2014 to 2019, were examined. The primary outcome was defined as TLR, and the secondary outcome was MACCEs at the 1-year follow-up. TLRs and MACCEs occurred in 175 (4.8%) and 524 (14.3%) patients, respectively. Multivariate logistic regression analysis demonstrated that in-stent occlusion (ISO) (odds ratio [OR] 2.604, 95% confidence interval [CI] 1.695 to 4.001), hemodialysis (OR 1.784, 95% CI 1.062 to 2.997), diabetes mellitus with insulin use (OR 1.741, 95% CI 1.060 to 2.861), moderate-to-severe calcification (OR 1.726, 95% CI 1.197 to 2.487), and the right coronary artery as the target vessel (OR 1.468, 95% CI 1.018 to 2.117) were significantly associated with TLR. Hemodialysis (OR 2.214, 95% CI 1.574 to 3.113), ISO (OR 1.499, 95% CI 1.127 to 1.993), arteriosclerosis obliterans (OR 1.414, 95% CI 1.074 to 1.863), and multivessel disease (OR 1.356, 95% CI 1.117 to 1.647) were significantly associated with MACCEs. One-year outcomes of new-generation drug-eluting stents for CTO-PCI were favorable, and ISO as a lesion factor and hemodialysis as a patient factor were strongly associated with TLR and MACCEs, respectively., Competing Interests: Declaration of competing interest Dr. Tsuchikane is a consultant for Asahi Intecc, Boston Scientific, and Kaneka. Dr. Osamu Katoh is a consultant for Asahi Intecc, Nipro, and Canon Medical. The remaining authors have no competing interests to declare., (Copyright © 2024 Elsevier Inc. All rights reserved.)

Background/Aim: The effect of β-adrenergic blockers on everolimus-eluting stent (EES) implantation is unknown. We aimed to investigate how β-blockers affect the outcomes of EES by using the Tokyo-MD PCI registry data and analyse real-world data in this drug-eluting stent era in Japan. Patients and Methods: We selected 1,899 patients who underwent EES implantation. We compared patients with β-blocker administration versus those without, at follow-up regarding the incidence rate of ischemia-driven target lesion revascularization (ID-TLR), all-cause death, cardiac death, acute myocardial infarction (AMI), and stent thrombosis (ST). Results: Patients in the β-blocker group had higher coronary risks than those in the non-β-blocker group. Although no significant difference was observed in the five-year incidence of all-cause death, cardiac death, AMI, and ST between the two groups, the incidence of IDTLR was significantly lower in the β-blocker group (4.5% vs. 6.6%; p=0.04). β-Blocker administration (hazard ratio=0.61; p=0.016) was negatively associated with IDTLR via multivariate analysis. Conclusion: β-Blocker administration reduced ID-TLR after percutaneous coronary intervention using an EES despite the greater comorbid risks and more severe disease lesions. [ABSTRACT FROM AUTHOR]

Introduction: In-stent restenosis (ISR) remains a challenging issue despite the great advance of drug-eluting stents (DES). In addition, the consensus was lacking regarding the optimal strategy for DES-ISR. Therefore, we aimed to evaluate angiographic and clinical outcomes of the two most effective treatments DES vs. drug-eluting balloon (DCB) for patients with DES-ISR.Methods: This meta-analysis used the data from the randomized controlled trials (RCTs), which were identified by a systematic search in the databases of PubMed, Embase, and Cochrane Library. Target lesion revascularization (TLR) was regarded as the primary endpoint. In addition, the late angiographic outcomes and other clinical outcomes, namely, cardiac death, myocardial infarction (MI), target vessel revascularization, stent thrombosis, and major adverse cardiac events, were also included for analysis.Results: Five RCTs with about 1,193 patients were included in this meta-analysis for the analysis. For the primary endpoint, the overall pooled outcomes suggested repeat DES implantation was associated with a significant reduction in the term of TLR compared with DCB angioplasty (risk ratio = 1.53, 95% CI 1.15–2.04, p = 0.003). But no significant difference in angiographic outcomes and other clinical endpoints were observed between DES and DCB. In the subgroup analysis, DCB was inferior to new-generation DES (NG-DES)/everolimus-eluting stent (EES) in the term of TLR. In addition, this non-significant trend was also noted in the subgroup of the paclitaxel-eluting stent (PES) vs. DCB. For the angiographic endpoints, EES, not PES, was associated with larger minimum lumen diameter [mean difference (MD) = −0.25, 95% CI −0.38 to −0.11, p = 0.0003], lower percent diameter stenosis (MD = 7.29%, 95% CI 2.86–11.71%, p = 0.001), and less binary restenosis (OR = 2.20, 95% CI 1.18–4.11, p = 0.01). But NG-DES/EES was comparable to DCB in cardiac death, MI, and stent thrombosis.Conclusions: For the patients with DES-ISR, treatment with DES, especially NG-DES/EES could reduce the risk of TLR significantly compared to DCB at long-term follow-up.

