Twelve-month safety and effectiveness of TCD-17187 drug-coated balloon for the treatment of atherosclerotic lesions in the superficial femoral and proximal popliteal artery.

PURPOSE: The aim of this preapproval trial was to evaluate the 12-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and/or proximal popliteal artery (PA). METHODS: This was a prospective, multicenter, core laboratory adjudicated, single-arm trial. From October 2019 to November 2020, a total of 121 symptomatic peripheral artery disease patients with SFA and/or proximal PA lesions were enrolled. The primary effectiveness endpoint was 12-month primary patency defined as freedom from restenosis as determined by duplex ultrasonography in the absence of clinically driven target lesion revascularization (CD-TLR). The safety endpoint was the major adverse event (MAE) rate defined as freedom from a composite of device- and procedure-related death within 30 days, and index limb major amputation and/or CD-TLR through follow-up. RESULTS: Average age was 74.5 ± 7.3 years and the frequency of diabetes mellitus was 67.5%. Average lesion length and vessel diameter were 106.0 ± 52.6 and 5.2 ± 0.8 mm, respectively. The frequency of chronic total occlusion and bilateral calcification was 17.5% and 50.8% of patients, respectively. The 12-month primary patency rate calculated by Kaplan-Meier analysis was 81.1%, while 12-month freedom from CD-TLR was 95.8%. The MAE rate at 30 days was 1.7% and all events comprised CD-TLR. There were no instances of device- or procedure-related deaths, major amputations, or thrombosis throughout the 12-month evaluation period. CONCLUSION: This preapproval trial confirmed the safety and effectiveness of TCD-17187 DCB in the treatment of atherosclerotic lesions in the SFA and/or proximal PA.

Impact of tolvaptan on improvement of tricuspid regurgitation and right ventricular dimension in patients with right-sided heart failure.

Managing right-sided chronic heart failure (CHF) due to tricuspid regurgitation (TR) remains a clinical challenge. Tolvaptan (TLV), a vasopressin V2 receptor inhibitor, is effective in controlling decompensated HF. However, its effects on right-sided CHF caused by TR are unclear. We sought to clarify the effects of TLV in CHF patients complicated with TR. The cohort consisted of 33 CHF patients with moderate or severe TR and permanent atrial fibrillation, who required hospitalization for HF. We observed 19 patients treated with TLV plus conventional therapies (TLV group) and 14 patients with conventional therapies alone (conventional group). Clinical characteristics, echocardiographic parameters, and laboratory data were investigated. Baseline characteristics were similar between groups. In the TLV group, the severity of TR at admission was 73.7% moderate and 26.3% severe. In the conventional group, these percentages were 85.7% and 14.3%, respectively. During the follow-up, the severity of TR improved in the TLV group (trivial-mild: 52.6%; moderate: 36.8%; severe: 10.5%) (p < 0.01). However, it did not improve in the conventional group (trivial-mild: 21.4%; moderate: 50.0%; severe: 28.6%) (p = 0.08). The diameter of the tricuspid annulus (p < 0.01), basal (p = 0.02), and mid right ventricle (p = 0.04) was reduced at follow-up in the TLV group. Nevertheless, these parameters did not change in the conventional group. Serum creatinine levels were maintained (p = 0.74) in the TLV group, but deteriorated in the conventional group (p = 0.03). TLV reduced right ventricular dimensions and improved TR without deterioration of renal function. Thus, TLV may be a new drug for the treatment of CHF patients with TR.

Effect of high-dose strong statin for preventing periprocedural ischemic complications of carotid artery stenting.

