Publications by authors named "Azfar Zaman"

129 Publications

Smoking status and mortality outcomes following percutaneous coronary intervention.

Eur J Prev Cardiol 2020 Feb 4. Epub 2020 Feb 4.

Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK.

Objective: The aim of this study was to assess the impact of smoking on short (30-day) and intermediate (30-day to 6-month) mortality following percutaneous coronary intervention (PCI).

Background: The effect of smoking on mortality post-PCI is lacking in the modern PCI era.

Methods: This was a retrospective analysis of prospectively collected data comparing short- and intermediate-term mortality amongst smokers, ex-smokers and non-smokers.

Results: The study cohort consisted of 12,656 patients: never-smokers (n = 4288), ex-smokers (n = 4806) and current smokers (n = 3562). The mean age (±standard deviation) was 57 (±11) years in current smokers compared with 67 (±11) in ex-smokers and 67 (±12) in never-smokers; p < 0.0001. PCI was performed for acute coronary syndrome (ACS) in 84.1% of current smokers, 57% of ex-smokers and 62.9% in never-smokers; p < 0.0001. In a logistic regression model, the adjusted odds ratios (95% confidence intervals (CIs)) for 30-day mortality were 1.60 (1.10-2.32) in current smokers and 0.98 (0.70-1.38) in ex-smokers compared with never-smokers. In the Cox proportional hazard model, the adjusted hazard ratios (95% CI) for mortality between 30 days and 6 months were 1.03 (0.65-1.65) in current smokers and 1.19 (0.84-1.67) in ex-smokers compared with never-smokers.

Conclusion: This large observational study of non-selected patients demonstrates that ex-smokers and never-smokers are of similar age at first presentation to PCI, and there is no short- or intermediate-term mortality difference between them following PCI. Current smokers undergo PCI at a younger age, more often for ACS, and have higher short-term mortality. These findings underscore the public message on the benefits of smoking cessation and the harmful effects of smoking.
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http://dx.doi.org/10.1177/2047487320902325DOI Listing
February 2020

Improving lipid management in patients with acute coronary syndrome: The ACS Lipid EuroPath tool.

Atheroscler Suppl 2020 Dec;42:e65-e71

Servicio de Cardiología, Hospital Ramón y Cajal, Madrid, Spain.

Post-acute coronary syndrome (ACS) patients are at very high risk for recurrent events and mortality, despite the availability of effective pharmacological approaches. In 2018, the ACS EuroPath Survey, performed in collaboration with 555 European cardiologists, identified a sub-optimal LDL-C management in post-ACS patients. Based on these premises, the ACS EuroPath II project led to the development of a self-assessment tool to improve lipid management in these very high risk patients, taking into consideration the new 2019 ESC/EAS guidelines. This tool is built in 3 sections. The first is a questionnaire to assess the lipid management practice from the acute phase up to 12 months of follow-up. The main topics covered in this section relate to 1) acute phase (lipid management of ACS patients during hospitalization; 2) discharge (lipid management at discharge, with focus on follow-up plan); 3) follow-up (lipid management at the time of first and subsequent follow-ups); 4) referral pathway for definitive lipid management care of post-ACS patients; 5) evaluation of the achieved goal at 6 months to 1 year and key implications. The second section is a brief report to position the results against other European Union clinical practice and European guidelines. The last section allows the physician to evaluate and consider the implementation of one or more strategies, successfully developed in leading European centers, in order to optimize their own clinical practice.
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http://dx.doi.org/10.1016/j.atherosclerosissup.2021.01.011DOI Listing
December 2020

Lipid-lowering therapy and low-density lipoprotein cholesterol goal achievement in patients with acute coronary syndromes: The ACS patient pathway project.

Atheroscler Suppl 2020 Dec;42:e49-e58

Department of Pharmacological and Biomolecular Sciences, University of Milan, Milan, IRCCS MultiMedica, Sesto S. Giovanni, Milan, Italy. Electronic address:

Background And Aims: Post-acute coronary syndrome (ACS) patients are at very high risk for recurrent events and mortality, despite the availability of effective pharmacological approaches. Aim of this survey was to evaluate the compliance to ESC/EAS guidelines during the management of ACS patients and the effectiveness of secondary prevention in seven European countries.

Methods: By means of an online questionnaire, data on 2775 ACS patients (either acute case or follow-up patients) were collected, including data on lipid profile, medications, follow-up visit planning, screening for familial hypercholesterolemia.

Results: Lipid profiles were obtained for 91% of ACS patients in the acute phase, mostly within the first day of hospitalization (73%). During hospitalization, 93% of the patients received a lipid-lowering treatment; at discharge, only 66% of the patients received a high intensity statin therapy. At the first follow-up, most of the patients (77.6%) had LDL-C >70 mg/dL; among them, 41% had no change in their lipid-lowering therapies. Similar data were obtained during the second follow-up visit. The analysis of a subgroup of patients with at least 2 follow-up visits and known LDL-C levels showed that the percentage of patients at goal increased from 9% to 32%, and patients with LDL-C <100 mg/dL raised from 23% to 72%. Among acute cases, 44 were admitted with a diagnosis of familial hypercholesterolemia (FH); only 18% of the remaining patients were screened for FH.

Conclusions: Contemporary lipid management of very high CV risk patients is sub-optimal despite available treatments. Greater efforts are warranted to optimize cardiovascular prevention.
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http://dx.doi.org/10.1016/j.atherosclerosissup.2021.01.009DOI Listing
December 2020

Aspirin Versus Dual Antiplatelet Therapy in Patients Undergoing Trans-Catheter Aortic Valve Implantation, Updated Meta-Analysis.

Cardiovasc Drugs Ther 2021 Feb 15. Epub 2021 Feb 15.

Department of Cardiothoracic Services, Freeman Hospital, Newcastle-upon-Tyne, NE7 7DN, UK.

Background: The Antiplatelet Therapy for Patients Undergoing Transcatheter Aortic-Valve Implantation (POPular TAVI) trial reported comparable composite endpoints of ischemic events using aspirin compared to dual antiplatelet therapy (DAPT). However, this trial was not powered to detect individual differences in ischemic events. We sought to conduct a meta-analysis to compare aspirin to DAPT on ischemic and bleeding events following TAVI.

Methods: The MEDLINE database was searched from inception until September 2020 and only randomized clinical trials of patients receiving antiplatelet therapy following TAVI were included. The treatment effect was reported as rate ratios (RRs) with 95% confidence intervals.

Results: Four randomized clinical trials of 1086 TAVI patients were included. There was a 51% reduction in major or life-threatening bleeding with aspirin compared with DAPT [RR 0.49, (95%CI 0.31 to 0.78)]. Aspirin was not associated with an increased risk of death [RR 1.01, (95%CI 0.62 to 1.65)], cardiovascular death [RR 1.15, (95%CI 0.56 to 2.36)], ischemic stroke [RR 0.93, (95%CI 0.51 to 1.70)], or MI [RR 0.53, (95%CI 0.18 to 1.57)].

Conclusions: This meta-analysis supports the use of aspirin as the optimal antiplatelet strategy following TAVI procedures in reducing bleeding without an increase in ischemic events compared with dual antiplatelet therapy.
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http://dx.doi.org/10.1007/s10557-021-07146-6DOI Listing
February 2021

Survival relative to pacemaker status after transcatheter aortic valve implantation.

