Publications by authors named "Rasha Al-Lamee"

89 Publications

IMPACT OF THE PLACEBO EFFECT ON SYMPTOMS, QUALITY OF LIFE AND FUNCTIONAL OUTCOMES IN ANGINA PECTORIS: A meta-analysis of randomized placebo-controlled trials.

Can J Cardiol 2021 May 8. Epub 2021 May 8.

Division of Cardiology, Department of Internal Medicine, Città della Salute e della Scienza, Torino.

Background: The placebo effect is a well described phenomenon in blinded studies evaluating anti-anginal therapeutics, although its impact on clinical research metrics remains unknown. We conducted a systematic review and meta-analysis to quantify the impact of placebo on endpoints of symptoms, life-quality and functional outcomes in randomized placebo-controlled trials (RCTs) of symptomatic stable coronary artery disease.

Methods: We systematically reviewed MEDLINE, EMBASE, and the Cochrane database for double-blind RCTs of anti-angina therapeutics. Patients randomized to the placebo-arm were the study population. Main outcomes were the changes in exercise performance (exercise treadmill test [ETT] parameters), quality of life (Seattle Angina Questionnaire domains), symptoms (Canadian Cardiovascular Society angina class) and drug usage (nitroglycerin tabs/week) between baseline and following placebo. The primary outcome was ETT total duration time. Data were pooled with a random effect model.

Results: Seventy-eight RCTs (83% drug-controlled, 17% procedure-controlled) were included encompassing 4,925 patients randomized to placebo. ETT total duration time was significantly improved following placebo as compared to baseline (mean [95% confidence interval]: 29.2 [20.6-37.8] seconds) with evidence of high heterogeneity (I 2 = 98%) At subgroup analysis, crossover design was associated with a smaller placebo effect on ETT performance than parallel study design (p for interaction=0.001). A significant placebo effect was observed for all secondary outcomes with overall high heterogeneity.

Conclusion: A substantial placebo effect was present in angina RCTs across a variety of functional and life-quality metrics. High variability in placebo effect size was present, mostly unexplained by differences in study and patient characteristics (PROSPERO CRD42019132797).
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http://dx.doi.org/10.1016/j.cjca.2021.04.022DOI Listing
May 2021

Reusable snorkel masks adapted as particulate respirators.

PLoS One 2021 5;16(4):e0249201. Epub 2021 Apr 5.

National Heart and Lung Institute, Imperial College London, London, United Kingdom.

Introduction: During viral pandemics, filtering facepiece (FFP) masks together with eye protection form the essential components of personal protective equipment (PPE) for healthcare workers. There remain concerns regarding insufficient global supply and imperfect protection offered by currently available PPE strategies. A range of full-face snorkel masks were adapted to accept high grade medical respiratory filters using bespoke-designed 3D-printed connectors. We compared the protection offered by the snorkel to that of standard PPE using a placebo-controlled respirator filtering test as well as a fluorescent droplet deposition experiment. Out of the 56 subjects tested, 42 (75%) passed filtering testing with the snorkel mask compared to 31 (55%) with a FFP3 respirator mask (p = 0.003). Amongst the 43 subjects who were not excluded following a placebo control, 85% passed filtering testing with the snorkel versus to 68% with a FFP3 mask (p = 0.008). Following front and lateral spray of fluorescence liquid particles, the snorkel mask also provided superior protection against droplet deposition within the subject's face, when compared to a standard PPE combination of FFP3 masks and eye protection (3.19x108 versus 6.81x108 fluorescence units, p<0.001). The 3D printable adaptors are available for free download online at https://www.ImperialHackspace.com/COVID-19-Snorkel-Respirator-Project/.

Conclusion: Full-face snorkel masks adapted as particulate respirators performed better than a standard PPE combination of FFP3 mask and eye protection against aerosol inhalation and droplet deposition. This adaptation is therefore a promising PPE solution for healthcare workers during highly contagious viral outbreaks.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249201PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8021169PMC
April 2021

Optimising physiological endpoints of percutaneous coronary intervention.

EuroIntervention 2021 Apr 2;16(18):e1470-e1483. Epub 2021 Apr 2.

National Heart and Lung Institute, Imperial College London, London, United Kingdom.

Invasive coronary physiology to select patients for coronary revascularisation has become established in contemporary guidelines for the management of stable coronary artery disease. Compared to revascularisation based on angiography alone, the use of coronary physiology has been shown to improve clinical outcomes and cost efficiency. However, recent data from randomised controlled trials have cast doubt upon the value of ischaemia testing to select patients for revascularisation. Importantly, 20-40% of patients have persistence or recurrence of angina after angiographically successful percutaneous coronary intervention (PCI). This state-of-the-art review is focused on the transitioning role of invasive coronary physiology from its use as a dichotomous test for ischaemia with fixed cut-points, towards its utility for real-time guidance of PCI to optimise physiological results. We summarise the contemporary evidence base for ischaemia testing in stable coronary artery disease, examine emerging indices which allow advanced physiological guidance of PCI, and discuss the rationale and evidence base for post-PCI physiological assessments to assess the success of revascularisation.
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http://dx.doi.org/10.4244/EIJ-D-20-00988DOI Listing
April 2021

Controversies in revascularisation for stable coronary artery disease.

Clin Med (Lond) 2021 03;21(2):114-118

National Heart and Lung Institute, London, UK and Hammersmith Hospital, London, UK.

Recent randomised controlled trials, such as ISCHEMIA and ORBITA, have overturned most of what we were taught in medical school about hospital procedures considered necessary for patients with stable coronary artery disease. In this article, we discuss what these trials mean for physicians and patients considering revascularisation procedures with the hope of reducing the risk of death or alleviating angina.
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http://dx.doi.org/10.7861/clinmed.2020-0922DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8002764PMC
March 2021

COVID-19 and its impact on the cardiovascular system.

Open Heart 2021 03;8(1)

Cardiology, Imperial College Healthcare NHS Trust, London, UK.

