Angina without angiographic evidence of obstructive coronary artery disease (ANOCA) is a highly prevalent condition with insufficient pathophysiological knowledge and lack of evidence-based medical ...therapies. This affects ANOCA patients prognosis, their healthcare utilization and quality of life. In current guidelines, performing a coronary function test (CFT) is recommended to identify a specific vasomotor dysfunction endotype. The NetherLands registry of invasive Coronary vasomotor Function testing (NL-CFT) has been designed to collect data on ANOCA patients undergoing CFT in the Netherlands.
The NL-CFT is a web-based, prospective, observational registry including all consecutive ANOCA patients undergoing clinically indicated CFT in participating centers throughout the Netherlands. Data on medical history, procedural data and (patient reported) outcomes are gathered.
The implementation of a common CFT protocol in all participating hospitals promotes an equal diagnostic strategy and ensures representation of the entire ANOCA population. A CFT is performed after ruling out obstructive coronary artery disease. It comprises of both acetylcholine vasoreactivity testing as well as bolus thermodilution assessment of microvascular function. Optionally, continuous thermodilution or Doppler flow measurements can be performed. Participating centers can perform research using own data, or pooled data will be made available upon specific request via a secure digital research environment, after approval of a steering committee.
NL-CFT will be an important registry by enabling both observational and registry based (randomized) clinical trials in ANOCA patients undergoing CFT.
•NL-CFT is a web-based, prospective, observational registry.•All consecutive ANOCA patients undergoing clinically indicated CFT are included.•NL-CFT enables both observational and registry based (randomized) clinical trials.
Background
We aimed to evaluate the association between public media and trends in new presentations of acute coronary syndrome (ACS) during the first wave of the coronavirus disease 2019 (COVID‑19) ...in the Netherlands.
Methods
New ACS presentations per week in 73 hospitals during the first half of 2019 and 2020 were retrieved from the national organisation Dutch Hospital Data and incidence rates were calculated. Stratified analyses were performed by region, type of ACS and patient characteristics.
Results
After the first confirmed COVID‑19 case and during lockdown, numbers declined by up to 41% (95% confidence interval (CI): 36–47%) compared to 2019. This reduction was more pronounced for non-ST-segment elevation myocardial infarction (NSTEMI) (48%; 95% CI: 39–55%) and unstable angina (UA; 50%; 95% CI: 40–59%) than for STEMI (34%; 95% CI: 23–43%). There was no association between ACS and COVID‑19 incidence rate per region. After the steep decline, a public campaign encouraged patients not to postpone hospital visits. Numbers then increased, without a rebound effect. Trends were similar irrespective of sex, age or socio-economic status. During the outbreak, compared to coronary artery bypass graft procedures, relatively more (acute) percutaneous coronary interventions for NSTEMI and UA were performed.
Conclusion
New ACS presentations decreased by up to 41%. Lockdown measures and public campaigns, rather than COVID‑19 incidence, were associated with significant changes in new ACS presentations. Even though causality cannot be established, this emphasises the role of the public media and healthcare organisations in informing patients to prevent underdiagnoses of ACS and associated health damage.
Recently, the European Society of Cardiology (ESC) has updated its guidelines for the management of patients with acute coronary syndrome (ACS) without ST-segment elevation. The current consensus ...document of the Dutch ACS working group and the Working Group of Interventional Cardiology of the Netherlands Society of Cardiology aims to put the 2020 ESC Guidelines into the Dutch perspective and to provide practical recommendations for Dutch cardiologists, focusing on antiplatelet therapy, risk assessment and criteria for invasive strategy.
Background
There are nationwide concerns about the unemployment rate among young Dutch cardiologists and the increase in temporary positions. Therefore, the aim of this study was to investigate the ...unemployment rate in this subgroup as well as the length of time between the end of their training and the acquisition of a permanent position.
Methods
All cardiologists who completed their training between January 2015 and December 2018 were invited to fill in an online questionnaire about their demographic characteristics, professional profile and employment status. The unemployment rate was calculated and Kaplan-Meier curves were used to determine the time between the end of training and the first permanent contract.