Background: Several paclitaxel-coated balloons have been proved to provide better efficacy results than uncoated balloons in femoropopliteal lesions. But the efficacy and safety of FREEWAY balloons have not been investigated in Chinese patients. This study aimed to evaluate the efficacy and safety performance of FREEWAY paclitaxel-coated balloons vs. uncoated balloons in Chinese femoropopliteal artery lesions.Methods: In this prospective multi-center randomized controlled FREEWAY-CHINA study, 311 patients with symptomatic lower limb ischemia (Rutherford category 2–5) and femoropopliteal lesions of 14 Chinese centers were randomly assigned in a 1:1 ratio to endovascular treatment with either FREEWAY paclitaxel-coated balloons or uncoated balloons (control). The primary endpoint was the 6-month clinically-driven target lesion revascularization (CD-TLR) rate. Secondary endpoints included the device and technical success rate, the ankle-brachial indexes (ABIs), Rutherford category change, the 6-month primary and secondary patency rates, severe adverse effects, and the 12-month CD-TLR rate.Results: The two groups were comparable in terms of their demographic and lesion characteristics. Patients' mean age was 70 years, and 70% were men. The mean lesion length was 71 mm. The 6-month CD-TLR rate was 2.6% in the FREEWAY group and 11.7% in the control group (P = 0.001). The 12-month CD-TLR rate was 2.7% in the FREEWAY group and 13.2% in the control group (P = 0.0005). Other endpoints, including patency rates, major adverse events, and ABI or Rutherford change, did not differ between the two groups.Conclusion: The FREEWAY balloon resulted in an effective decrease in CD-TLR rates and had similar safety results compared to the uncoated balloon in Chinese femoropopliteal artery patients at the 12-month follow-up appointment.

Background: The coronary artery with an interarterial course CAIAC is the most threatening coronary anomaly, especially if it concerns the left coronary. Percutaneous coronary intervention PCI is scarcely described given its low prevalence and lack of long-term outcome data. Therefore, we assessed through this case series the feasibility and safety of PCI in this population. Methods: This is an observational multicentric study including patients with CAIAC arising from the opposite sinus of Valsalva. The primary endpoints were immediate angiographic success and target lesion revascularization. Results: During the period of the study, we performed 27235 PCI in six Cath labs, 26 procedures concerning abnormal coronaries including 12 with CAIAC. The median age was 57 years extremes: 43-78 with male predominance 1:11. Anomalous coronary artery was Right coronary artery RCA in eight patients, Left main LM in three patients, and left anterior descending LAD in one patient. The stenosis was located in all cases in proximal segments beyond the interarterial course proximal LAD, the superior genius of the RCA, or the proximal segment of mid-RCA. Five patients showed slit-like ostium and all have an angle take-off <45° on CT scan. After a median follow-up of 24 months, four subjects presented target lesion revascularization TLR, all were initially treated with either a bare-metal stent or with balloons. Conclusions: PCI of patients with CAIAC is feasible and appears safe. The operator should carefully analyze the angiogram before PCI to choose the appropriate guiding catheter and should be acquainted with the different techniques for improving backup. [ABSTRACT FROM AUTHOR]

