Clinical trials and regulatory science in cardiology最新文献

英文中文

WITHDRAWN: A Registry Comparison of ESC and NICE guidelines 95 in the assessment of stable angina in a UK district hospital 撤回:ESC和NICE指南95在英国一家地区医院评估稳定型心绞痛的注册比较

Clinical trials and regulatory science in cardiology

Pub Date : 2015-08-17 DOI: 10.1016/J.CTRSC.2015.08.004

J. Ball, A. Cai, A. Pineau, Mitchell Brown, K. Budack, B. Cooper

引用次数: 0

WITHDRAWN: Cost-effectiveness analysis of left atrial appendage occlusion compared with seven pharmacological strategies for stroke prevention in atrial fibrillation 撤回:左心耳闭塞与7种预防房颤卒中药物策略的成本-效果分析

Clinical trials and regulatory science in cardiology

Pub Date : 2015-08-11 DOI: 10.1016/J.CTRSC.2015.08.005

V. Lee, R. Tsai, I. Chow, B. Yan, M. Kaya, Jai-Wun Park, Y. Lam

引用次数: 0

Safety and performance of the next generation EnligHTN™ renal denervation system in patients with drug-resistant, uncontrolled hypertension: The EnligHTN III first-in-human multicentre study 新一代EnligHTN™肾去神经支配系统在耐药、不受控制的高血压患者中的安全性和性能:EnligHTN III首次人体多中心研究

Clinical trials and regulatory science in cardiology

Pub Date : 2015-08-01 DOI: 10.1016/j.ctrsc.2015.08.007

Stephen G. Worthley , Gerard T. Wilkins , Mark W. Webster , Joseph K. Montarello , Paul R. Antonis , Robert J. Whitbourn , Roderic J. Warren

Background/objectives

Catheter-based renal denervation for the treatment of drug-resistant hypertension has been intensively investigated in recent years. To date, only limited data have been published using multi-electrode radiofrequency ablation systems that can deliver lesions with a pre-determined pattern. This study was designed to evaluate the safety and efficacy of the next generation EnligHTN™ renal denervation system. Six-month primary endpoint data are presented here.

Methods

We conducted this first-in-human, prospective, multi-center, non-randomized study in 39 patients (62% male, mean age 63 years, and mean baseline office blood pressure 174/93 mm Hg) with drug-resistant hypertension. The primary safety and efficacy objectives were to characterize, from baseline to 6 months post-procedure, the rate of serious procedural and device related adverse events, as adjudicated by an independent Clinical Events Committee, and the reduction of office systolic blood pressure.

Results

Renal artery denervation, using the next generation EnligHTN multi-electrode system significantly reduced office blood pressure from baseline to 1, 3, and 6 months by − 19/7, − 26/9 and − 25/7 mm Hg, respectively (P ≤ 0.0005). No serious device or procedure related adverse events affecting the renal arteries or renal function occurred through.

Conclusions

Renal sympathetic denervation using the next generation EnligHTN renal denervation system resulted in safe, rapid, and significant mean office blood pressure reduction that was sustained through 6 months. Future studies will need to address the utility of this system against an appropriate placebo based comparator.

背景/目的近年来，以导管为基础的肾去神经支配治疗耐药高血压已被广泛研究。到目前为止，仅发表了有限的使用多电极射频消融系统的数据，该系统可以以预先确定的模式传递病变。本研究旨在评估下一代EnligHTN™肾去神经系统的安全性和有效性。这里给出了六个月的主要终点数据。方法:我们对39例耐药高血压患者(男性62%，平均年龄63岁，平均基线办公室血压174/93 mm Hg)进行了这项首次人体前瞻性、多中心、非随机研究。主要的安全性和有效性目标是从基线到手术后6个月，由独立临床事件委员会裁定的严重手术和器械相关不良事件的发生率，以及办公室收缩压的降低。结果采用新一代EnligHTN多电极系统进行肾动脉去神经治疗后，从基线到1、3和6个月，办公室血压分别显著降低- 19/7、- 26/9和- 25/7 mm Hg (P≤0.0005)。整个过程中未发生严重的影响肾动脉或肾功能的器械或手术相关不良事件。结论采用新一代EnligHTN肾去神经系统进行肾交感神经去神经治疗可安全、快速、显著地降低平均办公室血压，并持续6个月。未来的研究将需要解决该系统与适当的基于安慰剂的比较物的效用。

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引用次数: 4

Increased risk for vascular complications due to GP IIb/IIIa-antagonists in patients with cardiogenic shock supported by intraaortic balloon pump (IABP) 经主动脉内球囊泵(IABP)支持的心源性休克患者GP IIb/ iia拮抗剂导致血管并发症的风险增加

Clinical trials and regulatory science in cardiology

Pub Date : 2015-08-01 DOI: 10.1016/j.ctrsc.2015.08.008

Jens Röther , Monique Tröbs, Annika Schuhbäck, Josef Ludwig, Stephan Achenbach, Christian Schlundt

Background

IABP is routinely used to support coronary blood flow and systemic circulation in patients with cardiogenic shock. Our aim was to explore the incidence of vascular complications associated with the use of IABP in this scenario and their influence on mortality.

