bluuebunny/crossref_metadata_2025 huggingface dataset:
Assay of macrotroponin I not complexed with troponin T: effect on the performance of troponin T to predict myocardial infarction
Authors: Pemberton C J , Raudsepp S D , Lee J A , Wise J , Jina K , Powell J , Aldous S , Troughton R , Pickering J , Than M , Peacock F W , Richards A M
Published: November 2023

Background

Cardiac troponin-immunoglobulin (Ig) complexes (macrotroponin) can interfere with cardiac troponin (cTn) test performance. However, the role of this interference has not been fully explored. We developed a specific, novel, 2-hour prototype immunoassay of monomer IgG-bound TnI (bTnI-IgG). Using this assay, our purpose was to examine the potential contribution of cTnT binding to macro-TnI, and report its effects on the clinical diagnostic and predictive performance of highly sensitive TnT (hs-TnT) and TnI (hs-TnI) assays.

Methods

Using the bTnI-IgG assay, we evaluated EDTA blood samples taken at presentation (t=0) from two ED acute chest pain studies; SPACE (n=1066) and FAST-TRAC (n=1440), with statistical analysis (logistic regression, ROC curves), to AMI and 1-year outcomes, alone and in combination, with hsTnT (Roche) and hsTnI (Abbott/Beckmann) tests. Pathway analysis was used to identify if single bTnI-IgG measurements improve risk stratification in low and high AMI risk.

Results

In individual and combined study datasets, bTnI-IgG concentrations in patients with adjudicated acute MI (n=336) were lower than all other diagnoses (p<0.001). Singularly, and in multivariable models containing hs-TnT or hs-TnI concentrations, bTnI-IgG was an independent predictor of MI. Amongst all patients with MI not ruled-out on presentation (hs-TnT >5ng/L) and not high-risk (hsTnT<14ng/L), the addition of bTnI-IgG to a model containing hs-TnT, HxMI and sex improved discrimination (AUC increase of 0.014 (95%CI: 0.004 to 0.025) from 0.788 to 0.802, p=0.009). Within a diagnostic pathway analyses of n=2126 matched patient data points, adding presentation bTnI-IgG measurement alone to an MI risk stratification model consisting of hs-TnT ≤URL, HxMI and sex yielded 14% more low risk patients identified (n=586 v 667 patients) through improved specificity (77% to 88%) whilst maintaining an overall sensitivity of >99%. bTnI-IgG also predicted 1-year mortality and new stroke in all patients (Odds Ratios 0.292 [95%CI 0.130 to 0.654] p=0.009) and 0.255 ([95%CI 0.078 to 0.834] p=0.024), respectively.

Conclusions

Measurement of bTnI-IgG that is free from cTnT could potentially improve ED presentation diagnostic test performance and risk stratification of MI patients using criteria that includes hs-TnT. No effects upon hs-TnI assays were observed. This data suggests current hs-TnT test design and measurements may be impacted by binding interactions between TnT and TnI. Finally, bTnI-IgG can independently predict mortality and stroke outcomes within 1 year of index presentation.
Does a high baseline high sensitivity cardiac troponin T allow for the early diagnosis of acute myocardial infarction?
Authors: Knott J , Ola O , De Michieli L , Akula A , Yang E , Gharacholou M , Lewis B , Mehta R , Sandoval Y , Jaffe A
Published: November 2023

Background

Guidelines suggest that the diagnosis of acute myocardial infarction (MI) is likely when high concentrations of high-sensitivity cardiac troponin (hs-cTn) are present in the initial sample. These concentration thresholds are much higher than the 99th percentile and are said to provide a high positive predictive value (PPV) for acute MI1.

Purpose

Evaluate the PPV of recommended baseline hs-cTnT thresholds (>52 and >100 ng/L) for the diagnosis of acute MI from our multi-center United States (US) experience.

Methods

Retrospective, multicenter (n=22), observational biomarker study involving consecutive, adult patients presenting to the emergency department (ED) in whom at least 1 hs-cTnT measurement was obtained within 12 hours of presentation (CV DataMart Biomarker cohort). The primary endpoint was also evaluated in an adjudicated cohort of consecutive patients presenting to the ED with at least 1 hs-cTnT >99th percentile (ACTION cohort). These cases were adjudicated based on the Fourth Universal Definition of MI by trained physicians. The primary efficacy endpoint was the PPV of acute MI (type 1 or 2), type 1 MI and type 2 MI during index hospitalization using baseline hs-cTnT thresholds of >52 ng/L and >100 ng/L.

