Background:The results of previous clinical trials on the effects of ezetimibe-statin combination therapy on atherosclerosis are inconsistent, and the anti-atherosclerotic effect of ezetimibe remains ...controversial.Methods and Results:We conducted a prospective, randomized open-label study at 10 centers. One hundred and twenty-eight statin-naïve patients with acute coronary syndrome (ACS) undergoing intravascular ultrasound (IVUS)-guided percutaneous coronary intervention were randomized to receive either 2 mg/day pitavastatin plus 10 mg/day ezetimibe, or 2 mg/day pitavastatin. One hundred and 3 patients had evaluable IVUS of non-culprit coronary lesions at baseline and at follow-up. The primary endpoint was the percentage change in non-culprit coronary plaque volume (PV) and lipid PV on integrated backscatter IVUS. Mean low-density lipoprotein cholesterol was reduced from 123 mg/dL to 64 mg/dL in the combination therapy group (n=50) and 126 mg/dL to 87 mg/dL in the statin alone group (n=53; between-group difference, 16.9%, P<0.0001). The percent change in PV was −5.1% in the combination therapy group and −6.2% in the statin alone group (P=0.66), although both groups had reduction of PV compared with baseline (both P<0.01). The percent change in lipid PV did not differ between the groups (4.3 vs. −3.0%, P=0.37).Conclusions:In statin-naïve patients with ACS, combined therapy with ezetimibe and statin did not result in a significant change in coronary plaque regression or tissue component compared with statin alone. Clinical Trial Registration: www.clinicaltrials.gov (NCT00549926)
Purpose: To describe the feasibility of balloon angioplasty using a long balloon for chronic femoropopliteal occlusions by evaluating angiographic dissection patterns for optimization of outcomes in ...balloon angioplasty. Methods: A retrospective, single-center analysis examined 101 symptomatic patients (mean age 75.6±9.9 years; 65 men) with single de novo femoropopliteal occlusive lesions treated with balloon angioplasty between August 2012 and October 2016. The patients were classified into 2 groups for comparison of angiographic dissection patterns: 51 patients were treated with balloon angioplasty using long balloons (L-BA; defined as ≥220 mm in length) and 50 patients were treated with short balloon angioplasty (S-BA; defined as <150-mm-long balloons). Results: Severe vessel dissection patterns, defined as type C or higher, were fewer in the L-BA group (47.1% vs 70.0% in the S-BA group, p=0.019) and the total dissection length was shorter (92.7±72.6 vs 160.4±84.6 mm in the S-BA group, p<0.001). Although the results showed no significant differences between the two groups regarding the length of chronic total occlusions (L-BA: 228.6±73.2 vs S-BA: 226.0±53.8 mm, p=0.83), inflation pressure (L-BA; 8.2±2.6 vs S-BA: 8.1±2.9 atm, p=0.86), and the other lesion characteristics, inflation time was significantly longer in the L-BA group (161.2±68.7 seconds vs 51.1±54.0 seconds in the S-BA group, p<0.001). Multivariate analysis identified a balloon length ≥220 mm as an independent negative predictor of severe vessel dissection (odds ratio 0.29, 95% confidence interval 0.11 to 0.83, p=0.02). Conclusion: Using long balloons for balloon angioplasty may help prevent severe vessel dissection in chronic femoropopliteal occlusions.
