Endovascular Treatment as an Alternative to Bypass Surgery for Juxtarenal Aortic Occlusion: Results from the CHAOS (CHronic Abdominal Aortic Occlusion, ASian Multicenter) Registry.

BACKGROUND: Juxtarenal aortic occlusion (JRAO), in which the occlusion of the aorta extends to just below the renal artery, is often treated by bypass surgery because of concerns about the risk of procedural failure and fatal embolization to abdominal organs when treated with endovascular treatment (EVT). This study assessed the outcome of EVT for JRAO compared with aorto-biiliac /aorto-bifemoral (AOB) or axillo-bifemoral (AXB) bypass. METHODS: A retrospective review of an international database created by 30 centers in Asia (CHronic Abdominal Aortic Occlusion, ASian Multicenter registry) was performed for patients who underwent revascularization for chronic total occlusion of the infrarenal aorta from 2007 to 2017. Of the 436 patients, 130 with JRAO (Forty-seven AOBs, 32 AXBs, and 51 EVTs) from 25 institutions were included in this study. RESULTS: Patients were significantly older in the AXB and EVT groups and more malnourished in the EVT group than the AOB group. EVT was attempted but failed in 1 patient. Seven patients (1 [2.1%] in the AOB group, 1 [3.1%] in the AXB group, and 5 [9.8%] in the EVT group) died during hospitalization, but most of the causes in the EVT group were not related to the revascularization procedure. No visceral embolism was observed, which had been concerned, even though protection was performed only in 2 cases of the EVT group. At the latest follow-up (median duration 3.0 years), the ankle-brachial pressure index was significantly higher in the order of AOB, EVT, and AXB. At 4 years, the estimated primary and secondary patency rates of the AOB group (87.5% and 90.3%, respectively) were significantly higher than the AXB group (66.7% and 68.6%, respectively). CONCLUSIONS: AOB remains the gold standard and should be the first choice for acceptable risk patients. For frail patients, EVT is a good option and likely preferable as a first-line treatment compared to AXB.

Comparison of Aortobifemoral Bypass and Endovascular Treatment for Chronic Infrarenal Abdominal Aortic Occlusion From the CHAOS (CHronic Abdominal Aortic Occlusion, ASian Multicenter) Registry.

PURPOSE: To directly compare the clinical outcomes of aortobifemoral bypass surgery (ABF) and endovascular treatment (EVT) for chronic total occlusion (CTO) of the infrarenal abdominal aorta (IAA). MATERIALS AND METHODS: In this retrospective, multicenter study, we used an international database of 436 patients who underwent revascularization for CTO of the IAA between 2007 and 2017 at 30 Asian cardiovascular centers. After excluding 52 patients who underwent axillobifemoral bypass surgery, 384 patients (139 ABFs and 245 EVTs) were included in the analysis. Propensity score-matched analysis was performed to compare clinical results in the periprocedural period and the long-term. RESULTS: Propensity score matching extracted 88 pairs. Procedure time (ABF; 288 [240-345] minutes vs EVT; 159 [100-205] minutes, p<0.001) and length of hospital stay (17 [12-23] days vs 5 [4-13] days, p<0.001) were significantly shorter in the EVT group than in the ABF group, while the proportions of procedural success (98.9% versus 96.6%, p=0.620), complications (9.1% versus 12.3%, p=0.550), and mortality (2.3% versus 3.8%, p=1.000) were not different between the groups. At 1 months, ABI significantly increased more in the ABF group for both in a limb with the lower (0.56 versus 0.50, p=0.018) and the higher (0.49 versus 0.34, p=0.001) baseline ABI, while the change of the Rutherford category was not significantly different between the groups (p=0.590). At 5 years, compared with the EVT group, the ABF group had significantly better primary patency (89.4±4.3% versus 74.8±4.3%, p=0.035) and survival rates (86.9±4.5% versus 66.2±7.5%, p=0.007). However, there was no significant difference between the groups for secondary patency (100.0%±0.0% versus 93.5%±3.9%, p=0.160) and freedom from target lesion revascularization (TLR) (89.3±4.3% vs 77.3±7.3%, p=0.096). CONCLUSION: Even with recent advancements in EVT, primary patency was still significantly better for ABF in CTO of the IAA. However, there was no difference between the groups in terms of secondary patency and freedom from TLR at 5 years. Furthermore, there was no difference in procedural success, complications, mortality, and improvement in the Rutherford classification during the periprocedural period, with significantly shorter procedure time and hospital stay in the EVT group.

