AbstractObjectiveTo show that limiting dual antiplatelet therapy (DAPT) to six months in patients with event-free ST-elevation myocardial infarction (STEMI) results in a non-inferior clinical outcome ...versus DAPT for 12 months.DesignProspective, randomised, multicentre, non-inferiority trial.SettingPatients with STEMI treated with primary percutaneous coronary intervention (PCI) and second generation zotarolimus-eluting stent.ParticipantsPatients with STEMI aged 18 to 85 that underwent a primary PCI with the implantation of second generation drug-eluting stents were enrolled in the trial. Patients that were event-free at six months after primary PCI were randomised at this time point.InterventionsPatients that were taking DAPT and were event-free at six months were randomised 1:1 to single antiplatelet therapy (SAPT) (ie, aspirin only) or to DAPT for an additional six months. All patients that were randomised were then followed for another 18 months (ie, 24 months after the primary PCI).Main outcome measuresThe primary endpoint was a composite of all cause mortality, any myocardial infarction, any revascularisation, stroke, and thrombolysis in myocardial infarction major bleeding at 18 months after randomisation.ResultsA total of 1100 patients were enrolled in the trial between 19 December 2011 and 30 June 2015. 870 were randomised: 432 to SAPT versus 438 to DAPT. The primary endpoint occurred in 4.8% of patients receiving SAPT versus 6.6% of patients receiving DAPT (hazard ratio 0.73, 95% confidence interval 0.41 to 1.27, P=0.26). Non-inferiority was met (P=0.004 for non-inferiority), as the upper 95% confidence interval of 1.27 was smaller than the prespecified non-inferiority margin of 1.66.ConclusionsDAPT to six months was non-inferior to DAPT for 12 months in patients with event-free STEMI at six months after primary PCI with second generation drug-eluting stents.Trial registrationClinicaltrials.gov NCT01459627.
Purpose
Traditionally, interpretation of myocardial perfusion imaging (MPI) is based on visual assessment. Computer-based automated analysis might be a simple alternative obviating the need for ...extensive reading experience. Therefore, the aim of the present study was to compare the diagnostic performance of automated analysis with that of expert visual reading for the detection of obstructive coronary artery disease (CAD).
Methods
206 Patients (64% men, age 58.2 ± 8.7 years) with suspected CAD were included prospectively. All patients underwent
99m
Tc-tetrofosmin single-photon emission computed tomography (SPECT) and invasive coronary angiography with fractional flow reserve (FFR) measurements. Non-corrected (NC) and attenuation-corrected (AC) SPECT images were analyzed both visually as well as automatically by commercially available SPECT software. Automated analysis comprised a segmental summed stress score (SSS), summed difference score (SDS), stress total perfusion deficit (S-TPD), and ischemic total perfusion deficit (I-TPD), representing the extent and severity of hypoperfused myocardium. Subsequently, software was optimized with an institutional normal database and thresholds. Diagnostic performances of automated and visual analysis were compared taking FFR as a reference.
Results
Sensitivity did not differ significantly between visual reading and most automated scoring parameters, except for SDS, which was significantly higher than visual assessment (
p
< 0.001). Specificity, however, was significantly higher for visual reading than for any of the automated scores (
p
< 0.001 for all). Diagnostic accuracy was significantly higher for visual scoring (77.2%) than for all NC images scores (
p
< 0.05), but not compared with SSS AC and S-TPD AC (69.8% and 71.2%,
p
= 0.063 and
p
= 0.134). After optimization of the automated software, diagnostic accuracies were similar for visual (73.8%) and automated analysis. Among the automated parameters, S-TPD AC showed the highest accuracy (73.5%).
Conclusion
Automated analysis of myocardial perfusion SPECT can be as accurate as visual interpretation by an expert reader in detecting significant CAD defined by FFR.
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.
A multimodal approach is advised for neurological prognostication in comatose patients after out-of-hospital cardiac arrest (OHCA). Grey-white matter differentiation (grey-white ratio, GWR) obtained ...from a brain CT scan performed < 24 hours after return of circulation can be part of this approach. The aims of this study were to investigate the frequency and method of reporting the GWR in brain CT scan reports and their association with outcome.