Results
In total, 174 participants were included (mean age 35 ± 3 years, 64% male, median follow-up 2.3 years (interquartile range 1.4–3.2 years)). The unemployment rate was 0.6% (
n
= 1). Only 12 participants (7%) started their career with a permanent position. The percentage of cardiologists with a temporary position was 82%, 61% and 33% at 1, 2 and 3 years, respectively. The percentage of cardiologists with a temporary position did not differ with regard to age, gender, holding a PhD degree or type of teaching institution attended (academic vs non-academic). Forty-four per cent of participants perceived the current job market to be problematic.
Conclusions
The unemployment rate among young cardiologists in the Netherlands was low between 2015 and 2018. The vast majority of cardiologists start their career on a temporary contract. Three years later, 33% still hold temporary positions. Due to the resultant job insecurity, many young cardiologists describe the job market as problematic.
Objectives
We sought to investigate angiographic indications for the use of the STENTYS technique and evaluated the long-term safety and clinical efficacy of the stent.
Background
Coronary lesions ...involving complex anatomy, including aneurysmatic, ectatic, or tapered vessel segments often carry a substantial risk of stent malapposition. The self-apposing stent technique may reduce the risk of stent malapposition and therefore improve clinical outcomes.
Methods
A total of 120 consecutive patients treated with the STENTYS stent were included (drug-eluting stent (DES) n = 101, bare-metal stent (BMS) n = 19). All lesions were scored for angiographic indications for the STENTYS stent, including aneurysms, ectasias, tapering, absolute diameters, bifurcation lesions, and saphenous vein grafts. Off-line quantitative coronary angiography analyses were performed pre-procedure and post-procedure. Five years follow-up was obtained including cardiac death, target vessel myocardial infarction (TV-MI), target vessel revascularisation, stent thrombosis, and the composite endpoint target vessel failure (cardiac death, TV-MI and target vessel revascularisation).
Results
Angiographic indications for STENTYS use were aneurysm (30%), ectasia (19%), tapering (27%), bifurcation lesions (8%), and saphenous vein graft lesions (16%) and absolute diameters (22%). Mean maximal diameter was 4.51 ± 0.99 mm. At 5‑year follow-up target vessel failure rates were 24.1% in the total cohort (DES 22.8% vs. BMS 33%,
p
= 0.26). Definite stent thrombosis rate was 3.8% at 5‑year follow-up in this cohort with complex and high-risk lesions (DES 4.5% vs. BMS 0%,
p
= 0.39).
Conclusions
Angiographic indications for the use of the self-apposing stent were complex lesions with atypical coronary anatomy. Our data showed reasonable stent thrombosis rates at 5‑year follow-up, considering the high-risk lesion characteristics.
The bare-metal Tryton Side Branch (SB) Stent™ (Tryton Medical, Durham, NC, USA) is used with a drug-eluting stent (DES) in the main branch (MB) to treat bifurcation lesions. It is argued that a ...drug-eluting Tryton-version is needed to improve clinical outcomes, although previous registries have shown good clinical results. More insights in neo-intimal hyperplasia (NIH) growth patterns of the Tryton treatment strategy are needed to decide if and where to drug-coat the stent. Ten patients returned for follow-up angiography (mean follow-up time 393 ± 103 days) and optical coherence tomography (OCT) pullbacks from the MB were obtained in all patients and from the SB in six patients. A per-strut analysis showed an uncovered strut rate of 0.7 % and an incompletely-apposed strut rate of 0.8 %. Most incompletely-apposed struts were found at the bifurcation region, in the luminal half facing towards the SB. Mean NIH thickness in the proximal MB, distal MB and SB were 0.14 ± 0.11, 0.19 ± 0.11, and 0.34 ± 0.19 mm, respectively, with a variety of growth patterns observed in the SB. We found good vascular healing of the DES in the MB, while healing was less favourably in the SB part. Furthermore, we observed a variety of NIH growth patterns in this SB part and more studies are needed to investigate the relation between growth patterns and clinical outcomes.
Aims
Percutaneous coronary intervention (PCI) of a bifurcation lesion (BL) is still associated with poorer clinical outcomes when compared with PCI of a non-BL. Therefore, several dedicated coronary ...bifurcation stents, such as the Tryton Side Branch Stent™ (Tryton Medical, Durham, NC, USA), were developed to improve clinical outcomes. We investigated 6-month clinical outcomes after placement of a Tryton stent in 91 patients treated for 93 BLs in our centre.
