Publications by authors named "Guillaume Cayla"

144 Publications

Transcatheter aortic valve replacement performed with selective telemetry monitoring: A prospective study.

Int J Cardiol 2021 May 20;330:158-163. Epub 2021 Feb 20.

Department of Cardiology, CHU Montpellier, Montpellier University, Montpellier, France. Electronic address:

Background: 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.

Methods: 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.

Results: 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.

Conclusions: Using rigorous periprocedural selection criteria, patients' admission in GCW without TM can be routinely and safely performed in 1/3 of patients after TAVR.
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http://dx.doi.org/10.1016/j.ijcard.2021.02.028DOI Listing
May 2021

Life-threatening arrhythmias in anterior ST-segment elevation myocardial infarction patients treated by percutaneous coronary intervention: adverse impact of morphine.

Eur Heart J Acute Cardiovasc Care 2020 Oct 14. Epub 2020 Oct 14.

Université de Strasbourg, Pôle d'Activité Médico-Chirurgicale Cardio-Vasculaire, Nouvel Hôpital Civil, Centre Hospitalier Universitaire, BP 426, 67091 Strasbourg, France.

Aims: Important controversies remain concerning the determinants of life-threatening arrhythmias during ST-segment elevation myocardial infarction (STEMI) and their impact on late adverse events. This study sought to investigate which factors might facilitate ventricular tachycardia (VT) and ventricular fibrillation (VF), in a homogeneous population of anterior STEMI patients defined by abrupt left anterior descending coronary artery (LAD) occlusion and no collateral flow.

Methods And Results: The 967 patients, who entered into the CIRCUS (Does Cyclosporine ImpRove Clinical oUtcome in ST elevation myocardial infarction patients) study, were assessed for further analysis. Acute VT/VF was defined as VT (run of tachycardia >30 s either self-terminated or requiring electrical/pharmacological cardioversion) or VF documented by electrocardiogram or cardiac monitoring, during transportation to the cathlab or initial hospitalization. VT/VF was documented in 136 patients (14.1%). Patients with VT/VF were younger and had shorter time from symptom onset to hospital arrival. Site of LAD occlusion, thrombus burden, area at risk, pre-percutaneous coronary intervention Thrombolysis in Myocardial Infarction flow, and ST-segment resolution were similar to that of patients without VT/VF. There was no impact of VT/VF on left ventricular remodelling or clinical outcomes. By multivariate analysis, the use of morphine (odds ratio 1.71; 95% confidence interval (1.13-2.60); P = 0.012) was the sole independent predictor of VT/VF occurrence.

Conclusions: In STEMI patients with LAD occlusion, our findings support the view that morphine could favour severe ventricular arrhythmias.
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http://dx.doi.org/10.1093/ehjacc/zuaa005DOI Listing
October 2020

Is coronary multivessel disease in acute myocardial infarction patients still associated with worse clinical outcomes at 1-year?

Clin Cardiol 2021 Mar 14;44(3):429-437. Epub 2021 Feb 14.

Cardiology Department, Les Hôpitaux de Chartres, Chartres, France.

Background: ST-elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) are associated with a worse prognosis. However, few comparisons are available according to coronary status in the era of modern reperfusion and optimized secondary prevention.

Hypothesis: We hypothesized that the difference in prognosis according to number of vessel disease in STEMI patients has reduced.

Methods: All consecutive STEMI patients undergoing primary percutaneous coronary intervention (PCI) within 24 h of symptoms onset between January 1, 2014 and June 30, 2016 enrolled in the CRAC (Club Régional des Angioplasticiens de la région Centre) France PCI registry were analyzed. Baseline characteristics, management, and outcomes at 1-year were analyzed according to coronary status (one-, two-, and three-VD).

Results: A total of 1886 patients (mean age 62.2 ± 14.0 year; 74% of male) were included. Patients with MVD (two or three-VD) represented 53.7%. They were older with higher cardiovascular risk factor profile. At 1 year, the rate of major adverse cardiovascular events (MACE, defined as all-cause death, stroke or re-MI) was 10%, 12%, and 12% in one-, two, and three-VD respectively (p = .28). In multivariable adjusted Cox proportional hazard regression model, two- and three-VD were not associated with higher rate of MACE compared to patients with single VD (HR, 1.09; 95%CI 0.76-1.56 for two-VD; HR, 0.74; 95%CI 0.48-1.14 for three-VD).

Conclusions: MVD still represents an important proportion of STEMI patients but their prognoses were not associated with worse clinical outcomes at 1-year compared with one-VD patients in a modern reperfusion area and secondary medication prevention.
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http://dx.doi.org/10.1002/clc.23567DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7943894PMC
March 2021

Should Hemoglobin Drop Be Added to Bleeding Classifications in ACS?

J Am Coll Cardiol 2021 Feb;77(4):389-391

Sorbonne Université, ACTION Group, INSERM UMRS_1166 Institut de cardiologie, Pitié-Salpêtrière University Hospital (AP-HP), Paris, France.

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http://dx.doi.org/10.1016/j.jacc.2020.11.050DOI Listing
February 2021

Performing elective cardiac invasive procedures during the COVID-19 outbreak: a position statement from the European Association of Percutaneous Cardiovascular Interventions (EAPCI).

EuroIntervention 2021 Feb;16(14):1177-1186

Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.

The rearrangement of healthcare services required to face the coronavirus disease 2019 (COVID-19) pandemic led to a drastic reduction in elective cardiac invasive procedures. We are already facing a "second wave" of infections and we might be dealing during the next months with a "third wave" and subsequently new waves. Therefore, during the different waves of the COVID-19 pandemic we have to face the problems of how to perform elective cardiac invasive procedures in non-COVID patients and which patients/procedures should be prioritised. In this context, the interplay between the pandemic stage, the availability of healthcare resources and the priority of specific cardiac disorders is crucial. Clear pathways for "hot" or presumed "hot" patients and "cold" patients are mandatory in each hospital. Depending on the local testing capacity and intensity of transmission in the area, healthcare facilities may test patients for SARS-CoV-2 infection before the interventional procedure, regardless of risk assessment for COVID-19. Pre-hospital testing should always be conducted in the presence of symptoms suggestive of SARS-CoV-2 infection. In cases of confirmed or suspected COVID-19 positive patients, full personal protective equipment using FFP 2/N95 masks, eye protection, gowning and gloves is indicated during cardiac interventions for healthcare workers. When patients have tested negative for COVID-19, medical masks may be sufficient. Indeed, individual patients should themselves wear medical masks during cardiac interventions and outpatient visits.
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http://dx.doi.org/10.4244/EIJ-D-20-01291DOI Listing
February 2021

PRADOC: a trial on the efficiency of a transition care management plan for hospitalized patients with heart failure in France.

