Publications by authors named "Didier Blanchard"

73 Publications

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

Femoral Versus Nonfemoral Peripheral Access for Transcatheter Aortic Valve Replacement.

J Am Coll Cardiol 2019 12;74(22):2728-2739

Department of Cardiology, La Cavale Blanche University Hospital Centre, Optimization of Physiological Regulations, Science and Technical Training And Research Unit, University of Western Brittany, Brest, France.

Background: Femoral access is the gold standard for transcatheter aortic valve replacement (TAVR). Guidelines recommend reconsidering surgery when this access is not feasible. However, alternative peripheral accesses exist, although they have not been accurately compared with femoral access.

Objectives: This study compared nonfemoral peripheral (n-FP) TAVR with femoral TAVR.

Methods: Using the data from the national prospective French registry (FRANCE TAVI [French Transcatheter Aortic Valve Implantation]), this study compared the characteristics and outcomes of TAVR procedures according to whether they were performed through a femoral or a n-FP access, using a pre-specified propensity score-based matching between groups. Subanalysis during 2 study periods (2013 to 2015 and 2016 to 2017) and among low/intermediate-low and intermediate-high/high volume centers were performed.

Results: Among 21,611 patients, 19,995 (92.5%) underwent femoral TAVR and 1,616 (7.5%) underwent n-FP TAVR (transcarotid, n = 914 or trans-subclavian, n = 702). Patients in the n-FP access group had more severe disease (mean logistic EuroSCORE 19.95 vs. 16.95; p < 0.001), with a higher rate of peripheral vascular disease, known coronary artery disease, chronic pulmonary disease, and renal failure. After matching, there was no difference in the rate of post-procedural death and complications according to access site, except for a 2-fold lower rate of major vascular complications (odds ratio: 0.45; 95% confidence interval: 0.21 to 0.93; p = 0.032) and unplanned vascular repairs (odds ratio: 0.41; 95% confidence interval: 0.29 to 0.59; p < 0.001) in those who underwent n-FP access. The comparison of outcomes provided similar results during the second study period and in intermediate-high/high volume centers.

Conclusions: n-FP TAVR is associated with similar outcomes compared with femoral peripheral TAVR, except for a 2-fold lower rate of major vascular complications and unplanned vascular repairs. n-FP TAVR may be favored over surgery in patients who are deemed ineligible for femoral TAVR and may be a safe alternative when femoral access risk is considered too high.
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http://dx.doi.org/10.1016/j.jacc.2019.09.054DOI Listing
December 2019

The influence of silica surface groups on the Li-ion conductivity of LiBH/SiO nanocomposites.

Phys Chem Chem Phys 2019 Oct 3;21(40):22456-22466. Epub 2019 Oct 3.

Inorganic Chemistry and Catalysis, Debye Institute for Nanomaterials Science, Utrecht University, Utrecht, The Netherlands.

Lithium borohydride is a promising lithium ion conductor for all-solid-state batteries. However, the compound only exhibits high ionic conductivity at elevated temperatures, typically above 110 °C. It was shown that the addition of oxides such as silica or alumina increases the room temperature ionic conductivity by 3 orders of magnitude. The origin of this remarkable effect is not yet well understood. Here, we investigate the influence of oxide surface groups on the ionic conductivity of LiBH/SiO nanocomposites. We systematically varied the density and nature of the surface groups of mesoporous silica by heat treatment at different temperatures, or surface functionalization, and subsequently prepared LiBH/SiO nanocomposites by melt infiltration. The ionic conductivity is strongly influenced by the heat treatment temperature, hence the density of the free surface silanol groups. Replacing some of the silanol groups with hydrophobic surface groups resulted in an order of magnitude reduction of the room temperature ionic conductivity, suggesting that their presence is crucial to obtain high ionic conductivity in the nanocomposites. This systematic study and insight provide a basis for further exploration of the impact of surface groups, and for the rational design of novel solid-state nanocomposite electrolytes via interface engineering.
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http://dx.doi.org/10.1039/c9cp04235kDOI Listing
October 2019

Assessment of Long-Term Structural Deterioration of Transcatheter Aortic Bioprosthetic Valves Using the New European Definition.

Circ Cardiovasc Interv 2019 04;12(4):e007597

Normandie Univ, UNIROUEN, INSERM U1096, Rouen University Hospital, Department of Cardiology, FHU REMOD-VHF, France (E.D., A.S., C.T., P.Y.L., G.A., A.C., H.E.).

Background: The durability of transcatheter aortic bioprosthetic valves is a crucial issue, but data are scarce, especially beyond 5 years of follow-up. We aimed to assess long-term (7 years) structural valve deterioration (SVD) and bioprosthetic valve failure of transcatheter aortic bioprosthetic valves.

Methods And Results: Consecutive patients with at least 5-year follow-up available undergoing transcatheter aortic valve implantation from April 2002 to December 2011 in 5 French centers were included. Incidence of SVD and bioprosthetic valve failure were defined according to newly standardized criteria of the European Association of Percutaneous Cardiovascular Interventions/European Society of Cardiology/European Association for Cardio-Thoracic Surgery and reported as cumulative incidence function to account for the competing risk of death. One thousand four hundred three consecutive patients were included with a mean age of 82.6±7.5 years and with a mean logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) of 21.3±7.5%. A balloon-expandable valve was used in 83.7% of cases. Survival rates were 83.5% (95% CI, 81.4%-85.5%) and 18.6% (95% CI, 15.3%-21.8%) at 1 and 7 years, respectively. Median duration of follow-up was 3.9 years. Bioprosthetic valve failure occurred in 19 patients with a 7-year cumulative incidence of 1.9% (95% CI, 1.4%-2.4%). SVD occurred in 49 patients (moderate, n=32; severe, n=17) with a 7-year cumulative incidence of moderate and severe SVD of 7.0% (95% CI, 5.6%-8.4%) and 4.2% (95% CI, 2.9%-5.5%), respectively. Five patients had aortic valve reintervention (1.0%; 95% CI, 0.4%-1.6%) including 1 case of surgical aortic valve replacement and 4 redo-transcatheter aortic valve implantation. The incidences of SVD and bioprosthetic valve failure were not significantly different between balloon and self-expandable prostheses.

Conclusions: The long-term assessment of transcatheter aortic bioprosthetic valves durability is limited by the poor survival of our population beyond 5 years. Further studies are warranted, particularly in younger and lower-risk patients.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007597DOI Listing
April 2019

Five-Year Clinical Outcome and Valve Durability After Transcatheter Aortic Valve Replacement in High-Risk Patients.