Recently, Society for Vascular Surgery guideline recommends evaluating anatomic pattern with use of Global Limb Anatomic Staging System (GLASS) in Chronic Limb-Threatening Ischemia (CLTI) patients. ...The aim of this study is to validate GLASS stage into CLTI patients on hemodialysis (HD) and investigate the impact of GLASS stage to wound healing and amputation-free survival (AFS). Between April 2009 and March 2018, we performed EVT for 154 limbs in CLTI patients on HD. GLASS was defined as femoropopliteal (FP) and infrapopliteal (IP) segments separately graded (0–4), then combined into three GLASS stages for the limb (I–III). We divided them into three GLASS stages with using this system. We compared the clinical outcomes between three groups (GLASS I, GLASS II, and GLASS III). Patient characteristics were almost similar between the three groups. Lesion characteristics was more complex and the rate of success was lower in GLASS III. Cox regression multivariate analysis revealed that diabetes mellitus (HR 2.4, 95% CI 1.37–4.01,
p
< 0.01) and WIfI high (HR 2.3, 95% CI 1.04–6.01,
p
= 0.04) were the predictors of non-wound healing, whereas age (HR 1.6, 95% CI 1.09–2.29,
p
= 0.01), WIfI clinical stage 4 (HR 2.4, 95% CI 1.30–4.36,
p
< 0.01), and non-ambulatory status (HR 2.0, 95% CI 1.17–3.29,
p
= 0.01) were the predictors of AFS. GLASS stage in CLTI patient on HD could not predict wound healing, and AFS in this study.
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. (Circ J 2012; 76: 2697–2704)
Background:Selective use of distal filter protection during percutaneous coronary intervention (PCI) for acute coronary syndromes (ACS) decreased the incidence of no-reflow phenomena and in-hospital ...serious adverse cardiac events compared with conventional PCI in patients with attenuated plaque ≥5 mm; however, its long-term clinical outcome remains unknown.Methods and Results:Patients who had ACS with attenuated plaque ≥5 mm were assigned to receive distal protection (DP) (n=98) or conventional treatment (CT) (n=96). The rate of major adverse cardiovascular events (MACE), a composite of death from any cause, non-fatal myocardial infarction, or target vessel revascularization (TVR) at 1 year, was the pre-specified secondary endpoint of the trial. MACE at 1 year occurred in 12 patients (12.2%) in the DP group and 3 patients (3.1%) in the CT group (P=0.029), which was driven by a higher risk of TVR (11 11.2% vs. 2 2.1%, P=0.018). In patients treated with bare-metal stents (n=42), MACE occurred in 25.0% of the patients in the DP group and in none of the patients in the CT group (P=0.029), whereas in patients treated with drug-eluting stents (n=151), rates of MACE were similar in the groups (8.1% vs. 3.9%, P=0.32).Conclusions:In ACS patients with attenuated plaque ≥5 mm, the 1-year rates of MACE were higher in the DP group than in the CT group. This effect might be mitigated by the use of drug-eluting stents.
The Crosser catheter is a unique device that facilitates antegrade intraluminal recanalization by high-frequency vibration energy and cavitation. We used this device not only as a chronic total ...occlusion (CTO) crossing device, but also as a flossing device in stenotic lesions and we also evaluated the efficacy of this device when used with both the “Crosser preceding” and the “Guidewire preceding” in CTOs. Complications related to this device were investigated, too. We retrospectively analyzed a total of 90 consecutive patients with peripheral artery disease in the femoropopliteal artery and below-the-knee artery (BTA). Primary technical success was defined as the successful delivery of this device into the distal true lumen. Secondary technical success was defined as successful revascularization. The safety endpoints were events of angiographic complications, including the occurrence of detachment of the metal tip from the shaft, slow flow, dissections, and perforations. Overall primary technical success rate was 93.3% and the secondary technical success rate was 96.7%. Detachment and slow flow occurred 14.4 and 4.4%, respectively, with no occurrences of either dissection or perforation. A predictor of detachment was Proposed Peripheral Arterial Calcium Scoring System (PACSS) grade 4 (OR 14.6; CI 1.26–168.5;
P
= 0.032). The Crosser catheter is useful not only as a CTO crossing device used with both the “Crosser preceding” and the “Guidewire preceding”, but also as a flossing device in stenotic lesions. But we have to pay attention to complications related to the Crosser.
