Impact of Baseline and Postprocedural Intravascular Ultrasound Findings on 1-Year Primary Patency After Drug-Coated Balloon Treatment of Femoropopliteal Lesions.

PURPOSE: Drug-coated balloons (DCBs) are commonly used for endovascular treatment of femoropopliteal lesions. Here, we employed intravascular ultrasound (IVUS) to investigate the predictors of restenosis after DCB treatment. METHODS: This retrospective and single-center study was performed to examine 1-year primary patency after DCB treatment and to identify the risk factors for restenosis by analyzing clinical characteristics, angiographic findings, and IVUS measurements. We included 111 consecutive patients undergoing DCB treatment for de novo femoropopliteal lesions at our hospital from July 2018 to March 2020. RESULTS: The primary patency rate was found to be 80.0% at 1 year. The Cox proportional hazard multivariate analysis revealed that restenosis was independently associated with chronic total occlusion (CTO; p < 0.001), circumferential calcification (p = 0.023), and smaller postprocedural minimum lumen area (MLA; p = 0.036). Furthermore, receiver operating characteristic curve analysis showed that the cutoff value of postprocedural MLA to prevent restenosis was 12.7 mm2, with an area under the curve of 0.774 (p< 0.001). The multivariate analysis indicated that patients with a postprocedural MLA below 12.7 mm2 (n = 44) had a significantly smaller distal reference vessel size (p < 0.001) compared to those with a postprocedural MLA over 12.7 mm2 (n = 67). CONCLUSIONS: Restenosis after DCB treatment was shown to correlate with CTO, circumferential calcification, and postprocedural MLA as evaluated by IVUS. Moreover, smaller vessel sizes might represent a particular challenge to the DCB strategy due to the difficulty of restoring a sufficient postprocedural lumen area by balloon dilatation.

Ecological, physiological, and biomechanical differences between gametophytes and sporophytes of Chondrus ocellatus (Gigartinales, Rhodophyta)1.

Although variation among habitats in the ratio of gametophytes to sporophytes has been reported in various gigartinacean species, factors controlling the phase ratio remain poorly understood. Over 18 months, we examined the phase ratio of Chondrus ocellatus at three sites: a sheltered intertidal site, Hiruga A; an exposed intertidal site, Hiruga B; and a subtidal site, Shikimi. The mean proportion of gametophytes at Hiruga A (73.1%) was significantly higher than that at Shikimi (51.2%) and Hiruga B (44.7%). Due to a significantly higher water retention ability of the gametophytes, it was expected that the gametophytes would exhibit higher desiccation tolerance. After dehydration treatments, however, neither the photosynthetic rate of vegetative blades nor the survival rate of spores was significantly different between the phases. Measurements of blade strength indicated that the sporophytic blades were less stiff and more flexible, and a culture experiment revealed that the sporophytic germlings showed a significantly higher growth rate. Flexible blades and fast-growing germlings are considered advantageous for colonizing wave-swept intertidal habitats, so these properties may have caused the different fluctuation pattern of phase ratio among the sites. The present data demonstrate that biomechanical and physiological differences between the two phases of C. ocellatus make one phase advantageous in certain environmental conditions, and that these differences likely cause an unequal ratio of isomorphic phases.

Impact of Scoring Balloons on Percutaneous Transluminal Angioplasty Outcomes in Femoropopliteal Lesions.

Purpose: To investigate the efficacy of scoring balloons for immediate success of percutaneous transluminal angioplasty (PTA) in femoropopliteal lesions. Materials and Methods: Between 2013 and 2019, 398 consecutive patients with de novo femoropopliteal lesions were treated using PTA in our hospital. The procedure success rate was compared among patients undergoing PTA with vs without scoring balloons after 1:1 propensity score matching on hemodialysis, TransAtlantic Inter-Society Consensus II classification, Peripheral Arterial Calcium Scoring System (PACSS) grade, lesion length, and use of intravascular ultrasound. Propensity matching produced 84 patients (mean age 73.4±8.3; 65 men) treated with scoring balloons and 84 patients (mean age 75.6±8.7; 56 men) treated with plain balloons. Kaplan-Meier analysis investigated patency after the procedure in both groups; estimates are given with the 95% confidence interval (CI). Results: Residual stenosis <30% was achieved more often (77.4% vs 57.1%, p=0.005) and severe arterial dissection occurred less frequently (16.7% vs 29.8%, p=0.043) in the scoring balloon group vs the plain balloon group, respectively. The rate of provisional stenting was significantly lower after scoring balloon use (13.3% vs 29.8%, p=0.008). Multivariable analysis revealed that use of scoring balloons (p<0.001) and prolonged inflation time (p<0.001) were independent predictors of successful angioplasty, whereas chronic total occlusion (p=0.005) and longer lesion length (p=0.005) were predictors of an unsuccessful procedure. Among 108 patients with PACSS 0-3 lesions in the matched population, Kaplan-Meier analysis showed better primary patency at 18 months in the scoring balloon group in the intention to treat analysis [68.6% (95% CI 53.5% to 80.6%) vs 43.0% (95% CI 28.7% to 58.5%), p=0.044]. Conclusion: Scoring balloons may be effective in restoring acute lumen gain and preventing severe arterial dissection in femoropopliteal lesions. Moreover, scoring balloons might be associated with better primary patency at 18 months in PACSS 0-3 lesions.