ESC Heart Fail 2021 Apr 25;8(2):1649-1655. Epub 2020 Dec 25.

Department of Cardiology, Montpellier University Hospital, Montpellier Cedex 5, 34295, France.

Aims: Transition care programmes are designed to improve coordination of care between hospital and home. For heart failure patients, meta-analyses show a high efficacy but with moderate evidence level. Moreover, difficulties for implementation of such programmes limit their extrapolation.

Methods And Results: We designed a mixed-method study to assess the implementation of the PRADO-IC, a nationwide transition programme that aims to be offered to every patient with heart failure in France. This programme consists essentially in an administrative assistance to schedule follow-up visits and in a nurse follow-up during 2 to 6 months and aims to reduce the annual heart failure readmission rate by 30%. This study assessed three quantitative aims: the cost to avoid a readmission for heart failure within 1 year (primary aim, intended sample size 404 patients), clinical care pathways, and system economic outcomes; and two qualitative aims: perceived problems and benefits of the PRADO-IC. All analyses will be gathered at the end of study for a joint interpretation. Strengths of this study design are the randomized controlled design, the population included in six centres with low motivation bias, the primary efficiency analysis, the secondary efficacy analyses on care pathway and clinical outcomes, and the joint qualitative analysis. Limits are the heterogeneity of centres and of intervention in a control group and parallel development of other new therapeutic interventions in this field.

Conclusions: The results of this study may help decision-makers to support an administratively managed transition programme.
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http://dx.doi.org/10.1002/ehf2.13086DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006694PMC
April 2021

Effect of Sex on Outcomes of Coronary Rotational Atherectomy Percutaneous Coronary Intervention (From the European Multicenter Euro4C Registry).

Am J Cardiol 2021 03 5;143:29-36. Epub 2021 Jan 5.

Department of Cardiology, Rangueil Toulouse University Hospital, University Paul Sabatier, Toulouse, France.

Data regarding the potential influence of gender on outcomes of rotational atherectomy (RA) percutaneous coronary intervention (PCI) are scarce and conflicting. Using the Euro4C registry, an international prospective multicentric registry of RA PCI, we evaluated the influence of gender on clinical outcomes of RA PCI. Between October 2016 and July 2018, 966 patients were included. In them, 267 (27.6%) were females. Female patients were older than males (77.7 years old ± 9.8 vs 73.3 ± 9.5 years old respectively, p < 0.001) had a poorer renal function (43,1% of females had a GFR < 60 ml/min:1.73m² vs 30.4% of males, p < 0.001) and were more frequently admitted for an acute coronary syndrome (32.2% vs 22.3% p = 0.002). During RA procedure, women were less likely to be treated by radial approach (65.0% vs 74.4%, p = 0.004). In-hospital major adverse cardiac event rate-defined as cardiovascular death, myocardial infarction, stroke/transient ischemic attack, target lesion revascularization, and coronary artery bypass grafting surgery-was higher in the female group (7.1% vs 3.7%, p = 0.043). However, coronary perforation, dissection, slow/low flow and tamponade did not significantly differ in gender, neither did cardiovascular medications at discharge. At 1 year follow-up, rate of major adverse cardiac event was 18.4% in the female group vs 11.2% in the male group (adjusted Hazard Ratio 1.82 [1.24 to 2.67], p = 0.002). No significant bleeding differences were observed in gender, neither in hospital, nor during follow-up. In conclusion women had worse clinical outcomes following RA PCI during hospitalization and at 1 year follow-up than did men.
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http://dx.doi.org/10.1016/j.amjcard.2020.12.040DOI Listing
March 2021

Transcarotid versus transfemoral access in patients undergoing transcatheter aortic valve replacement with complex aortofemoral anatomy.

Catheter Cardiovasc Interv 2020 Dec 16. Epub 2020 Dec 16.

Department of Cardiovascular Surgery, University Hospital of Montpellier, Montpellier, France.

Aims: While major vascular complications (MVC) remains an issue after Transfemoral (TF) transcatheter aortic valve replacement (TAVR), we compared outcomes in TF versus transcarotid (TC) approaches in patients with complex vascular anatomy.

Methods And Results: Among patients undergoing TAVR in our center between 2015 and 2018, we evaluated patients with complex vascular anatomy defined on CT scan as: (a) iliofemoral diameter between 5.5 and 6 mm or <6.5 mm with severe calcifications or tortuosity AND/OR (b) abdominal aorta pathology. The primary endpoint included access failure, mortality, MVC, major bleeding and stroke at 1-month. Among 483 patients, 131 (31.2%) with complex vascular anatomy underwent TF (n = 51;39.2%) or TC (n = 80;60.8%) TAVR. The mean age was 81.7 ± 6.9. TC group had higher STS score (p = .01), higher incidence of coronary artery disease (p = .04) and lower left ventricular ejection fraction (p < .001). In TC group, primary endpoint occurred twice less without reaching significance compared to TF group (n = 8; 10.0% vs. n = 10; 19.6% respectively; p = .1). Incidence of MVC was higher in TF group (11.8 vs. 1.3% in the TC group; p = .01) with similar incidence of stroke between groups (p = .8).

Conclusions: Despite higher patient risk profile, TC approach in complex aortofemoral anatomy provides similar favorable outcomes with less MVC compared to TF approach.
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http://dx.doi.org/10.1002/ccd.29438DOI Listing
December 2020

Myocardial Injury After Balloon Predilatation Versus Direct Transcatheter Aortic Valve Replacement: Insights From the DIRECTAVI Trial.

