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Endovascular treatment (EVT) is the main treatment for peripheral artery disease (PAD). Despite advances in device development, the restenosis rate remains high in patients with femoropopliteal lesions (FP). This study aimed to evaluate the effectiveness of exercise training in reducing the 1-year in-stent restenosis rate of bare metal nitinol stents for FPs. This prospective, randomized, open-label, multicenter study was conducted from January 2017 to March 2019. We randomized 44 patients who had claudication with de novo stenosis or occlusion of the FP into an intensive exercise group (n = 22) and non-intensive exercise group (n = 22). Non-intensive exercise was defined as walking for less than 30 min per session, fewer than three times a week. We assessed exercise tolerance using an activity meter at 1, 3, 6, and 12 months, and physiotherapists ensured maintenance of exercise quality every month. The primary endpoint was instant restenosis defined as a peak systolic velocity ratio > 2.5 on duplex ultrasound imaging. Kaplan–Meier analysis was used to evaluate the data. There were no significant differences in background characteristics between the groups. Six patients dropped out of the study within 1 year. In terms of the primary endpoint, intensive exercise significantly improved the patency rate of bare nitinol stents at 12 months. The 1-year freedom from in-stent restenosis rates were 81.3% in the intensive exercise group and 47.6% in the non-intensive exercise group (p = 0.043). No cases of stent fracture were observed in the intensive exercise group. Intensive exercise is safe and reduces in-stent restenosis in FP lesions after endovascular therapy for PAD. Clinical trial registration: University Hospital Medical Information Network Clinical Trials Registry (No. UMIN 000025259).

Purpose: Information on the relationship between frailty and the outcome of endovascular therapy (EVT) in elderly patients with lower extremity peripheral artery disease (PAD) is scarce. This study aimed to reveal the impact of frailty on the prognosis of super-elderly patients who underwent EVT. Materials and Methods: From August 2015 to August 2016, 335 consecutive patients who underwent EVT were enrolled in the I-PAD registry from 7 institutes in Nagano prefecture. Among them, we categorized 323 patients into 4 groups according to age and the presence or absence of frailty as follows: elderly with frailty (age ≥ 75, Clinical Frailty Scale [CFS] ≥ 5), elderly without frailty (age ≥ 75, CFS ≤ 4), young with frailty (age < 75, CFS ≥ 5), and young without frailty (age < 75, CFS ≤ 4); we analyzed them accordingly. The primary endpoints were major adverse cardiovascular and limb events (MACLE), defined as a composite of cardiovascular death, myocardial infarction, stroke, admission for heart failure, major amputation, and revascularization. The secondary endpoint was cardiovascular death. Results: The median follow-up period was 2.7 years. In the elderly with frailty, elderly without frailty, young with frailty, and young without frailty groups, the freedom rates from MACLE were 34.9%, 55.7%, 35.4%, and 63.0%, respectively (pConclusion: Frailty as defined by CFS might be a predictor of MACLE incidence in patients with PAD who underwent EVT. By considering treatment indications for patients with PAD by focusing on frailty rather than age, we may examine whether EVT policies are appropriate and manage patient and caregiver expectations for potential improvement in functional outcomes. Further studies are expected to investigate whether changes in frailty after EVT change prognosis.

Nutritional status is a novel approach to prognostic assessment in patients with cardiovascular disease. However, assessment of nutritional status in elderly patients is challenging due to the significant differences between young patients. The TCBI (Triglycerides × Total cholesterol × Body Weight Index) is a novel and simple nutritional index for predicting long-term outcomes in patients with coronary artery disease. This retrospective study evaluated the efficacy of TCBI in 597 elderly (≥ 75 years) patients enrolled in the SHINANO 5 year registry. The SHINANO 5 year registry, a prospective observational multicenter cohort study, had enrolled 1501 consecutive patients who underwent elective/urgent percutaneous coronary intervention (PCI). In this study, patients were categorized into TCBI quartile groups. The primary endpoints were the occurrence of major adverse cardiac and cerebrovascular events (MACCE), including all-cause death, stroke, and myocardial infarction at 5 year. The mean duration of follow up was 4.3 ± 1.7 years. The average patient age was 80.9 ± 4.3 years. MACCE was observed in 61 (40.9%) patients in the lowest TCBI quartile group. Kaplan–Meier analysis demonstrated an inverse relationship between MACCE and TCBI (log-lank P