Results

The CV DataMart Biomarker cohort consisted of 143,709 patients, amongst whom 3,003 (2.1%) were diagnosed with acute MI using ICD codes. In the CV DataMart Biomarker cohort, baseline hs-cTnT concentrations of >52 ng/L and >100 ng/L resulted in PPVs of 12% (95% CI: 11, 12) and 17% (95% CI: 17, 19) for acute MI, respectively. In patients with chest pain and baseline hs-cTnT concentrations >52 ng/L, PPV for acute MI was 17% (95% CI: 15, 18), and in those with hs-cTnT concentrations >100 ng/L, PPV was 22% (95% CI: 19, 25). The adjudicated ACTION cohort consisted of 2,107 patients, amongst whom 155 (7.4%) were diagnosed with acute MI including 64 (41%) with type 1 MI and 91 (59%) with type 2 MI. In the ACTION cohort, baseline hs-cTnT concentrations of >52 ng/L and >100 ng/L resulted in PPVs of 46% (95% CI: 40, 53) and 62% (95% CI: 53, 70) for acute MI, respectively. In patients with chest pain and baseline hs-cTnT concentrations >52 ng/L, PPV was 67% (95% CI: 57, 76) for acute MI, 52% (95% CI: 41, 62) for type 1 MI and 15% (95% CI: 8.4, 24) for type 2 MI. In those with chest pain and baseline hs-cTnT concentrations >100 ng/L, PPV was 77% (95% CI: 65, 87) for acute MI, 64% (95% CI: 51, 75) for type 1 MI and 14% (95% CI 6.4, 24) for type 2 MI (Figure).

Conclusion

Using previously recommended high-risk hs-cTnT thresholds of 52 and 100 ng/L in US patients provides reasonable performance to rule-in acute MI when used in patients with chest pain. When used more broadly across all-comers, the diagnostic performance is poor.
Fractional flow reserve and fractional flow reserve gradient from coronary CT angiography for future coronary events
Authors: Hong D , Dai N , Lee S H , Shin D , Choi K H , Kim S M , Park T K , Yang J H , Song Y B , Hahn J Y , Choi S H , Choe Y H , Gwon H C , Ge J , Lee J M
Published: November 2023

Background

Coronary computed tomography angiography (CCTA)-derived fractional flow reserve (FFRCT) is per-vessel index reflecting cumulative hemodynamic burden while percutaneous coronary intervention is per-lesion treatment that relieves ischemia in a focal lesion.

Purpose

We sought to evaluate additive prognostic value of local gradient of FFRCT (FFRCT gradient) in addition to FFRCT to predict future coronary events.

Methods

The current study included 239 patients (617 vessels) who underwent CCTA within 6-36 months prior to index angiography, of which 202 vessels had future coronary events and 415 vessels did not. Future coronary events were defined as a composite of vessel-specific myocardial infarction or urgent revascularization during mean interval of 1.5 years. Preexisting disease patterns were classified according to cumulative burden and local severity of coronary atherosclerosis, expressed as FFRCT ≤0.80 and FFRCT gradient ≥0.025/mm, respectively.

Results

Both FFRCT (per 0.01 decrease; HR 1.039, 95% CI 1.029-1.050, P<0.001) and FFRCT gradient (per 0.01 increase; HR 1.140, 95% CI 1.096-1.185, P<0.001) were significantly associated with the risk of future coronary events. Severe local disease defined by FFRCT gradient≥0.025/mm showed significantly higher risk of future coronary events than FFRCT gradient<0.025/mm in both FFRCT>0.80 (52.2% vs. 29.4%, HR 2.212, 95% CI 1.357-3.607, P=0.001) and FFRCT≤0.80 groups (59.6% vs. 39.4%, HR 1.894, 95% CI 1.255-2.856, P=0.002). Adding FFRCT gradient into model with FFRCT alone showed significantly increased predictability for future coronary events (global chi-square 43.1 vs. 37.5, P=0.018), and physiologic classification of disease patterns integrating both FFRCT and FFRCT gradient was independent predictor of future coronary events (HR 1.325, 95% CI 1.135-1.548, P<0.001).