J Am Heart Assoc 2020 12 10;9(24):e018405. Epub 2020 Dec 10.

Department of Cardiology Montpellier University Hospital Montpellier France.

Background Myocardial injury is associated with higher mortality after transcatheter aortic valve replacement (TAVR) and might be increased by prior balloon aortic valvuloplasty (BAV). We aimed to evaluate the impact of prior BAV versus direct prosthesis implantation on myocardial injury occurring after (TAVR) with balloon-expandable prostheses. Methods and Results The DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) trial, an open-label randomized study, demonstrated noninferiority of TAVR without BAV (direct TAVR group) compared with systematic BAV (BAV group) with the Edwards SAPIEN 3 valve. High-sensitivity troponin was assessed before and the day after the procedure. Incidence of myocardial injury after the procedure (high-sensitivity troponin elevation >15× the upper reference limit [14 ng/L]) was the main end point. Impact of myocardial injury on 1-month adverse events (all-cause mortality, stroke, major bleeding, major vascular complications, transfusion, acute kidney injury, heart failure, pacemaker implantation, and aortic regurgitation) was evaluated. Preprocedure and postprocedure high-sensitivity troponin levels were available in 211 patients. The mean age of patients was 83 years (78-87 years), with 129 men (61.1%). Mean postprocedure high-sensitivity troponin was 124.9±81.4 ng/L in the direct TAVR group versus 170.4±127.7 ng/L in the BAV group (=0.007). Myocardial injury occurred in 42 patients (19.9%), including 13 patients (12.2%) in the direct TAVR group and 29 (27.9%) in the BAV group (=0.004). BAV increased by 2.8-fold (95% CI, 1.4-5.8) myocardial injury probability. Myocardial injury was associated with 1-month adverse events (=0.03). Conclusions BAV increased the incidence and magnitude of myocardial injury after TAVR with new-generation balloon-expandable valves. Myocardial injury was associated with 1-month adverse events. These results argue in favor of direct SAPIEN 3 valve implantation. Registration URL: https://www.Clinicaltrials.gov; Unique identifier: NCT02729519.
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http://dx.doi.org/10.1161/JAHA.120.018405DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7955361PMC
December 2020

Optical Coherence Tomography to Guide Percutaneous Coronary Intervention of the Left Main Coronary Artery: the LEMON study.

EuroIntervention 2020 Nov 24. Epub 2020 Nov 24.

Department of Cardiology, Institut Mutualiste Montsouris, Paris, France.

Aims: IVUS is currently recommended by international guidelines to guide left main stem (LMS) PCI. Although OCT resolution outmatches IVUS, this tool is not yet recommended in LMS angioplasty due to the absence of data. This pilot study aimed to analyze the feasibility, safety and impact of OCT-guided LMS PCI.

Methods And Results: This prospective, multicenter trial investigated whether patients might benefit from OCT-guided PCI for mid/distal LMS according to a pre-specified protocol. The primary endpoint was procedural success defined as follows: residual angiographic stenosis <50% + TIMI 3 flow in all branches + adequate OCT stent expansion (LEMON criteria). Seventy patients were included in the final analysis (median age: 72 (64-81) y, 73% male). The OCT pre-specified protocol was applied in all patients. The primary endpoint was achieved in 86 % of subjects. Adequate stent expansion was observed in 86%, significant edge dissection in 30% and residual significant struts malapposition in 24% of the cases. OCT guidance modified operators' strategy in 26% of the patients. The one-year survival free from major clinical adverse events was 98.6 (97.2-100) %.

Conclusions: This study is the first to report the feasibility and performance of OCT-guided LMS PCI according to a pre-specified protocol.
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http://dx.doi.org/10.4244/EIJ-D-20-01121DOI Listing
November 2020

Three-year clinical outcomes with the ABSORB bioresorbable vascular scaffold in real life: Insights from the France ABSORB registry.

Catheter Cardiovasc Interv 2020 Nov 19. Epub 2020 Nov 19.

Département de Cardiologie, Clinique Saint-Hilaire, Rouen, France.

Objectives: The aim of this study was to determine the 3-year outcomes of patients treated with Absorb bioresorbable vascular scaffold (BVS) implantation.

Background: Randomized trials and observational registries performed in patients undergoing percutaneous coronary intervention have demonstrated higher 1-year and midterm rates of device thrombosis and adverse events with BVS compared to contemporary drug eluting stent. Data on long-term follow-up of patients treated with BVS are scarce.

Methods: All patients treated with BVS were included in a large nationwide prospective multicenter registry (FRANCE ABSORB). The primary endpoint was a composite of cardiovascular death, myocardial infarction, and target lesion revascularization at 3 years. Secondary endpoints were 3-year scaffold thrombosis and target vessel revascularization (TVR).

Results: Between September 2014 and April 2016, 2070 patients were included (mean age 55 ± 11 years; 80% men). The indication was acute coronary syndrome (ACS) in 49% of patients. At 3 years, the primary endpoint occurred in 184 patients (8.9%) and 3-year mortality in 43 patients (2.1%). Scaffold thrombosis and TVR rates through 3 years were, respectively, 3 and 7.6%. In a multivariable analysis, independent predictors of primary endpoint occurrence were diabetes, oral anticoagulation, active smoking, absence of initial angiographic success and the association of a total BVS length ≥30 mm with the use of 2.5 mm diameter BVS.

Conclusions: Although 3-year mortality was low in this ACS population, device-related events were significant beyond 1 year. Total BVS length and 2.5 mm BVS were associated with higher rates of MACE at long-term follow-up.
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http://dx.doi.org/10.1002/ccd.29369DOI Listing
November 2020

Ticagrelor versus clopidogrel in elective percutaneous coronary intervention (ALPHEUS): a randomised, open-label, phase 3b trial.

Lancet 2020 11 14;396(10264):1737-1744. Epub 2020 Nov 14.

Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address:

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.
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http://dx.doi.org/10.1016/S0140-6736(20)32236-4DOI Listing
November 2020

Long-Term Antithrombotic Treatments Prescribed for Cardiovascular Diseases in Patients with Hemophilia: Results from the French Registry.