Catheter Cardiovasc Interv 2021 Jan 27. Epub 2021 Jan 27.

Sussex Cardiac Center, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK.

Objectives: To determine whether a permanent pacemaker (PPM) in situ can enhance survival after transcatheter aortic valve implantation (TAVI), in a predominantly inoperable or high risk cohort.

Background: New conduction disturbances are the most frequent complication of TAVI, often necessitating PPM implantation before hospital discharge.

Methods: We performed an observational cohort analysis of the UK TAVI registry (2007-2015). Primary and secondary endpoints were 30-day post-discharge all-cause mortality and long-term survival, respectively.

Results: Of 8,651 procedures, 6,815 complete datasets were analyzed. A PPM at hospital discharge, irrespective of when implantation occurred (PPM 1.68% [22/1309] vs. no PPM 1.47% [81/5506], odds ratio [OR] 1.14, 95% confidence interval [CI] 0.71-1.84; p = .58), or a PPM implanted peri- or post-TAVI only (PPM 1.44% [11/763] vs. no PPM 1.47% [81/5506], OR 0.98 [0.51-1.85]; p = .95) did not significantly reduce the primary endpoint. Patients with a PPM at discharge were older, male, had right bundle branch block at baseline, were more likely to have received a first-generation self-expandable prosthesis and had experienced more peri- and post-procedural complications including bailout valve-in-valve rescue, bleeding and acute kidney injury. A Cox proportional hazards model demonstrated significantly reduced long-term survival in all those with a PPM, irrespective of implantation timing (hazard ratio [HR] 1.14 [1.02-1.26]; p = .019) and those receiving a PPM only at the time of TAVI (HR 1.15 [1.02-1.31]; p = .032). The reasons underlying this observation warrant further investigation.

Conclusions: A PPM did not confer a survival advantage in the first 30 days after hospital discharge following TAVI.
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http://dx.doi.org/10.1002/ccd.29498DOI Listing
January 2021

Outcomes of COVID-19 Positive Acute Coronary Syndrome Patients; a multisource Electronic Healthcare Records Study from England.

J Intern Med 2021 Jan 19. Epub 2021 Jan 19.

Keele Cardiovascular Research Group, Institute for Prognosis Research, School of Primary Care, Keele University, Stoke On Trent, United Kingdom of Great Britain and Northern Ireland.

Background: Patients with underlying cardiovascular disease and Coronavirus disease 2019 (COVID-19) infection are at increased risk of morbidity and mortality.

Objectives: This study was designed to characterise the presenting profile and outcomes of patients hospitalized with acute coronary syndrome (ACS) and COVID-19 infection.

Methods: This observational cohort study was conducted using multisource data from all acute NHS hospitals in England. All consecutive patients hospitalized with diagnosis of ACS with or without COVID-19 infection between 1 March- 31 May 2020 were included. The primary outcome was in-hospital and 30-day mortality.

Results: A total of 12,958 patients were hospitalized with ACS during the study period, of which 517 (4.0%) were COVID-19 positive and were more likely to present with non-ST elevation acute myocardial infarction. COVID-19 ACS group were generally older, Black Asian and Minority ethnicity, more comorbid and had unfavourable presenting clinical characteristics such as elevated cardiac troponin, pulmonary oedema, cardiogenic shock and poor left ventricular systolic function compared with non-COVID-19 ACS group. They were less likely to receive an invasive coronary angiography (67.7% vs 81.0%), percutaneous coronary intervention (PCI) (30.2% vs 53.9%) and dual antiplatelet medication (76.3% vs 88.0%). After adjusting for all the baseline differences, patients with COVID-19 ACS had higher in-hospital (adjusted odds ratio (aOR) 3.27 95% confidence interval (CI) 2.41-4.42) and 30-day mortality (aOR 6.53 95%CI 5.1-8.36) compared to the non COVID-19 ACS group.

Conclusion: COVID-19 infection was present in 4% of patients hospitalized with an ACS in England and is associated with lower rates of guideline recommended treatment and significant mortality hazard.
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http://dx.doi.org/10.1111/joim.13246DOI Listing
January 2021

One-Month Dual Antiplatelet Therapy Following Percutaneous Coronary Intervention With Zotarolimus-Eluting Stents in High-Bleeding-Risk Patients.

Circ Cardiovasc Interv 2020 11 10;13(11):e009565. Epub 2020 Nov 10.

Cardiovascular Research Foundation, New York, NY (A.J.K., G.W.S.).

Background: Despite treatment guidance endorsing shortened dual antiplatelet therapy (DAPT) duration in high bleeding risk (HBR) patients after drug-eluting stents, limited evidence exists to support these recommendations. The present study was designed to examine the safety and effectiveness of 1-month DAPT duration following percutaneous coronary intervention with zotarolimus-eluting stents in HBR patients.

Methods: Onyx ONE Clear was a prospective, multicenter, nonrandomized study evaluating the safety and effectiveness of 1-month DAPT followed by single antiplatelet therapy in HBR patients undergoing percutaneous coronary intervention with Resolute Onyx drug-eluting stents. The primary analysis of cardiac death or myocardial infarction between 1 month and 1 year was performed in the prespecified one-month clear population of patients pooled from the Onyx ONE US/Japan study and Onyx ONE randomized controlled trial. One-month clear was defined as DAPT adherence and without major adverse events during the first month following percutaneous coronary intervention.

Results: Among patients enrolled in Onyx ONE US/Japan (n=752) and Onyx ONE randomized controlled trial (n=1018), 1506 patients fulfilled one-month clear criteria. Mean HBR characteristics per patient was 1.6 with 44.7% having multiple risks. By 2 months and 1 year, respectively, 96.9% and 89.3% of patients were taking single antiplatelet therapy. Between 1 month and 1 year, the rate of the primary end point was 7.0%. The 1-sided upper 97.5% CI was 8.4%, less than the performance goal of 9.7% (<0.001).

Conclusions: Among HBR patients who were event free before DAPT discontinuation at 1 month, favorable safety and effectiveness through 1 year support treatment with Resolute Onyx drug-eluting stents as part of an individualized strategy for shortened DAPT duration following percutaneous coronary intervention. Registration: URL: https://www.clinicaltrials.gov; Unique identifier NCT03647475.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.120.009565DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7665241PMC
November 2020

Pharmacology before, during and after percutaneous coronary intervention.

Heart 2020 Nov 4. Epub 2020 Nov 4.

Cardiology, James Cook University Hospital, Middlesborough, UK.

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http://dx.doi.org/10.1136/heartjnl-2019-315090DOI Listing
November 2020

A randomised controlled trial of the sirolimus-eluting biodegradable polymer ultra-thin Supraflex stent versus the everolimus-eluting biodegradable polymer SYNERGY stent for three-vessel coronary artery disease: rationale and design of the Multivessel TALENT trial.

EuroIntervention 2020 Dec 18;16(12):e997-e1004. Epub 2020 Dec 18.

Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.

Aims: The purpose of the Multivessel TALENT trial is to compare clinical outcomes of the novel Supraflex Cruz stent with those of the SYNERGY stent in patients with three-vessel disease (3VD) undergoing state-of-the-art percutaneous coronary intervention (PCI).