Two-year results of endovascular therapy for femoropopliteal artery disease in Japan during the introduction of drug-eluting devices.

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.

Characteristics, Antithrombotic Patterns, and Prognostic Outcomes in Claudication and Critical Limb-Threatening Ischemia Undergoing Endovascular Therapy.

PURPOSE: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study aimed to clarify differences in clinical features and prognostic outcomes between IC and CLTI, and prognostic factors in patients undergoing endovascular therapy (EVT). MATERIALS AND METHODS: A total of 692 patients with 808 limbs were enrolled from 20 institutions in Japan. The primary measurements were the 3-year rates of major adverse cardiovascular event (MACE) and reintervention. RESULTS: Among patients, 79.0% had IC and 21.0% had CLTI. Patients with CLTI were more frequently women and more likely to have impaired functional status, undernutrition, comorbidities, hypercoagulation, hyperinflammation, distal artery disease, short single antiplatelet and long anticoagulation therapies, and late cilostazol than patients with IC. Aortoiliac and femoropopliteal diseases were dominant in patients with IC and infrapopliteal disease was dominant in patients with CLTI. Patients with CLTI underwent less frequently aortoiliac intervention and more frequently infrapopliteal intervention than patients with IC. Longitudinal change of ankle-brachial index (ABI) exhibited different patterns between IC and CLTI (pinteraction=0.002), but ABI improved after EVT both in IC and in CLTI (p<0.001), which was sustained over time. Dorsal and plantar skin perfusion pressure in CLTI showed a similar improvement pattern (pinteraction=0.181). Distribution of Rutherford category improved both in IC and in CLTI (each p<0.001). Three-year MACE rates were 20.4% and 42.3% and 3-year reintervention rates were 22.1% and 46.8% for patients with IC and CLTI, respectively (log-rank p<0.001). Elevated D-dimer (p=0.001), age (p=0.043), impaired functional status (p=0.018), and end-stage renal disease (p=0.019) were independently associated with MACE. After considering competing risks of death and major amputation for reintervention, elevated erythrocyte sedimentation rate (p=0.003) and infrainguinal intervention (p=0.002) were independently associated with reintervention. Patients with CLTI merely showed borderline significance for MACE (adjusted hazard ratio 1.700, 95% confidence interval 0.950-3.042, p=0.074) and reintervention (adjusted hazard ratio 1.976, 95% confidence interval 0.999-3.909, p=0.05). CONCLUSIONS: The CLTI is characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared with IC. Also, CLTI has approximately twice MACE and reintervention rates than IC, and the underlying inflammatory coagulation disorder per se is associated with these outcomes. CLINICAL IMPACT: The underlying difference between intermittent claudication (IC) and critical limb-threatening ischemia (CLTI) still remains unclear. This prospective multicenter observational study, JPASSION study found that CLTI was characterized not only by more systemic comorbidities and distal disease but also by more inflammatory coagulation disorder compared to IC. Also, CLTI had approximately twice major adverse cardiovascular event (MACE) and reintervention rates than IC. Intriguingly, the underlying inflammatory coagulation disorder per se was independently associated with MACE and reintervention. Further studies to clarify the role of anticoagulation and anti-inflammatory therapies will contribute to the development of post-interventional therapeutics in the context of peripheral artery disease.

Cilostazol effectiveness in reducing drug-coated stent restenosis in the superficial femoral artery: The ZERO study.

