Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document.

Abstract:

:The Academic Research Consortium (ARC)-2 initiative revisited the clinical and angiographic end point definitions in coronary device trials, proposed in 2007, to make them more suitable for use in clinical trials that include increasingly complex lesion and patient populations and incorporate novel devices such as bioresorbable vascular scaffolds. In addition, recommendations for the incorporation of patient-related outcomes in clinical trials are proposed. Academic Research Consortium-2 is a collaborative effort between academic research organizations in the United States and Europe, device manufacturers, and European, US, and Asian regulatory bodies. Several in-person meetings were held to discuss the changes that have occurred in the device landscape and in clinical trials and regulatory pathways in the last decade. The consensus-based end point definitions in this document are endorsed by the stakeholders of this document and strongly advocated for clinical trial purposes. This Academic Research Consortium-2 document provides further standardization of end point definitions for coronary device trials, incorporating advances in technology and knowledge. Their use will aid interpretation of trial outcomes and comparison among studies, thus facilitating the evaluation of the safety and effectiveness of these devices.

journal_name

Circulation

journal_title

Circulation

authors

Garcia-Garcia HM,McFadden EP,Farb A,Mehran R,Stone GW,Spertus J,Onuma Y,Morel MA,van Es GA,Zuckerman B,Fearon WF,Taggart D,Kappetein AP,Krucoff MW,Vranckx P,Windecker S,Cutlip D,Serruys PW,Academic Research Consortium

doi

10.1161/CIRCULATIONAHA.117.029289

subject

Has Abstract

pub_date

2018-06-12 00:00:00

pages

2635-2650

issue

24

eissn

0009-7322

issn

1524-4539

pii

CIRCULATIONAHA.117.029289

journal_volume

137

pub_type

杂志文章,评审
  • Single and two-dimensional echocardiographic visualization of the effects of septal myectomy in idiopathic hypertrophic subaortic stenosis.

    abstract::Although the postoperative hemodynamic and echocardiographic features of idiopathic hypertrophic subaortic stenosis have been studied, the expected consistent postoperative thinning of the interventricular septum has not been reported. In this study, the short-term effects of septal myectomy were evaluated in 16 patie...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.58.5.850

    authors: Schapira JN,Stemple DR,Martin RP,Rakowski H,Stinson EB,Popp RL

    更新日期:1978-11-01 00:00:00

  • Effects of brain natriuretic peptide on exercise hemodynamics and neurohormones in isolated diastolic heart failure.

    abstract:BACKGROUND:Experimental models suggest that brain natriuretic peptide (BNP) can modify left ventricular diastolic performance. The aim of this study was to evaluate the effects of BNP on resting and exercise hemodynamics and neurohormones in patients with isolated diastolic heart failure. METHODS AND RESULTS:Six patie...

    journal_title:Circulation

    pub_type: 临床试验,杂志文章,随机对照试验

    doi:10.1161/01.cir.93.11.2037

    authors: Clarkson PB,Wheeldon NM,MacFadyen RJ,Pringle SD,MacDonald TM

    更新日期:1996-06-01 00:00:00

  • Protective effects of N-2-mercaptopropionyl glycine against myocardial reperfusion injury after neutrophil depletion in the dog: evidence for the role of intracellular-derived free radicals.

    abstract::Reperfusion of the previously ischemic myocardium is associated with the production of oxygen free radicals and their metabolites, which contribute to the ultimate extent of irreversible myocardial injury. The relative importance of polymorphonuclear leukocytes vs intracellular-derived oxygen metabolites has remained ...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.73.5.1077

    authors: Mitsos SE,Askew TE,Fantone JC,Kunkel SL,Abrams GD,Schork A,Lucchesi BR

    更新日期:1986-05-01 00:00:00

  • Impaired heart rate response to graded exercise. Prognostic implications of chronotropic incompetence in the Framingham Heart Study.

    abstract:BACKGROUND:Previous reports have suggested that an attenuated exercise heart rate response may be associated with coronary heart disease risk and with mortality. These observations may parallel the association between reduced heart rate variability during normal activities and adverse outcome. This investigation was de...

