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Background: Elderly patients are at high-risk of bleeding, but are under-represented in clinical trials. Objectives: The aims were to determine the incidence and the predictive factors of bleeding and to assess the impact of bleeding on further ischemic outcomes in elderly patients after acute coronary syndrome (ACS) treated with percutaneous coronary intervention. Methods: From the 877 patients aged ≥ 75 years included in the ANTARCTIC randomized trial, data on Bleeding Academic Research Consortium (BARC) bleeding complications and major adverse cardiovascular events (MACE), defined as the composite of cardiovascular death, myocardial infarction, and stroke, were collected over 1 year. Results: Clinically relevant bleeding events (BARC types 2, 3, or 5) were observed in 20.6% of patients (n = 181) at 1 year, of which, one third occurred in the first month. Anemia (adjusted hazard ratio [adj.HR] 3.98, 95% confidence interval [CI] 1.41–11.22; p = 0.009), severe chronic renal failure (adj.HR 1.83, 95% CI 1.12–2.98; p = 0.015), and femoral access (adj.HR 2.54, 95% CI 1.71–3.77; p < 0.001) were independently associated with clinically relevant bleeding events, while age > 85 years (adj.HR 2.22, 95% CI 1.14–4.30; p = 0.018) was independently associated with major bleeding events (BARC types 3 or 5). Patients with a clinically relevant bleeding event had a higher rate of MACE at 1 year (adj.HR 2.04, 95% CI 1.24–3.38; p = 0.005), with a particularly strong effect on stroke (adj.HR 5.55, 95% CI 2.04–15.06; p < 0.001). Conclusions: Clinically relevant bleeding events were observed in one out of five elderly patients undergoing stenting for an ACS and were strongly associated with further stroke occurrence. Rather than the antiplatelet therapy, comorbidities and an age > 85 years predicted bleeding outcomes in this elderly population. Clinical Trial Registration: Clinicaltrials.gov identifier: NCT01538446. https://www.clinicaltrials.gov. [ABSTRACT FROM AUTHOR]

BACKGROUND In patients with ST-elevation myocardial infarction (STEMI) who have multivessel disease, percutaneous coronary intervention (PCI) for nonculprit lesions (complete revascularization) is superior to treatment of the culprit lesion alone. However, whether complete revascularization that is guided by fractional flow reserve (FFR) is superior to an angiography-guided procedure is unclear. METHODS In this multicenter trial, we randomly assigned patients with STEMI and multivessel disease who had undergone successful PCI of the infarct-related artery to receive complete revascularization guided by either FFR or angiography. The primary outcome was a composite of death from any cause, nonfatal myocardial infarction, or unplanned hospitalization leading to urgent revascularization at 1 year. RESULTS The mean (±SD) number of stents that were placed per patient for nonculprit lesions was 1.01±0.99 in the FFR-guided group and 1.50±0.86 in the angiography-guided group. During follow-up, a primary outcome event occurred in 32 of 586 patients (5.5%) in the FFR-guided group and in 24 of 577 patients (4.2%) in the angiography-guided group (hazard ratio, 1.32; 95% confidence interval, 0.78 to 2.23; P=0.31). Death occurred in 9 patients (1.5%) in the FFR-guided group and in 10 (1.7%) in the angiography-guided group; nonfatal myocardial infarction in 18 (3.1%) and 10 (1.7%), respectively; and unplanned hospitalization leading to urgent revascularization in 15 (2.6%) and 11 (1.9%), respectively. CONCLUSIONS In patients with STEMI undergoing complete revascularization, an FFR-guided strategy did not have a significant benefit over an angiography-guided strategy with respect to the risk of death, myocardial infarction, or urgent revascularization at 1 year. However, given the wide confidence intervals for the estimate of effect, the findings do not allow for a conclusive interpretation. [ABSTRACT FROM AUTHOR]

Background ATLANTIC was a randomized study comparing pre- and in-hospital treatment with a ticagrelor loading dose (LD) in ongoing ST-segment elevation myocardial infarction (STEMI). We sought to compare patient characteristics and clinical outcomes in France with other countries participating in ATLANTIC. Methods The population comprised 1862 patients, 660 (35.4%) from France and 1202 from 12 other countries. The main endpoints were reperfusion (≥ 70% ST-segment elevation resolution) and TIMI flow grade 3 before (co-primary endpoints) and after percutaneous coronary intervention (PCI). Other endpoints included a composite ischaemic endpoint (death/myocardial infarction/stroke/urgent revascularization/definite stent thrombosis) and bleeding events at 30 days. Results In France, median times from first LD to angiography and between first and second LDs were 49 and 35 min, respectively, and were similar to other countries. French patients were younger (mean 58.7 vs 61.9 years, p < 0.0001) and characterized by a higher rate of radial access (89.9% vs 54.8%, p < 0.0001), more frequent use of pre-hospital glycoprotein (GP) IIb/IIIa inhibitors (14.1% vs 3.1%, p < 0.0001) and intravenous enoxaparin (57.3% vs 10.1%, p < 0.0001). In France, as in other countries, the co-primary endpoints did not differ between the two randomization groups. The composite ischaemic endpoint was numerically lower in France (3.3% vs 5.1%, p = 0.07), with a lower mortality (1.4% vs 3.3%, p = 0.01). PLATO major bleeding was numerically less frequent in France (1.8% vs 3.2%, p = 0.07). Conclusions The French population appears to have better outcomes than the rest of the study population, and seems related to differences in demographics and management characteristics. Trial registry ClinicalTrials.gov ( NCT01347580 ). [ABSTRACT FROM AUTHOR]

Background: Elderly patients are at high risk of ischaemic and bleeding events. Platelet function monitoring offers the possibility to individualise antiplatelet therapy to improve the therapeutic risk-benefit ratio. We aimed to assess the effect of platelet function monitoring with treatment adjustment in elderly patients stented for an acute coronary syndrome.Methods: We did this multicentre, open-label, blinded-endpoint, randomised controlled superiority study at 35 centres in France. Patients aged 75 years or older who had undergone coronary stenting for acute coronary syndrome were randomly assigned (1:1), via a central interactive voice-response system based on a computer-generated permuted-block randomisation schedule with randomly selected block sizes, to receive oral prasugrel 5 mg daily with dose or drug adjustment in case of inadequate response (monitoring group) or oral prasugrel 5 mg daily with no monitoring or treatment adjustment (conventional group). Randomisation was stratified by centre. Platelet function testing was done 14 days after randomisation and repeated 14 days after treatment adjustment in patients in the monitoring group. Study investigators and patients were not masked to treatment allocation, but allocation was concealed from an independent clinical events committee responsible for endpoint adjudication. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, and Bleeding Academic Research Consortium-defined bleeding complications (types 2, 3, or 5) at 12 months' follow-up. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01538446.Findings: Between March 27, 2012, and May 19, 2015, we randomly assigned 877 patients to the monitoring group (n=442) or the conventional group (n=435). The primary endpoint occurred in 120 (28%) patients in the monitoring group compared with 123 (28%) patients in the conventional group (hazard ratio [HR], 1·003, 95% CI 0·78-1·29; p=0·98). Rates of bleeding events did not differ significantly between groups.Interpretation: Platelet function monitoring with treatment adjustment did not improve the clinical outcome of elderly patients treated with coronary stenting for an acute coronary syndrome. Platelet function testing is still being used in many centres and international guidelines still recommend platelet function testing in high-risk situations. Our study does not support this practice or these recommendations.Funding: Eli Lilly and Company, Daiichi Sankyo, Stentys, Accriva Diagnostics, Medtronic, and Fondation Coeur et Recherche. [ABSTRACT FROM AUTHOR]

