Need For Target Lesion Revascularization Research Articles

Long-term risks for patency loss in patients with hemodialysis after bare self-expandable nitinol stent implantation to femoropopliteal artery occlusive lesions

BackgroundAlthough patients receiving hemodialysis (HD+) have significantly different backgrounds, including a history of progressive atherosclerotic disease, compared with those not receiving hemodialysis (HD−), there are no studies evaluating the risks for loss of primary patency (PP) and need for target lesion revascularization (TLR) in HD+ patients following bare self-expandable nitinol stent (BSNS) implantation to femoropopliteal (FP) artery occlusive lesions, after adjusting for differences using propensity score (PS) analysis in observed characteristics between groups. MethodsWe studied 531 limbs of 432 Japanese patients (HD+, n=107; HD−, n=325) who received BSNS implantation to FP lesions between 2004 and 2014. Patients were followed-up for an average of 44.3±33.6months. We compared the long-term results between HD+ and HD− patients using the Cox-proportional hazard model with adjustment for inverse probability treatment weight (IPTW) of PS, which was calculated for covariates with HD as a dependent variable. ResultsPP rate in HD+ vs. HD− patients at 9years after the procedure was 19.1% vs. 47.9%, with a freedom from TLR rate of 47.6% vs. 62.9%, respectively. Adjusted HRs in HD+ patients with 95% confidence intervals (CIs) were as follows: loss of PP: HR 1.64, 95% CI 1.052–2.557, P=0.03; TLR: HR 1.862, 95% CI 1.104–3.139, P=0.02. ConclusionsThe present study suggests that HD+ patients have an increased risk for loss of PP and need for TLR after BSNS implantation to FP lesions.

Risk factors for major leg amputation in patients treated endovascularly due to critical limb ischaemia

Introduction. Critical limb ischaemia (CLI) is an advanced phase of chronic lower extremity ischaemia linked to increased mortality, decreased quality of life, and the risk of leg amputation. The aim of this study was to determine factors affecting the risk of leg amputation among patients with CLI treated endovascularly as a first approach. Material and methods. Of 118 patients treated endovascularly, 32 (27%) had a leg amputated. Their clinical data were analysed retrospectively. Results. Patients who had a leg amputated initially had a higher Rutherford class, were older, and had a greater prevalence of comorbidities. In multivariate analysis, amputation-free survival was shortened by a history of dyslipidaemia, female gender, blood creatinine concentration, the need for target lesion revascularization, smoking habit, Rutherford class, and leukocyte blood count. Whereas, the factors which decreased the risk of leg amputation were: use of statins, the number of previous interventions, and blood LDL cholesterol concentration. Angiographic classification of lesion severity did not affect endovascular procedure outcome. Conclusions. The risk of major amputation following endovascular treatment in patients with CLI was associated with a number of characteristics, mainly: atherosclerosis risk factors and necrosis advancement, and the number of reinterventions. To avoid endangering patients and the unnecessary utilization of resources, it would seem to be worth performing large studies to determine a risk stratification scoring system for patients with CLI, which could enable the qualification of risk-adjusted patients for endovascular or surgical revascularization or for primary leg amputation.

Early and late clinical outcomes after saphenous vein graft treatment with MGuardTM stents vs. drug-eluting stents

ABSTRACT Background The MGuard TM stent, which has a microscopic polymer mesh coating, is intended to reduce the distal embolization of fragments during percutaneous coronary intervention (PCI) in saphenous vein grafts (SVG). This study evaluated the early and late clinical outcomes of patients undergoing PCI in SVG with MGuard TM stents vs. drug-eluting stents (DES). Methods Observational, retrospective study conducted at two tertiary centers, involving a cohort of patients with SVG lesions submitted to elective or emergency treatment with MGuard TM stents or DES. Results A total of 271 patients were included, of whom 220 were treated with DES. The MGuard TM group had a higher proportion of women (25.5% vs. 10.5%; p = 0.01), with a mean age of 65.0 ± 13.9 years vs. 69.0 ± 9.6 years ( p = 0.06). The DES group more frequently used distal protection filter (5.8% vs. 10.0%; p = 0.001). Angiographic success was attained in most cases (96.2% vs. 98.0%; p = 0.22). The MGuard TM group had lower rates of early major adverse cardiovascular events (MACE) than the DES group (1.9% vs. 13.6%; p = 0.01), due solely to the lower incidence of periprocedural infarction. However, the MACE rate at 1 year was higher in the MGuard TM group (14.3% vs. 4.4%; p = 0.01) at the expense of a higher rate of target lesion revascularization (7.1% vs. 1.3%; p = 0.048). Conclusions The use of the MGuard TM stent resulted in a reduction of events during hospitalization; however, in the long term the DES were superior in reducing major outcomes, mainly the need for target lesion revascularization.