PURPOSE: Drug-eluting stents (DESs) play an important role in endovascular therapy (EVT) for femoropopliteal (FP) lesions. Cilostazol improves patency after bare-metal nitinol stent (BNS) implantation for femoropopliteal lesions. This study aimed to establish whether cilostazol is effective in improving the patency of DESs and determine whether BNS or DESs with or without cilostazol are more effective in improving the 12-month patency after EVT for FP lesions. MATERIALS AND METHODS: In this prospective, open-label, multicenter study, 85 patients with symptomatic peripheral artery disease due to de novo FP lesions were enrolled and treated with DESs with cilostazol from eight cardiovascular centers between April 2018 and May 2019. They were compared with 255 patients from the DEBATE SFA study, in which patients were randomly assigned to the BNS, BNS with cilostazol, or DES groups. The primary endpoint was the 12-month patency rate using duplex ultrasound (peak systolic velocity ratio < 2.5). This study was approved by the ethics committee of each hospital. RESULTS: The 12-month patency rates for the BNS, BNS with cilostazol, DES, and DES with cilostazol groups were 77.6%, 93.1%, 82.8%, and 94.2%, respectively (p = 0.007). The 12-month patency rate was higher in the DES with cilostazol group than in the DES group (p = 0.044). In small vessels, the DES with cilostazol group had a higher patency rate than the DES group (100.0% vs. 83.4%, p = 0.023). CONCLUSIONS: DES with cilostazol showed better patency than DES alone. Cilostazol improved patency after EVT with DES in FP lesions and small vessels. CLINICAL TRIAL REGISTRATION: University Hospital Medical Information Network Clinical Trials Registry (no. UMIN 000032473).

The modified interventional method of antegrade common femoral artery access closure using the Angio-Seal device: modified Angio-Seal haemostasis technique: Modified Angio-Seal haemostasis technique.

Aims: Antegrade femoral puncture is frequently performed in endovascular therapy, with haemostasis achieved through manual compression. The aim of this paper is to report the novel method of achieving haemostasis using the Angio-Seal device for antegrade punctures of the femoral artery. Methods and results: Between September 2017 and March 2018, a total of 50 consecutive patients who underwent endovascular therapies (EVT) through the common femoral artery with an antegrade puncture using a 6 Fr introducer sheath were retrospectively analysed. After EVT, all patients received a 6 Fr Angio-Seal STS Plus Vascular Closure Device. All procedures were performed using the following new technique. First, we inserted the Angio-Seal guidewire from the inserted EVT sheath into the artery. Second, we removed the EVT sheath and inserted the Angio-Seal sheath and then removed the dilator and Angio-Seal guidewire. Under angiography using an 18 G needle sheath, we pulled back the Angio-Seal sheath as near to the insertion site of the vessel as possible. Finally, a collagen sponge and plug were inserted as per the standard technique. In all patients, the Angio-Seal was successfully deployed, and haemostasis was achieved within several minutes. No major complications occurred. Conclusions: We demonstrated the feasibility and efficacy of achieving haemostasis using the Angio-Seal device in an antegrade femoral puncture using the novel method.

Three-Year Clinical Outcomes of the Innova™ Self-Expanding Nitinol Stent for the Treatment of Femoropopliteal Lesions.

PURPOSE: To report the 3-year results of Innova™ stent implantation for the treatment of femoropopliteal (FP) lesions in a real-world setting. METHODS: This single-arm, retrospective, multicenter clinical study analyzed 481 lesions from 453 consecutive patients with symptomatic peripheral artery diseases (Rutherford category 1-6) who underwent endovascular therapy with implantation of Innova™ self-expanding nitinol stent for FP lesions. The primary outcome measure was the 3-year restenosis rate based on doppler-ultrasound or angiographic criteria. The secondary outcome measures included the rates of 3-year major amputation and major adverse limb events. RESULTS: Restenosis following Innova™ implantation was found in 61% of the cases at 3 years. At the end of 3 years, the rates of major amputations and major adverse limb events were 3 and 31%, respectively. In cases free from restenosis at 1 year, no predictive factors for restenosis at 3 years could be determined. CONCLUSION: The present study demonstrated mid-term clinical outcomes after Innova™ stent implantation for the treatment of FP lesions in a real-world population. The Innova™ stent demonstrated acceptable clinical outcomes in a real-world setting.

Differences in Intravascular Ultrasound Measurement Values Between Treatment Modalities for Restenosis in Femoropopliteal Lesions.

BACKGROUND: The risk of restenosis after intervention is higher in femoropopliteal than in aortoiliac lesions. However, the appropriate endovascular therapy (EVT) for preventing restenosis after intervention for femoropopliteal lesions remains unknown. This study aimed to elucidate the relationship between lesion characteristics and patency after EVT using intravascular ultrasound (IVUS) measurement and to determine the predictors of restenosis on IVUS.Methods and Results:This prospective observational study was performed at 18 Japanese centers. We evaluated the lesion characteristics before and after EVT for femoropopliteal lesion using IVUS. Angiographic or duplex ultrasound follow-up was performed at 1 year after EVT. A total of 263 lesions underwent EVT between December 2016 and December 2017. In total, 20 lesions (8 cases of isolated common femoral artery lesion and 12 cases of restenosis lesion) were excluded, and 243 lesions were enrolled in this study. A total of 181 lesions were treated with stent placement, and 62 lesions were treated only with balloon angioplasty. In the case of stent use, a larger distal plaque burden was associated with restenosis, while a lower calcification angle was associated with higher patency in the case of balloon angioplasty alone. CONCLUSIONS: The factors related to patency differed depending on the treating modality. The findings suggest that IVUS is a useful tool for predicting patency because it can provide a more accurate evaluation after EVT for femoropopliteal lesions.

