bluuebunny/crossref_metadata_2025 huggingface dataset:
Credibility of Risk scores in predicting coronary artery disease severity in non-ST segment elevation acute coronary syndrome patients
Authors: Elhusseini S
Published: November 2020

Objectives

We aimed to assess the value of Global Registry of Acute Coronary Events (GRACE) and Thrombolysis in Myocardial Infarction (TIMI) risk scores (RSs) for predicting coronary artery disease (CAD) severity and prognosis in patients with non-ST segment elevation acute coronary syndrome (NSTE-ACS).

Background

Patients with NSTE-ACS are at varying risks of death and recurrent cardiac events, early risk stratification plays a central role, different scores are now available based on initial clinical history, ECG, and laboratory tests that enable early risk stratification on admission.

Methods

A prospective study was conducted including 100 patients (age, 45–68 years) with NSTE-ACS who were admitted at our hospital from January 2018 to January 2019. The two RSs (TIMI& GRACE) were calculated from the initial clinical history, electrocardiogram, and laboratory values collected and recorded on admission. All patients were subjected to conventional coronary angiography during admission, Patients were divided into two groups: 1) patients with syntax score ≤32 (test group, 80 patients) and 2) patients with syntax score >32 (comparative group, 20 patients). Median follow-up duration was 6 (4–9) days.

Results

Regarding correlation between coronary angiographic severity based on syntax score and the clinical profile based on the two RSs (TIMI&GRACE) in NSTE-ACS patients, statistically significant correlation were found between GRACE score and syntax score (r=0.789; P=0.001) with GRACE score accuracy: 94% and negative predictive value (NPV): 98.7%, whereas no statistically significant correlation were found between TIMI score and syntax score (r=0.087; P=0.388) with TIMI score accuracy: 32% and NPV: 73.1%.

Conclusions

In conclusion the GRACE score provides a quick and reliable prediction of CAD severity in NSTE-ACS patients, It allows accurate risk estimation, categorizes patients and consequently can help in making accurate therapeutic decisions either with the use of invasive strategies in high risk selected patients or the use of conservative strategies in low risk patients in presence of limited resources.

Funding Acknowledgement

Type of funding source: None
Optimizing diagnosis of obstructive coronary artery disease by CT angiography: RCT's final results and 12-months follow-up
Authors: Dias Ferreira Reis J.P , Ramos R , Modas Daniel P , Aguiar Rosa S , Almeida Morais L , Cruz M , Moreira R , Mendonca T , Monteiro A , Leal C , Marques H , Figueiredo L , Cruz Ferreira R
Published: November 2020

Aim

In patients (pts) with suspected coronary artery disease (CAD), computed tomographic angiography (CTA) may improve pt selection for invasive coronary angiography (ICA) as alternative to functional testing. However. the role of CTA in symptomatic pts after abnormal functional test (FT) is incompletely defined.

Methods and results

This randomized clinical trial conducted in single academic tertiary center selected 218 symptomatic pts with mild to moderately abnormal FT referred to ICA to receive either the originally intended ICA (n=103) or CTA (n=115). CTA interpretation and subsequent care decisions were made by the clinical team. Pts with high risk features on FT, previous acute coronary syndrome, previously documented CAD, chronic kidney disease (GFR<60ml/min/1.73m2) or persistent atrial fibrillation were excluded. The primary endpoint was the percentage of ICA with no significant obstructive CAD (no stenosis ≥50%) in each group. Diagnostic (DY) and revascularization (RY) yields of ICA in either group were also assessed. Pts were followed up for at least 1 year for the primary safety endpoint of all cause death/ nonfatal myocardial infarction/ stroke. Unplanned revascularization

(UP) and symptomatic status (SS) were also evaluated. Pts averaged 68±9 years of age, 60% were male, 29% were diabetic. Nuclear perfusion stress test was used in 33.9% in CTA group and 31.1% in control group (p=0.655). Mean post (functional) test probability of obstructive CAD was 34%. Overall prevalence of obstructive CAD was 32.1%. In the CTA group, ICA was cancelled by referring physicians in 83 of the pts (72.2%) after receiving CTA results. For those undergoing ICA, non-obstructive

CAD was found in 5 pts (15.6%) in the CTA-guided arm and 60 (58.3%) in the usual care arm (p<0.001 Mean cumulative radiation exposure related to diagnostic work up was similar in both groups (6±14 vs 5±14mSv, p=0.152). Both DY (84.4% vs 41.7, p<0.001) and RY (71.9% vs 38.8%, p=0.001) yields were significantly higher for CTA-guided ICA as compared to standard FT-guided ICA. The rate of the primary safety endpoint was similar between both groups (1.9% vs 0%, p=0.244), as well as the rates of UP (0.9% vs 0.9%, p=1.000) and SS (persistent angina: 29.6% vs 24.8%, p=0.425).

Conclusions

In pts with suspected CAD and mild to moderately abnormal ischemia test, a diagnostic strategy including CTA as gatekeeper is safe, effective and significantly improves diagnostic and revascularization yields of ICA.

Funding Acknowledgement

Type of funding source: None
Early vascular healing following bioresorbable-polymer sirolimus-eluting stent implantation in comparison with durable-polymer everolimus-eluting stent: sequential optical coherence tomography study
Authors: Ogura K , Tsujita H , Arai T , Sakai R , Tanaka H , Masaki R , Oishi Y , Nomura K , Arai K , Sekimoto T , Kondo S , Tsukamoto S , Mori H , Matsumoto H , Shinke T
Published: November 2020

Background

Orsiro ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) might facilitate early vascular healing responses that seems to be associated with improved long-term clinical outcomes. We compared the early vascular healing responses to BP-SES and Xience durable-polymer everolimus-eluting stent (DP-EES) in patients with chronic coronary syndrome (CCS) using optical coherence tomography (OCT).