Methods

Therefor we analysed 204 consecutive patients between 2002 and 2013 treated with IAPB in cardiogenic shock for vascular complications and mortality within 30 days after implantation of IAPB. Primary endpoints were severe bleeding (TIMI-definition: intracranial bleeding, loss of haemoglobin (Hb) > 5 g/dl or haematocrit (PCV) > 15%), vascular complications with therapeutic consequence (venous thrombosis, arterial embolism) and stroke.

Results

80 (39%) patients died within 30 days after implantation of IABP. In 42 (21%) patients, vascular complications occurred: severe bleeding was present in 26 patients (62% of all complications), 13 (31%) patients suffered from venous thrombosis or arterial embolism and 3 (7%) patients from stroke. 25% of the patients who died had a vascular complication. The rate in patients who overcame cardiogenic shock was 17.7% (p = 0.22). Multivariate analyses showed treatment with Glycoprotein (GP) IIb/IIIa- inhibitors to be an independent risk factor for the occurrence of vascular complications (p = 0.04).

Conclusion

Vascular events with the use of IABP are common but in our study, not significantly associated with a higher mortality. Treatment with GP IIb/IIIa-antagonists is associated with a higher risk of vascular events.

背景:在心源性休克患者中，常规使用diabp来支持冠状动脉血流和体循环。我们的目的是探讨在这种情况下使用IABP相关的血管并发症的发生率及其对死亡率的影响。方法对2002 ~ 2013年连续204例经IAPB治疗心源性休克患者的血管并发症及IAPB植入后30天内的死亡率进行分析。主要终点是严重出血(timi定义:颅内出血，血红蛋白(Hb)丢失;5 g/dl或红细胞压积(PCV);15%)、有治疗后果的血管并发症(静脉血栓、动脉栓塞)和中风。结果80例(39%)患者在IABP植入后30 d内死亡。42例(21%)患者发生血管并发症:26例(占所有并发症的62%)患者出现严重出血，13例(31%)患者患有静脉血栓形成或动脉栓塞，3例(7%)患者患有中风。25%的患者死于血管并发症。心源性休克的发生率为17.7% (p = 0.22)。多因素分析显示，糖蛋白(GP) IIb/IIIa-抑制剂治疗是血管并发症发生的独立危险因素(p = 0.04)。结论:血管事件与IABP的使用是常见的，但在我们的研究中，与更高的死亡率没有显著相关。使用GP IIb/ iiia拮抗剂治疗与血管事件的高风险相关。

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引用次数: 0

Three-dimensional binding sites volume assessment during cardiac pacing lead extraction 心脏起搏铅提取过程中三维结合位点体积评估

Clinical trials and regulatory science in cardiology

Pub Date : 2015-07-01 DOI: 10.1016/j.ctrsc.2015.08.006

Bich Lien Nguyen , Alessandro Persi , Eli S. Gang , Fabrizio Fattorini , Alessandra Oliva , Antonio Vitarelli , Nicola Alessandri , Robert J. Siegel , Antonio Ciccaglioni , Carlo Gaudio

Background/objectives

Binding sites are the principal cause of failed lead removal and complications, and are not directly visualized by fluoroscopy. We aimed to assess binding sites between permanent cardiac pacing leads and cardiovascular structures using CartoSound™ three-dimensional (3D) imaging technology (Biosense Webster Inc., Diamond Bar, CA) during transvenous lead extraction, and compared outcomes to standard approach.

Methods

We recruited 291 patients undergoing percutaneous lead extraction, and 3D CartoSound anatomical mapping of the superior vena cava, right atrium (RA), coronary sinus, right ventricle (RV), pacing leads, and binding sites before, during, and after lead removal was randomly performed in 46 of them (38 men; mean age 73.7 ± 10.5 years; 1.96 leads/patient; mean time-from-implant of 62.7 ± 51.8 months) using a 10-Fr 3D SoundStar™ catheter and integrated into the Carto® mapping system.