Background: Mineralocorticoid receptor antagonists (MRA) improve outcome in the setting of post-myocardial infarction (MI) heart failure (HF).Objectives: The study sought to assess the benefit of an early MRA regimen in acute MI irrespective of the presence of HF or left ventricular (LV) dysfunction.Methods: We randomized 1,603 patients to receive an MRA regimen with a single intravenous bolus of potassium canrenoate (200 mg) followed by oral spironolactone (25 mg once daily) for 6 months in addition to standard therapy or standard therapy alone. The primary outcome of the study was the composite of death, resuscitated cardiac arrest, significant ventricular arrhythmia, indication for implantable defibrillator, or new or worsening HF at 6-month follow-up. Key secondary/safety outcomes included death and other individual components of the primary outcome and rates of hyperkalemia at 6 months.Results: The primary outcome occurred in 95 (11.8%) and 98 (12.2%) patients in the treatment and control groups, respectively (hazard ratio [HR]: 0.97; 95% confidence interval [CI]: 0.73 to 1.28). Death occurred in 11 (1.4%) and 17 (2.1%) patients in the treatment and control groups, respectively (HR: 0.65; 95% CI: 0.30 to 1.38). In a non-pre-specified exploratory analysis, the odds of death were reduced in the treatment group (3 [0.5%] vs. 15 [2.4%]; HR: 0.20; 95% CI: 0.06 to 0.70) in the subgroup of ST-segment elevation MI (n = 1,229), but not in non-ST-segment elevation MI (p for interaction = 0.01). Hyperkalemia >5.5 mmol/l(-1) occurred in 3% and 0.2% of patients in the treatment and standard therapy groups, respectively (p < 0.0001).Conclusions: The study failed to show the benefit of early MRA use in addition to standard therapy in patients admitted for MI. (Aldosterone Lethal effects Blockade in Acute myocardial infarction Treated with or without Reperfusion to improve Outcome and Survival at Six months follow-up; NCT01059136). [ABSTRACT FROM AUTHOR]

The American Heart Association (AHA) and the American College of Cardiology (ACC) have recently updated their joint guidelines for the management of patients with non-ST-elevation acute coronary syndromes (NSTE-ACS, including unstable angina [UA] and non-ST-elevation myocardial infarction [NSTEMI]). These guidelines replace the 2007 guidelines and the focused updates from 2011 and 2012 and now combine UA and NSTEMI into a new classification, NSTE-ACS, and updating the terminology around noninvasive management to ischemia-guided strategy. The latest guidelines include updated recommendations for the use of the oral antiplatelet agents (P2Y12 inhibitors) prasugrel and ticagrelor as part of dualantiplatelet therapy—the cornerstone of treatment for these patients. This report provides a comprehensive overview of the new and modified recommendations for the management of patients with NSTE-ACS and the evidence supporting them. Also, where appropriate, similarities and differences between the current recommendations of the AHA/ACC and those of the European Society of Cardiology (ESC) are highlighted. For example, the AHA/ACC recommends the P2Y12 inhibitor ticagrelor over clopidogrel in all patients with NSTE-ACS and clopidogrel, prasugrel, or ticagrelor for patients in whom percutaneous coronary intervention is planned, whereas the ESC guidelines specifically recommend individual P2Y12 inhibitors for particular patient subgroups. [ABSTRACT FROM AUTHOR]

Abstract: Improvements in the management of haemophilia have led to a significant increase in the life expectancy of haemophilia patients, which is now close to the life expectancy in the general male population. Therefore, age-related conditions, especially cardiovascular disease (CVD), have become increasingly common in these patients. The management of CVD, especially that of coronary artery disease (CAD), acute coronary syndrome (ACS) and atrial fibrillation (AF), is particularly challenging in patients with haemophilia due to the need to find an adequate balance between bleeding and ischemic risk, requiring close coordination between cardiologists and haemophilia specialists. However, specific recommendations and relevant literature and data are scarce. Therefore, we propose pragmatic and practical therapeutic suggestions, based on the available literature and our own experience, for the management of ACS, stable angina and AF in patients with haemophilia. Overall, evidence and experience suggest that they should be treated much in the same way as the general CVD population, following standard guidelines, while choosing available treatment options known to be associated with low rates of bleeding complications. Treatments advocated for patient with haemophilia include antiplatelet therapy (aspirin and P2Y12 inhibitors), antithrombin therapy such as heparin or bivalirudin, glycoprotein IIb/IIIa inhibitors (GPIIb/IIIa inhibitors), transradial cardiac catheterization, and use of bare metal (BMS) or drug-eluting stents (DES). Antithrombotic agents with shorter half-lives that are reversible or have an antidote offer a safer choice in this setting. In addition, optimal clotting factor replacement therapy should be tailored to the increased risk of bleeding associated with invasive procedures and antithrombotic therapies, particularly during the acute phase of ACS. [Copyright &y& Elsevier]

Abstract: Drug-eluting stents are the default treatment for acute coronary syndromes, unless concerns or contraindications preclude dual antiplatelet therapy (DAPT). Platelet microemboli and mediators from activated platelets can undermine the restoration of perfusion. Therefore, ST-segment elevation MI (STEMI) patients should receive antiplatelet treatments regardless of reperfusion strategy. This review offers an evidence-based comparison of the P2Y12 antagonists that have been evaluated in STEMI. While several studies support clopidogrel in STEMI, the benefits emerge several hours after administration and vary considerably reflecting genetic, cellular and clinical inter-individual differences. Although higher clopidogrel loading doses may improve outcomes, ticagrelor and prasugrel are more potent, produce less inter-individual variability, and show a faster onset of action. Ticagrelor and prasugrel improve outcomes compared to clopidogrel, with manageable bleeding risks, although further studies with a longer follow up are needed. Studies directly comparing ticagrelor and prasugrel are now needed. In the meantime, most current guidelines focus on clopidogrel and, therefore, need revision. While several polymorphisms influence platelet activity, CYP2C19 variants are the most consistently linked to clopidogrel responsiveness. Consensus groups should consider the studies needed to allow routine pharmacogenomic testing. The evidence-based use of P2Y12 antagonists in DAPT should further reduce the morbidity and mortality associated with STEMI. [Copyright &y& Elsevier]

The aim of this study was to evaluate platelet reactivity and 30-day bleeding events in patients treated with prasugrel 10 mg after acute coronary syndromes. A total of 444 patients with acute coronary syndromes treated with percutaneous coronary intervention and prasugrel 10 mg/day were monitored by measurement of the vasodilator-stimulated phosphoprotein (VASP) index 2 to 4 weeks after hospital discharge. Platelet reactivity was also assessed using the Verify Now P2Y12 assay and light transmission aggregometry. Bleeding events (per the Bleeding Academic Research Consortium [BARC] definition) and ischemic events (death, myocardial infarction, and definite stent thrombosis) were collected over 30 days of follow-up. Two thirds of the patients presented with ST-segment elevation myocardial infarctions, 28.8% had diabetes, and 12.4% were aged >75 years. High ontreatment platelet reactivity according to 3 prespecified definitions (VASP index ≽50%, platelet reactivity ≽235 P2Y12 reaction units, and residual platelet reactivity ≽46.2%) was found in 6.8%, 3.4%, and 3.2% of patients, respectively. Obesity (body mass index >30 kg/m²) and multivessel disease were the only independent factors associated with high ontreatment platelet reactivity (p = 0.006 and p = 0.045, respectively). At 30 days, there was no major bleeding complication (BARC grade 3 or 5), and 1.6% of patients had recurrent ischemic events. Nuisance bleeding (BARC grade 1) and minor bleeding (BARC grade 2) occurred in 14.2% (n = 63) and 2.5% (n = 11) of patients, respectively, but were not predicted by VASP index. In conclusion, patients with acute coronary syndromes receiving maintenance doses of prasugrel have low rates of HPR and ischemic events within the first month. Minor or minimal bleeding is frequent, but not major bleeding. VASP was poorly correlated with the risk for minor or minimal bleeding. [ABSTRACT FROM AUTHOR]

Abstract: Background: Upper Gastrointestinal Symtoms (UGS) is a reason for discontinuation in patients treated by Low Dose Aspirin (LDA). The nationwide UGLA survey was designed to evaluate the prevalence and the pattern of UGS in patients on LDA, to assess the independent correlates of UGS and finally to determine their impact on treatment compliance. Methods: The UGLA survey was carried out on a representative sample of 10,000 subjects aged 50 or over. Prevalence and clinical impact of UGS related to LDA was appraised by standardised multi-choice questions. Results: A total of 8106 propositus (8106/10,000) accepted to participate in the survey. Among them, 986 (12.2%) were treated with LDA. The prevalence of UGS was 15.4% in subjects on chronic LDA (152/986), 70% being gastroesophageal reflux (GER) (heartburn and/or regurgitation). UGS was reported to occur at least once a week in 60% of propositus (91/152) and daily life was reported to be moderately and severely impaired in 53% (81/152) and 20% (30/152) of them, respectively. UGS impacted compliance to treatment in 12% of propositus with UGS. A prior history of dyspeptic symptoms was predictive of LDA-related UGS (OR: 17.60; CI 95%: 11.52–26.88) whereas neither, gender nor aspirin dosage (ranging from 75 and 325mg) predicted the occurrence of UGS. Conclusions: Fifteen percent of patients treated with LDA suffered UGS, mostly GER symptoms which had a negative impact on daily life in 3 out of 4 patients and on treatment compliance in 1 out of 8 patients. [Copyright &y& Elsevier]

The article discusses results of a study that examines the association of clinical, angiographic and genetic factors with early coronary stent thrombosis. The study design, setting and subjects are described. The study of 23 genetic variants in 15 different genes showed the significant determinants of early coronary stent thrombosis. Some of the nongenetic independent correlates are acuteness of percutaneous coronary intervention (PCI), complex lesions, left ventricular function less than 40 percent, higher dose of clopidogrel loading and use of proton pump inhibitors. The study has successfully identified the three genes and two clopidogrel-related factors that were associated with early coronary stent thrombosis.