Methods

A total of 40 patients with CCS receiving OCT-guided PCI were included. 20 patients were assigned to BP-SES, and 20 to DP-EES. OCT was performed immediately after stent placement (post-procedure) and at 1 month follow-up. Struts were recorded as uncovered if any part was visibly exposed in the lumen or covered if a layer of tissue covered all reflecting surfaces. The incidence of intrastent thrombus (IS-Th) and irregular protrusion (IRP) were also assessed.

Results

At 1 month, the percentage of uncovered struts was significantly lower in the BP-SES compared with the DP-EES (2.8±1.6% vs. 5.8±1.8%, respectively; p<0.001), and that of malapposed struts was similar between both groups (2.5±3.1% vs. 2.4±2.2%; p=0.76). There were no differences in the incidence of IS-Th (65.0% vs. 55.0% at post-procedure; p=0.54, 30.0% vs. 35.0% at 1 month; p=0.75) and IRP (30.0% vs. 25.0% at post-procedure; p=0.74). IRP had completely resolved at 1 month in both groups.

Conclusion

Early vascular healing response to Orsiro BP-SES implantation was revealed in CCS patients at 1 month compared with Xience DP-EES. Orsiro BP-SES may have a potential to shorten the dual antiplatelet therapy duration.

Funding Acknowledgement

Type of funding source: None
Diagnostic reliability of quantitative flow ratio for detection of myocardial ischemia compared with other angiographic and experience-dependent visual predicted indices
Authors: Otsuka M , Satomi N , Kahata M , Kitagawa S , Kumagai A , Inoue K , Koganei H , Enta K , Ishii Y
Published: November 2020

Background

Quantitative flow ratio (QFR) is an image-based virtual fractional flow reserve (FFR) computed by three dimensional quantitative coronary angiography (3D-QCA) and estimated flow velocity. Several studies have reported that QFR had a good diagnostic performance as compared with wire-based FFR or instantaneous wave-free ratio (iFR).

Purpose

We compared the diagnostic reliability of QFR for detection of myocardial ischemia with other angiographic and visual predicted indices.

Methods

In 301 coronary lesions (263 patients) from our QFR database for previously-reported two studies, the diagnostic reliability of QFR, several angiographic and visual predicted indices were investigated using ROC analysis as reference of FFR≤0.8 or iFR≤0.89. Visual predicted FFR were estimated by 3 physicians (25-year experienced expert, 10-year experienced senior physician and 3-year experienced trainee) blinded to other indices.

Results

Area under the curve (AUC) of each index in ROC analysis is shown in Table.

Conclusion

QFR was reliable index detecting myocardial ischemia compared with other angiographic and experience-dependent visual predicted indices.

Funding Acknowledgement

Type of funding source: None
Safety and efficacy of a hyperaemic agent, intracoronary nicorandil 4mg, for invasive physiological assessments during fractional flow reserve measurement
Authors: Nishikura T , Wakabayashi K , Aizawa N , Suzuki T , Shibata K , Furuya T , Kosaki R , Fukuoka H , Ikeda N , Kikuchi M , Miyoshi F , Tanno K
Published: November 2020

Background

Fractional flow reserve (FFR) is one of most reliable index for the determining the functional severity coronary artery stenosis. Adenosine is the most commonly used agent for maximal hyperaemia. However, adenosine can cause chest discomfort, bronchial hyper-reactivity, and atrioventricular block. The aim of this study is to evaluate the safety and efficacy of intracoronary nicorandil as an alternative hyperaemic agent for FFR.

Methods and results

We enrolled consecutive 82 patients (87 lesions) who underwent FFR measurement in our center from Nov. 2018. We compared three groups; intravenous infusion of adenosine (150 μg/kg/min); and adenosine added intracoronary nicorandil 2mg; and intracoronary nicorandil 4mg. Mean FFR value was 0.83±0.09, 0.82±0.09, 0.82±0.08, There was a strong correlation among three groups (R2>0.9). Mean cyclic change in FFR was 0.026±0.023, 0.019±0.010, 0.016±0.014, respectively, cyclic change was smallest in intracoronary nicorandil 4mg group (vs ATP; p<0.001, vs ATP + nicorandil 2mg; p<0.001). By Wilcoxon test, mean FFR value of nicorandil 4mg was significant lower than ATP (p=0.0021), and equal to ATP + nicorandil 2mg (p=0.98).

Conclusions

Intracoronary nicorandil 4mg is a simple, safe, and effective way to induce steady-state hyperaemia for FFR.

Figure 1

Funding Acknowledgement

Type of funding source: None
Insufficient lipid lowering therapy could not bring favorable prognostic effect in high risk patients who were functionally deferred percutaneous coronary intervention
Authors: Abe T , Jujo K , Moriyama T , Iwanami Y , Shimazaki K , Hara M , Nakazawa G , Hagiwara N , Saito K
Published: November 2020

Introduction

Deferral of percutaneous coronary intervention (PCI) of a functionally insignificant stenosis is associated with favorable long-term prognoses. However, previous reports revealed that patients with fractional flow reserve (FFR) 0.81–0.85 had higher cardiovascular adverse event rates than those with FFR >0.85. Numbers of large clinical trials established the lower, the better strategy for low-density lipoprotein cholesterol (LDL-C) management for patients after PCI. However, in the real clinical practice, the achievement rate of target LDL-C is often insufficient in patients with atherosclerotic risk factors who were functionally deferred PCI.

Purpose

We aimed to examine optimal LDL-C management for patients with intermediate coronary stenosis deferred PCI by FFR measurement.

