Beta-Blocker Interruption or Continuation after Myocardial Infarction.

BACKGROUND: The appropriate duration of treatment with beta-blocker drugs after a myocardial infarction is unknown. Data are needed on the safety and efficacy of the interruption of long-term beta-blocker treatment to reduce side effects and improve quality of life in patients with a history of uncomplicated myocardial infarction. METHODS: In a multicenter, open label, randomized, noninferiority trial conducted at 49 sites in France, we randomly assigned patients with a history of myocardial infarction, in a 1:1 ratio, to interruption or continuation of beta-blocker treatment. All the patients had a left ventricular ejection fraction of at least 40% while receiving long-term beta-blocker treatment and had no history of a cardiovascular event in the previous 6 months. The primary end point was a composite of death, nonfatal myocardial infarction, nonfatal stroke, or hospitalization for cardiovascular reasons at the longest follow-up (minimum, 1 year), according to an analysis of noninferiority (defined as a between-group difference of <3 percentage points for the upper boundary of the two-sided 95% confidence interval). The main secondary end point was the change in quality of life as measured by the European Quality of Life-5 Dimensions questionnaire. RESULTS: A total of 3698 patients underwent randomization: 1846 to the interruption group and 1852 to the continuation group. The median time between the last myocardial infarction and randomization was 2.9 years (interquartile range, 1.2 to 6.4), and the median follow-up was 3.0 years (interquartile range, 2.0 to 4.0). A primary-outcome event occurred in 432 of 1812 patients (23.8%) in the interruption group and in 384 of 1821 patients (21.1%) in the continuation group (risk difference, 2.8 percentage points; 95% confidence interval [CI], <0.1 to 5.5), for a hazard ratio of 1.16 (95% CI, 1.01 to 1.33; P = 0.44 for noninferiority). Beta-blocker interruption did not seem to improve the patients' quality of life. CONCLUSIONS: In patients with a history of myocardial infarction, interruption of long-term beta-blocker treatment was not found to be noninferior to a strategy of beta-blocker continuation. (Funded by the French Ministry of Health and ACTION Study Group; ABYSS ClinicalTrials.gov number, NCT03498066; EudraCT number, 2017-003903-23.).

ßeta blocker interruption after uncomplicated myocardial infarction: rationale and design of the randomized ABYSS trial.

BACKGROUND: The long-term use of ß-blocker after myocardial infarction (MI) when global left ventricular ejection fraction (LVEF) is preserved has not been studied in the era of modern myocardial reperfusion and secondary prevention therapies. It is unknown whether ß-blockers are useful in stable post-MI patients without reduced LVEF and without heart failure. METHODS: The Assessment of ß-blocker interruption 1 Year after an uncomplicated myocardial infarction on Safety and Symptomatic cardiac events requiring hospitalization (ABYSS) Trial enrolled in 49 centers in France, 3,700 patients with a prior (>6 months) history of MI and a LVEF >40%, chronically treated with a ß-blocker and without any major cardiovascular event (MACE) in the past 6 months. These patients were randomized to interruption or continuation of their ß-blocker therapy. The primary objective is to demonstrate the noninferiority of interruption vs continuation of the ß-blocker therapy on the primary composite endpoint of all-cause death, stroke, MI, hospitalization for any cardiovascular reason at the end of follow-up (accrual follow-up) with a one-year minimum follow-up for the last randomized patient. Secondary objectives will focus on patient reported outcomes with the evaluation of the quality of life before and after randomization with the EQ5D-5L questionnaire. Enrolment has been completed. CONCLUSION: The ABYSS trial evaluates the cardiovascular safety of ß-blocker interruption in stabilized post-MI patients without heart failure nor reduced LVEF. ABYSS trial is a reappraisal of ß-blockers life-long therapy in stable post-MI patients without reduced LVEF. CLINICAL TRIAL REGISTRATION: NCT03498066 (clinicaltrials.gov).

Use and outcomes of the PK Papyrus covered stent in France: SOS PK Papyrus Registry.

OBJECTIVES: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS). BACKGROUND: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP. METHODS: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST). RESULTS: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion. CONCLUSIONS: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.

Cyclosporine before PCI in Patients with Acute Myocardial Infarction.