The article focuses on a study which investigated if immediate intervention on admission can cause a reduction in myocardial infarction. The study included 352 patients from 13 centers in France, who were diagnosed with acute coronary syndromes without ST-segment elevation. The peak troponin value during hospitalization and the composite of death were measured on each patient. Study authors compared the clinical outcome of immediate and delayed intervention. They concluded that immediate and delayed intervention showed no difference in reducing myocardial infarction in patients with acute coronary syndromes without ST-segment elevation.

We present the case of a 67-year-old woman with cardiomyopathy induced by inappropriate sinus tachycardia (IST) and a particularly high average heart rate. The patient was resistant and/or intolerant to treatment with conventional rate-slowing medications. We used ivabradine—a specific sinus node If current inhibitor—and successfully lowered the heart rate (33 beats per minute mean heart rate decrease). Symptoms, systolic function, and heart rate variability parameters recovered dramatically. No side effect was noted. We suggest that ivabradine—evaluated in trials to treat stable angina—should be considered as a second-line treatment in patients with very symptomatic and refractory IST. [ABSTRACT FROM AUTHOR]

Intravascular lithotripsy (IVL) is a novel and appealing device for the preparation of coronary calcified lesions before stenting. This technology has received CE mark and FDA approval, according to the data of the CAD studies. However, these clinical trials show numerous limits as the exclusion of a subset of lesions (Left main, CTO, in stent restenosis ...) and patients' over-selection. In this view, applications of IVL results in daily practice are debatable according to the lack of evidence in unselected patients. FRANCE-LILI is a prospective national academic registry evaluating the safety and effectiveness of adjunctive intravascular lithotripsy in coronary angioplasty in an all-comers patient population in France. The registry is registered with the ClinicalTrials.gov database (NCT05113407) and managed by the French Coronary Atheroma and Interventional Cardiology Group (GACI) of the French Society of Cardiology (FSC). France LILI will prospectively enroll 500 subjects. The primary endpoint is target vessel failure (TVF) at one year, defined as a composite of cardiac death, myocardial infarction (MI) according to the Academic Research Consortium-2 (ARC-2) definition (except for an MI clearly attributed to a non-target vessel) and revascularization of the target vessel. All endpoints are evaluated and confirmed by an independent adjudication committee. This national prospective academic registry will provide fruitful data on IVL in an unselected population of complex coronary lesions. [ABSTRACT FROM AUTHOR]

BACKGROUND: Limited information is available on the comparative efficacy and safety of different stent platforms in patients at high bleeding risk undergoing an abbreviated dual antiplatelet therapy duration after percutaneous coronary intervention (PCI). The aim of this study was to compare the safety and effectiveness of the biodegradable-polymer sirolimus-eluting stent with the durable-polymer zotarolimus-eluting stent in patients at high bleeding risk receiving 1 month of dual antiplatelet therapy after PCI. METHODS: The Bioflow-DAPT Study is an international, randomized, open-label trial conducted at 52 interventional cardiology hospitals in 18 countries from February 24, 2020, through September 20, 2021. Patients with a clinical indication to PCI because of acute or chronic coronary syndrome who fulfilled 1 or more criteria for high bleeding risk were eligible for enrollment. Patients were randomized to receive either biodegradable-polymer sirolimus-eluting stents or durable-polymer, slow-release zotarolimus-eluting stents after successful lesion preparation, followed by 1 month of dual antiplatelet therapy and thereafter single antiplatelet therapy. The primary outcome was the composite of death from cardiac causes, myocardial infarction, or stent thrombosis at 1 year, and was powered for noninferiority, with an absolute margin of 4.1% at 1-sided 5% alpha. RESULTS: A total of 1948 patients at high bleeding risk were randomly assigned (1:1) to receive biodegradable-polymer sirolimus-eluting stents (969 patients) or durable-polymer zotarolimus-eluting stents (979 patients). At 1 year, the primary outcome was observed in 33 of 969 patients (3.6%) in the biodegradable-polymer sirolimus-eluting stent group and in 32 of 979 patients (3.4%) in the durable-polymer zotarolimus-eluting stent group (risk difference, 0.2 percentage points; upper boundary of the 1-sided 95% CI, 1.8; upper boundary of the 1-sided 97.5% CI, 2.1; P<0.0001 for noninferiority for both tests). CONCLUSIONS: Among patients at high risk for bleeding who received 1 month of dual antiplatelet therapy after PCI, the use of biodegradable-polymer sirolimus-eluting stents was noninferior to the use of durable-polymer zotarolimus-eluting stents with regard to the composite of death from cardiac causes, myocardial infarction, or stent thrombosis. [ABSTRACT FROM AUTHOR]

Background: While admission of patients with acute coronary syndromes (ACS) in cardiology intensive care unit (CICU) is usual, in-hospital major outcomes in lower risk patients may be evaluated after early coronary angiography according to the European guidelines. Methods: Consecutive ACS patients were prospectively included after coronary angiography evaluation within 24 h and percutaneous coronary intervention (PCI), when required. Patients were classified as high- or low-risk according to hemodynamics, rhythmic state, ischemic and bleeding risks. Major in-hospital outcomes were assessed. Results: From January to June 2021, 277 patients were enrolled (62.8% with ST-segment elevation myocardial infarction (STEMI) (n = 174); 37.2% with non-NSTEMI (NSTEMI) (n = 103). PCI was required for 260 patients (93.9%). Seventy-four patients (26.7%) were classified as low-risk (n = 47 NSTEMI; n= 27 STEMI) and 203 patients (73.3%) as high-risk of events. All patients were monitored in CICU. While 38 patients (18.7%) from the high-risk group reached the primary endpoint, mainly related to rhythmic or conduction disorder (n = 24, 11.8%) or unstable hemodynamics (n = 17; 8.4%), only 1 patient (1.3%) in the low-risk group had one major outcome (no fatal bleeding); p < 0.01. The negative predictive value of our patient stratification for the absence of major in-hospital outcome was 100% (CI95%: 100–100%) for STEMI and 97.9% [CI95%: 93.2–100%] for NSTEMI patients. Conclusions: Stratification of ACS patients after early coronary angiography and most of the time PCI, identify a population with very low risk of in-hospital events (1/4 of all ACS and 1/2 of NSTEMI) who may probably not require ECG monitoring and/or CICU admission. (NCT04378504). [ABSTRACT FROM AUTHOR]

Despite the evolution of stent technology, there is a non-negligible risk of in-stent restenosis (ISR) after Percutaneous coronary intervention (PCI). Large-scale registry data on the prevalence and clinical management of ISR is lacking. The aim was to describe the epidemiology and management of patients with ≥1 ISR lesions treated with PCI (ISR PCI). Data on characteristics, management and clinical outcomes were analyzed for patients undergoing ISR PCI in the France-PCI all-comers registry. Between January 2014 and December 2018, 31,892 lesions were treated in 22,592 patients, 7.3 % of whom underwent ISR PCI. Patients undergoing ISR PCI were older (68.5 vs 67.8; p < 0.001), and more likely to have diabetes (32.7 % vs 25.4 %, p < 0.001), chronic coronary syndrome or multivessel disease. ISR PCI concerned drug eluting stents (DES) ISR in 48.8 % of cases. Patients with ISR lesions were more frequently treated with DES than drug eluting balloon or balloon angioplasty (74.2 %, 11.6 % and 12.9 %, respectively). Intravascular imaging was rarely used. At 1 year, patients with ISR had higher target lesion revascularization rates (4.3 % vs. 1.6 %; HR 2.24 [1.64–3.06]; p < 0.001). In a large all-comers registry, ISR PCI was not infrequent and associated with worse prognosis than non-ISR PCI. Further studies and technical improvements are warranted to improve the outcomes of ISR PCI. Abbreviations: DEB: drug eluting balloon; DES: drug eluting stent; HR: hazard ratio; POBA: plain old balloon angioplasty; ISR: in-stent restenosis; TLR: target lesion revascularization. [Display omitted] • ISR PCI is performed with relevant frequency in routine clinical practice (7-8%). • Approximately 10-20% of ISR are treated with POBA. • Intravascular imaging is largely underused (< 2%). • At 1 year, patients with ISR PCI have higher TLR rates than non-ISR PCI (4.3% vs. 1.6%; HR 2.24 [1.64-3.06]; p <0.001). [ABSTRACT FROM AUTHOR]