Thromb Haemost 2021 Mar 24;121(3):287-296. Epub 2020 Oct 24.

Centre Régional de Traitement des Hémophiles, Hôpital Saint-Eloi, CHRU de Montpellier, Montpellier, France.

Cardiovascular diseases (CVDs) are a major issue in aging patients with hemophilia (PWHs). Antithrombotic agents are widely used in the general population for CVD treatment, but this recommendation is not fully applicable to PWHs. To improve treatment strategies, a prospective case-control study (COCHE) that analyzed CVD management and follow-up (2 years/patient) in PWHs was performed in France from 2011 to 2018. In total, 68 PWHs (median age: 65 years [39-89]; 48 mild, 10 moderate, and 10 severe hemophilia) were included ( = 50 with acute coronary syndrome,  = 17 with atrial fibrillation,  = 1 with both). They were matched with 68 control PWHs without antithrombotic treatment. In our series, bleeding was significantly influenced by (1) hemophilia severity, with a mean annualized bleeding ratio significantly higher in COCHE patients than in controls with basal clotting factor level up to 20%, (2) antihemorrhagic regimen (on-demand vs. prophylaxis) in severe (hazard ratio [HR] = 16.69 [95% confidence interval, CI: 8.2-47.26];  0.0001) and moderate hemophilia (HR = 42.43 [95% CI: 1.86-966.1];  = 00028), (3) type of antithrombotic treatment in mild hemophilia, with a significantly higher risk of bleeding in COCHE patients than in controls for dual-pathway therapy (HR = 15.64 [95% CI: 1.57-115.8];  = 0019), anticoagulant drugs alone (HR = 9.91 [95% CI: 1.34-73.47];  = 00248), dual antiplatelet therapy (HR = 5.31 [95% CI: 1.23-22.92];  = 00252), and single antiplatelet therapy (HR = 3.76 [95% CI: 1.13-12.55];  = 00313); and (4) HAS-BLED score ≥3 (odds ratio [OR] = 33 [95% CI: 1.43-761.2];  = 00065). Gastrointestinal bleeding was also significantly higher in COCHE patients than in controls (OR = 15 [95% CI: 1.84-268];  = 00141). The COCHE study confirmed that antithrombotic treatments in PWHs are associated with increased bleeding rates in function of hemophilia-specific factors and also of known factors in the general population.
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http://dx.doi.org/10.1055/s-0040-1718410DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7895544PMC
March 2021

Hospital admissions for acute myocardial infarction before and after lockdown according to regional prevalence of COVID-19 and patient profile in France: a registry study.

Lancet Public Health 2020 10 18;5(10):e536-e542. Epub 2020 Sep 18.

Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris (AP-HP), Université de Paris, Paris, France; French Alliance for Cardiovascular Trials, Paris, France. Electronic address:

Background: The COVID-19 pandemic has had a profound effect on general health care. We aimed to evaluate the effect of a nationwide lockdown in France on admissions to hospital for acute myocardial infarction, by patient characteristics and regional prevalence of the pandemic.

Methods: In this registry study, we collected data from 21 centres participating in the ongoing French Cohort of Myocardial Infarction Evaluation (FRENCHIE) registry, which collects data from all patients admitted for ST segment elevation myocardial infarction (STEMI) or non-ST segment elevation myocardial infarction (NSTEMI) within 48 h of symptom onset. We analysed weekly hospital admissions over 8 weeks: the 4 weeks preceding the institution of the lockdown and the 4 weeks following lockdown. The primary outcome was the change in the number of hospital admissions for all types of acute myocardial infarction, NSTEMI, and STEMI between the 4 weeks before lockdown and the 4 weeks after lockdown. Comparisons between categorical variables were made using χ tests or Fisher's exact tests. Comparisons of continuous variables were made using Student's t tests or Mann-Whitney tests. Poisson regression was used to determine the significance of change in hospital admissions over the two periods, after verifying the absence of overdispersion. Age category, region, and type of acute myocardial infarction (STEMI or NSTEMI) were used as covariables. The FRENCHIE cohort is registered with ClinicalTrials.gov, NCT04050956.

Findings: Between Feb 17 and April 12, 2020, 1167 patients were consecutively admitted within 48 h of acute myocardial infarction (583 with STEMI, 584 with NSTEMI) and were included in the study. Admissions for acute myocardial infarction decreased between the periods before and after lockdown was instituted, from 686 before to 481 after lockdown (30% decrease; incidence rate ratio 0·69 [95% CI 0·51-0·70]). Admissions for STEMI decreased from 331 to 252 (24%; 0·72 [0·62-0·85]), and admissions for NSTEMI decreased from 355 to 229 (35%; 0·64 [0·55-0·76]) following institution of the lockdown, with similar trends according to sex, risk factors, and regional prevalence of hospital admissions for COVID-19.

Interpretation: A marked decrease in hospital admissions was observed following the lockdown, irrespective of patient characteristics and regional prevalence of COVID-19. Health authorities should be aware of these findings, in order to adapt their message if the COVID-19 pandemic persists or recurs, or in case of future major epidemics.

Funding: Recherche Hospitalo-Universitaire en Santé iVasc.
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http://dx.doi.org/10.1016/S2468-2667(20)30188-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7498416PMC
October 2020

Immediate vs Delayed Stenting in ST-Elevation Myocardial Infarction: Rationale and Design of the International PRIMACY Bayesian Randomized Controlled Trial.

Can J Cardiol 2020 Nov 25;36(11):1805-1814. Epub 2020 Jan 25.

Hospital of Annecy, Centre Hospitalier Annecy Genevois, Annecy, France.

Background: Primary percutaneous coronary intervention is used to restore blood flow in the infarct-related coronary artery, followed by immediate stenting to prevent reocclusion. Stents implanted in thrombus-laden arteries cause distal embolization, which paradoxically impairs myocardial reperfusion and ventricular function. Whether a strategy of delayed stenting improves outcomes in patients with acute ST-elevation myocardial infarction (STEMI) is uncertain.