Little is known about the impact of changes in body mass index (BMI) after the percutaneous coronary intervention (PCI) on long-term outcomes in patients with coronary artery disease (CAD). Therefore, this study aimed to clarify this issue. We investigated data on CAD obtained from the SHINANO Registry, a prospective, observational, multicenter cohort study, from 2012 to 2013 in Nagano, Japan. One year after PCI, the enrolled patients were divided into the following three groups based on changes in BMI by tertiles: reduced, maintained, and elevated BMI. The associations among the groups and the 4-year outcomes [major adverse cardiac events (MACEs), all-cause death, Q-wave myocardial infarction, and stroke] were examined. Five hundred seventy-two patients were divided into the reduced, maintained, and elevated BMI groups. Over the 4-year follow-up period, the cumulative incidence of MACEs was 10.5% (60 cases). In the Kaplan–Meier analysis, the incidence rates of MACE were significantly higher in the reduced BMI group than in the maintained and elevated BMI groups [17.7% versus (vs.) 7.3% vs. 9.0%, p = 0.004]. Multivariable cox regression analysis showed that the reduced group showed increased risks of MACEs (hazard ratio 2.15; 95% confidence interval 1.29–3.57; p = 0.003). The long-term clinical outcomes of patients with CAD who underwent PCI were affected by the reduction in BMI after PCI. Furthermore, the elevation of BMI after PCI was not a poor prognostic factor.

Purpose: To determine whether limb-based patency (LBP) after infrainguinal revascularization for chronic limb-threatening ischemia (CLTI) is similar between bypass surgery and endovascular therapy (EVT). Materials and Methods: The database for the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) study was interrogated to identify 130 patients (mean age 73±8 years; 94 men) who underwent bypass surgery and 271 patients (mean age 74±10 years; 178 men) who underwent EVT alone. Skin perfusion pressure (SPP) and the ankle-brachial index (ABI) were measured before the procedure and at 0, 1, and 3 months after revascularization. The outcome measure was hemodynamically evaluated LBP (SPP ≥10 mm Hg or ABI ≥0.1) maintained over the first 3 months after treatment. Any reintervention or major amputation was regarded as loss of LBP. The associations between the revascularization strategy (bypass vs EVT) and between the preoperative characteristics and the study outcome (ie, SPP- or ABI-based LBP), were determined using generalized linear mixed models with a logit link function. Patency rates are presented with the 95% confidence interval (CI). Results: The bypass surgery group had a higher stage of limb severity (WIfI) and anatomic complexity (GLASS) than the EVT group, whereas the EVT group had a higher prevalence of heart failure. Both SPP- and ABI-based LBP rates were higher in the bypass group than in the EVT group. SPP-based LBP rates at 3 months were 73.8% (95% CI 63.4% to 84.2%) in the bypass group and 46.2% (95% CI 38.5% to 53.8%) in the EVT group; the corresponding ABI-based LBP rates were 71.5% (95% CI 61.8% to 81.2%) and 44.0% (95% CI 37.3% to 50.7%). Conclusion: LBP is an important concept in the new global vascular guidelines for assessing the anatomic and hemodynamic status of CLTI patients. The present study found that LBP was significantly lower in the EVT group vs the bypass surgery group.

We investigated the prognostic effects of hyperuricemia and high or low body mass index (BMI) in peripheral artery disease (PAD) after endovascular therapy (EVT). Between July 2015–2016, 357 consecutive patients with PAD who underwent EVT were enrolled. Patients were divided into 2 groups: BMI < 25 kg/m2 (low BMI) and ≥ 25 kg/m2 (high BMI); they were also divided into 2 more groups based on the presence/absence of hyperuricemia. The primary and secondary endpoints were major adverse cardiovascular and limb events (MACLE), and all-cause death at 3 years post-EVT. Patients with hyperuricemia had significantly lower freedom from MACLE than patients without hyperuricemia at 3 years (57.0 vs 71.9%, p = .0068). The overall survival of patients with hyperuricemia was significantly lower than that of patients without hyperuricemia (63.9 vs 81.7%, p = .0012). Patients with hyperuricemia who had low BMI experienced significantly lower freedom from MACLE than those without hyperuricemia who had low BMI (48.2 vs 69.9%, p = .002). The overall survival of patients with hyperuricemia who had low BMI was significantly lower than that of patients without hyperuricemia who had low BMI (55.2 vs 77.1%, p = .003). Patients with hyperuricemia had significantly more MACLE and a lower survival at 3 years than patients without hyperuricemia, even if they had a low BMI.