Methods And Results: In this prospective, randomised, 1:1 balanced, multicentre, open-label trial, 1,550 patients with de novo 3VD without left main disease will be assigned to the Supraflex Cruz or SYNERGY arm. The following treatment principles of "best practice" PCI will be applied: Heart Team consensus based on SYNTAX score II treatment recommendation, functional lesion evaluation by quantitative flow ratio (QFR), stent optimisation by intravascular imaging, optimal pharmacological treatment and prasugrel monotherapy. The primary endpoint is a non-inferiority comparison of the patient-oriented composite endpoint (POCE) of all-cause death, any stroke, any myocardial infarction, or any revascularisation, at 12 months post procedure. The powered secondary endpoint is a superiority comparison of the vessel-oriented composite endpoint (VOCE), defined as vessel-related cardiovascular death, vessel-related myocardial infarction, or clinically and physiologically indicated target vessel revascularisation, at 24 months.

Conclusions: The Multivessel TALENT trial will be evaluating a novel treatment strategy for complex coronary artery disease with state-of-the-art PCI based on angiography-derived QFR with novel ultra-thin Supraflex Cruz stents, compared with SYNERGY stents. Clinical Trial Registration URL: https://www.clinicaltrials.gov/ct2/show/NCT04390672. Unique Identifier: NCT04390672 Visual summary. Flow chart of the Multivessel TALENT trial. 3VD: three-vessel disease; QFR: quantitative flow ratio; IVUS: intravascular ultrasound; OCT: optical coherence tomography; CTO: chronic total occlusion; OMT: optimal medical therapy; POCE: patient-oriented composite endpoint; VOCE: vessel-oriented composite endpoint.
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http://dx.doi.org/10.4244/EIJ-D-20-00772DOI Listing
December 2020

The ultra-thin strut sirolimus-eluting coronary stent: SUPRAFLEX.

Future Cardiol 2021 Mar 10;17(2):227-237. Epub 2020 Sep 10.

Department of Cardiology, National University of Ireland Galway, Galway, H91 TK33, Ireland.

Percutaneous coronary interventions with drug-eluting stents is currently the preferred revascularization treatment strategy for coronary artery disease. Following the first generation, the second-generation drug-eluting stents was designed with a thinner strut, better biocompatible polymer with/without bioresorbable coating or even polymer-free struts. The SUPRAFLEX stent system has ultra-thin struts (60 μm) across all stent diameters and a biodegradable polymer coating, enabling 70% of the sirolimus elution within 7 days. SUPRAFLEX has been assessed in large scale randomized controlled trials. This review summarizes the design of the SUPRAFLEX stent, the results of the pivotal clinical trials and outlines the ongoing research programs.
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http://dx.doi.org/10.2217/fca-2019-0083DOI Listing
March 2021

The predictive value of CHADS-VASc score on in-hospital death and adverse periprocedural events among patients with the acute coronary syndrome and atrial fibrillation who undergo percutaneous coronary intervention: a 10-year National Inpatient Sample (NIS) analysis.

Cardiovasc Revasc Med 2020 Aug 7. Epub 2020 Aug 7.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute of Primary Care and Health Sciences, Keele University, Stoke-on-Trent, United Kingdom; Department of Cardiology, Thomas Jefferson University Hospital, Philadelphia, PA, United States of America. Electronic address:

Background: The predictive value of CHADS-VASc score regarding the in-hospital death and periprocedural adverse events following percutaneous coronary intervention (PCI) among patients with acute coronary syndrome (ACS) and concomitant atrial fibrillation (AF) is not established.

Methods: We retrospectively analyzed data of patients with the in-hospital and primary diagnosis of ACS, with concomitant AF, who underwent PCI during the 2004-2014 period from the US National Inpatient Sample database. A CHADS-VASc score was incorporated into multiple covariate-adjusted logistic regression analyses to determine its independent impact on designated outcomes.

Results: A total of 283,890 patients hospitalized with the primary diagnosis of ACS who underwent PCI and had an AF on record were included in the analysis. The average reported prevalence of AF in the whole cohort of ACS patients was 10.0% with a significant increasing trend during the observed 10-year period (p < .001). The average age of the cohort was 72.1 ± 11 years, 63.4% were male while the median CHADS-VASc score was 3 (IQR 2-4). Following adjustment for baseline covariates, incremental increase in CHADS-VASc score was independently associated with an increased odds of in-hospital death (OR 1.20, CI 95% 1.18-1.22), periprocedural vascular injury (OR 1.18, 95% CI 1.17-1.20), bleeding (OR 1.17, 95% CI 1.16-1.18), stroke/transient ischemic attack (OR 1.17, 95% CI 1.15-1.19), and acute kidney injury (OR 1.05, 95% CI 1.04-1.06).

Conclusions: The CHADS-VASc score provides important prognostic information in ACS patients undergoing PCI. It is independently associated with in-hospital death and adverse periprocedural events following PCI in patients presenting with ACS and concomitant AF.
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http://dx.doi.org/10.1016/j.carrev.2020.08.003DOI Listing
August 2020

Correction: Design, development, testing at ISO standards and in vivo feasibility study of a novel polymeric heart valve prosthesis.

Biomater Sci 2020 08 29;8(16):4639. Epub 2020 Jul 29.

Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge, UK.

Correction for 'Design, development, testing at ISO standards and in vivo feasibility study of a novel polymeric heart valve prosthesis' by Joanna R. Stasiak et al., Biomater. Sci., 2020, DOI: .
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http://dx.doi.org/10.1039/d0bm90064hDOI Listing
August 2020

Effect of Levothyroxine on Left Ventricular Ejection Fraction in Patients With Subclinical Hypothyroidism and Acute Myocardial Infarction: A Randomized Clinical Trial.

JAMA 2020 07;324(3):249-258

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University, Newcastle upon Tyne, United Kingdom.

Importance: Thyroid hormones play a key role in modulating myocardial contractility. Subclinical hypothyroidism in patients with acute myocardial infarction is associated with poor prognosis.

Objective: To evaluate the effect of levothyroxine treatment on left ventricular function in patients with acute myocardial infarction and subclinical hypothyroidism.

Design, Setting, And Participants: A double-blind, randomized clinical trial conducted in 6 hospitals in the United Kingdom. Patients with acute myocardial infarction including ST-segment elevation and non-ST-segment elevation were recruited between February 2015 and December 2016, with the last participant being followed up in December 2017.

Interventions: Levothyroxine treatment (n = 46) commencing at 25 µg titrated to aim for serum thyrotropin levels between 0.4 and 2.5 mU/L or identical placebo (n = 49), both provided in capsule form, once daily for 52 weeks.

Main Outcomes And Measures: The primary outcome measure was left ventricular ejection fraction at 52 weeks, assessed by magnetic resonance imaging, adjusted for age, sex, type of acute myocardial infarction, affected coronary artery territory, and baseline left ventricular ejection fraction. Secondary measures were left ventricular volumes, infarct size (assessed in a subgroup [n = 60]), adverse events, and patient-reported outcome measures of health status, health-related quality of life, and depression.