Methods

This observational study included 293 consecutive patients with coronary stenosis deferred PCI due to greater FFR than 0.80. We separately analyzed 90 patients with 0.81–0.85 of FFR and 203 patients with >0.85. Patients in each group were further classified into 2 groups based on LDL-C level at one year after FFR measurement; the Lower LDL-C group (<100 mg/dL) and the Higher LDL-C group (>100 mg/dL). The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) including death, non-fatal myocardial infarction, ischemic stroke, heart failure hospitalization and unplanned revascularization.

Results

Patients with FFR 0.81–0.85 had a significantly higher MACCE rate than those with FFR >0.85 (hazard ratio (HR): 1.77, 95% confidence interval (CI): 1.02–3.07, p=0.043). In patients with FFR 0.81–0.85, the Lower LDL-C group (n-=53) had a significantly lower rate of the primary endpoint than the Higher LDL-C group (HR: 0.41, 95% CI: 0.18–0.97, Log-rank p=0.036, Figure A). Whereas, there was no significant difference in the event rate between 2 groups in patients with FFR >0.85 (Log-rank p=0.42, Figure B).

Conclusion

Uncontrolled LDL-C level was associated with higher MACCE rate in patients who were deferred PCI due to FFR 0.81–0.85. These results suggested that even in patients who were deferred PCI, those with coronary artery stenosis of lower FFR value should receive strict LDL-C lowering therapy with close monitoring.

Figure 1

Funding Acknowledgement

Type of funding source: None
Revascularization decisions in patients with stable angina and intermediate lesions: results of the second International Survey on Interventional Strategy (ISIS-2)
Authors: Toth G , Wijns W , Fournier S , Toth B , Johnson N , Barbato E
Published: November 2020

Background

ISIS-1 survey (conducted in 2012–2013) demonstrated a significant disconnect between guideline recommendations on invasive functional and imaging assessment of coronary stenosis severity and effective intention to adoption in patients with chronic coronary syndromes (CCS). Ever since, more evidences and new indexes/tools have become available, supposedly resulting into a simplified adoption. Therefore, six years later the second survey was repeated (ISIS-2) with the aim to evaluate a possible evolution in the intended adoption of invasive diagnostic tools.

Methods

ISIS-2 was conducted via a web-based platform from June to December 2019. Here, five complete angiograms were provided, presenting only focal intermediate stenoses. FFR and quantitative coronary angiography (QCA) values were known and kept concealed to the participants. Estimation of stenosis significance was asked for each lesion. In case of uncertainty, the most appropriate adjunctive invasive diagnostic method among QCA, intravascular ultrasound, optical coherence tomography, or invasive functional test (i.e. with FFR or a non-hyperemic index) was to be selected. Primary endpoint of the study was the rate of requested adjunctive functional or imaging assessment, as indicated by guideline recommendations. Secondary endpoint was the rate and accuracy of purely angiography-based decisions.

Results

A total of 411 participants performed 3749 lesion evaluations in ISIS-2: 2237 (60%) decisions were taken solely on angiogram and expressed no need for further evaluation with adjunctive tools. This rate of angiographic reliance was significantly reduced in ISIS-2 as compared with ISIS-1 (3139 [71%]; p<0.001). Here the decision (significant or non-significant) was discordant with the known functional significance in 870 (39%) cases, markedly less as in ISIS-1 (1459, 46%; p<0.001). In ISIS-2, participants expressed the need for either invasive functional assessment or intravascular imaging in 1110 (29%) and 379 (11%) cases, respectively. These rates were significantly higher as compared with ISIS-1 (928 [21%]; p<0.001 and 354 [8%]; p<0.001, respectively).

Conclusions

ISIS-2 survey suggests an evolving pattern over 6 years in the intention to integrate coronary angiography with invasive coronary physiology and imaging testing in patients with CCS.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Unrestricted grant from Abbott Medical
Clinical outcomes of drug-eluting stent era according to chronic kidney disease and diabetes (IRIS-DES registry)
Authors: Kim D.W
Published: November 2020

Aims

Clinical outcomes in patients who underwent percutaneous coronary intervention (PCI) using various generation drug-eluting stent (DES) stratified by the degree of renal dysfunction and diabetes were not fully elucidated.

Methods and results

This study included 16,741 patients enrolled in the multicenter IRIS-DES registry. Renal insufficiency was graded according to the baseline renal function. The primary endpoint was major adverse cardiocerebrovascular event (MACCE), defined as a composite of all cause death, myocardial infarction, cerebrovascular events, and target vessel revascularization. Among 16,741 patients, 11,274 (67%) had eGFR ≥60 ml min–1 1.73m–2 at baseline, 4,280 (26%) had eGFR of ≥30 and <60, and 1187 (7%) had eGFR <30. At 3.6 years of follow-up (interquartile range, 2.97–4.87 yrs), the cumulative incidence of MACCE substantially increased according to the severity of renal insufficiency (11.3% in eGRF ≥60, 16.0% in eGFR of ≥30 and <60, and 29.7% in eGRF <30, respectively, P<0.001). After multivariable adjustment of clinical covariates, as compared with patients with eGFR ≥60, the hazard ratios for MACCE was significantly higher in patients with eGFR of ≥30 and <60 (hazard ratio [HR] 1.3, 95% confidence interval [CI] 1.1–1.4) and in patients with eGFR <30 (HR 2.0, 95% CI 1.7–2.4). This effect showed better consistent trends in non-diabetes and non- renal insufficiency in subgroup analysis of the primary endpoint (Figure 3).

Conclusions

Renal insufficiency is significantly associated with worse clinical outcomes in the DES era. Also, the effect on MACCE was consistent, being better in non-diabetes and non- renal insufficiency.