Genetic engineering of eggplant accumulating ß-carotene in fruit.

KEY MESSAGE: Genetic engineering of eggplant using fruit-specific EEF48 promoter-driven bacterial PSY gene, crtB, confers ß-carotene accumulation in fruit. Eggplant (Solanum melongena L.) is globally cultivated especially in Asia and is an important source of nutrients in the diets of low-income consumers in developing countries. Since fruits of eggplant have low provitamin A carotenoid content, it is expected to develop eggplant with high carotenoid content for combatting vitamin A deficiency. To achieve this, the present study implemented a metabolic engineering strategy to modify the carotenoid biosynthetic pathway in eggplant. Expression analysis of carotenogenic genes in eggplant tissues showed that the expression of the endogenous phytoene synthase (PSY) was low in fruit and callus. Orange-colored calluses were generated from ectopic expression of crtB gene, which encodes bacterial PSY, in eggplant cells. The orange calluses accumulated > 20 µg g-1 FW of ß-carotene, which was approximately 150-fold higher than that of the untransformed calluses. These observations suggest that the PSY expression is the rate-limiting step for ß-carotene production in callus and fruit. Since the orange calluses did not regenerate plants, we chose eggplant EEF48 gene, which is presumably expressed in fruit. We amplified its promoter region by TAIL-PCR and showed that the EEF48 promoter is indeed active in eggplant fruit. Subsequently, transgenic eggplant lines having EEF48 promoter-driven crtB were produced. Among the transgenic lines produced, one line set fruit containing 1.50 µg g-1 FW of ß-carotene, which was 30-fold higher than that of the untransformed fruits (0.05 µg g-1 FW). The self-pollinated progenies showed a 3:1 segregation ratio for the presence and absence of the transgene, which was linked to the ß-carotene accumulation in fruit. These results provide a strategy for improvement of carotenoid content in eggplant fruit.

Self-Expanding Nitinol Stent vs Percutaneous Transluminal Angioplasty in the Treatment of Femoropopliteal Lesions: 3-Year Data From the SM-01 Trial.

PURPOSE: To report the midterm outcomes of a trial comparing self-expanding nitinol stents to percutaneous transluminal angioplasty (PTA) with provisional stenting in the treatment of obstructive disease in the superficial femoral and popliteal arteries. MATERIALS AND METHODS: The SM-01 study ( ClinicalTrials.gov identifier NCT01183117), a single-blinded, multicenter, randomized controlled trial in Japan, enrolled 105 consecutive patients with de novo or postangioplasty restenotic femoropopliteal lesions; after removing protocol violations (1 from each group), 51 patients (mean age 74±8 years; 36 men) in the stent group and 52 patients (mean age 73±8 years; 35 men) in the PTA group were included in the intention-to-treat analysis. The groups were well-matched at baseline. Patients were followed to 36 months with duplex imaging. Three-year primary patency was assessed based on a duplex-derived peak systolic velocity ratio <2.5. Freedom from clinically-driven target vessel revascularization (TVR) and target lesions revascularization (TLR) were estimated using the Kaplan-Meier method. RESULTS: The technical success rate was higher (100% vs 48%, p<0.001) and the frequency of vascular dissection was lower (4% vs 31%, p<0.001) in the stent group. The S.M.A.R.T stent group had a higher 3-year primary patency rate (73% vs 51%, p=0.033). Freedom from clinically-driven TVR and TLR were not significantly different between the groups. CONCLUSION: The S.M.A.R.T. stent maintained a higher primary patency rate than PTA at 3 years in this randomized trial; the need for clinically-driven revascularization was similar for both therapies.