Paclitaxel-eluting devices (PED) reduce restenosis and target lesion revascularization (TLR) in femoropopliteal intervention. Recent data suggest a two-fold increased long-term mortality in patients treated with PED. The aim of our study is to evaluate if endovascular therapy (EVT) with PED increases mortality risk in patients with symptomatic lower limb peripheral artery disease (PAD) compared to non-eluting devices (NED). The study is a retrospective, single-center registry on patients undergoing EVT for PAD from January 2009 to June 2018. Propensity score analysis on logistic regression model for independent predictors of long-term mortality was used to match PED and NED patients. Mortality was assessed at 2, 5 and 7 years in the entired matched population and in a sub-group of patients ≤75 years. During the study period, 1294 patients, 718 NED and 576 PED, met the inclusion/exclusion criteria and entered in the study. Propensity score matching analysis identified 854 matched patients, 414 PED and 440 NED. The population was mainly characterized by diabetic patients with CLI (80%) and high prevalence of CAD (30%), heart failure (15%) and renal insufficiency (20%). Mean follow-up length was 58 ± 34 months, (median 52.5). Mortality was 18% in NED vs 12% in PED patients at two years (p = 0.01), 36% vs 30% at 5 years (p = 0.03) and 41% vs 39% at seven years (p = 0.2) respectively. In patients ≤75 years, mortality at 7-year was 28% in PED vs 36% in NED, p = 0.07. These results suggest a reduced mortality at 2 and 5 years with PED as compare to NED treatment in a real-world CLI scenario. At 7-year follow-up, the advantage was numerically evident only in patients ≤75 years. • Angioplasty of lower limb arteries is associated with a high incidence of restenosis. • Paclitaxel-eluting devices reduce restenosis and target lesion revascularization in lower limb ischemia. • Recent data are conflicting about long-term mortality in patients treated with PED. • In real world scenario paclitaxel-eluting devices reduce major limb adverse events and mortality at 2 and 5 years follow-up. [ABSTRACT FROM AUTHOR]

Data on the mid-term clinical outcomes after endovascular treatment (EVT) using a Crosser catheter (C. R. Bard, Inc.) as a crossing or flossing device for a heavily calcified lesion in the common femoral artery (CFA) or popliteal artery (PA) are lacking. The aim of this study was to investigate the safety and efficacy of EVT using a Crosser catheter for isolated and heavily calcified CFA or PA disease. We retrospectively analyzed 64 consecutive patients (72 lesions; CFA 30, PA 42) who underwent EVT for heavily calcified CFA or PA lesions with Crosser catheters between April 2015 and April 2019. The primary endpoint was clinically driven target lesion revascularization (CD-TLR). The median follow-up was 18.5 months. The mean age of the study population was 70 ± 9.5 years, with a male prevalence of 73.6%. The mean Proposed Peripheral Artery Calcification Scoring System grade was 2.9 ± 0.9. Procedure success, defined as 50% or less residual stenosis without suboptimal results, was achieved in 94.4% of lesions. There were no cases of bailout stenting or target lesion-related complications. After EVT, the 1-year CD-TLR-free rate for CFA and PA lesions was 87.4 and 76.8%, respectively. The corresponding rates at 2 years were 82.2 and 62.8%, respectively. In the multivariate analysis used to define CD-TLR predictors for CFA and PA lesions, hemodialysis was the only independent predictor (HR 3.35, 95% CI 1.02–13.95, P = 0.045). EVT with a Crosser device for heavily calcified CFA and PA lesions seems to be safe and feasible. [ABSTRACT FROM AUTHOR]

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length. [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction and objectives: Coronary in-stent restenosis (ISR) is associated with a high target lesion revascularization rate, while the drug-eluting balloon (DEB) presents IA class level of evidence for its treatment. Nevertheless, very long-term outcomes of DEB for ISR in non-selected populations of patients are unknown. Our goal is to evaluate the very long-term (5 year) effectiveness of DEBs in a real-world registry. Methods: Retrospective registry from an ISR cohort treated with DEB. The primary outcome was the rate of target lesion revascularization (TLR) at 5 years. Secondary outcomes were evaluated according to the ARC-2 criteria. Results: From January 2010 through December 2013, 53 ISRs were treated using DEBs in 48 patients. Patients were old (69.3 ± 11.8 years-old) and 55.8% had diabetes. The rate of TLR at 1 year was 9.4%, and 20.8% at 3 and 5 years, respectively. The rate of late TLR (after the first year) was 11.4%, only after DEB for bare metal ISR. The 5-year TLR was not associated with diabetes (22.7% vs 19.2%; P = .76) and was not significantly lower after cutting-balloon (12.5% vs 24.3%; P = .47) or in bare-metal stent ISR (20.6% vs 21.1%; P = .96). There was no definite/probable stent thrombosis of the lesions treated with DEB at follow-up. Conclusions: In a real-world cohort, the 5-year TLR rate after DEB for ISR was 20.8%. Late TLR accounted for half of the TLR at follow-up (after DEB for bare metal ISR), while the rate of TLR seemed to stabilize at 3 years. There was no stent thrombosis of the lesions treated with DEB.

