Abstract:
BACKGROUND:Drug-coated balloons (DCBs) are a predominant revascularization therapy for symptomatic femoropopliteal artery disease. Because of the differences in excipients, paclitaxel dose, and coating morphologies, varying clinical outcomes have been observed with different DCBs. We report the results of 2 studies investigating the pharmacokinetic and clinical outcomes of a new DCB to treat femoropopliteal disease. METHODS:In the ILLUMENATE Pivotal Study (Prospective, Randomized, Single-Blind, U.S. Multi-Center Study to Evaluate Treatment of Obstructive Superficial Femoral Artery or Popliteal Lesions With A Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon), 300 symptomatic patients (Rutherford class 2-4) were randomly assigned to DCB (n=200) or standard angioplasty (percutaneous transluminal angioplasty [PTA]) (n=100). The primary safety end point was freedom from device- and procedure-related death through 30 days, and freedom from target limb major amputation and clinically driven target lesion revascularization through 12 months. The primary effectiveness end point was primary patency through 12 months. In the ILLUMENATE PK study (Pharmacokinetic Study of the Stellarex Drug-Coated Angioplasty Balloon), paclitaxel plasma concentrations were measured after last DCB deployment and at prespecified times (at 1, 4, 24 hours and at 7 and 14 days postprocedure) until no longer detectable. RESULTS:In the ILLUMENATE Pivotal Study, baseline characteristics were similar between groups: 50% had diabetes mellitus, 41% were women, mean lesion length was 8.3 cm, and 44% were severely calcified. The primary safety end point was met (92.1% for DCB versus 83.2% for PTA, P=0.025 for superiority) and the primary patency rate was significantly higher with DCB (76.3% for DCB versus 57.6% for PTA, P=0.003). Primary patency per Kaplan-Meier estimates at day 365 was 82.3% for DCB versus 70.9% for PTA (P=0.002). The rate of clinically driven target lesion revascularization was significantly lower in the DCB cohort (7.9% versus 16.8%, P=0.023). Improvements in ankle-brachial index, Rutherford class, and quality of life were comparable, but the PTA cohort required twice as many revascularizations. Pharmacokinetic outcomes showed that all patients had detectable paclitaxel levels after DCB deployment that declined within the first hour (54.4±116.9 ng/mL to 1.4±1.0 ng/mL). CONCLUSIONS:The data demonstrate superior safety and effectiveness of the Stellarex DCB in comparison with PTA, and plasma levels of paclitaxel fall to low levels within 1 hour. CLINICAL TRIAL REGISTRATION:URL: http://clinicaltrials.gov. Unique identifiers: NCT01858428 and NCT01912937.
journal_name
Circulationjournal_title
Circulationauthors
Krishnan P,Faries P,Niazi K,Jain A,Sachar R,Bachinsky WB,Cardenas J,Werner M,Brodmann M,Mustapha JA,Mena-Hurtado C,Jaff MR,Holden AH,Lyden SPdoi
10.1161/CIRCULATIONAHA.117.028893subject
Has Abstractpub_date
2017-09-19 00:00:00pages
1102-1113issue
12eissn
0009-7322issn
1524-4539pii
CIRCULATIONAHA.117.028893journal_volume
136pub_type
杂志文章,多中心研究,随机对照试验相关文献
CIRCULATION文献大全abstract:BACKGROUND:Vascular injury and atherothrombosis involve vessel infiltration by inflammatory leukocytes, migration of medial vascular smooth muscle cells to the intimal layer, and ultimately acute thrombosis. A strategy to simultaneously target these pathological processes has yet to be identified. The secreted protein,...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.112.105452
更新日期:2012-09-11 00:00:00
abstract:BACKGROUND:More than 300 000 out-of-hospital cardiac arrests (OHCA) occur each year in the United States. The relationship between time of day and OHCA outcomes in the prehospital setting is unknown. Any such association may have important implications for emergency medical services resource allocation. METHODS AND RE...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.113.002058
更新日期:2013-04-16 00:00:00
abstract:BACKGROUND:Conflicting results from recent observational studies have raised questions concerning the benefit of β-blockers for patients undergoing coronary artery bypass grafting (CABG). Furthermore, the efficacy of long-term β-blocker therapy in CABG patients after hospital discharge is uncertain. METHODS AND RESULT...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.114.014209
更新日期:2015-06-23 00:00:00
abstract:BACKGROUND:In the patient with mitral regurgitation who is being considered for valvular surgery, cardiac catheterization is usually performed to quantify the severity of regurgitation and to determine its influence on left ventricular volumes and systolic function. Magnetic resonance imaging (MRI) potentially provides...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.92.5.1151
更新日期:1995-09-01 00:00:00
abstract:BACKGROUND:The Synergy Between Percutaneous Coronary Intervention With TAXUS and Cardiac Surgery (SYNTAX) trial demonstrated that in patients with 3-vessel or left main coronary artery disease, coronary artery bypass graft surgery (CABG) was associated with a lower rate of cardiovascular death, myocardial infarction, s...