BACKGROUND: Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling. METHODS: In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume. RESULTS: A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups. CONCLUSIONS: In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.).

Everolimus drug-eluting stent performance in patients with long coronary lesions: The multicenter Longprime registry.

OBJECTIVES: To assess the efficacy and safety of the Xience Prime everolimus-eluting stent (EES) in long coronary lesions in a real-world population. BACKGROUND: Long lesions are considered difficult technically and in terms of achieving successful clinical outcomes. With first generation DES, MACE can be as high as 10% at a short-medium term follow-up. There are a few data available in this subset regarding the use of second generation DES METHODS: A prospective, multicenter registry of consecutive patients (aged 64.8 ± 11.2 years, 77% men and 33% diabetics) in 29 tertiary hospitals with de novo > 24 mm lesions in vessels of 2.25-4 mm was performed. The primary and secondary endpoints were major adverse cardiac events (MACE; cardiac death, myocardial infarction, and target lesion revascularization) and stent thrombosis (ST) at 1, 12, and 24 months. Patients were on dual antiplatelet therapy during 12 months. RESULTS: A total of 610 patients with 705 long lesions were included (1.2 per patient). Lesion length was 34.59 ± 11.17 mm and vessel size 2.93 ± 0.41 mm. Stented length was 39.83 ± 14.08 mm (1.4 stents per lesion). Predilatation/postdiltatation was performed in 75 and 33% of the cases, intravascular ultrasound in 15%. The device success rate was 99.1%. MACE and ST rates at 1, 12, and 24-months follow-up were 0.3, 2.1, and 5.4% and 0.2, 0.7, and 1.5%, respectively. CONCLUSION: In this real-world population, the Xience Prime EES performs extremely well in long lesions, with a very low rate of both MACE and ST.

Incidence and Significance of Spontaneous ST Segment Re-elevation After Reperfused Anterior Acute Myocardial Infarction　- Relationship With Infarct Size, Adverse Remodeling, and Events at 1 Year.

BACKGROUND: Up to 25% of patients with ST elevation myocardial infarction (STEMI) have ST segment re-elevation after initial regression post-reperfusion and there are few data regarding its prognostic significance.Methods and Results:A standard 12-lead electrocardiogram (ECG) was recorded in 662 patients with anterior STEMI referred for primary percutaneous coronary intervention (PPCI). ECGs were recorded 60-90 min after PPCI and at discharge. ST segment re-elevation was defined as a ≥0.1-mV increase in STMax between the post-PPCI and discharge ECGs. Infarct size (assessed as creatine kinase [CK] peak), echocardiography at baseline and follow-up, and all-cause death and heart failure events at 1 year were assessed. In all, 128 patients (19%) had ST segment re-elevation. There was no difference between patients with and without re-elevation in infarct size (CK peak [mean±SD] 4,231±2,656 vs. 3,993±2,819 IU/L; P=0.402), left ventricular (LV) ejection fraction (50.7±11.6% vs. 52.2±10.8%; P=0.186), LV adverse remodeling (20.1±38.9% vs. 18.3±30.9%; P=0.631), or all-cause mortality and heart failure events (22 [19.8%] vs. 106 [19.2%]; P=0.887) at 1 year. CONCLUSIONS: Among anterior STEMI patients treated by PPCI, ST segment re-elevation was present in 19% and was not associated with increased infarct size or major adverse events at 1 year.

Platelet function monitoring to adjust antiplatelet therapy in elderly patients stented for an acute coronary syndrome (ANTARCTIC): an open-label, blinded-endpoint, randomised controlled superiority trial.

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.

Assessment of cardiovascular risk factors in a Roma community from Southwestern France.

OBJECTIVES: Roma from Central-Eastern Europe experience a reduced life expectancy in comparison with the general population. Predisposing cardiovascular risk factors could be the underlying reason for this. Here for the first time epidemiologic data on the distribution of cardiovascular risk factors in a subgroup of French Roma has been presented. METHODS: A descriptive epidemiological field survey was conducted in the Manouche community of Pau, Southwestern France. Fifty participants were included (17 men and 33 women) all living in caravans. A questionnaire to ask for demographic and health information was used, and biometric measurements were took in order to assess cardiovascular risk factors. RESULTS: Our sample included 18% diabetics, 32% people suffering from hypertension, 28% subjects with hypercholesterolemia, and 34% smokers. The prevalence of overweight and obesity was, respectively, 40% and 38% and that of abdominal obesity 64%. These frequencies were about twice those found in the general French population. CONCLUSION: Although our sample was of limited size, our data suggest that French Manouches express a high-risk profile regarding cardiovascular disease, as has been reported for Roma from various countries. Both intrinsic and environmental factors may explain this.

