bluuebunny/crossref_metadata_2025_split huggingface dataset:
Long-term PCI outcomes in chronic versus acute coronary syndromes: 5-year results of the TARGET All Comers trial
Authors: Patel K , Lansky A , Kelbaek H , Xu B , Van Royen N , Johnson T , Anderson R , Wijns W , Baumbach A 
Published: November 2023

Abstract

Introduction
In the TARGET AC trial, the biodegradable-polymer sirolimus-eluting Firehawk stent was non-inferior to the everolimus-eluting XIENCE stent with respect to target lesion failure (TLF) at 12 months; however, long-term safety and efficacy in the setting of an acute coronary syndrome (ACS) are not known.

Purpose
To assess the long-term outcomes in ACS vs chronic coronary syndromes (CCS) with the Firehawk stent vs the XIENCE stent

Methods
The TARGET AC study was a multicentre, open label, noninferiority trial of all comer patients randomised 1:1 (stratified by STEMI) to Firehawk or XIENCE stents. In this substudy, outcomes were compared based on clinical presentation (ACS vs CCS) and treatment allocation.

Results
A total of 1653 patients were enrolled (728 with ACS and 922 with CCS) with 94% completing 5-year follow-up. Baseline characteristics were well matched. Target lesion failure (TLF) (15.5% vs 17.7%; p=0.24), patient-oriented composite endpoint (death, any myocardial infarction, or any revascularization) (32.0% vs 34.4%; p=0.31), and stent thrombosis (4.1% vs 3.3%; p=0.40) were similar between ACS and CCS patients (Table 1). Among the ACS cohort, outcomes at 5 years for Firehawk vs XIENCE were not different for TLF (16.0% vs 14.9%; p=0.70), ischemia-driven target lesion revascularisation (ID-TLR) (5.6% vs 8.3%; p=0.17), or definite/probable stent thrombosis (2.7% vs 4.6%; p=0.18). The same was true for the CCS cohort, with 5-year outcomes for Firehawk vs XIENCE for TLF (18.0% vs 17.4%; p=0.82), ID-TLR (6.4% vs 5.0%; p=0.37), and definite/probable stent thrombosis (3.0% vs 1.8%; p=0.26) similar between groups.

Conclusions
One in three patients presenting with CCS or ACS had a major adverse event at 5 years. Long-term, the Firehawk stent was as safe and effective as the XIENCE stent irrespective of clinical presentation.
Poor prognosis after successful primary PCI in STEMI patients with calcified nodule
Authors: Kondo S , Mizukami T , Kobayashi N , Yamamoto M H , Sugiyama T , Kakuta T , Wakabayashi K , Suwa S , Dohi T , Mori H , Kimura S , Mitomo S , Higuma T , Yonetsu T , Shinke T 
Published: November 2023

Abstract

Background
The prognostic impact of the underlying causes of ST-elevation myocardial infarction (STEMI) diagnosed by optical coherence tomography (OCT) has not been systematically examined in real-world settings.

Methods
We executed a post-hoc analysis of the TACTICS/TACTICS background registry, an investigator-initiated, multicenter, observational study conducted at 22 Japanese hospitals, involving 1046 STEMI patients (symptom onset within 24 hours) who underwent primary PCI included 441 patients with OCT-guidance. Underlying causes of STEMI (plaque rupture [PR], plaque erosion [PE] and calcified nodule [CN]) were identified in 338 patients using established OCT definition at independent core-laboratory. Major adverse cardiac events (MACE: cardiovascular death, MI, heart failure, or ischemia-driven revascularization) at 1 year were adjudicated by an independent clinical event committee.