Results: Among the 95 participants randomized, the mean (SD) age was 63.5 (9.5) years, 72 (76.6%) were men, and 65 (69.1%) had ST-segment elevation myocardial infarction. The median serum thyrotropin level was 5.7 mU/L (interquartile range, 4.8-7.3 mU/L) and the mean (SD) free thyroxine level was 1.14 (0.16) ng/dL. The primary outcome measurements at 52 weeks were available in 85 patients (89.5%). The mean left ventricular ejection fraction at baseline and at 52 weeks was 51.3% and 53.8%, respectively, in the levothyroxine group compared with 54.0% and 56.1%, respectively, in the placebo group (adjusted difference in groups, 0.76% [95% CI, -0.93% to 2.46%]; P = .37). None of the 6 secondary outcomes showed a significant difference between the levothyroxine and placebo treatment groups. There were 15 (33.3%) and 18 (36.7%) cardiovascular adverse events in the levothyroxine and placebo groups, respectively.

Conclusions And Relevance: In this preliminary study involving patients with subclinical hypothyroidism and acute myocardial infarction, treatment with levothyroxine, compared with placebo, did not significantly improve left ventricular ejection fraction after 52 weeks. These findings do not support treatment of subclinical hypothyroidism in patients with acute myocardial infarction.

Trial Registration: isrctn.org Identifier: http://www.isrctn.com/ISRCTN52505169.
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http://dx.doi.org/10.1001/jama.2020.9389DOI Listing
July 2020

A National Evaluation of Emergency Cardiac Surgery After Percutaneous Coronary Intervention and Postsurgical Patient Outcomes.

Am J Cardiol 2020 09 7;130:24-29. Epub 2020 Jun 7.

Keele Cardiovascular Research Group, Keele University, Stoke-on-Trent, UK; Department of Cardiology, Royal Stoke University Hospital, Stoke-on-Trent, UK. Electronic address:

There is limited national data regarding emergency cardiac surgery for complications sustained after percutaneous coronary intervention (PCI). This study aimed to examine emergency cardiac surgery after PCI in England and Wales and postsurgical patient outcomes. We analyzed patients in the British Cardiovascular Intervention Society database who underwent PCI between 2007 and 2014 and compared characteristics and outcomes for patients with and without emergency cardiac surgery. A total of 549,303 patients were included in the analysis and 362 (0.07%) underwent emergency cardiac surgery. There was a modest decline in the annual rate of emergency cardiac surgery from 0.09% to 0.06% between 2007 and 2014. Variables associated with emergency cardiac surgery included receipt of circulatory support (Odds ratio (OR) 39.20 95% confidence interval (CI) 27.75 to 55.36), aortic dissection (OR 28.39 95%CI 14.59 to 55.26), coronary dissection (OR 18.50 95%CI 13.60 to 25.18), coronary perforation (OR 7.86 95%CI 4.27 to 14.46), cardiac tamponade (OR 6.77 95%CI 3.13 to 14.66), and on-site surgical cover (OR 2.15 95%CI 1.56 to 2.97). After adjustments, patients with emergency cardiac surgery were at increased odds of 30-day mortality (OR 4.41 95%CI 2.94 to 6.62) and in-hospital major adverse cardiac and cerebrovascular events (OR 1.63 95%CI 1.07 to 2.48). On site surgical cover was independently associated with increased odds of mortality (OR 1.26 95%CI 1.20 to 1.33) following emergency cardiac surgery. In conclusion, emergency cardiac surgery after PCI is a rarely required procedure and in England and Wales there appears to be a decline in recent years. Patients who underwent emergency cardiac surgery have higher risk of adverse outcomes and longer length of hospital stay.
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http://dx.doi.org/10.1016/j.amjcard.2020.05.041DOI Listing
September 2020

A comparison of cardiovascular risk scores in native and migrant South Asian populations.

SSM Popul Health 2020 Aug 11;11:100594. Epub 2020 May 11.

Freeman Hospital, Newcastle-upon-Tyne, UK.

Background: South Asians have increased cardiovascular risk burden but little data exists comparing cardiovascular (CV) risk models in migrant and native South Asians. Our retrospective cohort study in patients presenting with first acute myocardial infarction(MI) compares the predictive value of CV risk scores in native and UK migrant South Asians.

Methods: Retrospective cohort study of 80 UK-based patients of South Asian origin admitted with first presentation MI, excluding patients with known coronary artery disease. A retrospective 10-year CV risk was calculated for each patient using four cardiovascular risk models: Framingham Risk Score(Risk), World Health Organisation(Risk), American College of Cardiology/American Heart Association(ACC/AHA) (Risk), and 3Joint British Societies'(Risk). Our aim was to assess agreement between these risk scores and conduct comparative analysis with native South Asians.

Results: Risk identified the largest proportion of migrant South Asians as 'high risk' with 65% of subjects having an estimated >20% 10-year CV risk. Risk provided the lowest 10-year CV risk estimates for South Asian migrants, identifying 21.25% of the migrant cohort as >20% risk of major CV event. Comparative analysis with the native South Asian cohort demonstrated Risk as the risk model most likely to identify patients as 'high'(>20%) risk(55.9%; p = 0.224).

Conclusions: This study represents the first analysis of predictive cardiovascular risk scores comparing migrant and native South Asian populations. Significant variation between the CV risk scores were observed, leading to inaccuracies in patient cardiovascular risk estimation. Given the growing burden of cardiovascular disease in Asian countries and different population characteristics, we highlight the need for population specific CV disease risk models whilst providing stimulus for further large-scale prospective studies.
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http://dx.doi.org/10.1016/j.ssmph.2020.100594DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7322355PMC
August 2020

Design, development, testing at ISO standards and in vivo feasibility study of a novel polymeric heart valve prosthesis.

Biomater Sci 2020 Aug 1;8(16):4467-4480. Epub 2020 Jul 1.

Department of Chemical Engineering and Biotechnology, University of Cambridge, Cambridge, UK.

Clinically available prosthetic heart valves are life-saving, but imperfect: mechanical valves requiring anticoagulation therapy, whilst bioprosthetic valves have limited durability. Polymer valves offer the prospect of good durability without the need for anticoagulation. We report the design and development of a polymeric heart valve, its bench-testing at ISO standards, and preliminary extra-vivo and in vivo short-term feasibility. Prototypes were manufactured by injection moulding of styrenic block copolymers to achieve anisotropic mechanical properties. Design was by finite element stress-strain modelling, which has been reported previously, combined with feedback from bench and surgery-based testing using various combinations of materials, valve geometry and processing conditions. Bench testing was according to ISO 5840:2015 standards using an in vitro cardiovascular hydrodynamic testing system and an accelerated fatigue tester. Bench comparisons were made with a best-in-class bio-prosthesis. Preliminary clinical feasibility evaluations included extra-vivo and short-term (1-24 hours) in vivo testing in a sheep model. The optimised final prototype met the requirements of ISO standards with hydrodynamic performance equivalent to the best-in-class bioprosthesis. Bench durability of greater than 1.2 billion cycles (30 years equivalent) was achieved (still ongoing). Extra-vivo sequential testing (n = 8) allowed refinement of external diameter, 3D shape, a low profile, flexibility, suturability, and testing of compatibility to magnetic resonance imaging and clinical sterilisation. In vivo short-term (1-24 hours) feasibility (n = 3) confirmed good suturability, no mechanical failure, no trans-valvular regurgitation, competitive trans-valvular gradients, and good biocompatibility at histopathology. We have developed and tested at ISO standards a novel prosthetic heart valve featuring competitive bench-based hydrodynamics and durability, well beyond the ISO requirements and comparable to a best-in-class bioprosthesis. In vivo short-term feasibility testing confirmed preliminary safety, functionality and biocompatibility, supporting progression to a long-term efficacy trial.
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http://dx.doi.org/10.1039/d0bm00412jDOI Listing
August 2020

Effect of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size in anterior STEMI: PiCSO in ACS study.