Effects of high-speed rotational atherectomy in peripheral artery disease patients with calcified lesions: a retrospective multicenter registry.

Calcified lesions still remain a technical challenge even in the treatment of infrainguinal artery disease. The aim of this retrospective, multicenter observational study was to investigate interventional outcomes of a high-speed rotational atherectomy device (Rotablator™) and to compare clinical outcomes in patients who underwent Rotablator and those who did not even after failed balloon angioplasty because of underlying calcified lesions. This study enrolled patients who underwent Rotablator (Rota group) and those who did not (Non-rota group) between January 2010 and 2014 December at 12 hospitals. A total of 67 limbs and 68 lesions in 65 patients were included (Rota group; 54 limbs and 55 lesions in 52 patients, Non-rota group; 13 limbs and 13 lesions in 13 patients). In the Rota group, a technical success rate was 94.5% with a complication rate of 1.8%, and all lesions underwent subsequent postdilatation following the adjunctive use of Rotablator, and approximately half of above-the-knee lesions underwent stent implantation. The Rota group had a significantly lower clinically driven reintervention rate at 12 months than the Non-rota group (26.5% vs. 58.3%, respectively, p = 0.046). In addition, Rota group showed a trend toward a higher amputation-free survival compared to the Non-rota group at 1 month (Rota; 98.0% vs. Non-rota; 84.6%, respectively, p = 0.10). Rotablator was used as an adjunctive device with a high technical success and a low complication rates, and Patients who underwent Rotablator yielded a significantly lower clinically driven reintervention rate at 12 months compared to those who did not even after failed balloon angioplasty.

Peak systolic velocity ratio derived from quantitative vessel analysis for restenosis after femoropopliteal intervention: a multidisciplinary review from Endovascular Asia.

With technological improvements in the endovascular armamentarium, there have been tremendous advances in catheter-based femoropopliteal artery intervention during the last decade. However, standardization of the methodology for assessing outcomes has been underappreciated, and unvalidated peak systolic velocity ratios (PSVRs) of 2.0, 2.4, and 2.5 on duplex ultrasonography have been arbitrarily but routinely used for assessing restenosis. Quantitative vessel analysis (QVA) is a widely accepted method to identify restenosis in a broad spectrum of cardiovascular interventions, and PSVR needs to be validated by QVA. This multidisciplinary review is intended to disseminate the importance of QVA and a validated PSVR based on QVA for binary restenosis in contemporary femoropopliteal intervention.

Off-label use of Angio-Seal vascular closure device for the repair of femoral pseudoaneurysm after transfemoral coronary intervention.

Pseudoaneurysm was caused at the puncture site of the left groin after percutaneous coronary intervention. Balloon tamponade was attempted for hemostasis at the aneurysmal site. However, hemostasis was not achieved. Next, direct puncture of the pseudoaneurysm was tried. A 0.014-inch guidewire was crossed from the neck of the pseudoaneurysm to the left common femoral artery. The wire was replaced with a 0.035-inch guidewire. An 8F Angio-Seal (Terumo Interventional Systems, Somerset, NJ) was inserted, and a collagen plug was deployed at the neck of the pseudoaneurysm. Final angiography revealed completion of hemostasis. Three-dimensional computed tomography angiography after 8 months revealed no evidence of recurrence.

Periprocedural and Long-Term Outcomes of Stent Implantation for De Novo Subclavian Artery Disease.