Impact of Prolonged Inflation Times During Plain Balloon Angioplasty on Angiographic Dissection in Femoropopliteal Lesions.

PURPOSE: To investigate if balloon angioplasty with a prolonged inflation time (>3 minutes) can prevent postdilation dissection in femoropopliteal lesions. METHODS: A retrospective single-center analysis examined 294 consecutive patients (mean age 74.1±8.7 years; 215 men) with de novo femoropopliteal lesions treated with balloon angioplasty between 2013 and 2018. The patients were classified into 2 groups to compare angiographic dissection patterns: 175 patients treated with balloon angioplasty for 3 minutes (3-minute group) and 119 treated for >3 minutes (>3-minute group). RESULTS: Mean balloon inflation time was 7.8±2.7 minutes in the >3-minute group. Severe dissections (type C or higher) were observed less frequently after balloon dilation in the >3-minute group (22.7% vs 50.9%, p<0.001); therefore, significantly more patients in the >3-minute group had successful endovascular treatment after initial balloon angioplasty (57.1% vs 38.3%, p=0.001). Additional balloon dilation was attempted more frequently in the 3-minute group (30.9% vs 14.3%, p=0.001); as a result, there were more patients in whom additional balloon dilation repaired severe dissection that occurred after the initial dilation (25.1% vs 10.9%, p=0.001). Multivariate analysis revealed that chronic total occlusion (p<0.001) and longer lesion (p<0.001) were independent predictors of severe dissection, and prolonged dilation time was independently related to preventing severe dissection (p<0.001). Among 171 patients undergoing successful balloon angioplasty without stent implantation, the Kaplan-Meier estimates of primary patency within 1 year did not differ significantly according to inflation time. CONCLUSION: Balloon dilation with prolonged inflation time (>3 minutes) may be effective as an initial strategy to prevent severe dissection in femoropopliteal lesions compared to inflation for 3 minutes.

Sustained Effectiveness of Cilostazol After Endovascular Treatment of Femoropopliteal Lesions: Midterm Follow-up From the Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) Study.

PURPOSE: To investigate the midterm safety and effectiveness of cilostazol treatment in claudicant patients undergoing endovascular therapy. METHODS: The Sufficient Treatment of Peripheral Intervention by Cilostazol (STOP-IC) study ( ClinicalTrials.gov identifier NCT00912756; University Hospital Medical Information Network identifier UMIN000002091) enrolled 200 patients (mean age 73 years; 131 men) treated for femoropopliteal disease from March 2009 to April 2011 at 13 cardiovascular centers in Japan. The participants were randomized 1:1 to receive oral aspirin with or without cilostazol. Of the 100 patients assigned to the 2 treatment groups, 7 patients in the cilostazol group and 2 patients in the no-cilostazol group were withdrawn from the study without undergoing endovascular treatment, leaving 93 patients in the cilostazol group and 98 patients in the no-cilostazol group for follow-up analysis. The primary outcome measure was primary patency; secondary outcome measures were freedom from clinically-driven target lesion revascularization (CD-TLR) and overall survival. Outcomes were analyzed on an intention-to-treat basis using the Kaplan-Meier method; estimates were compared with the log-rank test. RESULTS: The median follow-up was 38.1 months (interquartile range 25.1, 47.7). Among the 93 subjects in the cilostazol group, 7 died and 26 withdrew from administration 1 year after the endovascular procedure. Discontinuation of cilostazol was not a significant factor for restenosis. Primary patency was significantly higher in the cilostazol group than in the no-cilostazol group (69% vs 54%, p=0.026) at 3 years. The cilostazol group also had better 3-year freedom from CD-TLR (78% vs 63%, p=0.014), although overall survival estimates did not differ significantly (p=0.95). CONCLUSION: These results suggest that the safety and effectiveness of cilostazol treatment were sustained in patients with femoropopliteal disease undergoing endovascular treatment.

Sheathless guide catheter in transradial percutaneous coronary intervention for ST-segment elevation myocardial infarction.