Statin therapy has been shown to induce carotid atherosclerotic plaque regression and reduce the periprocedural ischemic complications of carotid artery stenting (CAS). This study assessed the safety and usefulness of pretreatment using a high-dose strong statin (HDSS) to reduce the periprocedural ischemic complications of CAS. We analyzed 117 carotid lesions treated by CAS that were evaluated with magnetic resonance imaging (MRI) within 48 h after the procedure. For 67 lesions, an HDSS (rosuvastatin 20 mg or atorvastatin 40 mg daily) were prescribed from at least 14 days before CAS to at least 14 days after procedure (HDSS group). Clinical and angiographic data, as well as in-hospital outcomes, of the HDSS group were retrospectively compared with 50 lesions with conventional treatment without an HDSS (non-HDSS group). There were no significant differences in the baseline clinical and procedural characteristics between the two groups. There was no side effect related to the HDSS. Stroke rates were similar between the two groups (3.0% in HDSS group vs 8.0% in non-HDSS group, p = 0.22). All were minor strokes. Compared to the non-HDSS group, the HDSS group had a lower frequency of new lesions on diffusion-weighted imaging (DWI) with MRI (25.4% vs 44.0%, p = 0.0345). New ipsilateral DWI-positive rate in the HDSS group was significantly lower than in the non-HDSS group (16.4% vs 34.0%, p = 0.0275). Nonipsilateral (contralateral or posterior circulation) DWI-positive rates were similar between the two groups (13.4% vs 20.0%, p = 0.34). Pretreatment with an HDSS might reduce the periprocedural ischemic complications of CAS.

Prolonged Autonomic Fluctuation Derived from Parasympathetic Hypertonia after Carotid Endarterectomy but not Stenting.

BACKGROUND: Carotid endarterectomy (CEA) is a standard treatment for carotid artery stenosis, but the incidence after periprocedural myocardial infarction (MI) is not negligible. The mechanism for the higher risk of MI following CEA compared with the carotid artery stenting (CAS) is unclear. We hypothesized that it may be explained by different autonomic nervous responses. METHODS: This prospective, nonrandomized, observational study enrolled 50 patients from 2 centers: 25 underwent CEA and 25 CAS. Cardiac autonomic nervous activity was evaluated using 24-hour high-resolution ambulatory electrocardiography with parameters such as deceleration capacity (DC) and heart rate variability before the procedure, and at 1 week and 1-3 months after the procedure. RESULTS: One week after CEA, decreased DC and increased acceleration capacity were recognized. Standard deviation of sequential 5-minute NN interval means and the low-frequency and high-frequency components were all decreased. By the later phase measurement, these changes returned to baseline or beyond. The results suggest that diminished autonomic activity reversed to excessive parasympathetic dominance. In contrast, the patients treated by CAS showed no remarkable autonomic modification in the early or later phases. CONCLUSIONS: Distinct changes of sympathovagal response observed after CEA coincides with the time at which MI onset occurs, suggesting prolonged autonomic fluctuation may be a factor in the MI incidence after CEA.

Clinical outcomes of balloon angioplasty alone versus nitinol stent implantation in patients with small femoropopliteal artery disease: Observations from the Retrospective Multicenter Analysis for Femoropopliteal Stenting (REAL-FP).

OBJECTIVES: We sought to assess whether balloon angioplasty (BA) alone for small femoropopliteal disease improved the outcome following endovascular therapy as compared with stent implantation. BACKGROUND: The optimal strategy of endovascular therapy for small vessel arteries in femoropopliteal disease remains unclear. METHODS: We performed a multicenter retrospective analysis of 337 consecutive patients (371 limbs) with femoropopliteal arteries 4.0 mm or less in diameter and 150 mm or less in length. RESULTS: Cumulative 3-year incidence of primary patency was significantly higher in the BA group than in the stent group (53.8% vs. 34.2%, P = 0.002). While assisted-primary patency and freedom from any major adverse limb events were also significantly higher in the BA group than in the stent group (70.9% vs. 44.2%, P < 0.001 and 60.6% vs. 36.4%, P = 0.001, respectively), secondary patency did not significantly differ between the two groups (86.9% vs. 86.9%, P = 0.67). Predictors of restenosis were diabetes mellitus (hazard ratio [HR], 1.61; 95% confidence interval [CI], 1.14-2.31; P = 0.01), no administration of cilostazol (HR, 1.50; 95% CI, 1.07-2.13; P = 0.02), stent implantation (HR, 1.68; 95% CI, 1.15-2.41; P = 0.01), and lesion length >75.0 mm(HR, 2.09; 95% CI, 1.50-2.92; P < 0.001). CONCLUSIONS: Lesions in small (<4.0 mm diameter) FP vessels demonstrated better primary patency at 3 years when successfully treated with balloon angioplasty alone as opposed to routine or bailout stenting. This difference was especially pronounced for lesions 75 to 150 mm in length.