Objective To observe the occurrence of long-term adverse cardiac events in coronary heart disease (CHD) patients with high inter-arm blood pressure difference (IABPD) after percutaneous coronary intervention (PCI) . Methods A total of 855 patients with CHD who received PCI and implanted of second-generation drug-eluting stents (DES) were enrolled. The blood pressure of patients’both upper arms was measured by electronic sphygmomanometer at admission or within 1 week after PCI, and IABPD was calculated. Patients were divided into high IABPD group (≥ 10 mmHg) and normal IABPD group (< 10 mmHg). All patients were followed up through outpatient, online or telephone for (44. 5 ± 26. 4) months. The endpoint events were major adverse cardiac events (MACE), including cardiovascular death, MI, stroke, and symptom-driven target vessel revascularization (TVR). Results A total of 112 cases of MACE occurred in normal IABPD group during follow-up, including 43 cases of cardiovascular death, 12 cases of MI, 15 cases of stroke, and 64 cases of symptom-driven TVR. In the high IABPD group, 80 cases of MACE occurred during follow-up, including 3 cardiovascular deaths, 4 MI, 3 stroke, and 14 symptom-driven TVR. The symptom-driven TVR of patients in the normal LABBD group was differently from that of high LABPD group. Conclusion In CHD patients after PCI, the incidence of symptom driven TRV in patients with high IABPD (≥10 mmHg) is higher than that of patients with normal IABPD (< 10 mmHg) during long-term follow-up. [ABSTRACT FROM AUTHOR]

Measurement of the coronary artery calcification score using multidetector computed tomography (MDCT) is a useful noninvasive test for the diagnosis of coronary artery disease. However, whether pre-intervention assessment of the target vessel coronary artery calcification (TV-CAC) score is associated with stent expansion failure and future target lesion revascularization (TLR), remains unknown. This study aimed to determine the association between the TV-CAC score measured by MDCT and stent expansion rate in patients who underwent IVUS-guided PCI for stable angina. We conducted a retrospective observational study including 135 consecutive patients (186 target lesions) who underwent MDCT and were scheduled for the first PCI. The patients were divided into 2 groups based on the median value of the TV-CAC score. The primary outcome was the stent expansion rate measured by IVUS after stent implantation. The secondary outcome was TLR within 1 year. Stent expansion rate was associated with the TV-CAC score (p < 0.001). According to the ROC curve analysis, the TV-CAC score had the largest area under the curve (AUC) for the stent expansion area of 0.90 (AUC = 0.893, p < 0.001). The TV-CAC score was a positive predictor for stent expansion rate of <90% (odds ratio: 7.54, p < 0.001). Mediation analysis showed that stent under-expansion was a mediator of the association between high TV-CAC and TLR. Our study demonstrates that pre-intervention assessment of TV-CAC using MDCT is a predictor of stent expansion. The TV-CAC score might predict the complexity and help in the PCI operative strategy. • The present study showed that high TV-CAC assessed using the multidetector computed tomography is a predictor of stent under-expansion. • Stent under-expansion is a mediator of the association between high TV-CAC score and in-stent restenosis. • Assessing the TV-CAC score before PCI might be clinically useful to reduce future TLR due to stent under-expansion. [ABSTRACT FROM AUTHOR]