OBJECTIVES: The aim of this study was to assess the safety and efficacy of sheathless guide catheters in transradial percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). BACKGROUND: Transradial PCI for STEMI offers significant clinical benefits, including a reduced incidence of vascular complications. As the size of the radial artery is small, the radial artery is frequently damaged in this procedure using large-bore catheters. A sheathless guide catheter offers a solution to this problem as it does not require an introducer sheath. However, the efficacy and safety of sheathless guide catheters remain to be fully determined in emergent transradial PCI for STEMI. METHODS: Data on consecutive STEMI patients undergoing primary PCI at the Sendai Kousei Hospital between September 2010 and May 2013 were analyzed. The primary endpoint was the rate of acute procedural success without access site crossover. Secondary endpoints included door-to-balloon time, fluoroscopy time, volume of contrast, and radial artery stenosis or occlusion rate. RESULTS: We conducted transradial PCI for 478 patients with STEMI using a sheathless guide catheter. Acute procedural success was achieved in 466 patients (97.5%). The median door-to-balloon time was 45 min (range, 15-317 min). The median fluoroscopy time was 16.4 min (range, 10-90 min). The median volume of contrast was 134 mL (range, 31-431 mL). Radial stenosis or occlusion developed in 14 (3.8%) of the 370 evaluable patients. CONCLUSIONS: This study showed that use of a sheathless guide catheter taking a transradial approach was effective and safe in primary PCI for STEMI. © 2015 Wiley Periodicals, Inc.

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.

Specific decrease in solution viscosity of antibodies by arginine for therapeutic formulations.

Unacceptably high viscosity is observed in high protein concentration formulations due to extremely large therapeutic dose of antibodies and volume restriction of subcutaneous route of administration. Here, we show that a protein aggregation suppressor, arginine hydrochloride (ArgHCl), specifically decreases viscosity of antibody formulations. The viscosities of bovine gamma globulin (BGG) solution at 250 mg/mL and human gamma globulin (HGG) solution at 292 mg/mL at a physiological pH were too high for subcutaneous injections, but decreased to an acceptable level (below 50 cP) in the presence of 1,000 mM ArgHCl. ArgHCl also decreased the viscosity of BGG solution at acidic and alkaline pHs. Interestingly, ArgHCl decreased the viscosity of antibody solutions (BGG, HGG, and human immunoglobulin G) but not globular protein solutions (α-amylase and α-chymotrypsin). These results indicate not only high potency of ArgHCl as an excipient to decrease the solution viscosity of high concentration antibodies formulations but also specific interactions between ArgHCl and antibodies.

A multicenter randomized comparison of paclitaxel-coated balloon catheter with conventional balloon angioplasty in patients with bare-metal stent restenosis and drug-eluting stent restenosis.

BACKGROUND: The aim of this study was to investigate the efficacy and safety of paclitaxel-coated balloon (PCB) for the treatment of the bare-metal stent restenosis (BMS-ISR) and drug-eluting stent restenosis (DES-ISR). METHODS: This study was a prospective, multicenter, randomized (2:1) trial conducted in 208 patients with 213 in-stent restenosis lesions (BMS-ISR: 123 lesions, DES-ISR: 90 lesions) at 13 centers in Japan. Patients were randomly assigned to a PCB group (137 patients with 142 lesions) or a conventional balloon angioplasty (BA) group (71 patients with 71 lesions). The primary end point was target vessel failure at 6-month follow-up. RESULTS: Clinical and angiographic follow-up 6 months after intervention was performed in 207 patients (99.5%) with 208 lesions (97.7%). Target vessel failure was noted in 6.6% of the PCB group and 31.0% of the BA group (P < .001). Recurrent restenosis occurred in 4.3% of the PCB group and 31.9% of the BA group (P < .001). Late lumen loss was lower in the PCB group than in the BA group (0.11 ± 0.33 mm vs 0.49 ± 0.50 mm, P < .001). In PCB-treated lesions, recurrent restenosis occurred in 1.1% of patients with BMS-ISR and in 9.1% of patients with DES-ISR (P = .04). Late lumen loss was lower in patients with BMS-ISR than in patients with DES-ISR (0.05 ± 0.28 mm vs 0.18 ± 0.38 mm, P = .03). CONCLUSIONS: This randomized clinical study suggested that PCB provided much better clinical and angiographic outcomes than did conventional BA in patients with BMS-ISR and DES-ISR. Drug-eluting stent restenosis was associated with poorer outcomes compared with BMS-ISR after treatment with PCB.