Circulation 2018 12;138(23):2597-2607

Department of Cardiology, Parly 2 Hospital, Le Chesnay, France (X.F.).

Background: The FRANCE-2 registry (French Aortic National Corevalve and Edwards) previously reported good early- and medium-term clinical and echocardiographic efficacy for transcatheter aortic valve replacement. We here report 5-year follow-up results from the registry.

Methods: The registry includes all consecutive patients undergoing transcatheter aortic valve replacement for severe aortic stenosis in France. Follow-up is scheduled at 30 days, 6 months, then annually from 1 to 5 years. Clinical events were defined according to the Valve Academic Research Consortium criteria, and hemodynamic structural valve deterioration (SVD) was defined according to the consensus statement by the European Association of Percutaneous Cardiovascular Interventions.

Results: Between January 2010 and January 2012, 4201 patients were enrolled in 34 centers. Five-year vital status was available for 95.5% of patients; 88.1% had clinical evaluation or died. Overall, at 5 years, all-cause mortality was 60.8% (n=2478; 95% CI, 59.3% to 62.3%). The majority of cardiovascular events occurred in the first month after valve implantation, and incidence remained low thereafter, at <2% per year up to 5 years, except for heart failure. The rate of heart failure was 14.3% at 1 year, then decreased over time to <5% per year. In cumulative incidence function, the rates of severe SVD and moderate/severe SVD at 5 years were 2.5% and 13.3%, respectively. Mortality did not differ between patients with or without severe SVD (hazard ratio, 0.71; 95% CI, 0.47-1.07; P=0.1). Finally, in the population of patients with severe SVD, 1 patient (1.7%) experienced a stroke, and 8 patients presented ≥1 heart failure event (13.3%).

Conclusions: The 5-year follow-up results of the FRANCE-2 registry represent the largest long-term data set available in a high-risk population. In surviving patients, the low rate of clinical events and the low level of SVD after 1 year support the long-term efficacy of transcatheter aortic valve replacement in both types of transcatheter prosthesis featuring in the registry.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.118.036866DOI Listing
December 2018

Transcarotid Compared With Other Alternative Access Routes for Transcatheter Aortic Valve Replacement.

Circ Cardiovasc Interv 2018 11;11(11):e006388

Department of Cardiac Surgery and Cardiology, Quebec Heart and Lung Institute, Laval University, Canada (C.C., J.R.-C., E.D., D.D., R.D., J.-M.P., R.P., F.M., T.R.-G., D.K., S.M.).

Background The optimal access for patients undergoing transcatheter aortic valve replacement (TAVR) who are not candidates for a transfemoral approach has not been elucidated. The purpose of this study was to compare the safety, feasibility, and early clinical outcomes of transcarotid TAVR compared with thoracic approaches. Methods and Results From a multicenter consecutive cohort of 329 alternative-access TAVR patients (2012-2017), we identified 101 patients who underwent transcarotid TAVR and 228 patients who underwent a transapical or transaortic TAVR. Preprocedural success and 30-day clinical outcomes were compared using multivariable propensity score analysis to account for between-group differences in baseline characteristics. All transcarotid cases were performed under general anesthesia, mainly using the left common carotid artery (97%). Propensity-matched groups had similar rates of 30-day all-cause mortality (2.1% versus 4.6%; P=0.37), stroke (2.1% versus 3.5%; P=0.67; transcarotid versus transapical/transaortic, respectively), new pacemaker implantation, and major vascular complications. Transcarotid TAVR was associated with significantly less new-onset atrial fibrillation (3.2% versus 19.0%; P=0.002), major or life-threatening bleeding (4.3% versus 19.9%; P=0.002), acute kidney injury (none versus 12.1%; P=0.002), and shorter median length of hospital stay (6 versus 8 days; P<0.001). Conclusions Transcarotid vascular access for TAVR is safe and feasible and is associated with encouraging short-term clinical outcomes. Our data suggest a clinical benefit of transcarotid TAVR with respect to atrial fibrillation, major bleeding, acute kidney injury, and length of stay compared with the more invasive transapical or transaortic strategies. Randomized studies are required to ascertain whether transcarotid TAVR yields equivalent results to other alternative vascular access routes.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.006388DOI Listing
November 2018

Impact of coronary artery disease in patients undergoing transcatheter aortic valve replacement: Insights from the FRANCE-2 registry.

Clin Cardiol 2017 Dec 16;40(12):1316-1322. Epub 2017 Dec 16.

Department of Cardiology, European Hospital of Georges Pompidou, Public Assistance Hospitals of Paris, Paris Descartes University, Paris, France.

Background: Coronary artery disease (CAD) is common in patients undergoing transcatheter aortic valve replacement (TAVR). However, the impact of CAD distribution before TAVR on short- and long-term prognosis remains unclear.

Hypothesis: We hypothesized that the long-term clinical impact differs according to CAD distribution in patients undergoing TAVR using the FRench Aortic National CoreValve and Edwards (FRANCE-2) registry.

Methods: FRANCE-2 is a national French registry including all consecutive TAVR performed between 2010 and 2012 in 34 centers. Three-year mortality was assessed in relation to CAD status. CAD was defined as at least 1 coronary stenosis >50%.

Results: A total of 4201 patients were enrolled in the registry. For the present analysis, we excluded patients with a history of coronary artery bypass. CAD was reported in 1252 patients (30%). Half of the patients presented with coronary multivessel disease. CAD extent was associated with an increase in cardiovascular risk profile and in logistic EuroSCORE (European System for Cardiac Operative Risk Evaluation) (from 19.3% ± 12.8% to 21.9% ± 13.5%, P < 0.001). Mortality at 30 days and 3 years was 9% and 44%, respectively, in the overall population. In multivariate analyses, neither the presence nor the extent of CAD was associated with mortality at 3 years (presence of CAD, hazard ratio [HR]: 0.90; 95% confidence interval [CI]: 0.78-1.07). A significant lesion of the left anterior descending (LAD) was associated with higher 3-year mortality (HR: 1.42; 95% CI: 1.10-1.87).

Conclusions: CAD is not associated with decreased short- and long-term survival in patients undergoing TAVR. The potential deleterious effect of LAD disease on long-term survival and the need for revascularization before or at the time of TAVR should be validated in a randomized control trial.
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http://dx.doi.org/10.1002/clc.22830DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6490315PMC
December 2017

Acute Myocardial Infarction: Changes in Patient Characteristics, Management, and 6-Month Outcomes Over a Period of 20 Years in the FAST-MI Program (French Registry of Acute ST-Elevation or Non-ST-Elevation Myocardial Infarction) 1995 to 2015.