Significant improvements in percutaneous coronary intervention (PCI) technology have enabled cardiovascular procedures to be performed without onsite cardiac surgery facilities. However, little is known about the association between onsite cardiac surgical support and long-term outcomes of PCI, particularly among emergent and complex cases. We investigated whether the presence or absence of cardiovascular surgery affects the long-term prognosis after PCI, emergent and complex elective cases. The SHINANO 5-year registry, a prospective, observational, and multicenter cohort study registry in Nagano, Japan, consecutively included 1665 patients who underwent PCI between August 2012 and July 2013. The procedures were performed at 11 hospitals with onsite cardiac surgery facilities [onsite surgery (+) group; n = 1257] and 8 hospitals without onsite cardiac surgery facilities [onsite surgery (−) group; n = 408]. The primary endpoint was all-cause mortality and the secondary endpoint was major adverse cardiac and cerebrovascular events [MACCE: all-cause death, Q-wave myocardial infarction, non-fatal stroke, and target lesion revascularization]. The onsite surgery group (+) had a lower rate of emergent PCI and ST-segment elevation myocardial infarction (40.8% vs. 51.7%, p p p p p = 0.421) and MACCE incidence (31.6% vs. 28.9%, p = 0.354) between the groups. Also, there were no differences in the mortality rate and incidence of MACCE among emergent cases of ST-segment elevation myocardial infarction and complex elective cases who underwent PCI. Long-term outcomes of PCI appear to be comparable between institutions with and without onsite cardiac surgical facilities.

Background Unlike age, frailty is often not taken into account in treatment indications of Endovascular treatment (EVT). One of the reason is that there was little known the relationship between frailty and the outcome of EVT for super elderly patients with peripheral artery disease (PAD). We investigate impacts of frailty on the super elderly patient prognosis who underwent EVT. Purpose To investigate impacts of frailty on the super elderly patient prognosis who underwent EVT. Methods From August 2015 to July 2016, 335 consecutive patients who underwent EVT were enrolled in the I-PAD registry from 7 institutes in Nagano prefecture. Among them, we selected and analyzed 91 super elderly PAD patients (≥80 years-old) and divided them into two groups:those with moderate or higher frailty (Clinical Frailty Scale (CFS) ≥6, n=28) and those without (CFS ≤5, n=63). The primary endpoints were cardiovascular death and major adverse cardiovascular and limb events (MACLE), defined as a composite of cardiovascular death, myocardial infarction, stroke, admission for heart failure, major amputation and revascularization. Results The median follow-up period was 2.7 years. Freedom rate from cardiovascular death and MACLE were significantly lower among patients with moderate or higher frailty than among those without (47.0% vs. 58.0%, P=0.03; 39.1% vs. 68.5%, P Conclusion The prognosis of super elderly patients with moderate or higher frailty is worse than those without. Funding Acknowledgement Type of funding source: None

Background Hyperuricemia (≥7.0 mg / dl) is known to be one of the risks of arteriosclerosis. For a long time, it has been said that metabolic syndrome and high-BMI has been implicated to hyperuricemia and also that it's a consequence of those patient background, not a cause of arteriosclerosis. Now, the accumulation of data about hyperurisemia is still not enough. Also the importance of secondary prevention for patients after endovascular treatment (EVT) is still unclear too. Purpose To investigate the impact of hyperuricemia on prognosis of all patients and low-BMI patients after EVT. Methods From July 2015 to July 2016, 335 consecutive PAD patients who performed EVT were enrolled in I-PAD registry. And we divided them into 2 groups; with hyperuricemia or not, and analyzed them. In addition to that, among them, we selected 245 low-BMI patients ( Result At 3 years in the patients group with hyperuricemia, overall survival and freedom from MACLE were significantly lower (57.7% vs 83.4% P=0.0012; 30.3% vs 68.6% P=0.0095) than the group without hyperuricemia. Even among the low-BMI patients, in the patients with hyperuricemia, overall survival and freedom from MACLE were significantly lower (55.2% vs 77.1% P=0.003; 48.2% vs 69.9% P=0.002) than the patients without hyperuricemia at 3 years. Conclusion In this study, the prognosis of patients after EVT with hyperuricemia was worse than the patient without. And even among the low-BMI patients, The prognosis after EVT with hyperuricemia was worse than the patient without. Funding Acknowledgement Type of funding source: None