Methods and results
All consecutive patients who have undergone PCI of a BL treated with the Tryton stent in our centre were included. Outcomes were defined as any death, cardiac death, myocardial infarction (MI), any revascularisation, ischaemia-driven target vessel revascularisation (TVR), ischaemia-driven target lesion revascularisation (TLR), stent thrombosis, and target vessel failure (TVF; composite of cardiac death, MI, and ischaemia-driven TVR). Event rates were estimated using the Kaplan-Meier method. Thirty-eight (42 %) patients with acute coronary syndrome (ACS) were included (16 % ST-segment elevation MI (STEMI)). The 6-month event rates were 5.4 % (death), 4.3 % (cardiac death), 2.2 % (MI), 4.5 % (any revascularisation), 4.5 % (TVR), 4.5 % (TLR) and 9.7 % (TVF).
Conclusion
In a real-world all-comers single-centre registry, the use of the Tryton Side Branch Stent was associated with acceptable procedural and promising clinical outcomes at 6 months, including ACS and STEMI patients.
Abstract
Introduction
The Genous stent is a bare metal stent (BMS) together with a technique of capturing endothelial progenitor cells. The successor of the Genous endothelial progenitor cell ...capturing (EPC) stent, the COMBO stent, combines this technique with the drug eluting polymer. The current studies showed promising results of the COMBO stent, however the additional value of EPC technique in overcoming neointimal hyperplasia has yet to be proven.
Purpose
This study sought to evaluate the efficacy and safety of the Genous EPC stent compared to BMS in a patient population with low risk for restenosis.
Methods
TRIAS-LR was an investigator-initiated, prospective, multicentre, single blind trial randomizing patients with low risk of restenosis 1:1 to Genous ECS or BMS. Patients were recruited between 2007 and 2014 at 31 sites across Europe. The study enrolment was terminated at 70% of the planned inclusion due to slow enrolment and change of guidelines. Patients or lesions were considered low risk if all of the following criteria were met: 1) reference vessel diameter >2.8mm, 2) lesion length <20mm, 3) no thrombolysis in myocardial infarction (TIMI) flow of 0, and 4) patient without diabetes mellitus. Clinical follow-up was obtained yearly. The trial was monitored and independent clinical event committee adjudicated serious adverse clinical events. The primary endpoint was target lesion failure (TLF), composite of cardiac death, target-vessel myocardial infarction (TV-MI) or target lesion revascularization (TLR) at 1 year. Secondary endpoint included the composite of death or MI at 5-year follow-up.
Results
In total, 838 patients were enrolled of whom 422 patients with 476 lesions were randomly assigned to Genous EPC stent and 416 patients with 480 lesions to BMS. The mean age was 64 years, 74% were males and in 76% patients were treated in elective setting. At 1 year TLF had occurred in 3.6% (n=15) of the Genous arm and in 6.1% (n=25) of the BMS arm (p=0.094; risk difference of −2.5%). However, this difference disappeared, at 5-years of follow-up; TLF rate was 12.6% (n=51) in the Genous arm versus 14.3% (n=58) in the BMS arm (p=0.385; risk difference of −1.7%). The secondary objective of the composite death or MI at 5 years occurred in 11.6% (n=47) in the Genous arm and 9.9% (n=40) in the BMS arm (p=0.479; risk difference of 1.7%). At 5 years definite stent thrombosis (ST) occurred in 0.5% (n=2) of the Genous arm, no definite ST had occurred in the BMS arm (p=0.162).
Conclusion
TRIAS-LR trial showed no differences between Genous EPC and BMS throughout 5-year follow-up in patients considered as low risk of restenosis.
Kaplan-Meier plot of composite endpoints
Funding Acknowledgement
Type of funding source: Private company. Main funding source(s): OrbusNeich Medical BV
Abstract
Aims
Patients with cardiac disease are considered high risk for poor outcomes following hospitalization with COVID-19. The primary aim of this study was to evaluate heterogeneity in ...associations between various heart disease subtypes and in-hospital mortality.