Int J Cardiol Heart Vasc 2020 Jun 15;28:100526. Epub 2020 May 15.

Freeman Hospital, Newcastle upon Tyne, UK.

Background: The aim of this clinical research was to investigate the effects of Pressure-controlled intermittent Coronary Sinus Occlusion (PiCSO) on infarct size at 5 days after primary percutaneous coronary intervention (pPCI) in patients with ST-segment elevation myocardial infarction (STEMI).

Methods And Results: This comparative study was carried out in four UK hospitals. Forty-five patients with anterior STEMI presenting within 12 h of symptom onset received pPCI plus PiCSO (initiated after reperfusion; n = 45) and were compared with a propensity score-matched control cohort from INFUSE-AMI (n = 80). Infarct size (% of LV mass, median [interquartile range]) measured by cardiac magnetic resonance (CMR) at day 5 was significantly lower in the PiCSO group (14.3% [95% CI 9.2-19.4%] vs. 21.2% [95% CI 18.0-24.4%]; p = 0.023). There were no major adverse cardiac events (MACE) related to the PiCSO intervention.

Conclusions: PiCSO, as an adjunct to pPCI, was associated with a lower infarct size at 5 days after anterior STEMI in a propensity score-matched population.
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http://dx.doi.org/10.1016/j.ijcha.2020.100526DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7229496PMC
June 2020

Transcatheter aortic valve implantation via surgical subclavian versus direct aortic access: A United Kingdom analysis.

Int J Cardiol 2020 06 21;308:67-72. Epub 2020 Mar 21.

Sussex Cardiac Centre, Brighton and Sussex University Hospitals NHS Trust, Brighton, UK. Electronic address:

Background: Surgical subclavian (SC) and direct aortic (DA) access are established alternatives to the default transfemoral route for transcatheter aortic valve implantation (TAVI). We sought to find differences in survival and procedure-related outcomes after SC- versus DA-TAVI.

Methods: We performed an observational cohort analysis of cases prospectively uploaded to the UK TAVI registry. To ensure the most contemporaneous comparison, the analysis focused on SC and DA procedures performed from 2013 to 2015.

Results: Between January 2013 and July 2015, 82 (37%) SC and 142 (63%) DA cases were performed that had validated 1-year life status. Multivariable regression analysis showed procedure duration was longer for SC cases (SC 193.5 ± 65.8 vs. DA 138.4 ± 57.7 min; p < .01) but length of hospital stay was shorter (SC 8.6 ± 9.5 vs. DA 11.9 ± 10.8 days; p = .03). Acute kidney injury was observed less frequently after SC cases (odds ratio [OR] 0.35, 95% confidence interval [CI 0.12-0.96]; p = .042) but vascular access site-related complications were more common (OR 9.75 [3.07-30.93]; p < .01). Procedure-related bleeding (OR 0.54 [0.24-1.25]; p = .15) and in-hospital stroke rate (SC 3.7% vs. DA 2.1%; p = .67) were similar. There were no significant differences in in-hospital (SC 2.4% vs. DA 4.9%; p = .49), 30-day (SC 2.4% vs. DA 4.2%; p = .71) or 1-year (SC 14.5% vs. DA 21.9%; p = .344) mortality.

Conclusions: Surgical subclavian and direct aortic approaches can offer favourable outcomes in appropriate patients. Neither access modality conferred a survival advantage but there were significant differences in procedural metrics that might influence which approach is selected.
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http://dx.doi.org/10.1016/j.ijcard.2020.03.059DOI Listing
June 2020

Percutaneous coronary intervention for left main stem disease: Impact of diabetes mellitus on mortality.

Catheter Cardiovasc Interv 2020 10 5;96(4):E416-E422. Epub 2020 Mar 5.

Cardiology Department, Freeman Hospital, Newcastle upon Tyne, UK.

Objectives: We assessed the impact of diabetes mellitus (DM) on mortality after percutaneous coronary intervention (PCI) for left main stem (LMS) disease. Second, we compared mortality outcomes between non-insulin treated (NITDM) and insulin treated diabetes (ITDM) in different clinical settings.

Background: There is a paucity of "real world" outcomes data in diabetic patients undergoing LMS PCI.

Methods: We undertook a retrospective analysis of consecutive patients undergoing unprotected LMS PCI at 2 high volume tertiary centers. Diabetic status and clinical setting for PCI were recorded. The primary outcome measure was all-cause 30-day and long-term mortality (up to 36 months) post index PCI.

Results: Between 2003 and 2017, 2,675 patients undergoing index LMS PCI were analyzed. Of those, 77.1% were non-DM, 15.8% NITDM, and 7.1% ITDM. Overall, DM status was not associated with higher 30-day mortality (OR 1.39, 95% CI 0.89-2.16, p = .15). During a median follow-up of 36 months, there was a borderline statistical association of DM with long-term mortality in all PCI settings (HR 1.31, 95% CI 1.00-1.71, p = .05). Compared to non-DM, ITDM but not NITDM was associated with short- and long-term mortality in all clinical presentations.

Conclusions: Overall, DM did not impact on 30-day mortality and had only a borderline statistical association with long-term mortality. It did not have an influence on mortality in non-emergency LMS PCI. The impact of DM on mortality outcomes following LMS PCI was only significant in the insulin treated patients.
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http://dx.doi.org/10.1002/ccd.28818DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687181PMC
October 2020

Polymer-based or Polymer-free Stents in Patients at High Bleeding Risk.

N Engl J Med 2020 03 12;382(13):1208-1218. Epub 2020 Feb 12.

From Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (S.W.); Montefiore Medical Center (A.L.), Columbia University Irving Medical Center-New York-Presbyterian Hospital (A.J.K., S.O.M.), the Cardiovascular Research Foundation (A.J.K., S.O.M., I.J., G.W.S.), Mount Sinai Medical Center (R. Mehran), and the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai (G.W.S.) - all in New York; Isala Zwolle, Zwolle, the Netherlands (E.K.); Medical University of Silesia, Katowice (E.K.), and Poland Miedziowe Centrum Zdrowia, Lubin (A.W.) - both in Poland; Piedmont Heart Institute, Atlanta (D.E.K.); the Division of Cardiovascular Diseases, Scripps Clinic, La Jolla (M.J.P.), and Medtronic, Santa Rosa (S.B., L.B., M.L.) - both in California; Instituto Dante Pazzanese de Cardiologia, São Paulo (A. Abizaid); University Hospitals Cleveland Medical Center, Cleveland (D.I.S.); GenesisCare Cardiology, Alexandria, NSW (S.G.W.), and St. Andrew's Hospital, Adelaide, SA (C.T.) - both in Australia; Freeman Hospital and Newcastle University, Newcastle upon Tyne, United Kingdom (A.Z.); Stredoslovensky Ustav Srdcovych a Cievnych Chorob, Banska Bystrica, Slovakia (M.H., P.P.); Hospital Serdang, Kajang, Malaysia (A.K.A.G., K.S.); Acibadem City Clinic, Sofia, Bulgaria (I.P.); Galway University Hospitals-University Hospital Galway, Galway, Ireland (D.M.); Hospital Clínico Universitario Virgen de la Arrixaca, El Palmar (E.P.), and Hospital Universitario La Paz and Hospital La Paz Institute for Health Research, Madrid (R. Moreno) - all in Spain; Centro Cardiologico Monzino IRCCS, Milan (F.F.); Waikato Hospital, Hamilton, New Zealand (S.P.); Seoul National University Hospital, Seoul (H.-S.K.), and Keimyung University Dongsan Medical Center, Daegu (S.-H.H.) - both in South Korea; and Centre Hospitalier Universitaire Charleroi, Charleroi, Belgium (A. Aminian).