Background: ST-segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI) management has evolved considerably over the past 2 decades. Little information on mortality trends in the most recent years is available. We assessed trends in characteristics, treatments, and outcomes for acute myocardial infarction in France between 1995 and 2015.Methods: We used data from 5 one-month registries, conducted 5 years apart, from 1995 to 2015, including 14 423 patients with acute myocardial infarction (59% STEMI) admitted to cardiac intensive care units in metropolitan France.Results: From 1995 to 2015, mean age decreased from 66±14 to 63±14 years in patients with STEMI; it remained stable (68±14 years) in patients with NSTEMI, whereas diabetes mellitus, obesity, and hypertension increased. At the acute stage, intended primary percutaneous coronary intervention increased from 12% (1995) to 76% (2015) in patients with STEMI. In patients with NSTEMI, percutaneous coronary intervention ≤72 hours from admission increased from 9% (1995) to 60% (2015). Six-month mortality consistently decreased in patients with STEMI from 17.2% in 1995 to 6.9% in 2010 and 5.3% in 2015; it decreased from 17.2% to 6.9% in 2010 and 6.3% in 2015 in patients with NSTEMI. Mortality still decreased after 2010 in patients with STEMI without reperfusion therapy, whereas no further mortality gain was found in patients with STEMI with reperfusion therapy or in patients with NSTEMI, whether or not they were treated with percutaneous coronary intervention.Conclusions: Over the past 20 years, 6-month mortality after acute myocardial infarction has decreased considerably for patients with STEMI and NSTEMI. Mortality figures continued to decline in patients with STEMI until 2015, whereas mortality in patients with NSTEMI appears stable since 2010. [ABSTRACT FROM AUTHOR]

Background: Because rotational atherectomy (RA) is associated with arterial trauma and platelet activation, patients treated with RA may benefit from more potent antiplatelet drugs. The aim of this trial was to assess the superiority of ticagrelor over clopidogrel in reducing post procedure troponin release. Methods: TIRATROP (TIcagrelor in Rotational Atherectomy to reduce TROPonin enhancement) is a multicenter double-blind randomized controlled trial that included 180 patients with severe calcified lesions requiring RA who received either clopidogrel (300 mg loading dose, then 75 mg/d) or ticagrelor (loading dose 180 mg then 90 mg twice daily). Blood samples were collected at the beginning (T0), and 6, 12, 18, 24 and 36 h after the procedure. Primary end point was troponin release within the first 24 h using area under the curve analysis (troponin level as a function of time). Results: The mean age of patients was 76 ± 10 years, 35% had diabetes. RA was used to treat 1, 2 or 3 calcified lesions in 72%, 23% and 5% of patients, respectively. Troponin release within the first 24 h was similar in both the ticagrelor (adjusted mean ±SD of ln AUC 8.85 ± 0.33) and the clopidogrel (8.77 ± 0.34, p = 0.60) arms. Independent predictors for troponin enhancement were acute coronary syndrome presentation, renal failure, elevated C-Reactive protein and multiple lesions treated with RA. Conclusion: Troponin release did not differ among treatment arms. Our results suggest that greater platelet inhibition does not affect periprocedural myocardial necrosis in the setting of RA. [ABSTRACT FROM AUTHOR]

Background: Elderly patients are underrepresented in acute myocardial infarction trials. Our aim was to determine whether, in elderly patients, changes in management in the past 15 years are associated with improved 1-year mortality after hospital admission for myocardial infarction.Methods: We used data from 4 1-month French registries, conducted 5 years apart from 1995 to 2010, including 3389 elderly patients (≥75 years of age).Results: From 1995 to 2010, mean age remained stable (82.1 years), similar in ST- and non-ST-elevation myocardial infarction patients. Obesity, diabetes, hypertension, and hypercholesterolemia increased. History of prior myocardial infarction, stroke, and peripheral artery disease remained stable, while history of heart failure decreased. Major changes in management were noted: early percutaneous coronary intervention, early treatment with antiplatelet agents, low-molecular-weight heparin, beta-blockers, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and statins all increased. Early mortality after hospital admission decreased from 25.0% to 8.4%. One-year mortality decreased from 36.2% to 20.0% (adjusted hazard ratio 2010 vs 1995: 0.47, 0.39-0.57), both for ST-elevation myocardial infarction (36.8% to 21.1%) and non-ST-elevation myocardial infarction (34.8% to 19.1%). Mortality reduction was observed in all age groups, including those ≥85 years of age (from 46.2% to 31.4%). The study period, however, was no longer associated with decreased mortality when variables reflecting management changes were taken into account.Conclusions: Early and 1-year mortality after hospital admission of elderly patients with acute myocardial infarction has substantially decreased over the past 15 years. This improvement is likely mediated by increasing use of recommended management strategies. These data support the application of guidelines derived from trials mostly including younger patients to elderly populations as well. [ABSTRACT FROM AUTHOR]

A response by Gilles Montalescot and colleagues to a letter to the editor about their article "ABOARD Investigators, Immediate vs. Delayed Intervention for Acute Coronary Syndromes: A Randomized Clinical Trial," published in a 2009 issue, is presented.

Background: Transcatheter aortic valve implantation (TAVI) is the preferred treatment for symptomatic severe aortic stenosis (AS) in a majority of patients across all surgical risks. Patients and methods: Paravalvular leak (PVL) and patient–prosthesis mismatch (PPM) are two frequent complications of TAVI. Therefore, based on the large France-TAVI registry, we planned to report the incidence of both complications following TAVI, evaluate their respective risk factors, and study their respective impacts on long-term clinical outcomes, including mortality. Results: We identified 47,494 patients in the database who underwent a TAVI in France between 1 January 2010 and 31 December 2019. Within this population, 17,742 patients had information regarding PPM status (5138 with moderate-to-severe PPM, 29.0%) and 20,878 had information regarding PVL (4056 with PVL ≥ 2, 19.4%). After adjustment, the risk factors for PVL ≥ 2 were a lower body mass index (BMI), a high baseline mean aortic gradient, a higher body surface area, a lower ejection fraction, a smaller diameter of TAVI, and a self-expandable TAVI device, while for moderate-to-severe PPM we identified a younger age, a lower BMI, a larger body surface area, a low aortic annulus area, a low ejection fraction, and a smaller diameter TAVI device (OR 0.85; 95% CI, 0.83–0.86) as predictors. At 6.5 years, PVL ≥ 2 was an independent predictor of mortality and was associated with higher mortality risk. PPM was not associated with increased risk of mortality. Conclusions: Our analysis from the France-TAVI registry showed that both moderate-to-severe PPM and PVL ≥ 2 continue to be frequently observed after the TAVI procedure. Different risk factors, mostly related to the patient's anatomy and TAVI device selection, for both complications have been identified. Only PVL ≥ 2 was associated with higher mortality during follow-up. [ABSTRACT FROM AUTHOR]