Transcatheter closure of atrial septal defect protects from pulmonary edema: septal occluder device gradually reduces LR shunt.

A 56-year-old woman was diagnosed as atrial septal defect (ASD) with pulmonary hypertension; pulmonary blood flow/systemic blood flow (Qp/Qs) of 2.3, pulmonary artery pressure (PAP) of 71/23(39) mmHg and diastolic dysfunction of left ventricle. PAP was improved after medical therapy; therefore, transcatheter ASD closure was performed. Seven days later, left-sided heart failure occurred, however, the improvement of Qp/Qs (1.7) and PAP of 51/21(32) was confirmed. Diuretic therapy was introduced which led to further decrease of PAP 40/12(25) and Qp/Qs (1.1). Because of gradual decrease of Qp/Qs, this patient appeared to be protected from acute pulmonary edema.

Penetration rate of the placement of a drug-eluting stent for the treatment of superficial femoral artery lesions in Japan.

Stent placement for treating superficial femoral artery (SFA) lesions has been approved. The Zilver PTX stent, a drug-eluting stent (DES) for treating SFA lesions, has been available in Japan since 2012. However, the penetration rate of this DES has not yet been reported. This prospective multicenter registry study enrolled 314 patients (354 limbs) to be treated by stent placement in 2014 (UMIN000011551). The primary endpoint was the measurement of the penetration rate of the DES. The secondary endpoints were measuring the freedom from restenosis, freedom from target lesion revascularization (TLR), freedom from major adverse limb event (MALE), and the survival rate at 12 months postoperatively. Female patients comprised 28% participants. The mean age was 73.1 ± 9.2 years. A total of 56% patients had diabetes mellitus (DM), 36% patients were receiving hemodialysis, and 30% used cilostazol at baseline. The mean lesion length was 156 ± 101 mm, and the percentage of TASC II C/D lesions was 58%. Critical limb ischemia (CLI) was observed in 32% limbs. The penetration rates of the Zilver PTX stent were only 8%. The primary patency rate was similar between DES and bare-metal stents (BMS) at 12 months postoperatively (77 vs. 84%, p = 0.52). In this study, the rates of freedom from restenosis, freedom from TLR, freedom from MALE, and the survival rate at 12 months postoperatively were 83, 86, 85, and 89%, respectively. The penetration rate of a first-generation DES placement for treating SFA lesions is low in Japan. On the other hand, BMS is well utilized and its primary patency is acceptable.

Simultaneous Intravascular Ultrasound Usage Overcomes Misinterpretation When Evaluating Lipid-Rich Plaques With Optical Frequency Domain Imaging--Ex Vivo Study.

BACKGROUND: The aim of this study was to investigate the accuracy of optical frequency domain imaging (OFDI) in lipid-rich plaque detection and determine the causes of "misinterpretation," and evaluate whether these limitations can be overcome with intravascular ultrasound (IVUS) using ex-vivo human coronaries. METHODS AND RESULTS: The OFDI images and corresponding 218 histological segments were evaluated. Segments with a poor signal and diffuse borders on OFDI, classified as lipid-rich plaques, were compared with the histological segments and IVUS images. Using histological images as the gold standard, the sensitivity, specificity, positive predictive value, and negative predictive value of OFDI for the detection of lipid-rich plaques were 93%, 93%, 85%, and 97%, respectively. The causes of false-positive diagnosis of lipid-rich plaque (11 segments) were superficial macrophage infiltration causing signal attenuation (8/11 segments, 73%) and tangential signal dropout of light (3/11 segments, 27%), whereas the cause of false-negative diagnosis was thickening of the fibrous cap (5 segments, 100%). Simultaneous IVUS helped to correct the misinterpretation of OFDI results and improved the diagnostic accuracy; the sensitivity, specificity, positive predictive value, and negative predictive value of OFDI with adjunct use of IVUS were 96%, 99%, 99%, and 98%, respectively. CONCLUSIONS: OFDI occasionally over- or underestimates the existence of lipid-rich plaques, which may be overcome with adjunctive usage of IVUS.