Objectives The aim of this study was to evaluate the 24-month outcome of drug-coating balloon (DCB) versus bare-metal stent (BMS) for the treatment of disabling claudication and critical limb ischemia in patients with complex femoropopliteal lesions regarding technical success, primary patency, secondary patency, target lesion revascularization, and limb salvage rate. Background Complex femoropopliteal lesions are difficult to treat, and the effective protocols for intervention remain to be developed. Patients and methods This was a multicenter, prospective, randomized controlled two-arm blind interventional study. A total of 80 patients (92 limbs) complaining of disabling claudication or critical limb ischemia owing to complex femoropopliteal occlusive lesions were randomly assigned into two groups according to the intervention approach used from May 2016 to August 2020. Group A included 42 patients (47 limbs) who have been assigned for treatment with paclitaxel DCBs and group B included 38 patients (45 limbs) assigned for treatment with BMSs. The follow-up period was for 24 months, with regular visits at 3, 6, 9, 12, 15, 18, and 24 months or when new concerns emerged. All data were analyzed by using Statistical Package of Social Science for Windows, version 22.0 and MedCalc Windows. Results The 1-year primary patency rates in the DCB and BMS groups were 87.2 and 75.6% (P=0.15), respectively, and the corresponding 2-year rates were 76.6 and 57.8, respectively (P=0.05). However, the 1-year secondary patency rates in the DCB and BMS groups were 95.7 and 91.1% (P=0.43), respectively, and the corresponding 2-year rates were 91.4 and 75.5%, respectively (P=0.05). There is a statistically significant difference regarding the primary and secondary patency rates at 24 months between both the groups (P=0.05). The 2-year major limb amputation rate was 6.3% in DCB group versus 11.1% in BMS group (P=0.48), which was statistically insignificant. The postprocedural ankle–brachial index shows highly significant difference between both the groups at 24 months (P<0.001). Conclusion The 2-year outcomes showed superior efficacy, higher safety, and greater clinical benefits of DCBs than BMSs for the treatment of complex femoropopliteal lesions. A statistically significant lower rate of restenosis and occlusions and statistically significant higher 2-year primary and secondary patency rates were observed in the DCB group than in the BMS group. However, more studies with a larger sample and long-term follow-up are required. [ABSTRACT FROM AUTHOR]

Purpose: To report the safety and effectiveness outcomes through 2 years of the BioMimics 3D Vascular Stent System in the treatment of symptomatic patients with atherosclerotic femoropopliteal disease. Materials and Methods: The tubular, nitinol BioMimics 3D stent, which was designed to impart a helical shape to the arterial segment, was implanted in 271 patients (mean age 68.4±9.5 years; 180 men) with de novo femoropopliteal lesions enrolled at 43 investigational sites [31 US (n=162), 6 German (n=78), and 6 Japanese (n=31)] in the prospective, single-arm MIMICS-2 investigational device exemption trial (ClinicalTrials.gov identifier NCT02400905) between June 2015 and October 2016. Mean lesion length was 81.2±38.4 mm, 30.0% of patients had total occlusions, and 45.9% had moderate to severe calcification. Primary safety and effectiveness endpoints were compared at 1 year with prespecified objective performance goals (OPGs) set by the VIVA Physicians organization. Outcomes through 2 years are reported. Results: The primary effectiveness endpoint of 12-month primary stent patency was met by 182 of 249 patients (73.1%, 95% CI 67.3% to 78.2%), exceeding the OPG of 66%. The primary safety endpoint of 30-day freedom from major adverse events (MAEs) was met in 268 of 269 patients (99.6%, 95% CI 97.7% to 100%), exceeding the OPG of 88%. Kaplan-Meier estimates of freedom from loss of primary patency were 83.1% at 12 months and 70.2% at 24 months, freedom from MAEs estimates were 86.9% at 12 months and 79.2% at 24 months, and freedom from clinically-driven target lesion revascularization estimates were 88.0% at 12 months and 83.0% at 24 months. At 24 months, 88.2% of patients showed improvement of ≥1 Rutherford category; the ankle-brachial index was >0.9 for 64.4% vs 11.3% at baseline. There were no cases of stent fracture. Conclusion: Through 24 months, the BioMimics 3D Vascular Stent System provided safe and effective treatment for femoropopliteal lesions in patients with symptomatic peripheral artery disease. [ABSTRACT FROM AUTHOR]

Purpose: To compare the safety and efficacy of drug-coated balloon (DCB) vs uncoated balloon angioplasty in the treatment of de novo and restenotic infrapopliteal lesions in patients with chronic limb-threatening ischemia (CLTI). Materials and Methods: The prospective, multicenter, randomized study AcoArt II–BTK study (ClinicalTrials.gov identifier NCT02137577) enrolled 120 patients who were randomly assigned to angioplasty with either a DCB (n=61; mean age 70.7±7.4 years; 36 men) or a conventional balloon catheter (n=59; mean age 70.8±9.0 years; 36 men). There were no significant differences observed in baseline clinical or target lesion characteristics between the groups. The target lesion length was 169.95±86.35 mm in the DCB group vs 179.93±80.16 mm in the control group, and approximately three-quarters of the lesions were chronic occlusions. Primary patency was assessed by angiography at 6 months, and mortality and clinically-driven target lesion revascularization (CD-TLR) were evaluated at 12 months. Results: Primary patency at 6 months was 75.0% in the DCB group and 28.3% in the control group (p<0.001), while late lumen loss was 0.43±0.62 mm for DCBs vs 0.99±0.55 mm for controls (p<0.001). Freedom from CD-TLR at 12 months was 91.5% in the DCB group vs 76.8% in the controls (p=0.03); there was no significant difference in mortality (1.7% DCB vs 3.6% controls; p=0.53). Conclusion: This study demonstrated that the Litos/Tulip DCBs are safe and effective in treating infrapopliteal lesions, with improved angiographic and clinical outcomes vs plain balloon angioplasty. The DCBs demonstrated significantly higher primary patency with fewer CD-TLRs than conventional angioplasty. The safety of the DCBs was noninferior to that of the uncoated balloons after 1 year of follow-up. [ABSTRACT FROM AUTHOR]