Results

CartoSound was able to detect more intracardiac binding sites compared to fluoroscopy (RA 17.4% vs. 4.3%, p = 0.04; RV 43.5% vs. 21.7%, p = 0.04), but was unable to assess the subclavian/innominate veins. Binding sites volume correlated positively with time-from-implant (r = 0.38, p < 0.05), and powered-sheath use (r = 0.39, p < 0.05), and negatively with procedural success (r = − 0.37, p < 0.05). When compared to standard approach, CartoSound use was characterized by a significantly lower mean procedure time (p = 0.0001), major complications (p = 0.03), and greater procedure success rates (p = 0.03).

Conclusions

Real-time 3D binding sites assessment is feasible and improves transvenous lead extraction outcomes. Its role as a complementary information requires extensive validation, and might be beneficial for a tailored strategy.

背景/目的结合位点是铅去除失败和并发症的主要原因，并且不能通过透视直接观察到。我们的目的是使用CartoSound™三维(3D)成像技术(Biosense Webster Inc.， Diamond Bar, CA)在经静脉导联提取过程中评估永久性心脏起搏导联与心血管结构之间的结合位点，并将结果与标准方法进行比较。方法我们招募了291例经皮取铅术患者，随机选取其中46例(男性38例;平均年龄73.7±10.5岁;1.96领导/病人;使用10-Fr 3D SoundStar™导管并集成到Carto®测绘系统，平均植入时间为62.7±51.8个月。结果scartosound能检测到更多的心内结合位点(RA 17.4% vs. 4.3%， p = 0.04;RV 43.5% vs. 21.7%， p = 0.04)，但无法评估锁骨下静脉/无名静脉。结合位点体积与植入时间呈正相关(r = 0.38, p <0.05)，动力护套使用(r = 0.39, p <0.05)，与手术成功率呈负相关(r = - 0.37, p <0.05)。与标准方法相比，使用CartoSound的特点是平均手术时间显著缩短(p = 0.0001)，主要并发症(p = 0.03)，手术成功率更高(p = 0.03)。结论实时三维结合位点评估是可行的，可提高经静脉铅拔出效果。它作为补充信息的作用需要广泛的验证，并且可能对量身定制的策略有益。

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引用次数: 2

Optimize the duration of DAPT following DES implantation: An updated system review and meta-analysis of 10 randomized trials 优化DES植入后DAPT的持续时间:10项随机试验的最新系统回顾和荟萃分析

Clinical trials and regulatory science in cardiology

Pub Date : 2015-06-01 DOI: 10.1016/j.ctrsc.2015.08.003

Xin-Lin Zhang , Qing-Qing Zhu , Li Zhu , Su-Qin Shi , Jian-Zhou Chen , Jun Xie , Wei Huang , Biao Xu

Background

The appropriate duration of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine following drug-eluting stenting in percutaneous coronary intervention (PCI) remains uncertain.

Methods and results

A systemic search was conducted in PubMed, EMBASE and the Cochrane Central Register of Controlled Trials (CENTRAL), for randomized trials evaluating the relative efficacy and safety performance of an extended with a control duration DAPT after drug-eluting stents (DES) implantation. Ten trials including 32,135 patients were included. Compared with DAPT of 3 to 6 months, an extended DAPT duration of 12 months or longer significantly increased risk of major bleeding by 90% (RR: 1.90, 95% CI: 1.23 to 2.94, p = 0.004), but did not reduced incidences of any documented ischemic events. Compared with 12-month duration, a more extended DAPT (18 to 30 months) significantly increased risk of all-cause death (RR: 1.30, 95% CI: 1.02 to 1.65, p = 0.035) and major bleeding (RR: 1.61, 95% CI: 1.25 to 2.07, p < 0.001), decreased risk of myocardial infarction (RR: 0.53, 95% CI: 0.43 to 0.66, p < 0.001) and stent thrombosis (RR: 0.33, 95% CI: 0.21 to 0.51, p < 0.001), no difference was detected regarding cardiac death and stroke.

Conclusions

A short DAPT (3 to 6 months) decreases major bleeding while maintains antithrombotic efficacy compared with an extended DAPT (≥ 12 months). A more extended DAPT (18 to 30 months) decreases ischemic events, whereas increases risks of all-cause death and major bleeding than standard 12-month therapy. A 3-to-6-month DAPT might be preferable for a broad group of patients undergoing DES implantation.