Background The current consensus is that frail patients have high risks of mortality. However, it remains unclear whether frailty is associated with mortality risks in super-elderly patients with peripheral artery disease (PAD). Methods The I-PAD registry was a prospective multicenter observational study involving 12 institutions in Nagano prefecture in Japan. From July 2015 to July 2016, the I-PAD registry enrolled 371 consecutive PAD patients who had undergone endovascular therapy (EVT). Among them, we selected and analysed 109 PAD patients who were >80 years old when they had undergone EVT and divided them into two groups: those with frailty (Clinical Frailty Scale≥5, n=47) and those without frailty (Clinical Frailty Scale≤4, n=62). The primary endpoints were overall survival and major adverse limb events (MALE), defined as a composite of all-cause death, major amputation and revascularization. Results The median follow-up period was 1.58±0.3 years. Overall, 109 patients with a mean age of 84.8±4.0 years, of whom 63.3% were men, were included. Overall survival and freedom from MALE were significantly lower among patients with frailty than among those without frailty (60.5% vs. 91.6%, P Conclusion The prognosis of super-elderly patients with frailty is worse than that of patients without frailty.

Introduction In patients with peripheral artery disease (PAD) it is known that CVD is one of prognostic factors. But, it is unclear whether left ventricular ejection fraction (LVEF) affects prognosis of PAD patients. So we investigated that LVEF affects prognosis of PAD patients. Methods From July 2015 to July 2016, 371 consecutive PAD patients who performed endovascular treatment (EVT) were enrolled in I-PAD registry. We could conduct follow up survey about 337 (age 73.8±9.6, men 72.4%) patients and divided two groups according to their LVEF (group with LVEF≤40%, n=18, group without LVEF≤40%, n=319). The primary end point was major adverse limb events (MALE: TLR, TVR, major amputations) and secondary end point was all-cause death. Results The median follow-up period was 13.6±5.7 months. The 18 months MALE and all-cause death rate were significantly higher in the group with low LVEF than group without low LVEF (61.1% vs 21.6% p Conclusion LVEF was significantly associated with MALE and all-cause death in patients with PAD.

Introduction In patients with critical limb ischemia (CLI) it is known that malnutrition, low BMI, inflammation and so on are prognostic factors. But, it is unclear whether left ventricular ejection fraction (LVEF) affects prognosis of CLI patients. So we investigated that LVEF affects prognosis of CLI patients. Methods From July 2015 to July 2016, 371 consecutive peripheral artery disease patients who performed endovascular treatment (EVT) were enrolled in I-PAD registry. 179 of them were patients with CLI. We could conduct follow up survey about 126 (age 75.5±11.1, men 63.5%) and divided two groups according to their LVEF (group with LVEF≤40%, n=13, group without LVEF≤40%, n=113). The primary end point was major adverse limb events (MALE: TLR, TVR, major amputations) and secondary end point was all-cause death. Results The median follow-up period was 11.5±6.7 months. The 18 months MALE rate was significant higher in the group with low LVEF than group without low LVEF (76.9% vs 37.2% p Conclusion LVEF was associated with MALE in patients with CLI.

Background Diabetes mellitus (DM) is known to be one of the risks of arteriosclerosis. However, it is still unknown whether DM is a risk factor also in secondary prevention of frail patients after endovascular treatments (EVT) Purpose To investigate impact of diabetes on patients with frail after EVT. Methods From July 2015 to July 2016, 371 consecutive PAD patients who performed EVT were enrolled in I-PAD registry. We could conduct follow up survey 361 patients (446 lesions) and divided into 2 groups; with diabetes (185 patients, 226 lesions) or without diabetes (176 patients, 220 lesions) and analyzed. And among them,we selected 96 patients with frail and divided into 2 groups; with diabetes (49 patients, 70 lesions) or without diabetes (46 patients, 58 lesions) and analyzed. We defined frail patients as the patients with Clinical Frailty Scale 5 (mild frail) or higher. The primary end point was all-cause-death and major adverse limb events (MALE: TLR, TVR, major amputations) at 1 year. Result At 1 years in the patients group with diabetes, overall survival and freedom from MALE were significantly lower (81.7% vs 95.8% P Conclusion The prognosis of patients with diabetes after EVT was worse than the patient without. On the other hand, the prognosis of frail patients with diabetes after EVT was no difference with the frail patient without diabetes in this study.

