Target Lesion Revascularization Rate Research Articles

Laser versus balloon angioplasty in endovascular management of infragenicular tibial arterial occlusion in critical limb ischemic TASC D: Six L Trial

We aim to compare cool excimer laser-assisted angioplasty versus tibial balloon angioplasty (TBA) in critical limb ischemia (CLI) patients, with tibial artery occlusive disease. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease. 80 patients underwent 89 endorevascularizations for tibial occlusions; 47 using TBA and 42 using cool excimer laser-assisted angioplasty. All patients were Rutherford Category 4, 5, or 6, with TASC D lesions.Five-year sustained clinical improvement was enhanced with laser angioplasty (76%) compared to TBA (62%; P=0.1004). Rate of revascularization performed due to progression of arteriosclerosis was significantly higher post-TBA (P=0.006). Major adverse clinical events at 5 years were significantly more pronounced in TBA, 38% versus 66% (P=0.001). Laser angioplasty patients had significantly improved quality time spent without symptoms of disease or toxicity of treatment (10.5 months; P=0.048) with an incremental cost of €2073.19 per quality-adjusted life-year gained.Tibial endovascularization bestows an exceptional outcome in CLI TASC D lesions. Both laser angioplasty and TBA impart recuperated clinical and technical success rates and are superior to bypass surgery. Laser is cost-effective with superior quality time spent without symptoms of disease or toxicity of treatment and quality-adjusted life-years. It offers superior quality of life, with enhanced immediate clinical improvement, reduced binary restenosis, and target lesion revascularization rates. It boosts outstanding survival rates, free from major clinical events at 5 years.

The efficacy of everolimus-eluting stent implantation in patients with ST-segment elevation myocardial infarction: outcomes of 2-year clinical follow-up.

First-generation drug-eluting stents (DES) demonstrated delay in vascular healing and increase in incidence of late and very late stent thrombosis compared with bare-metal stents (BMS). Second-generation DES, however, have shown a reduction of late and very late stent thrombosis compared with first-generation DES. Thus, we decided to evaluate whether the second-generation everolimus-eluting stent (EES) has an advantage over BMS in Japanese patients with ST-segment elevation myocardial infarction (STEMI). This study was conducted in two centers, retrospective, non-randomized and observational design in patients with STEMI. Three-hundred eighty patients were randomly selected to receive EES (198 patients) or cobalt-chromium BMS (182 patients). The primary endpoints were cardiac death, recurrent myocardial infarction (MI), target lesion revascularization (TLR), target vessel revascularization (TVR), and stent thrombosis (ST). At 2years, the rates of TLR, TVR, and recurrent MI were significantly lower in the EES group than in the BMS group (TLR 1.5 vs. 8.3%, p<0.05; TVR 2.5 vs. 9.4%, p<0.05; recurrent MI 1.0 vs. 4.1%, p<0.05), and the rate of ST was also significantly lower in the EES group than in the BMS group (0.5 vs. 4.3%, p<0.05). Thus, major adverse cardiac events defined at the composite cardiac death, MI, TLR, TVR, or ST were significantly lower in EES group than in BMS group (3.0 vs. 9.9%, p=0.008). The rate of cardiac death, however, did not differ between both groups. In STEMI patients, EES may be associated with improved outcomes-specifically, a significant reduction in TVR, ST, and recurrent MI compared to BMS throughout 2years.

Mechanism of in-stent restenosis after second-generation drug-eluting stents (DES): is it different from bare-metal stents and first-generation DES?

First-generation drug-eluting stents (DES) have dramatically reduced the rate of in-stent restenosis (ISR) and subsequent target lesion revascularization (TLR) compared with bare-metal stents (BMS) (1). However, widespread use of first-generation DES has drawn attention to several unresolved, clinically relevant issues such as late stent thrombosis (ST) and late restenosis (2). Histopathological studies of first-generation DES have revealed that a chronic reaction to components of the permanent polymer reaction may lead to the delayed arterial healing, which is associated with increased risks of late DES failure (3,4). In addition, neoatherosclerosis is suggested as another cause of very late ST and late TLR (5). To overcome these limitations, biocompatible and biodegradable polymers have been developed and equipped with second-generation DES. Recent clinical trials demonstrated that second-generation DES has the improved efficacy and safety compared with those of first-generation DES (6,7). Nevertheless, second-generation DES, as well as first-generation DES, are not immune to ISR. In fact, Cassese et al. reported a large cohort of patients with angiographic surveillance that ISR rate of second-generation DES remains higher than 10% (8). Therefore, it is important to elucidate the mechanism of ISR after second-generation DES compared with that of BMS and first-generation DES, which may play a crucial role in the newly developed DES.