Intravascular lithotripsy (IVL) is a promising new technology for disrupting de-novo calcified coronary lesions (DNL) before percutaneous coronary intervention (PCI). We assessed 12-month outcomes of IVL in patients undergoing PCI for DNL or intra stent restenosis (ISR) lesions related to device underexpansion. Prospective analysis of patients in the multicentre all-comers French Shock Initiative IVL registry. The primary safety endpoints in this analysis were in-hospital and 12-month major adverse cardiovascular events (MACE: cardiac death, myocardial infarction or target vessel revascularization). The primary effectiveness endpoint was procedural success, defined as <30% residual stenosis without severe angiographic complications. Event rates were analysed for the cohort and for DNL and ISR procedures separately. A total of 220 lesions were treated (76.7% DNL and 23.3% ISR) in 202 patients. Procedural success was achieved in 95.5% of patients (DNL group: 96.5%; ISR group: 92.0%). In-hospital MACE occurred in 6.4% of cases, mainly driven by periprocedural infarctions. The rate of MACE-free survival at 1 year was 86.6% in the overall cohort. Rates of target vessel (TVR) and lesion (TLR) revascularisation were 6.4% and 2.5%, respectively. The 1-year MACE rate was 91.5% in DNL group and 83.8% in ISR group. In this large all-comers IVL cohort, rates of in-hospital and 1-year MACE were moderate. The safety and efficiency of IVL was comparable in DNL and ISR lesions. A comparative study of the impact of IVL on outcomes appears warranted. • A total of 220 lesions (76.7% de novo lesions / DNL and 23.3% intra stentrestenosis/ISR) were treated by intravascular lithotripsy in 202 patients. • Procedural success was achieved in 95.5% of patients, with no difference between DNL and ISR groups (96.5% vs 92%; p=0.24). • MACE-free survival at 1 year was 86.6% in the overall cohort, with no difference between DNL and ISR (91.5% vs 83.8%; p = 0.15). [ABSTRACT FROM AUTHOR]

Purpose: Proton-pump Inhibitors use and CYP2C19 loss-of-function alleles are associated with reduced responsiveness to standard clopidogrel doses and increased cardiovascular events. Methods: Post-myocardial infarction patients heterozygous (wild type [wt]/*2, n = 41) or homozygous (*2/*2, n = 7) for the CYP2C19* 2 genetic variant were matched with patients not carrying the variant (wt/wt, n = 58). All patients were randomized to a 300- or 900-mg clopidogrel loading dose. A PK/PD model was defined using the variation of the P2Y reaction unit relative to baseline. Results: Carriage of CYP2C19* 2 allele and the use of omeprazole/esomeprazole were associated with the inter-individual variability in the active metabolite clearance. The relationship between inhibition of platelet aggregation (IPA, %) and the active metabolite AUC (h*μg/L) was described by a sigmoid function (Emax 56±5%; E 15.9±0.8 h*μg/L) with a gamma exponent (7.04±2.26). Conclusion: This on/off shape explains that a small variation of exposure may have a clinical relevance. [ABSTRACT FROM AUTHOR]

(1) Background: Despite the improvement of the in-hospital survival rate after aborted sudden cardiac death (SCD), cerebral anoxia may have severe neurologic consequences and may impair long-term outcome and quality of life of surviving patients. The aim of this study was to assess neurological outcomes at one year after resuscitated cardiac arrest; (2) Methods: This prospective, observational, and multicentre study included patients >18 yo admitted in the catheterisation laboratory for coronary angiography after aborted SCD between 1 May 2018 and 31 May 2020. Only patients who were discharged alive from hospital were evaluated. The primary endpoint was survival without neurological sequelae at one-year follow-up defined by a cerebral performance category (CPC) of one or two. Secondary end points included all-cause mortality, New York Heart Association (NYHA) functional class, neurologic evaluation at discharge, three-month and one-year follow-up using the CPC scale, and quality of life at 1 year using the Quality of Life after Brain Injury (QOLIBRI) questionnaire; (3) Results: Among 143 patients admitted for SCD within the study period, 61 (42.7%) were discharged alive from hospital, among whom 55 (90.1%) completed the one-year follow-up. No flow and low flow times were 1.9 ± 2.4 min and 16.5 ± 10.4 min, respectively. For 93.4% of the surviving patients, an initial shockable rhythm (n = 57) was observed and acute coronary syndrome was diagnosed in 75.4% of them (n = 46). At 1 year, survival rate without neurologic sequelae was 87.2% (n = 48). Patients with poor outcome were older (69.3 vs. 57.4 yo; p = 0.04) and had lower body mass index (22.4 vs. 26.7; p = 0.013) and a lower initial Left Ventricle Ejection Fraction (LVEF) (32.1% vs. 40.3%; p = 0.046). During follow-up, neurological status improved in 36.8% of patients presenting sequelae at discharge, and overall quality of life was satisfying for 66.7% of patients according to the QOLIBRI questionnaire; (4) Conclusions: Among patients admitted to the catheterisation laboratory for aborted SCD, mainly related to Acute Coronary Syndrom (ACS), less than a half of them were alive at discharge. However, the one-year survival rate without neurological sequelae was high and overall quality of life was good. [ABSTRACT FROM AUTHOR]

Introduction: Long-term follow-up after an acute coronary syndrome (ACS) presents a crucial challenge due to the high residual cardiovascular risk and the potential for major bleeding events. Although several treatment strategies are available, this article focuses on patients who have undergone percutaneous coronary intervention (PCI) for ACS, which is a frequent clinical situation. This position paper aims to support physicians in daily practice to improve the management of ACS patients.Material and methods: A group of recognized international and French experts in the field provides an overview of current evidence-based recommendations - supplemented by expert opinion where such evidence is lacking - and a practical guide for the management of patients with ACS after hospital discharge.Results: The International Collaborative Group underlines the need of a shared collaborative approach, and a care plan individualized to the patient's risk profile for both ischaemia and bleeding. Each follow-up appointment should be viewed as an opportunity to optimize the personalized approach, to reduce adverse clinical outcomes and improve quality of life. As risks - both ischaemic and haemorrhagic - evolve over time, the risk-benefit balance should be assessed in an ongoing dynamic process to ensure that patients are given the most suitable treatment at each time point.Conclusions: This Expert Opinion aims to help clinicians with a practical guide underlying the proven strategies and the remaining gaps of evidence to optimize the management of coronary patients. [ABSTRACT FROM AUTHOR]

Increasing operators' experience and improvement of the technique have resulted in a drastic reduction in complications following transcatheter aortic valve replacement (TAVR) in patients with lower surgical risk. In parallel, the procedure was considerably simplified, with a routine default approach including local anesthesia in the catheterization laboratory, percutaneous femoral approach, radial artery as the secondary access, prosthesis implantation without predilatation, left ventricle wire pacing and early discharge. Thus, the "simplified" TAVR adopted in most centers nowadays is a real revolution of the technique. However, simplified TAVR must be accompanied upstream by a rigorous selection of patients who can benefit from a minimalist procedure in order to guarantee its safety. The minimalist strategy must not become dogmatic and careful pre-, per- and post-procedural evaluation of patients with well-defined protocols guarantee optimal care following TAVR. This review aims to evaluate the benefits and limits of the simplified TAVR procedure in a current and future vision. [ABSTRACT FROM AUTHOR]

Right ventricular (RV) dysfunction and tricuspid regurgitation (TR) may impact prognosis of patients undergoing Transcatheter Aortic Valve Implantation (TAVI). We aimed to evaluate the evolution of previous RV dysfunction and/or significant TR after TAVI procedure. All patients undergoing TAVI between January 2018 and January 2019 were enrolled in this prospective cohort. Patients with at least one right heart (RH) abnormality at baseline including RV dysfunction (TAPSE < 17 mm, S-wave < 9.5 cm/s, Fractional area change < 35%, Strain > −20%, Tei > 0.54) and/or significant TR (Effective Regurgitant Orifice Area ≥ 40 mm2 and/or Regurgitant Volume ≥ 45 mL) underwent transthoracic echocardiography at day 1 and 6-month after TAVI. The primary endpoint was the regression of pre-TAVI RV dysfunction and/or significant TR at 6-month follow-up. The study enrolled 144 patients including 76 women (52.8%) with a mean age of 81.1 ± 6.8 yo, a mean EuroSCORE 2 of 5.2 ± 3.9%. At least one RH abnormality was observed in 53 patients (36.8%). At 6-month, at least one RV dysfunction parameter significantly improved in 26 patients (63.4%), TAPSE increasing from 13.0 ± 2.6 to 16.0 ± 9.8 mm, p < 0.0001 and S-wave from 7.7 ± 1.2 to 10.0 ± 2.6 cm/s, p = 0.004. Among 31 patients with baseline significant TR, TR decreased in 14 (45.2%); p = 0.003. Among patients with baseline RH abnormalities, 13 (24.5%) fully recovered. Baseline significant TR was predictive of 6-month clinical outcomes (OR = 3.1, 95%CI = [1.01–9.0], p = 0.03). In our recent intermediate surgical risk TAVI population, RV dysfunction and/or significant TR are frequent at baseline and fully or partially recover in most patients at 6-month follow-up. • RV dysfunction and significant TR are frequently observed prior TAVI and improve after the procedure in most of cases. • RV dysfunction may be a decision-making parameter in favor of TAVI in patients with severe AS. • Significant TR may not be, by itself, an argument for surgery as TR improves in most of patients following TAVI. [ABSTRACT FROM AUTHOR]