This is a post-hoc descriptive analysis of the COACT trial. The primary endpoint was the reporting of GWR by the radiologist. Secondary endpoints were APACHE IV score, Cerebral Performance Categories at discharge and 90-day follow-up, Glasgow Coma Scale at discharge, GWR-stratified 1-year survival, and RAND-36 stratified by normal versus abnormal GWR. Associations were analysed using multivariable analysis.
A total of 427 OHCA patients were included in this study, 234 (55%) of whom underwent a brain CT scan within 24 hours after ROSC. Median time between arrest and initial CT scan was 12 hours. In 195 patients (83%), the GWR was described in the reports, but always expressed qualitatively. The GWR was deemed abnormal in 57 (29%) CT scans. No differences were found in secondary endpoints between the two groups.
GWR was frequently described in CT scan reports. Early abnormal GWR, as assessed qualitatively by a radiologist within 24 hours after ROSC, was a poor predictor of neurological prognosis.
In cardiac arrest, ventricular fibrillation (VF) waveform characteristics such as amplitude spectrum area (AMSA) are studied to identify an underlying myocardial infarction (MI). Observational ...studies report lower AMSA-values in patients with than without underlying MI. Moreover, experimental studies with 12-lead ECG-recordings show lowest VF-characteristics when the MI-localisation matches the ECG-recording direction. However, out-of-hospital cardiac arrest (OHCA)-studies with defibrillator-derived VF-recordings are lacking.
Multi-centre (Amsterdam/Nijmegen, the Netherlands) cohort-study on the association between AMSA, ST-elevation MI (STEMI) and its localisation. AMSA was calculated from defibrillator pad-ECG recordings (proxy for lead II, inferior vantage point); STEMI-localisation was determined using ECG/angiography/autopsy findings.
We studied AMSA-values in 754 OHCA-patients. There were statistically significant differences between no STEMI, anterior STEMI and inferior STEMI (Nijmegen: no STEMI 13.0mVHz 7.9–18.6, anterior STEMI 7.5mVHz 5.6–13.8, inferior STEMI 7.5mVHz 5.4–11.8, p = 0.006. Amsterdam: 11.7mVHz 5.0–21.9, 9.6mVHz 4.6–17.2, and 6.9mVHz 3.2–16.0, respectively, p = 0.001). Univariate analyses showed significantly lower AMSA-values in inferior STEMI vs. no STEMI; there was no significant difference between anterior and no STEMI. After correction for confounders, adjusted absolute AMSA-values were numerically lowest for inferior STEMI in both cohorts, and the relative differences in AMSA between inferior and no STEMI was 1.4–1.7 times larger than between anterior and no STEMI.
This multi-centre VF-waveform OHCA-study showed significantly lower AMSA in case of underlying STEMI, with a more pronounced difference for inferior than for anterior STEMI. Confirmative studies on the impact of STEMI-localisation on the VF-waveform are warranted, and might contribute to earlier diagnosis of STEMI during VF.
The amplitude spectrum area (AMSA) of the ventricular fibrillation (VF) waveform predicts shock success and clinical outcome after out-of-hospital cardiac arrest (OHCA). Recently, also AMSA-changes ...demonstrated prognostic value. Until now, most studies focused on early shocks, while many patients require prolonged resuscitations. We studied AMSA and its changes in relation to shock success, for both the early and later phase of resuscitation.
Per-shock VF-waveform analysis of a prospective OHCA-cohort (Nijmegen, The Netherlands). The absolute AMSA and relative AMSA-changes (ΔAMSA) were calculated from three-second VF-segments prior to defibrillation. Shocks were categorised as early (#1–3) or late (#4–8). Shock success was defined as return of organised rhythm.
Shock success was 46% for early (131/286) and 52% for late shocks (85/162), p = 0.18. Early shock success varied from 23% to 70% with increasing quartiles of AMSA (p-trend<0.001). For late shocks, there also was an association with AMSA, with a narrower range in shock success from 43% to 68% (p-trend = 0.04). Higher values of ΔAMSA were associated with shock success in the early, but not in the later phase.
AMSA relates to shock success during the entire resuscitation, but associations were most apparent for early shocks. AMSA-changes were also associated with shock success, but only in the early phase of resuscitation. In an era of smart defibrillators, absolute AMSA and relative changes hold promise for studies on early guidance of resuscitation, whereas additional studies are warranted to further characterize shock prediction in the later phase.