Objectives: The clinical impact of SARS-CoV-2 has varied across countries with varying cardiovascular manifestations. We review the cardiac presentations, in-hospital outcomes and development of cardiovascular complications in the initial cohort of SARS-CoV-2 positive patients at Imperial College Healthcare National Health Service Trust, UK.

Methods: We retrospectively analysed 498 COVID-19 positive adult admissions to our institute from 7 March to 7 April 2020. Patient data were collected for baseline demographics, comorbidities and in-hospital outcomes, especially relating to cardiovascular intervention.

Results: Mean age was 67.4±16.1 years and 62.2% (n=310) were male. 64.1% (n=319) of our cohort had underlying cardiovascular disease (CVD) with 53.4% (n=266) having hypertension. 43.2%(n=215) developed acute myocardial injury. Mortality was significantly increased in those patients with myocardial injury (47.4% vs 18.4%, p<0.001). Only four COVID-19 patients had invasive coronary angiography, two underwent percutaneous coronary intervention and one required a permanent pacemaker implantation. 7.0% (n=35) of patients had an inpatient echocardiogram. Acute myocardial injury (OR 2.39, 95% CI 1.31 to 4.40, p=0.005) and history of hypertension (OR 1.88, 95% CI 1.01 to 3.55, p=0.049) approximately doubled the odds of in-hospital mortality in patients admitted with COVID-19 after other variables had been controlled for.

Conclusion: Hypertension, pre-existing CVD and acute myocardial injury were associated with increased in-hospital mortality in our cohort of COVID-19 patients. However, only a low number of patients required invasive cardiac intervention.
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http://dx.doi.org/10.1136/openhrt-2020-001472DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7969760PMC
March 2021

Non ST-elevation myocardial infarction (NSTEMI) patients with total coronary artery occlusion: More than meets the eye.

Int J Cardiol 2021 06 27;333:52. Epub 2021 Feb 27.

Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UK.

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http://dx.doi.org/10.1016/j.ijcard.2021.02.058DOI Listing
June 2021

Achieving optimal adherence to medical therapy by telehealth: Findings from the ORBITA medication adherence sub-study.

Pharmacol Res Perspect 2021 02;9(1):e00710

Department of Chemical Pathology and Metabolic Diseases, University Hospitals of Leicester, Leicester, UK.

Introduction: The ORBITA trial of percutaneous coronary intervention (PCI) versus a placebo procedure for patients with stable angina was conducted across six sites in the United Kingdom via home monitoring and telephone consultations. Patients underwent detailed assessment of medication adherence which allowed us to measure the efficacy of the implementation of the optimization protocol and interpretation of the main trial endpoints.

Methods: Prescribing data were collected throughout the trial. Self-reported adherence was assessed, and urine samples collected at pre-randomization and at follow-up for direct assessment of adherence using high-performance liquid chromatography with tandem mass spectrometry (HPLC MS/MS).

Results: Self-reported adherence was >96% for all drugs in both treatment groups at both stages. The percentage of samples in which drug was detected at pre-randomization and at follow-up in the PCI versus placebo groups respectively was: clopidogrel, 96% versus 90% and 98% versus 94%; atorvastatin, 95% versus 92% and 92% versus 91%; perindopril, 95% versus 97% and 85% versus 100%; bisoprolol, 98% versus 99% and 96% versus 97%; amlodipine, 99% versus 99% and 94% versus 96%; nicorandil, 98% versus 96% and 94% versus 92%; ivabradine, 100% versus 100% and 100% versus 100%; and ranolazine, 100% versus 100% and 100% versus 100%.

Conclusions: Adherence levels were high throughout the study when quantified by self-reporting methods and similarly high proportions of drug were detected by urinary assay. The results indicate successful implementation of the optimization protocol delivered by telephone, an approach that could serve as a model for treatment of chronic conditions, particularly as consultations are increasingly conducted online.
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http://dx.doi.org/10.1002/prp2.710DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7876856PMC
February 2021

Cost-effectiveness analysis of percutaneous coronary intervention for single-vessel coronary artery disease: an economic evaluation of the ORBITA trial.

BMJ Open 2021 02 9;11(2):e044054. Epub 2021 Feb 9.

Australian Centre for Health Services Innovation (AusHSI) and Centre for Healthcare Transformation, Queensland University of Technology (QUT), Brisbane, Queensland, Australia

Objective: To evaluate the cost-effectiveness of percutaneous coronary intervention (PCI) compared with placebo in patients with single-vessel coronary artery disease and angina despite anti-anginal therapy.

Design: A cost-effectiveness analysis comparing PCI with placebo. A Markov model was used to measure incremental cost-effectiveness, in cost per quality-adjusted life-years (QALYs) gained, over 12 months. Health utility weights were estimated using responses to the EuroQol 5-level questionnaire, from the Objective Randomised Blinded Investigation with optimal medical Therapy of Angioplasty in stable angina trial and UK preference weights. Costs of procedures and follow-up consultations were derived from Healthcare Resource Group reference costs and drug costs from the National Health Service (NHS) drug tariff. Probabilistic sensitivity analysis was undertaken to test the robustness of results to parameter uncertainty. Scenario analyses were performed to test the effect on results of reduced pharmaceutical costs in patients undergoing PCI, and the effect of patients crossing over from placebo to PCI due to refractory angina within 12 months.

Setting: Five UK NHS hospitals.

Participants: 200 adult patients with stable angina and angiographically severe single-vessel coronary artery disease on anti-anginal therapy.

Interventions: At recruitment, patients received 6 weeks of optimisation of medical therapy for angina after which they were randomised to PCI or a placebo procedure.

Outcome Measures: Incremental cost-effectiveness ratio (ICER) expressed as cost (in £) per QALY gained for PCI compared with placebo.

Results: The estimated ICER is £90 218/QALY gained when using PCI compared with placebo in patients receiving medical treatment for angina due to single-vessel coronary artery disease. Results were robust under sensitivity analyses.