Funding Acknowledgement

Type of funding source: Foundation. Main funding source(s): CVRF
Multifactorial intervention and effect on morbidity, preventive medication and mortality in patients with type 2 diabetes within cardiac rehabilitation
Authors: Soja A.M.B , Carlson N , Rasmusen H.K , Sjoel A , Thygesen L.C , Zwisler A.D.O
Published: November 2020

Background

Although studies have reported beneficial impact of cardiac rehabili-ta-tion in the overall population, knowledge from clinical randomized trials of the effect of cardiac rehabilitation in patients with type 2 diabetes is still sparse.

Purpose

In the randomized DANSUK trial, we aimed to evaluate the short- and long-term effect on cardiovascular disease, hospital readmissions, mortality and use of preventive medication in patients with type 2 diabetes referred to comprehensive cardiac rehabilitation by comparing an intensified, targeted, multifactorial intervention with standard of care.

Methods

From 2000 to 2004 a total of 151 patients with type 2 diabetes and with ischemic heart disease (53%), heart failure (18%), or high-risk patients with at least three risk factors for ischemic heart disease (29%) were included in the DANSUK trial. The patients were allocated to standard of care (N=76) following current guidelines or comprehensive cardiac rehabilitation during a twelve weeks program with a stepwise implementation of behaviour modification and preventive medication to reach treatment goals (N=75). Clinical outcomes were compared after three and fourteen years of follow-up using national registries. Primary composite outcome measure included overall mortality, myocardial infarction or acute first-time readmission.

Results

Mean age was 66 years and more than one third of the population were women. After three years of follow-up, no difference in primary outcome was obtained (HR: 0,87; 95% CI: 0,58–1,32), but when hospitalized within the first three years, mean length of stay was significantly reduced by 25% in patients who had attended comprehensive cardiac rehabilitation compared to standard of care (5,8 vs. 7,7 days; p<0.04). After fourteen years of follow-up there was still no difference in the combined endpoint between the two treatment groups.

Conclusions

Although the DANSUK trial earlier has demonstrated reductions in several risk factors and in the use of preventive medication in patients with abnormal glucose metabolism attending comprehensive cardiac rehabilitation compared to standard of care, these effects did not translate into the primary composite endpoint after three and fourteen years of follow-up in patients with known type 2 diabetes at enrolment. Nevertheless, there was a significant reduction in length of stay when admitted to hospital in the cardiac rehabilitation group compared to standard of care within the first three years of follow-up.

Funding Acknowledgement

Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): The Danish Heart Foundation
Antiplatelet therapy prescription patterns for acute coronary syndrome: a decade analysed
Authors: Gupta S , Belley-Cote E , Basha A , McEwen C , Wu N , Mehta S , Schwalm J.-D , Whitlock R
Published: November 2020

Background/Introduction

Guidelines recommend dual antiplatelet therapy (DAPT) with acetylsalicylic acid (ASA) and ticagrelor following acute coronary syndrome (ACS) regardless of management strategy. Despite this, prescription practices lag and appropriate DAPT is not utilized.

Purpose

We aimed to trend differences in P2Y12 inhibitor prescriptions between ACS patients managed with percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG). As well, we wanted to analyze the impact practice-changing trial publications, national guideline updates, and publicly funded drug coverage plans may have on prescription patterns.

Methods

From national databases, we obtained data for ACS patients in the province of Ontario, Canada between 2008 and 2018. Using an interrupted-time series with data aggregated monthly, we evaluated types of P2Y12 inhibitor prescribed at hospital discharge and changes to antiplatelet prescription patterns following publication of Ticagrelor versus Clopidogrel in Patients with Acute Coronary Syndrome (PLATO), Canadian Cardiovascular Society (CCS) antiplatelet therapy guidelines, and ticagrelor coverage by a publicly funded medication plan.

Results

We included 114,142 ACS patients; 49% underwent PCI and 8% required CABG. Between October 2008 and March 2018, the proportion of patients discharged on P2Y12 inhibitors increased from 73.4% to 87% (p<0.0001) for PCI patients and 11.4% to 31.4% (p<0.0001) for CABG patients. PLATO publication was associated with a 1.3% (p=0.002) monthly decline in clopidogrel prescriptions amongst PCI patients. The 2010 CCS antiplatelet therapy guidelines were associated with a 0.7% (p<0.0001) monthly decline in clopidogrel prescriptions amongst PCI patients. The approval of ticagrelor by publicly funded medication plan was associated with an increase in ticagrelor prescriptions within the first month (24.5%; p<0.0001) and a continued monthly increase (0.4%; p<0.0001) in PCI patients. The approval was also associated with an increase in monthly ticagrelor prescriptions (0.2%; p<0.0001) amongst CABG patients. The 2012 CCS antiplatelet therapy guidelines were associated with a decline in clopidogrel prescriptions within the first month (6.1%; p=0.003) and a monthly increase in ticagrelor prescriptions (0.3%; p=0.05) amongst PCI patients.

Conclusion

Drug coverage by a publicly funded medication plan and guideline updates had significant impact on P2Y12 inhibitor prescription practices. Despite improvements, P2Y12 inhibitor prescriptions for CABG patients are far behind PCI patients. Further research is necessary to address barriers to appropriate antiplatelet therapy in the ACS population.

Antiplatelet Prescription Patterns

Funding Acknowledgement

Type of funding source: Public hospital(s). Main funding source(s): New Investigator Fund - Hamilton Health Sciences Foundation, Hamilton, Canada
Role of smoking on body fat distribution and coronary artery disease
Authors: Sabet M , Elkaffas S , Bakhoum S.W.G , Kandil H
Published: November 2020

Introduction

Smoking and obesity are recognized as important modifiable risk factors for coronary artery disease (CAD). However, the general perception that smoking protects against obesity is a common reason for starting, and/or not quitting smoking.