Conclusions

Patients with severe local disease defined by high FFRCT gradient showed significantly increased risk of future coronary events irrespective of FFRCT. Integrating both FFRCT and FFRCT gradient showed incremental predictability for future coronary events than FFRCT alone.Graphic Abstract
ARCANGELO: an observational, prospective study with acute coronary syndrome patients undergoing percutaneous coronary intervention who receive cangrelor transitioning to oral P2Y12 inhibitors
Authors: De Luca L , Calabro P , Capranzano P , Musumeci G , Di Mario C , Bolognese L
Published: November 2023

Background

The use of oral platelet P2Y12 receptor inhibitors, to reduce the risk of thrombotic complications related to Percutaneous Coronary Intervention (PCI), have some limitations in the acute phase, e.g., the delayed onset of action and lack of bioavailability in critical patients. Cangrelor is the only intravenous P2Y12 inhibitor, which based on its quick onset and offset of action is a valid alternative option for antiplatelet therapy, particularly for patients who are unable to take oral medications or for whom oral administration is not adequate. Notably, during the clinical development program of cangrelor, ticagrelor and prasugrel were not marketed and, therefore, the pivotal studies were conducted only with transitioning to clopidogrel. The aim of ARCANGELO study was the evaluation of the safety and effectiveness of cangrelor when administered to patients with Acute Coronary Syndrome (ACS) undergoing PCI in a real-world setting, including patients who received cangrelor transitioning to either clopidogrel, prasugrel, or ticagrelor.

Methods

Adult patients eligible to PCI for ACS who received cangrelor and who consented to take part in the study in 28 Italian centers, were followed in the 30 days after PCI. Bleedings, major adverse cardiac events (MACEs), and adverse events were recorded. The primary outcome was the incidence of any bleedings, according to BARC (Bleeding Academic Research Consortium) criteria, at 30 days post-PCI.

Results

A total of 1,004 patients were enrolled and 995 (99.2%) patients were eligible for analysis. Median (IQR) age was 65 (56-73) years, and 771 (77.5%) patients were males. 597 (59.9%) patients had ST-segment Elevation Myocardial Infarction; 509 (51.2%) patients had multi-vessel vessel coronary artery disease. A radial artery access was used in 926 (93.1%) patients and drug-eluting stents were implanted in almost all patients (n=972, 97.7%). All 995 patients included in the analysis received 30 micrograms/kg by intravenous bolus and 4 micrograms/kg/min by intravenous infusion. 730 patients (73.4%) were then transitioned to ticagrelor, 127 (12.8%) to prasugrel, and 138 (13.9%) to clopidogrel. 52 (5.2%) (95% CI 3.9% - 6.8%) patients experienced at least one bleeding event up to 30 days post-PCI. Five patients (0.5%) experienced at least one BARC type 3-5 (moderate-severe) bleeding (all type 3). Fourteen (1.4%) patients presented with at least one MACEs during observation (6 [0.6%] death, 7 [0.7%] myocardial infarction, 2 [0.2%] stent thrombosis). Six (0.6%) patients experienced at least one Treatment-Emergent Adverse Events related to cangrelor.

Conclusions

The results of this large real-world evidence study confirm that the use of cangrelor in patients with ACS undergoing PCI and transition strategy to the currently used P2Y12 oral inhibitors is safe and effective in daily practice.
Prognostic value of a novel artificial intelligence-based coronary computed tomography angiography-derived ischemia algorithm for patients with suspected coronary artery disease
Authors: Baer S , Nabeta T , Maaniitty T , Bax J J , Saraste A , Earls J , Min J K , Knuuti J
Published: November 2023

Introduction

Coronary computed tomography angiography (CCTA) has emerged as the first-line, non-invasive imaging tool to detect coronary artery disease (CAD) in patients with low to intermediate pre-test probability of CAD. However, CCTA cannot directly assess the presence of ischemia, which may lead to further downstream testing. A novel artificial-intelligence (AI)-based algorithm, comprising a machine-learned method that leverages atherosclerosis and vascular morphology features to determine vessel-level coronary ischemia from CCTA images, may be useful in this regard.

Purpose

We aimed to investigate the prognostic value of the AI-based ischemia algorithm for clinical events among symptomatic patients with suspected CAD referred for CCTA.

Methods

The AI-based ischemia algorithm was calculated by analysts blinded for patient characteristics and clinical outcomes using CCTA data from patients with suspected CAD who underwent clinically indicated CCTA at a large tertiary care center from February 2007 to December 2016. The primary endpoint was the composite of death, myocardial infarction (MI), and unstable angina pectoris (uAP) throughout a median follow-up of 8.1 years (IQR 6.0-9.6). Secondary endpoints were the association between the AI-based ischemia algorithm and the primary endpoint among patients with no/non-obstructive (i.e. ≤50%) CAD vs. obstructive (i.e. >50% stenosis) CAD in CCTA.