Background: Polymer-free drug-coated stents provide superior clinical outcomes to bare-metal stents in patients at high bleeding risk who undergo percutaneous coronary intervention (PCI) and are treated with 1 month of dual antiplatelet therapy. Data on the use of polymer-based drug-eluting stents, as compared with polymer-free drug-coated stents, in such patients are limited.

Methods: In an international, randomized, single-blind trial, we compared polymer-based zotarolimus-eluting stents with polymer-free umirolimus-coated stents in patients at high bleeding risk. After PCI, patients were treated with 1 month of dual antiplatelet therapy, followed by single antiplatelet therapy. The primary outcome was a safety composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year. The principal secondary outcome was target-lesion failure, an effectiveness composite of death from cardiac causes, target-vessel myocardial infarction, or clinically indicated target-lesion revascularization. Both outcomes were powered for noninferiority.

Results: A total of 1996 patients at high bleeding risk were randomly assigned in a 1:1 ratio to receive zotarolimus-eluting stents (1003 patients) or polymer-free drug-coated stents (993 patients). At 1 year, the primary outcome was observed in 169 of 988 patients (17.1%) in the zotarolimus-eluting stent group and in 164 of 969 (16.9%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% confidence interval [CI], 3.5; noninferiority margin, 4.1; P = 0.01 for noninferiority). The principal secondary outcome was observed in 174 patients (17.6%) in the zotarolimus-eluting stent group and in 169 (17.4%) in the polymer-free drug-coated stent group (risk difference, 0.2 percentage points; upper boundary of the one-sided 97.5% CI, 3.5; noninferiority margin, 4.4; P = 0.007 for noninferiority).

Conclusions: Among patients at high bleeding risk who received 1 month of dual antiplatelet therapy after PCI, use of polymer-based zotarolimus-eluting stents was noninferior to use of polymer-free drug-coated stents with regard to safety and effectiveness composite outcomes. (Funded by Medtronic; ONYX ONE ClinicalTrials.gov number, NCT03344653.).
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http://dx.doi.org/10.1056/NEJMoa1910021DOI Listing
March 2020

Smoking status and mortality outcomes following percutaneous coronary intervention.

Eur J Prev Cardiol 2020 Feb 3:2047487320902325. Epub 2020 Feb 3.

Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK.

Objective: The aim of this study was to assess the impact of smoking on short (30-day) and intermediate (30-day to 6-month) mortality following percutaneous coronary intervention (PCI).

Background: The effect of smoking on mortality post-PCI is lacking in the modern PCI era.

Methods: This was a retrospective analysis of prospectively collected data comparing short- and intermediate-term mortality amongst smokers, ex-smokers and non-smokers.

Results: The study cohort consisted of 12,656 patients: never-smokers ( = 4288), ex-smokers ( = 4806) and current smokers ( = 3562). The mean age (±standard deviation) was 57 (±11) years in current smokers compared with 67 (±11) in ex-smokers and 67 (±12) in never-smokers;  < 0.0001. PCI was performed for acute coronary syndrome (ACS) in 84.1% of current smokers, 57% of ex-smokers and 62.9% in never-smokers;  < 0.0001. In a logistic regression model, the adjusted odds ratios (95% confidence intervals (CIs)) for 30-day mortality were 1.60 (1.10-2.32) in current smokers and 0.98 (0.70-1.38) in ex-smokers compared with never-smokers. In the Cox proportional hazard model, the adjusted hazard ratios (95% CI) for mortality between 30 days and 6 months were 1.03 (0.65-1.65) in current smokers and 1.19 (0.84-1.67) in ex-smokers compared with never-smokers.

Conclusion: This large observational study of non-selected patients demonstrates that ex-smokers and never-smokers are of similar age at first presentation to PCI, and there is no short- or intermediate-term mortality difference between them following PCI. Current smokers undergo PCI at a younger age, more often for ACS, and have higher short-term mortality. These findings underscore the public message on the benefits of smoking cessation and the harmful effects of smoking.
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http://dx.doi.org/10.1177/2047487320902325DOI Listing
February 2020

DyeVert™ PLUS EZ System for Preventing Contrast-Induced Acute Kidney Injury in Patients Undergoing Diagnostic Coronary Angiography and/or Percutaneous Coronary Intervention: A UK-Based Cost-Utility Analysis.

Pharmacoecon Open 2020 Sep;4(3):459-472

Leeds Teaching Hospitals NHS Trust, Leeds, UK.

Background: Contrast-induced acute kidney injury (CI-AKI) is a complication commonly associated with invasive angiographic procedures and is considered the leading cause of hospital-acquired acute kidney injury. CI-AKI can lead to a prolonged hospital stay, with a substantial economic impact, and increased mortality. The DyeVert™ PLUS EZ system (FDA approved and CE marked) is a device that has been developed to divert a portion of the theoretical injected contrast media volume (CMV), reducing the overall volume of contrast media injected and aortic reflux, and potentially improving long-term health outcomes.

Objectives: To assess the long-term costs and health outcomes associated with the introduction of the DyeVert™ PLUS EZ system into the UK health care service for the prevention of CI-AKI in a cohort of patients with chronic kidney disease (CKD) stage 3-4 undergoing diagnostic coronary angiography (DAG) and/or percutaneous coronary intervention (PCI), and to compare these costs and outcomes with those of the current practice.

Methods: A de novo economic model was developed based on the current pathway of managing patients undergoing DAG and/or PCI and on evidence related to the clinical effectiveness of DyeVert™ in terms of its impact on relevant clinical outcomes and health service resource use. Clinical data used to populate the model were derived from the literature or were based on assumptions informed by expert clinical input. Costs included in the model were from the NHS and personal social services perspective and obtained from the literature and UK-based routine sources. Probabilistic distributions were assigned to the majority of model parameters so that a probabilistic analysis could be undertaken, while deterministic sensitivity analyses were also carried out to explore the impact of key parameter variation on the model results.

Results: Base-case results indicate that the intervention leads to cost savings (- £435) and improved effectiveness (+ 0.028 QALYs) over the patient's lifetime compared with current practice. Output from the probabilistic analysis points to a high likelihood of the intervention being cost-effective across presented willingness-to-pay (WTP) thresholds. The overall long-term cost saving for the NHS associated with the introduction of the DyeVert™ PLUS EZ system is over £19.7 million for each annual cohort of patients. The cost savings are mainly driven by a lower risk of subsequent diseases and their associated costs.

Conclusions: The introduction of the DyeVert™ PLUS EZ system has the potential to reduce costs for the health care service and yield improved clinical outcomes for patients with CKD stage 3-4 undergoing angiographic procedures.
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http://dx.doi.org/10.1007/s41669-020-00195-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7426357PMC
September 2020

Impact of established cardiovascular disease on outcomes in the randomized global leaders trial.

Catheter Cardiovasc Interv 2020 Dec 19;96(7):1369-1378. Epub 2019 Dec 19.