Conclusions: The ICER for PCI compared with placebo, in patients with single-vessel coronary artery disease and angina on anti-anginal medication, exceeds the threshold of £30 000 used by the National Institute of Health and Care Excellence when undertaking health technology assessment for the NHS context. The ORBITA study is registered with ClinicalTrials.gov, number NCT02062593.
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http://dx.doi.org/10.1136/bmjopen-2020-044054DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7875263PMC
February 2021

Randomized blinded placebo-controlled trials of renal sympathetic denervation for hypertension: A meta-analysis.

Cardiovasc Revasc Med 2021 Jan 30. Epub 2021 Jan 30.

National Heart and Lung Institute, Imperial College London, London, United Kingdom.

Background: The efficacy of renal denervation has been controversial, but the procedure has now undergone several placebo-controlled trials. New placebo-controlled trial data has recently emerged, with longer follow-up of one trial and the full report of another trial (which constitutes 27% of the total placebo-controlled trial data). We therefore sought to evaluate the effect of renal denervation on ambulatory and office blood pressures in patients with hypertension.

Methods: We systematically identified all blinded placebo-controlled randomized trials of catheter-based renal denervation for hypertension. The primary efficacy outcome was ambulatory systolic blood pressure change relative to placebo. A random-effects meta-analysis was performed.

Results: 6 studies randomizing 1232 patients were eligible. 713 patients were randomized to renal denervation and 519 to placebo. Renal denervation significantly reduced ambulatory systolic blood pressure (-3.52 mmHg; 95% CI -4.94 to -2.09; p < 0.0001), ambulatory diastolic blood pressure (-1.93 mmHg; 95% CI -3.04 to -0.83, p = 0.0006), office systolic blood pressure size (-5.10 mmHg; 95% CI -7.31 to -2.90, p < 0.0001) and office diastolic pressure (effect size -3.11 mmHg; 95% CI -4.43 to -1.78, p < 0.0001). Adverse events were rare and not more common with denervation.

Conclusions: The totality of blinded, randomized placebo-controlled data shows that renal denervation is safe and provides genuine reduction in blood pressure for at least 6 months post-procedure. If this effect continues in the long term, renal denervation might provide a life-long 10% relative risk reduction in major adverse cardiac events and 7.5% relative risk reduction in all-cause mortality.
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http://dx.doi.org/10.1016/j.carrev.2021.01.031DOI Listing
January 2021

Achieving Optimal Medical Therapy: Insights From the ORBITA Trial.

J Am Heart Assoc 2021 Feb 26;10(3):e017381. Epub 2021 Jan 26.

National Heart and Lung InstituteImperial College London London UK.

Background In stable coronary artery disease, medications are used for 2 purposes: cardiovascular risk reduction and symptom improvement. In clinical trials and clinical practice, medication use is often not optimal. The ORBITA (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina) trial was the first placebo-controlled trial of percutaneous coronary intervention. A key component of the ORBITA trial design was the inclusion of a medical optimization phase, aimed at ensuring that all patients were treated with guideline-directed truly optimal medical therapy. In this study, we report the medical therapy that was achieved. Methods and Results After enrollment into the ORBITA trial, all 200 patients entered a 6-week period of intensive medical therapy optimization, with initiation and uptitration of risk reduction and antianginal therapy. At the prerandomization stage, the median number of antianginals established was 3 (interquartile range, 2-4). A total of 195 patients (97.5%) reached the prespecified target of ≥2 antianginals; 136 (68.0%) did not stop any antianginals because of adverse effects, and the median number of antianginals stopped for adverse effects per patient was 0 (interquartile range, 0-1). Amlodipine and bisoprolol were well tolerated (stopped for adverse effects in 4/175 [2.3%] and 9/167 [5.4%], respectively). Ranolazine and ivabradine were also well tolerated (stopped for adverse effects in 1/20 [5.0%] and 1/18 [5.6%], respectively). Isosorbide mononitrate and nicorandil were stopped for adverse effects in 36 of 172 (20.9%) and 32 of 141 (22.7%) of patients, respectively. Statins were well tolerated and taken by 191 of 200 (95.5%) patients. Conclusions In the 12-week ORBITA trial period, medical therapy was successfully optimized and well tolerated, with few drug adverse effects leading to therapy cessation. Truly optimal medical therapy can be achieved in clinical trials, and translating this into longer-term clinical practice should be a focus of future study. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT02062593.
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http://dx.doi.org/10.1161/JAHA.120.017381DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955412PMC
February 2021

Instantaneous wave-free ratio guided multivessel revascularisation during percutaneous coronary intervention for acute myocardial infarction: study protocol of the randomised controlled iMODERN trial.

BMJ Open 2021 01 15;11(1):e044035. Epub 2021 Jan 15.

Cardiology, Radboudumc, Nijmegen, The Netherlands

Introduction: Recent randomised clinical trials showed benefit of non-culprit lesion revascularisation in ST-elevation myocardial infarction (STEMI) patients. However, it remains unclear whether revascularisation should be performed at the index procedure or at a later stage.

Methods And Analysis: The instantaneous wave-free ratio (iFR) Guided Multivessel Revascularisation During Percutaneous Coronary Intervention for Acute Myocardial Infarction trial is a multicentre, randomised controlled prospective open-label trial with blinded evaluation of endpoints. After successful primary percutaneous coronary intervention (PCI), eligible STEMI patients with residual non-culprit lesions are randomised, to instantaneous wave-free ratio guided treatment of non-culprit lesions during the index procedure versus deferred cardiac MR-guided management within 4 days to 6 weeks. The primary endpoint of the study is the combined occurrence of all-cause death, recurrent myocardial infarction and hospitalisation for heart failure at 12 months follow-up. Clinical follow-up includes questionnaires at 3 months and outpatient visits at 6 months and 12 months after primary PCI. Furthermore, a cost-effectiveness analysis will be performed.

Ethics And Dissemination: Permission to conduct this trial has been granted by the Medical Ethical Committee of the Amsterdam University Medical Centres (loc. VUmc, ID NL60107.029.16). The primary results of this trial will be shared in a main article and subgroup analyses or spin-off studies will be shared in secondary papers.