Purpose

To detect the quantity, quality and relative distribution of subcutaneous adipose tissue (SAT) and visceral adipose tissue (VAT) estimated by abdominal computed tomography in smokers versus non- smokers.

Methods

The abdominal muscular wall was traced manually to calculate SAT and VAT areas (cm2) (outside and inside abdominal muscular wall respectively) as well as SAT density [Hounsfield units (HU)] at L4-L5 in 409 consecutive patients referred for evaluation of chest pain by multi-slice computed tomography coronary angiography (MSCT-CA).

Results

26% of the studied patients (n=107) were current smokers, while the remaining 74% (n=302) never smoked. Coronary artery atherosclerosis was more prevalent in smokers compared to non-smokers (64.5% vs 55.0%; p=0.09). Smokers had statistically significantly lower body mass index (BMI) (31.2±4.3 vs. 32.5±4.7 kg/m2; p=0.015), hip circumference (HC) (98.6±22.5 vs. 103.9±20.9 cm; p=0.031), total fat area (441.62±166.34 vs. 517.95±169.51cm2; p<0.001), and SAT area (313.07±125.54 vs. 390.93±143.28 cm2; p<0.001) as compared to non-smokers. However, smokers had statistically significantly greater waist-to-hip ratio (0.98±0.08 vs. 0.96±0.08; p=0.010), VAT/SAT area ratio (0.41±0.23 vs. 0.35±0.20; p=0.013), and denser SAT depot (−98.91±7.71 vs. −102.08±6.44 HU; p<0.001).

Conclusion

Smoking contributes to CAD and to the pathogenic redistribution of body fat towards VAT, through limiting SAT potential to expand.

Funding Acknowledgement

Type of funding source: None
Apabetalone, a selective BET protein inhibitor, reduces ischemic cardiovascular events and hospitalization for heart failure in patients with acute coronary syndrome and type 2 diabetes
Authors: Ray K.K , Nicholls S.J , Buhr K.A , Ginsberg H.N , Kalantar-Zadeh K , Johansson J.O , Kulikowski E , Toth P.P , Wong N , Sweeney M , Schwartz G.G
Published: November 2020

Background

Despite established treatments, patients with type 2 diabetes mellitus (T2DM) and acute coronary syndrome (ACS) are at higher risk of ischemic cardiovascular (CV) events and hospitalization for heart failure (HHF) compared to those without T2DM. LDL-C lowering or use of GLP-1 agonists predominantly affects ischemic CV events, with little effect on HHF. Conversely, treatment with SGLT-2 inhibitors reduces HHF, with less effect on ischemic CV events. Preclinical studies indicate that bromodomain and extra-terminal (BET) proteins coordinate gene transcription for pathways that promote atherothrombotic events as well as heart failure. We assessed the clinical effect of apabetalone (APB), a novel BET protein inhibitor, on a composite of non-fatal ischemic CV events, HHF, and CV death in a post hoc analysis of the BETonMACE trial

Methods

BETonMACE was a double-blind, placebo-controlled phase 3 study in patients with T2DM and recent acute coronary syndrome receiving standard of care risk factor management. In 13 countries, 2425 patients were enrolled. We conducted a time-to-event analysis for first adjudicated CV death or non-fatal MI, stroke, or HHF using a log-rank test and Cox proportional hazards model.

Results

At baseline median age was 62 years, 25.6% were female, 87.6% white, and use of high intensity statin, ACE inhibitors/ angiotensin II blockers, dual antiplatelet therapy and beta blocker were 90, 88, 92 and 91% respectively. A total of 312 subjects had an endpoint event, with 139 (11.5%) patients in the ABP group and 173 (14.3%) among PBO (HR 0.78, 95% CI 0.63–0.98, p=0.03, Figure). At 26 months, the absolute risk reduction was 3.2% and number needed to treat was 31. Numerically favorable HRs were observed for each component endpoint except for stroke (Table).

Conclusion

This present analysis suggests that BET inhibition with APB may be a novel pathway through which to reduce both HHF and ischemic CV events in high risk patients with T2DM thus impacting broader clinical outcomes with potentially large benefits for patients and healthcare systems.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Resverlogix Corp
Prognosis in patients with prior myocardial infarction and PEGASUS-TIMI 54 criteria in the CLARIFY registry
Authors: Biscaglia S , Campo G , Fox K , Tardif J.C , Tendera M , Greenlaw N , Ford I , Stanley B , Ferrari R , Steg P.G
Published: November 2020

Background/Introduction

The PEGASUS-TIMI 54 trial showed that prolonged treatment with ticagrelor reduces the cumulative occurrence of ischemic adverse events. CLARIFY is the biggest real life registry on chronic coronary syndrome.

Purpose

- To evaluate the percentage of patients eligible for long-term ticagrelor therapy in the CLARIFY registry.

– To compare the outcome of this subgroup of patients with those with PEGASUS exclusion criteria or without PEGASUS inclusion criteria.

Methods

Within the CLARIFY population, we selected post MI patients and we excluded those with missing info (post MI evaluable population). Then, we divided patients into 3 groups: excluded (meeting PEGASUS exclusion criteria, namely use of P2Y12 receptor antagonists or chronic oral anticoagulant, any stroke, coronary-artery bypass grafting in the past 5 years); eligible (meeting PEGASUS high-risk inclusion criteria, namely age≥65 years; diabetes; multivessel disease; creatinine clearance <60 ml/min) and ineligible (not meeting PEGASUS high-risk inclusion criteria).

We therefore compared the ischemic (CV death, MI and stroke) and bleeding (major bleeding) outcome of the 3 groups adjusting for age, sex, smoking and geographical region.