Trial of a Paclitaxel-Coated Balloon for Femoropopliteal Artery Disease

BackgroundThe treatment of peripheral artery disease with percutaneous transluminal angioplasty is limited by the occurrence of vessel recoil and restenosis. Drug-coated angioplasty balloons deliver antiproliferative agents directly to the artery, potentially improving vessel patency by reducing restenosis.MethodsIn this single-blind, randomized trial conducted at 54 sites, we assigned, in a 2:1 ratio, 476 patients with symptomatic intermittent claudication or ischemic pain while at rest and angiographically significant atherosclerotic lesions to angioplasty with a paclitaxel-coated balloon or to standard angioplasty. The primary efficacy end point was primary patency of the target lesion at 12 months (defined as freedom from binary restenosis or from the need for target-lesion revascularization). The primary safety end point was a composite of freedom from perioperative death from any cause and freedom at 12 months from limb-related death (i.e., death from a medical complication related to a limb), amputation, and reintervention.ResultsThe two groups were well matched at baseline; 42.9% of the patients had diabetes, and 34.7% were current smokers. At 12 months, the rate of primary patency among patients who had undergone angioplasty with the drug-coated balloon was superior to that among patients who had undergone conventional angioplasty (65.2% vs. 52.6%, P=0.02). The proportion of patients free from primary safety events was 83.9% with the drug-coated balloon and 79.0% with standard angioplasty (P=0.005 for noninferiority). There were no significant between-group differences in functional outcomes or in the rates of death, amputation, thrombosis, or reintervention.ConclusionsAmong patients with symptomatic femoropopliteal peripheral artery disease, percutaneous transluminal angioplasty with a paclitaxel-coated balloon resulted in a rate of primary patency at 12 months that was higher than the rate with angioplasty with a standard balloon. The drug-coated balloon was noninferior to the standard balloon with respect to safety. (Funded by Lutonix–Bard; LEVANT 2 ClinicalTrials.gov number, NCT01412541.)

A 10‐month angiographic and 4‐year clinical outcome of everolimus‐eluting versus sirolimus‐eluting coronary stents in patients with diabetes mellitus (the diabedES IV randomized angiography trial)

We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes. There are limited data on long-term outcome after EES vs SES implantation in diabetic patients. We randomized 213 patients with diabetes and coronary artery disease to EES (n = 108) or SES (n = 105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up. At 10-month angiographic follow-up, in-stent late lumen loss was 0.20 ± 0.53 mm and 0.11 ± 0.49 mm (P = 0.28), and angiographic restenosis rate was 3.8% and 5.2% (P = 0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P = 0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P = 0.28). EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.

Long-term safety and performance of the orbital atherectomy system for treating calcified coronary artery lesions: 5-Year follow-up in the ORBIT I trial.

The ORBIT I trial, a first-in-man study, was conducted to evaluate the safety and performance of the orbital atherectomy system (OAS) in treating de novo calcified coronary lesions. Fifty patients were enrolled between May and July 2008 based on several criteria, and were treated with the OAS followed by stent placement. The safety and performance of the OAS were evaluated by procedural success, device success, and overall major adverse cardiovascular event (MACE) rates, including cardiac death, myocardial infarction (MI) and need for target lesion revascularization (TLR). Our institution enrolled and treated 33 of the 50 patients and continued follow-up for 5 years. Average age was 54 years and 91% were males. Mean lesion length was 15.9 mm. Device success was 100%, and average number of orbital atherectomy devices (OAD) used per patient was 1.3. Stents were placed directly after OAS in 31/32 patients (96.9%). All stents (average stent per lesion 1.1) were successfully deployed with 0.3% residual stenosis. The overall cumulative MACE rate was 6.1% in-hospital, 9.1% at 30 days, 12.1% at 6 months, 15.2% at 2 years, 18.2% at 3 years and 21.2% at 5 years (4 total cardiac deaths). None of the patients had Q-wave MIs. Angiographic complications were observed in 5 patients. No flow/slow flow due to distal embolization was observed. The ORBIT I trial suggests that OAS treatment continues to offer a safe and effective method to change compliance of calcified coronary lesions to facilitate optimal stent placement in these difficult-to-treat patients.