Rationale and design of the Cyclosporine to ImpRove Clinical oUtcome in ST-elevation myocardial infarction patients (the CIRCUS trial).

BACKGROUND: Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction (STEMI). The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention (PPCI) has been associated with a reduction of infarct size in STEMI patients. METHODS: CIRCUS is an international, prospective, multicenter, randomized, double-blinded, placebo-controlled trial. The study is designed to compare the efficacy and safety of cyclosporine versus placebo, in addition to revascularization by PPCI, in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow ≤1 in the culprit left anterior descending coronary artery. Patients are randomized in a 1:1 fashion to 2.5 mg/kg intravenous infusion of cyclosporine or matching placebo performed in the minutes preceding PCI. The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality, rehospitalization for heart failure or heart failure worsening during initial hospitalization, and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography. Secondary outcomes will be tested using a hierarchical sequence of left ventricular (LV) ejection fraction and absolute measurements of LV volumes. The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction. RESULTS: Recruitment lasted from April 2011 to February 2014. The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction. The 12-months results are expected to be available in 2015. CONCLUSIONS: The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up.

Platelet function monitoring in elderly patients on prasugrel after stenting for an acute coronary syndrome: design of the randomized antarctic study.

BACKGROUND: Elderly patients are at high risk for both ischemic and bleeding events. Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio. STUDY DESIGN: The ANTARCTIC study is designed to demonstrate the superiority of a strategy of platelet function monitoring with dose and drug adjustment in patients initially on prasugrel 5 mg as compared with a more conventional strategy using prasugrel 5 mg without monitoring and without adjustment (Conventional Treatment Arm) to reduce the primary end point evaluated 1 year after stent percutaneous coronary intervention in elderly patients presenting with an acute coronary syndrome (ACS). ANTARCTIC is a multicenter, prospective, open-label study with 2 parallel arms. A total of 852 elderly patients (≥ 75 years) undergoing stent percutaneous coronary intervention for ACS are to be enrolled. The primary end point is the time to first occurrence of cardiovascular death, myocardial infarction, stroke, definite stent thrombosis, urgent revascularization, and bleeding complications (Bleeding Academic Research Consortium definition 2, 3, or 5). Platelet function analyses will be performed 14 days after randomization and repeated 14 days later in patients who require a change in treatment. CONCLUSION: ANTARCTIC is a nationwide, prospective, open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting.

A Phase 2, randomized, partially blinded, active-controlled study assessing the efficacy and safety of variable anticoagulation reversal using the REG1 system in patients with acute coronary syndromes: results of the RADAR trial.

AIMS: We sought to determine the degree of anticoagulation reversal required to mitigate bleeding, and assess the feasibility of using pegnivacogin to prevent ischaemic events in acute coronary syndrome (ACS) patients managed with an early invasive approach. REG1 consists of pegnivacogin, an RNA aptamer selective factor IXa inhibitor, and its complementary controlling agent, anivamersen. REG1 has not been studied in invasively managed patients with ACS nor has an optimal level of reversal allowing safe sheath removal been defined. METHODS AND RESULTS: Non-ST-elevation ACS patients (n = 640) with planned early cardiac catheterization via femoral access were randomized 2:1:1:2:2 to pegnivacogin with 25, 50, 75, or 100% anivamersen reversal or heparin. The primary endpoint was total ACUITY bleeding through 30 days. Secondary endpoints included major bleeding and the composite of death, myocardial infarction, urgent target vessel revascularization, or recurrent ischaemia. Enrolment in the 25% reversal arm was suspended after 41 patients. Enrolment was stopped after three patients experienced allergic-like reactions. Bleeding occurred in 65, 34, 35, 30, and 31% of REG1 patients with 25, 50, 75, and 100% reversal and heparin. Major bleeding occurred in 20, 11, 8, 7, and 10% of patients. Ischaemic events occurred in 3.0 and 5.7% of REG1 and heparin patients, respectively. CONCLUSION: At least 50% reversal is required to allow safe sheath removal after cardiac catheterization. REG1 appears a safe strategy to anticoagulate ACS patients managed invasively and warrants further investigation in adequately powered clinical trials of patients who require short-term high-intensity anticoagulation.