Results

Among the 11811 post-MI evaluable patients, 4706 (39.8%) were included in the eligible group, 5715 (48.4%) in the excluded group, and 1390 in the ineligible group (11.8%). Both the ischemic and bleeding endpoints were significantly different among the 3 groups with the excluded patients with the worst and ineligible patients with the best outcome (see table). The same trend was shown for CV death, while the occurrence of MI was not significantly different among the 3 groups. In the eligible group, the ratio between ischemic and bleeding events was 6:1, whereas between CV death and major bleeding was 3.5:1.

Conclusions

Around 40% of CLARIFY post-MI patients could benefit from prolonged ticagrelor therapy. In this group of patients, ischemic risk seems to be higher than the bleeding one.

Ischemic & bleeding risk in the 3 groups

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): CLARIFY registry was funded by Servier
Long-term persistence to low-dose aspirin for cardiovascular prevention in routine clinical practice in United Kingdom and Germany
Authors: Vora P , Soriano-Gabarro M , Russell B , Morgan Stewart H
Published: November 2020

Background

Low-dose aspirin is effective in the prevention of ischemic vascular events and studies have shown a preventative effect on colorectal cancer (CRC). Discontinuation of low-dose aspirin is associated with increased risk of ischaemic vascular events. However, data on long-term persistence to low-dose aspirin from routine clinical practice are limited.

Purpose

To assess the long-term persistence to low-dose aspirin therapy in the primary and secondary cardiovascular (CVD) prevention population

Methods

This retrospective cohort study used data from United Kingdom (UK) – The Health Improvement Network database and Germany (DE) – IQVIA Disease Analyzer and analyzed using an adaptation of Observational Health Data Sciences and Informatics (OHDSI) ATLAS Tool. Patients 18 years or older, with at least two prescriptions of low-dose aspirin (75–100mg) within the first year of index date during the study period between 2007 and 2018, and with at least 12 months of observation before and after the index date were included in the study. The patients with a CVD diagnosis or a CABG/PCI procedure before the index date or a prescription of dual antiplatelet at index date were classified as secondary CVD prevention. The remaining patients were classified as potential primary CVD prevention. The index date was first prescription of low-dose aspirin. Persistence was calculated if the gap between two prescriptions exceeds 60 days. Patients with such gaps still receiving prescription after 60 days were plotted based on the number of gaps identified during the follow-up and if no prescription was recorded then they were considered discontinued.

Results

The total number of patients receiving low-dose aspirin was 327,806 (183,089 in UK and 144,717 in DE with up to 10 years of follow-up). A total of 112,887 and 101,704 received low-dose aspirin for secondary CVD prevention; 70,202 and 43,013 potentially for primary CVD prevention in UK and DE, respectively. Persistence at two years with a few gaps was 67% and 59% in UK and DE for secondary CVD prevention; 57% and 53% for primary CVD prevention, respectively. With multiple Gaps, 50% and 36% still receive prescription low-dose aspirin for 10 years in UK and DE, respectively for secondary CVD prevention. For Primary prevention, 36% and 32% receive prescription of aspirin for 10 years with multiple gaps in UK and DE (Figure).

Conclusion

After the initial drop in persistence the patients tend to continue their low-dose aspirin treatment for long-term, although with multiple gaps. Overall, the persistence was higher in secondary compared to primary CVD prevention. Improving persistence to low-dose aspirin therapy in the initial years may help in continuity of their treatment over long-term. Persistence might be underestimated due to potential over the counter use of low-dose aspirin.

Funding Acknowledgement

Type of funding source: Private company. Main funding source(s): Bayer AG
How many CCS- and ACS-patients might reach the newly recommended LDL-C-target <55mg/dl in clinical practice if guidelines were applied – an estimate from the DYSIS II study population
Authors: Gitt A.K , Horack M , Lautsch D , Zahn R , Ferrieres J
Published: November 2020

Background

The 2019 ESC guidelines for the management of dyslipidemia even further lowered the LDL-C-target values for the very high-risk population from <70mg/dl to <55mg/dl. Population based studies already had shown that the previous target was difficult to reach. It is yet unclear how many patients in clinical practice might be treated to the new target.

Methods

The Dyslipidemia International Study (DYSIS II) prospectively collected data of patients with chronic coronary syndromes (CCS) and acute coronary syndromes (ACS) (all on statins) in 18 countries in Europe, the Middle East, South- and East Asia to document patient characteristics, medication and a current lipid profile from 2012 to 2014 under real life conditions in physicians' offices and hospitals. We took these real-life lipid profiles and data on the kind/dose of used statins to estimate how treatment escalation such as changing statin treatment to a high dose (atorvastatin ≥40mg / rosuvastatin≥20mg), adding ezetimibe and adding a PCSK9-inhibitor might help to bring LDL-C-levels to the recommended <55mg/dl target.

Results

A total of 7,865 patients were enrolled into DYSIS II, 6,794 had CCS and 1,071 ACS. Under the documented statin treatment in DYSIS only 12.7% of patients reached an LDL-C <55mg/dl. Putting all patients on high dose statins in combination with ezetimibe, 64.1% would reach the target. If PCSK9-inhibitors would be used in the remaining patients not at goal a total of 94.0% would match the goal.

Conclusion

Our analysis indicates that in real life practice the use available lipid-lowering medications would substantially increase the percentage of CCS- and ACS-patients reaching the newly recommended 2019 ESC guideline LDL-C-target of <55 mg/dl from less than 20% to more than 90% of the population.