Management of drug eluting stent in-stent restenosis: A systematic review and meta-analysis.

The optimal management for coronary drug eluting stent in-stent restenosis (DES ISR) is unclear. We performed a meta-analysis of observational and randomized studies to compare the outcomes of management of DES ISR using DES, drug eluting balloon (DEB), or balloon angioplasty (BA). Eligible studies (25 single arm and 13 comparative, including 4 randomized studies with a total of 7,474 patients with DES ISR) were identified using MEDLINE search and proceedings of international meetings. Outcomes studied include major adverse cardiac events (MACE), target lesion revascularization (TLR), target vessel revascularization (TVR), myocardial infarction (MI), stent thrombosis (ST), and mortality. Follow-up ranged from 0.5 to 3.5 years (mean 1.4 years). The rate of TLR was significantly lower in the DES (odds ratio [OR] 0.50, 95% confidence interval [CI] 0.36-0.69) and DEB (OR 0.31, 95% CI 0.18-0.55) groups compared to BA. Similarly, TVR rate was significantly lower in the DES (OR 0.55, 95% CI 0.39-0.77) and DEB (OR 0.32, 95% CI 0.18-0.58) groups compared to BA. All other outcomes were similar between the DES/BA and DEB/BA comparisons. TLR was significantly lower in the DES group compared to BA for vessels < or > 2.75 mm. Treatment of coronary DES ISR with DES or DEB is associated with a reduction in the risk of TLR and TVR compared to BA alone. The relative risk reduction for TLR with DES is similar to DEB. DEBs have a potential role in the treatment of DES ISR by avoiding placement of another layer of stent. © 2015 Wiley Periodicals, Inc.

The influence of age on clinical outcomes in patients treated with the resolute zotarolimus‐eluting stent

To evaluate the rate of clinical events and bleeding risk according to age in patients undergoing percutaneous coronary intervention (PCI) with a new-generation drug-eluting stent (DES) enrolled in the RESOLUTE Global Clinical Program. This study represents a pooled analysis of five trials included in the RESOLUTE program including 5,130 patients, of whom 1,675 (32.6%) were ≥70 years old (elderly patients). After adjusting for confounders, age ≥70 years was a significant predictor of high mortality at 30 days (0.6 vs. 0.1%, P = 0.017) and 2 years (7.2 vs. 2%, P < 0.001). No differences were seen with respect to acute myocardial infarction (MI) or target lesion and vessel revascularization rates between young and elderly patients. Bleeding rates were higher in the elderly throughout follow-up. In the elderly, 7 of the 27 (26%) patients with bleeding episodes died, with a median time between bleeding episode to death of 21 days. In the younger population, 1 patient of 17 with a bleeding episode died (400 days later). Elderly patients undergoing PCI with a new-generation DES have increased mortality and bleeding risk, with similar rates of acute MI and repeat revascularization. Bleeding risk was higher in the elderly and strongly related to death. Target lesion failure rates were not significantly different between the two age groups, suggesting that the Resolute zotarolimus-eluting stent (R-ZES) is effective for patients younger and older than 70 years of age. R-ZES may be recommended for elderly patients when PCI with a DES is identified as a suitable option.