Results
Of 1046 patients with STEMI, 441 (42.2%) underwent OCT-guided primary PCI deemed for analysis. TIMI 3 flow grade was obtained in 95.0% of patients on final angiogram, and optimal post-PCI OCT findings (minimum lumen area ≥4.5 mm2 or ≥70% of the mean reference lumen area) was achieved in 77.9%. The prevalence of PR, PE, and CN was 68.3%, 24.2%, and 3.7%, respectively. One-year MACE occurred most frequently in patients with CN (31.2%), then PR (14.0%) and PE (2.8%) (log-rank P&lt;0.0001). On multivariate Cox regression analysis, the underlying ACS cause was associated with 1-year MACE (CN [HR 9.98, 95%CI 1.99–50.1, p=0.005]; PR [HR 4.84, 95%CI 1.49–15.7, p=0.009]; PE as reference).

Conclusion
OCT-guided primary PCI for STEMI patients seemed feasible for optimizing PCI and stratifying risk for future MACE.Figure
CT pericoronary adipose tissue density predicts coronary allograft vasculopathy and adverse clinical outcomes after cardiac transplantation
Authors: Wall C , Weir-Mccall J , Tweed K , Hoole S P , Gopalan D , Huang Y , Corovic A , Peverelli M , Dey D , Bennett M , Rudd J H F , Kydd A , Bhagra S , Tarkin J M 
Published: November 2023

Abstract

Background
Coronary allograft vasculopathy (CAV) is a common cause of heart transplant failure. Coronary Computed Tomography Angiography (CCTA) is used to assess for luminal stenoses in patients with suspected CAV, but additional non-invasive markers are needed to detect early disease and guide the use of treatments that can prevent or slow CAV progression.

Purpose
We tested the hypotheses that: 1) coronary artery inflammation assessed by pericoronary adipose tissue (PCAT) density and/or total vessel volume-to-myocardial mass ratio (V/M) measured by CCTA could improve the ability to detect CAV in heart transplant patients; and 2) these semi-automated quantitative CCTA metrics would be associated with adverse clinical outcomes.

Methods
In this retrospective observational cohort study, PCAT density, V/M, and lesion composition were measured in consecutive CCTAs from patients who underwent heart transplantation at a single site between 2010 to 2021. These parameters were incorporated into predictive models for CAV as defined by International Society for Heart & Lung Transplant criteria, and evaluated against long-term clinical outcomes.

Results
A total of 126 CCTAs were analysed from 94 patients after heart transplant (mean age 49 [SD 14.5] years, 40% female) without CAV (n=86) and with CAV (n=40). PCAT density was higher in transplant patients with CAV (-73.0 HU [SD 9.26]) than without CAV (-77.9 HU [SD 8.23]), and age and sex-matched controls (n=12; -86.19 HU, [SD 5.38]), p&lt;0.001 for both. Unlike patients with atherosclerotic coronary artery disease (n=32), CAV lesions were predominately non-calcified, comprised of mostly fibrous or fibrofatty tissue. V/M was lower in patients with CAV than without (32.4 mm3/g vs. 44.4 mm3/g, p&lt;0.001). PCAT density and V/M improved the ability to predict CAV from AUC 0.78 to 0.87 on receiver operating characteristic analysis (Figure A) when added to donor age and donor/recipient hypertension status (p&lt;0.0001). PCAT density above -66 HU was associated with a greater incidence of all-cause mortality (OR 16.6 95%CI 2.88-109.98, p&lt;0.01; Figure B, box-plot) and the composite endpoint of death, CAV progression, acute rejection, and coronary revascularisation (OR 6.3 95%CI 1.6-32.9, p=0.01) over 5.25 (SD 2.1) years.

