Clinical trials and regulatory science in cardiology最新文献

{"title":"WITHDRAWN: A Registry Comparison of ESC and NICE guidelines 95 in the assessment of stable angina in a UK district hospital","authors":"J. Ball, A. Cai, A. Pineau, Mitchell Brown, K. Budack, B. Cooper","doi":"10.1016/J.CTRSC.2015.08.004","DOIUrl":"https://doi.org/10.1016/J.CTRSC.2015.08.004","url":null,"abstract":"","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"66 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-08-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/J.CTRSC.2015.08.004","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051744","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"WITHDRAWN: Cost-effectiveness analysis of left atrial appendage occlusion compared with seven pharmacological strategies for stroke prevention in atrial fibrillation","authors":"V. Lee, R. Tsai, I. Chow, B. Yan, M. Kaya, Jai-Wun Park, Y. Lam","doi":"10.1016/J.CTRSC.2015.08.005","DOIUrl":"https://doi.org/10.1016/J.CTRSC.2015.08.005","url":null,"abstract":"","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-08-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/J.CTRSC.2015.08.005","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051760","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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","authors":"Stephen G. Worthley ,&nbsp;Gerard T. Wilkins ,&nbsp;Mark W. Webster ,&nbsp;Joseph K. Montarello ,&nbsp;Paul R. Antonis ,&nbsp;Robert J. Whitbourn ,&nbsp;Roderic J. Warren","doi":"10.1016/j.ctrsc.2015.08.007","DOIUrl":"10.1016/j.ctrsc.2015.08.007","url":null,"abstract":"<div><h3>Background/objectives</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"8 ","pages":"Pages 4-10"},"PeriodicalIF":0.0,"publicationDate":"2015-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.007","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051788","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Increased risk for vascular complications due to GP IIb/IIIa-antagonists in patients with cardiogenic shock supported by intraaortic balloon pump (IABP)","authors":"Jens Röther ,&nbsp;Monique Tröbs,&nbsp;Annika Schuhbäck,&nbsp;Josef Ludwig,&nbsp;Stephan Achenbach,&nbsp;Christian Schlundt","doi":"10.1016/j.ctrsc.2015.08.008","DOIUrl":"10.1016/j.ctrsc.2015.08.008","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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) &gt;<!--> <!-->5<!--> <!-->g/dl or haematocrit (PCV) &gt;<!--> <!-->15%), vascular complications with therapeutic consequence (venous thrombosis, arterial embolism) and stroke.</p></div><div><h3>Results</h3><p>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% (<em>p</em> <!-->=<!--> <!-->0.22). Multivariate analyses showed treatment with Glycoprotein (GP) IIb/IIIa- inhibitors to be an independent risk factor for the occurrence of vascular complications (<em>p</em> <!-->=<!--> <!-->0.04).</p></div><div><h3>Conclusion</h3><p>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.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"8 ","pages":"Pages 1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-08-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.008","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051801","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Three-dimensional binding sites volume assessment during cardiac pacing lead extraction","authors":"Bich Lien Nguyen ,&nbsp;Alessandro Persi ,&nbsp;Eli S. Gang ,&nbsp;Fabrizio Fattorini ,&nbsp;Alessandra Oliva ,&nbsp;Antonio Vitarelli ,&nbsp;Nicola Alessandri ,&nbsp;Robert J. Siegel ,&nbsp;Antonio Ciccaglioni ,&nbsp;Carlo Gaudio","doi":"10.1016/j.ctrsc.2015.08.006","DOIUrl":"10.1016/j.ctrsc.2015.08.006","url":null,"abstract":"<div><h3>Background/objectives</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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<!--> <!-->&lt;<!--> <!-->0.05), and powered-sheath use (r<!--> <!-->=<!--> <!-->0.39, p<!--> <!-->&lt;<!--> <!-->0.05), and negatively with procedural success (r<!--> <!-->=<!--> <!-->−<!--> <!-->0.37, p<!--> <!-->&lt;<!--> <!-->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).