journal_title:Circulation
pub_type: 杂志文章,随机对照试验
doi:10.1161/CIRCULATIONAHA.114.009985
更新日期:2014-09-30 00:00:00
abstract:BACKGROUND:Noninvasively assessed pulmonary pressure elevations and left ventricular (LV) diastolic dysfunction are associated with increased mortality in adults with sickle cell disease, but their relationship to exercise intolerance has not been evaluated prospectively. METHODS AND RESULTS:Echocardiography, 6-minute...
journal_title:Circulation
pub_type: 临床试验,杂志文章,多中心研究
doi:10.1161/CIRCULATIONAHA.111.032920
更新日期:2011-09-27 00:00:00
abstract:BACKGROUND:Iron overload has an increasing worldwide prevalence and is associated with significant cardiovascular morbidity and mortality. Elevated iron levels in the myocardium lead to impaired systolic and diastolic function and elevated oxidative stress. Taurine accounts for 25% to 50% of the amino acid pool in myoc...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.CIR.0000124229.40424.80
更新日期:2004-04-20 00:00:00
abstract:BACKGROUND:After a myocardial infarction, the injured region becomes fibrotic and the myocardial scar may expand if the ventricular wall lacks elasticity. Cardiac dilatation may precipitate the vicious cycle of progressive heart failure. The present study evaluated the functional benefits of increasing elastin within a...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.CIRCULATIONAHA.105.523795
更新日期:2005-08-30 00:00:00
abstract::Ethmozin, a phenothiazine derivative, is an antiarrhythmic drug synthesized in the USSR. Preliminary data suggest that it is effective against a diversity of ectopic arrhythmias. The present study, carried out in the USSR, was designed to assess efficacy and patient tolerance of this new drug. Thirty-seven patients wi...
journal_title:Circulation
pub_type: 临床试验,杂志文章
doi:10.1161/01.cir.61.2.450
更新日期:1980-02-01 00:00:00
abstract:BACKGROUND:Previous studies have shown that hypertrophy of surviving myocytes after myocardial infarction (MI) is limited. Progressive ventricular dilatation after MI may occur when compensatory hypertrophy cannot restore left ventricular (LV) wall stress to normal. METHODS AND RESULTS:To test whether induction of add...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.84.4.1819
更新日期:1991-10-01 00:00:00
abstract:BACKGROUND:Anisotropic conduction properties may provide a substrate for reentrant arrhythmias. We investigated the age-dependent changes of structural and functional anisotropy in isolated right atria from infant (1 to 2 months), young (6 to 12 months), and old (6 to 10 years) dogs. METHODS AND RESULTS:The histology ...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.0000015506.36371.0d
更新日期:2002-04-30 00:00:00
abstract:BACKGROUND:The composition of plaque is a major determinant of coronary-related clinical syndromes. Intravascular ultrasound (IVUS) elastography has proven to be a technique capable of reflecting the mechanical properties of phantom material and the femoral arterial wall. The aim of this study was to investigate the ca...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.102.6.617
更新日期:2000-08-08 00:00:00
abstract:BACKGROUND:Plasma C-reactive protein (CRP) concentrations are increased in obese and/or hyperinsulinemic individuals. The goal of this study was to determine if the relation between insulin resistance and CRP was independent of obesity. METHODS AND RESULTS:Plasma CRP concentrations were measured before and after 3 mon...
journal_title:Circulation
pub_type: 临床试验,杂志文章
doi:10.1161/01.cir.0000041046.32962.86
更新日期:2002-12-03 00:00:00
abstract:BACKGROUND:C-reactive protein (CRP) plasma levels have been associated with short- and long-term occurrence of coronary events. We investigated whether circulating inflammatory cell responsiveness to low-grade stimuli could contribute to the reported association between CRP and coronary events. METHODS AND RESULTS:We ...
journal_title:Circulation
pub_type: 临床试验,杂志文章
doi:10.1161/01.cir.103.18.2236
更新日期:2001-05-08 00:00:00
abstract:BACKGROUND:Perivascular adipose tissue (PVAT) surrounds most vessels and shares common features with brown adipose tissue (BAT). Although adaptive thermogenesis in BAT increases energy expenditure and is beneficial for metabolic diseases, little is known about the role of PVAT in vascular diseases such as atheroscleros...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.112.104489
更新日期:2012-08-28 00:00:00
abstract:BACKGROUND:Alterations in the balance of matrix metalloproteinases (MMPs) and their specific tissue inhibitors (TIMPs) are involved in left ventricular (LV) remodeling. Whether their expression is related to interstitial fibrosis or LV dysfunction in patients with chronic pressure overload-induced LV hypertrophy, howev...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.104.516963
更新日期:2005-08-23 00:00:00
abstract:BACKGROUND:Ranolazine is a novel antianginal agent that may reduce symptoms without affecting hemodynamics and has shown cardiac antiischemic effects in in vivo and in vitro models. In one study it increased active pyruvate dehydrogenase (PDHa). Other agents that increase PDHa and so increase glucose and decrease fatty...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.93.1.135
更新日期:1996-01-01 00:00:00
abstract:BACKGROUND:Although phase 2 reentry is said to be responsible for initiation of ventricular tachycardia (VT) in Brugada syndrome, information about the activation sequence during VT is limited. METHODS AND RESULTS:We developed an experimental Brugada syndrome model using a canine isolated right ventricular preparation...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.CIR.0000105762.94855.46
更新日期:2004-01-06 00:00:00
abstract::A Y-shaped lesion in the right atrium allows induction of atrial flutter in dogs. We recorded the activation sequence during this tachycardia from 96 endocardial bipolar electrodes using intracavitary electrode arrays during 12 separate episodes in three isolated perfused hearts. In each case a reentrant impulse circu...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.76.5.1155
更新日期:1987-11-01 00:00:00
abstract:BACKGROUND:It is unknown whether adenosine can precondition human myocardium against ischemia in vivo. METHODS AND RESULTS:Thirty patients were randomized to receive a 10-minute intracoronary infusion of adenosine (2 mg/min) or normal saline; 10 minutes later, they underwent percutaneous transluminal coronary angiopla...