Methods: The Primary Reperfusion Secondary Stenting (PRIMACY) is a Bayesian prospective, randomized, open-label, blinded end point trial in which delayed vs immediate stenting in patients with STEMI were compared for prevention of cardiovascular death, nonfatal myocardial infarction, heart failure, or unplanned target vessel revascularization at 9 months. All participants were immediately reperfused, but those assigned to the delayed arm underwent stenting after an interval of 24 to 48 hours. This interval was bridged with antithrombin therapy to reduce thrombus burden. In the principal Bayesian hierarchical random effects analysis, data from exchangeable trials will be combined into a study prior and updated with PRIMACY into a posterior probability of efficacy.

Results: A total of 305 participants were randomized across 15 centres in France and Canada between April 2014 and September 2017. At baseline, the median age of participants was 59 years, 81% were male, and 3% had a history of percutaneous coronary intervention. Results from PRIMACY will be updated from the patient-level data of 1568 participants enrolled in the Deferred Stent Trial in STEMI (DEFER; United Kingdom), Minimalist Immediate Mechanical Intervention (MIMI; France), Danish Trial in Acute Myocardial Infarction-3 (DANAMI-3; Denmark), and Impact of Immediate Stent Implantation Versus Deferred Stent Implantation on Infarct Size and Microvascular Perfusion in Patients With ST Segment-Elevation Myocardial Infarction (INNOVATION, South Korea) trials.

Conclusions: We expect to clarify whether delayed stenting can safely reduce the occurrence of adverse cardiovascular end points compared with immediate stenting in patients with STEMI.
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http://dx.doi.org/10.1016/j.cjca.2020.01.019DOI Listing
November 2020

Successful linkage of French large-scale national registry populations to national reimbursement data: Improved data completeness and minimized loss to follow-up.

Arch Cardiovasc Dis 2020 Aug - Sep;113(8-9):534-541. Epub 2020 Jul 22.

Department of Cardiology, CHRU Brest, 29200 Brest, France; RHU STOP-AS, 76000 Rouen, France. Electronic address:

Background: Registries, a cornerstone of contemporary medicine, frequently suffer from incomplete documentation and losses to follow-up. By linking data to a single-payer national claims database, national registries may be enriched and the quality enhanced.

Aims: To explore the value of data from the French Système National des Données de Santé (SNDS) as a resource to enhance the quality of registries when combined with data from electronic case report forms, and to assess the power to minimize data gaps and losses to follow-up.

Methods: A probabilistic algorithm was developed to link and match records in the SNDS with patient data from the electronic case report forms of two registries on transcatheter aortic valve implantation: FRANCE-2 and FRANCE-TAVI. The algorithm created patient profiles from transcatheter aortic valve implantation procedures in the SNDS, matching them as closely as possible to the profiles in the registry databases. The objective was to achieve 90% linkage of the populations. The linked database was analysed for completeness and loss to follow-up. For validation, mortality curves for the linked registry cohorts were compared with those for the original populations.

Results: A total of 34,397 unique registries entries were identified, and 89.9% of patients in the SNDS could be linked. Rates of losses to follow-up over 2 years were 1.0% in the linked FRANCE-TAVI population compared with 40.3% based on electronic case report form documentation. For FRANCE-2, 3-year rates of losses to follow-up were 1.7% and 6.1%, respectively. Mortality curves for populations based on SNDS and electronic case report form data were practically superimposable.

Conclusions: Linking data from a single-payer national claims database to national registries using a probabilistic approach is feasible and can close data gaps and practically abolish losses to follow-up in the registry population.
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http://dx.doi.org/10.1016/j.acvd.2020.04.006DOI Listing
September 2020

Mapping interventional cardiology in Europe: the European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas Project.

Eur Heart J 2020 07;41(27):2579-2588

Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany.

Aims: The European Association of Percutaneous Cardiovascular Interventions (EAPCI) Atlas of Interventional Cardiology has been developed to map interventional practice across European Society of Cardiology (ESC) member countries. Here we present the main findings of a 16-country survey in which we examine the national availability of interventional infrastructure, human resource, and procedure volumes.

Methods And Results: Sixteen ESC member countries participated in the EAPCI Atlas survey. Interventional data were collected by the National Cardiac Society of each participating country. An annual median of 5131 [interquartile range (IQR) 4013-5801] diagnostic heart procedures per million people were reported, ranging from <2500 in Egypt and Romania to >7000 in Turkey and Germany. Procedure rates showed significant correlation (r = 0.67, P = 0.013) with gross national income (GNI) per capita. An annual median of 2478 (IQR 1690-2633) percutaneous coronary interventions (PCIs) per million people were reported, ranging from <1000 in Egypt and Romania to >3000 in Switzerland, Poland, and Germany. Procedure rates showed significant correlation with GNI per capita (r = 0.62, P = 0.014). An annual median of 48.2 (IQR 29.1-105.2) transcatheter aortic valve implantation procedures per million people were performed, varying from <25 per million people in Egypt, Romania, Turkey, and Poland to >100 per million people in Denmark, France, Switzerland, and Germany. Procedure rates showed significant correlation with national GNI per capita (r = 0.92, P < 0.001).

Conclusion: The first report from the EAPCI Atlas has shown considerable international heterogeneity in interventional cardiology procedure volumes. The heterogeneity showed association with national economic resource, a reflection no doubt of the technological costs of developing an interventional cardiology service.
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http://dx.doi.org/10.1093/eurheartj/ehaa475DOI Listing
July 2020

Long-term outcomes after acute myocardial infarction in patients with familial hypercholesterolemia: The French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction program.

J Clin Lipidol 2020 May - Jun;14(3):352-360.e6. Epub 2020 Apr 8.

Department of Pharmacology, Hôpital St Antoine, Université Pierre et Marie Curie, Paris, France.

Background: Patients with familial hypercholesterolemia (FH) are prone to develop acute myocardial infarction (AMI) at a younger age.

Objectives: The aim of the present study was to assess 5-year outcomes after AMI according to the presence of FH in a large multicenter cohort of patients.

Methods: The French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction consists of nationwide surveys recruiting patients over a 1- to 2-month period every 5 years. Patients recruited in 2005 and 2010 were followed up to 5 years.

