Abstract:
:The evaluation for European Union market approval of coronary stents falls under the Medical Device Directive that was adopted in 1993. Specific requirements for the assessment of coronary stents are laid out in supplementary advisory documents. In response to a call by the European Commission to make recommendations for a revision of the advisory document on the evaluation of coronary stents (Appendix 1 of MEDDEV 2.7.1), the European Society of Cardiology (ESC) and the European Association of Percutaneous Cardiovascular Interventions (EAPCI) established a Task Force to develop an expert advisory report. As basis for its report, the ESC-EAPCI Task Force reviewed existing processes, established a comprehensive list of all coronary drug-eluting stents that have received a CE mark to date, and undertook a systematic review of the literature of all published randomized clinical trials evaluating clinical and angiographic outcomes of coronary artery stents between 2002 and 2013. Based on these data, the TF provided recommendations to inform a new regulatory process for coronary stents. The main recommendations of the task force include implementation of a standardized non-clinical assessment of stents and a novel clinical evaluation pathway for market approval. The two-stage clinical evaluation plan includes recommendation for an initial pre-market trial with objective performance criteria (OPC) benchmarking using invasive imaging follow-up leading to conditional CE-mark approval and a subsequent mandatory, large-scale randomized trial with clinical endpoint evaluation leading to unconditional CE-mark. The data analysis from the systematic review of the Task Force may provide a basis for determination of OPC for use in future studies. This paper represents an executive summary of the Task Force's report.
journal_name
Eur Heart Jjournal_title
European heart journalauthors
Byrne RA,Serruys PW,Baumbach A,Escaned J,Fajadet J,James S,Joner M,Oktay S,Jüni P,Kastrati A,Sianos G,Stefanini GG,Wijns W,Windecker Sdoi
10.1093/eurheartj/ehv203subject
Has Abstractpub_date
2015-10-07 00:00:00pages
2608-20issue
38eissn
0195-668Xissn
1522-9645pii
ehv203journal_volume
36pub_type
杂志文章,评审abstract::Left ventricular volume and ejection fraction were measured by 2-dimensional echocardiography from 2 orthogonal apical long axis views in 90 patients admitted with acute transmural myocardial infarction. Results were correlated with worst Killip class during hospital stay, enzymatic infarct size (peak CK-MB) and morta...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a061638
更新日期:1984-03-01 00:00:00
abstract::A recent report of the EuroHeart project has shown that women are still underrepresented in many cardiovascular clinical trials, while important gender differences are present within most areas of heart disease. As the burden of cardiovascular disease is increasing in middle-aged women relative to men, a more profound...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/ehr048
更新日期:2011-06-01 00:00:00
abstract:AIMS:This study compares the functional outcome and cardiorespiratory response to exercise, in patients who have undergone arterial switch for transposition of the great arteries, with normal controls and patients who have undergone atrial switch operation. METHODS AND RESULTS:Fifteen patients who had undergone arteri...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1053/euhj.2000.2425
更新日期:2001-06-01 00:00:00
abstract::To assess the value of exercise stress testing and of mental stress as predictors of hypertension, we studied 130 normotensive males 14-18 years of age. Sixty-five had at least one hypertensive parent (SHT), while 65 had normotensive parents (SNT). Systolic (SBP) and diastolic (DBP) blood pressure, rate-pressure produ...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a061894
更新日期:1985-06-01 00:00:00
abstract::To analyse quantitatively a coronary arterial segment from a cineangiogram, an end-diastolic or neighbouring frame is usually selected. However, different cardiologists may select other (although usually neighbouring) frames, even when the same selection criteria are followed. It is also possible that the frames are s...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/10.suppl_f.54
更新日期:1989-11-01 00:00:00
abstract:Aim:Studies have reported less favourable outcomes in women compared with men after primary percutaneous coronary intervention (PCI) in ST-segment elevation myocardial infarction (STEMI). Whether sex-specific differences in the magnitude or prognostic impact of infarct size or post-infarction cardiac function explain t...