Trial Registration Number: NCT03298659.
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http://dx.doi.org/10.1136/bmjopen-2020-044035DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813313PMC
January 2021

Adapting the role of handheld echocardiography during the COVID-19 pandemic: A practical guide.

Perfusion 2021 Jan 9:267659120986532. Epub 2021 Jan 9.

Department of Cardiology, Imperial College Healthcare NHS Foundation Trust, London, UK.

The COVID-19 pandemic has altered our approach to inpatient echocardiography delivery. There is now a greater focus to address key clinical questions likely to make an immediate impact in management, particularly during the period of widespread infection. Handheld echocardiography (HHE) can be used as a first-line assessment tool, limiting scanning time and exposure to high viral load. This article describes a potential role for HHE during a pandemic. We propose a protocol with a reporting template for a focused core dataset necessary in delivering an acute echocardiography service in the setting of a highly contagious disease, minimising risk to the operator. We cover the scenarios typically encountered in the acute cardiology setting and how an expert trained echocardiography team can identify such pathologies using a limited imaging format and include cardiac presentations encountered in those patients acutely unwell with COVID-19.
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http://dx.doi.org/10.1177/0267659120986532DOI Listing
January 2021

Total coronary occlusion in non ST elevation myocardial infarction: Time to change our practice?

Int J Cardiol 2021 04 4;329:1-8. Epub 2021 Jan 4.

Molecular and Clinical Sciences Research Institute, St George's, University of London, London, UK.

Based on 12‑lead electrocardiogram (ECG) findings, myocardial infarction (MI) patients are dichotomized to ST-elevation MI (STEMI) and non ST-elevation MI (NSTEMI) in terms of management strategy. NSTEMI patients are increasing in numbers worldwide, among which an approximately 30% are associated with a total occlusion of a coronary artery. This review summarizes recent evidence in epidemiology, clinical, laboratory, ECG and prognostic characteristics of this NSTEMI sub-group. Patients with a diagnosis of NSTEMI and a total occluded coronary artery (TOCA) represent a sub-group of NSTEMI patients with total occlusion of coronary arteries and associated high-risk that are frequently not managed according to a STEMI-like pathway. The present review echoes a call for action in changing our everyday clinical practice. Therefore, we propose a new triage algorithm by which recognition of high-risk features in NSTEMI patients is central in order to identify STEMI 'equivalents' among NSTEMI patients in terms of similar pathology and high-risk who may benefit from immediate invasive strategy (<2 h).
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http://dx.doi.org/10.1016/j.ijcard.2020.12.082DOI Listing
April 2021

Management of Acute Coronary Syndromes During the Coronavirus Disease 2019 Pandemic: Deviations from Guidelines and Pragmatic Considerations for Patients and Healthcare Workers.

Interv Cardiol 2020 Apr 24;15:e16. Epub 2020 Nov 24.

Imperial College Healthcare NHS Trust London, UK.

Coronavirus disease 2019 (COVID-19) is forcing cardiology departments to rapidly adapt existing clinical guidelines to a new reality and this is especially the case for acute coronary syndrome pathways. In this focused review, the authors discuss how COVID-19 is affecting acute cardiology care and propose pragmatic guideline modifications for the diagnosis and management of acute coronary syndrome patients, particularly around the appropriateness of invasive strategies as well as length of hospital stay. The authors also discuss the use of personal protective equipment for healthcare workers in cardiology. Based on shared global experiences and growing peer-reviewed literature, it is possible to put in place modified acute coronary syndrome treatment pathways to offer safe pragmatic decisions to patients and staff.
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http://dx.doi.org/10.15420/icr.2020.21DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7726851PMC
April 2020

Gender-Related Differences in Clinical Presentation and Angiographic Findings in Patients with Ischemia and No Obstructive Coronary Artery Disease (INOCA): A Single-Center Observational Registry.

Int J Angiol 2020 Dec 14;29(4):250-255. Epub 2020 May 14.

International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, Hammersmith Hospital, London, United Kingdom.

Ischemia and no obstructive coronary arteries (INOCA) is a common clinical presentation, with a variety of causes that are often not fully investigated in routine clinical practice. The goal of our study was to characterize a real-world population of patients with INOCA, with a deeper focus on symptoms and stress test findings. The study population consisted of 435 patients who underwent diagnostic coronary angiography for anginal symptoms and/or evidence of myocardial ischemia at non-invasive imaging. In all patients angiography demonstrated nonobstructive coronary artery disease (CAD, less than 30% luminal diameter stenosis or fractional flow reserve > 0.8 and/or instantaneous wave-free ratio  > 0.89). Fifty-four percent of the patients were women. Atypical clinical presentation was more common in women (59.5 vs. 49.5%,  = 0.037). Women were more likely to have normal coronary arteries than men (41.8 vs. 16.2%,  < 0.001), and less likely than men to have hemodynamically non-significant CAD (32.1 vs. 55.1%,  < 0.001). No significant correlation between typicality of symptoms and evidence of ischemia was found in those patients (244/435, 56.1%) who had either dobutamine stress echocardiography or electrocardiogram stress test. INOCA is a common clinical condition, prevalent in women often presenting with atypical symptoms.
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http://dx.doi.org/10.1055/s-0040-1709500DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7690983PMC
December 2020

COURAGE, ORBITA, and ISCHEMIA: Percutaneous Coronary Intervention for Stable Coronary Artery Disease.

Interv Cardiol Clin 2020 10;9(4):469-482

Imperial College Healthcare NHS Trust, Hammersmith Hospital, Du Cane Road, London W12 0HS, UK; Imperial College London, Hammersmith Hospital, Du Cane Road, London W12 0HS, UK. Electronic address:

This review article summarizes key landmark trials that have shaped understanding of the role of percutaneous coronary intervention (PCI) in stable coronary artery disease (CAD). The relationship between stenosis, ischemia, and angina is more complex than first imagined. Anginal relief remains the primary indication for PCI in stable CAD. The first placebo-controlled PCI trial showed a surprisingly small effect size, suggesting a significant placebo effect. PCI in stable CAD has not been shown to improve mortality or overall myocardial infarction rates, even in the presence of significant ischemia. Rather, risk reduction medical therapy remains the main intervention for improving outcomes.
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http://dx.doi.org/10.1016/j.iccl.2020.07.003DOI Listing
October 2020

An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

Eur Heart J 2020 10;41(37):3504-3520

Centre for Cardiovascular Medicine and Devices, William Harvey Research Institute, Queen Mary University of London and Barts Heart Centre, London, UK.