Obesity is associated with marked increases in plasma leptin concentration, and hyperleptinemia is an independent risk factor for coronary artery disease. As a result, the purpose of this ...investigation was to test the following hypotheses: 1) leptin receptors are expressed in coronary endothelial cells; and 2) hyperleptinemia induces coronary endothelial dysfunction. RT-PCR analysis revealed that the leptin receptor gene is expressed in canine coronary arteries and human coronary endothelium. Furthermore, immunocytochemistry demonstrated that the long-form leptin receptor protein (ObRb) is present in human coronary endothelium. The functional effects of leptin were determined using pressurized coronary arterioles (<130 microm) isolated from Wistar rats, Zucker rats, and mongrel dogs. Leptin induced pharmacological vasodilation that was abolished by denudation and the nitric oxide synthase inhibitor N(omega)-nitro-l-arginine methyl ester and was absent in obese Zucker rats. Intracoronary leptin dose-response experiments were conducted in anesthetized dogs. Normal and obese concentrations of leptin (0.1-3.0 microg/min ic) did not significantly change coronary blood flow or myocardial oxygen consumption; however, obese concentrations of leptin significantly attenuated the dilation to graded intracoronary doses of acetylcholine (0.3-30.0 microg/min). Additional experiments were performed in canine coronary rings, and relaxation to acetylcholine (6.25 nmol/l-6.25 micromol/l) was significantly attenuated by obese concentrations of leptin (625 pmol/l) but not by physiological concentrations of leptin (250 pmol/l). The major findings of this investigation were as follows: 1) the ObRb is present in coronary arteries and coupled to pharmacological, nitric oxide-dependent vasodilation; and 2) hyperleptinemia produces significant coronary endothelial dysfunction.
To describe an innovative distal protection technique, “
sheath rendezvous method
”, during endovascular treatment for subclavian arterial occlusions. 4.5F and 6F guiding sheath were inserted from ...left brachial and common femoral artery, respectively. 0.014″ guidewire retrogradely passed through occlusion and into antegrade sheath to establish a pull-through system. 3.0 mm balloon was used to expand occlusion and anchor to deliver retrograde sheath into antegrade one. Both sheaths locked by balloon dilatation crossed occlusion until antegrade sheath passed over lesion. Balloon expandable stent was delivered within antegrade sheath. Sheath was removed, and stent was implanted. We obtained an excellent outcome without complications.
This study aimed to determine the clinical impact of the Global Limb Anatomical Staging System (GLASS) and develop a model to determine the grade of difficulty for target artery path (TAP) using ...GLASS stage.
This was a single centre retrospective study. Endovascular treatment (EVT) was performed for 400 lesions in 257 patients with critical limb threatening ischaemia (CLTI) between April 2009 and March 2018. All lesions were divided into three groups (GLASS Ⅰ, Ⅱ, and Ⅲ), which were compared in terms of patient characteristics, lesion characteristics, technical success, and procedural complications. All observations were then randomly assigned to the derivation set or validation set at a ratio of 2:1 (derivation set: 166 patients; validation set: 91 patients). Predictors of technical success for TAP were identified by multivariable analysis. Each predictor was assigned a score based on its regression coefficient, and the total score was calculated. This value was used to categorise all lesions into the following four groups: low (score 0), intermediate (score 1), difficult (score 2), and very difficult (score ≥ 3).
No significant differences in patient characteristics were observed between the three GLASS groups. In GLASS Ⅲ group, anatomic/limb severity and procedural complications were observed frequently, and the technical success rate was lower than that in the other groups. Through multivariable analysis, absence of pedal modifier (P)0 or P1, GLASS Ⅲ, total occlusion, and severe calcification predicted technical failure. The four groups stratified according to GLASS score demonstrated stepwise and highly reproducible difference in the probability of technical success for TAP. The area under the receiver operating characteristic (ROC) curve was 0.95 in the development group and 0.93 in the validation sample.
In GLASS Ⅲ, anatomic/limb severity was more complex and procedural complications were more frequent. The GLASS scoring system reliably predicts the technical success of de novo TAP in patients with CLTI.
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