Background: The predictive ability of patient frailty on clinical outcomes after revascularization in patients with critical limb ischemia remains largely unknown. Methods and Results: We enrolled 643 patients with critical limb ischemia treated with endovascular therapy (N=486) or bypass surgery (N=157) in January 2010 to January 2016, and prospectively assessed them using a 9-level clinical frailty scale (CFS). Patients were divided into 3 groups according to CFS levels: low (CFS level, 1–3; N=234), intermediate (CFS level, 4–6; N=196), and high (CFS level, 7–9; N=213) groups. Clinical follow-up rate was 95.8% at 2 years. In the low, intermediate, and high CFS groups, 2-year overall survival rates were 80.5%, 63.1%, and 49.3% ( P P P =0.01; high CFS group: adjusted hazard ratio, 2.22; 95% confidence interval, 1.52–3.23; P P =0.004; high CFS group: adjusted hazard ratio, 2.34; 95% confidence interval, 1.64–3.35; P 75 years, those who underwent endovascular therapy or bypass surgery, and those with or without chronic renal failure, without significant interactions. Conclusions: Frailty was independently associated with 2-year overall survival and amputation-free survival in patients with critical limb ischemia treated with revascularization, irrespective of age, revascularization mode, and chronic renal failure status.

Diabetes is known to be one of the risks of arteriosclerosis. However, the therapeutic goal of HbA1c in diabetic elderly is still unclear, in particular, in secondary prevention after percutaneous coronary intervention (PCI). Between August 2012 and July 2013, a total of 1665 consecutive patients

The SYNTAX score stratifies risk among drug-eluting stent-treated patients and is based on lesion characteristics alone. The Clinical SYNTAX Score (CSS) combines the SYNTAX score with age, ejection fraction, and creatinine clearance. We evaluated the predictive value of combining clinical factors

There has been an increased use of drug-eluting stents (DES) for percutaneous coronary intervention (PCI). It was considered that patients with DES needed longer dual anti-platelet therapy (DAPT) than those with bare-metal stents (BMS) to prevent stent thrombosis. Although longer DAPT duration may

The current understanding is that hyperuricemia(HUA) is associated with an increased risk of cardiovascular disease. However, it remains unclear whether HUA carries a risk of cardiovascular disease in patients with diabetes mellitus(DM). Three hundred five patients underwent percutaneous coronary

Background— Stent fracture (SF) after drug-eluting stent implantation has recently become an important concern because of its potential association with in-stent restenosis and stent thrombosis. However, the incidence and clinical impact of SF after everolimus-eluting stent implantation remain unclear. Methods and Results— A total of 1035 patients with 1339 lesions undergoing everolimus-eluting stent implantation and follow-up angiography 6 to 9 months after index procedure were analyzed. SF was defined as complete or partial separation of the stent, as assessed by plain fluoroscopy or intravascular ultrasound during follow-up. We assessed the rates of SF and major adverse cardiac events, defined as cardiac death, myocardial infarction, stent thrombosis, and clinically driven target lesion revascularization within 9 months. SF was observed in 39 of 1339 lesions (2.9%) and in 39 of 1035 patients (3.8%). Ostial stent location and lesions with hinge motion, tortuosity, or calcification were independent predictors of SF. The rate of myocardial infarction and target lesion revascularization were significantly higher in the SF group than in the non-SF group (5.1% versus 0.4%; P =0.018 and 25.6% versus 2.0%; P P =0.018). Major adverse cardiac events within 9 months were significantly higher in the SF group than in the non-SF group (25.6% versus 2.3%; P Conclusions— SF after everolimus-eluting stent implantation occurs in 2.9% of lesions and is associated with higher rate of major adverse cardiac events, driven by higher target lesion revascularization and stent thrombosis.

We thank Dr Paul D. Williams, Dr Mama A. Mamas, and Dr Douglas G. Fraser for their interest in our article.1 First, we investigated the stent fracture after Xience V (Abbott Vascular) and Promus (Boston Scientific). As they note, our results, therefore, do not apply to all everolimus-eluting stents. Second, they suggest that double stent strut layer shown in Figure 4 is the consequence of stent fracture rather than longitudinal stent deformation. Actually, it may well be that there is considerable overlap between …