This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.
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http://dx.doi.org/10.1093/eurheartj/ehaa503DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7577516PMC
October 2020

An EAPCI Expert Consensus Document on Ischaemia with Non-Obstructive Coronary Arteries in Collaboration with European Society of Cardiology Working Group on Coronary Pathophysiology & Microcirculation Endorsed by Coronary Vasomotor Disorders International Study Group.

EuroIntervention 2021 Jan;16(13):1049-1069

Translational and Clinical Research Institute, Faculty of Medical Sciences, Newcastle University and Cardiothoracic Centre, Freeman Hospital, Newcastle upon Tyne NHS Foundation Trust, Newcastle upon Tyne, United Kingdom.

This consensus document, a summary of the views of an expert panel organized by the European Association of Percutaneous Cardiovascular Interventions (EAPCI), appraises the importance of ischaemia with non-obstructive coronary arteries (INOCA). Angina pectoris affects approximately 112 million people globally. Up to 70% of patients undergoing invasive angiography do not have obstructive coronary artery disease, more common in women than in men, and a large proportion have INOCA as a cause of their symptoms. INOCA patients present with a wide spectrum of symptoms and signs that are often misdiagnosed as non-cardiac leading to under-diagnosis/investigation and under-treatment. INOCA can result from heterogeneous mechanism including coronary vasospasm and microvascular dysfunction and is not a benign condition. Compared to asymptomatic individuals, INOCA is associated with increased incidence of cardiovascular events, repeated hospital admissions, as well as impaired quality of life and associated increased health care costs. This consensus document provides a definition of INOCA and guidance to the community on the diagnostic approach and management of INOCA based on existing evidence from research and best available clinical practice; noting gaps in knowledge and potential areas for further investigation.
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http://dx.doi.org/10.4244/EIJY20M07_01DOI Listing
January 2021

Complete Revascularization by Percutaneous Coronary Intervention for Patients With ST-Segment-Elevation Myocardial Infarction and Multivessel Coronary Artery Disease: An Updated Meta-Analysis of Randomized Trials.

J Am Heart Assoc 2020 06 1;9(12):e015263. Epub 2020 Jun 1.

Columbia University Medical Center/New York-Presbyterian Hospital New York NY.

Background For patients with ST-segment-elevation myocardial infarction (STEMI) and multivessel coronary artery disease, the optimal treatment of the non-infarct-related artery has been controversial. This up-to-date meta-analysis focusing on individual clinical end points was performed to further evaluate the benefit of complete revascularization with percutaneous coronary intervention for patients with STEMI and multivessel coronary artery disease. Methods and Results We systematically identified all randomized trials comparing complete revascularization with percutaneous coronary intervention to culprit-only revascularization for multivessel disease in STEMI and performed a random-effects meta-analysis. The primary efficacy end point was cardiovascular death analyzed on an intention-to-treat basis. Secondary end points included all-cause mortality, myocardial infarction, and unplanned revascularization. Ten studies (7542 patients) were included: 3664 patients were randomized to complete revascularization and 3878 to culprit-only revascularization. Across all patients, complete revascularization was superior to culprit-only revascularization for reduction in the risk of cardiovascular death (relative risk [RR], 0.68; 95% CI, 0.47-0.98; =0.037; I=21.8%) and reduction in the risk of myocardial infarction (RR, 0.65; 95% CI, 0.54-0.79; <0.0001; I=0.0%). Complete revascularization also significantly reduced the risk of unplanned revascularization (RR, 0.37; 95% CI, 0.28-0.51; <0.0001; I=64.7%). The difference in all-cause mortality with percutaneous coronary intervention was not statistically significant (RR, 0.85; 95% CI, 0.69-1.04; =0.108; I=0.0%). Conclusions For patients with STEMI and multivessel disease, complete revascularization with percutaneous coronary intervention significantly improves hard clinical outcomes including cardiovascular death and myocardial infarction. These data have implications for clinical practice guidelines regarding recommendations for complete revascularization following STEMI.
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http://dx.doi.org/10.1161/JAHA.119.015263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7429036PMC
June 2020

Safety of Revascularization Deferral of Left Main Stenosis Based on Instantaneous Wave-Free Ratio Evaluation.

JACC Cardiovasc Interv 2020 07 13;13(14):1655-1664. Epub 2020 May 13.

Cardiovascular Science, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address:

Objectives: The aim of this study was to assess the long-term clinical outcomes of patients with left main coronary artery (LM) stenosis in whom treatment strategy was based on the instantaneous wave-free ratio (iFR).

Background: The overall safety of iFR to guide revascularization decision making in patients with stable coronary artery disease has been established. However, no study has examined the safety of deferral of revascularization of LM disease on the basis of iFR.

Methods: This multicenter observational study included 314 patients in whom LM stenosis was deferred (n = 163 [51.9%]) or revascularized (n = 151 [48.1%]) according to the iFR cutoff ≤0.89. The primary endpoint was a composite of all-cause death, nonfatal myocardial infarction, and ischemia-driven target lesion revascularization. The secondary endpoints were each individual component of the primary endpoint and also cardiac death.

Results: At a median follow-up period of 30 months, the primary endpoint occurred in 15 patients (9.2%) in the deferred group and 22 patients (14.6%) in the revascularized group (hazard ratio: 1.45; 95% confidence interval: 0.75 to 2.81; p = 0.26), indicating no evidence of a significant difference between the 2 groups. For the secondary endpoints, findings in the iFR-based deferral and revascularization groups were as follows: all-cause death, 3.7% versus 4.6%; cardiac death, 1.2% versus 2.0%; nonfatal myocardial infarction, 2.5% versus 5.3%; and target lesion revascularization, 4.3% versus 5.3% (p > 0.05 for all).