Acute heart failure (AHF) management is challenging, with high morbidity and readmission rates. There is little evidence of the benefit of HF monitoring during hospitalization. The aim of the study was to assess whether daily bedside echocardiographic monitoring (JetEcho) improved outcomes in AHF. In this prospective, open, two parallel-arm study (clinicaltrials.gov: NCT02892227), participants from two university hospitals were randomized to either standard of care (SC) or daily treatment adjustment including diuretics guided by JetEcho evaluating left ventricular filling pressure and volemia. The primary outcome was 30-day readmission rate. Key secondary outcomes were six-month cumulative incidence death, worsening HF during hospitalization and increasing of myocardial and renal biomarkers. From 250 included patients, 115 were finally analyzed in JetEcho group and 112 in SC group. Twenty-two (19%) patients were readmitted within 30 days in JetEcho group and 17 (15%) in SC group (relative risk [RR] 1.26; 95% confidence interval [CI], 0.70–2.24; p = 0.4). Worsening HF occurred in 17 (14%) patients in the JetEcho group and 24 (20%) in the SC group (RR 0.7; 95% [CI] 0.39 to 1.2; p = 0.2). No significant difference was found between the two groups concerning natriuretic peptides and renal function (p > 0.05 for all). The cumulative incidence rate of death from any cause at six months from discharge was 8.7% in the JetEcho group and 11.6% in the SC group (HR 0.63, 95% [CI] 0.3–1.4, p = 0.3). In AHF patients, a systematic daily bedside echocardiographic monitoring did not reduce 30-day readmission rate for HF and short-term clinical outcomes. [ABSTRACT FROM AUTHOR]

If several randomized studies allowed to better apprehend what should be the best antithrombotic strategy in patients with concomitant coronary artery disease (CAD) and atrial fibrillation (AF), there are still several clinical situations with a gap of evidence. We conducted a national French survey in September–October 2020 among cardiologists in order to assess what are daily practices regarding the antithrombotic management in several specific clinical settings where no or little scientific evidence is available. The questionnaires were built by a committee of 6 cardiologists routinely involved in the field of CAD and/or AF. Among the 6388 French cardiologists, 483 (7.6%) cardiologists participated to the survey. The rate of participation was rather homogeneous across the country. The mean age of participants was 48 +/− 12.7. There were 134 women (27.7%) and 349 men. Altogether, 181 (37.5%) cardiologists worked in private, 153 (31.7%) in non-universitary public and 83 (17.2%) in universitary public centers. The remaining had shared activity. Among the participants, 150 were interventional (coronary) cardiologists (31.1%). Others were general cardiologists (n = 229), specialists in the field of rhythmology (n = 43), heart failure (n = 17) or imaging (n = 44). The survey consisted of 10 questions pertaining to 2 virtual clinical scenarios. The present survey is an illustration of how therapeutic decisions may vary in such situations with little or no scientific evidence. Such surveys may help experts to build consensus (answers with little variability) and to target the need for future trials and more research (answers with a lot of variability). • Management of antithrombotics is critical in patients with concomitant coronary artery disease and atrial fibrillation • There are several clinical situations with complete evidence gaps in this specific context • Our survey is a perfect illustration of how therapeutic decisions may vary in situations with little scientific evidence • Such surveys may help experts to build consensus and to target the need for future trials and more research. [ABSTRACT FROM AUTHOR]

Re -POT (proximal optimization technique (POT)) is a simple provisional sequential technique for percutaneous coronary bifurcation revascularization with better arterial geometry respect compared to classical techniques. Re -POT has demonstrated excellent mechanical and short-term clinical results. The multicenter CABRIOLET registry (NCT03550196) evaluate the long-term clinical benefit of the re-POT sequence in non-selected patients. All consecutive patients presenting a coronary bifurcation lesion for which provisional stenting was indicated were included in 5 european centers. Re -POT strategy was systematically attempted. The primary endpoint was target lesion failure (TLF), comprising cardiac death, myocardial infarction, stent thrombosis and target lesion revascularization (TLR) at 12 months' follow-up. The secondary endpoints were the individual components of the primary endpoint, all-cause death, target vessel failure (TVF) and target vessel revascularization (TVR). Complex bifurcation was defined as Medina 0.1.1 or 1.1.1. A total of 500 patients aged 67.7 ± 11.7 years, 78.4% male, were included from 2015 to 2019, 174 of whom (34.8%) were considered having complex bifurcation lesions. Bifurcations involved the left main in 35.2% of cases. The full re-POT sequence was systematically performed in all cases. At 1 year, TLF was 2.0% (1.7% in complex vs. 2.1% in non-complex bifurcation; p = NS), and TLR was 1.6%, (1.1% vs. 1.8% respectively; p = NS). TVF and TVR rates were 3.2% and 2.8%. On multivariate analysis, only multivessel disease was predictive of TLF at 1 year (OR = 1.66 (1.09–2.53), p = 0.02). In this large prospective all-comer registry, provisional stenting with re-POT technique appeared safe and effective at 1 year, without anatomical bifurcation restriction. • Re-POT demonstrated a better respect of coronary bifurcation physiology than KBI. • Sequential technique re-POT is recommended by the European Bifurcation Club. • CABRIOLET is the first clinical evaluation of the long-term benefit of the re-POT. • Re-POT demonstrated excellent clinical results at 1 year, only 2% of TLF. • Re-POT is an efficient technique for bifurcation provisional stenting. [ABSTRACT FROM AUTHOR]

Mechanical complications (MC) (i.e., free wall rupture (FWR), papillary muscle rupture (PMR) and ventricular septal rupture (VSR)) are rare complications of ST- elevation acute myocardial infarction (STEMI). Incidence of MC according to pre-hospital delay remains unknown. We aimed to determine the rates of MC according to pre-hospital delay. Analysis was conducted on the MODIF registry data. Patients were allocated to four groups according to pre-hospital delay: 0 to 12 h, 12 to 24 h, 24 to 36 h and 36 to 48 h. 6185 patients with complete data were analyzed. Mean age was 64.1 years old and 75.7% of patients were males. Eighty-three patients (1.34%) presented with MC: 44 (0.71%) experienced a FWR, 17 (0.27%) a PMR, and 22 (0.36%) a VSR. Global rates of MC were 0.82%, 1.43%, 1.24% and 5.07% in the four groups of pre-hospital delays - 0 to 12 h, 12 to 24 h, 24 to 36 h and 36 to 48 h - respectively (p < 0.001). In-hospital mortality rates were high: 44.2%, 47.1% and 54.6% for FWR, PMR and VSR, respectively. In multivariate analysis, factors independently related to the occurrence of MC were older age, female sex, simultaneous COVID-19 infection, absence of dyslipidemia, initial TIMI flow 0 or 1 in the culprit artery, 36 to 48 h-pre-hospital delay and absence of revascularization by percutaneous coronary intervention (PCI) with stent implantation. The probability of MC in STEMI increases with pre-hospital delay. Mechanical complications of STEMI remain associated with a very poor prognosis. [Display omitted] • Data on mechanical complications in STEMI are scarce and outdated. • The present study describes, from a large contemporary nationwide database, the correlation between pre-hospital delay and mechanical complication occurrence. • Probability of Mechanical Complication in STEMI increases with pre-hospital delay, in particular over 36 h. [ABSTRACT FROM AUTHOR]

Background: There is limited evidence that fractional flow reserve (FFR) is effective in guiding therapeutic strategy in multivessel coronary artery disease (CAD) beyond prespecified percutaneous coronary intervention or coronary graft surgery candidates.Objectives: The FUTURE (FUnctional Testing Underlying coronary REvascularization) trial aimed to evaluate whether a treatment strategy based on FFR was superior to a traditional strategy without FFR in the treatment of multivessel CAD.Methods: The FUTURE trial is a prospective, randomized, open-label superiority trial. Multivessel CAD candidates were randomly assigned (1:1) to treatment strategy based on FFR in all stenotic (≥50%) coronary arteries or to a traditional strategy without FFR. In the FFR group, revascularization (percutaneous coronary intervention or surgery) was indicated for FFR ≤0.80 lesions. The primary endpoint was a composite of major adverse cardiac or cerebrovascular events at 1 year.Results: The trial was stopped prematurely by the data safety and monitoring board after a safety analysis and 927 patients were enrolled. At 1-year follow-up, by intention to treat, there were no significant differences in major adverse cardiac or cerebrovascular events rates between groups (14.6% in the FFR group vs 14.4% in the control group; hazard ratio: 0.97; 95% confidence interval: 0.69-1.36; P = 0.85). The difference in all-cause mortality was nonsignificant, 3.7% in the FFR group versus 1.5% in the control group (hazard ratio: 2.34; 95% confidence interval: 0.97-5.18; P = 0.06), and this was confirmed with a 24 months' extended follow-up. FFR significantly reduced the proportion of revascularized patients, with more patients referred to exclusively medical treatment (P = 0.02).Conclusions: In patients with multivessel CAD, we did not find evidence that an FFR-guided treatment strategy reduced the risk of ischemic cardiovascular events or death at 1-year follow-up. (Functional Testing Underlying Coronary Revascularisation; NCT01881555). [ABSTRACT FROM AUTHOR]