Circulation 2017 Nov 27;136(20):1908-1919. Epub 2017 Aug 27.

Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology; Université Paris-Descartes, Paris, France; INSERM U-970, France (E.P., N.A., N.D.).

Background: ST-segment-elevation myocardial infarction (STEMI) and non-ST-segment-elevation myocardial infarction (NSTEMI) management has evolved considerably over the past 2 decades. Little information on mortality trends in the most recent years is available. We assessed trends in characteristics, treatments, and outcomes for acute myocardial infarction in France between 1995 and 2015.

Methods: We used data from 5 one-month registries, conducted 5 years apart, from 1995 to 2015, including 14 423 patients with acute myocardial infarction (59% STEMI) admitted to cardiac intensive care units in metropolitan France.

Results: From 1995 to 2015, mean age decreased from 66±14 to 63±14 years in patients with STEMI; it remained stable (68±14 years) in patients with NSTEMI, whereas diabetes mellitus, obesity, and hypertension increased. At the acute stage, intended primary percutaneous coronary intervention increased from 12% (1995) to 76% (2015) in patients with STEMI. In patients with NSTEMI, percutaneous coronary intervention ≤72 hours from admission increased from 9% (1995) to 60% (2015). Six-month mortality consistently decreased in patients with STEMI from 17.2% in 1995 to 6.9% in 2010 and 5.3% in 2015; it decreased from 17.2% to 6.9% in 2010 and 6.3% in 2015 in patients with NSTEMI. Mortality still decreased after 2010 in patients with STEMI without reperfusion therapy, whereas no further mortality gain was found in patients with STEMI with reperfusion therapy or in patients with NSTEMI, whether or not they were treated with percutaneous coronary intervention.

Conclusions: Over the past 20 years, 6-month mortality after acute myocardial infarction has decreased considerably for patients with STEMI and NSTEMI. Mortality figures continued to decline in patients with STEMI until 2015, whereas mortality in patients with NSTEMI appears stable since 2010.
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http://dx.doi.org/10.1161/CIRCULATIONAHA.117.030798DOI Listing
November 2017

6- Versus 24-Month Dual Antiplatelet Therapy After Implantation of Drug-Eluting Stents in Patients Nonresistant to Aspirin: Final Results of the ITALIC Trial (Is There a Life for DES After Discontinuation of Clopidogrel).

JACC Cardiovasc Interv 2017 06;10(12):1202-1210

Poly de St. Laurent, Rennes, France.

Objectives: The aim of this study was to test the hypothesis that 6-month dual antiplatelet therapy (DAPT) is noninferior to 24-month DAPT in aspirin-sensitive patients.

Background: The ITALIC (Is There a Life for DES After Discontinuation of Clopidogrel) trial showed that rates of bleeding and thrombotic events at 1 year were much the same with 6 versus 12 months of DAPT after percutaneous coronary intervention with second-generation drug-eluting stents. In this report, 2-year follow-up is presented.

Methods: In a multicenter randomized study, patients with confirmed nonresistance to aspirin undergoing drug-eluting stent implantation were allocated to 6 or 24 months of DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-percutaneous coronary intervention. The secondary endpoints comprised the same composite endpoint at 24 months and each individual component.

Results: Overall, 2,031 patients from 70 centers were screened; 926 were randomized to 6-month and 924 to 24-month DAPT. Noninferiority was demonstrated for 6- versus 12-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p = 0.0002). At 2 years, the composite endpoint was unchanged, at 3.5% for 6 months and 3.7% for 24 months (p = 0.79), and rates of myocardial infarction (1.3% vs. 1.0%; p = 0.51), stroke (0.6% vs. 0.8%; p = 0.77), and target vessel revascularization (1.0% vs. 0.3%; p = 0.09) were likewise similar. There was a trend toward higher mortality with longer DAPT (2.2% vs. 1.2%; p = 0.11). Four patients (0.4%) in the 24-month group and none in the 6-month group had major bleeding.

Conclusions: Two-year outcomes in the ITALIC trial confirmed the 1-year results and showed that patients receiving 6-month DAPT after percutaneous coronary intervention with second-generation drug-eluting stent have similar outcomes to those receiving 24-month DAPT.
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http://dx.doi.org/10.1016/j.jcin.2017.03.049DOI Listing
June 2017

An unusual cause of myocardial ischemia: Compression of a left internal mammary artery grafting to the left anterior descending artery by a pacemaker lead.

J Cardiol Cases 2017 Sep 22;16(3):74-76. Epub 2017 Jun 22.

Clinique Saint Gatien, 37000 Tours, France.

An 83-year-old patient, with prior history of coronary artery disease treated by coronary-artery bypass graft with left internal mammary artery (LIMA) to the left anterior descending artery (2001) and angioplasty of the right coronary artery (2012) and prior pacemaker through left subclavian vein (2014), was referred to coronary angiography for an anterior silent ischemia. It found no evolving lesion on the native coronary artery network (compared with 2012 review) but revealed an external compression of the LIMA bridge by the pacemaker lead. Conservative treatment was chosen rather than explantation and reimplantation of stimulus material or LIMA angioplasty. < This case highlights the interest for preferential use of the cephalic pathway in patients with left internal mammary bypass graft undergoing cardiac pacing.>.
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http://dx.doi.org/10.1016/j.jccase.2017.05.006DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6149267PMC
September 2017

France: coronary and structural heart interventions from 2010 to 2015.

EuroIntervention 2017 May;13(Z):Z25-Z31

Department of Cardiology, University Hospital of Clermont-Ferrand, UMR 6284 Auvergne University, Clermont-Ferrand, France.

France, with its 66 million inhabitants, has a long tradition in interventional cardiology, with numerous innovations and contributions to the dynamism of European activity. The development of interventional cardiology requires supervised training, organisation and participation in studies. This also translates into an ever-expanding clinical activity since 2010, such as the coronary and structural interventions that are detailed in the present review.
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http://dx.doi.org/10.4244/EIJ-D-16-00824DOI Listing
May 2017

A strange nature of right ventricular tumour: the first case report of osseous metaplasia in the heart.

Eur Heart J Cardiovasc Imaging 2017 Sep;18(9):1069

Service de cardiologie interventionnelle et d'imagerie cardiaque, Clinique Saint Gatien, 8 place de la cathédrale, 37000 Tours, France.

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http://dx.doi.org/10.1093/ehjci/jex098DOI Listing
September 2017

An unusual cause of cardiogenic shock: Left atrial compression by a spontaneous rupture of an aneurysm of the descending thoracic aorta.