    journal_title:Circulation

    pub_type: 杂志文章,多中心研究

    doi:10.1161/01.cir.93.8.1520

    authors: Lauer MS,Okin PM,Larson MG,Evans JC,Levy D

    更新日期:1996-04-15 00:00:00

  • Augmentation of left ventricular contractility by cardiac sympathetic neural stimulation.

    abstract:BACKGROUND:Electric stimulation of mediastinal sympathetic cardiac nerves increases cardiac contractility but is not selective for the left ventricle because it elicits sinus tachycardia and enhanced atrioventricular conduction. The aim of this study was to identify sympathetic neural structures inside the heart that s...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/CIRCULATIONAHA.109.874263

    authors: Meyer C,Rana OR,Saygili E,Gemein C,Becker M,Nolte KW,Weis J,Schimpf T,Knackstedt C,Mischke K,Hoffmann R,Kelm M,Pauza D,Schauerte P

    更新日期:2010-03-23 00:00:00

  • A recombinant, chimeric enzyme with a novel mechanism of action leading to greater potency and selectivity than tissue-type plasminogen activator.

    abstract:BACKGROUND:Early intervention with thrombolytic agents has been shown unequivocally to reduce mortality after acute myocardial infarction. Presently used agents have disadvantages such as short half-life, immunogenicity, hypotension, and bleeding complications. Therefore, there is a need to develop improved thrombolyti...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.86.2.548

    authors: Robinson JH,Browne MJ,Carey JE,Chamberlain PD,Chapman CG,Cronk DW,Dodd I,Entwisle C,Esmail AF,Kalindjian SB

    更新日期:1992-08-01 00:00:00

  • Childhood physical, environmental, and genetic predictors of adult hypertension: the cardiovascular risk in young Finns study.

    abstract:BACKGROUND:Hypertension is a major modifiable cardiovascular risk factor. The present longitudinal study aimed to examine the best combination of childhood physical and environmental factors to predict adult hypertension and furthermore whether newly identified genetic variants for blood pressure increase the predictio...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/CIRCULATIONAHA.111.085977

    authors: Juhola J,Oikonen M,Magnussen CG,Mikkilä V,Siitonen N,Jokinen E,Laitinen T,Würtz P,Gidding SS,Taittonen L,Seppälä I,Jula A,Kähönen M,Hutri-Kähönen N,Lehtimäki T,Viikari JS,Juonala M,Raitakari OT

    更新日期:2012-07-24 00:00:00

  • On the mechanisms of ventricular tachycardia acceleration during programmed electrical stimulation.

    abstract:BACKGROUND:The pathophysiological mechanisms leading to acceleration of ventricular tachycardia (VT) are still unclear. METHODS AND RESULTS:High-resolution epicardial mapping was used to study the mechanisms of VT acceleration by programmed electrical stimulation (PES) in a model of sustained reentrant VT in Langendor...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.83.5.1621

    authors: Brugada J,Brugada P,Boersma L,Mont L,Kirchhof C,Wellens HJ,Allessie MA

    更新日期:1991-05-01 00:00:00

  • Risk factors for venous thromboembolism.

    abstract::Until the 1990s, venous thromboembolism (VTE) was viewed primarily as a complication of hospitalization for major surgery (or associated with the late stage of terminal illness). However, recent trials in patients hospitalized with a wide variety of acute medical illnesses have demonstrated a risk of VTE in medical pa...

    journal_title:Circulation

    pub_type: 杂志文章,评审

    doi:10.1161/01.CIR.0000078469.07362.E6

    authors: Anderson FA Jr,Spencer FA

    更新日期:2003-06-17 00:00:00

  • Pregnancy in cyanotic congenital heart disease. Outcome of mother and fetus.

    abstract::In a series of 416 women with congenital heart disease seen in the Royal Brompton National Heart and Lung Hospital, London, and the Hospital Giovanni Bosco, Torino, Italy, there were 822 pregnancies. The outcomes of 96 pregnancies in 44 patients with cyanotic congenital heart disease were studied. Patients with the Ei...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.89.6.2673

    authors: Presbitero P,Somerville J,Stone S,Aruta E,Spiegelhalter D,Rabajoli F

    更新日期:1994-06-01 00:00:00

  • Regional myocardial perfusion in patients with atherosclerotic coronary artery disease, at rest and during angina pectoris induced by tachycardia.

    abstract::We studied regional myocardial perfusion by scintigraphic computer-assisted analysis of initial distribution, washout rates, and residual activity of 133Xe injected into the left coronary artery of four patients with normal arteriograms and 14 patients with coronary stenosis. At rest, residual activity in poststenotic...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.55.3.423

    authors: Maseri A,L'Abbate A,Pesola A,Michelassi C,Marzilli M,De Nes M

    更新日期:1977-03-01 00:00:00

  • Differentiation between obesity and insulin resistance in the association with C-reactive protein.