Abstract: Background: Aldosterone levels are high early after admission for ST elevation myocardial infarction (STEMI) concomitantly with high risk of sudden death and life-threatening ventricular arrhythmia. Methods: We assessed the hypothesis that early aldosterone blockade on admission for primary percutaneous coronary intervention (PCI) may be associated with a reduction of life-threatening ventricular arrhythmia in a prospective cohort-nested case (n=159) versus historical control (n=623) study. All cases were treated on admission by 200mg IV bolus of potassium canrenoate, followed by 25mg PO spironolactone daily during the coronary care unit stay. The primary endpoint – in-hospital composite of death, resuscitated cardiac arrest and ventricular tachycardia – was assessed by logistic regression models adjusted on major pre-specified variables and validated by a bootstrap procedure and propensity-score based analyses. Results: Aldosterone blockade was associated with lower risks of the primary endpoint (adjusted ORs 0.26, 95% CI [0.13–0.57]), resuscitated cardiac arrest (adjusted OR 0.39, 95% CI [0.16–0.94]), ventricular tachycardia or fibrillation (adjusted ORs 0.23, 95% CI [0.12–0.45]), as well as ventricular arrhythmia requiring resuscitation or anti-arrhythmic therapy (adjusted OR 0.41, 95% CI [0.19–0.88]). All findings were confirmed by the bootstrap procedure. The benefit on death or resuscitated cardiac arrest seemed sustained at 6month follow-up. Conclusions: Early aldosterone blockade in patients presenting for primary PCI for STEMI is associated with significant reductions in rates of life-threatening arrhythmia and cardiac arrest independent of the initial risk profile, heart failure or hemodynamic status. These findings support the concept of aldosterone blockade early after STEMI, warranting further confirmation by ongoing randomized trials. [Copyright &y& Elsevier]

Background: The optimal management of patients with ST-segment elevation myocardial infarction (STEMI) presenting late->12 hours following symptom onset-is still under debate.Objectives: The purpose of this study was to describe characteristics, temporal trends, and impact of revascularization in a large population of latecomer STEMI patients.Methods: The authors analyzed the data of 3 nationwide observational studies from the FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) program, conducted over a 1-month period in 2005, 2010, and 2015. Patients presenting between 12 and 48 hours after symptom onset were classified as latecomers.Results: A total of 6,273 STEMI patients were included in the 3 cohorts, 1,169 (18.6%) of whom were latecomers. After exclusion of patients treated with fibrinolysis and patients deceased within 2 days after admission, 1,077 patients were analyzed, of whom 729 (67.7%) were revascularized within 48 hours after hospital admission. At 30-day follow-up, all-cause death rate was significantly lower among revascularized latecomers (2.1% vs 7.2%; P < 0.001). After a median follow-up of 58 months, the rate of all-cause death was 30.4 (95% CI: 25.7-35.9) per 1,000 patient-years in the revascularized latecomers group vs 78.7 (95% CI: 67.2-92.3) per 1,000 patient-years in the nonrevascularized latecomers group (P < 0.001). In multivariate analysis, revascularization of latecomer STEMI patients was independently associated with a significant reduction of mortality occurrence during follow-up (HR: 0.65 [95% CI: 0.50-0.84]; P = 0.001).Conclusions: Coronary revascularization of latecomer STEMI patients is associated with better short and long-term clinical outcomes. [ABSTRACT FROM AUTHOR]

Telemetry monitoring (TM) with or without intensive care unit (ICU) admission is the standard of care after Transcatheter aortic valve replacement (TAVR). Regarding to improvements of the technique and procedural results, TM may be considered only in selected patients. We aimed to confirm feasibility and safety of selective TM in patients undergoing TAVR. We prospectively evaluated 449 consecutive patients undergoing TAVR. Patients were transferred to general cardiology ward (GCW) without TM after the procedure when stable clinical state, transfemoral access, no baseline right bundle branch block (RBBB), left ventricular ejection fraction (LVEF) > 40%, and no complication including any electrocardiogram (ECG) change within 1 h after the procedure ("low-risk" group). Others patients were considered for TM in ICU ("high-risk" group). The primary endpoint evaluated in-hospital major adverse events after unit admission according to VARC-2 criteria. The mean age was 81.8 ± 7.5 years and mean EuroSCORE II was 7.5 ± 4.8%. In total, 116 patients (25.8%) were considered as "low-risk" patients and 163 patients (36.3%) were referred to GCW, including those with immediate pacemaker implantation. A total of 96 patients (21.3%) reached the primary endpoint including mainly conductive disorders (12.8%). No major adverse events, particularly no late severe conductive disorder, occurred in the "low-risk" group (negative predictive value of 100%). Baseline RBBB (p < 0.01), LVEF < 40% (p = 0.02) and "high-risk" group (p < 0.01) were predictive of outcomes. Using rigorous periprocedural selection criteria, patients' admission in GCW without TM can be routinely and safely performed in 1/3 of patients after TAVR. • TAVR is feasible and safe without telemetry monotoring in one third of patients. • Rigorous predefined medical and ECG criteria and 1-h post procedure monitoring without adverse events and without any ECG changes allow this strategy. [ABSTRACT FROM AUTHOR]

Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.Funding: ACTION Study Group and AstraZeneca. [ABSTRACT FROM AUTHOR]

Objectives: To validate the performance of an automatic tool to estimate a patient's peak skin dose (PSD) and a skin dose map from data collected by a radiation dose management system (RDMS) during interventional procedures.Methods: In total, 288 eligible consecutive patients undergoing abdominopelvic embolisation or planned coronary angioplasty using radiochromic films were screened between June 2018 and March 2019. For 98 included patients, PSD was measured using radiochromic films (PSDFilm) and computed by RDMS (PSDRDMS) using one flat and two anthropomorphic phantoms. Statistical concordance between PSDFilm and PSDRDMS was computed with Lin's concordance correlation coefficient and clinical concordance with the Bland and Altman graphic; values were compared using the paired Mann-Whitney-Wilcoxon test.Results: In total, 190/288 patients were excluded and 98 patients were analysed (69 men, mean age 66 ± 14 years). The PSDFilm median (1st; 3rd quartile) was 0.59 Gy (0.40; 1.08). PSDRDMS was 0.62 Gy (0.43; 1.22) for the flat phantom and 0.62 Gy (0.42; 1.19) for anthropomorphic phantoms. The concordance between PSDFilm and PSDRDMS was good for both phantoms (flat: 0.94 [0.91; 0.95]; anthropomorphic 0.94 [0.91; 0.96]). Compared with the values of PSDFilm, the values of PSDRDMS were significantly increased by 5% (- 4%; 16%) for flat phantom (p = 0.001) and 7% (- 6%; 22%) for anthropomorphic phantoms (p = 0.002) for vascular procedures and 9% (- 4%; 26%, p = 0.01) and 6% (- 4%; 23%, p = 0.02) for cardiac procedures, respectively. Dose map representations matched for most patients. The gaps identified were due to table displacement during fluoroscopy events and the use of a wedge filter.Conclusions: The RDMS skin dose map tool allowed the computation of the PSD and skin dose distribution for all patients with fewer constraints than radiochromic films. However, the computed PSD was overestimated, increasing the number of patients requiring follow-up.Key Points: • A good concordance correlation was identified between the peak skin dose (PSD) values measured with radiochromic films and estimated with the radiation dose management system (RDMS) skin dose map tool. • Differences were related to table displacement during fluoroscopy events and the use of a wedge filter, which are not accounted in the Digital Imaging and Communications in Medicine Radiation Dose Structured Reports. • For all procedures, the estimated PSDs were significantly higher than the measured PSDs by 5% (- 4%; 18%) for flat phantom (p < 0.001) and 6% (- 5%; 22%) for anthropomorphic phantoms (p < 0.001). [ABSTRACT FROM AUTHOR]