Prognostic impact of high-intensity lipid-lowering therapy under-prescription after acute myocardial infarction in women.

AIMS: Women are less likely to receive lipid-lowering therapy (LLT) after acute myocardial infarction (AMI). We analysed whether this under-prescription currently persists and has an impact on long-term outcomes. METHODS AND RESULTS: The FAST-MI programme consists of nationwide registries including all patients admitted for AMI ≤ 48 h from onset over a 1 month period in 2005, 2010, and 2015, with long-term follow-up. This analysis focused on high-intensity LLT (atorvastatin ≥ 40 mg or equivalent, or any combination of statin and ezetimibe) in women and men. Women accounted for 28% (N = 3547) of the 12 659 patients. At discharge, high-intensity LLT was significantly less prescribed in women [54 vs. 68% in men, P < 0.001, adjusted odds ratio (OR) 0.78(95% confidence interval (CI) 0.71-0.87)], a trend that did not improve over time: 2005, 25 vs. 35% (P = 0.14); 2010, 66 vs. 79% (P < 0.001); 2015, 67 vs. 79.5% (P = 0.001). In contrast, female sex was not associated with a lack of other recommended treatments at discharge: beta-blockers [adjusted OR 0.98(95% CI 0.88-1.10), P = 0.78], or renin-angiotensin blockers [adjusted OR 0.94(95% CI 0.85-1.03), P = 0.18]. High-intensity LLT at discharge was significantly associated with improved 5 year survival and infarct- and stroke-free survival in women [adjusted hazard ratios (HR) 0.74(95% CI 0.64-0.86), P < 0.001 and adjusted HR: 0.81(95% CI: 0.74-0.89); P < 0.001, respectively]. Similar results were found using a propensity score-matched analysis [HR for 5 year survival in women with high-intensity LLT: 0.82(95% CI 0.70-0.98), P = 0.03]. CONCLUSION: Women suffer from a bias regarding the prescription of high-intensity LLT after AMI, which did not attenuate between 2005 and 2015, with potential consequences on both survival and risk of cardiovascular events.

Lipid-lowering therapy (LLT) is under-prescribed in women after acute myocardial infarction (AMI). Whether this difference persists over time and influences long-term outcomes is unclear. Women still suffer from insufficient prescription of high-intensity LLT at discharge after an AMI, even in the most recent years of the study, with a 5 year survival significantly reduced in women who did not receive high-dose LLT Propensity score matched analysis showed similar results on survival and cardiovascular events.

P2Y12 Inhibitor Loading Time Before Elective PCI and the Prevention of Myocardial Necrosis.

BACKGROUND: There are dated and conflicting data about the optimal timing of initiation of P2Y12 inhibitors in elective percutaneous coronary intervention (PCI). Peri-PCI myocardial necrosis is associated with poor outcomes. We aimed to assess the impact of the P2Y12 inhibitor loading time on periprocedural myocardial necrosis in the population of the randomized Assessment of Loading With the P2Y12 Inhibitor Ticagrelor or Clopidogrel to Halt Ischemic Events in Patients Undergoing Elective Coronary Stenting (ALPHEUS) trial, which compared ticagrelor with clopidogrel in high-risk patients who received elective PCI. METHODS: The ALPHEUS trial divided 1809 patients into quartiles of loading time. The ALPHEUS primary outcome was used (type 4 [a or b] myocardial infarction or major myocardial injury) as well as the main secondary outcome (type 4 [a or b] myocardial infarction or any type of myocardial injury). RESULTS: Patients in the first quartile group (Q1) presented higher rates of the primary outcome (P = 0.01). When compared with Q1, incidences of the primary outcome decreased in patients with longer loading times (adjusted odds ratio [adjOR], 0.70 [0.52.-0.95]; P = 0.02 for Q2; adjOR 0.65 [0.48-0.88]; P < 0.01 for Q3; adjOR 0.66 [0.49-0.89]; P < 0.01 for Q4). Concordant results were found for the main secondary outcome. There was no interaction with the study drug allocated by randomization (clopidogrel or ticagrelor). Bleeding complications (any bleeding ranging between 4.9% and 7.3% and only 1 major bleeding at 48 hours) and clinical ischemic events were rare and did not differ among groups. CONCLUSIONS: In elective PCI, administration of the oral P2Y12 inhibitor at the time of PCI could be associated with more frequent periprocedural myocardial necrosis than an earlier administration. The long-term clinical consequences remain unknown.