Randomized comparison of the Nobori biolimus A9-eluting stent with the sirolimus-eluting stent in patients with stenosis in native coronary arteries.

OBJECTIVES: The aim of this randomized-controlled trial is to compare biolimus A9-eluting stent (Nobori) to sirolimus eluting stent (Cypher). BACKGROUND: The Nobori coronary stent is coated only abluminally with a biodegradable polymer, poly-lactic acid, and the antiproliferative agent biolimus A9. This stent has been studied in randomized trials versus Taxus Express and Taxus Liberte and showed noninferiority and superiority for in-stent late loss. This is the first randomized trial of Nobori stent versus Cypher stent. METHODS: We conducted a randomized (3:2), controlled trial comparing Nobori and Cypher, in 335 patients (198 Nobori and 137 Cypher) at 15 centers in Japan. Patients with de-novo lesions in up to two native coronary arteries were considered for enrollment. The primary endpoint was freedom from target vessel failure (TVF), a composite of cardiac death, myocardial infarction, and target vessel revascularization at 9 months. RESULTS: At 9 months, the primary endpoint of freedom from TVF was 92.6% in Nobori and 93.8% in Cypher arm (noninferiority test P < 0.001). As main secondary endpoints, the in-stent late loss was 0.12 ± 0.30 mm and 0.14 ± 0.34 mm in Nobori and Cypher stents, respectively. Target lesion revascularization was 0.5% in Nobori and 3.9% in Cypher treated patients (P = 0.04). Definite and probable stent thromboses were not recorded in any patient. CONCLUSIONS: Despite the relatively small number of patients, this well controlled clinical trial confirmed the primary hypothesis of non-inferiority of the Nobori biolimus A9-eluting stent to the Cypher sirolimus-eluting stent for freedom from TVF. Both stents showed excellent midterm results.

Interatrial mechanical dyssynchrony shown by tissue doppler imaging during atrial flutter.

Although regular supraventricular tachycardia is traditionally classified on the basis of P-wave morphology, diagnostic accuracy is limited to information obtained from surface electrocardiography. Intracardiac electrophysiology is a conclusive although invasive diagnostic method. We report a case of regular supraventricular tachycardia with a heart rate of 162 bpm. M-mode echocardiography of the interatrial septum clarified both the atrial rate and the ventricular response ratio. Tissue Doppler M-mode imaging demonstrated the delay between the posterior wall motion of the left and right atrium. Although it deserves further study, transthoracic echocardiography may provide useful information in addition to electrocardiography.

Role of Cardiac Magnetic Resonance (CMR) in Determining Implantable Cardioverter-Defibrillator (ICD) Indication in Acromegalic Cardiomyopathy: A Case Report.

Potentially fatal arrhythmia is one of the causes of premature death in acromegalic cardiomyopathy patients who are not properly treated. Implantable cardioverter-defibrillator (ICD) is one of the most effective and established treatments to prevent sudden cardiac death due to potentially fatal tachyarrhythmia. However, since the indication of ICD changes depending on whether it is ischemic cardiomyopathy or non-ischemic cardiomyopathy, proper diagnosis is important in patients with these diseases. Cardiac magnetic resonance (CMR) is a convenient and useful tool for diagnosing these. Both potentially fatal arrhythmias and coronary artery disease (CAD) are known to be important complications of acromegaly. Herein, we present a case of potentially fatal tachyarrhythmia due to acromegalic cardiomyopathy with the acute coronary syndrome. Furthermore, we mention the usefulness of CMR in the case which is difficult to determine the indication for an ICD.

Catheter-based ultrasound renal denervation in patients with resistant hypertension: the randomized, controlled REQUIRE trial.