    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

    authors: McLaughlin T,Abbasi F,Lamendola C,Liang L,Reaven G,Schaaf P,Reaven P

    更新日期:2002-12-03 00:00:00

  • Patient and hospital differences underlying racial variation in outcomes after coronary artery bypass graft surgery.

    abstract:BACKGROUND:Few studies have examined the association of race and outcomes after coronary artery bypass graft (CABG) surgery while controlling for both patient and hospital effects. METHODS AND RESULTS:We retrospectively analyzed data on a cohort of 566,785 white and 24,354 black Medicare beneficiaries 65 years old and...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.CIR.0000157728.49918.9F

    authors: Konety SH,Vaughan Sarrazin MS,Rosenthal GE

    更新日期:2005-03-15 00:00:00

  • The association between urinary sodium excretion and blood pressure in children.

    abstract::This study explored the association between sodium excretion and blood pressure (BP). A new method was used to minimize the measurement error introduced by the large intrinsic variability of 24-hour sodium excretion. The ratio of intra- to interindividual variation was used to estimate the number of measurements neede...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.62.1.97

    authors: Cooper R,Soltero I,Liu K,Berkson D,Levinson S,Stamler J

    更新日期:1980-07-01 00:00:00

  • Relations of insulin sensitivity to longitudinal blood pressure tracking: variations with baseline age, body mass index, and blood pressure.

    abstract:BACKGROUND:The relations of insulin sensitivity (IS) to hypertension incidence may vary according to baseline age, body mass index (BMI), and blood pressure (BP). METHODS AND RESULTS:We investigated the relations of IS (insulin sensitivity index, ISI(0,120)) to 4-year incidence of hypertension and BP progression in 19...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/CIRCULATIONAHA.105.535039

    authors: Arnlöv J,Pencina MJ,Nam BH,Meigs JB,Fox CS,Levy D,D'Agostino RB,Vasan RS

    更新日期:2005-09-20 00:00:00

  • Long-term results of heart operations performed by surgeons-in-training.

    abstract:BACKGROUND:We investigated the association between trainees performing supervised operations and late outcomes of patients undergoing cardiac surgery. METHODS AND RESULTS:Data were prospectively collected on patients who underwent coronary artery bypass graft surgery, aortic valve replacement, or a combination of thes...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/CIRCULATIONAHA.107.756379

    authors: Stoica SC,Kalavrouziotis D,Martin BJ,Buth KJ,Hirsch GM,Sullivan JA,Baskett RJ

    更新日期:2008-09-30 00:00:00

  • Novel gene mutations in patients with left ventricular noncompaction or Barth syndrome.

    abstract:BACKGROUND:Mutations in the gene G4.5 result in a wide spectrum of severe infantile cardiomyopathic phenotypes, including isolated left ventricular noncompaction (LVNC), as well as Barth syndrome (BTHS) with dilated cardiomyopathy (DCM). The purpose of this study was to investigate patients with LVNC or BTHS for mutati...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.103.9.1256

    authors: Ichida F,Tsubata S,Bowles KR,Haneda N,Uese K,Miyawaki T,Dreyer WJ,Messina J,Li H,Bowles NE,Towbin JA

    更新日期:2001-03-06 00:00:00

  • Diagnostic value of pericardial biopsy: improvement with extensive sampling enabled by pericardioscopy.

    abstract:BACKGROUND:The clinical significance of pericardial biopsy is controversial. The aim of this study was to assess the feasibility and diagnostic value of 3 approaches to pericardial biopsy: fluoroscopic control and standard sampling, pericardioscopy guidance with standard sampling, and pericardioscopy guidance with exte...