Conclusions: Deferral of revascularization of LM stenosis on the basis of iFR appears to be safe, with similar long-term outcomes to those in patients in whom LM revascularization was performed according to iFR values.
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http://dx.doi.org/10.1016/j.jcin.2020.02.035DOI Listing
July 2020

ISCHEMIA Trial: Was It Worth the Wait?

Circulation 2020 Aug 22;142(6):517-519. Epub 2020 Apr 22.

Boston University School of Medicine, Boston Medical Center, MA (A.K.J.).

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http://dx.doi.org/10.1161/CIRCULATIONAHA.120.045007DOI Listing
August 2020

Effects of Percutaneous Coronary Intervention on Death and Myocardial Infarction Stratified by Stable and Unstable Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials.

Circ Cardiovasc Qual Outcomes 2020 02 17;13(2):e006363. Epub 2020 Feb 17.

Imperial College London, United Kingdom (L.C., J.H., C.R., A.N.N., C.K., D.M.,M.F., M.S.-S., G.C., S.S., R.A.-L., D.P.F., Y.A.).

Background: In patients presenting with ST-segment-elevation myocardial infarction, percutaneous coronary intervention (PCI) reduces mortality when compared with fibrinolysis. In other forms of coronary artery disease (CAD), however, it has been controversial whether PCI reduces mortality. In this meta-analysis, we examine the benefits of PCI in (1) patients post-myocardial infarction (MI) who did not receive immediate revascularization; (2) patients who have undergone primary PCI for ST-segment-elevation myocardial infarction but have residual coronary lesions; (3) patients who have suffered a non-ST-segment-elevation acute coronary syndrome; and (4) patients with truly stable CAD with no recent infarct. This analysis includes data from the recently presented International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) and Complete versus Culprit-Only Revascularization Strategies to Treat Multivessel Disease after Early PCI for STEMI (COMPLETE) trials.

Methods And Results: We systematically identified all randomized trials of PCI on a background of medical therapy for the treatment of CAD. The ISCHEMIA trial, presented in November 2019, was eligible for inclusion. Data were combined using a random-effects meta-analysis. The primary end point was all-cause mortality. Forty-six trials, including 37 757 patients, were eligible. In the 3 unstable scenarios, PCI had the following effects on mortality: unrevascularized post-MI relative risk (RR) 0.68 (95% CI, 0.45-1.03); =0.07; multivessel disease following ST-segment-elevation myocardial infarction (RR, 0.84 [95% CI, 0.69-1.04]; =0.11); non-ST-segment-elevation acute coronary syndrome (RR, 0.84 [95% CI, 0.72-0.97]; =0.02). Overall, in these unstable scenarios PCI was associated with a significant reduction in mortality (RR, 0.84 [95% CI, 0.75-0.93]; =0.02). In unstable CAD, PCI also reduced cardiac death (RR, 0.69 [95% CI, 0.53-0.90]; =0.007) and MI (RR, 0.74 [95% CI, 0.62-0.90]; =0.002). For stable CAD, PCI did not reduce mortality (RR, 0.98 [95% CI, 0.87-1.11]), cardiac death (RR, 0.89 [95% CI, 0.71-1.12]; =0.33), or MI (RR, 0.96 [95% CI, 0.86-1.08]; =0.54).

Conclusions: PCI prevents death, cardiac death, and MI in patients with unstable CAD. For patients with stable CAD, PCI shows no evidence of an effect on any of these outcomes.
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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006363DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7034389PMC
February 2020

Determining the Predominant Lesion in Patients With Severe Aortic Stenosis and Coronary Stenoses: A Multicenter Study Using Intracoronary Pressure and Flow.

Circ Cardiovasc Interv 2019 12 22;12(12):e008263. Epub 2019 Nov 22.

National Heart and Lung Institute, Hammersmith Hospital, Imperial College London, United Kingdom (Y.A., J.P.H., C.C., C.R., R.A.-L., R.P., T.W., D.F., J.M., P.S., S.S.).

Background: Patients with severe aortic stenosis (AS) often have coronary artery disease. Both the aortic valve and the coronary disease influence the blood flow to the myocardium and its ability to respond to stress; leading to exertional symptoms. In this study, we aim to quantify the effect of severe AS on the coronary microcirculation and determine if this is influenced by any concomitant coronary disease. We then compare this to the effect of coronary stenoses on the coronary microcirculation.

Methods: Group 1: 55 patients with severe AS and intermediate coronary stenoses treated with transcatheter aortic valve implantation (TAVI) were included. Group 2: 85 patients with intermediate coronary stenoses and no AS treated with percutaneous coronary intervention were included. Coronary pressure and flow were measured at rest and during hyperemia in both groups, before and after TAVI (group 1) and before and after percutaneous coronary intervention (group 2).

Results: Microvascular resistance over the wave-free period of diastole increased significantly post-TAVI (pre-TAVI, 2.71±1.4 mm Hg·cm·s versus post-TAVI 3.04±1.6 mm Hg·cm·s [=0.03]). Microvascular reserve over the wave-free period of diastole significantly improved post-TAVI (pre-TAVI 1.88±1.0 versus post-TAVI 2.09±0.8 [=0.003]); this was independent of the severity of the underlying coronary stenosis. The change in microvascular resistance post-TAVI was equivalent to that produced by stenting a coronary lesion with an instantaneous wave-free ratio of ≤0.74.

Conclusions: TAVI improves microcirculatory function regardless of the severity of underlying coronary disease. TAVI for severe AS produces a coronary hemodynamic improvement equivalent to the hemodynamic benefit of stenting coronary stenoses with instantaneous wave-free ratio values <0.74. Future trials of physiology-guided revascularization in severe AS may consider using this value to guide treatment of concomitant coronary artery disease.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008263DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6924937PMC
December 2019

The Goldilocks Guide to Getting Medical Therapy 'Just Right': Insights From the ISCHEMIA Trial.