Coronary angiography is the standard of care after Out-of-Hospital Cardiac Arrest (OHCA), but its benefit for patients without persistent ST-segment elevation (STE) remains controversial. All patients admitted for coronary angiography after a resuscitated OHCA were consecutively included in this prospective study. Three patient groups were defined according to post-resuscitation ECG: STE or new left bundle branch block (LBBB) (group 1); other ST/T repolarization disorders (group 2) and no repolarisation disorders (group 3). The proportion and predictive factors of an acute coronary lesion, defined by acute coronary occlusion or thrombotic lesion or lesion associated with flow impairment, were evaluated according to different groups as well as thirty-day mortality. Among 129 consecutive patients: 62 (48.1%), 30 (23.3%) and 30 (23.3%) patients were included in groups 1, 2 and 3 respectively. An acute coronary lesion was observed in 43% (n = 55) of patients, mainly in group 1 (n = 44, 70.9%). Initial coronary TIMI 0/1 flow was more frequently observed in group 1 than in group 2 (n = 25, 40.3% vs n = 1, 3.3%) and never in group 3. Chest pain and STE or new LBBB were independently associated with an acute coronary lesion (adj. OR = 7.14 [1.85–25.00]; p = 0.004 and adj. OR = 11.10 [3.70–33.33]; p < 0.001 respectively). In absence of any repolarization disorders, acute coronary lesion or occlusion were excluded with negative predictive values of 93.3% and 100% respectively. The one-month survival rate was 38.8% and was better in patients among the group 1 compared to those from the 2 other groups (n = 28, 45.2% vs n = 21, 35%, respectively; p = 0.014). Considering the high negative predictive value of post-resuscitation ECG to exclude acute coronary lesion and occlusion after OHCA, a delayed coronary angiography appears a reliable alternative for patients without repolarization disorders. • Post-resuscitation ECG appears as a useful triage method to guide the indication of immediate coronary angiography • Except for patients with ST-segment elevation or new LBBB, an acute coronary occlusion was very rarely observed (< 2%) • Absence of any repolarization disorders was associated with a very high predictive value to exclude acute coronary lesion • Chest pain and ST-segment elevation or new LBBB were the best predictive factors of an acute coronary lesion [ABSTRACT FROM AUTHOR]

The lifelong use of β-adrenoceptor antagonists (β-blockers) after a myocardial infarction (MI) has been the standard of care based on trials performed before the era of revascularization, when heart failure was common. Large randomized trials in the mid-1980s demonstrated that β-blockers played a major role in improving the in-hospital and long-term survival of patients admitted for MI. However, the implementation of rapid myocardial reperfusion led to a substantial survival benefit and a reduction of heart failure because of reduced infarct size. Modern large longitudinal registries did not provide sufficient evidence to support long-term β-blocker therapy in patients with uncomplicated acute MI. The long-term prescription of this therapy has become a matter of debate given the lack of contemporary evidence, frequent side effects, and treatment adherence issues. Furthermore, this shift into the reperfusion era led to a downgraded recommendation for the use of β-blockers in post-MI patients (class IIa B recommendation) in the 2017 European Society of Cardiology (ESC) recommendations for the treatment of ST-segment elevation MI (STEMI). Three large ongoing multicenter randomized trials (AβYSS, REDUCE-SWEDEHEART, and REBOOT-CNIC) are evaluating early discontinuation of β-blockers after an uncomplicated acute MI. The tested hypothesis is that β-blocker withdrawal is safe versus major adverse cardiovascular events and improves quality of life by reducing side effects. Thus, the present review summarizes the exhaustive evidence-based data for long-term β-blocker use after uncomplicated MI and the ongoing trials. [ABSTRACT FROM AUTHOR]

Large registries and epidemiologic studies have demonstrated that elderly patients (≥ 75 years old) represent a growing proportion of the acute coronary syndrome (ACS) population and are exposed to a high risk of both bleeding and ischemic events. In this setting, most of the randomized trials excluded elderly patients while evaluating therapeutic strategies in ACS and only few trials specifically dedicated their design to the elderly population, leading to a paucity of data. Elderly patients are less likely to be treated with an invasive strategy or potent antithrombotic drugs compared with younger patients, while they are exposed to a greater risk of mortality. Nevertheless, the benefit of an invasive approach in ST-segment elevation myocardial infarction (STEMI) has been consistently demonstrated in non-dedicated large percutaneous coronary intervention randomized trials, regardless of the patient's age. European clinical practice guidelines recommend that STEMI in elderly patients should not be treated differently than in younger patients. However, the therapeutic decision should be based on a combined evaluation of both (1) the patient's frailty, including functional or cognitive impairment, and (2) the balance between bleeding and ischemic risks. This review outlines the evidence on the optimal reperfusion and antithrombotic strategies among STEMI elderly patients, suggesting a patient-centered approach to apprehend the balanced therapeutic decision in the very old patient. [ABSTRACT FROM AUTHOR]

Background: Currently, cardiovascular disease (CVD) is widely acknowledged to be the first leading cause of fatality in the world with 31% of all deaths worldwide and is predicted to remain as such in 2030. Furthermore, CVD is also a major cause of morbidity in adults worldwide. Among these diseases, the coronary artery disease (CAD) is the most common cause, accounting for over 40% of CVD deaths. Despite a decline in mortality rates, the consequences of more effective preventive and management programs, the burden of CAD remains significant. Indeed, the rise in the prevalence of modifiable risk factors due to changes in lifestyle and health behaviors has further increased the burden of this epidemic. Our objective was to evaluate the hospital burden of CAD via MI trends and Percutaneous Coronary Intervention (PCI) in the French Prospective Payment System (PPS). Methods: MI/PCI were identified in the national PPS database from 2009 to 2014 for patients aged 20 to 99, living in metropolitan France. We examined hospitalisation, readmission and mortality trends using standardised rates. Results: Over the six-year period, we identified 678,021 patients, representing 900,121 stays of which, 215,224 had a MI and a PCI. Admission trends increased by nearly 25%. Acute MI cases increased every year, with an alarming increase in women, and more specifically in young women. Men were 3 times more hospitalised than women, who were older. A North-South divide was noted. Twenty seven percent of patients experienced readmission within 1 month. Trajectories of care were significantly different by sex and age. Overall in-hospital death was 3.3%, decreasing by 15% during the period. The highest adjusted mortality rates were observed for inpatients aged <40 or >80. Conclusion: We outlined the public health burden of this condition and the importance of improving the trajectories of care as an aid for better care. [ABSTRACT FROM AUTHOR]

Background The prevalence and associated-risk of asymptomatic multisite artery disease (MSAD) in high risk coronary patients are unknown. Whether systematic identification and aggressive management of asymptomatic MSAD is clinically relevant in high risk coronary patients has not been evaluated. Methods We randomly assigned 521 high risk coronary patients defined by the presence of three-vessel coronary disease ( n = 304) or recent acute coronary syndrome beyond the age of 75 years ( n = 215) to either a strategy of systematic detection of asymptomatic MSAD combined with an aggressive secondary prevention ( n = 263) or to a more conventional strategy based on treatment of coronary artery disease only with standard of care ( n = 258). The primary end point was the time to first occurrence of death, any organ failure or ischemic event leading to re-hospitalization through two years of follow-up. Results The pro-active strategy identified asymptomatic MSAD in 21.7% of patients with few revascularizations (3.6%); the pro-active pharmacological secondary prevention was obtained in > 85% of patients and life-style changes in < 60% of patients. At 2-year follow-up, the primary end point occurred in 44.9% of patients in the pro-active group and 43.0% of patients in the conventional group (HR 1.03; 95% confidence interval [CI], 0.80 to 1.34]. The rate of major bleeding did not differ significantly between groups (4.6% vs 5.0%; HR, 0.97; 95% CI, 0.40 to 1.91). Conclusion In high risk coronary patients, there is no apparent benefit of a systematic detection of asymptomatic extra-coronary atherothrombotic disease and intensified treatment over a 2-year follow-up period. (Funded by the Academic Allies in Cardiovascular Trials Initiatives and Organized Networks and Institut de l'Athérothrombose; AMERICA ClinicalTrials.gov number, NCT00445835 ). [ABSTRACT FROM AUTHOR]