Catheter-based renal denervation in the treatment of arterial hypertension: An expert consensus statement on behalf of the French Society of Hypertension (SFHTA), French Society of Radiology (SFR), French Society of Interventional Cardiology (GACI), French Society of Cardiology (SFC), French Association of Private Cardiologists (CNCF), French Association of Hospital Cardiologists (CNCH), French Society of Thoracic and Cardiovascular Surgery (SFCTCV) and French Society of Vascular and Endovascular Surgery (SCVE).

Several high-quality, randomized, sham-controlled trials have provided evidence supporting the efficacy and safety of radiofrequency, ultrasound and alcohol catheter-based renal denervation (RDN) for reducing blood pressure (BP). A French clinical consensus document has therefore been developed to propose guidance for the appropriate use of RDN in the management of hypertension along with a dedicated care pathway and management strategy. The French experts group concluded that RDN can serve as an adjunct therapy for patients with confirmed uncontrolled, resistant essential hypertension despite treatment with≥3 antihypertensive drugs, including a long-acting calcium channel blocker, a renin-angiotensin system blocker and a thiazide/thiazide-like diuretic at maximally tolerated doses. Patients should have (1) an estimated glomerular filtration rate of≥40mL/min/1.73m2; (2) an eligible renal artery anatomy on pre-RDN scans and (3) exclusion of secondary forms of hypertension. Additional indications might be considered for patients with difficult-to-control hypertension. Any indication of RDN should be validated by multidisciplinary hypertension teams consisting of both hypertension specialists and endovascular interventionalists in European Society of Hypertension (ESH) Excellence Centres or ESH-BP clinics. Patients should be informed about the benefit/risk ratio of RDN. Expertise in renal artery interventions and training in RDN techniques are needed for endovascular interventionalists conducting RDN procedures while centres offering RDN should have the necessary resources to manage potential complications effectively. Lastly, all patients undergoing RDN should have their data collected in a nationwide French registry to facilitate monitoring and evaluation of RDN outcomes, contributing to ongoing research and quality improvement efforts.

Biventricular versus left ventricular only stimulation: an echocardiographic substudy of the B-LEFT HF trial.

BACKGROUND: The noninferiority of left ventricular pacing alone (LVp) compared with biventricular pacing (BIV) has not been yet definitely documented. In this study, we reviewed all the original echocardiographic measures of the Biventricular versus Left Univentricular Pacing with ICD Back-up in Heart Failure Patients (B-LEFT HF) trial in order to investigate mechanisms underlying LV remodelling with both pacing modalities. METHODS: Patients with New York Heart Association functional class (NYHA) III or IV despite optimal medical therapy, LVEF 35% or less, left ventricular end-diastolic diameter (LVEDD) more than 55 mm, QRS duration at least 130 ms were randomized to BIV or LVp for 6 months. The primary end point was a composite of at least 1 point decrease in NYHA class and at least 5 mm decrease in left ventricular end-systolic diameter (LVESD). An additional end point was a LVp reverse remodelling defined as at least 10% decrease in LVESD. Mitral regurgitation and all echocardiographic measures were reassessed after 6-month follow-up. RESULTS: One hundred and forty-three patients were enrolled. Seventy-six patients were in the BIV and 67 were in the LVp group. Left ventricular volumes decreased significantly without difference between groups (P = 0.8447). Similarly, left ventricular diameters decreased significantly in both groups with a significant decrease in LVESD with BIV (P < 0.0001), but not with LVp (P = 0.1383). LVEF improved in both groups without difference (P = 0.8072). Mitral regurgitation did not improve either with BIV, or with LVp. CONCLUSION: The echocardiographic sub-analysis of B-LEFT study showed the substantial equivalence of LVp in favouring left ventricular reverse remodelling as compared with BIV.