Abstract 20675: Longest Available Follow-Up of Drug-Eluting Stents in Real World Practice - Outcomes up to 12 Years From the DESIRE Registry

Background: Despite the marked efficacy demonstrated by drug-eluting stents (DES) in reducing neointimal proliferation, and therefore, the need for target lesion revascularization (TLR), persistent concerns regarding long-term safety and efficacy, especially in more complex subset, are still. Methods: The DESIRE Registry is a large, prospective, non-randomized, single center study assessing the late outcomes of unselected pts treated with DES. Overall, 5,541 pts were consecutively enrolled from May/02-Jun/14. Clinical follow-up (FU) (97%) was performed yearly up to 12 yrs (median 4.9 yrs). Stent thrombosis (ST) was defined according to the ARC. Results: Mean age was 65 yrs, 31% had diabetes, 29% current smokers, 42% presented with ACS (17% recent myocardial infarction, MI), and the majority of lesions were highly complex (67% type B2/C). Overall, there were 8,919 lesions treated with 9,537 DES, and angiographic success was 99%. During the FU period, cumulative event rates were major adverse cardiac events (cardiac death, myocardial infarction, or TLR) 32%, myocardial infarction 8%, TLR 21%, and cardiac death 6%. As for stent thrombosis, overal rate was 2.4%, given that 95% of patients were free from this event up to 12 years. In the multivariate model, independent predictors of major adverse cardiac events were: prior revascularization by percutaneous intervention (HR 1.21, p=0.03) or surgery (HR 1.53, p<0.001), dyslipidemia (HR 1.20, p=0.03), renal insufficiency (HR 1.41, p<0.001), peripheral vascular disease (HR 2.06, p<0.001), long lesions (HR 1.38, p<0.001), acute coronary syndrome (HR 1.39, p<0.001), and residual stenosis (HR 1.02, p<0.001). As for stent thrombosis, predictors were: recent myocardial infarction (HR 2.66, p=0.001), multiple stents implanted (HR 1.89, p=0.002), saphenous vein graft (HR 2.21, p=0.004), and residual stenosis (HR 1.03, p=0.03). Conclusions: At very long-term follow-up (up to 12 years) in a large cohort of patients from the real world practice, cumulative event rates included TLR in 21% and stent thrombosis in 2.4%. Overall, there were no safety concers, given that 95% of patients were free from stent thrombosis up to 12 years.

Long-term outcome of the unrestricted use of everolimus-eluting stents compared to sirolimus-eluting stents and paclitaxel-eluting stents in diabetic patients: The Bern–Rotterdam diabetes cohort study

BackgroundNewer generation everolimus-eluting stents (EES) improve clinical outcome compared to early generation sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES). We investigated whether the advantage in safety and efficacy also holds among the high-risk population of diabetic patients during long-term follow-up. MethodsBetween 2002 and 2009, a total of 1963 consecutive diabetic patients treated with the unrestricted use of EES (n=804), SES (n=612) and PES (n=547) were followed throughout three years for the occurrence of cardiac events at two academic institutions. The primary end point was the occurrence of definite stent thrombosis. ResultsThe primary outcome occurred in 1.0% of EES, 3.7% of SES and 3.8% of PES treated patients ([EES vs. SES] adjusted HR=0.58, 95% CI 0.39–0.88; [EES vs. PES] adjusted HR=0.29, 95% CI 0.13–0.67). Similarly, patients treated with EES had a lower risk of target-lesion revascularization (TLR) compared to patients treated with SES and PES ([EES vs. SES], 5.6% vs. 11.5%, adjusted HR=0.68, 95% CI: 0.55–0.83; [EES vs. PES], 5.6% vs. 11.3%, adjusted HR=0.51, 95% CI: 0.33–0.77). There were no differences in other safety end points, such as all-cause mortality, cardiac mortality, myocardial infarction (MI) and MACE. ConclusionIn diabetic patients, the unrestricted use of EES appears to be associated with improved outcomes, specifically a significant decrease in the need for TLR and ST compared to early generation SES and PES throughout 3-year follow-up.