Coronary angiographic characteristics that influence fractional flow reserve.

BACKGROUND: Percutaneous coronary intervention (PCI) guided with fractional flow reserve (FFR) has been shown to improve clinical outcome. Although coronary angiography is the standard method for PCI guidance, the visual severity of stenosis is not always correlated with functional severity, suggesting that there are additional angiographic factors that affect functional ischemia. METHODS AND RESULTS: To evaluate angiographic predictors of positive FFR in stenotic lesions, angiographic characteristics of 260 consecutive patients (362 lesions) who underwent FFR testing from April 2009 to September 2012 were analyzed. A scoring system (STABLED score) using these predictors was developed and compared with quantitative coronary angiography (QCA). %Diameter stenosis >50% (OR, 8.43; P<0.0001), tandem lesion (OR, 4.00; P<0.0001), true bifurcation (OR, 2.42; P=0.028), lesion length >20 mm (OR, 5.40; P=0.0002), and distance from ostium <20 mm (OR, 1.94; P=0.028) were determined as independent predictors of positive FFR. Area under the ROC curve for probability of positive FFR using the STABLED score (Stenosis 2 points, TAndem lesion 1 point, Bifurcation 1 point, LEsion length 1 point, Distance from ostium 1 point) was 0.85, higher than that for QCA stenosis alone (0.76). STABLED score ≥3 had 72.3% sensitivity and 83.6% specificity for predicting positive FFR, and PPV was 76.7%. CONCLUSIONS: Specific angiographic features are applicable for predicting functional ischemia. STABLED score correlates well with FFR.

Cilostazol reduces angiographic restenosis after endovascular therapy for femoropopliteal lesions in the Sufficient Treatment of Peripheral Intervention by Cilostazol study.

BACKGROUND: It remains unclear whether cilostazol, which has been shown to improve the clinical outcomes of endovascular therapy for femoropopliteal lesions, also reduces angiographic restenosis. METHODS AND RESULTS: The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study investigated whether cilostazol reduces the 12-month angiographic restenosis rate after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. Two hundred patients with femoropopliteal lesions treated from March 2009 to April 2011 at 13 cardiovascular centers were randomly assigned 1:1 to receive oral aspirin with or without cilostazol. The primary end point was 12-month angiographic restenosis rate. Secondary end points were the restenosis rate on duplex ultrasound, the rate of major adverse cardiac events, and target lesion event-free survival. Researchers evaluated all follow-up data and assessed the end points in a blinded fashion. The mean lesion length and reference vessel diameter at the treated segment were 128±86 mm and 5.4±1.4 mm, respectively. The frequency of stent used was similar between groups (88% versus 90% in the cilostazol and noncilostazol group, respectively, P=0.82). During the 12-month follow-up period, 11 patients died and 152 patients (80%) had evaluable angiographic data at 12 months. The angiographic restenosis rate at 12 months was 20% (15/75) in the cilostazol group versus 49% (38/77) in the noncilostazol group (P=0.0001) by intention-to-treat analysis. The cilostazol group also had a significantly higher event-free survival at 12 months (83% versus 71%, P=0.02), although cardiovascular event rates were similar in both groups. CONCLUSIONS: Cilostazol reduced angiographic restenosis after percutaneous transluminal angioplasty with provisional nitinol stenting for femoropopliteal lesions. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00912756; and URL: https://www.umin.ac.jp. Unique identifier: UMIN000002091.

Transradial intervention for patients with ST elevation myocardial infarction with or without cardiogenic shock.