Cardiac arrests often occur in public places, but despite the undisputed impact of bystander CPR, it is debated whether one should act as a rescuer after alcohol consumption due to the perceived ...adverse effects. We provide the first objective data on the impact of alcohol levels on CPR-skills.
Pre-specified analysis of a randomised study at the Lowlands music festival (August 2019, the Netherlands) on virtual reality vs face-to-face CPR-training. Participants with an alcohol level ≥ 0.5‰ (WHO-endorsed cut-off for traffic participation) were eligible provided they successfully completed a tandem gait test. We studied alcohol levels (AL, ‰) in relation to CPR-quality (compression depth and rate) and CPR-scenario performance.
Median age of the 352 participants was 26 (22–31) years, 56% were female, with n = 214 in Group 1 (AL = 0‰), n = 85 in Group 2 (AL = 0–0.5‰) and n = 53 in Group 3 (AL ≥ 0.5‰). There were no significant differences in CPR-quality (depth: 57 49–59 vs 57 51–60 vs 55 mm 47–59, p = 0.16; rate: 115 104–121 vs 114 106–122 vs 111 min−1 95–120, p = 0.19). There were no significant correlations between alcohol level and compression depth (Spearman’s rho −0.113, p = 0.19) or rate (Spearman’s rho −0.073, p = 0.39). CPR-scenario performance scores (maximum 13) were not different between groups (12 (9–13) vs 12 (9–13) vs 11 (9–13), p = 0.80).
In this study on festival attendees, we found no association between alcohol levels and CPR-quality or scenario performance shortly after training.
Lowlands Saves Lives is registered on https://www.clinicaltrials.gov (NCT04013633).
Shock-resistant ventricular fibrillation (VF) poses a therapeutic challenge during out-of-hospital cardiac arrest (OHCA). For these patients, new treatment strategies are under active investigation, ...yet underlying trigger(s) and substrate(s) have been poorly characterised, and evidence on coronary angiography (CAG) data is often limited to studies without a control group.
In our OHCA-registry, we studied CAG-findings in OHCA-patients with VF who underwent CAG after hospital arrival. We compared baseline demographics, arrest characteristics, CAG-findings and outcomes between patients with VF that was shock-resistant (defined as >3 shocks) or not shock-resistant (≤3 shocks).
Baseline demographics, arrest location, bystander resuscitation and AED-use did not differ between 105 patients with and 196 patients without shock-resistant VF. Shock-resistant VF-patients required more shocks, with higher proportions endotracheal intubation, mechanical CPR, amiodaron and epinephrine. In both groups, significant coronary artery disease (≥1 stenosis >70%) was highly prevalent (78% vs. 77%, p = 0.76). Acute coronary occlusions (ACOs) were more prevalent in shock-resistant VF-patients (41% vs. 26%, p = 0.006). Chronic total occlusions did not differ between groups (29% vs. 33%, p = 0.47). There was an association between increasing numbers of shocks and a higher likelihood of ACO. Shock-resistant VF-patients had lower proportions 24-h survival (75% vs. 93%, p < 0.001) and survival to discharge (61% vs. 78%, p = 0.002).
In this cohort of OHCA-patients with VF and CAG after transport, acute coronary occlusions were more prevalent in patients with shock-resistant VF compared to VF that was not shock-resistant, and their clinical outcome was worse. Confirmative studies are warranted for this potentially reversible therapeutic target.
Collateral artery growth is a potent natural defence mechanism to prevent death and myocardial infarction in occlusive artery disease. Given the high prevalence of arterial obstructive disease, a ...therapeutic compound stimulating collateral vessel growth could have a major impact on morbidity and mortality world wide. Although experimental studies on the stimulation of arteriogenesis have been promising, not a single drug has been proved to be applicable in clinical practice, either because of lack of efficacy or because of undesired side effects. This review summarises current knowledge on the mechanisms of collateral artery growth and examines problems that arise from the clinical implementation of pro-arteriogenic treatments to date. Future directions in the translation from bench to bedside and potential new approaches to the stimulation of vascular growth are discussed.
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