journal_title:European heart journal
pub_type: 杂志文章,meta分析,评审
doi:10.1093/eurheartj/ehx159
更新日期:2017-06-01 00:00:00
abstract::Coronary vasodilator responses to pharmacological (acetylcholine) and physiological (cold pressor test and flow dependent dilation) stimuli are impaired in hypertensive patients. The ability of angiotensin-converting enzyme inhibitors to restore normal coronary responses in hypertension and the potential mechanisms in...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:
更新日期:1998-09-01 00:00:00
abstract::Recent innovations have the potential to improve rhythm control therapy in patients with atrial fibrillation (AF). Controlled trials provide new evidence on the effectiveness and safety of rhythm control therapy, particularly in patients with AF and heart failure. This review summarizes evidence supporting the use of ...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/ehz782
更新日期:2019-12-07 00:00:00
abstract:AIMS:Intense exercise places disproportionate strain on the right ventricle (RV) which may promote pro-arrhythmic remodelling in some athletes. RV exercise imaging may enable early identification of athletes at risk of arrhythmias. METHODS AND RESULTS:Exercise imaging was performed in 17 athletes with RV ventricular a...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehv202
更新日期:2015-08-07 00:00:00
abstract::In 16 people with essential hypertension, heart rate (HR), blood pressure (BP) and relative cardiac volumes were measured at rest and during submaximal upright exercise before and after 10 mg of sublingual nifedipine using radionuclide ventriculography. In 10 patients who had had no previous therapy (BP 152/103 +/- 5/...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a061863
更新日期:1985-04-01 00:00:00
abstract:BACKGROUND:Anti-ischaemic therapy with nitrates and/or calcium channel blockers profoundly affects the results of pharmacological stress echocardiography with coronary vasodilators but the influence on catecholamine stress testing remains unsettled. AIMS:The present study aimed to assess the effects of non-beta-blocke...
journal_title:European heart journal
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.1093/oxfordjournals.eurheartj.a015226
更新日期:1997-02-01 00:00:00
abstract::Left ventricular pressure overload results in the development of left ventricular hypertrophy (LVH) which is considered an adaptive mechanism of the heart to normalize systolic wall-stress. Impairment of both contractility and relaxation occurs, implying that the hypertrophied myocardium is very sensitive to ischaemia...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:
更新日期:1993-11-01 00:00:00
abstract::A double-blind, placebo-controlled trial comparing the antiarrhythmic effects of lidocaine (given intravenously as a bolus injection of 100 mg followed by an infusion of 2 mg min-1) and propafenone (given as a bolus of 105 mg followed by 300 mg orally every 8 h) was conducted in the first 24 h following acute myocardi...
journal_title:European heart journal
pub_type: 临床试验,杂志文章
doi:10.1093/oxfordjournals.eurheartj.a062428
更新日期:1988-11-01 00:00:00
abstract:AIMS:Major bleeding after percutaneous coronary intervention (PCI) is an independent risk factor for early and late mortality. We developed and validated a risk score predictive of major bleeding after PCI using the femoral approach. METHODS AND RESULTS:Baseline clinical and procedural variables from two contemporary,...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1093/eurheartj/ehm194
更新日期:2007-08-01 00:00:00
abstract:AIMS:In mechanical heart valve recipients, low-dose international normalized ratio (INR) self-management of oral anticoagulants can reduce the risk of developing thrombo-embolic events and improve long-term survival compared with INR control by a general practitioner. Here, we present data on the safety of low-dose INR...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1093/eurheartj/ehm391
更新日期:2007-10-01 00:00:00
abstract:AIMS:Aortic aneurysm/dissection (AAD) is a life-threatening disorder lacking effective pharmacotherapeutic remedies. Aldehyde dehydrogenase 2 (ALDH2) polymorphism is tied with various risk factors for AAD including hypertension, atherosclerosis, and hypercholesterolaemia although direct correlation between the two rema...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehaa352
更新日期:2020-07-07 00:00:00
abstract::Transesophageal echocardiographic evaluation of right and left pulmonary arteries, up to the origin of their lobar branches, was prospectively performed with a single plane probe in 32 consecutive patients (18 M, 14 F, aged 55.5 +/- 14.6, from 32 to 80 years) with clinical or echocardiographic suspicion of pulmonary e...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060947
更新日期:1995-04-01 00:00:00
abstract:AIMS:To evaluate the effectiveness and safety of bivalirudin as used in routine care. Bivalirudin has been studied as an alternative to heparin plus glycoprotein IIb/IIIa inhibitor (GPI) during percutaneous coronary intervention (PCI). Trials have indicated that bivalirudin is non-inferior to heparin with respect to de...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehp437
更新日期:2010-03-01 00:00:00
abstract:AIMS:The purpose of this study was to identify novel genetic variants influencing circulating asymmetric dimethylarginine (ADMA) and symmetric dimethylarginine (SDMA) levels and to evaluate whether they have a prognostic value on cardiovascular mortality. METHODS AND RESULTS:We conducted a genome-wide association stud...