J Cardiol Cases 2017 May 6;15(5):153-154. Epub 2017 Mar 6.

Service de Cardiologie Interventionnelle et d'Imagerie Cardiaque, Clinique Saint Gatien, Tours, France.

A 77-year-old woman presented with a feverish hemodynamic collapse, acute respiratory distress, and dorsal pain, initially treated as a septic shock. Transthoracic echocardiogram revealed an impressive compression of the left atrial cavity, by an extrinsic mass preventing the left ventricle from refilling. Thoracic computed tomography revealed a large hemomediastinum emerging from an aneurysm of the descending thoracic aorta compressing the left atrium. The patient died in refractory cardiogenic collapse. < In the management of cardiovascular collapse, the understanding of the mechanism or the cause is essential. For this purpose, echocardiogram is a fast and indispensable tool, sometimes allowing discovering surprising etiology.>.
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http://dx.doi.org/10.1016/j.jccase.2016.12.009DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6147379PMC
May 2017

Changes in One-Year Mortality in Elderly Patients Admitted with Acute Myocardial Infarction in Relation with Early Management.

Am J Med 2017 May 5;130(5):555-563. Epub 2017 Jan 5.

Assistance Publique-Hôpitaux de Paris (AP-HP), Department of Cardiology, Hôpital Européen Georges Pompidou (HEGP), Paris, France; Université Paris-Descartes, Paris, France.

Background: Elderly patients are underrepresented in acute myocardial infarction trials. Our aim was to determine whether, in elderly patients, changes in management in the past 15 years are associated with improved 1-year mortality after hospital admission for myocardial infarction.

Methods: We used data from 4 1-month French registries, conducted 5 years apart from 1995 to 2010, including 3389 elderly patients (≥75 years of age).

Results: From 1995 to 2010, mean age remained stable (82.1 years), similar in ST- and non-ST-elevation myocardial infarction patients. Obesity, diabetes, hypertension, and hypercholesterolemia increased. History of prior myocardial infarction, stroke, and peripheral artery disease remained stable, while history of heart failure decreased. Major changes in management were noted: early percutaneous coronary intervention, early treatment with antiplatelet agents, low-molecular-weight heparin, beta-blockers, angiotensin-converting enzyme inhibitor or angiotensin receptor blocker, and statins all increased. Early mortality after hospital admission decreased from 25.0% to 8.4%. One-year mortality decreased from 36.2% to 20.0% (adjusted hazard ratio 2010 vs 1995: 0.47, 0.39-0.57), both for ST-elevation myocardial infarction (36.8% to 21.1%) and non-ST-elevation myocardial infarction (34.8% to 19.1%). Mortality reduction was observed in all age groups, including those ≥85 years of age (from 46.2% to 31.4%). The study period, however, was no longer associated with decreased mortality when variables reflecting management changes were taken into account.

Conclusions: Early and 1-year mortality after hospital admission of elderly patients with acute myocardial infarction has substantially decreased over the past 15 years. This improvement is likely mediated by increasing use of recommended management strategies. These data support the application of guidelines derived from trials mostly including younger patients to elderly populations as well.
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http://dx.doi.org/10.1016/j.amjmed.2016.12.005DOI Listing
May 2017

Late Outcomes of Transcatheter Aortic Valve Replacement in High-Risk Patients: The FRANCE-2 Registry.

J Am Coll Cardiol 2016 10;68(15):1637-1647

Department of Cardiology, Brest University Hospital, Brest, France.

Background: Transcatheter aortic valve replacement (TAVR) has revolutionized management of high-risk patients with severe aortic stenosis. However, survival and the incidence of severe complications have been assessed in relatively small populations and/or with limited follow-up.

Objectives: This report details late clinical outcome and its determinants in the FRANCE-2 (FRench Aortic National CoreValve and Edwards) registry.

Methods: The FRANCE-2 registry prospectively included all TAVRs performed in France. Follow-up was scheduled at 30 days, at 6 months, and annually from 1 to 5 years. Standardized VARC (Valve Academic Research Consortium) outcome definitions were used.

Results: A total of 4,201 patients were enrolled between January 2010 and January 2012 in 34 centers. Approaches were transarterial (transfemoral 73%, transapical 18%, subclavian 6%, and transaortic or transcarotid 3%) or, in 18% of patients, transapical. Median follow-up was 3.8 years. Vital status was available for 97.2% of patients at 3 years. The 3-year all-cause mortality was 42.0% and cardiovascular mortality was 17.5%. In a multivariate model, predictors of 3-year all-cause mortality were male sex (p < 0.001), low body mass index, (p < 0.001), atrial fibrillation (p < 0.001), dialysis (p < 0.001), New York Heart Association functional class III or IV (p < 0.001), higher logistic EuroSCORE (p < 0.001), transapical or subclavian approach (p < 0.001 for both vs. transfemoral approach), need for permanent pacemaker implantation (p = 0.02), and post-implant periprosthetic aortic regurgitation grade ≥2 of 4 (p < 0.001). Severe events according to VARC criteria occurred mainly during the first month and subsequently in <2% of patients/year. Mean gradient, valve area, and residual aortic regurgitation were stable during follow-up.

Conclusions: The FRANCE-2 registry represents the largest database available on late results of TAVR. Late mortality is largely related to noncardiac causes. Incidence rates of severe events are low after the first month. Valve performance remains stable over time.
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http://dx.doi.org/10.1016/j.jacc.2016.07.747DOI Listing
October 2016

β blockers and mortality after myocardial infarction in patients without heart failure: multicentre prospective cohort study.

BMJ 2016 09 20;354:i4801. Epub 2016 Sep 20.

Department of Cardiology, Hôpital Européen Georges Pompidou, 75015 Paris, France Assistance Publique-Hôpitaux de Paris, Paris, France Université Paris-Descartes, Paris, France.

Objective: To assess the association between early and prolonged β blocker treatment and mortality after acute myocardial infarction.

Design: Multicentre prospective cohort study.

Setting: Nationwide French registry of Acute ST- and non-ST-elevation Myocardial Infarction (FAST-MI) (at 223 centres) at the end of 2005.

Participants: 2679 consecutive patients with acute myocardial infarction and without heart failure or left ventricular dysfunction.

Main Outcome Measures: Mortality was assessed at 30 days in relation to early use of β blockers (≤48 hours of admission), at one year in relation to discharge prescription, and at five years in relation to one year use.