Treatment of small coronary arteries with a paclitaxel-coated balloon catheter in the PEPCAD I study: are lesions clinically stable from 12 to 36 months?

The one-year outcome of lesions in small coronary arteries by using a paclitaxel-iopromide-coated (3 µg/mm²) balloon catheter (DCB) has yielded good six-month angiographic and one-year clinical data. We now report the three-year clinical follow-up. One hundred and twenty patients with >70% stenoses <22 mm in length in small coronary vessels (vessel diameter: 2.25-2.8 mm) were treated with the DCB. The primary endpoint was angiographic in-segment late lumen loss. The secondary endpoints encompassed all other angiographic and clinical data up to three years post intervention. In total 82/120 (68.3%) patients with a vessel diameter of 2.35±0.19 mm were treated with the DCB only, and 32/120 (26.7%) patients required additional bare metal stent (BMS) deployment. Both the 12- and 36-month major adverse cardiac event rates were 5/82 (6.1%) for DCB only and 12/32 (37.5%) for DCB+BMS, primarily due to the need for target lesion revascularisation in 4/82 (4.9%) patients and 9/32 (28.1%) (p<0.001) patients, respectively. Total MACE rate after 36 months was 18/120 (15%; intention-to-treat). Treatment of small vessel coronary artery disease with a paclitaxel-iopromide-coated balloon exhibited good six-month angiographic and one-year clinical data that persisted during the three-year follow-up period. Randomised trials will clarify its role as an alternative to drug-eluting stents in the treatment of small vessel coronary artery disease. (ClinicalTrials.gov Identifier: NCT00404144).

Stent thrombosis after primary angioplasty - incidence, timing and long term prognostic: 5 year follow-up registry

Objective: This study sought to assess long term incidence, timing and prognostic of stent thrombosis (ST) after drug-eluting stent (DES) or bare-metal stent (BMS) implantation in patients undergoing primary percutaneous coronary intervention (PPCI). Background: Although DES remarkably reduced the incidence of stent-restenosis and the need for target lesion revascularization (TLR) compared to BMS, its widespread use has raised concerns regarding the occurrence of very late ST (>1 year). The incidence and timing of ST remain unsettled, with consequent uncertainty about risk stratification and long-term recommendations for antiplatelet medications. Methods: From 2001 to 2007 consecutive patients undergoing PPCI single tertiary-care center were included and prospectively followed up for at least 5 years. We analyzed ST occurrence as defined by the Academic Research Consortium (ARC) and also assessed the cumulative incidence of major adverse cardiac events (MACE) defined as death, reinfarction or TLR at 5-year follow up. Results: There were 1156 STEMI patients undergoing PPCI in study period. Patients not receiving a stent (92, 7.9%) were excluded from the analysis. Forty patients (3.8%) were lost to follow up. Mean follow up time was 64.3 months. DES was used in 417 (39.2%). Patients receiving DES were more likely to be younger (61±10 vs 69±11, p=0.03) and have single vessel disease (56 vs 48%, p= 0.02). No other baseline characteristics were found to differ between the 2 groups (Diabetes 18.3%, Severe LV dysfunction 10.2%). Five-year definite ST was found in 6 patients (1.44%) in the DES group and in 4 (0.75%) in BMS group. Considering definite or probable ST the total events number raised to 11 (2.6%) in the DES group and to 22 (4.1%) in BMS group. There was also no difference in the timing of ST (very late ST for BMS 1.1% vs 1.4% for DES, p=ns). Interestingly, ST was associated with an increase in 5-year MACE as compared to pts with reinfarction not due to ST (33 vs 19.8%, p=ns). This was not driven by a mortality difference. Conclusion: Stent thrombosis is an infrequent event (3,38%) after PPCI at 5-year follow up. DES use in this setting was not associated with an increases risk of ST. Although ST is linked with dismal prognosis, this does not seem to be worse than a reinfartion unrelated to ST.