Impact of intravascular ultrasound on the long‐term clinical outcomes in the treatment of coronary ostial lesions

To evaluate the long-term outcomes of patients with ostial lesions who underwent percutaneous coronary intervention (PCI) with and without the use of intravascular ultrasound (IVUS). A higher rate of adverse cardiac events is associated with PCI of ostial lesions as compared with nonostial disease. From 7/2002 to 8/2010, 225 patients with 233 coronary ostial lesions underwent PCI with (n = 82) and without (n = 143) IVUS guidance. Ostial lesions included both native aorto-ostial or major coronary vessel (left anterior descending, left circumflex, and ramus intermedius) lesions. Clinical outcomes [cardiovascular death, myocardial infarction (MI), and target lesion revascularization (TLR)] at a mean follow-up of 4.2 ± 2.5 years were compared between patients undergoing PCI of an ostial lesion with and without use of IVUS using univariate and propensity score adjusted analyses. Aorto-ostial lesions (n = 109) comprised 47% of lesions, whereas the remaining lesions (53%) involved major coronary vessels. After propensity score adjustment, IVUS use was associated with lower rates of the composite of cardiovascular death, MI, or TLR (HR 0.54, 95% CI 0.29-0.99; P = 0.04), composite MI or TLR (HR 0.39, 95% CI 0.18-0.83; P = 0.01), and MI (HR 0.31, 95% CI 0.11-0.85; P = 0.02) as compared with no IVUS. The use of IVUS was also associated with a trend towards a lower rate of TLR (HR 0.42, 95% CI 0.17-1.02; P = 0.06). PCI of coronary ostial lesions with the use of IVUS was associated with significantly lower rates of adverse cardiac events.

Circulation : Clinical Summaries

<i>Circulation</i> : Clinical Summaries

The Contemporary Safety and Effectiveness of Lower Extremity Bypass Surgery and Peripheral Endovascular Interventions in the Treatment of Symptomatic Peripheral Arterial Disease

Treatment for symptomatic peripheral artery disease includes lower extremity bypass surgery (LEB) and peripheral endovascular interventions (PVIs); however, limited comparative effectiveness data exist between the 2 therapies. We assessed the safety and effectiveness of LEB and PVI in patients with symptomatic claudication and critical limb ischemia. In a community-based clinical registry at 2 large integrated healthcare delivery systems, we compared 883 patients undergoing PVI and 975 patients undergoing LEB between January 1, 2005 and December 31, 2011. Rates of target lesion revascularization were greater for PVI than for LEB in patients presenting with claudication (12.3±2.7% and 19.0±3.5% at 1 and 3 years versus 5.2±2.4% and 8.3±3.1%, log-rank P<0.001) and critical limb ischemia (19.1±4.8% and 31.6±6.3% at 1 and 3 years versus 10.8±2.5% and 16.0±3.2%, log-rank P<0.001). However, in comparison with PVI, LEB was associated with increased rates of complications up to 30 days following the procedure (37.1% versus 11.9%, P<0.001). There were no differences in amputation rates between the 2 groups. Findings remained consistent in sensitivity analyses by using propensity methods to account for treatment selection. In patients with symptomatic peripheral artery disease, in comparison with LEB, PVI was associated with fewer 30-day procedural complications, higher revascularization rates at 1 and 3 years, and no difference in subsequent amputations.

Abstract 12908: Effects of Metabolic Syndrome on In-Stent Restenosis After PCI: Obesity Paradox and Sex-Associated Differences

Background: The impact of metabolic syndrome (MetS) on the efficacy of PCI remains controversial. Hypothesis: This controversy may be due in part to a positive influence of obesity (the “obesity paradox”) among the factors included in the definition of MetS. Fat distribution also varies by sex, possibly confounding the impact of obesity. Methods: To elucidate the possible effects of obesity in MetS patients on in-stent restenosis (ISR) or target lesion revascularization (TLR), 546 patients treated with coronary stents (BMS or DES) were stratified according to the presence of MetS with or without obesity, using NCEP-ATP III guidelines. Waist circumference or BMI (in patients without waist circumference data) was used for diagnosis of obesity. Follow-up angiography was scheduled 8 to 9 months after PCI to obtain ISR, which was defined as %diameter stenosis (%DS)&gt;50%. Results: Mean age of the subjects was 70.5±9.8 years, and 32.1% were female. By standard criteria, 286 patients (52.4%) were diagnosed as MetS, and 320 patients (58.6%) met criteria for obesity. Among MetS patients, 61 patients (21.3% of MetS patients) were categorized as non-obesity. At 8 to 9 months follow-up, % DS, ISR rates, and TLR rates had trends to be higher in MetS than no-MetS (ISR; 26.6% in MetS, 20.0% in non-MetS, p=0.085). These parameters showed no difference between obesity and non-obesity (ISR; 23.8% in obesity, 23.0% in non- obesity, p=0.918, TLR; 14.1% in obesity, 15.0% in non-obesity, p=0.805). In patients with MetS (Figure), however, the ratio of %DS and ISR were significantly greater in the absence of obesity in female patients, whereas no difference was observed in male patients. In multivariate analysis, non-obesity was an independent predictor for ISR or TLR in female patients with MetS. Conclusions: Overall, obesity was not related to ISR or TLR after PCI. In female MetS patients, however, comorbidity of obesity appeared to be paradoxically protective.