INTRODUCTION: The purpose of the current study was to investigate the periprocedural and long-term outcomes of stent implantation for de novo subclavian artery (SCA) disease. MATERIAL AND METHODS: We retrospectively investigated consecutive patients with de novo SCA lesions undergoing elective endovascular therapy procedures at our center between April 2004 and September 2015. All patients were included in the analyses of periprocedural outcomes, including procedural and clinical success. Subsequently, patients who completed the clinical follow-up and were assessed with brachial systolic pressure differences between the diseased and the contralateral arms, or angiographic stenosis, after stent implantation with procedural success were included in the analyses of long-term outcomes, including primary patency. RESULTS: There were 62 patients (median 71.0 years, interquartile range 65.3-76.0 years; 45 men) with 62 de novo SCA lesions included in the analyses of periprocedural outcomes. There were 46 stenoses (74.2%) and 16 occlusions (25.8%). Our results indicated high procedural success rates for overall (95.2%), stenotic (97.8%), and occlusive (87.5%) lesions. Similarly, high clinical success rates were observed for overall (91.9%), stenotic (93.5%), and occlusive (87.5%) lesions. The median follow-up time was 6.0 years (interquartile range, 2.6-8.3 years). There were 48 patients with 48 de novo SCA lesions included in the analyses of long-term outcomes. Primary patency estimates were 97.7% (1 year), 97.7% (3 years), 93.1% (5 years), and 87.6% (7 years). Also, we observed a high estimate for freedom from reintervention for the target vessel (93.8%). CONCLUSION: Stent implantation for de novo SCA disease can be performed successfully and safely with favorable periprocedural and long-term outcomes.

Cardiac function response to stenting in atherosclerotic renal artery disease with and without heart failure: results from the Carmel study.

AIMS: Consensus-derived guidelines recommend renal stenting for patients with atherosclerotic renal artery disease (ARAD) and heart failure (HF). The aim of this prospective multi-centre observational study was to verify our hypothesis that changes in E/e', an echocardiographic correlate of left ventricular (LV) filling pressure, following renal stenting may differ between ARAD patients with and without HF. METHODS AND RESULTS: This study enrolled de novo ARAD patients undergoing renal stenting at 14 institutions. The primary endpoint was the difference in E/e' change between ARAD patients with and without HF. Clinical and echocardiographic data were prospectively collected at baseline, the day following renal stenting, and 1 month and 6 months afterwards. ARAD patients with HF were defined as patients with New York Heart Association (NYHA) Class 2 and more, or a history of HF hospitalization. A total of 76 patients were included, and 39% were ARAD patients with HF. ARAD patients with HF had significantly lower estimated glomerular filtration rate (P = 0.028) and higher NYHA functional class (P < 0.001) and Minnesota Living with Heart Failure Questionnaire (MLHFQ) score (P = 0.001) than ARAD patients without HF. Also, ARAD patients with HF had significantly lower LV ejection fraction (P = 0.003) and e'-velocity (P = 0.003) and higher E/e' ratio (P = 0.001), left atrial volume index (LAVI) (P = 0.046), LV end-diastolic volume (LVEDV) (P = 0.001), LV end-systolic volume (LVESV) (P = 0.001), and LV mass index (P = 0.009) than ARAD patients without HF. All procedures were successful. In contrast to blood pressure and renal function, there was a significant interaction in E/e' (Pinteraction  < 0.001) between time and HF, and ARAD patients with HF showed a significant (P < 0.001) decrease in E/e' albeit those without HF. By the same token, there was a significant interaction in NYHA class (Pinteraction  < 0.001), MLHFQ score (Pinteraction  = 0.018), E-velocity (Pinteraction  = 0.002), LAVI (Pinteraction  = 0.001), LVEDV (Pinteraction  = 0.003), and LVESV (Pinteraction  = 0.001) between time and HF with a significant improvement in all these variables in ARAD patients with HF (NYHA class, P = 0.001; MLHFQ score, P = 0.002; E-velocity, P = 0.005; LAVI, P = 0.001; LVEDV, P = 0.017; and LVESV, P = 0.011). CONCLUSIONS: Change in LV filling pressure after renal stenting differed between ARAD patients with and without HF, with a significant improvement in LV filling pressure in patients with HF-ARAD. These unique findings might support clinical cardiac benefits of renal stenting in ARAD patients with HF.

Clinical outcomes of endovascular treatment for chronic aortic occlusion: a retrospective multicentre registry: EVT for chronic aortic occlusion.