Conclusions
Heart transplant patients with CAV have higher PCAT density and lower V/M than those without. Patients with very high PCAT density on CT had markedly increased incidence of all-cause mortality and major adverse clinical events. These semi-automated metrics could be a useful addition to standard clinical CCTA reporting for diagnosis and monitoring of CAV.Diagnostic Benefit of CTCA MetricsPCAT is predictor of Future Mortality
First in human study BIOMAG-I: 12 months results of the sirolimus eluting resorbable coronary magnesium scaffold system (DREAMS 3G) in the treatment of subjects with de novo coronary artery lesions
Authors: Haude M , Wlodarczak A , Van Der Schaaf R , Torzewski J , Ferdinande B , Escaned J , Iglesias J F , Bennett J , Toth G , Joner M , Toelg R , Wiemer M , Olivecrona G , Vermeersch P , Waksman R 
Published: November 2023

Abstract

Background/Introduction
Bioresorbable scaffolds have emerged as an attractive alternative to polymeric scaffolds. A 3rd generation drug-eluting resorbable magnesium scaffold (DREAMS 3G) was developed to enhance the performance of previous scaffold generations and achieve angiographic outcomes comparable to those of contemporary drug-eluting stents.

Purpose
The aim of the BIOMAG-I first-in-human (FIM) study was to assess the angiographic, clinical and safety performance of DREAMS 3G in patients with de novo coronary artery lesions. We assessed the 12-month safety and performance of this novel device as well intravascular imaging data at baseline, 6- and 12-month follow-up.

Methods
In this prospective, multicentre, non-randomized, first-in-human study 116 subjects with 117 coronary artery lesions were enrolled at 14 centers in Europe. Clinical follow-up was scheduled at 1, 6 and 12-months and annually thereafter until 5 years. Invasive imaging assessments were scheduled 6 and 12-months post-procedure. Vasomotion was assessed in a subgroup of subjects during the 12-months follow-up. The primary endpoint was in-scaffold LLL at six months. Secondary endpoints include in-segment LLL, TLF, clinically driven target lesion revascularization (TLR), cardiac death, target-vessel myocardial infarction (TV-MI) and scaffold thrombosis.

Results
Preliminary in-scaffold LLL (n=89 subjects) remained stable from 6 months (0.20 ± 0.28 mm) to 12 months (0.24 ± 0.35 mm). Interim intravascular ultrasound assessments and optical coherence tomography findings corroborated the QCA results with a preservation of the lumen area from 6 (IVUS: 7.0 ± 2.5 mm2; OCT: 8.1 ± 2.7 mm2) to 12 months (IVUS: 7.2 ± 2.6 mm2; OCT: 7.8 ± 2.6 mm2). Vasomotion assessment in a subgroup of subjects confirmed the motility of the scaffolded segment at 12 months follow up: after Acetylcholine administration: 12.5% ± 7.5 (n=27); after nitro administration: 10.7% ± 9.2 (n=22). Up to 12-months follow up, 3 clinically driven TLR were reported (3.4%). No cardiac death, no TV-MI and no scaffold thrombosis were reported up to 12 months. Full data set of the 116 subjects will be available upon presentation.

Conclusions
The novel third-generation drug-eluting magnesium scaffold, DREAMS 3G, showed a continuous favorable safety and efficacy profile up to 12 months and stable angiographic parameters between 6 and 12 months. Intravascular imaging assessment showed a preservation of the lumen area between 6 and 12 months.
Very Early Discharge of LOw-Risk ST Elevation MI patients after successful primary percutaneous coronary intervention (VEDLOR-STEMI) study
Authors: Yalamanchi R , Narra L , Nandhini V , Reddy Y V C , Mahilmaran A , Sengottuvelu G , Oomman A , Showkathali R 
Published: November 2023

Abstract

Background
Current European guidelines recommend discharging low-risk STEMI patients after successful primary PCI at 48-72 hours, based on meta-analysis and large observational studies. There is overall trend towards reducing hospital stay after the COVID-19 pandemic with the risk of cross-infection and to reduce the strain on bed capacity in hospitals.

Purpose
With this background, we decided to create a pathway to implement very early discharge (within 48 hours) of low-risk STEMI patients after successful primary PCI. The aim of this study is to assess the feasibility and safety of this approach in our centre.