Treatment of drug-eluting stents in-stent restenosis with paclitaxel-coated balloon angioplasty: Insights from the French “real-world” prospective GARO Registry

BackgroundData about paclitaxel-eluting balloon (PCB) angioplasty to treat drug-eluting stents (DES) in-stent restenosis (ISR) were mainly collected in selected patient populations in the setting of randomized trials. The main goal of this prospective registry was to confirm the positive findings of these studies in an unselected population in clinical practice. MethodsConsecutive patients with DES-ISR treated by PCB angioplasty were recruited in this prospective real-world registry. The primary endpoint was clinically driven target-lesion revascularization (TLR) at 9months. Secondary endpoints included acute technical success, in-hospital outcomes, 9-month major adverse cardiac events (MACE) a composite of death, myocardial infarction (MI) and TLR and the occurrence of target vessel revascularization. ResultsA total of 206 patients (67.7±10.2years, 80.6% male, 41.3% diabetics) with 210 lesions were recruited. Unstable coronary artery disease was present in 55.3% of patients. The time from DES implantation to DES-ISR was 3.0±2.4years. Quantitative analyses revealed that patterns of treated DES-ISR were focal in 55.7% and diffuse in 44.3%. The reference diameter was 2.76±0.64mm. The 9-month follow-up rate was 90.8% (187/206). At 9months, the TLR rate was 7.0% (13/187) whereas the rates for MACE, MI and cardiac death were 10.7% (20/187), 4.8% (9/187) and 2.1% (4/187) respectively. Results were consistent in patients with paclitaxel and non-paclitaxel-eluting stents (PES) ISR. ConclusionThis large prospective registry demonstrated acceptable rates of TLR and MACE at 9months after treatment of DES-ISR by PCB angioplasty. PCB angioplasty was equally effective in patients with PES-ISR and non PES-ISR.

Bioresorbable scaffolds in daily clinical routine: a practical review of all-comers results.

Bioresorbable scaffolds (BRS) are a major advancement in interventional cardiology, but experience with BRS use in daily routine is currently limited. Here, we review technical features of commercially available BRS and place them in context with current clinical scientific evidence. Everolimus and novolimus-eluting poly-L-lactic acid (PLLA)-based BRS are commercially available in Europe. The everolimus-eluting BRS is the most widely investigated BRS and several all-comers investigations with this device are ongoing. Of the patients in these studies, 37-100% underwent catheterization due to acute coronary syndrome and up to 25% were diabetic. Up to 64.7% of all lesions treated were considered to be complex. Follow-up varied between 30 days and 1 year. The target lesion revascularization rate was up to 10% and scaffold thrombosis was 0-3%. Accumulating data on BRS application are now available. Several studies have demonstrated that BRS implantation is technically feasible in a variety of different patient subsets and clinical presentations, and follow-up results support BRS use. Patients with acute coronary syndrome represent the most investigated subpopulation, and results suggest that BRS use for this indication is reasonable.

Paclitaxel-Eluting Balloon vs Standard Angioplasty to Reduce Restenosis in Diabetic Patients With In-Stent Restenosis of the Superficial Femoral and Proximal Popliteal Arteries