Results: Of 5147 patients discharged alive and in whom FH status could be assessed, 2.8% had probable/definite FH, using an adapted Dutch Lipid Clinic score. They were 12 years younger, on average, than non-FH patients. Before adjustment, their 5-year survival and event-free survival did not differ from non-FH patients. After adjustment, however, both mortality (hazard ratio [HR] 1.82, 95% confidence interval [CI] 1.15-2.89; P = .011) and the combined endpoint of death, AMI, or stroke (HR 2.22, 95% CI: 1.51-3.26; P < .001) were higher in FH patients. The higher risk in FH patients was also present in patients receiving high-intensity lipid-lowering therapy at discharge: adjusted HR for mortality 2.29, 95% CI: 1.18 to 4.47, P = .015; HR for cardiovascular events 2.57, 95% CI: 1.48 to 4.48, P = .001. Concordant results were observed in propensity score-marched cohorts.

Conclusions: The risk of long-term mortality and cardiovascular events is twice as high in FH than in non-FH patients, when adjusted on baseline characteristics, even for those receiving high-intensity lipid-lowering therapy. Additional therapeutic measures are needed in these patients.
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http://dx.doi.org/10.1016/j.jacl.2020.03.008DOI Listing
April 2020

Blunting periprocedural myocardial necrosis: Rationale and design of the randomized ALPHEUS study.

Am Heart J 2020 07 29;225:27-37. Epub 2020 Apr 29.

Sorbonne Université, ACTION Study Group, INSERM UMRS1166, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France. Electronic address:

Background: Clopidogrel associated with aspirin is the recommended treatment for patients undergoing elective percutaneous coronary intervention (PCI). Although severe PCI-related events are rare, evidence suggests that PCI-related myocardial infarction and myocardial injury are frequent complications that can impact the clinical prognosis of the patients. Antiplatelet therapy with a potent P2Y receptor inhibitor such as ticagrelor may reduce periprocedural ischemic complications while maintaining a similar safety profile as compared with conventional dual antiplatelet therapy by aspirin and clopidogrel in this setting.

Methods: Assessment of Loading with the P2Y inhibitor ticagrelor or clopidogrel to Halt ischemic Events in patients Undergoing elective coronary Stenting (ALPHEUS) (NCT02617290) is an international, multicenter, randomized, parallel-group, open-label study in patients with stable coronary artery disease who are planned for an elective PCI. In total, 1,900 patients will be randomized before a planned PCI to a loading dose of ticagrelor 180 mg or a loading dose of clopidogrel (300 or 600 mg) in addition to aspirin. Patients will then receive a dual antiplatelet therapy with aspirin and ticagrelor 90 mg twice daily or clopidogrel 75 mg once daily for 30 days. The primary ischemic end point is PCI-related myocardial infarction (myocardial infarction type 4a or 4b) or major myocardial injury within 48 hours (or at hospital discharge if earlier) after elective PCI/stent. Safety will be evaluated by major bleeding events (Bleeding Academic Research Consortium type 3 or 5) at 48 hours (or discharge if it occurs earlier).

Conclusion: ALPHEUS is the first properly sized trial comparing ticagrelor to clopidogrel in the setting of elective PCI and is especially designed to show a reduction in periprocedural events, a surrogate end point for mortality.
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http://dx.doi.org/10.1016/j.ahj.2020.04.017DOI Listing
July 2020

TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome: The TROUPER trial.

Am Heart J 2020 07 30;225:19-26. Epub 2020 Apr 30.

Aix-Marseille Univ, Intensive cardiac care unit, Assistance Publique-Hôpitaux de Marseille, Hôpital Nord, Marseille, France; Mediterranean Association for Research and Studies in Cardiology (MARS Cardio), Marseille, France; Aix Marseille Univ, INSERM, INRA, C2VN, Marseille, France.

Chronic kidney disease (CKD) is associated with an increased risk of acute coronary syndrome (ACS) and cardiovascular death. CKD patients suffering from ACS are exposed to an increased risk of thrombotic recurrences and a higher bleeding rate than patients with normal renal function. However, CKD patients are excluded or underrepresented in clinical trials. Therefore, determining the optimal antiplatelet strategy in this population is of utmost importance. We designed the TicagRelor Or Clopidogrel in severe or terminal chronic kidney patients Undergoing PERcutaneous coronary intervention for acute coronary syndrome (TROUPER) trial: a prospective, controlled, multicenter, randomized trial to investigate the optimal P2Y12 antagonist in CKD patients with ACS. Patients with stage ≥3b CKD are eligible if the diagnosis of ACS is made and invasive strategy scheduled. Patients are randomized 1:1 between a control group with a 600-mg loading dose of clopidogrel followed by a 75-mg/d maintenance dose for 1 year and an experimental group with a 180-mg loading dose of ticagrelor followed by a 90-mg twice daily maintenance dose for the same duration. The primary end point is defined by the rate of major adverse cardiovascular events, including death, myocardial infarction, urgent revascularization, and stroke at 1 year. Safety will be evaluated by the bleeding rate (Bleeding Academic Research Consortium). To demonstrate the superiority of ticagrelor on major adverse cardiovascular events, we calculated that 508 patients are required. The aim of the TROUPER trial is to compare the efficacy of ticagrelor and clopidogrel in stage >3b CKD patients presenting with ACS and scheduled for an invasive strategy. RCT# NCT03357874.
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http://dx.doi.org/10.1016/j.ahj.2020.04.013DOI Listing
July 2020

Clinical evaluation of a dose management system-integrated 3D skin dose map by comparison with radiochromic films.

Eur Radiol 2020 Sep 24;30(9):5071-5081. Epub 2020 Apr 24.

Department of Medical Imaging, CHU Nimes, Medical Imaging Group Nimes, University Montpellier, EA 2415, Bd Prof Robert Debré, 30029, Nîmes Cedex 9, France.