Spot Stenting is Preferable in Long Diffuse Coronary Lesions: Possible Incremental Value of Physiologic and Intracoronary Imaging Modalities

The treatment of long and diffuse coronary lesions with percutaneous coronary intervention (PCI) has been problematic since the era of plain balloon angioplasty. With the advent of bare-metal stents (BMS), long and multiple stents were used to completely cover the diseased segments in order to improve outcomes. Lesion length has been proven to be a factor related to higher rates of restenosis and target lesion revascularization (TLR) and the risk was further increased by the multiplicity of implanted stents. Covering the lesion with the least number of non-overlapping stents might reduce the risk of restenosis. This strategy, called spot stenting , was initially tested in the BMS era to treat discrete high-grade disease within moderately diseased vessel segments and has been shown to significantly reduce restenosis rates. Drug-eluting stents (DES) have been consistently shown to reduce restenosis and the need for TLR and thus provide improved clinical efficacy compared with BMS. However, even with DES, diffuse disease and long lesions are still associated with an increased risk of restenosis, need for TLR and major adverse cardiac events (MACE). A major long-term concern regarding DES is the potential for stent thrombosis which is increased after complex procedures with implantation of longer, multiple and overlapping stents. Data are limited but recent reports suggest that even when DES are used, selective stenting of only the severely narrowed areas of long lesions reduces the risk of MACE compared to full lesion coverage. The data supporting the spot stenting approach along with some considerations regarding the technique are presented herein.

Rationale and design of the LEADERS FREE trial: A randomized double-blind comparison of the BioFreedom drug-coated stent vs the Gazelle bare metal stent in patients at high bleeding risk using a short (1 month) course of dual antiplatelet therapy

Major bleeding is a powerful predictor of morbidity and mortality after percutaneous coronary intervention (PCI). To avoid prolonged dual antiplatelet therapy (DAPT), current guidelines recommend using a bare metal stent when PCI is indicated to treat patients at high risk of bleeding. The Biolimus A9-coated BioFreedom is a new stainless steel drug-coated stent devoid of polymer and has been shown to be associated with a low median late-loss of 0.17 mm at 12 months of follow-up. In an animal model, 98% of the drug has diffused into the vessel wall at 1 month. It is therefore reasonable to consider that such a device may have a potential safety advantage, and a lesser dependence on prolonged DAPT than a polymer-coated drug-eluting stent. A total of 2456 patients considered at high risk of bleeding will be randomized in a double-blind fashion to the BioFreedom drug-coated stent or to a control arm (Gazelle bare metal stent). Both groups will be treated with DAPT during 1 month only, followed by long-term aspirin alone. At 1-year follow-up, the primary safety endpoint (a composite of cardiac death, myocardial infarction and stent thrombosis) will be assessed by a non-inferiority analysis, and the primary efficacy endpoint (clinically driven target lesion revascularization) by a superiority analysis. This trial should help better characterize a neglected subset of PCI patients and quantify both their thrombotic and bleeding risks. It has the potential to decrease the need for target lesion revascularization in patients unable to tolerate a prolonged course of DAPT and will assess the shortest DAPT course ever used with an active stent.

MISAGO 2: One-Year Outcomes After Implantation of the Misago Self-Expanding Nitinol Stent in the Superficial Femoral and Popliteal Arteries of 744 Patients

To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117). Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed. In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure. The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.

Everolimus-eluting stents compared with paclitaxel-eluting stents for treatment of coronary in-stent restenoses