Purpose: To report the 3-year safety and effectiveness outcomes from the prospective all-comers DEBATE-ISR study (ClinicalTrials.gov identifier NCT01558531) of symptomatic diabetic patients with femoropopliteal in-stent restenosis (ISR) undergoing treatment with paclitaxel-eluting balloons compared with historical diabetic controls. Methods: From January 2010 to December 2011, 44 consecutive diabetic patients (mean age 74±11 years; 32 men) were treated with drug-eluting balloons (DEBs) and enrolled in the study. The control group comprised 42 consecutive diabetic patients (age 76±7 years; 23 men) treated with conventional balloon angioplasty (BA) from 2008 to 2009. Results: No significant differences in terms of clinical, angiographic, or procedural characteristics were observed between the study groups. Critical limb ischemia was present in the majority of patients. Tosaka class III ISR was observed in more than half of the patients. Mean lesion length was 132±86 and 137±82 mm in the DEB and BA groups, respectively (p=0.7). At 3-year follow-up, the rate of target lesion revascularization (TLR) was 40% in the DEB group vs 43% in the BA group (p=0.8); Kaplan-Meier analysis showed no significant differences in terms of freedom from TLR. The presence of a Tosaka class III occlusion was associated with a worse outcome in both study groups (odds ratio 3.96, 95% confidence interval 1.55 to 10.1, p=0.004). Conclusion: Using DEBs for femoropopliteal ISR yielded similar results to BA in terms of TLR at 3-year follow-up. The treatment of more complex ISR lesions was associated with an increased rate of TLR, irrespective of the technology used.

Long-term outcomes of rotational atherectomy in coronary bifurcation lesions

The aim of the present study was to determine the long-term outcomes of bifurcation lesions following a rotational atherectomy (ROTA). In this retrospective study, patients that had undergone a ROTA of the bifurcation coronary lesions in Juntendo University Hospital (Tokyo, Japan) were enrolled between January 2007 and December 2009, and received follow-up for a median duration of 48 months (range, 12-84 months). A total of 337 patients were enrolled. Each patient was treated with an average of 1.2±0.4 ROTA burrs (mean size, 2.9±0.3 mm). Baseline lesion length, reference diameter, minimal lumen diameter (MLD) and percentage of diameter stenosis (%DS) prior to the procedure were comparable between the DM and non-DM patients. Furthermore, MLD, %DS and acute gain following the procedure were similar between the two groups. At follow-up, DM patients exhibited a significantly decreased MLD (1.97±0.92 vs. 2.26±0.73 mm; P=0.0038), increased %DS (27.9±21.3 vs. 20.2±13.3%; P=0.022) and late loss (0.70±0.45 vs. 0.42±0.36 mm; P=0.0047) compared with the non-DM patients. Follow-up examinations (mean duration, 52.2±19.4 months) revealed that the DM patients experienced significantly higher rates of target lesion revascularization (TLR) [28 (15.7%) vs. 8 (5.0%); P=0.0011], target lesion (TL) restenosis [46 (25.8%) vs. 20 (12.6%); P=0.0019] and major adverse cardiac events (MACE) [36 (20.2%) vs. 19 (12.0%), P=0.039] compared with the non-DM patients. Although the usage of ROTA and drug-eluting stent evidently improved long-term outcomes in patients with bifurcation lesions, DM remained an independent risk factor for TLR, TL restenosis and MACE. Therefore, the management of DM in bifurcation lesions treated with ROTA requires increased investigation in future clinical practice.

Paclitaxel-coated versus plain balloon angioplasty in the treatment of infrainguinal vein bypass stenosis

The aim of this study was to compare the clinical and hemodynamic outcomes of plain vs paclitaxel-coated percutaneous transluminal angioplasty (PTA) in patients with infrainguinal vein bypass stenosis. A single-center retrospective analysis was conducted of consecutive patients treated by infrainguinal bypass PTA. Primary study end points were primary and assisted primary patency. Secondary end points were clinical and hemodynamic improvement, limb salvage, and survival. Society for Vascular Surgery reporting standards were applied. From April 2008 to November 2014, 83 infrainguinal vein bypasses were treated for graft stenosis by plain (group A, n = 41) or by paclitaxel-coated PTA (group B, n = 42). The groups did not differ significantly in mean age (71.9 years for both groups; P = .99), hypertension (P = 1.0), hyperlipidemia (P = .5), diabetes (P = .6), coronary artery disease (P = 1.0), smoking (P = 1.0), preoperative ankle-brachial index (P = .08), or bypass characteristics (below-knee, P = .82). Technical success rate was 100% for both groups. Mean follow-up was 2.9 years for group A patients and 2.2 years for group B patients (P = .08). No patient was lost to follow-up. Primary patency rates were 88% vs 87% and 73% vs 75% (P = .19) and assisted primary patency rates were 88% vs 90% and 77% vs 84% (P = .76) for group A and B patients at 1 and 2 years, respectively. Repeat target lesion revascularization rates were 22% vs 14% (P = .17). At the last follow-up, there were eight vs seven bypass occlusions (P = .74) for group A and B patients, respectively. In univariate analysis, proximal in-graft stenosis (Cox F, P = .041), bypass failure <6 months after bypass surgery (Cox F, P = .013), more than one bypass stenosis per graft (Cox F, P = .047), and redo bypass procedure (Cox F, P = .0001) were significantly related to assisted primary bypass patency. Immediate hemodynamic and sustained clinical improvement rates were 88% vs 86% and 70% vs 73% for group A and B patients, respectively. There were three vs one major amputations (P = .36) and eight vs seven deaths (P = .78) in group A and B patients, respectively. Paclitaxel-coated and plain angioplasty of significant infrainguinal vein bypass stenoses performed equally well in clinical and hemodynamic improvement and in primary and assisted primary bypass patency rates.