Funding Acknowledgement

Type of funding source: Private grant(s) and/or Sponsorship. Main funding source(s): MSD
Identification of the high-risk patient in primary percutaneous coronary intervention: development and validation of a novel predictive index
Authors: Blake S , Proscia C , Eleuteri A , Groves D , Stables R.H
Published: November 2020

Background

Primary percutaneous coronary intervention (PPCI) is the best treatment for patients with ST elevation myocardial infarction (STEMI). Several risk scores have been created to help risk-stratify these patients but few of these can be calculated in-lab, during the acute event. Development of a score that could be applied during PPCI could aid operators' decisions regarding adjunctive therapies and post-procedural surveillance which could improve patient outcomes. This study aimed to develop a simple, practical risk model that could be applied during PPCI to identify high-risk patients.

Methods

Demographic, clinical and outcome data were collected for all patients, as part of the HEAT-PPCI trial, who underwent PPCI for suspected STEMI between February 2012 and November 2013 at our hospital. Independent predictors of the composite outcome of 28-day mortality or severe impairment of LV function (ejection fraction ≤35%) were identified using multiple logistic regression. A risk model was fitted and internal validation was performed by bootstrapping. External validation was performed on a separate cohort of patients with STEMI.

Results

The derivation cohort included 1271 patients, with 131/1271 = 10.3% experiencing the composite outcome of 28-day mortality or poor LV function. Three variables were required to predict the outcome: age (OR:2.07, 95% CI 1.55 to 2.78), location of the culprit artery (OR:6.16, 95% CI 4.00 to 9.47), myocardial blush grade post-PPCI (OR:2.32, 95% CI 1.39 to 3.88). External validation was performed on 324 patients undergoing PPCI from a different centre. The model showed good discrimination on ROC-curve analysis (c statistic 0.79, 95% CI 0.75 to 0.83) and performed well on external validation (c statistic 0.87, 95% CI 0.72 to 0.95). Accuracy of the risk model on the validation data was improved by simple recalibration. The model was used to create a risk prediction chart that can be used in-lab during PPCI (Figure 1).

Conclusions

We have developed a risk model that accurately predicts 28-day mortality or poor LV function following STEMI using age, culprit location and myocardial blush grade. The model can assist operators in identifying high-risk patients during PPCI.

Funding Acknowledgement

Type of funding source: Public hospital(s). Main funding source(s): National Health Service, UK
Compliance with guideline-directed basic pharmacotherapy and late adverse events in patients with stable coronary artery disease after isolated surgical revascularization
Authors: Yepanchintseva O , Mikhaliev K , Shklianka I , Zharinov O , Todurov B
Published: November 2020

Background

Long-term basic pharmacotherapy may have a major impact upon clinical course and survival in patients with stable coronary artery diseases (CAD) after isolated coronary artery bypass grafting (CABG).

Purpose

To determine the role of compliance with guideline-directed basic pharmacotherapy in the prevention of late major adverse clinical events (MAEs) in patients with stable CAD after isolated CABG at 3-year follow-up.

Methods

A single-centre study included 576 patients with stable CAD, consecutively enrolled for isolated CABG during the period 2011–2017. Follow-up median was 34 months (interquartile range 13–60 months). Two (0.3%) patients died early after CABG, thus 574 (99.7%) patients were followed post-discharge. At 3-year follow-up, data on MAEs were available in 251 patients, mean age (61±9) years, 218 (86.9%) males. Among them, MAEs occurred in 55 (21.9%) cases.

Results

Basic CAD pharmacotherapy after CABG was comparable in MAEs vs. no-MAEs groups, with the vast majority of patients receiving guideline-recommended therapy at discharge, namely angiotensin-converting enzyme inhibitors (ACEIs) or angiotensin-II receptors blockers (ARBs) (79.6% vs. 88.8%, respectively; p=0.109), statins (98.1% vs. 99.0%, respectively; p=0.619) and antiplatelet drugs (98.1% vs. 99.5%, respectively; p=0.327). At 3-year follow-up, MAEs group, as opposed to no-MAEs group, was characterized by the lower usage of ACEI/ARBs (68.5% vs. 87.2%, respectively; p=0.001) and statins (59.3% vs. 86.7%, respectively; p<0.001), as well as triple basic CAD therapy (ACEI or ARBs/statins/antiplatelet drugs: 35.2% vs. 70.4%, respectively; p<0.001).

Conclusion

At 3-year follow-up, MAEs in patients with stable CAD after isolated CABG were associated with more frequent discontinuation of previously prescribed guideline-directed basic pharmacotherapy, namely ACEI/ARBs and statins, as well as triple basic CAD therapy.

Funding Acknowledgement

Type of funding source: None
Chronic total occlusion (CTO) revascularization a comparison from Japanese and European expert CTO operators registries
Authors: Takeshi S , Gerald S Werner W.G , Muramatsu T.M , Giunta G.R , Ribeiro R.M , Sumitsuji A.S , Okada N.O , Sianos S.G , Puglisi P.S , Pieri P.P , Tsuchikane E.T , Galassi G.A
Published: November 2020

Background

Development of different strategies and devices improved CTO revascularization. However, technical and procedural success might be influenced by several factors including geographical expertise.

Methods

A total of 4412 CTO coronary treated lesions (Japan 1531 Europe 2881) (mean age 64.5±10.7, male 85.2%, JCTO score 2.09±1.24) were analyzed in European and Japanese registries during the year 2016. The primary endpoint was to assess technical success rate of CTO-PCI cases and procedural outcomes.