Results: β blockers were used early in 77% (2050/2679) of patients, were prescribed at discharge in 80% (1783/2217), and were still being used in 89% (1230/1383) of those alive at one year. Thirty day mortality was lower in patients taking early β blockers (adjusted hazard ratio 0.46, 95% confidence interval 0.26 to 0.82), whereas the hazard ratio for one year mortality associated with β blockers at discharge was 0.77 (0.46 to 1.30). Persistence of β blockers at one year was not associated with lower five year mortality (hazard ratio 1.19, 0.65 to 2.18). In contrast, five year mortality was lower in patients continuing statins at one year (hazard ratio 0.42, 0.25 to 0.72) compared with those discontinuing statins. Propensity score and sensitivity analyses showed consistent results.

Conclusions: Early β blocker use was associated with reduced 30 day mortality in patients with acute myocardial infarction, and discontinuation of β blockers at one year was not associated with higher five year mortality. These findings question the utility of prolonged β blocker treatment after acute myocardial infarction in patients without heart failure or left ventricular dysfunction.Trial registration Clinical trials NCT00673036.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5029148PMC
http://dx.doi.org/10.1136/bmj.i4801DOI Listing
September 2016

Fifteen-year trends in the management of cardiogenic shock and associated 1-year mortality in elderly patients with acute myocardial infarction: the FAST-MI programme.

Eur J Heart Fail 2016 09;18(9):1144-52

AP-HP, Hôpital Européen Georges Pompidou, Paris, France, and Université Paris-Descartes, Paris, France.

Aims: Alhough cardiogenic shock (CS) after acute myocardial infarction (AMI) is more common in elderly patients, information on the epidemiology of these patients is scarce. This study aimed to assess the trends in prevalence, characteristics, management, and outcomes of elderly patients admitted with CS complicating AMI between 1995 and 2010, using data from the FAST-MI programme.

Methods And Results: We analysed the incidence and 1-year mortality of CS in four nationwide French surveys carried out 5 years apart from 1995 to 2010, including consecutive AMI patients over 1-month periods. Among the 10 610 patients, 3389 were aged ≥75 years, of whom 9.9% developed CS. The prevalence of CS decreased in elderly patients from 11.6% in 1995 to 6.7% in 2010 (P = 0.02). Over the 15-year period, the characteristics of elderly patients with CS changed, with more diabetes, hypertension, and hypercholesterolaemia. The use of PCI increased markedly in elderly patients with and without CS, reaching 51% and 59%, respectively, in 2010. In addition, medical therapy also evolved, with more patients receiving antithrombotic agents, beta-blockers, and statins. Over time, 1-year mortality decreased by 32% among elderly patients with CS but remained high (59% in 2010). ST-segmet elevation myocardial infarction and previous AMI were independent correlates of increased 1-year death, while study period was associated with decreased mortality (2010 vs, 1995: hazard ratio 0.40, 95% confidence interval 0.27-0.61, P < 0.001), along with early use of PCI.

Conclusion: Cardiogenic shock in elderly patients with AMI remains a major clinical concern. However, 1-year mortality declined in these patients, a decrease potentially mediated by broader use of PCI and the improvement of global patient management.
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http://dx.doi.org/10.1002/ejhf.585DOI Listing
September 2016

Short and long-term outcomes of alcohol septal ablation with the trans-radial versus the trans-femoral approach: A single center-experience.

Int J Cardiol 2016 Oct 25;220:7-13. Epub 2016 Jun 25.

Department of Cardiology, Ramsay Générale de Santé, Institut Cardiovasculaire Paris-Sud-Hôpital Privé Jacques Cartier, Massy, France. Electronic address:

Background: Although the trans-radial approach (TR) has been applied to various subsets of patients in percutaneous coronary intervention, the feasibility, efficacy, acute procedural and long-term outcomes of TR versus trans-femoral approach (TF) for alcohol septal ablation (ASA) have not yet been determined.

Objectives: The aim of this study was to compare the short and long-term outcomes of ASA with the TR approach compared to the TF approach.

Methods: We retrospectively analyzed 240 patients who underwent an ASA procedure at our institution from November 1999 to November 2015. The TR approach was performed in 172 cases and the TF approach in the remaining 68 cases.

Results: The use of TR approach progressively increased from 62% in 1999-2005 to 91% in 2011-2015 (p=0.0001). The TF and TR group had similar age, baseline NYHA class (NYHA 3 or 4) and mean left ventricular outflow tract peak gradient before ASA. Total contrast used (TR: 73.2±47.2ml; TF: 88.7±49.3ml, p=0.11), total radiation Air kerma area product (TR: 43.7±48.0Gycm(-2); TF: 55.9±48.2Gycm(-2); p=0.39) and peak left ventricular outflow tract gradient immediately after ASA (TR: 19.1±19.6mmHg; TF: 20.4±18.0mmHg, p=0.63) were similar in both groups. Procedural success was 91.9% and 91.2% in the TR and TF groups, respectively (p=0.53). At 30days, there was 2 intra-hospital death (1 in TF and 1 in TR), 1 major stroke in the TF group and 1 coronary artery dissection in the TR group. Vascular complications were less frequent in the TR group (0.58% vs. 7.3%; p=0.002). The mean length of follow-up was 4.56±4.34years (IQR 0.69-8.2; median 2.92years; maximum: 15.5years). By Kaplan-Meier estimate, the observed survival in the overall cohort was comparable to the expected survival for a sex and age-matched comparable general French population at 10years (86.9 vs. 83.6%, p=0.88). Survival was similar between the TR and TF group (92.1% vs. 89.7% at 6years, respectively; p=0.71).

Conclusions: Alcohol septal ablation from the radial approach can be performed with similar acute and long-term success, but with lower vascular complications compared to the femoral approach.
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http://dx.doi.org/10.1016/j.ijcard.2016.06.127DOI Listing
October 2016

Factors Associated With Infarct-Related Artery Patency Before Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction (from the FAST-MI 2010 Registry).

Am J Cardiol 2016 Jan 23;117(1):17-21. Epub 2015 Oct 23.

Department of Cardiology, Assistance Publique-Hôpitaux de Paris, Hôpital Européen Georges Pompidou, Paris, France; Université Paris-Descartes, Paris, France.