    journal_title:Circulation

    pub_type: 临床试验,杂志文章

    doi:10.1161/01.cir.0000051366.97361.ea

    authors: Seferović PM,Ristić AD,Maksimović R,Tatić V,Ostojić M,Kanjuh V

    更新日期:2003-02-25 00:00:00

  • Intravascular ultrasound evaluation of the effect of rotational atherectomy in obstructive atherosclerotic coronary artery disease.

    abstract:BACKGROUND:High-speed rotational atherectomy uses a diamond-coated, elliptical burr to abrade occlusive atherosclerosis, especially noncompliant calcified plaque. METHODS AND RESULTS:Intravascular ultrasound (IVUS) was used to analyze 28 patients after atherectomy. Arteries treated and imaged were left main (three), l...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.86.5.1383

    authors: Mintz GS,Potkin BN,Keren G,Satler LF,Pichard AD,Kent KM,Popma JJ,Leon MB

    更新日期:1992-11-01 00:00:00

  • Coronary stenting with a new, radiopaque, balloon-expandable endoprosthesis in pigs.

    abstract:BACKGROUND:Intracoronary stents may be effective when used as "bail-out" devices for acute complications after percutaneous transluminal coronary angioplasty. Furthermore, preliminary reports have demonstrated some promising results with stents with regard to the reduction of restenosis. Several stent devices are avail...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.83.5.1788

    authors: van der Giessen WJ,Serruys PW,van Beusekom HM,van Woerkens LJ,van Loon H,Soei LK,Strauss BH,Beatt KJ,Verdouw PD

    更新日期:1991-05-01 00:00:00

  • High-resolution intravascular magnetic resonance imaging: monitoring of plaque formation in heritable hyperlipidemic rabbits.

    abstract:BACKGROUND:The individual makeup of atherosclerotic plaque has been identified as a dominant prognostic factor. With the use of an intravascular magnetic resonance (MR) catheter coil, we evaluated the effectiveness of high-resolution MR in the study of the development of atherosclerotic lesions in heritable hyperlipide...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.99.8.1054

    authors: Zimmermann-Paul GG,Quick HH,Vogt P,von Schulthess GK,Kling D,Debatin JF

    更新日期:1999-03-02 00:00:00

  • Beta-blocker treatment of dilated cardiomyopathy. Beneficial effect of carteolol in mice.

    abstract:BACKGROUND:The effects of carteolol, a nonselective beta-adrenergic receptor blocker with intrinsic sympathomimetic activity, were compared with those of metoprolol in a murine model of viral myocarditis and dilated cardiomyopathy caused by encephalomyocarditis virus. METHODS AND RESULTS:In the acute experiment, BALB/...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.83.6.2021

    authors: Tominaga M,Matsumori A,Okada I,Yamada T,Kawai C

    更新日期:1991-06-01 00:00:00

  • Protease-Activated Receptor-2 Plays a Critical Role in Vascular Inflammation and Atherosclerosis in Apolipoprotein E-Deficient Mice.

    abstract:BACKGROUND:The coagulation system is closely linked with vascular inflammation, although the underlying mechanisms are still obscure. Recent studies show that protease-activated receptor (PAR)-2, a major receptor of activated factor X, is expressed in both vascular cells and leukocytes, suggesting that PAR-2 may contri...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/CIRCULATIONAHA.118.033544

    authors: Hara T,Phuong PT,Fukuda D,Yamaguchi K,Murata C,Nishimoto S,Yagi S,Kusunose K,Yamada H,Soeki T,Wakatsuki T,Imoto I,Shimabukuro M,Sata M

    更新日期:2018-10-16 00:00:00

  • Thrombin facilitation of voltage-gated sodium channel activation in human cardiomyocytes: implications for ischemic sodium loading.

    abstract:BACKGROUND:Thrombin plays a role in mediating ischemic injury and cardiac arrhythmias, but the mechanisms involved are poorly understood. Because voltage-gated sodium channels (VGSCs) have not previously been considered, putative effects of thrombin on VGSC function were investigated in human isolated cardiomyocytes. ...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.0000034510.64828.96

    authors: Pinet C,Le Grand B,John GW,Coulombe A

    更新日期:2002-10-15 00:00:00

  • Cardiac epinephrine synthesis. Regulation by a glucocorticoid.