journal_title:Circulation
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1161/01.cir.95.11.2500
更新日期:1997-06-03 00:00:00
abstract:BACKGROUND:Gaps of sufficient cross-sectional dimensions within linear radiofrequency (RF) lesions may allow conduction through the lesion. The purpose of this study was to examine the effects of different gap geometries on conduction through discontinuous RF lesions. METHODS AND RESULTS:Radiofrequency lesions were cr...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.105.596593
更新日期:2006-04-11 00:00:00
abstract:BACKGROUND:The mechanisms responsible for tumor necrosis factor (TNF)-induced LV structural remodeling in the adult heart are not known. METHODS AND RESULTS:We generated a line of transgenic mice (MHCsTNF) with cardiac restricted overexpression of TNF that develop progressive LV dilation/remodeling from 4 to 12 weeks ...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/hc3401.093154
更新日期:2001-08-14 00:00:00
abstract::Despite a 2% to 3% prevalence of echocardiographically defined mitral valve prolapse (MVP) in the general population, the actual burden, risk stratification, and treatment of the so-called arrhythmic MVP are unknown. The clinical profile is characterized by a patient, usually female, with mostly bileaflet myxomatous d...
journal_title:Circulation
pub_type: 杂志文章,评审
doi:10.1161/CIRCULATIONAHA.118.034075
更新日期:2019-09-10 00:00:00
abstract:BACKGROUND:Active myocarditis is characterized by large heterogeneity of clinical presentation and evolution. This study describes the characteristics and the long-term evolution of a large sample of patients with biopsy-proven active myocarditis, looking for accessible and valid early predictors of long-term prognosis...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.113.003092
更新日期:2013-11-26 00:00:00
abstract::Acute myocardial ischemia leads to a gradual increase in beta-adrenergic receptors at the cell surface. This increase occurs rapidly after onset of global ischemia (15 minutes) and persists even after prolonged periods of global ischemia. This alteration can be observed both in vivo and in vitro in isolated perfused h...
journal_title:Circulation
pub_type: 杂志文章,评审
doi:
更新日期:1990-09-01 00:00:00
abstract:BACKGROUND:Pharmacological ventricular rate control is an acceptable atrial fibrillation (AF) therapy limited by systemic toxicity. We postulate that focal catheter-based drug delivery into the atrioventricular nodal (AVN) region may effectively control ventricular rate during AF without systemic toxicity. This study e...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/CIRCULATIONAHA.105.609420
更新日期:2006-05-23 00:00:00
abstract:BACKGROUND:Most survival prediction models for coronary artery bypass grafting surgery are limited to in-hospital or 30-day end points. We estimate a long-term survival model using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database and Centers for Medicare and Medicaid Services. METHODS AND RESU...
journal_title:Circulation
pub_type: 杂志文章,多中心研究
doi:10.1161/CIRCULATIONAHA.111.066902
更新日期:2012-03-27 00:00:00
abstract:BACKGROUND:Randomized trials that studied clinical outcomes after percutaneous coronary intervention (PCI) with bare metal stenting versus coronary artery bypass grafting (CABG) are underpowered to properly assess safety end points like death, stroke, and myocardial infarction. Pooling data from randomized controlled t...
journal_title:Circulation
pub_type: 杂志文章,meta分析
doi:10.1161/CIRCULATIONAHA.107.752147
更新日期:2008-09-09 00:00:00
abstract:BACKGROUND:Off-pump coronary artery bypass surgery (OPCAB) has been revived and has gained popularity, although the exact subsets of patients who might benefit most from this technique are unknown. The aim of this retrospective study was to compare the results of coronary artery bypass grafting surgery (CABG) in octoge...
journal_title:Circulation
pub_type: 杂志文章
doi:
更新日期:2002-09-24 00:00:00
abstract:BACKGROUND:Tenascin is a large extracellular matrix glycoprotein generally found in adult tissues undergoing active remodeling such as healing wounds and tumors. To determine the potential role of tenascin-C (TN-C) in the pathophysiology of atherosclerosis, we investigated the pattern of expression of TN-C in human cor...
journal_title:Circulation
pub_type: 杂志文章
doi:10.1161/01.cir.99.10.1284
更新日期:1999-03-16 00:00:00