Early infarct-related artery (IRA) patency is associated with better clinical outcomes in patients with ST-elevation myocardial infarction (STEMI). Using the French Registry of ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2010 registry, we investigated factors related to IRA patency (thrombolysis in myocardial infarction [TIMI] 2/3 flow) at the start of procedure in patients admitted for primary percutaneous coronary intervention. FAST-MI 2010 is a nationwide French registry including 4,169 patients with acute MI. Of 1,452 patients with STEMI with primary percutaneous coronary intervention, 466 (32%) had TIMI 2/3 flow of IRA before the procedure. Mean age (62 ± 14 years in both groups), Global Registry of Acute Coronary Event score (141 ± 31 vs 142 ± 34), and time from onset to angiography (472 ± 499 vs 451 ± 479 minutes) did not differ according to IRA patency (TIMI 2/3 vs TIMI 0/1). Using multivariate logistic regression analysis, IRA patency was more frequently found in patients having called earlier (time from onset to electrocardiogram [ECG] <120 minutes; odds ratio [OR] 1.49; 95% confidence interval [CI] 1.17 to 1.89), or receiving rapid-onset of action (prasugrel or glycoprotein IIb-IIIa) antiplatelet therapy in the prehospital setting (OR 1.59, 95% CI 1.14 to 2.21). Increasing time from diagnostic ECG to angiography was also associated with IRA patency (>90 minutes; OR 1.37, 95% CI 1.08 to 1.75). In conclusion, preprocedural IRA patency is observed in one third of patients with STEMI, it is more frequently found in patients having received fast-acting antiplatelet therapy before angiography, and in patients having called early. Higher IRA patency with increasing time delays from qualifying ECG to angiography suggests an additional role of spontaneous or medication-mediated fibrinolysis.
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http://dx.doi.org/10.1016/j.amjcard.2015.09.043DOI Listing
January 2016

Cyclosporine before PCI in Patients with Acute Myocardial Infarction.

N Engl J Med 2015 Sep 30;373(11):1021-31. Epub 2015 Aug 30.

From Centre Hospitalier Universitaire (CHU) Arnaud de Villeneuve (T.-T.C.) and Clinique du Millénaire (C.P.), Montpellier, Hôpitaux Universitaires de Strasbourg, Nouvel Hôpital Civil, Strasbourg (O.M.), CHU de Nimes, Nimes (G.C.), Hôpital Cardiovasculaire Louis Pradel (G. Rioufol, E.B.-C., C.B., I.B., C.J., G.D., N.M., M.O.), Claude Bernard University (G. Rioufol, E.B.-C., C.B., I.B., C.J., G.D., N.M., M.O.), Centre Hospitalier Saint-Joseph et Saint-Luc (J.-F.A.), Clinique de la Sauvegarde (V.M.), Clinique du Tonkin (P.S.), Clinical Investigation Center and Explorations Fonctionnelles Cardiovasculaires (C.B., I.B., C.J., G.D., N.M., M.O.), Lyon, CHU de Tours (D.A.) and Clinique Saint-Gatien (D.B.), Tours, Hôpital Guillaume et René Laennec, Nantes (P.G.), CHU de Rangueil, Toulouse (M.E.), Centre Hospitalier de Pau, Pau (N.D.), Hôpital Haut Lévèque, Bordeaux (P. Coste), Hôpital A. Michallon-CHU de Grenoble, Grenoble (G.V.), Hôpital Henri Duffau, Avignon (M.M.), Centre Hospitalier du Pays d'Aix, Aix-en-Provence (B.J.), Hôpital Gabriel Montpied, Clermont Ferrand (P.M.), Hôpital Charles Nicolle, Rouen (C.T.), Clinique de la Fourcade, Bayonne (J.-N.L.), Assistance Publique-Hôpitaux de Paris, Hôpital Bichat, Paris (P.G.S.), Hôpital du Bocage, Dijon (Y.C.), Centre Hospitalier General, Chartres (G. Range), Centre Hospitalier de Compiègne, Compiègne (J.C.), CHU d'Angers, Angers (F.P.), CHU de Nancy-Brabois, Vandœuvre-lès-Nancy (F.M.), CHU de Mulhouse (O.R.) and Clinique du Diaconat (O.I.), Mulhouse, Centre Hospitalier d'Annecy, Annecy (L.B.), Polyclinique des Fleurs, Ollioules (P.B.), Hôpital de La Cavale Blanche, Brest (M.G.), Clinique Esquirol, Agen (P. Colin, F.D.P.), Institut Jacques Cartier, Massy (M.-C.M.), Centre Hospitalier Henri Mondor, Créteil (J.-L.D.-R.), Hôpital Claude Galien, Quincy sous Sénat (T.U.), Hôpital Pontchaillou, Rennes (H.L.B.), Clinique de l'Ormeau, Tarbes (T.B.), Hôpital de la Côte de Nacre, Caen (G.G.), and Hôpital Cardi

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.).
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http://dx.doi.org/10.1056/NEJMoa1505489DOI Listing
September 2015

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

Am Heart J 2015 Jun 13;169(6):758-766.e6. Epub 2015 Mar 13.

Hôpital de La Cavale Blanche, Brest, France.

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.
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http://dx.doi.org/10.1016/j.ahj.2015.02.020DOI Listing
June 2015

Antiplatelet therapy following transcatheter aortic valve implantation.

Heart 2015 Jul 6;101(14):1118-25. Epub 2015 May 6.

Department of Cardiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands.

Objective: There is limited evidence to support decision making on antiplatelet therapy following transcatheter aortic valve implantation (TAVI). Our aim was to assess the efficacy and safety of aspirin-only (ASA) versus dual antiplatelet therapy (DAPT) following TAVI.

Methods: We performed a systematic review and pooled analysis of individual patient data from 672 participants comparing single versus DAPT following TAVI. Primary endpoint was defined as the composite of net adverse clinical and cerebral events (NACE) at 1 month, including all-cause mortality, acute coronary syndrome (ACS), stroke, life-threatening and major bleeding.

Results: At 30 days a NACE rate of 13% was observed in the ASA-only and in 15% of the DAPT group (OR 0.83, 95% CI 0.48 to 1.43, p=0.50). A tendency towards less life-threatening and major bleeding was observed in patients treated with ASA (OR 0.56, 95% CI 0.28 to 1.11, p=0.09). Also, ASA was not associated with an increased all-cause mortality (OR 0.91, 95% CI 0.36 to 2.27, p=0.83), ACS (OR 0.5, 95% CI 0.05 to 5.51, p=0.57) or stroke (OR 1.21; 95% CI 0.36 to 4.03, p=0.75).

Conclusions: No difference in 30-day NACE rate was observed between ASA-only or DAPT following TAVI. Moreover, a trend towards less life-threatening and major bleeding was observed in favour of ASA. Consequently the additive value of clopidogrel warrants further investigation.
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http://dx.doi.org/10.1136/heartjnl-2014-307053DOI Listing
July 2015

Impact of gender on use of revascularization in acute coronary syndromes: the national observational study of diagnostic and interventional cardiac catheterization (ONACI).