Circ Cardiovasc Qual Outcomes 2019 11 13;12(11):e006265. Epub 2019 Nov 13.

International Centre for Circulatory Health, National Heart and Lung Institute, Imperial College London, United Kingdom (C.A.R., M.F., R.A.-L.).

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http://dx.doi.org/10.1161/CIRCOUTCOMES.119.006265DOI Listing
November 2019

Dobutamine Stress Echocardiography Ischemia as a Predictor of the Placebo-Controlled Efficacy of Percutaneous Coronary Intervention in Stable Coronary Artery Disease: The Stress Echocardiography-Stratified Analysis of ORBITA.

Circulation 2019 12 11;140(24):1971-1980. Epub 2019 Nov 11.

Imperial College Healthcare NHS Trust, London, UK (R.K.A-L., M.J.S.-S., J.P.H., A.N.N., C.R., S.S., S.N., R.P., I.M., C.C., Y.A., H.S., R.A., G.C., G.K., J.M., J.E.D., D.P.F.).

Background: Dobutamine stress echocardiography is widely used to test for ischemia in patients with stable coronary artery disease. In this analysis, we studied the ability of the prerandomization stress echocardiography score to predict the placebo-controlled efficacy of percutaneous coronary intervention (PCI) within the ORBITA trial (Objective Randomised Blinded Investigation With Optimal Medical Therapy of Angioplasty in Stable Angina).

Methods: One hundred eighty-three patients underwent dobutamine stress echocardiography before randomization. The stress echocardiography score is broadly the number of segments abnormal at peak stress, with akinetic segments counting double and dyskinetic segments counting triple. The ability of prerandomization stress echocardiography to predict the placebo-controlled effect of PCI on response variables was tested by using regression modeling.

Results: At prerandomization, the stress echocardiography score was 1.56±1.77 in the PCI arm (n=98) and 1.61±1.73 in the placebo arm (n=85). There was a detectable interaction between prerandomization stress echocardiography score and the effect of PCI on angina frequency score with a larger placebo-controlled effect in patients with the highest stress echocardiography score (=0.031). With our sample size, we were unable to detect an interaction between stress echocardiography score and any other patient-reported response variables: freedom from angina (=0.116), physical limitation (=0.461), quality of life (=0.689), EuroQOL 5 quality-of-life score (=0.789), or between stress echocardiography score and physician-assessed Canadian Cardiovascular Society angina class (=0.693), and treadmill exercise time (=0.426).

Conclusions: The degree of ischemia assessed by dobutamine stress echocardiography predicts the placebo-controlled efficacy of PCI on patient-reported angina frequency. The greater the downstream stress echocardiography abnormality caused by a stenosis, the greater the reduction in symptoms from PCI.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02062593.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.119.042918DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6903430PMC
December 2019

Sex Differences in Instantaneous Wave-Free Ratio or Fractional Flow Reserve-Guided Revascularization Strategy.

JACC Cardiovasc Interv 2019 10;12(20):2035-2046

Imelda Hospital, Bonheiden, Belgium.

Objectives: This study sought to evaluate sex differences in procedural characteristics and clinical outcomes of instantaneous wave-free ratio (iFR)- and fractional flow reserve (FFR)-guided revascularization strategies.

Background: An iFR-guided strategy has shown a lower revascularization rate than an FFR-guided strategy, without differences in clinical outcomes.

Methods: This is a post hoc analysis of the DEFINE-FLAIR (Functional Lesion Assessment of Intermediate stenosis to guide Revascularization) study, in which 601 women and 1,891 men were randomized to iFR- or FFR-guided strategy. The primary endpoint was 1-year major adverse cardiac events (MACE), a composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization.

Results: Among the entire population, women had a lower number of functionally significant lesions per patient (0.31 ± 0.51 vs. 0.43 ± 0.59; p < 0.001) and less frequently underwent revascularization than men (42.1% vs. 53.1%; p < 0.001). There was no difference in mean iFR value according to sex (0.91 ± 0.09 vs. 0.91 ± 0.10; p = 0.442). However, the mean FFR value was lower in men than in women (0.83 ± 0.09 vs. 0.85 ± 0.10; p = 0.001). In men, an FFR-guided strategy was associated with a higher rate of revascularization than an iFR-guided strategy (57.1% vs. 49.3%; p = 0.001), but this difference was not observed in women (41.4% vs. 42.6%; p = 0.757). There was no difference in MACE rates between iFR- and FFR-guided strategies in both women (5.4% vs. 5.6%, adjusted hazard ratio: 1.10; 95% confidence interval: 0.50 to 2.43; p = 0.805) and men (6.6% vs. 7.0%, adjusted hazard ratio: 0.98; 95% confidence interval: 0.66 to 1.46; p = 0.919).

Conclusions: An FFR-guided strategy was associated with a higher rate of revascularization than iFR-guided strategy in men, but not in women. However, iFR- and FFR-guided strategies showed comparable clinical outcomes, regardless of sex. (Functional Lesion Assessment of Intermediate Stenosis to guide Revascularization [DEFINE-FLAIR]; NCT02053038).
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http://dx.doi.org/10.1016/j.jcin.2019.06.035DOI Listing
October 2019

Artificial Intelligence for Aortic Pressure Waveform Analysis During Coronary Angiography: Machine Learning for Patient Safety.

JACC Cardiovasc Interv 2019 10 25;12(20):2093-2101. Epub 2019 Sep 25.

Department of Cardiology, Hammersmith Hospital, Imperial College Healthcare NHS Trust, London, United Kingdom. Electronic address:

Objectives: This study developed a neural network to perform automated pressure waveform analysis and allow real-time accurate identification of damping.

Background: Damping of aortic pressure during coronary angiography must be identified to avoid serious complications and make accurate coronary physiology measurements. There are currently no automated methods to do this, and so identification of damping requires constant monitoring, which is prone to human error.