AIMS: The aim of this study was to evaluate the clinical outcomes of endovascular treatment (EVT) for chronic aortic occlusion (CAO) using multicentre registry data. METHODS AND RESULTS: From April 2003 to December 2015, data on 73 consecutive patients (55 men and 18 women; aged 70.7±12.2 years) who underwent EVT for CAO were collected retrospectively from 15 centres in Japan. The primary endpoint was the primary patency at 12 months after EVT. Secondary endpoints were procedural success and periprocedural complication rates. We analysed 67 patients who underwent complete endovascular revascularisation after 2007. Initial procedural success was achieved in 63 cases (94.0%). Complications occurred in three patients (4.5%) (stroke, n=1; distal embolism, n=1; access-site haematoma requiring blood transfusion, n=1). In patients after successful EVT (n=63), the primary and secondary patency rates at 12 months were 90.7% and 97.7%, respectively. During a mean follow-up period of 17.8 months, restenosis/re-occlusion was observed in eight patients (12.7%). CONCLUSIONS: EVT for CAO could be performed safely with a high procedural success rate. The short-term clinical outcome was acceptable despite lesion complexity.

The Importance of Patency of Tibial Run Off Arteries on Clinical Outcomes After Stenting for Chronic Total Occlusions in the Superficial Femoro-popliteal Artery.

OBJECTIVE/BACKGROUND: The aim was to evaluate the impact of patent tibial arteries on stenting for chronic total occlusions (CTO) in superficial femoropopliteal artery (SFA) lesions. Additionally, the efficacy of additive tibial percutaneous transluminal angioplasty (PTA) was evaluated. METHODS: A total of 238 limbs in 199 patients with de novo SFA CTO lesions treated with bare nitinol stents between 2009 and 2015 were retrospectively identified. These limbs were divided into two groups (group A [number of patent tibial arteries at baseline angiogram ≥ 2, 127 limbs in 104 patients] vs. group B [number of patent tibial arteries at baseline angiogram ≤ 1, 111 limbs in 95 patients]). Furthermore, the efficacy of additive tibial PTA on stenting for SFA CTO lesions was evaluated by comparing subgroups (group B with tibial PTA vs. without tibial PTA). The primary end point was freedom from major adverse limb events (MALE) two years after PTA, defined as a composite of ischaemic driven target lesion revascularisation (TLR) and major amputation. RESULTS: Group A had a significantly higher MALE free survival rate two years after PTA compared with group B (80.9% vs. 43.5%; p < .001), which was mainly driven by higher TLR free survival rates (80.9% vs. 45.9%; p < .001). In subgroup analysis, patients in group B with tibial PTA had significantly higher MALE free survival rate at two years compared with those without tibial PTA (65.5% vs. 26.2%; p = .001). CONCLUSION: The presence of patent tibial arteries was an important predictor of MALE after PTA for SFA CTO lesions. Furthermore, additional tibial PTA on SFA CTO stenting might be beneficial for clinical outcomes.

Clinical Outcomes of Drug-Eluting Balloon for In-Stent Restenosis Based on the Number of Metallic Layers.

BACKGROUND: This study assesses clinical outcomes after drug-eluting balloon treatment for recurrent in-stent restenosis lesions based on the number of metallic layers. METHODS AND RESULTS: We enrolled 304 consecutive patients (333 lesions) treated with percutaneous coronary intervention using drug-eluting balloon for in-stent restenosis lesions between March 2014 and June 2015. Per the number of stent layers previously implanted to the lesion, the patients were categorized into 3 groups, 1 stent layer (1L), 166 patients; 2 stent layers (2L), 87 patients; and ≥3 stent layers (≥3L), 51 patients. The end points were major adverse cardiovascular events (MACE), including cardiac death, target lesion revascularization, myocardial infarction, and definite or probable stent thrombosis. No significant differences were observed in patients' baseline characteristics among the groups. The 1-year MACE and target lesion revascularization rates were significantly higher in the ≥3L group than those in the 1L and 2L groups (MACE: 1L, 16.9%; 2L, 16.1%; and ≥3L, 43.1%, P<0.01; target lesion revascularization: 1L, 14.5%; 2L, 14.9%; and ≥3L, 41.2%, P<0.01). The multivariable Cox regression analysis revealed that the number of metallic layers (≥3L compared with 1L; hazard ratio, 3.17; [95% CI, 1.75-5.76]; P<0.01 and hemodialysis [hazard ratio, 2.21; (95% CI, 1.12-4.36); P=0.02]) were independent predictors for MACE. No significant differences were observed in the occurrence of cardiac death among the groups ( P=0.34). CONCLUSIONS: Seemingly, drug-eluting balloon is less effective for ≥3L in-stent restenosis lesions. Hemodialysis and in-stent restenosis with the number of metallic layers are independent predictors for MACE.