Methods
This is a single arm, open label prospective observational study of patients undergoing primary PCI in a single high volume tertiary cardiac center. The inclusion criteria included patients ≤70 years with STEMI presenting within 12 hours of symptom onset, one or two vessel disease (&gt;50% stenosis) who underwent successful primary PCI with TIMI 3 flow with LVEF of ≥45% after 24 hrs. Patients with persistent arrhythmia after PCI, recurrent ischemic symptoms, severe anaemia (Hb ≤7 g/dl), eGFR ≤ 45ml/min/1.73 m2 and cardiogenic shock were excluded. We created specific pathways to identify and implement the very early discharge protocol (within 48 hours) in these patients with regular telephone follow up (1st and 3rd post-discharge days) and direct clinic visit at 1 week and after 1 month. The primary outcome of the study was major adverse cardiovascular event at 1 week and 30 days after discharge. Secondary outcome included patient’s satisfaction on early discharge.

Results
From Mar 2021 to Dec 2022, 84 [mean age 55 ± 9 yrs, 16 (18.2%) females] out of 106 patients provided informed consent to be included in the study. Diabetes, Hypertension, Dyslipidemia, and smoking history were noted in 46 (52.2%), 39 (44.3%), 41 (46.5%) and 6 (6.8%) patients respectively. Mean LVEF was 50±5% after 24 hours of primary PCI. The procedural characteristics of the patients are provided in Table 1. Five patients (5.7%) had minor complictions post discharge; 2 had access site pain, one had giddiness due to hypotension, one had chest pain post discharge, and another had allergic reaction. All of them were managed without the need for re-admission. At one week follow up, except for 2 patients, all others (98%) were satisfied with this early discharge protocol. There was no major adverse cardiac event at 1 week and 30 days.

Conclusion
This single centre study shows that very early discharge (within 48 hrs) of low-risk STEMI patients after successful primary PCI is feasible and safe with appropriate discharge pathway and follow-up arrangements. Larger studies are needed to confirm this finding.
Remote ischemic peri-conditioning suppressed the activation of cardiac sympathetic nervous system in patients with acute myocardial infarction: a randomized controlled trial
Authors: Kondo T , Watanabe T , Yamada T , Morita T , Kawasaki M , Kikuchi A , Kawai T , Nishimoto Y , Seo M , Nakamura J , Kayama K , Tamura Y , Fujita T , Fukunami M 
Published: November 2023

Abstract

Background
The activation of cardiac sympathetic nervous system is associated with poor prognosis in patients with acute myocardial infarction (AMI). Remote ischemic peri-conditioning (RIPC) is reported to improve clinical outcome in patients with AMI. However, there is not fully clarified whether RIPC could have an effect on cardiac sympathetic activity.

Purpose
The purpose of this study is to investigate the effect of RIPC on cardiac sympathetic activity in patients with AMI.

Methods
We randomly assigned 157 patients with suspected AMI undergoing emergent percutaneous coronary intervention to receive transient limb ischemia (by inflating a cuff at 200 mmHg for 4×5 minutes: RIPC group, n=77) or no procedure (control group, n=80) upon arrival to the cardiac catheterization laboratory. After excluding inappropriate patients such as those who were diagnosed with other than AMI, we analyzed 122 patients (62 patients in RIPC and 60 in control group). The primary endpoint was cardiac sympathetic activity assessed by the cardiac MIBG imaging washout rate (WR) at discharge and 1 year after discharge. WR and late heart-to-mediastinum ratio (HMR) in cardiac MIBG was calculated from the chest anterior view images obtained at 20 and 200 min after isotope injection.

Results
Patients in RIPC and control group had similar demographic and clinical characteristics at baseline. There was no significant difference in WR between two groups at discharge. Although WR was significantly decreased 1 year after the discharge in both groups, patients in RIPC group showed significantly lower WR than those in control group (22.0 [15.1-30.6]% and 26.5 [18.4-34.4]%, p=0.0269) 1 year after the discharge. Late HMR significantly decreased during 1-year follow-up in patients only in RIPC group (p=0.0133) and patients in RIPC group tended to show higher late HMR compared to those in control group (2.01 [1.79-2.25] and 1.92 [1.72-2.11], p=0.0581) 1 year after the discharge.