Everolimus-eluting stent (EES) implantation was superior to paclitaxel-eluting stent (PES) implantation for treatment of de-novo coronary artery disease. We evaluated the outcome of EES compared with PES for treatment of restenosis in bare-metal and drug-eluting stents (DES). In a prospective observational study patients with in-stent restenosis (ISR) were treated with EES (N=91) or PES (N=107). Dual antiplatelet therapy was given for 6 months. Patients were scheduled for 6 months angiographic follow-up and 24 months clinical follow-up. Primary outcome measure was the occurrence of major adverse cardiac events (MACE) defined as a composite of cardiac death, any myocardial infarction and target lesion revascularization (TLR). Baseline data showed some differences between groups including frequency of DES restenosis, length of stented segment and reference vessel diameter. For EES versus PES occurrence of MACE (18.7% vs. 15.0%, p=0.48) and need for TLR did not differ (13.2% vs. 9.3%, p=0.39). In-stent late loss was similar with 0.20±0.39 mm for EES and 0.18±0.31mm for PES (p=0.34). Binary angiographic restenosis rate for the total segment was 18.0% and 16.7% (p=0.85), respectively. In multivariable analysis the stented length (p=0.014), minimal lumen diameter post stenting (p<0.01) and repeated restenosis (p<0.001) were risk factors for a higher late loss but not type of DES or presence of diabetes mellitus. In this observational registry treatment of DES and BMS restenosis with EES versus PES implantation resulted in similar clinical and angiographic outcome.

Drug-Coated Balloons for Coronary and Peripheral Interventional Procedures

Paclitaxel-coated balloon (PCB) angioplasty reduces neointimal proliferation, restenosis, and clinical need for target lesion revascularization (TLR). PCB was superior for coronary restenosis in bare-metal and drug-eluting stents compared with uncoated balloon angioplasty and was noninferior compared with paclitaxel-eluting stents. PCB angioplasty should be considered for treatment of coronary in-stent restenosis. For de novo lesions, PCB plus endothelial progenitor cell capturing stents reduced restenosis and TLR in early reports. Among patients with de novo lesions and diabetes, the combination of PCB plus bare-metal stent revealed similar results in lesions compared with paclitaxel-eluting stents. The early results for PCB in small vessels are also very encouraging. Dual antiplatelet therapy duration may be shorter with PCB angioplasty compared with drug-eluting stents. Nevertheless, the risk for thrombotic vessel occlusion is minimized. Considering peripheral arterial disease, PCB angioplasty for femoropopliteal lesions was superior to uncoated balloon angioplasty. Registries indicate PCB to also be effective in lesions below the knee. Since there is no certain class effect, efficacy and safety have to be demonstrated for different types of PCB for coronary and peripheral interventions.

Sirolimus‐ versus paclitaxel‐eluting stents for coronary bifurcations intervention

Relative efficacy and safety of sirolimus-eluting stents (SES) compared with paclitaxel-eluting stents (PES) remains controversial. It is unknown whether there are different effect and safety in coronary bifurcation treatment between SES and PES. The meta-analysis was performed to compare the clinical outcomes of SES and PES in coronary bifurcation intervention. Five head-to-head clinical trials of SES versus PES in coronary bifurcation intervention were included. A total of 2,567 patients were involved in the meta-analysis. Mean follow-up period ranged from 6 to 35 months. The primary end points were the need for target lesion revascularization (TLR) and main-branch restenosis. Secondary end points were target vessel revascularization (TVR), cardiac death, major adverse cardiac events (MACE), and stent thrombosis. Compared with PES, SES significantly reduced the risk of TLR (5.3% vs. 10.6%, odds ratio (OR) 0.52; 95% confidence interval (CI) = 0.38-0.70, P < 0.001), main-branch restenosis (4.59% vs. 12.59%, OR 0.31; 95% CI = 0.18-0.55, P < 0.001) and TVR (7.05% vs. 12.57%, OR 0.58; 95% CI = 0.42-0.81, P = 0.001) in coronary bifurcation intervention. In addition, SES group also had a significantly lower incidence of MACE (8.20% vs. 14.13%, OR 0.58; 95% CI = 0.40-0.84, P = 0.004) than PES group. However, there were no statistical difference with respect to the incidence of cardiac death (1.64% vs. 1.09%, P = 0.19) and stent thrombosis (0.84% vs. 1.08%, P = 0.64) between SES and PES groups. Compared with PES, SES reduced the incidence of TLR, main-branch restenosis and MACE in coronary bifurcation intervention, while the risk of stent thrombosis was similar between SES and PES groups.