Department of Cardiology, National University of Ireland Galway, Galway, Ireland.

Objective: To investigate the impact of different anti-platelet strategies on outcomes after percutaneous coronary intervention (PCI) in patients with established cardiovascular disease (CVD).

Methods: GLOBAL LEADERS was a randomized, superiority, all-comers trial comparing one-month dual anti-platelet therapy (DAPT) with ticagrelor and aspirin followed by 23-month ticagrelor monotherapy (experimental treatment) with standard 12-month DAPT followed by 12-month aspirin monotherapy (reference treatment) in patients treated with a biolimus A9-eluting stent. Established CVD was defined as ≥1 prior myocardial infarction, PCI, coronary artery bypass operation, stroke, or established peripheral vascular disease. The primary endpoint was a composite of all-cause death or new Q-wave MI at 2-years. The secondary safety endpoint was BARC 3 or 5 bleeding. Exploratory secondary endpoints were the patient-orientated composite endpoint and net adverse clinical events.

Results: Among the 15,761 patients in this cohort were 6,693 patients (42.5%) with established CVD. Compared to those without established CVD, these patients had significantly higher rates of the primary (5.1 vs. 3.3%, HR1.59[1.36-1.86], p < .001) and secondary composite endpoints with no significant differences in bleeding. There was a nonsignificant reduction in the primary endpoint in patients with established CVD receiving the experimental treatment (4.6 vs. 5.6%, HR0.82[0.66-1.02], p = .07). When comparing patients without CVD to those with one or three territories of CVD, the hazard ratio for the primary endpoint increased in unadjusted and adjusted models.

Conclusions: The poorer outcomes in patients with established CVD are not mitigated by prolonged monotherapy with a potent P2Y12 inhibitor suggesting a greater need to focus on modifiable risk factors.
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http://dx.doi.org/10.1002/ccd.28649DOI Listing
December 2020

Outcomes of Direct Flow Medical vs Sapien 3 Transcatheter Aortic Valve Devices.

J Cardiovasc Transl Res 2020 10 17;13(5):790-795. Epub 2019 Dec 17.

Cardiothoracic Centre, Freeman Hospital, Freeman Rd, High Heaton, Newcastle upon Tyne, NE7 7DN, UK.

This retrospective study was aimed to compare the safety and efficacy of the Direct Flow Medical (DFM) valve with the more established Sapien 3 (S3) valve in transfemoral TAVI in high-risk aortic stenosis (AS) patients. Between February 2014 and August 2016, 99 and 68 patients had the S3 and DFM valves at our center, respectively. The device success rate was statistically similar among the S3 and DFM groups (p = 0.15). The overall post-procedural complication rate was similar between the two groups (p = 0.4). The procedural time was significantly shorter in the S3 group (p < 0.001) and the post-procedure peak pressure gradient (p < 0.001) was significantly higher in the DFM group. However, the frequency of valvular or paravalvular leaks was similar between both valve groups. We found no significant differences in terms of safety between the DFM and S3 valves. This study confirms the safety and efficacy of the DFM valve in high-risk AS patients.
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http://dx.doi.org/10.1007/s12265-019-09948-4DOI Listing
October 2020

Sample Timing, Diagnosis of Subclinical Thyroid Dysfunction and Mortality in Acute Myocardial Infarction: ThyrAMI1 Study.

J Clin Endocrinol Metab 2020 04;105(4)

Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.

Objective: The objective of this study was to determine the impact of blood sample timing on the diagnosis of subclinical thyroid dysfunction (SCTD) and mortality in patients with acute myocardial infarction (AMI).

Patients, Design, And Main Outcome Measures: Patients with AMI had thyroid function evaluated on admission between December 2014 and December 2016 and those with abnormal serum thyrotropin (TSH) had repeat thyroid function assessed at least a week later. The association between sample timing and SCTD was evaluated by logistic regression analysis. Secondary outcomes were confirmation of SCTD on repeat testing and all-cause mortality up to June 2018.

Results: Of the 1806 patients [29.2% women, mean (± standard deviation) age of 64.2 (±12.1) years] analyzed, the prevalence of subclinical hypothyroidism (SCH) was 17.2% (n = 311) and subclinical hyperthyroidism (SHyper) was 1.2% (n = 22) using a uniform TSH reference interval. The risk of being diagnosed with SCTD varied by sample timing in fully-adjusted models. The risk of SCH was highest between 00.01 and 06.00 hours and lowest between 12.01 and 18.00 hours, P for trend <.001, and risk of SHyper was highest between 12.01 hours and 18.00 hours and lowest between 00.01 hours and 06.00 hours. Furthermore, time of the initial sample was associated with the risk of remaining in a SCH state subsequently. Mortality in SCH patients was not elevated when a uniform TSH reference interval was utilized. However, when time period-specific TSH reference ranges were utilized, the mortality risk was significantly higher in SCH patients with HR (95% CI) of 2.26 (1.01-5.19), P = .04.

Conclusions: Sample timing impacts on the diagnosis and prognosis of SCH in AMI patients. If sample timing is not accounted for, SCH is systemically misclassified, and its measurable influence on mortality is lost.
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http://dx.doi.org/10.1210/clinem/dgz143DOI Listing
April 2020

Outcomes Following Percutaneous Coronary Intervention in Saphenous Vein Grafts With and Without Embolic Protection Devices.

JACC Cardiovasc Interv 2019 11;12(22):2286-2295

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute for Primary Care and Health Sciences, Keele University, Stoke-on-Trent, United Kingdom. Electronic address:

Objectives: The aim of this study was to describe the early (inpatient and 30-day) and late (1-year) outcomes of percutaneous coronary intervention (PCI) in saphenous vein grafts (SVGs), with and without the use of embolic protection devices (EPD), in a large, contemporary, unselected national cohort from the database of the British Cardiovascular Intervention Society.

Background: There are limited, and discrepant, data on the clinical benefits of the adjunctive use of EPDs during PCI to SVGs in the contemporary era.

Methods: A longitudinal cohort of patients (2007 to 2014, n = 20,642) who underwent PCI to SVGs in the British Cardiovascular Intervention Society database was formed. Clinical, demographic, procedural, and outcome data were analyzed by dividing into 2 groups: no EPD (PCI to SVGs without EPDs, n = 17,730) and EPD (PCI to SVGs with EPDs, n = 2,912).

Results: Patients in the EPD group were older, had more comorbidities, and had a higher prevalence of moderate to severe left ventricular systolic dysfunction. Mortality was lower in the EPD group during hospital admission (0.70% vs. 1.29%; p = 0.008) and at 30 days (1.44% vs. 2.01%; p = 0.04) but similar at 1 year (6.22% vs. 6.01%; p = 0.67). Following multivariate analyses, no significant difference in mortality was observed during index admission (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.42 to 1.19; p = 0.19), at 30 days (OR: 0.87; 95% CI: 0.60 to 1.25; p = 0.45), and at 1 year (OR: 0.92; 95% CI: 0.77 to 1.11; p = 0.41), along with similar rates of in-hospital major adverse cardiovascular events (OR: 1.16; 95% CI: 0.83 to 1.62; p = 0.39) and stroke (OR: 0.68; 95% CI: 0.20 to 2.35; p = 0.54). In propensity score-matched analyses, lower inpatient mortality was observed in the EPD group (OR: 0.46; 95% CI: 0.13 to 0.80; p = 0.002), although the adjusted risk for the periprocedural no-reflow or slow-flow phenomenon was higher in patients in whom EPDs were used (OR: 2.16; 95% CI: 1.71 to 2.73; p < 0.001).