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 (PSD) and computed by RDMS (PSD) using one flat and two anthropomorphic phantoms. Statistical concordance between PSD and PSD 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 PSD median (1st; 3rd quartile) was 0.59 Gy (0.40; 1.08). PSD 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 PSD and PSD was good for both phantoms (flat: 0.94 [0.91; 0.95]; anthropomorphic 0.94 [0.91; 0.96]). Compared with the values of PSD, the values of PSD 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).
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http://dx.doi.org/10.1007/s00330-020-06877-8DOI Listing
September 2020

Transaxillary compared with transcarotid access for TAVR: a propensity-matched comparison from a French multicentre registry.

EuroIntervention 2020 11;16(10):842-849

Heart Team, Institute Cœur-Poumons, CHU Lille, Lille, France.

Aims: No randomised study comparing the outcomes of transcarotid (TC) and transaxillary (TAx) TAVR has been conducted to date. The purpose of this study was to understand which approach should be the preferred alternative by comparing their outcomes using a propensity-matched comparison in a French multicentre registry.

Methods And Results: From 2010 to 2018, a French multicentre prospective registry included 502 patients, with 374 undergoing TC-TAVR and 128 TAx-TAVR for symptomatic aortic stenosis. Patients treated through TAx access were matched 1:2 with patients treated through the TC route by using a propensity score (20 clinical, anatomical and procedural variables) and by date of the procedure. The first outcome was mortality at one-month follow-up. The second outcome was one-month stroke/transient ischaemic attack (TIA). In propensity-matched analyses, the incidence of the primary outcome was similar in the TAx and TC groups (TAx 5.5% vs TC 4.5%, OR 1.23, 95% CI: 0.40-3.70). The secondary outcome was similar in TAx (3.2%) and TC (6.8%, OR 0.52, 95% CI: 0.14-1.84). Minor bleeding (2.7% vs 9.3%, OR 0.26, 95% CI: 0.07-0.92) and main access haematoma (3.6% vs 10.3%, OR 0.034, 95% CI: 0.09-0.92) were significantly more frequent with the TC access. One-month clinical efficacy and safety and one-year mortality did not differ according to the different routes.

Conclusions: One-month mortality, one-month stroke/TIA and one-year mortality are similar with TAx-TAVR and TC-TAVR. However, TC-TAVR is accompanied by more minor bleeding and main access haematoma compared with the transaxillary route.
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http://dx.doi.org/10.4244/EIJ-D-20-00117DOI Listing
November 2020

Post resuscitation electrocardiogram for coronary angiography indication after out-of-hospital cardiac arrest.

Int J Cardiol 2020 07 19;310:73-79. Epub 2020 Mar 19.

Cardiology Department, Caremeau University Hospital, Montpellier University, Nîmes, France. Electronic address:

Background: 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.

Methods: 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.

Results: 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).

Conclusion: 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.
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http://dx.doi.org/10.1016/j.ijcard.2020.03.037DOI Listing
July 2020

Clinical outcomes of PCI with rotational atherectomy: the European multicentre Euro4C registry.

EuroIntervention 2020 Jul 17;16(4):e305-e312. Epub 2020 Jul 17.

Department of Cardiology, Rangueil Toulouse University Hospital, Toulouse, France.

Aims: Despite the use of rotational atherectomy (RA) in interventional cardiology for over three decades, data regarding factors affecting the clinical outcomes of the RA procedure remain scarce. The aim of the present study was to describe the contemporary use and outcomes of RA in Europe.

Methods And Results: We conducted, for the first time, a prospective international registry in 8 European countries and 19 centres and included patients treated by percutaneous coronary intervention with RA. Between October 2016 and July 2018, 966 patients with complete data were recruited. Mean age was 74.5 years, 72.4% were male and 43.4% had diabetes. Initial presentation was an acute coronary syndrome (ACS) for 25.1% of the patients. Clinical success was observed in 91.9% of the procedures. The rate of in-hospital major adverse cardiac events (MACE) - defined as cardiovascular death, myocardial infarction, target lesion revascularisation, stroke and coronary artery bypass grafting - was 4.7%. At one year, the rate of MACE was 13.2%. Factors independently associated with the occurrence of MACE at one year were female gender, renal failure, ACS at admission, depressed left ventricular ejection fraction (LVEF) and presence of a significant left main coronary artery (LMCA) lesion.

Conclusions: Despite the high level of complexity of the studied population, RA turned out to be an effective procedure with a low rate of in-hospital complications and demonstrated good immediate and midterm results.
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http://dx.doi.org/10.4244/EIJ-D-19-01129DOI Listing
July 2020

Which strategy should be the global leader in antithrombotic therapy decision making in older patients?

EuroIntervention 2020 Apr 3;15(18):e1560-e1563. Epub 2020 Apr 3.

Cardiology Department, Nimes University Hospital, Montpellier University, ACTION Study Group, Nîmes, France.

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http://dx.doi.org/10.4244/EIJV15I18A285DOI Listing
April 2020

Routine CYP2C19 Genotyping to Adjust Thienopyridine Treatment After Primary PCI for STEMI: Results of the GIANT Study.

JACC Cardiovasc Interv 2020 03;13(5):621-630

Sorbonne Université-Université Paris 6, ACTION Study Group, Groupe Hospitalier Pitié-Salpêtrière (Assistance Publique Hôpitaux de Paris), INSERM UMRS 1166, Paris, France.

Objectives: The aim of this study was to evaluate prospectively the clinical impact of routine transmission of CYP2C19 genotype in the management of acute ST-segment elevation myocardial infarction with primary percutaneous coronary intervention.

Background: Response to clopidogrel differs widely among patients, notably because of CYP2C19 genetic polymorphisms.

Methods: CYP2C19 genotype (6 alleles) was determined centrally and communicated within 4.1 ± 1.9 days of primary percutaneous coronary intervention in 1,445 patients with ST-segment elevation myocardial infarction recruited at 57 centers in France. CYP2C19 metabolic status was predicted from genotype and served to adjust thienopyridine treatment. The primary endpoint was differences in 12-month outcomes (death, myocardial infarction, and stent thrombosis) between patients with the wild-type genotype or gain-of-function allele (class 1, n = 1,118) and those with loss-of-function (LOF) alleles (class 2, n = 272) who received optimized thienopyridine treatment.