Catheter Cardiovasc Interv 2015 Aug 24;86(2):E58-65. Epub 2015 Mar 24.

Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique Des Hôpitaux De Paris, France; Université Paris Descartes, Paris, France.

Objectives: To assess the impact of gender on myocardial revascularization using data collected in a French nationwide registry: the national observational study of diagnostic and interventional cardiac catheterization (ONACI).

Background: Gender differences in management of patients with acute coronary syndromes (ACS) have been reported.

Methods: We analysed data from a nationwide French prospective multicentre registry including 64,932 suspected ACS patients recruited in 99 centres from 2004 to 2008.

Results: Overall, women were older (70.7 ± 12.7 vs. 63.8 ± 12.9 years), had a higher cardiovascular risk profile, and were more frequently admitted with non ST-elevation myocardial infarction or unstable angina (NSTEMI/UA) compared to men (73% vs. 68%). Women had significantly more angiographically normal coronary arteries or non-significant coronary artery disease (CAD) in both STEMI (6% vs. 3%) and NSTEMI/UA (21% vs. 11%) while men had more severe CAD. After adjusting for age, cardiovascular risk factors, and extent of disease, myocardial revascularization (defined as the use of percutaneous coronary intervention (PCI) or coronary artery bypass grafting) was less frequently used in women (adjusted OR = 0.78; 95% CI: 0.77-0.83). For those receiving PCI, in-hospital mortality within 24 hr of intervention was higher in women (3.6% vs. 1.2%; adjusted OR = 1.51; 95% CI: 1.22-1.87).

Conclusions: In the present study, despite having a higher cardiovascular risk profile, women more frequently had normal vessel/non-significant angiographic coronary artery disease. In patients with significant coronary artery disease, myocardial revascularization was less frequently used in women whatever the type of ACS.
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http://dx.doi.org/10.1002/ccd.25921DOI Listing
August 2015

Determinants of improved one-year survival in non-ST-segment elevation myocardial infarction patients: insights from the French FAST-MI program over 15 years.

Int J Cardiol 2014 Nov 28;177(1):281-6. Epub 2014 Sep 28.

Assistance Publique-Hôpitaux de Paris (AP-HP), Hôpital Européen Georges Pompidou, Department of Cardiology, 75015 Paris, France; Université Paris-Descartes, 75006 Paris, France.

Background: Improved early outcome in non-ST elevation myocardial infarction (NSTEMI) patients has been mainly attributed to a broader use of invasive strategies. Little is known about the impact of other changes in early management.

Methods: We aimed to assess 15-year trends in one-year mortality and their determinants in NSTEMI patients. We used data from 4 one-month French registries, conducted 5 years apart from 1995 to 2010 including 3903 NSTEMI patients admitted to intensive care units.

Results: From 1995 to 2010, no major change was observed in patient characteristics, while therapeutic management evolved considerably. Early use of antiplatelet agents, β-blockers, ACE-inhibitors and statins increased over time (P < 0.001); use of newer anticoagulants (low-molecular-weight heparin, bivalirudin or fondaparinux) increased from 40.8% in 2000 to 78.9% in 2010 (P < 0.001); percutaneous coronary intervention (PCI)≤ 3 days of admission rose from 7.6% to 48.1% (P < 0.001). One-year death decreased from 20% to 9.8% (HR adjusted for baseline parameters, 2010 vs. 1995 = 0.47, 95% CI: 0.35-0.62). Early PCI (HR = 0.67; 95% CI: 0.49-0.90), use of newer anticoagulants (HR = 0.62; 95% CI: 0.48-0.78) and early use of evidence based medical therapy (HR = 0.54; 95% CI: 0.40-0.72) were predictors of improved one year-survival.

Conclusions: One-year mortality of NSTEMI patients decreased by 50% in the past 15years. Our data support current guidelines recommending early invasive strategies and use of newer anticoagulants for NSTEMI, and also show a strong positive association between early use of appropriate medical therapies and one-year survival, suggesting that these medications should be used from the start.
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http://dx.doi.org/10.1016/j.ijcard.2014.09.023DOI Listing
November 2014

6- versus 24-month dual antiplatelet therapy after implantation of drug-eluting stents in patients nonresistant to aspirin: the randomized, multicenter ITALIC trial.

J Am Coll Cardiol 2015 Mar 16;65(8):777-786. Epub 2014 Nov 16.

Hôpital de la Croix Rousse, Lyon France.

Background: The currently recommended duration of dual antiplatelet therapy (DAPT) in drug-eluting stent (DES) recipients is 12 months to reduce the risk of late stent thrombosis, particularly in those with acute coronary syndrome (ACS).

Objectives: This study hypothesized that antiplatelet treatment with DAPT for 6 months may be noninferior to 24-month DAPT in aspirin-sensitive patients.

Methods: A multicenter, randomized study assigned patients undergoing implantation of everolimus-eluting stents with confirmed nonresistance to aspirin to receive 6- or 24-month DAPT. The primary endpoint was a composite of death, myocardial infarction, urgent target vessel revascularization, stroke, and major bleeding at 12 months post-stenting.

Results: A total of 2,031 patients were enrolled in 70 European and Middle Eastern centers. The trial was prematurely terminated due to recruitment problems, leaving 941 patients randomized to 24-month DAPT and 953 to 6-month DAPT. The 2 treatment groups had similar baseline and procedural characteristics. There was no significant difference in the primary endpoint (24-month: 1.5% vs. 6-month: 1.6%; p = 0.85). Noninferiority was demonstrated for 6- versus 24-month DAPT, with an absolute risk difference of 0.11% (95% confidence interval: -1.04% to 1.26%; p for noninferiority = 0.0002). There were no significant differences in stent thrombosis or bleeding complications. In the 792 (44%) high-risk patients with ACS, primary and secondary endpoints did not significantly differ (hazard ratio: 1.7 [95% confidence interval: 0.519 to 6.057; p = 0.361]).

Conclusions: Rates of bleeding and thrombotic events were not significantly different according to 6- versus 24-month DAPT after PCI with new-generation DES in good aspirin responders. (Is There A LIfe for DES After Discontinuation of Clopidogrel [ITALICplus]; NCT01476020).
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http://dx.doi.org/10.1016/j.jacc.2014.11.008DOI Listing
March 2015

Long-term outcome in early survivors of cardiogenic shock at the acute stage of myocardial infarction: a landmark analysis from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) Registry.

Crit Care 2014 Sep 19;18(5):516. Epub 2014 Sep 19.