OBJECTIVES: To compare clinical outcomes between transradial (TRI) and transfemoral intervention (TFI) in primary percutaneous coronary intervention (PCI) in patients with ST elevation myocardial infarction (STEMI) with or without shock. BACKGROUND: TRI for STEMI has benefits in TRI high volume centers. However, TRI has not been reported for STEMI with shock even in such centers. METHODS: We retrospectively studied 425 STEMI patients who underwent primary PCI. Patients were divided into four groups according to approach site and presence of cardiogenic shock, including TRI without shock (TR group, n = 273), TRI with shock (TRS group, n = 38), TFI without shock (TF group, n = 71), and TFI with shock (TFS group, n = 43). RESULTS: PCI success rates were similar among the four groups. The TR group was superior to the TF group in terms of shorter cath lab to first device activation time, and lower access site complications, and 30-day mortality rates (1.1% vs. 11.3%, P < 0.001). In shock patients, cardiopulmonary arrest was commonly observed in both the TRS and TFS groups (42.1% and 51.2%, respectively). The TRS group showed a trend toward a shorter door to first device activation time compared to the TFS group and lower access site complications; however, 30-day mortality rate was 28.9% in TRS and 25.6% in TFS group (P = 0.7). CONCLUSIONS: In TRI high volume center, TRI for STEMI was safe and feasible as a default approach. TRI could be applied to severe shock patients with similar clinical outcome to TFI.

Diagnostic accuracy of Global Registry of Acute Coronary Events (GRACE) risk score in ST-elevation myocardial infarction for in-hospital and 360-day mortality in Japanese patients.

BACKGROUND: The purpose of the present study was to confirm the diagnostic accuracy of Global Registry of Acute Coronary Events (GRACE) risk score 1.0 (GRACE 1.0) and updated GRACE 1.0 (GRACE 2.0) for in-hospital and 360-day mortality in ST-elevation myocardial infarction (STEMI) in Japanese patients. GRACE 1.0 and GRACE 2.0 are the established predictive models in acute coronary syndrome, but their application to Japanese patients has not been fully verified. METHODS AND RESULTS: The present study retrospectively analyzed 412 consecutive STEMI patients who had undergone primary percutaneous coronary intervention from January 2006 to September 2011. All causes of death during hospitalization were examined to confirm the diagnostic accuracy of GRACE 1.0 on receiver operating characteristic (ROC) analysis. Similarly, all causes of death during the 360 days after hospitalization were analyzed to confirm the diagnostic accuracy of GRACE 2.0. The average GRACE 1.0 score was 175.8±50.9. In-hospital and 360-day mortality were 13.1% and 15.5%, respectively. Area under the ROC curve, which describes the diagnostic accuracy of the GRACE 1.0 predicted in-hospital mortality and the GRACE 2.0 predicted 360-day mortality, was as high as 0.95 and 0.92, respectively. CONCLUSIONS: Both GRACE 1.0 and GRACE 2.0 had a high diagnostic accuracy for prediction of in-hospital and 360-day mortality in Japanese STEMI patients.

Plaque protrusion detected by intravascular ultrasound during carotid artery stenting.

BACKGROUND: Stroke is a major complication of carotid artery stenting (CAS) that can occur during the procedure and for up to 30 days after the procedure in the late phase. Although the cause of late stroke after CAS is unknown, plaque protrusion may be one of the potential causes. This study aims to assess the rate of plaque protrusion during CAS by intravascular ultrasound (IVUS). METHODS: We performed 77 consecutive CAS procedures using IVUS between May 2008 and December 2012. The rate of plaque protrusion was assessed at the end of the procedure using IVUS and angiography. RESULTS: Mean age of patients was 72.5 ± 7.5 years. Sixty-eight patients were male and 42 had diabetes mellitus. In all, 65 PRECISE stents and 12 Carotid Wall stents were used. All cases were distally protected with filter devices. Six plaque protrusions (7.8%) through the stent struts were detected by IVUS but only 2 (2.6%) by angiography. A predictor of plaque protrusion was preprocedural severe stenosis with flow delay. Additional postdilations (n = 6) and stent-in-stent implantations (n = 4) were performed to correct the plaque protrusions. No remaining plaque protrusion was observed in the final IVUS. Overall stroke rate was 2.6% (major 0%, minor 2.6%), and these occurred in the catheterization laboratory, but no late stroke was observed at 30 days after procedure. CONCLUSIONS: IVUS can detect plaque protrusion better than angiography. Because adequate management of plaque protrusion may reduce stroke complications, IVUS usage is worth considering.