Methods: The neural network was trained and tested versus core laboratory expert opinions derived from 2 separate datasets. A total of 5,709 aortic pressure waveforms of individual heart beats were extracted and classified. The study developed a recurrent convolutional neural network to classify beats as either normal, showing damping, or artifactual. Accuracies were reported using the opinions of 2 independent core laboratories.

Results: The neural network was 99.4% accurate (95% confidence interval: 98.8% to 99.6%) at classifying beats from the testing dataset when judged against the opinions of the internal core laboratory. It was 98.7% accurate (95% confidence interval: 98.0% to 99.2%) when judged against the opinions of an external core laboratory not involved in neural network training. The neural network was 100% sensitive, with no beats classified as damped misclassified, with a specificity of 99.8%. The positive predictive and negative predictive values were 98.1% and 99.5%. The 2 core laboratories agreed more closely with the neural network than with each other.

Conclusions: Arterial waveform analysis using neural networks allows rapid and accurate identification of damping. This demonstrates how machine learning can assist with patient safety and the quality control of procedures.
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http://dx.doi.org/10.1016/j.jcin.2019.06.036DOI Listing
October 2019

Comparison of Major Adverse Cardiac Events Between Instantaneous Wave-Free Ratio and Fractional Flow Reserve-Guided Strategy in Patients With or Without Type 2 Diabetes: A Secondary Analysis of a Randomized Clinical Trial.

JAMA Cardiol 2019 09;4(9):857-864

University Magna Graecia, Catanzaro, Italy.

Importance: Invasive physiologic indices such as fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) are used in clinical practice. Nevertheless, comparative prognostic outcomes of iFR-guided and FFR-guided treatment in patients with type 2 diabetes have not yet been fully investigated.

Objective: To compare 1-year clinical outcomes of iFR-guided or FFR-guided treatment in patients with and without diabetes in the Functional Lesion Assessment of Intermediate Stenosis to Guide Revascularization (DEFINE-FLAIR) trial.

Design, Setting, And Participants: The DEFINE-FLAIR trial is a multicenter, international, randomized, double-blinded trial that randomly assigned 2492 patients in a 1:1 ratio to undergo either iFR-guided or FFR-guided coronary revascularization. Patients were eligible for trial inclusion if they had intermediate coronary artery disease (40%-70% diameter stenosis) in at least 1 native coronary artery. Data were analyzed between January 2014 and December 2015.

Interventions: According to the study protocol, iFR of 0.89 or less and FFR of 0.80 or less were used as criteria for revascularization. When iFR or FFR was higher than the prespecified threshold, revascularization was deferred.

Main Outcomes And Measures: The primary end point was major adverse cardiac events (MACE), defined as the composite of all-cause death, nonfatal myocardial infarction, or unplanned revascularization at 1 year. The incidence of MACE was compared according to the presence of diabetes in iFR-guided and FFR-guided groups.

Results: Among the total trial population (2492 patients), 758 patients (30.4%) had diabetes. Mean age of the patients was 66 years, 76% were men (1868 of 2465), and 80% of patients presented with stable angina (1983 of 2465). In the nondiabetes population (68.5%; 1707 patients), iFR guidance was associated with a significantly higher rate of deferral of revascularization than the FFR-guided group (56.5% [n = 477 of 844] vs 46.6% [n = 402 of 863]; P < .001). However, it was not different between the 2 groups in the diabetes population (42.1% [n = 161 of 382] vs 47.1% [n = 177 of 376]; P = .15). At 1 year, the diabetes population showed a significantly higher rate of MACE than the nondiabetes population (8.6% vs 5.6%; adjusted hazard ratio [HR], 1.88; 95% CI, 1.28-2.64; P < .001). However, there was no significant difference in MACE rates between iFR-guided and FFR-guided groups in both the diabetes (10.0% vs 7.2%; adjusted HR, 1.33; 95% CI, 0.78-2.25; P = .30) and nondiabetes population (4.7% vs 6.4%; HR, 0.83; 95% CI, 0.51-1.35; P = .45) (interaction P = .25).

Conclusions And Relevance: The diabetes population showed significantly higher risk of MACE than the nondiabetes population, even with the iFR-guided or FFR-guided treatment. The iFR-guided and FFR-guided treatment showed comparable risk of MACE and provided equal safety in selecting revascularization target among patients with diabetes.

Trial Registration: ClinicalTrials.gov identifier: NCT02053038.
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http://dx.doi.org/10.1001/jamacardio.2019.2298DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6646975PMC
September 2019

Preclinical evaluation of a thin-strut bioresorbable scaffold (ArterioSorb): acute-phase invasive imaging assessment and hemodynamic implication.

EuroIntervention 2020 Jun 12;16(2):e141-e146. Epub 2020 Jun 12.

Amsterdam University Medical Centre, University of Amsterdam, Amsterdam, the Netherlands.

Aims: The aim of this study was to assess the acute performance of the 95 µm ArterioSorb oriented poly L-lactic acid (PLLA) scaffold in comparison with the XIENCE metallic drug-eluting stent (DES) in porcine coronary arteries.

Methods And Results: In 15 non-atherosclerotic Yucatan mini pigs, the ArterioSorb (3.0/14 mm) and XIENCE (3.0/15 mm) were implanted in 25 and 15 vessels, respectively. Acute performance was evaluated by using quantitative coronary angiography (QCA) and optical coherence tomography (OCT). Following three-dimensional reconstruction of the coronary arteries, endothelial shear stress (ESS) was quantified using non-Newtonian steady-flow simulation. Acute recoil measured by QCA was comparable in the two arms. Post-procedural flow and scaffold/stent area by OCT did not differ between the two devices. ESS post procedure was comparable between ArterioSorb and XIENCE (2.21±1.97 vs 2.25±1.71 Pa, p=0.314).

Conclusions: Acute recoil, luminal dimensions and ESS in the ArterioSorb oriented PLLA scaffold with thin struts of 95 µm were comparable to those in the XIENCE metallic DES.
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http://dx.doi.org/10.4244/EIJ-D-18-01190DOI Listing
June 2020