Purpose: To present a subgroup analysis of patients from a large real-world study evaluating the safety and effectiveness of the Zilver PTX drug-eluting stent (DES) for treating femoropopliteal in-stent restenosis (ISR).Materials and Methods: This study examined patients enrolled in the Zilver PTX Japan Post-Market Surveillance Study (ClinicalTrials.gov identifier NCT02254837), a prospective, multicenter registry of 904 symptomatic patients with 1082 femoropopliteal lesions treated with the DES at 95 institutions in Japan. Five-year outcomes, including mortality, stent radiography, freedom from target lesion revascularization (TLR), and clinical benefit, were evaluated for 177 patients (mean age 74.2±8.3 years; 118 men) with 204 ISR lesions treated with the Zilver DES. Over half of the patients (108, 61.0%) were diabetic. Mean lesion length was 17.8±10.4 cm, and a third (72, 35.3%) were total occlusions. Outcome measures were all-cause mortality, thrombosis, freedom from TLR, and clinical benefit, defined as freedom from persistent or deteriorating ischemic symptoms.Results: No device-related or procedure-related deaths or paclitaxel-related adverse events were reported. All-cause mortality was 25.1% at 5 years. Stent fracture was observed in 5 stents through 5 years. The 5-year rate of freedom from clinically-driven TLR was 73.4%, and the rate of clinical benefit was 63.6%. Improvement in Rutherford category and ankle-brachial index was sustained through 5 years.Conclusion: The safety and effectiveness of the Zilver PTX stent for the treatment of femoropopliteal ISR lesions demonstrated that this device provides a favorable treatment option in this difficult-to-treat subgroup. [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the 36-month technical and clinical outcome after implantation of the 25-cm Viabahn endoprosthesis with Propaten bioactive surface in TransAtlantic Inter-Society Consensus II C and D lesions of the superficial femoral and proximal popliteal arteries.Materials and Methods: This prospective, multicenter, single-arm trial (ClinicalTrials.gov; identifier NCT01263665) enrolled 71 patients (mean age 66.7±8.3 years; 50 men) with lifestyle-limiting claudication or rest pain (Rutherford category 2-4) and long (>20-cm) lesions of the superficial femoral and proximal popliteal arteries. Primary endpoint was primary patency at 36 months. Secondary endpoints included primary assisted patency; secondary patency; freedom from target lesion revascularization (TLR); freedom from a composite of death, target vessel revascularization (TVR), and amputation; clinical success; and freedom from device fracture.Results: Primary patency estimated by Kaplan-Meier analysis was 40.6% at 36 months. Primary assisted patency and secondary patency estimates were 53.0% and 96.9%, respectively. Within 36 months, 27 patients had to undergo a TLR. Twenty-five patients (35.2%) had a TVR. Freedom from the composite of death, TVR, and amputation endpoint was 44.5%. The estimate of the sustained clinical success with stable or improved Rutherford category was 58.5%. No stent fracture was detected during follow-up.Conclusion: The primary patency rate without reintervention after treatment of long femoropopliteal lesions is low. However, secondary patency after implantation of a Viabahn endoprosthesis is high and seems to be superior to the use of other revascularization techniques, resulting in persistent clinical improvement. [ABSTRACT FROM AUTHOR]