Conclusion(s)
Remote ischemic peri-conditioning could suppress the augmented cardiac sympathetic activity in patients with acute myocardial infarction during 1-year follow-up.
Impact of new-onset versus preexisting atrial fibrillation on short- and long-term mortality in patients with STEMI treated with primary PCI
Authors: Klaric M , Milasinovic D , Mehmedbegovic Z , Mladenovic D J , Popovic J , Dukic D J , Travica L , Sarenac D , Asanin M , Stankovic G 
Published: November 2023

Abstract

Background
Comparative data on the effects of new-onset vs. preexisting atrial fibrillation (AF) on long-term mortality in patients with ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) are scarce. Therefore, the aim of this study was to assess the impact of new-onset vs. preexisting AF on mortality over 5 years after primary PCI.

Methods
Our analysis included 7 955 patients referred to primary PCI in the period from 2009 to 2019, for whom data regarding the presence and type of AF were available, from a prospective electronic registry of a high-volume catheterization laboratory. Patients were stratified into three groups according to the AF status: no AF vs. new-onset vs. preexisting AF. Cumulative mortality was compared with Kaplan Meier curves. Cox regression models were created to assess the mortality hazard at 30 days and 5 years according to the presence of new-onset and preexisting AF with no AF as the reference group. 30-day follow-up was available for 7 738 and 5-year for 5 049 patients.

Results
Preexisting AF was found in 3.1% of patients (n=246) and new-onset AF was recorded in 7.0% (n=560). Both new-onset and preexisting AF were associated with higher crude mortality rates compared to patients without AF, at 30 days (14.4% vs 16.0% vs. 5.2%, respectively; p&lt;0.001) and at 5 years as well (56.6% vs. 65.7% vs. 25.4%, respectively; p&lt;0.001). Cumulative mortality rates were significantly higher for both new-onset and preexisting AF, as compared to patients with no AF (Log rank p&lt;0.001, Figure). Patients with new-onset and preexisting AF were older and had a higher baseline risk profile including more frequently prior MI and stroke, more diabetes, hypertension, hyperlipidaemia, renal failure, Killip class ≥2 on admission and lower ejection fraction. When adjusted for these baseline differences, both new-onset and pre-existing AF independently predicted 5 year mortality (HR 1.6, 95%CI 1.4-1.9, p&lt;0.001, and HR 2.2, 95%CI 1.8-2.8, p&lt;0.001, respectively), but not at 30 days (HR 1.4, 95%CI 0.9-2.0, p=0.1, and HR 1.5 95%CI 0.9-2.5, p=0.1, respectively).

Conclusion
Both new-onset and pre-existing AF are independently associated with an increased risk of long-term mortality in patients with STEMI treated with primary PCI, whereas their impact on short-term mortality reflects the higher baseline risk profile of those patients.Cumulative mortality rates
Safety of early discharge after primary percutaneous coronary intervention in low risk ST-segment elevation myocardial infarction presented in a tertiary center without an established STEMI network
Authors: Kristo A , Gjana A , Pavli E , Duka A , Voci A , Zaimi G , Bileri A , Luzati M , Pane E , Dibra A , Kastrati A 
Published: November 2023

Abstract

Introduction
The application of ST-segment elevation myocardial infarction (STEMI) networks, is a key factor for improvements in outcomes of STEMI patients, leading to earlier treatment, better outcomes and shorter hospital stay. Current guidelines support an early discharge (48-72 h) in selected low risk patients. Yet, this strategy is not routinely applied, especially in centers without an established STEMI network.