Renal denervation is a promising new non-pharmacological treatment for resistant hypertension. However, there is a lack of data from Asian patients. The REQUIRE trial investigated the blood pressure-lowering efficacy of renal denervation in treated patients with resistant hypertension from Japan and South Korea. Adults with resistant hypertension (seated office blood pressure ≥150/90 mmHg and 24-hour ambulatory systolic blood pressure ≥140 mmHg) with suitable renal artery anatomy were randomized to ultrasound renal denervation or a sham procedure. The primary endpoint was change from baseline in 24-hour ambulatory systolic blood pressure at 3 months. A total of 143 patients were included (72 renal denervation, 71 sham control). Reduction from baseline in 24-hour ambulatory systolic blood pressure at 3 months was not significantly different between the renal denervation (-6.6 mmHg) and sham control (-6.5 mmHg) groups (difference: -0.1, 95% confidence interval -5.5, 5.3; p = 0.971). Reductions from baseline in home and office systolic blood pressure (differences: -1.8 mmHg [p = 0.488] and -2.0 mmHg [p = 0.511], respectively), and medication load, did not differ significantly between the two groups. The procedure-/device-related major adverse events was not seen. This study did not show a significant difference in ambulatory blood pressure reductions between renal denervation and a sham procedure in treated patients with resistant hypertension. Although blood pressure reduction after renal denervation was similar to other sham-controlled studies, the sham group in this study showed much greater reduction. This unexpected blood pressure reduction in the sham control group highlights study design issues that will be addressed in a new trial. CLINICAL TRIAL REGISTRATION: NCT02918305 ( http://www.clinicaltrials.gov ).

Timing of the restenosis following nitinol stenting in the superficial femoral artery and the factors associated with early and late restenoses.

OBJECTIVES: We sought to investigate the timing of restenosis and the restenosis factors following nitinol stenting in the superficial femoral artery (SFA). BACKGROUND: Restenosis following nitinol stenting in the SFA remains unsolved. METHODS: We analyzed 742 limbs in consecutive 585 patients who underwent successful endovascular therapy for de novo SFA lesions. Patency was assessed by duplex ultrasonography. Primary patency was defined as treated vessels without restenosis and secondary patency was defined as target vessels reopened by repeat revascularization. Receiver-operating characteristic (ROC) analysis was performed to delineate the timing of restenosis. Patients were subsequently classified into three groups: no restenosis, early restenosis, and late restenosis. Cox proportional hazard regression analyses were performed to explore the determinants of restenosis in each restenosis group. RESULTS: Primary and secondary patency was 67 and 86% at 6 years, respectively. ROC curves indicated the 369th day was the best cutoff point distinguishing the early (144 limbs) and the late (42 limbs) restenoses. Sustained patency was observed in 556 limbs. After multivariate analysis, cilostazol (P = 0.0007) was negatively associated; female gender (P = 0.0071), diabetes mellitus (P = 0.0428), critical limb ischemia (P = 0.0435), and stent fracture (P = 0.0004) were positively associated with the early restenosis. Trans Atlantic Inter-Society Consensus II C/D was positively associated with both the early (P = 0.0017) and the late (P = 0.0359) restenoses. CONCLUSIONS: Restenosis predominantly occurred within a year following nitinol stenting in the SFA, and the factors associated with the early restenosis were different from those with the late restenosis.

Long-term outcomes and risk stratification of patency following nitinol stenting in the femoropopliteal segment: retrospective multicenter analysis.

PURPOSE: To investigate the long-term outcomes of nitinol stenting in femoropopliteal lesions and to determine the factors associated with restenosis. METHODS: Between December 2003 and December 2009, 861 patients (603 men; mean age 72 years) underwent nitinol stenting of the femoropopliteal segment in 1017 limbs. A quarter (26%) of the patients had critical limb ischemia. Mean lesion length was 152±93 mm. Stent patency was assessed by either duplex ultrasound or angiography and analyzed by Kaplan-Meier estimation. The determinants of restenosis were explored with Cox proportional hazard regression analyses; the results are presented as the hazard ratio (HR) and 95% confidence interval (CI). Risk stratification of primary patency was subsequently analyzed using a score based on the significant prognostic factors identified in the multivariate model. RESULTS: Stent fracture occurred in 10% (104 limbs) of the lesions. At 1, 3, and 6 years, the primary patency rates were 77%, 67%, and 63%; secondary patency rates were 91%, 87%, and 87%; freedom from femoropopliteal bypass grafting was 99%, 97%, and 96%, respectively. Multivariate Cox regression analysis identified female gender (HR 1.899; 95% CI 1.318 to 2.737, p<0.001), ankle-brachial index <0.6 (HR 1.921; 95% CI 1.348 to 2.736, p<0.001), TASC II C/D lesion (HR 2.068; 95% CI 1.346 to 3.177, p = 0.0009), stent fracture (HR 1.937; 95% CI 1.203 to 3.118, p = 0.006), and the absence of cilostazol administration (HR 2.102; 95% CI 1.394 to 3.172, p<0.001) as strong independent factors associated with restenosis. After assigning a risk score based on the outcomes of the multivariate regression analysis (1 each for female gender, ABI <0.6, TASC II C/D, stent fracture, and absence of cilostazol therapy), primary patency was found to be lower in limb groups with a higher cumulative score (12-month primary patency: score 0: 93%, score 1: 80%, score 2: 73%, score 3; 47%, score 4: 0%, respectively; p<0.001). CONCLUSION: Endovascular therapy using nitinol stents for FP lesions yielded acceptable outcomes up to 6 years. Risk stratification for patency can play an important role in estimating future occurrence of restenosis after nitinol stent implantation in FP lesions.