Two-year clinical outcome in patients with small coronary artery disease treated with everolimus- versus paclitaxel-eluting stenting

BackgroundPercutaneous coronary interventions involving small coronary vessels represent a true challenge because of the increased risk of restenosis and adverse outcomes. We evaluated the 2-year clinical outcomes between single everolimus-eluting stents (EES) and paclitaxel-eluting stents (PES) in small coronary artery disease. MethodsFrom the data of SACRA (SmAll CoronaRy Artery treated by TAXUS Liberté) and PLUM (PROMUS/Xience V Everolimus-ELUting Coronary Stent for sMall coronary artery disease) registries, 245 patients with 258 lesions and 264 patients with 279 lesions, respectively, were enrolled in this study. ResultsThe 2-year clinical driven target lesion revascularization (4.5% vs. 10.6%, p=0.01) and target vessel revascularization (8.0% vs. 13.9%, p=0.03) rates were significantly lower in the EES group compared with the PES group. Major adverse cardiac events in the EES group tended to be lower than those in the PES group (8.7% vs. 14.3%, p=0.05). On the other hand, all new lesions for remote target vessel revascularization were observed at the proximal site of target lesions in both groups and those rates were not different between the two groups (3.4% vs. 3.3%, p>0.99). ConclusionEES showed better clinical results at 2-year follow-up compared with PES in small coronary artery diseases, however, new lesions at the proximal remote site of the target lesion remain problematic.

Short-Term and Long-Term Outcomes After Polytetrafluoroethylene-Covered Stent Implantation for the Treatment of Coronary Perforation

This study sought to evaluate the short-term and 3-year outcomes of polytetrafluoroethylene-covered stent (PCS) for patients with coronary perforation. Implantation of a PCS has improved the immediate clinical outcomes of patients with coronary perforation. However, there are few reports regarding long-term outcomes. We evaluated a total of 57 patients who were treated with PCS for coronary perforation from April 2004 to March 2015 at a single high-volume center in Japan. Landmark analysis was performed at 30 days to determine short-term and long-term outcomes. Major adverse cardiac events (MACE) were defined as death, myocardial infarction, target vessel revascularization, and requirement for surgical repair. Of 285 patients who experienced coronary perforation, 57 patients (20%) were treated with PCS. The MACE rates were 28% at 30 days, 22% at 1 year, and 38% at 3 years. 30-day MACE was mainly driven by high rates of myocardial infarction (18%) and surgical repair (16%). The rates of target lesion revascularization were 8% and 12% at 1 and 3 years, respectively. Definite stent thrombosis was reported in 2 patients during the follow-up period. In conclusion, despite the relatively high incidence of MACE during early stage of follow-up, implantation of a PCS provides acceptable late clinical outcomes.

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.

Nitinol stent implantation for femoropopliteal disease in patients on hemodialysis: results of the 3-year retrospective multicenter APOLLON study.