</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"7 ","pages":"Pages 1-6"},"PeriodicalIF":0.0,"publicationDate":"2015-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.006","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051774","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimize the duration of DAPT following DES implantation: An updated system review and meta-analysis of 10 randomized trials","authors":"Xin-Lin Zhang ,&nbsp;Qing-Qing Zhu ,&nbsp;Li Zhu ,&nbsp;Su-Qin Shi ,&nbsp;Jian-Zhou Chen ,&nbsp;Jun Xie ,&nbsp;Wei Huang ,&nbsp;Biao Xu","doi":"10.1016/j.ctrsc.2015.08.003","DOIUrl":"10.1016/j.ctrsc.2015.08.003","url":null,"abstract":"<div><h3>Background</h3><p>The appropriate duration of dual antiplatelet therapy (DAPT) with aspirin and a thienopyridine following drug-eluting stenting in percutaneous coronary intervention (PCI) remains uncertain.</p></div><div><h3>Methods and results</h3><p>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, <em>p</em> <!-->=<!--> <!-->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, <em>p</em> <!-->=<!--> <!-->0.035) and major bleeding (RR: 1.61, 95% CI: 1.25 to 2.07, <em>p</em> <!-->&lt;<!--> <!-->0.001), decreased risk of myocardial infarction (RR: 0.53, 95% CI: 0.43 to 0.66, <em>p</em> <!-->&lt;<!--> <!-->0.001) and stent thrombosis (RR: 0.33, 95% CI: 0.21 to 0.51, <em>p</em> <!-->&lt;<!--> <!-->0.001), no difference was detected regarding cardiac death and stroke.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"6 ","pages":"Pages 1-11"},"PeriodicalIF":0.0,"publicationDate":"2015-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.003","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051731","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"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","authors":"G. Barón-Esquivias, A. Fernández-Cisnal, Á. Arce-Léon, R. Toro, E. Cantero-Pérez, Juan Parejo-Matos, N. Romero-Rodríguez, E. Montero, Ángel Martínez","doi":"10.1016/J.CTRSC.2015.05.001","DOIUrl":"https://doi.org/10.1016/J.CTRSC.2015.05.001","url":null,"abstract":"","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2015-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/J.CTRSC.2015.05.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051689","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Galectin-3 and incident heart failure among patients with pre-existing coronary artery disease: The ADVANCE study","authors":"Carlos Iribarren ,&nbsp;Malini Chandra ,&nbsp;Jamal S. Rana ,&nbsp;Mark A. Hlatky ,&nbsp;Stephen P. Fortmann ,&nbsp;Thomas Quertermous ,&nbsp;Alan S. Go","doi":"10.1016/j.ctrsc.2015.08.002","DOIUrl":"10.1016/j.ctrsc.2015.08.002","url":null,"abstract":"<div><h3>Background</h3><p>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).</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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<!--> <!-->&lt;<!--> <!-->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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"5 ","pages":"Pages 1-7"},"PeriodicalIF":0.0,"publicationDate":"2015-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.002","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051721","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Endothelin receptor antagonism in single ventricle physiology with fontan palliation: A systematic review and meta-analysis","authors":"Gwendolyn Derk ,&nbsp;Ruopeng An ,&nbsp;Jamil Aboulhosn","doi":"10.1016/j.ctrsc.2015.08.001","DOIUrl":"10.1016/j.ctrsc.2015.08.001","url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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.</p></div><div><h3>Results</h3><p>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.</p></div><div><h3>Conclusions</h3><p>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.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"4 ","pages":"Pages 1-5"},"PeriodicalIF":0.0,"publicationDate":"2015-04-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.08.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"54051709","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Transparency in medical research: Time for a paradigm shift","authors":"Francesco Pelliccia ,&nbsp;Andrew J.S. Coats ,&nbsp;Luca Pani ,&nbsp;Carlo Gaudio ,&nbsp;Giuseppe Rosano","doi":"10.1016/j.ctrsc.2015.04.001","DOIUrl":"https://doi.org/10.1016/j.ctrsc.2015.04.001","url":null,"abstract":"","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"2 ","pages":"Pages 1-3"},"PeriodicalIF":0.0,"publicationDate":"2015-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.04.001","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"137406388","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}