背景:经皮冠状动脉介入治疗(PCI)中药物洗脱支架植入术后阿司匹林和噻吩吡啶双重抗血小板治疗(DAPT)的适当时间仍不确定。方法和结果系统检索PubMed、EMBASE和Cochrane中央对照试验注册库(Central)，随机试验评估药物洗脱支架(DES)植入后延长与对照持续时间DAPT的相对疗效和安全性。纳入了10项试验，包括32,135例患者。与3 ~ 6个月的DAPT相比，DAPT持续时间延长12个月或更长时间显著增加了90%的大出血风险(RR: 1.90, 95% CI: 1.23 ~ 2.94, p = 0.004)，但没有减少任何记录的缺血性事件的发生率。与12个月的持续时间相比，更长时间的DAPT(18 ~ 30个月)显著增加了全因死亡(RR: 1.30, 95% CI: 1.02 ~ 1.65, p = 0.035)和大出血(RR: 1.61, 95% CI: 1.25 ~ 2.07, p <0.001)，心肌梗死风险降低(RR: 0.53, 95% CI: 0.43 ~ 0.66, p <0.001)和支架血栓形成(RR: 0.33, 95% CI: 0.21 ~ 0.51, p <0.001)，在心脏性死亡和中风方面没有发现差异。结论与延长DAPT(≥12个月)相比，短时间DAPT(3 ~ 6个月)可减少大出血，同时保持抗血栓疗效。延长DAPT(18至30个月)可减少缺血性事件，但与标准的12个月治疗相比，全因死亡和大出血的风险增加。3- 6个月的DAPT可能更适合接受DES植入的广大患者。

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引用次数: 6

WITHDRAWN: Prognosis of patients with syncope seen in accident and emergency: A comparison of four different risk scores recommended by European society of cardiology guidelines 撤回:意外和急诊晕厥患者的预后:欧洲心脏病学会指南推荐的四种不同风险评分的比较

Clinical trials and regulatory science in cardiology

Pub Date : 2015-05-14 DOI: 10.1016/J.CTRSC.2015.05.001

G. Barón-Esquivias, A. Fernández-Cisnal, Á. Arce-Léon, R. Toro, E. Cantero-Pérez, Juan Parejo-Matos, N. Romero-Rodríguez, E. Montero, Ángel Martínez

引用次数: 0

Galectin-3 and incident heart failure among patients with pre-existing coronary artery disease: The ADVANCE study 预先存在的冠状动脉疾病患者的半乳糖凝集素-3与心力衰竭:ADVANCE研究

Clinical trials and regulatory science in cardiology

Pub Date : 2015-05-01 DOI: 10.1016/j.ctrsc.2015.08.002

Carlos Iribarren , Malini Chandra , Jamal S. Rana , Mark A. Hlatky , Stephen P. Fortmann , Thomas Quertermous , Alan S. Go

Background

Galectin-3 (Gal-3) is a novel fibrosis biomarker. We ascertained: 1) the correlates of Gal-3, and 2) its association with incident heart failure among 1312 participants in The ADVANCE study (871 subjects with acute myocardial infarction [AMI] and 441 subjects with stable angina).

Methods

Cohort design, with Gal-3 measured in stored baseline serum samples (2002–04). After a median (SD) follow-up of 8.1 (3.2) years, 74 incident heart failure events were documented.

Results

The significant independent correlates of Gal-3 were age, gender, diabetes, C-reactive protein and estimated glomerular filtration rate. In Cox regression with adjustment for these variables plus race, CAD presentation, smoking status, body mass index, hypertension and cholesterol lowering drugs, there was a 1.51-fold (95% CI, 1.24 to 1.85; p < 0.0001) increased hazard of heart failure for each SD linear increment in Gal-3. In the fully-adjusted model, quartile four of Gal-3 (relative to quartile one) was associated with 2.1-fold increased hazard of heart failure (95% CI, 1.05 to 4.2). The C-statistic increased to 0.78 from 0.75 (p = 0.12) and the net reclassification index was 0.13 (SE = 0.06; p = 0.03) after adding Gal-3 quartiles to the model containing all risk factors.

Conclusions

Gal-3 is a useful marker of heart failure risk among patients with pre-existing coronary disease and may play an etiological role in the development of heart failure.