Results

Primary Antegrade approach and success rate were 71.5% and 90.8% respectively in Japan while 77.0% and 94.1%, respectively in Europe, (p<0001). Primary Retrograde approach and success rate were 28.5% and 84.0% respectively in Japan, while 22.6% and 69.2%, in Europe (p<0001). There were no differences in technical success rate between Japan and Europe (89.9% vs 88.5%, p=0.13). Procedural time was higher in Japan than in Europe 156.3±1.8 vs 107.1±1.3 mins (p<0.001), but contrast media volume resulted the opposite 209.6±3.2 ml vs 267.5±2.4 ml, (p<0.001). Procedural complications were higher in Japan than Europe (death: 0.4% vs 0.07%, p=0.024, myocardial infarction: 1.2% vs 0.57% p=0.045, coronary artery occlusion: 0.26% vs 0.07% p=0.026, coronary perforation: 4.22% vs 3.04% p=0.045). A multivariate analysis showed that independent predictors of failed procedure were both for Japan and Europe unsuccessful retrograde crossing channel, severe lesion calcification and occlusion length>20mm.

Conclusions

Technical success rate was similar between Japan and Europe, but more retrograde approach was common in Japan. Unsuccessful retrograde crossing channel, severe lesion calcification and occlusion length>20mm were independent predictors of failed procedures for both countries. Procedural complications were higher in Japan probably because of longer procedural time and higher frequency of retrograde approach.

Funding Acknowledgement

Type of funding source: None
Prasugrel versus ticagrelor in patients with acute coronary syndrome undergoing percutaneous coronary intervention; a meta-analysis of randomized controlled trials
Authors: Rodriguez Z , Valdecanas A , Palileo N
Published: November 2020

Background

Dual antiplatelet therapy (DAPT) with ASA and a P2Y12 inhibitor is the cornerstone of anti-thrombotic therapy for patients undergoing PCI. The 2014 European Society of Cardiology (ESC)/European Association for Cardio-Thoracic Surgery (EACTS) guidelines on myocardial revascularization recommend DAPT with prasugrel or ticagrelor over clopidogrel, however, a comparison between the efficacy in reducing all cause mortality and major bleeding of prasugrel versus ticagrelor is sparse.

Objectives

To perform a meta-analysis of randomized controlled trials (RCT) in the determination of the efficacy and safety of prasugrel as compared to ticagrelor among ACS patients undergoing PCI.

Methods

Extensive search of PubMed, Cochrane Library, Ovid, EMBASE, Google scholar, Medline and Herdin was done up to November 2019. Studies were limited to RCTs comparing ticagrelor vs. prasugrel among acute coronary syndrome (ACS) patients undergoing PCI. Outcome measures include all-cause mortality and major bleeding. Statistical analysis was done using Review manager V5.3.

Results

Thirteen RCTs with 6086 patients were included in this study. Pooled analysis using random effects model showed no difference in reduction of all-cause mortality between prasugrel versus ticagrelor (92 vs 107, RR of 0.77, 95% CI of 0.58–1.02, p-value of 0.07, I2 of 0%). Likewise, major bleeding (using BARC and TIMI as defined by the Bleeding Academic Research Consortium scale and Thrombolysis in Myocardial Infarction definitio) was similar between prasugrel and ticagrelor (91 vs 111, RR of 0.83, 95% CI of 0.63–1.09, p-value of 0.18, I2 of 0%).

Conclusion

There were no significant differences in the reduction of all cause mortality and major bleeding among ACS patients undergoing PCI receiving prasugrel versus ticagrelor. Our study may support the equal recommendation of both P2Y12 inhibitors as in the above guidelines.

Funding Acknowledgement

Type of funding source: None
Patterns of revascularization in stable ischemic heart disease in the pre-ISCHEMIA era
Authors: Albuquerque F , Brizido C , Madeira S , Teles R , Raposo L , Gabriel H , Leal S , Goncalves M , Brito J , Goncalves P , Almeida M , Mendes M
Published: November 2020

Introduction

New evidence on the role of myocardial revascularization in stable ischemic heart disease (SIHD), recently presented, showed that revascularization guided by the presence of moderate-to severe ischemia relieves angina more effectively than optimal medical therapy (OMT), without a significant benefit in hard clinical endpoints.

Aim

To assess the representativeness of the ISCHEMIA trial in a real-world population and compare management strategies between patients who fulfill the eligibility criteria of the trial (Group 1, G1) and those who do not (Group 2, G2).

Methods and population

Single centre retrospective analysis including all consecutive patients referred to coronary angiography (CA) for SIHD from January 2018 to December 2019. Patients were stratified in two groups (G1 and G2) according to the ISCHEMIA trial inclusion and exclusion criteria. G1 was compared with G2 and with a subset of G2 with obstructive coronary artery disease (CAD), defined as ≥70% luminal stenosis in at least one coronary artery or >50% for the left main.

Results

A total of 1020 patients underwent CA, of whom only 124 (12.2%) would have been eligible for the ISCHEMIA trial (G1). Overall, there were no significant differences in baseline characteristics between the two groups. G1 patients had more extensive and severe disease, presenting more frequently with proximal left anterior descending (LAD) involvement (26.6% vs 10.4%; p<0.001), two vessel disease without proximal LAD stenosis (23.4% vs 10.3%; p<0.001) and three vessel disease (18.5% vs 5.9%; p<0.001). These patients had higher rates of revascularization, both CABG (25.8% vs 10.8%, p<0.001) and PCI (56.5% vs 39.5%, p<0.001). However, when comparing G1 with the subset of G2 patients with obstructive CAD, G1 patients had higher rates of CABG (26.8% vs 17.8%, p=0.034) but there were no differences on the rates of PCI (58.0% vs 56.9%, p=0.916).

Conclusions

Patients included in the ISCHEMIA trial are underrepresented in a real-world population of SIHD patients referred to coronary angiography. PCI rates were similar among patients with at least one significant coronary artery stenosis, regardless of previous evidence or severity of ischemia. Our findings underline the need for further refinement in criteria for revascularization in SIHD.

Funding Acknowledgement

Type of funding source: None