    abstract:BACKGROUND:The heart can synthesize epinephrine. Homogenates of rat heart, which contain the enzymes phenylethanolamine N-methyltransferase (PNMT) and nonspecific N-methyltransferase (NMT), methylate norepinephrine to form epinephrine. The cardiac atrium contains primarily PNMT and the cardiac ventricle contains both P...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.84.2.891

    authors: Kennedy B,Ziegler MG

    更新日期:1991-08-01 00:00:00

  • Depressed cardiac performance after mitral valve replacement. A problem of myocardial preservation during operation.

    abstract::Our experimental studies since 1972 show that the heart is preserved best during cardiopulmonary bypass when it is in the beating, nonworking state. Results after mitral valve replacement (MVR) from 1968 to 1974 using various techniques of cardiac preservation were compared. In group I were 47 patients (1968 to 1972) ...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:

    authors: Maloney JV Jr,Cooper N,Mulder DG,Buckberg GD

    更新日期:1975-08-01 00:00:00

  • Accumulation of ultrasmall superparamagnetic particles of iron oxide in human atherosclerotic plaques can be detected by in vivo magnetic resonance imaging.

    abstract:BACKGROUND:One of the features of high-risk atherosclerotic plaques is a preponderance of macrophages. Experimental studies with hyperlipidemic rabbits have shown that ultrasmall superparamagnetic particles of iron oxide (USPIOs) accumulate in plaques with a high macrophage content and that this induces magnetic resona...

    journal_title:Circulation

    pub_type: 临床试验,杂志文章

    doi:10.1161/01.CIR.0000068315.98705.CC

    authors: Kooi ME,Cappendijk VC,Cleutjens KB,Kessels AG,Kitslaar PJ,Borgers M,Frederik PM,Daemen MJ,van Engelshoven JM

    更新日期:2003-05-20 00:00:00

  • Comparison of long-term outcomes of atrial repair of simple transposition with implications for a late arterial switch strategy.

    abstract:BACKGROUND:We report the single-institution, long-term results of 358 patients with simple transposition of the great arteries surviving >30 days after a Mustard (n=226, 1965 to 1980) or Senning (n=132, 1978 to 1992) procedure. METHODS AND RESULTS:Outcome measures included late death, reintervention, ECG and ambulator...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.100.suppl_2.ii-176

    authors: Sarkar D,Bull C,Yates R,Wright D,Cullen S,Gewillig M,Clayton R,Tunstill A,Deanfield J

    更新日期:1999-11-09 00:00:00

  • Clinical features of arrhythmogenic right ventricular dysplasia/cardiomyopathy associated with mutations in plakophilin-2.

    abstract:BACKGROUND:Arrhythmogenic right ventricular dysplasia/cardiomyopathy (ARVD/C) is an inherited cardiomyopathy characterized by right ventricular dysfunction and ventricular arrhythmias. A recent study reported mutations in PKP2, encoding the desmosomal protein plakophilin-2, associated with ARVD/C. The purpose of our st...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/CIRCULATIONAHA.105.568642

    authors: Dalal D,Molin LH,Piccini J,Tichnell C,James C,Bomma C,Prakasa K,Towbin JA,Marcus FI,Spevak PJ,Bluemke DA,Abraham T,Russell SD,Calkins H,Judge DP

    更新日期:2006-04-04 00:00:00

  • Coronary angioplasty performed within the thrombolysis in Myocardial Infarction II study.

    abstract:BACKGROUND:Percutaneous transluminal coronary angioplasty (PTCA) of the infarct-related artery was performed within 42 days of recombinant tissue-type plasminogen activator (rt-PA) administration in 1,414 of the 3,534 patients who participated in the Thrombolysis In Myocardial Infarction (TIMI) II study. Primary angiog...

    journal_title:Circulation

    pub_type: 杂志文章

    doi:10.1161/01.cir.85.1.93

    authors: Baim DS,Diver DJ,Feit F,Greenberg MA,Holmes DR,Weiner BH,Williams DO,Schweiger MJ,Brown BG,Frederick MM

    更新日期:1992-01-01 00:00:00