Results

1574 patients were evaluated by the AI-based ischemia algorithm and 1540 were analyzable. Patients with positive AI-based ischemia findings (30.4%, n=468) had a significantly higher crude rate of the primary endpoint as compared to patients with negative AI-based ischemia findings (69.6%, n=1072) (HR 2.37, 95% CI 1.80-3.11, p<0.001), driven by higher rates of all endpoint composites (death: HR 1.48, 95% CI 1.13-2.22, p=0.007; MI: HR 5.42, 95% CI 3.10-9.49, p<0.001; uAP: HR 6.76, 95% CI 3.01-15.20, p<0.001). Results were consistent after adjusting for clinical confounders (age, sex, diabetes mellitus, smoking, hypertension, dyslipidemia, BMI>25 kg/m2, CAD family history) (primary endpoint: HR 1.66, 95% CI 1.24-2.22, p=0.001). Positive AI-based ischemia findings were associated with a significantly higher rate of the primary endpoint among patients with no/non-obstructive CAD in CCTA (n=1001/1487) (HR 2.56, 95% CI 1.53-4.27, p<0.001), but not among those with anatomically obstructive CAD in CCTA (n=486/1487) (HR 1.08, 95% CI 0.70-1.66, p=0.715).

Conclusions

A novel AI-based CCTA-derived ischemia algorithm was associated with a 1.7-fold increased adjusted rate of long-term death, MI, or uAP. This AI-based ischemia algorithm may be helpful to improve risk stratification, especially among patients with normal/non-obstructive CCTA.Kaplan Meier CCTA ≤50% and >50% stenosis
Clinical impact of high platelet reactivity in patients with atrial fibrillation and concomitant percutaneous coronary intervention on dual or triple antithrombotic therapy
Authors: Berteotti M , Gori A M , Giusti B , Fortini A , Grossi G , Ciardetti N , Migliorini A , Lotti E , Valenti R , Di Mario C , Marchionni N , Marcucci R
Published: November 2023

Background

High platelet reactivity (HPR) on clopidogrel is an established thrombotic risk factor after percutaneous coronary intervention (PCI). The introduction of more potent antiplatelet drugs has partially surpassed this issue. However, in the setting of concomitant atrial fibrillation (AF) and PCI clopidogrel is still the most adopted P2Y12 inhibitor.

Purpose

We sought to evaluate the possible clinical relevance of genetic and platelet function testing (PFT) in a real-world population with concomitant AF and PCI on dual (DAT) or triple (TAT) antithrombotic therapy.

Methods

All consecutive patients with history of AF discharged from our cardiology ward with DAT or TAT after a PCI from April 2018 to March 2021 were enrolled in an observational registry. For all subjects, blood serum samples were collected and tested for platelet reactivity by arachidonic acid and ADP (VerifyNow system) and genotyping of the CYP2C19*2 loss-of-function polymorphism. We recorded at 3 and 12-months follow-up: (1) major adverse cardiac and cerebrovascular events (MACCE), (2) major hemorrhagic or clinically relevant non-major bleeding and (3) all-cause mortality.

Results

A total of 147 patients were included (91, 62% on TAT). In 93.4% of patients, clopidogrel was chosen as P2Y12 inhibitor. P2Y12 dependent HPR resulted an independent predictor of MACCE both at 3 and 12 months (HR 2.93, 95% C.I. 1.03 to 7.56, p=0.027 and HR 1.67, 95% C.I. 1.20 to 2.34, p=0.003, respectively). At 3-months follow-up the presence of CYP2C19*2 polymorphism was independently associated with MACCE (HR 5.21, 95% C.I. 1.03 to 26.28, p=0.045).

Conclusions

In a real-world unselected population on TAT or DAT, the entity of platelet inhibition on P2Y12 inhibitor is a potent predictor of thrombotic risk, suggesting the clinical utility of this laboratory evaluation for a tailored antithrombotic therapy in this high-risk clinical scenario.
Ticagrelor versus Clopidogrel in diabetes patients afflicted with acute coronary syndrome stratified by renal function
Authors: Wang T , Shyu K
Published: November 2023

Background

Ticagrelor has been recommended in place of clopidogrel as part of dual antiplatelet therapy (DAPT) in diabetic patients with acute coronary syndrome (ACS). Chronic kidney disease (CKD) patients also have a worse prognosis in the setting of ACS, but the safety and efficacy data for the use of P2Y12 inhibitors in moderate to severe CKD patients (eGFR <60 mL/min/1.73m2) are insufficient.

Purpose

There has been limited data on the outcome of prescribing ticagrelor compared to clopidogrel in ACS-DM patients with chronic kidney disease (CKD).