Long-term results of the S.M.A.R.T. Control(TM) stent for superficial femoral artery lesions, J-SMART registry.

BACKGROUND: The use of a stent in the treatment of lesions of the superficial femoral artery (SFA) remains controversial. Although some reports have suggested that use of a nitinol stent in conjunction with aggressive medical management is effective for long SFA lesions, few long-term, large-scale studies have been done. METHODS AND RESULTS: A retrospective analysis was conducted of data from a multicenter study in which the S.M.A.R.T. Control(TM) stent was used for treatment of de novo SFA lesions. A total of 528 lesions in 432 patients were included. Mean patient age was 72.5±9.1 years; mean stent length was 15.7±8.1cm; 259 lesions (49%) were classified as C/D according to the TransAtlantic Inter-Society Consensus (TASC) II classification. Primary and secondary patency at 4 years was 66% and 87%, respectively. No cilostazol administration (41% re-stenosis group vs. 29% no-restenosis group, P<0.01), female gender (42% vs. 26%, P<0.01), younger age (70.7±9.3 years vs. 72.9±9.0 years, P<0.05), and chronic total occlusion (CTO; 72% vs. 52%, P<0.01) were independent predictors of re-stenosis. CONCLUSIONS: The S.M.A.R.T. Control(TM) stent provided good long-term durability in the treatment of SFA lesions, and no cilostazol administration, female gender, younger age and CTO were associated with re-stenosis.

[Role of bare metal stent in drug eluting stent era].

Although drug eluting stent (DES) reduced the target vessel revascularization, there are still some unsolved concerns such as late stent thrombosis, late catch up, adequate duration of dual antiplatelet agents and surgical complication after DES implantation. Individually bare metal stent should be used considering several factors such as patient characteristic, lesion characteristic, the tolerance of dual antiplatelet therapy for long-term, informed consent and also surgery after PCI.

Long-term clinical effectiveness of a drug-coated balloon for in-stent restenosis in Femoropopliteal lesions.

BACKGROUND: The short-term efficacy of paclitaxel-coated balloons (PCBs) has been established in femoropopliteal in-stent restenosis (ISR) lesions. The aim of this study was to compare 5-year clinical outcomes of patients with femoropopliteal ISR lesions undergoing percutaneous transluminal angioplasty (PTA) with and without PCB. METHODS: After 1:1 propensity score matching, we extracted 50 patients with femoropopliteal ISR lesions undergoing PTA with (n = 25) and without (n = 25) IN.PACT PCB (Medtronic, Minneapolis, MN) from 106 consecutive ISR patients treated in our hospital between 2009 and 2015. We compared the 5-year outcomes between PCB and non-PCB groups. The primary endpoint was the cumulative 5-year incidence of recurrent restenosis. All-cause mortality, target lesion revascularization (TLR) and unplanned major amputation were also assessed. RESULTS: The primary patency after PCB treatment at 5 years was significantly higher than the patency after non-PCB treatment (65.7% vs. 18.7%; hazard ratio [HR]: 6.11; 95% confidence intervals [CI]: 2.57-16.82; p < 0.001), as well as freedom from TLR (77.6% vs. 53.8%; HR: 3.55; 95% CI: 1.21-12.83; p = 0.020). All-cause mortality and unplanned major amputation rates did not significantly differ between the two groups. The Cox proportional hazard multivariate analysis showed that PCB was independently associated with preventing recurrent restenosis (HR: 0.17; 95% CI: 0.06-0.41; p < 0.001). CONCLUSIONS: At 5 years, patients with femoropopliteal ISR lesions undergoing PCB treatment showed significantly lower recurrent restenosis than those that underwent non-PCB treatment. EVIDENCE-BASED MEDICINE: Level of Evidence: Level 2b, Non-randomized controlled cohort/follow-up study.