Methods and results
We used data from the CAPACITY-COVID registry and LEOSS study. Multivariable Poisson regression models were fitted to assess the association between different types of pre-existing heart disease and in-hospital mortality. A total of 16 511 patients with COVID-19 were included (21.1% aged 66–75 years; 40.2% female) and 31.5% had a history of heart disease. Patients with heart disease were older, predominantly male, and often had other comorbid conditions when compared with those without. Mortality was higher in patients with cardiac disease (29.7%; n = 1545 vs. 15.9%; n = 1797). However, following multivariable adjustment, this difference was not significant adjusted risk ratio (aRR) 1.08, 95% confidence interval (CI) 1.02–1.15; P = 0.12 (corrected for multiple testing). Associations with in-hospital mortality by heart disease subtypes differed considerably, with the strongest association for heart failure (aRR 1.19, 95% CI 1.10–1.30; P < 0.018) particularly for severe (New York Heart Association class III/IV) heart failure (aRR 1.41, 95% CI 1.20–1.64; P < 0.018). None of the other heart disease subtypes, including ischaemic heart disease, remained significant after multivariable adjustment. Serious cardiac complications were diagnosed in <1% of patients.
Conclusion
Considerable heterogeneity exists in the strength of association between heart disease subtypes and in-hospital mortality. Of all patients with heart disease, those with heart failure are at greatest risk of death when hospitalized with COVID-19. Serious cardiac complications are rare during hospitalization.
Graphical Abstract
Graphical Abstract
After multivariable adjustment, the strongest association was found for heart failure and in-hospital mortality (aRR 1.19, 95% CI 1.10–1.30; P < 0.018 and in particular for severe (NYHA class III/IV) heart failure (aRR 1.41, 95% CI 1.20–1.64; P < 0.018). For the other heart disease subtypes, including ischaemic heart disease, no significant associations with in-hospital mortality were found after correction for multiple testing. BMI = body mass index; NYHA = New York Heart Association; PAD = peripheral arterial disease. *Significant after correcting for multiple testing.
Abstract
Background
One of the major long-term disadvantages of percutaneous coronary intervention (PCI) remains in-stent restenosis and need for repeat revascularisation. The polymer-regulated ...delivery of cytotoxic or cytostatic drugs, on drug-eluting stents (DES), impede the natural healing response of the damaged vessel wall. In animals, endothelial progenitor cells (EPCs) beneficially influence the repair of the coronary vessel wall after damage by stent placement. It is hypothesized that after immobilisation the EPCs differentiate into a functional endothelial layer and that this layer will prevent neointimal proliferation and thrombus formation. Anti-CD34+ antibodies are able to capture the EPCs. The Genous stent consist of a bare-metal stent with anti-CD34+ antibody coating.
Purpose
Demonstrating long-term performance of Genous EPC capturing stent (ECS) relative to DES regarding target lesion failure (TLF); the composite of cardiac death, myocardial infarction (MI) and any target lesion revascularisation (TLR) within 5 years.
Methods
We undertook an international, clinical trial in 26 centres planning to randomise 1300 patients with stable coronary artery disease and with a high risk of restenosis between treatment with either ECS or DES. After a routine review with 50% of the patients enrolled, early cessation of the trial was recommended by the data and safety monitoring board when TLF in the ECS population was substantially higher and treatment of new patients with an ECS would be unreasonable. The trial was terminated for safety reasons.
Results
A total of 622 were randomly assigned to receive either Genous ECS (304 patients, 367 lesions) or DES (318 patients, 388 lesions). Five year follow-up data was obtained in 95.5% of patients. TLF occurred in 29.1% of the ECS-treated patients and in 16.0% of the DES-treated patients (p<0.001) (Figure 1). This difference was driven by higher rates of TLR (22.9% vs. 10.7%, p<0.001), but not by cardiac death (6.5% vs. 4.5%, p=0.268), or MI (5.8% vs. 3.6%, p=0.175). Definite or probable stent thrombosis was seen in 8 ECS-treated patients (2.7%) and in 3 DES-treated patients (1%), p=0.11.
Figure 1. KM curves of TLF at 5year fu.
Conclusion
The Genous ECS is not sufficiently strong to compete with DES in terms of restenosis prevention in patients/lesions with a high risk of restenosis. If the addition of a EPCs capturing layer on a DES, like the COMBO stent, provides a lower risk of restenosis compared to DES will be tested in the ongoing SORT-OUT X trial.
Acknowledgement/Funding
OrbusNeich
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