半凝集素-3 (galectin -3, Gal-3)是一种新型的纤维化生物标志物。我们确定了:1)Gal-3的相关性，2)在ADVANCE研究的1312名参与者(871名急性心肌梗死[AMI]和441名稳定型心绞痛)中，Gal-3与心力衰竭的相关性。方法采用短设计，在贮存的基线血清样本中测定Gal-3(2002 - 2004)。在中位(SD)随访8.1(3.2)年后，记录了74例心力衰竭事件。结果Gal-3与年龄、性别、糖尿病、c反应蛋白和肾小球滤过率相关。对这些变量加上种族、冠心病表现、吸烟状况、体重指数、高血压和降胆固醇药物进行校正后，Cox回归结果为1.51倍(95% CI, 1.24 ~ 1.85;p & lt;0.0001) Gal-3中每增加一个SD线性增加心力衰竭的风险。在完全调整模型中，四分位数Gal-3(相对于四分位数1)与心力衰竭风险增加2.1倍相关(95% CI, 1.05至4.2)。c统计量由0.75增加到0.78 (p = 0.12)，净重分类指数为0.13 (SE = 0.06;p = 0.03)，在包含所有危险因素的模型中加入Gal-3四分位数。结论sgal -3是冠心病患者心衰风险的有效标志物，可能在心衰发生过程中起病因学作用。

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引用次数: 1

Endothelin receptor antagonism in single ventricle physiology with fontan palliation: A systematic review and meta-analysis 内皮素受体拮抗剂在单侧脑室生理学与fontan缓解:系统回顾和荟萃分析

Clinical trials and regulatory science in cardiology

Pub Date : 2015-04-01 DOI: 10.1016/j.ctrsc.2015.08.001

Gwendolyn Derk , Ruopeng An , Jamil Aboulhosn

Background

The prevalence of single ventricle patients palliated with Fontan operation continues to grow worldwide. This study systematically reviewed existing evidence and performed a meta-analysis to determine the safety and efficacy of endothelin receptor antagonism in single ventricle physiology with Fontan palliation.

Methods

Keyword and reference search was conducted in PubMed Cochrane Library, Web of Science, Google Scholar, and ClinicalTrials.gov databases. Inclusion criteria were — study design: randomized controlled trials, cohort studies, prospective studies, or retrospective studies; subjects: single ventricle patients with Fontan palliation; main outcome: exercise or functional capacity; language: English; and article type: peer-reviewed publications.

Results

Five studies met the inclusion criteria, including three pre–post studies, one randomized crossover open label clinical trial, and one double-blind randomized controlled clinical trial. Study durations ranged from 3.5 to 6 months, with a total sample size of 123. Bosentan was the single endothelin receptor blocker used in all studies. No significant increase in liver toxicity or other serious adverse events were reported in these studies. Meta-analysis found bosentan use to be associated with improvement in functional class (p = 0.0007); whereas no significant change in six-minute walk distance, resting oxygen saturation, and maximal oxygen consumption was identified.

Conclusions

Bosentan was found to be a safe and well tolerated endothelin receptor antagonist in Fontan patients over 3–6 months of therapy. Bosentan use was associated with improved functional capacity. Future studies with larger sample size and longer duration are warranted to examine the long-term safety and efficacy of endothelin blockade in Fontan physiology.

背景:在世界范围内，通过Fontan手术缓解的单脑室患者的患病率持续增长。本研究系统地回顾了现有的证据，并进行了荟萃分析，以确定内皮素受体拮抗剂在单心室生理学和Fontan姑息治疗中的安全性和有效性。方法在PubMed Cochrane Library、Web of Science、Google Scholar和ClinicalTrials.gov数据库中进行关键词和文献检索。纳入标准为:研究设计:随机对照试验、队列研究、前瞻性研究或回顾性研究;对象:Fontan姑息治疗的单脑室患者;主要结果:运动或功能能力;语言:英语;文章类型:同行评议的出版物。结果5项研究符合纳入标准，包括3项前后研究、1项随机交叉开放标签临床试验和1项双盲随机对照临床试验。研究持续时间为3.5至6个月，总样本量为123。波生坦是所有研究中使用的单一内皮素受体阻滞剂。在这些研究中没有肝毒性显著增加或其他严重不良事件的报道。荟萃分析发现，波生坦的使用与功能等级的改善相关(p = 0.0007);而6分钟步行距离、静息氧饱和度和最大耗氧量没有显著变化。结论波生坦是一种安全且耐受性良好的内皮素受体拮抗剂，治疗3-6个月。波生坦的使用与功能能力的改善有关。未来的研究需要更大的样本量和更长的持续时间来检验内皮素阻断对Fontan生理的长期安全性和有效性。

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引用次数: 0

Transparency in medical research: Time for a paradigm shift 医学研究的透明度:是时候进行范式转变了

Clinical trials and regulatory science in cardiology

Pub Date : 2015-02-01 DOI: 10.1016/j.ctrsc.2015.04.001

Francesco Pelliccia , Andrew J.S. Coats , Luca Pani , Carlo Gaudio , Giuseppe Rosano

引用次数: 0

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