Objective: Although thin-strut drug-eluting stents (DES) with a more flexible design are easily obtainable, data regarding using ultralong DES (=40 mm) for long coronary lesions are limited in the literature. Therefore, the current study assessed the safety and efficacy of an ultralong (=40 mm) and ultrathin (60 µm) biodegradable polymer-coated sirolimus-eluting stent (SES), Supralimus Grace, with a unique Long Dual Z-link (LDZ-link) design (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) in real-world patients with long coronary lesions. Methods: The assigned stents were implanted in 684 patients. The primary endpoint was target lesion failure (TLF), which is a composite of cardiovascular death, target vessel myocardial infarction (MI), and target lesion revascularization (TLR), whereas periprocedural secondary endpoints included device failure (failure of stent delivery, change of stent, and stent fracture) and patient-oriented composite endpoint (POCE), which is a composite of all deaths, any MI, and any revascularization, and stent thrombosis (ST). These outcomes were analyzed at one-year follow-up and during the procedure. Results: The patients' mean age was 52.7±15.9 years; 537 (78.5%) were males. 626 (91.5%) patients suffered from acute coronary syndrome and 58 (8.5%) patients from chronic coronary syndrome (CSS). 989 lesions were removed. The mean numbers of lesions and stents implanted per patient were 1.3±0.2 mm and 1.4±0.3 mm, respectively. TLF occurred in 42 (6.1%) as a result of cardiac death, target vessel MI, and TLR in 9 (1.3%), 20 (2.9%), and 13 (1.9%) patients, respectively. POCE was observed in 131 patients (19.1%) at one-year follow-up, mainly in 63 (9.2%) patients because of any revascularization. Stent failure was seen in 21 patients (3.1%) as a result of delivery failure (2.2%), edge dissection (0.8%), and fracture (0.1%). Definite and probable ST were observed in 8 (1.1%) and 9 (1.3%) patients, respectively. Conclusion: Ultralong (=40 mm), ultrathin (60 µm) Supralimus Grace stent can be safely implanted in vessels having long and multiple lesions. [ABSTRACT FROM AUTHOR]

Purpose: Develop a prediction model to determine the impact of patient and lesion factors on freedom from target lesion revascularization (ffTLR) for patients who are candidates for Zilver PTX drug-eluting stent (DES) treatment for femoropopliteal lesions. Methods: Patient factors, lesion characteristics, and TLR results from five global studies were utilized for model development. Factors potentially associated with TLR (sex, age, diabetes, hypertension, hypercholesterolemia, renal disease, smoking status, Rutherford classification, lesion length, reference vessel diameter (RVD), popliteal involvement, total occlusion, calcification severity, prior interventions, and number of runoff vessels) were analyzed in a Cox proportional hazards model. Probability of ffTLR was generated for three example patient profiles via combinations of patient and lesion factors. TLR was defined as reintervention performed for ≥ 50% diameter stenosis after recurrent clinical symptoms. Results: The model used records from 2227 patients. The median follow-up time was 23.9 months (range: 0.03–60.8). The Kaplan–Meier estimates for ffTLR were 90.5% through 1 year and 75.2% through 5 years. In a multivariate analysis, sex, age, Rutherford classification, lesion length, RVD, total occlusion, and prior interventions were significant factors. The example patient profiles have predicted 1-year ffTLRs of 97.4, 92.3, and 86.0% and 5-year predicted ffTLRs of 92.8, 79.5, and 64.8%. The prediction model is available as an interactive web-based tool (https://cooksfa.z13.web.core.windows.net). Conclusions: This is the first prediction model that uses an extensive dataset to determine the impact of patient and lesion factors on ffTLR through 5 years and provides an interactive web-based tool for expected patient outcomes with the Zilver PTX DES. Clinical Trial Registrations: Zilver PTX RCT unique identifier: NCT00120406; Zilver PTX single-arm study unique identifier: NCT01094678; Zilver PTX China study unique identifier: NCT02171962; Zilver PTX US post-approval study unique identifier: NCT01901289; Zilver PTX Japan post-market surveillance study unique identifier: NCT02254837. Levels of Evidence: Zilver PTX RCT: Level 2, randomized controlled trial; Single-arm study: Level 4, large case series; China study: Level 4, case series; US post-approval study: Level 4, case series Japan PMS study: Level 4, large case series. [ABSTRACT FROM AUTHOR]