Drug-Eluting Versus Bare-Metal Stent Implantation With or Without Cilostazol in the Treatment of the Superficial Femoral Artery.

BACKGROUND: New-generation bare-metal nitinol (BNS) and drug-eluting stents have improved long-term outcomes in patients undergoing endovascular therapy for femoropopliteal lesions. Furthermore, cilostazol reduces in-stent restenosis (ISR) after first-generation BNS implantation for femoropopliteal lesions. METHODS AND RESULTS: We studied 255 patients with femoropopliteal lesions treated at 25 cardiovascular centers. Patients were randomly assigned to the BNS group (Misago stent implantation without cilostazol), BNS with cilostazol group (Misago stent implantation with cilostazol), or drug-eluting stents group (Zilver PTX stent implantation without cilostazol). Primary end point was 1-year restenosis noted using duplex ultrasound (peak systolic velocity ratio, >2.0). Secondary end point was major adverse limb events (limb-related death, target lesion revascularization, major amputation, and major bleeding). During the 1-year follow-up, 12 patients (4.7%) died and 237 (92.9%) had relevant ultrasound findings. The 1-year ISR rate did not differ significantly among the BNS, BNS with cilostazol, and drug-eluting stents groups (28.4% versus 12.2% versus 21.0%; P=0.052). Although the 1-year ISR rate was significantly lower in the BNS with cilostazol group than in the BNS group, it was similar to that in the drug-eluting stents group ( P=0.16). Major adverse limb event was significantly higher in the BNS group (16.9% versus 6.5% versus 6.3%; P=0.034); however, target lesion revascularization and major bleeding were similar (9.7% versus 5.1% versus 3.6%; P=0.25, 4.8% versus 1.2% versus 2.4%; P=0.37, respectively). CONCLUSIONS: Misago stent implantation with cilostazol showed a comparable 1-year ISR rate with Zilver PTX. Cilostazol reduced the 1-year ISR rate after endovascular therapy when used with new-generation BNS. CLINICAL TRIAL REGISTRATION: URL: http://www.umin.ac.jp/ctr/ . Unique identifier: UMIN 000010071.

Steroid pulse therapy transiently destroys the discriminative histological structure of tonsils in IgA nephropathy: Tonsillectomy should be performed before or just after steroid pulse therapy.

OBJECTIVE: Tonsillectomy combined with steroid-pulse therapy is a widely accepted method for the treatment of IgA nephropathy (IgAN) in Japan. However, the indication of tonsillectomy for IgAN is still controversial, and the timing of tonsillectomy is not clearly defined for the protocol of this therapy. Based on the results of a randomized control trial in Japan, the Evidence-Based Clinical Practice Guidelines for IgA nephropathy 2014 (edited in Japan) recommended tonsillectomy combined with steroid-pulse therapy for Grade C1. However, this is not widely accepted worldwide. To clarify the validity and timing of tonsillectomy, we evaluated how the three-consecutive steroid-pulse therapy method affects the tonsil tissues of IgAN patients. METHODS: We examined tonsil specimens from 35 IgAN patients and 8 chronic tonsillitis patients. We compared the proportion of follicular area to total tonsillar area and the number of germinal centers between each group on hematoxylin and eosin stained pathological specimens to clarify the histopathological characteristics of tonsils from IgAN patients. Based on these findings, we examined the tonsils of patients after three-consecutive steroid-pulse therapy treatments (n=34) to determine the influence of this therapy on the tonsil tissues of IgAN patients. Moreover, we observed chronological changes in tonsil tissues after steroid-pulse therapy. RESULTS: The extrafollicular area was enlarged in IgAN patients before steroid-pulse therapy compared with chronic tonsillitis patients. Just after steroid-pulse therapy, the follicles became very small with blurry outlines, and the number of germinal centers was remarkably decreased. With a gradual decrease in oral prednisolone, the tonsil tissue structure was gradually restored. CONCLUSION: Tonsillectomy combined with steroid-pulse therapy is considered a reasonable treatment for IgAN. Steroid-pulse therapy-induced histological changes in tonsils were transient, indicating tonsillectomy should be performed before or just after steroid-pulse therapy.