Methods

This prospective, nationwide, multi-center, observational study, the Acute Coronary Syndrome-Diabetes Mellitus Registry (ACS-DM Registry) was compiled from consecutive patients between October 1, 2013 and September 30, 2016. The primary end point was repeated revascularisation and the composite outcome was CV death, repeat revascularisation and CV-related readmission, was stratified by renal function stages. The Cox proportional hazards models and propensity score models were applied to six-months, one-year, and two-year post ACS, respectively.

Results

There were 539 patients with moderate to severe CKD or on dialysis identified from ACS-DM Registry. There were 451 patients eligible for inclusion criteria of which 116 patients were taking ticagrelor and 335 patients were taking clopidogrel. At our two-year follow-up, the unadjusted incidence of primary end point resulted higher in Ticagrelor group (HR 2.09, 95% CI 1.37-3.18, p = 0.001). After adjustment, ticagrelor also had poor primary end point event and composite outcome as compared to clopidogrel (HR 2.24, 95% CI 1.36-3.68, p = 0.002; HR 1.63, 95% CI 1.06-2.48, p = 0.024, respectively). In regards to the repeated revascularisation issue, the clopidogrel was preferable within the eGFR strata (CKD stage III: HR 2.53, 95% CI 1.32-4.84, CKD stage IV: 1.06 (0.09-12.51), CKD stage V: 1.91 (0.80-4.59), P for interaction=0.684).

Conclusions

Cardiovascular benefits associated with ticagrelor may not be as significant as in the landmark trial. Our results show that patients taking ticagrelor was associated with increased CV events as compared to clopidogrel in ACS-DM patients with stage III-V CKD.propensity score matchingForest plots
Almost 1 in 2 patients with acute coronary syndrome are extremely high-risk and potential candidates for in-hospital triple lipid-lowering therapy: data from the CALLINICUS-Hellas Registry
Authors: Rallidis L , Kalogeras P , Leventis I , Tsamoulis D , Tasoulas D , Zapantiotis D , Kalantzis C , Malkots B , Bouratzis V , Delakis I , Potoupni V , Eleutheriou D , Daios S , Papathanasiou K , Vlachopoulos C
Published: November 2023

Introduction

The great heterogeneity of acute coronary syndrome (ACS) patients in the risk for cardiovascular events recurrence, prompted a recent position paper endorsed by the International Lipid Expert Panel to propose criteria, i.e. coexistence of multivessel coronary artery disease (CAD), polyvascular disease, heterozygous familial hypercholesterolemia (heFH), diabetes mellitus (DM) with estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2 and/or lipoprotein (a) [Lp(a)] >50 mg/dL etc., which define the extremely high-risk ACS patients for whom an low-density lipoprotein cholesterol (LDL-C) <40 mg/dL was proposed.

Purpose

To estimate the proportion of patients with ACS that fulfill the criteria of the extremely high-risk group and are potential candidates for "extremely" intensive early lipid-lowering therapy (LLT) aiming at an LDL-C <40 mg/dL.

Methods

We recruited 780 consecutive patients with ACS who were participants of the CALLINICUS-Hellas Registry which is a prospective multicenter observational study that explores the adherence to LLT, the achievement of LDL-C targets and the cardiovascular events at 6- and 24-months after hospital discharge of patients with ACS.

Results

The prevalence of high risk components was: heFH 13.5%, multivessel CAD 44%, polyvascular disease 3.2%,and DM with eGFR <60 ml/min/1.73 m2 and/or Lp(a) >50 mg/dL 8.1%. By excluding the overlapping between these conditions, 430 ACS patients (55.1%) had at least one of the characteristics which define the extremely high-risk patients (Figure). Presuming a 65% LDL-C reduction of the levels (the pretreatment if on LLT prior admission or the admission if not on prior LLT) of the extremely high-risk ACS patients by taking a maximum dual LLT (intense statin plus ezetimibe), 312 patients, i.e., 40% of all initially recruited patients would fail to achieve an LDL-C <40 mg/dL suggesting that they require additional LLT, namely, a proprotein convertase subtilisin/kexin type 9 inhibitor (PCSK9i).

Conclusions

Almost 1 in 2 patients with ACS have extremely high-risk characteristics and are candidates for in-hospital triple LLT (statin plus ezetimibe plus PCSK9i) aiming at an LDL-C <40 mg/dL, a strategy shown to improve plaque stability and possibly to reduce the recurrence rate of early coronary events.Figure
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

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

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<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

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<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<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<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<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

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

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 (>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

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

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<0.001) and at 5 years as well (56.6% vs. 65.7% vs. 25.4%, respectively; p<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<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<0.001, and HR 2.2, 95%CI 1.8-2.8, p<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

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 <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 <72 hours discharge group and 1 (2.2%) patient in the >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

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