journal_title:European heart journal
pub_type: 杂志文章,meta分析
doi:10.1093/eurheartj/eht447
更新日期:2014-02-01 00:00:00
abstract:AIMS:To assess the long-term benefit-risk ratio of drug-eluting (DES) vs. bare-metal stents (BMS) relative to stent size. METHODS AND RESULTS:All 826 consecutive BASKET (BAsel Stent Kosten-Effektivitäts Trial) patients randomized 2:1 to DES vs. BMS were followed after 3 years. Data were analysed separately for patient...
journal_title:European heart journal
pub_type: 杂志文章,随机对照试验
doi:10.1093/eurheartj/ehn516
更新日期:2009-01-01 00:00:00
abstract:AIMS:In patients with sick sinus syndrome, bradycardia can be treated with a single-lead pacemaker or a dual-chamber pacemaker. Previous trials have revealed that pacing modes preserving atrio-ventricular synchrony are superior to single-lead ventricular pacing, but it remains unclear if there is any difference between...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.1093/eurheartj/ehr022
更新日期:2011-03-01 00:00:00
abstract:AIMS:The guidelines of the European Society of Cardiology (ESC) define the current standard for the management of syncope, but are still incompletely applied in the clinical setting. METHODS AND RESULTS:Prospective systematic evaluation, on strict adherence to the guidelines, of consecutive patients referred for synco...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehi647
更新日期:2006-01-01 00:00:00
abstract:AIMS:The extent to which hospital and geographic characteristics influence the time course of uptake of evidence from key clinical trials and practice guidelines is unknown. The gap between evidence and practice is well recognized but the factors influencing this disjunction, and the extent to which such factors are mo...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1016/s0195-668x(03)00315-4
更新日期:2003-08-01 00:00:00
abstract:AIMS:White matter hyperintensities (WMH) progress with age and hypertension, but the key period of exposure to elevated blood pressure (BP), and the relative role of systolic BP (SBP) vs. diastolic BP (DBP), remains unclear. This study aims to determine the relationship between WMH and concurrent vs. past BP. METHODS ...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/ehaa756
更新日期:2020-11-26 00:00:00
abstract:AIMS:A lack of donor hearts has stimulated interest in using blood pumps to treat severe heart failure. We tested the hypothesis that a new continuous flow circulatory assist device could be employed safely to relieve symptoms of heart failure and evaluated the potential to prolong life. METHODS AND RESULTS:An intraca...
journal_title:European heart journal
pub_type: 杂志文章,多中心研究
doi:10.1093/eurheartj/ehi163
更新日期:2005-05-01 00:00:00
abstract::Pilots and new applicants with asymptomatic 'safe' WPW syndrome should be allowed to fly but not as pilot in sole command. Professional pilots with tachyarrhythmia related to a pre-excitation syndrome should usually be disqualified . Personnel who have undergone successful surgical treatment by ablation of an accessor...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:10.1093/eurheartj/5.suppl_a.119
更新日期:1984-03-01 00:00:00
abstract::In a 58-year-old man with vasospastic angina, we investigated the relationship between the antianginal effects of isosorbide dinitrate (ISDN) and plasma ISDN concentration. Despite adequate plasma ISDN levels, sustained therapy using ISDN tapes and oral ISDN (transcutaneously 160 mg and orally 100 mg ISDN day-1) faile...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/oxfordjournals.eurheartj.a060270
更新日期:1992-06-01 00:00:00
abstract:BACKGROUND:The calculation of valve resistance (R) rather than aortic valve area (AVA) has been proposed for the assessment of aortic stenosis (AS), based on the claim that it is less flow-dependent. Even more importantly, valve resistance has been reported to distinguish between truly severe and "pseudosevere" AS in p...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1016/j.ehj.2004.02.011
更新日期:2004-05-01 00:00:00
abstract::The first marathon run as an athletic event took place in the context of the Olympic Games in 1896 in Athens, Greece. Today, participation in a 'marathon run' has become a global phenomenon attracting young professional athletes as well as millions of mainly middle-aged amateur athletes worldwide each year. One of the...
journal_title:European heart journal
pub_type: 杂志文章
doi:10.1093/eurheartj/eht502
更新日期:2014-11-21 00:00:00
abstract::Nitrates are beneficial because they combine coronary and noncoronary effects. They have proven clinical efficacy, relieving symptoms and documented evidence of ischaemia. They can be given to patients by multiple routes and can be easily combined with other anti-ischaemic drugs including aspirin, heparin, calcium ant...
journal_title:European heart journal
pub_type: 杂志文章,评审
doi:
更新日期:1991-05-01 00:00:00