Purpose: To report the results of a study evaluating JetStream atherectomy for the treatment of in-stent restenosis (ISR). Materials and Methods: The JetStream XC atherectomy device, a rotational cutter with aspiration capacity, was evaluated in a prospective, multicenter study (JET-ISR) of 60 patients (mean age 70.2±10.8 years; 40 men) with femoropopliteal ISR (ClinicalTrials.gov identifier NCT02730234). Lesion length was 19.9±13.5 cm; 33 (55%) were chronic total occlusions and 26 (45%) were TransAtlantic Inter-Society Consensus class D. No drug-bearing device was allowed, and stenting was performed only for bailout. Lesion characteristics and stent integrity were evaluated by an independent core laboratory. The primary endpoint was target lesion revascularization (TLR) at 6 months with bailout stenting considered as TLR. Secondary endpoints included TLR (without bailout stenting) and clinical patency (no restenosis or TLR) at 1 year. The Kaplan-Meier method was employed to evaluate time-to-event endpoints; estimates are given with 95% confidence interval (CI). Results: Bailout stenting was required in 6 of 60 limbs (10%). There were no stent fractures or deformities after atherectomy + adjunctive angioplasty reported by the core laboratory. Kaplan-Meier estimates of freedom from TLR at 6 months and 1 year were 79.3% (95% CI 68.9% to 89.8%) and 60.7% (95% CI 47.8% to 73.6%), respectively. When bailout stenting at the index procedure was not considered a TLR event, freedom from TLR estimates at 6 months and 1 year were 89.3% (95% CI 81.2% to 97.4%) and 66.8% (95% CI 54.3% to 74.2%), respectively. Clinical patency rates at 6 months and 1 year were 77.5% (31/40) and 51.7% (15/29), respectively. Conclusion: JetStream atherectomy using the XC device and no drug-eluting devices is feasible, with good clinical patency and 1-year freedom from TLR. [ABSTRACT FROM AUTHOR]

Background: Clinical outcomes after percutaneous coronary intervention have improved with the use of drug-eluting stents, but data beyond 10 years are limited. The purpose of this study was to evaluate the clinical outcomes of patients undergoing sirolimus-eluting stent implantation with follow-up beyond 10 years and to determine the impact of clinical and angiographic characteristics on long-term prognosis., Methods and results: The clinical outcomes of 885 patients who had undergone sirolimus-eluting stent implantation at a single institution were retrospectively reviewed. Primary endpoints included in the analysis were clinically driven target lesion revascularization (cTLR) and target lesion revascularization (TLR). Univariate and multivariate nominal logistic regression was used for data analysis. The incidence rates of cTLR and TLR beyond 10 years after sirolimus-eluting stent implantation were 16.4% and 36.8%, respectively, with cTLR tending to decrease beyond 10 years. Acute coronary syndrome was a predominant trigger for cTLR. Age, statin use, and stent restenosis emerged as predictors of cTLR within 10 years, but no significant predictors other than age were identified beyond 10 years., Conclusions: Events continue to occur beyond 10 years after sirolimus-eluting stent implantation, with a trend toward an increase in acute coronary syndromes. It is important to be vigilant about the occurrence of acute coronary syndromes during long-term follow-up.

We characterized the performance, as well as the safety, of a second-generation thin-strut sirolimus-eluting stent with a biodegradable polymer, Alex Plus (Balton, Poland), implanted in patients with type 2 diabetes (DM) with a 4-year follow-up. We defined the primary endpoint as the 48-month rate of major cardiovascular adverse events (MACE), including cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR). The secondary endpoints were all-cause death, cardiac death, MI, and TLR rates at 12, 24, 36, and 48 months. We enrolled 232 patients in whom 282 stents were implanted, including 97 DM and 135 non-DM patients. The mean age of the DM patients was 69.5 ± 10.1 years and females accounted for 30% of the patients. DM patients had higher rates of arterial hypertension (97% vs. 88%, p = 0.016), dyslipidemia (86% vs. 70%, p = 0.005), prior MI (61% vs. 40%, p = 0.002), prior PCI (65% vs. 50%, p = 0.020), and prior CABG (14% vs. 5.9%, p = 0.029). We recorded statistically significant differences for MACE (HR 1.85, 95% CI 1.01-3.41, p = 0.046), cardiac death (HR 4.46, 95% CI 1.44-13.8, p = 0.010), and MI (HR 3.17, 95% CI 1.10-9.12, p = 0.033), but not for TLR, between DM and non-DM patients in terms of the analyzed endpoints at 4 years. Our study showed that Alex Plus was efficient and safe in a contemporary cohort of real-world DM patients undergoing percutaneous revascularization.