Purpose
To evaluate safety of early discharge in low risk STEMI patients treated with primary PCI by analyzing 30 days outcomes, in a unique tertiary center without an established STEMI network and serving a large area of population.

Methods
We prospectively collected data from 220 consecutive patients admitted to our center with diagnosis of STEMI, in two different time periods, categorized as low risk according to Zwolle risk score.175 patients were discharged within 72 hours and 45 patients after 72 hours. Follow-up was done by phone call at 30 days. Primary endpoint was occurrence of a major adverse event - a composite of death from cardiac cause, nonfatal myocardial re-infarction, and repeat intervention. Secondary endpoints were death from any cause, residual angina and re-hospitalization.

Results
The mean age was 58.12 +/-10.32 years. 193 (87%) of patients were male. 118 (53.6%) of them had inferior MI. Mean ejection fraction was 50% +/- 6.04%. Median symptom to hospital arrival time was 5.17 +/- 0.2 hours. Median length of hospital stay was 69.8 +/-17.09 hours. Primary endpoint occurred in 6 (3.4%) patients, all of them in the &lt;72 hours discharge group. 3 patients had cardiac death, 3 had nonfatal MI and eventually 2 of them had repeat intervention. Secondary endpoint occurred in 8 (4.6%) patients in the &lt;72 hours discharge group and 1 (2.2%) patient in the &gt;72 hours discharge group, all of them having residual angina.

Conclusion
In low risk STEMI patients treated with successful primary PCI, data from our study suggest that an early discharge strategy within 72 hours is associated with comparable outcomes regarding major adverse events compared to late discharge strategy.
Impact of ambulance paramedics missing STEMI diagnosis on subsequent management
Authors: Girolamo O , Tavella R , Pham M , Beltrame J , Worthley M , Zeitz C 
Published: November 2023

Abstract

Background/introduction
Acute ST elevation myocardial infarction (STEMI) is defined by acute changes in the electrocardiograph (ECG) reflecting acute occlusion of a coronary artery. Rapid and complete reperfusion of the culprit lesion improves immediate mortality and long-term outcomes. Systems of care have been developed to optimise recognition and management of acute STEMI to facilitate the best possible patient outcomes. Pre-hospital diagnosis by ambulance paramedics and activation of Code STEMI teams has been shown to significantly impact treatment times and patient outcomes. But what is the outcome if the diagnosis is missed?

Methods
We studied 559 consecutive STEMI cases presenting to our health network with two 24/7 interventional sites over a three-year period (2020-2022 inclusive), comparing the impact of arrival by ambulance or self-presentation. Ambulance arrival cases were further stratified by whether Code STEMI was activated prior to hospital arrival or afterwards. Patients who developed STEMI after presentation to hospital or who were transferred from another institution were excluded from this analysis. Only patients proceeding to percutaneous intervention of the culprit lesion were included. First medical contact (FMC) is either hospital door time or time of ambulance paramedic arrival at patient. ECG time reflects first recorded ECG, either by ambulance paramedic or hospital emergency department.

Results
Results are depicted in the table below.
Patients with STEMI had similar FMC to treatment times if diagnosed pre-hospital by the ambulance paramedic or after self-presentation to the emergency department. Interestingly, patients self-presenting to the emergency department had a longer symptom duration, perhaps reflecting uncertainty regarding the cause for symptoms and the rationale for not utilising ambulance services. Patients presenting via ambulance, where the diagnosis and activation of Code STEMI did not occur prior to hospital arrival, had less ST elevation and a significant delay in definitive treatment.

Conclusion(s)
Ambulance paramedics successfully diagnosed 69% of STEMI cases they transported, activating a Code STEMI prior to hospital arrival. Cases that were not pre-notified had less marked ST elevation, potentially creating uncertainty as to the diagnosis. Strategies to enable direct discussion of equivocal ECG changes and symptoms between ambulance paramedics and interventional cardiologists my assist in more complete recognition of all STEMI cases without creating excessive false activations.Table 1:Results