Results from a multicenter retrospective study of transradial iliac artery stenting in Japan.

Large-scale multicenter studies demonstrating the safety and effectiveness of transradial iliac artery stenting are lacking. We evaluated the data from a multicenter database in Japan. Transradial iliac artery stenting was performed on 115 lesions in 105 patients. The approach site was determined at the discretion of the operator. Patients with scheduled multiple sheath insertions for the bidirectional approach were excluded. Clinical data were retrospectively analyzed. The average age of this cohort was 71.1 ± 8.3 years. Eighty-six patients (81.9%) were male. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 39 (37.1%), 84 (80.0%), 69 (65.7%), and 78 patients (74.3%), respectively. Rutherford classifications 1, 2, 3, 4, and 5 comprised 40 (34.8%), 42 (36.5%), 28 (24.3%), 3 (2.6%), and 2 (1.7%) lesions, respectively, while Trans-Atlantic Inter-Society Consensus II classifications A, B, C, and D comprised 74 (64.3%), 21 (18.3%), 15 (13.0%), and 5 (4.3%), respectively. Twenty-seven lesions (23.5%) had chronic total occlusion. All lesions were successfully treated with 141 stents. Four patients (3.8%) required additional puncture of the common femoral artery for successful stent implantation. The ankle-brachial index significantly improved from 0.65 ± 0.17 to 0.95 ± 0.15 (P < 0.0001). None of the patients experienced any procedural or access site-related complications. Asymptomatic radial artery occlusion was observed in three cases (2.9%) after the procedure. There were no target lesion revascularizations or complications at 1 month. Compared to the traditional transfemoral approach, transradial iliac artery stenting is safe and feasible without any specific complications in carefully selected patients.

Clinical Outcomes of Transradial vs Nontransradial Aortoiliac Endovascular Therapy.

BACKGROUND: The introduction of radial-specific equipment has made transradial (TR) aortoiliac (AI) endovascular therapy (EVT) more convenient. OBJECTIVES: The authors aimed to investigate the perioperative outcomes of the TR approach in patients undergoing AI EVT for symptomatic peripheral artery disease. METHODS: The COMFORT (Contemporary Strategy for Aortoiliac Intervention) registry was a prospective, multicenter, observational study enrolling patients with symptomatic peripheral artery disease undergoing AI EVT between January 2021 and June 2023. The primary outcome was perioperative complications, whereas the secondary outcomes included core laboratory-evaluated residual stenosis >30%, time to hemostasis, time to ambulation, 30-day patency, and 30-day limb symptoms. These outcomes were compared between TR and non-TR AI EVT after propensity score matching. RESULTS: The TR approach was selected for 231 of the 947 patients (24.3%). The TR approach was chosen more in patients with a higher ankle-brachial index, chronic total occlusion, aortic lesion, bare nitinol stent implantation, and plain angioplasty, whereas it was chosen less in patients with dialysis, a history of AI EVT, chronic limb-threatening ischemia, bilateral calcification, and simultaneous infrainguinal EVT (all P < 0.05). After propensity score matching, the incidence of perioperative complications did not differ significantly between the groups (TR group: 6.0% vs non-TR group: 5.1%; P = 0.69). The proportions of residual stenosis, 30-day patency, and 30-day limb symptoms were not significantly different (all P > 0.05); however, the time to hemostasis and the time to ambulation were shorter in the TR group (both P < 0.05). CONCLUSIONS: Non-TR AI EVT and TR AI EVT using radial-specific equipment were associated with a similar risk of perioperative complications. The TR approach helps shorten the time required for hemostasis and ambulation.