The genous™ endothelial progenitor cell capture stent accelerates stent re‐endothelialization but does not affect intimal hyperplasia in porcine coronary arteries

To study the effect of endothelial progenitor cell (EPC) capture on the vascular response to coronary stenting. The introduction of drug-eluting stents has reduced the need for target lesion revascularization, but their effect on delayed healing, inflammation, and vascular dysfunction has emphasized the need to design strategies that improve current DES. One such strategy is to improve endothelialization by capturing CD34-positive cells (EPC) by the stent surface. The first human clinical trial using coronary EPC capture stents showed stent safety but neointimal thickness (NIT) was not reduced compared to bare metal stents (BMS). To understand these responses we studied the coronary response to the EPC capture stent in swine. The stent, coated with murine antihuman monoclonal CD34 antibodies, was assessed with QCA guided stent implantation in normal swine coronary arteries for early endothelialization at 2 and 5 days, and NIT at 28 and 90 days in comparison to control stents carrying a non-specific murine antibody or to BMS. The main finding was that while the EPC capture stent significantly improved early endothelialization it did not reduce NIT at 28 and 90 days. The EPC capture stent improves early endothelialization in swine but this does not affect neointimal thickness as compared to control stents at 28 and 90 days.

AS-220 Comparison of Mid-term Angiographic Assessments between Bare Metal Stent (S-stent) and Drug-Eluting (Paclitaxel-Eluting) Stent in the Large Coronary Artery

Drug-eluting stents (DES) have dramatically reduced the rate of restenosis and the need for target lesion revascularization (TLR) in a wide range of coronary lesions compared with bare metal stent (BMS). However, DES raises a matter of some concerns about the risk of prolonged dual anti-platelet therapy, the potential for late adverse events such as very late stent thrombosis. Thus, BMS may be still useful for selected lesions even in DES era. Therefore, we investigated mid-term angiographic outcomes of S-stent compared to paclitaxel-eluting stent (PES) for the treatment of large vessels.

Five‐year clinical outcomes of sirolimus‐eluting versus paclitaxel‐eluting stents in high‐risk patients

First generation drug-eluting stents have shown differential efficacy in high-risk patient subsets at one year. It is unclear whether these differences endure over the medium- to long-term. We compared the five-year clinical efficacy and safety of sirolimus-eluting stents (SES) and paclitaxel-eluting stents (PES) in a population of high-risk patients. The patient cohorts of the ISAR-DESIRE, ISAR-DIABETES, and ISAR-SMART-3 randomized trials were followed up for five years and data were pooled. The primary efficacy endpoint of the analysis was the need for target lesion revascularization (TLR) during a five-year follow-up period. The primary safety endpoint was the combination of death or myocardial infarction (MI) after five years. A total of 810 patients (405 patients in the SES group and 405 patients in the PES group) was included. Over five years TLR was reduced by 39% with SES compared with PES stent (hazard ratio [HR] 0.61; 95% confidence interval [CI] 0.44-0.85; P = 0.004). No difference was observed according to death or MI rates between the two groups (HR 1.10; 95% CI 0.80-1.50; P = 0.57). Definite stent thrombosis occurred in 0.2% (n = 1) in the SES group and in 1.6% (n = 6) in the PES group (HR 0.16; 95% CI 0.02-1.34; P = 0.12). In high-risk patient subsets the lower rate of 12-month TLR observed with SES in comparison PES is maintained out to five years. In terms of safety, although there was no difference in the overall incidence of death or MI, there was a trend towards more frequent stent thromboses with PES.

Percutaneous Coronary Intervention With Drug-Eluting Stent for Unprotected Left Main Trunk Disease: Safety and Efficacy Compared With Bare Metal Stent

Coronary artery bypass grafting has long been considered the standard revascularization treatment for unprotected left main trunk disease (ULMTD). Percutaneous coronary intervention (PCI) with bare metal stent (BMS) was performed on patients for whom coronary artery bypass grafting was a high risk or those selected by lesion anatomy such as large simple ostial or body lesion. However, its clinical indication is limited by the high rate of target lesion revascularization (TLR). PCI with drug-eluting stent (DES) is increasingly being performed because of its lower TLR rate. Randomized and meta-analysis studies demonstrate that PCI with DES for ULMTD, compared with BMS, could be more strongly associated with a significant reduction in the need for TLR without any additional adverse outcomes, although it has some limitations on indications.