First inappropriate implantable cardioverter defibrillator therapy is often due to inaccurate device programming: analysis of the French OPERA registry.

AIMS: Inappropriate therapy delivered by implantable cardioverter defibrillators (ICDs) remains a challenge. The OPERA registry measured the times to, and studied the determinants of, first appropriate (FAT) and inappropriate (FIT) therapies delivered by single-, dual- and triple-chamber [cardiac resynchronization therapy defibrillator (CRT-D)] ICD. METHODS AND RESULTS: We entered 636 patients (mean age = 62.0 ± 13.5 years; 88% men) in the registry, of whom 251 received single-, 238 dual-, and 147 triple-chamber ICD, for primary (30.5%) or secondary (69.5%) indications. We measured times to FAT and FIT as a function of multiple clinical characteristics, examined the effects of various algorithm components on the likelihood of FAT and FIT delivery, and searched for predictors of FAT and FIT. Over 22.8 ± 8.8 months of observation, 184 patients (28.9%) received FAT and 70 (11.0%) received FIT. Ventricular tachycardia (VT) was the trigger of 88% of FAT, and supraventricular tachycardia was the trigger of 91% of FIT. The median times to FIT (90 days; range 49-258) and FAT (171 days; 50-363) were similar. The rate of FAT was higher (P <0.001) in patients treated for secondary than primary indications, while that of FIT were similar in both groups. Out of 57 analysable FIT, 27 (47.4%) could have been prevented by fine tuning the device programming like the sustained rate duration or the VT discrimination algorithm. CONCLUSIONS: First inappropriate therapy occurred in 11% of 636 ICD recipients followed for ∼2 years. Nearly 50% of FIT could have been prevented by improving device programming.

Iron deficiency in heart failure patients: the French CARENFER prospective study.

AIMS: Iron deficiency (ID) is reported as one of the main co-morbidities in patients with chronic heart failure (CHF), which then influences quality of life and prognosis. The CARENFER study aimed to assess the prevalence of ID in a large panel of heart failure (HF) patients at different stages of the disease. METHODS AND RESULTS: This prospective cross-sectional nationwide study was conducted in 48 medical units in France in 2019. Serum ferritin concentration and transferrin saturation (TSAT) index were determined in all eligible patients with a diagnosis of HF. ID diagnosis was based on the European Society of Cardiology (ESC) 2016 guidelines. Patients were classified as having either a decompensated HF or a CHF. Left ventricular ejection fraction (LVEF) was categorized as preserved (≥50%), mildly reduced (40-49%), or reduced (<40%). ID diagnosis was determined in 1661 patients, of whom 1475 could be classified as having a decompensated HF or a CHF. Patients' median age was 78 years. Decompensated HF represented 60.1% of cases. The overall prevalence of ID was 49.6% (47.1-52.1). In CHF and decompensated HF patients, respectively, ID prevalence was 39.0% (35.1-43.1) and 58.1% (54.7-61.4), P < 0.001; TSAT < 20% was respectively reported in 34.7% and 70.0% of patients (P < 0.001). Patients with preserved LVEF were more likely to have an ID (57.5%) compared with patients with mildly reduced (47.4%) or reduced LVEF (44.3%) (P < 0.001). CONCLUSIONS: Iron deficiency was highly prevalent in patients with decompensated HF or CHF with preserved LVEF. ID prevalence defined by TSAT was higher than by the ESC criteria in decompensated HF patients, questioning the importance of ID definition to assess its prevalence.

Safety of conservative management for non-stenotic culprit lesions in STEMI patients treated with a two-step reperfusion strategy: a SUPER-MIMI sub-study.