Introduction: There are little data about patients with cardiogenic shock (CS) who survive the early phase of acute myocardial infarction (AMI). The aim of this study was to assess long-term (5-year) mortality among early survivors of AMI, according to the presence of CS at the acute stage.

Methods: We analyzed 5-year follow-up data from the French registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction (FAST-MI) 2005 registry, a nationwide French survey including consecutive patients admitted for ST or non-ST-elevation AMI at the end of 2005 in 223 institutions.

Results: Of 3670 patients enrolled, shock occurred in 224 (6.1%), and 3411 survived beyond 30 days or hospital discharge, including 99 (2.9%) with shock. Early survivors with CS had a more severe clinical profile, more frequent concomitant in-hospital complications, and were less often managed invasively than those without CS.

Conclusions: In patients surviving the early phase of AMI, CS at the initial stage carries an increased risk of death up to one year after the acute event. Beyond one year, however, mortality is similar to that of patients without shock.

Trial Registration: ClinicalTrials.gov number, NCT00673036, Registered May 5, 2008.
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http://dx.doi.org/10.1186/s13054-014-0516-yDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4192440PMC
September 2014

Late dislodgment of a prosthesis after mitral valve-in-valve implantation.

J Thorac Cardiovasc Surg 2014 May 14;147(5):e59-61. Epub 2014 Feb 14.

Service de chirurgie cardiologie, Hôpital Européen Georges Pompidou, Paris, France.

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http://dx.doi.org/10.1016/j.jtcvs.2013.11.067DOI Listing
May 2014

Acute mitral regurgitation in Takotsubo cardiomyopathy.

Eur Heart J Acute Cardiovasc Care 2015 Apr 3;4(2):197-9. Epub 2014 Feb 3.

Department of Cardiology, Georges Pompidou European Hospital, France.

Takotsubo cardiomyopathy (TTC) is a well-recognised entity that commonly manifests with chest pain, ST segment abnormalities and transient left ventricular apical ballooning without coronary artery obstructive disease. This syndrome usually portends a favourable outcome. In the rare haemodynamically unstable TTC patients, acute mitral regurgitation (MR) related to systolic anterior motion (SAM) of the mitral valve and left ventricular outflow tract obstruction (LVOTO) is to be considered. Bedside echocardiography is key in recognition of this latter condition as vasodilators, inotropic agents or intra-aortic balloon counter-pulsation worsen the patient's clinical status. We discuss here a case of TTC where nitrate-induced subaortic obstruction and mitral regurgitation led to haemodynamic instability.
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http://dx.doi.org/10.1177/2048872614521764DOI Listing
April 2015

Presentation and revascularization patterns of patients admitted for acute coronary syndromes in France between 2004 and 2008 (from the National Observational Study of Diagnostic and Interventional Cardiac Catheterization [ONACI]).

Am J Cardiol 2014 Jan 3;113(2):243-8. Epub 2013 Oct 3.

Department of Cardiology, Hôpital Européen Georges Pompidou, Assistance Publique des Hôpitaux de Paris, France; Université Paris Descartes, Paris, France; INSERM U970, Paris Cardiovascular Research Center PARCC, Paris, France.

Patients with acute coronary syndrome (ACS) comprise a heterogeneous group. Despite clear guidelines, the management of ACS in clinical practice is variable. We aimed to evaluate clinical characteristics and myocardial revascularization patterns of patients presenting with ACS from a large French nationwide registry. The National Observational Study of Diagnostic and Interventional Cardiac Catheterization is a multicenter registry including all interventional cardiology procedures performed since 2004. Patient demographics and co-morbidities, invasive parameters, treatment options, and procedural techniques were prospectively collected. The present study is focused on data collected between 2004 and 2008. Patients were recruited in 99 hospitals (55% in private clinics, 45% in public institutions). Over a 5-year period, 64,932 patients with ACS were included (mean age 65.7 ± 13.3; 73% men, 31% ST-elevation myocardial infarction [STEMI]). Patients presenting with unstable angina pectoris and non-ST-elevation myocardial infarction weresimilar with regards to clinical presentation and coronary artery disease (CAD) extension. Overall, these patients were older, had a higher cardiovascular risk profile, and had more severe CAD compared with STEMI patients. In-hospital mortality during the first 24 hours was higher in STEMI patients. Patient's characteristics and CAD were highly dependent on the type of ACS. Patients with unstable angina/non-STEMI were older and had a more severe CAD. In-hospital complications were higher in STEMI patients.
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http://dx.doi.org/10.1016/j.amjcard.2013.09.014DOI Listing
January 2014

Comparison of two antiplatelet therapy strategies in patients undergoing transcatheter aortic valve implantation.

Am J Cardiol 2014 Jan 5;113(2):355-60. Epub 2013 Oct 5.

University Hospital of Rouen, Hospital Charles Nicolle, Departments of Cardiology and Thoracic and Cardiovascular Surgery, INSERM UMR 1096, Rouen, France.

Dual antiplatelet therapy is commonly used in patients undergoing transcatheter aortic valve implantation (TAVI), but the optimal antiplatelet regimen is uncertain and remains to be determined. The objective of this study was to compare 2 strategies of antiplatelet therapy in patients undergoing TAVI. A strategy using monoantiplatelet therapy (group A, n = 164) was prospectively compared with a strategy using dual antiplatelet therapy (group B, n = 128) in 292 consecutive patients undergoing TAVI. The primary end point was a combination of mortality, major stroke, life-threatening bleeding (LTB), myocardial infarction, and major vascular complications at 30 days. All adverse events were adjudicated according to the Valve Academic Research Consortium. The primary end point occurred in 22 patients (13.4%) in the group A and in 30 patients (23.4%) in the group B (hazard ratio 0.51, 95% confidence interval 0.28 to 0.94, p = 0.026). LTB (3.7% vs 12.5%, p = 0.005) and major bleedings (2.4% vs 13.3%, p <0.0001) occurred less frequently in the group A, whereas the incidence of stroke (1.2% vs 4.7%, p = 0.14) and myocardial infarction (1.2% vs 0.8%, p = 1.0) was not significantly different between the 2 groups. The benefit of a strategy using mono versus dual antiplatelet therapy persisted after multivariate adjustment and propensity score analysis (hazard ratio 0.53, 95% confidence interval 0.28 to 0.95, p = 0.033). In conclusion, a strategy using mono versus dual antiplatelet therapy in patients undergoing TAVI reduces LTB and major bleedings without increasing the risk of stroke and myocardial infarction. The results of our study question the justification of dual antiplatelet therapy and require confirmation in a randomized trial.
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http://dx.doi.org/10.1016/j.amjcard.2013.09.033DOI Listing
January 2014