The clinical outcomes of nitinol stents for femoropopliteal arterial (FP) disease in patients on hemodialysis were assessed. Endovascular therapy (EVT) is accepted for symptomatic FP disease. However, the clinical outcomes of patients on dialysis are not well known. A multicenter retrospective study was conducted with data between November 2010 and August 2013. A total of 484 consecutive patients who successfully underwent EVT for FP disease with nitinol stents were recruited and analyzed. Patients were categorized into the hemodialysis group (N=161) and non-hemodialysis group (N=323). The primary measure was primary patency verified by duplex ultrasound at a rest peak systolic velocity (PSVR) of >2.5, and secondary measures were freedom from target lesion revascularization (TLR) and major amputation-free survival (AFS). Average follow-up duration was 19.5±13.5months. The primary patency rate at 3years was significantly lower in the hemodialysis group than the non-hemodialysis group (33.8 vs. 43.7%; p=0.036). Freedom from TLR at 3years was 55.0% in the hemodialysis group and 66.1% in the non-hemodialysis group (p=0.032). The hemodialysis group showed a significantly lower AFS rate at 3years than the non-hemodialysis group (86.4 vs. 58.2%; p<0.001). In hemodialysis patients, nitinol stent use resulted in a lower patency rate, higher TLR rate, and lower AFS rate compared to non-hemodialysis patients. These data suggest that nitinol stent implantation for FP arteries in hemodialysis patient needs to be reconsidered.

An analysis of the economic impact of drug-coated balloon use for the treatment of peripheral artery disease

&lt;p&gt;&lt;strong&gt;Background&lt;/strong&gt;: Drug-coated balloons (DCBs) are an alternative for patients with peripheral arterial disease. Costs and re-intervention rates are potentially reduced compared to other technologies. We assessed the economic impact of these endovascular therapies.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods&lt;/strong&gt;: An Italian National Healthcare Service-perspective budget impact model with a 5-year horizon was developed to compare relative costs of 4 index procedures (plain old balloon angioplasty (POBA), DCBs, and bare-metal and drug-eluting stents (BMSs, DESs)) based on 1-year repeat-procedure rates (target-lesion revascularization (TLR)). A published systematic review of TLR rates in patients with femoral-popliteal disease undergoing these treatments was used to measure effectiveness. Costs associated with each treatment were derived from diagnosis-related group tariffs. A decision analytic model was developed to estimate 1-year costs for index procedures and possible revascularizations.&lt;/p&gt;&lt;p&gt; &lt;/p&gt;&lt;p&gt;&lt;strong&gt;Results&lt;/strong&gt;: Pooled TLR rates show clear patient benefits for DCBs (6.9%) compared with POBA (21.6%) and BMSs (14.2%) and non-inferiority vs. DESs (7.3%). One-year payments for index and repeat interventions (by TLR rate) showed that DCBs were the least costly strategy, saving ~€1,000/patient vs. POBA. The potential savings were €8.7M, assuming 5% annual increase in DCB adoption over 5 years. &lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Conclusions&lt;/strong&gt;: Despite initial higher investment, DCB represent a cost-saving alternative to other technologies. &lt;strong&gt;&lt;/strong&gt;&lt;/p&gt;

Optimal threshold of postintervention minimum stent area to predict in-stent restenosis in small coronary arteries: An optical coherence tomography analysis.

The aim of this study was to determine the best threshold of postintervention minimum stent area (MSA) assessed by optical coherence tomography (OCT) to predict long-term in-stent restenosis (ISR) for 2.5 mm-diameter everolimus-eluting stents (EES). Percutaneous coronary intervention (PCI) for small coronary arteries remains challenging. Stent underexpansion is a strong predictor of late ISR. We performed a retrospective analysis of 69 lesions in 69 patients undergoing PCI with 2.5 mm-diameter stents using OCT for the assessment of postintervention MSA and subsequent 9-month angiographic follow-up. The rates of angiographic ISR and target lesion revascularization were 7.2% and 1.4%. The postintervention OCT-MSA of EES < 3.5 mm(2) for predicting ISR yielded a sensitivity of 80%, specificity of 71%, positive predictive value of 18%, and negative predictive value of 98%. There was a marginally significant trend between increasing MSA quartiles and decreasing ISR rate (P for trend = 0.07). Postintervention OCT-MSA of 3.5 mm(2) best predicted 9-month ISR following PCI with 2.5-mm-diameter EES. Further large, prospective, observational studies are warranted that validate this result. © 2015 Wiley Periodicals, Inc.