Conclusions: In this contemporary cohort, EPDs were used more commonly in higher risk patients but were associated with similar clinical outcomes in multivariate analyses. Lower inpatient mortality was observed in the EPD group in univariate and propensity score-matched analyses.
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http://dx.doi.org/10.1016/j.jcin.2019.08.037DOI Listing
November 2019

Ascertainment of Silent Myocardial Infarction in Patients Undergoing Percutaneous Coronary Intervention (from the GLOBAL LEADERS Trial).

Am J Cardiol 2019 12 26;124(12):1833-1840. Epub 2019 Sep 26.

Department of Cardiology, Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands; Cardialysis B.V., Rotterdam, the Netherlands.

Q-wave myocardial infarction (QWMI) comprises 2 entities. First, a clinically evident MI, which can occur spontaneously or be related to a coronary procedure. Second, silent MI which is incidentally detected on serial electrocardiographic (ECG) assessment. The prevalence of silent MI after percutaneous coronary intervention (PCI) in the drug-eluting stent era has not been fully investigated. The GLOBAL LEADERS is an all-comers multicenter trial which randomized 15,991 patients who underwent PCI to 2 antiplatelet treatment strategies. The primary end point was a composite of all-cause death or nonfatal new QWMI at 2-years follow-up. ECGs were collected at discharge, 3-month and 2-year visits, and analyzed by an independent ECG core laboratory following the Minnesota code. All new QWMI were further reviewed by a blinded independent cardiologist to identify a potential clinical correlate by reviewing clinical information. Of 15,968 participants, ECG information was complete in 14,829 (92.9%) at 2 years. A new QWMI was confirmed in 186 (1.16%) patients. Transient new Q-waves were observed in 28.5% (53 of 186) of them during the follow-up. The majority of new QWMI (78%, 146 of 186) were classified as silent MI due to the absence of a clinical correlate. Silent MI accounted for 22.1% (146 of 660) of all MI events. The prevalence of silent MI did not differ significantly between treatment strategies (experimental vs reference: 0.88% vs 0.98%, p = 0.5027). In conclusion, we document the prevalence of silent MI in an all-comers population undergoing PCI in this large-scale randomized trial.
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http://dx.doi.org/10.1016/j.amjcard.2019.08.049DOI Listing
December 2019

Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months' results from the S-FLEX UK registry.

BMJ Open 2019 10 11;9(10):e026578. Epub 2019 Oct 11.

Freeman Hospital, Newcastle Upon Tyne, UK

Objective: To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in 'real world' patient population requiring percutaneous coronary intervention (PCI).

Methods: National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months-overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE-composite of cardiac death, MI, emergent or repeat revascularisation).

Results: At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).

Conclusions: The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.
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http://dx.doi.org/10.1136/bmjopen-2018-026578DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6797413PMC
October 2019

Percutaneous Coronary Intervention and Outcomes in Patients With Lymphoma in the United States (Nationwide Inpatient Sample [NIS] Analysis).

Am J Cardiol 2019 10 24;124(8):1190-1197. Epub 2019 Jul 24.

Keele Cardiovascular Research Group, Centre for Prognosis Research, Institute of Primary Care and Health Sciences, Keele University, United Kingdom; Department of Cardiology, Royal Stoke Hospital, University Hospital North Midlands, Stoke-on-Trent, United Kingdom. Electronic address:

Characteristics and outcomes of patients with lymphoma undergoing percutaneous coronary intervention (PCI) are unknown. Therefore, we analyzed clinical characteristics and outcomes in patients that underwent PCI and had a concomitant diagnosis of Hodgkin's (HL) or non-Hodgkin's (NHL) lymphoma. We analyzed patients with and without lymphoma diagnosis from the Nationwide Inpatient Sample in the United States who underwent PCI procedure during 2004 to 2014. Multivariable regression analysis was performed to examine the association between lymphoma diagnosis and clinical outcomes post-PCI including short-term complications and in-hospital mortality. A total of 7,119,539 PCI procedures were included in the analysis and 18,052 patients had a diagnosis of lymphoma (0.25%). These patients were likely to experience in-hospital mortality (odds ratio [OR] 1.39, 95% confidence interval [CI] 1.25 to 1.54), stroke or transient ischemic attack (OR 1.75, 95% CI 1.61 to 1.90), and any in-hospital complication (OR 1.31, 95% CI 1.25 to 1.37), following PCI. In the lymphoma subtype-analysis, diagnosis of HL was associated with an increased odds of in-hospital death (OR 1.40, 95% CI 1.24 to 1.56), any in-hospital complication (OR 1.31, 95% CI 1.25 to 1.38), bleeding complications (OR 1.12 95% CI 1.05 to 1.20), and vascular complications (OR 1.13 95% CI 1.06 to 1.20) whereas these odds were not significantly associated with non-Hodgkin's diagnosis. Finally, both types of lymphoma were associated with increased odds of stroke/transient ischemic attack following PCI (OR 1.82, 95% CI 1.67 to 1.99 and OR 1.31, 95% CI 1.05 to 1.63, respectively). In conclusion, while the prevalence of lymphoma in the observed PCI cohort was low, a diagnosis of lymphoma was associated with an adverse prognosis following PCI, primarily in patients with the HL diagnosis.
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http://dx.doi.org/10.1016/j.amjcard.2019.07.015DOI Listing
October 2019

Rationale and design of the Onyx ONE global randomized trial: A randomized controlled trial of high-bleeding risk patients after stent placement with 1 month of dual antiplatelet therapy.

Am Heart J 2019 08 6;214:134-141. Epub 2019 May 6.

Department of Cardiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.

Background And Rationale: Polymer-free drug-eluting stent (DES) implantation in combination with 1-month dual antiplatelet therapy (DAPT) has shown superior safety and efficacy outcomes compared with bare-metal stents among patients with high-bleeding risk (HBR) treated with 1-month DAPT. The safety and efficacy of the newer-generation durable-polymer DES Resolute Onyx compared with polymer-free DES among HBR patients treated with 1-month DAPT is unknown.

Trial Design: The Onyx ONE global randomized trial is an international, prospective, randomized, blinded, controlled study enrolling HBR patients undergoing percutaneous coronary intervention. The trial will randomize up to 2,000 patients in a 1:1 fashion to receive either the durable-polymer Resolute Onyx DES or the polymer-free Biosensors BioFreedom DES. After index procedure, patients in both arms will be treated with 1 month of DAPT (aspirin and oral P2Y12 inhibitor), followed by single antiplatelet therapy thereafter. The primary end point is the composite end point of cardiac death, myocardial infarction, or stent thrombosis at 1-year follow-up. The powered secondary end point is target lesion failure (defined as the composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization) at 1 year. Patient follow-up is planned for 1, 2, and 6 months and 1 and 2 years after the procedure.

Conclusions: The Onyx ONE global randomized trial is the first study to directly compare the safety and efficacy of a durable polymer DES (Resolute Onyx) with a polymer-free DES (BioFreedom) in HBR patients treated with 1 month of DAPT.
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http://dx.doi.org/10.1016/j.ahj.2019.04.017DOI Listing
August 2019