Twenty-Four-Month Safety and Effectiveness of TCD-17187 Drug-Coated Balloon for Treatment of Atherosclerotic Lesions in Superficial Femoral and Proximal Popliteal Artery.

PURPOSE: In the present trial, the 24-month safety and effectiveness of the TCD-17187 drug-coated balloon (DCB) for the treatment of atherosclerotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PA) were evaluated in Japanese patients. METHODS: This was a prospective, multicenter, core laboratory-adjudicated, single-arm trial. From 2019 to 2020, 121 patients with symptomatic peripheral artery disease were enrolled. The primary effectiveness outcome measure was primary patency. The safety outcome measure was the major adverse event (MAE) rate. RESULTS: Age was 74.5 ± 7.3 years, and diabetes mellitus was present in 67.5%. Lesion length and reference vessel diameter (RVD) were 106.0 ± 52.6 mm and 5.2 ± 0.8 mm, respectively. Chronic total occlusion (CTO) and bilateral calcification rate (Grade 3 and 4 by peripheral arterial calcium scoring system (PACSS)) were 17.5% and 50.8%, respectively. The 24-month primary patency rate by duplex ultrasound was 71.3%, while freedom from clinically driven target lesion revascularization (CD-TLR) was 87.0%. The MAE rate was 13.2% and all events consisted of CD-TLR. There were no instances of device- or procedure-related deaths major amputations throughout the 24 months. Multivariate Cox proportional hazards regression analysis revealed significant differences associated with loss of primary patency in the following characteristics: CTO, restenotic lesion and RVD. CONCLUSION: This trial confirmed the safety and effectiveness of TCD-17187 DCB for atherosclerotic lesions of the SFA and/or proximal PA for up to 24 months. LEVEL OF EVIDENCE: Level 3, Cohort study. CLINICAL TRIAL REGISTRATION: URL: https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=brows&action=brows&recptno=R000038612&type=summary&language=J:Registration ID: UMIN000034122. Registration Date: September 13, 2018.

Efficacy of the S.M.A.R.T. Control vs. other stents for aortoiliac occlusive disease in contemporary clinical practice.

PURPOSE: To compare the safety and efficacy of the S.M.A.R.T. Control stent vs. other stents in patients with symptomatic aortoiliac occlusive disease (AIOD) followed for up to 4 years. METHODS: A subgroup analysis of data from a retrospective multicenter registry examined 2036 symptomatic patients (1659 men; mean age 71±8 years) who received stent-supported endovascular therapy for 2541 AIOD lesions between April 2005 and December 2009. The cohort was divided into the S.M.A.R.T. stent group (955 patients/1196 lesions) and the "other" stent group (1081 patients/1345 lesions). The main study outcomes of primary patency and event-free survival at 4 years were compared before and after propensity matching analysis. The rates for freedom from major amputation, surgical conversion, target lesion revascularization (TLR), and major adverse limb events were also assessed. RESULTS: The S.M.A.R.T. Control stent group had greater frequency of critical limb ischemia (CLI), TASC C/D lesions, and chronic total occlusions. The mean follow-up was 25±17 months in the S.M.A.R.T. group vs. 29±19 months in the other stent group. After propensity matching, 4-year primary patency (86% vs. 76%, p<0.001) and freedom from adverse limb events (93% vs. 90%, p=0.04) were greater in the S.M.A.R.T. Control stent group, while event-free survival rates (75% vs. 77%, p=0.50) were similar between groups. Univariate subgroup analysis showed that use of the S.M.A.R.T. stent was associated with greater primary patency in patients with renal insufficiency (serum creatinine >1.5 mg/dL) and CLI. CONCLUSION: After propensity matching analysis, the durability of the S.M.A.R.T. stent was superior to that of other stents, which might reflect differing design characteristics.

Effect of body position on skin perfusion pressure in patients with severe peripheral arterial disease.