Results: Detection of LOF alleles resulted in adjustment of P2Y inhibition in 85% of patients, with significantly higher use of prasugrel or double-dose clopidogrel. The primary endpoint did not differ between class 1 and class 2 patients (3.31% vs. 3.04%, respectively; p = 0.82). In contrast, carriers of LOF alleles without treatment adjustment had significantly worse outcomes (15.6%; p < 0.05). Bleeding rates were not different between groups.

Conclusions: In a real-world setting, a complete CYPC2C19 genotype can be mostly determined in <7 days using analysis of saliva deoxyribonucleic acid collected during the in-hospital phase among patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention. Genotype information led to stronger platelet inhibition treatment in the vast majority of LOF allele carriers and to similar clinical outcomes as in patients carrying the wild-type genotype or gain-of-function allele. (Genotyping Infarct Patients to Adjust and Normalize Thienopyridine Treatment [GIANT]; NCT01134380).
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http://dx.doi.org/10.1016/j.jcin.2020.01.219DOI Listing
March 2020

Prior Balloon Valvuloplasty Versus Direct Transcatheter Aortic Valve Replacement: Results From the DIRECTAVI Trial.

JACC Cardiovasc Interv 2020 03;13(5):594-602

Department of Cardiology, CHU Nimes, Montpellier University, Nimes, France.

Objectives: The aim of this study was to evaluate device success of transcatheter aortic valve replacement (TAVR) using new-generation balloon-expandable prostheses with or without balloon aortic valvuloplasty (BAV).

Background: Randomized studies are lacking comparing TAVR without BAV against the conventional technique of TAVR with BAV.

Methods: DIRECTAVI (Direct Transcatheter Aortic Valve Implantation) was an open-label noninferiority study that randomized patients undergoing TAVR using the Edwards SAPIEN 3 valve with or without prior balloon valvuloplasty. The primary endpoint was the device success rate according to Valve Academic Research Consortium-2 criteria, which was evaluated using a 7% noninferiority margin. The secondary endpoint included procedural and 30-day adverse events.

Results: Device success was recorded for 184 of 236 included patients (78.0%). The rate of device success in the direct implantation group (n = 97 [80.2%]) was noninferior to that in the BAV group (n = 87 [75.7%]) (mean difference 4.5%; 95% confidence interval: -4.4% to 13.4%; p = 0.02 for noninferiority). No severe prosthesis-patient mismatch or severe aortic regurgitation occurred in any group. In the direct implantation group, 7 patients (5.8%) required BAV to cross the valve. Adverse events were related mainly to pacemaker implantation (20.9% in the BAV group vs. 19.0% in the direct implantation group; p = 0.70). No significant difference was found between the 2 strategies in duration of procedure, contrast volume, radiation exposure, or rate of post-dilatation.

Conclusions: Direct TAVR without prior BAV was noninferior to the conventional strategy using BAV with new-generation balloon-expandable valves, but without procedural simplification. BAV was needed to cross the valve in a few patients, suggesting a need for upstream selection on the basis of patient anatomy. (TAVI Without Balloon Predilatation [of the Aortic Valve] SAPIEN 3 [DIRECTAVI]; NCT02729519).
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http://dx.doi.org/10.1016/j.jcin.2019.12.006DOI Listing
March 2020

Rationale and design of the Flow Evaluation to Guide Revascularization in Multivessel ST-Elevation Myocardial Infarction (FLOWER-MI) trial.

Am Heart J 2020 04 27;222:1-7. Epub 2019 Dec 27.

Clinical Research Unit and CIC 1418 INSERM, George-Pompidou European Hospital, AP-HP, Paris, France.

Background: In ST-elevation myocardial infarction (STEMI) patients presenting with multivessel disease (MVD), recent studies have demonstrated the superiority of fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI) for non-culprit lesions compared to culprit lesion treatment-only therapy. FFR- and angio-guided PCI have however never been compared in STEMI patients.

Trial Design: FLOWER-MI is an open-label multicenter national randomized clinical trial. The aim is to investigate FFR-guided complete revascularization in comparison to angio-guided complete revascularization in STEMI patients with successful PCI of the culprit lesion and ≥50% stenosis in at least one additional non-culprit lesion requiring PCI. Eligible patients will be randomized after successful primary PCI in a 1:1 fashion to either FFR-guided or angio-guided complete revascularization during the index procedure or a staged procedure before discharge (≤5 days). Patients assigned to FFR guidance first have FFR measured in each non-culprit vessel and only undergo PCI if FFR is ≤0.80. The primary end point of the study is a composite of major adverse cardiac events, including all-cause death, non-fatal MI, and unplanned hospitalization leading to urgent revascularization at 1 year. Secondary end points will include the individual adverse events, cost-effectiveness, quality of life, and 30-day, 6-month, and 3-year outcomes. Based on estimated event rates, a sample size of 1170 patients is needed to show superiority of the FFR-guided revascularization with 80% power.

Conclusion: The aim of FLOWER-MI trial is to assess whether FFR-guided complete revascularization in the acute setting is superior angio-guided complete revascularization.
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http://dx.doi.org/10.1016/j.ahj.2019.12.015DOI Listing
April 2020

Association between rs4149056 variant in and early discontinuation of statin after acute myocardial infarction.

Pharmacogenomics 2020 02;21(3):163-172

FACT (French Alliance for Cardiovascular Trials), an F-CRIN Network, Paris, France.

Data from two French surveys were used to analyze the association between in-hospital statin discontinuation and polymorphism (rs4149056) in patients with acute myocardial infarction. Using TaqMan allelic discrimination assay, 1674 and 1708 patients were genotyped for in 2005 and 2010, respectively. The association with in-hospital statin discontinuation was assessed after adjusting for confounding factors. In 2005, homozygosity for the reduced-function allele was associated with an increased risk of in-hospital statin discontinuation (OR: 3.68; p = 0.004) compared with the wild-type allele but this association disappeared in 2010. However, statin type and intensity-dose differed significantly between the surveys. polymorphism (rs4149056) does not seem to be a major determinant of early 'in-hospital' statin discontinuation after acute myocardial infarction.
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http://dx.doi.org/10.2217/pgs-2019-0109DOI Listing
February 2020