Background: In the observational SUPER-MIMI study, a minimalist immediate mechanical intervention (MIMI) technique-which involves restoring blood flow in the acute phase and postponing stenting-was shown to be safe and effective among patients with a high thrombotic burden after ST-segment elevation myocardial infarction (STEMI). We aim to assess whether a non-stenting strategy after a SUPER-MIMI strategy was safe at 4-year follow-up in patients enrolled in the SUPER-MIMI study who were not stented. Methods: This prospective cohort study assessed the long-term outcomes of a subgroup of patients included in the SUPER-MIMI study. Results: Among the 155 patients enrolled in the SUPER-MIMI study, 57 patients (36.8%) benefited from a conservative management (without stenting or balloon angioplasty) and were included in the current substudy. The mean duration of follow-up was 4.1±1.0 years. Four patients (7.0%) presented definite culprit lesion re-thrombosis, all of which occurred in the right coronary artery. The re-thrombosis rate appeared to be higher among patients with larger vessels: 2.9%, 8.3%, and 28.6% in arteries with diameters of 3-<4, 4-<5, and ≥5 mm, respectively. The overall rate of target lesion revascularization was 10.5%. There was one cardiac death and three rehospitalizations for heart failure. Overall, 82.5% of patients remained event free at a mean of 4.1±1.0 years. Conclusions: Conservative management of non-stenotic culprit lesions after a SUPER-MIMI strategy was associated with a high rate of re-thrombosis, particularly in patients with large coronary arteries.

Development and evaluation of the accuracy of an indicator of the appropriateness of interventional cardiology generated from a French registry.

BACKGROUND: Development of appropriateness indicators of medical interventions has become a major quality-of-care issue, especially in the domain of interventional cardiology (IC). The objective of this study was to develop and evaluate the accuracy of an indicator of the appropriateness of interventional cardiology acts (invasive coronary angiographies (ICA) and percutaneous coronary interventions (PCI)) in patients with coronary stable disease and silent ischemia, automated from a French registry. METHODS: All ICA and PCI recorded in a Regional IC Registry (ACIRA) and operated for a stable coronary artery disease or silent ischemia from January 1st to December 31th 2013 in eight IC hospitals of Aquitaine, southwestern France, were included. The indicator was developed to reflect European guidelines. Classification of appropriateness by the indicator, measured on the registry database, was compared to the classification of a reference standard (expert judgment applied through complete record review) on a random sample of 300 interventions. Accuracy parameters were estimated. A second version of the indicator was defined, based on the analysis of false negative and positive results, and its accuracy estimated. RESULTS: The second indicator accuracy was: sensitivity 63.5% (95% confidence interval CI [51.7-75.3]), specificity 76.0% (95%CI [70.4-81.6]), PPV 43.0% (95% CI [33.0-53.0]) and NPV 88.0% (95% CI [83.4-92.6]). When stratified on the type of act, parameters were better for ICA alone than for PCI. CONCLUSIONS: Accuracy of the indicator should raise with improvement of database quality. Despite its average accuracy, it is already used as a benchmark indicator for cardiologists. It is sent annually to each IC center with value of the indicator at the region level to allow a comparison.

Economic evaluation of fractional flow reserve-guided versus angiography-guided multivessel revascularisation in ST-segment elevation myocardial infarction patients in the FLOWER-MI randomised trial.

BACKGROUND: In patients with ST-segment elevation myocardial infarction (STEMI) who have multivessel disease, the FLOWER-MI trial found no significant clinical benefit to fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) compared to angiography-guided PCI. AIMS: Our aim was to estimate the cost-effectiveness and cost-utility of FFR-guided PCI, the secondary endpoint of the FLOWER-MI trial. METHODS: Costs, major adverse cardiovascular events (composite of all-cause death, non-fatal myocardial infarction [MI], and unplanned hospitalisation leading to urgent revascularisation), and quality-adjusted life years were calculated in both groups. The incremental cost-effectiveness and cost-utility ratios were estimated. Uncertainty was explored by probabilistic bootstrapping. The analysis was conducted from the perspective of the health care provider with a time horizon of one year. RESULTS: At one year, the average cost per patient was 7,560€ (±2,218) in the FFR-guided group and 7,089€ (±1,991) in the angiography-guided group (p-value<0.01). The point estimates for the incremental cost-effectiveness and cost-utility ratios found that the angiography-guided strategy was cost saving and improved outcomes, with a probabilistic sensitivity analysis confirming dominance. CONCLUSIONS: The FFR-guided strategy at one year is unlikely to be cost effective compared to the angiography-guided strategy on both clinical and quality of life outcomes.