BACKGROUND: Skin perfusion pressure (SPP) has been shown to be useful in the assessment of the severity of peripheral arterial disease (PAD), and ulcers can be cured when the SPP is ≥30-40 mmHg. The purpose of this study was to determine the best body position for measuring SPP in patients with severe PAD. METHODS AND RESULTS: We studied 24 limbs of 18 patients with PAD whose SPP was ≤40 mmHg. After patients had been resting supine for 10 min (Position I), their SPP was measured at the dorsum of the foot with a laser Doppler probe. Following measurement in the supine position, SPP was measured in the sitting position after the foot had been extended horizontally for 10 min (Position II), and in the sitting position after the foot had been lowered vertically for 10 min (Position III). SPP increased significantly from Position I to Positions II and III (25.3±10.9 mmHg, 40.6±12.7 mmHg, and 73.4±17.7 mmHg, respectively; P<0.0001). In all patients, SPP values exceeding 30 mmHg were obtained in Position III. CONCLUSIONS: The best SPP values were obtained in Position III, which is the ideal position for peripheral arterial circulation in patients with severe PAD.

Contemporary outcomes after endovascular treatment for aorto-iliac artery disease.

BACKGROUND: The patency and complications in aorto-iliac (AI) stenting remain poorly understood. The aim of this paper was to investigate the safety and efficacy after AI stenting. METHODS AND RESULTS: This study was performed as a large-scale multicenter, retrospective registry. A total of 2,147 consecutive patients with AI disease were enrolled. The safety endpoints were procedure success, complications and 30-day mortality. The efficacy endpoints were primary, assisted primary and secondary patency, overall survival, freedom from major adverse cardiovascular events (MACE; all-cause death, myocardial infarction and stroke), and major adverse cardiovascular and limb events (MACLE; any repeat revascularization for limb and leg amputation in addition to MACE). Procedure success, complication rate and 30-day mortality were 97.6%, 6.4% and 0.7%. Primary patency was 92.5%, 82.6% and 77.5% at 1, 3 and 5 years, assisted primary patency was 97.0%, 92.7% and 91.9% at 1, 3 and 5 years and secondary patency was 99.0%, 98.7% and 98.5% at 1, 3 and 5 years. The overall survival rate was 95.0%, 87.6%, and 79.3% at 1, 3 and 5 years. The cause of death was cardiovascular in 44.1%. Freedom from MACE (MACLE) was 93.3% (89.9%), 84.4% (76.7%), and 74.9% (66.8%) at 1, 3 and 5 years. Female gender, diabetes, renal failure, absence of aspirin, reference vessel diameter <8.0mm and outflow lesion were found to be independent predictors of primary patency. CONCLUSIONS: The safety and efficacy after AI stenting are feasible compared to surgical reconstruction.

Distal radial artery approach for endovascular therapy.

It has been reported that the distal transradial approach (dTRA) is safe and useful for percutaneous coronary intervention (PCI). In this study we evaluated the safety and efficacy of the dTRA for endovascular therapy (EVT). The dTRA for EVT was performed in 43 lesions from 35 patients. Approach site was determined at the discretion of the operator. Clinical data were analyzed retrospectively. Average patient age was 74.0 ± 6.5 years; 30 (86%) were male; average height was 161.1 ± 8.4 cm. Diabetes mellitus, hypertension, dyslipidemia, and smoking habit were present in 19 (54.3%), 31 (88.6%), 29 (82.9%), and 29 (82.9%) patients, respectively. Target lesions were iliac artery in 38 (88.4%) patients, superficial femoral artery in 4 (9.3%) and renal artery in the remaining patient (2.3%). Eight lesions (18.6%) were chronic total occlusions. Thirteen (30.2%), 2 (4.7%), and 28 (65.1%) lesions were treated using 4.5, 6, and 7 French long guiding systems, respectively. All lesions were successfully treated without any procedural or access site-related complications. No additional puncture sites were required. Ankle brachial index significantly improved from 0.62 ± 0.20 to 0.92 ± 0.17 (p < 0.0001) post-treatment for the lower limbs. There were no radial artery occlusions, target lesion revascularization, or complications 1 month later. Similar to PCI, the dTRA for EVT is safe and feasible without any specific complications in carefully selected patients.