Publications by authors named "Jean Fajadet"

180 Publications

Intravascular Lithotripsy for Treatment of Calcified Coronary Lesions: Patient-Level Pooled Analysis of the Disrupt CAD Studies.

JACC Cardiovasc Interv 2021 Apr 20. Epub 2021 Apr 20.

The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY.

Aims: The clinical outcomes of intravascular lithotripsy (IVL) to optimize target lesion preparation in severely calcified de novo coronary stenoses have been examined in four prospective studies (Disrupt CAD I, II, III, and IV). The aim of this pooled analysis was to assess the cumulative safety and effectiveness of coronary IVL.

Methods: Patient data were pooled from the Disrupt CAD studies which shared uniform study criteria, endpoint definitions and adjudication, and procedural follow-up. The primary safety endpoint was freedom from MACE (composite of cardiac death, all MI, or TVR) at 30 days. The primary effectiveness endpoint was procedural success, defined as stent delivery with a residual stenosis ≤30% by QCA without in-hospital MACE. Secondary outcomes included serious angiographic complications, target lesion failure (TLF), cardiac death (CD) and stent thrombosis (ST) at 30 days.

Results: Between December 2015 and April 2020, 628 patients were enrolled at 72 sites from 12 countries. Presence of severe calcification was confirmed in 97.0% of target lesions with an average calcified segment length of 41.5 ± 20.0 mm. The primary safety and effectiveness endpoints were achieved in 92.7% and 92.4% of patients, respectively. At 30 days, the rates of TLF, CD, and ST were 7.2%, 0.5%, and 0.8%. Post-IVL and final serious angiographic complications were 2.1% and 0.3% with no IVL-associated perforations, abrupt closure or episodes of no-reflow.

Conclusions: In the largest cohort of patients treated with coronary IVL assessed to date, coronary IVL safely facilitated successful stent implantation in severely calcified coronary lesions with a high rate of procedural success.
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http://dx.doi.org/10.1016/j.jcin.2021.04.015DOI Listing
April 2021

First-in-Man trial of a drug-free bioresorbable stent designed to minimize the duration of coronary artery scaffolding.

J Biomater Sci Polym Ed 2021 Apr 21:1-16. Epub 2021 Apr 21.

Hôpital Européen Georges Pompidou, Centre Hospitalier Universitaire Paris-Descartes, APHP, Paris, France.

For the last two decades, various degradable stents have been proposed to treat coronary artery diseases and replace metallic stents to avoid residual foreign material after healing. To date, the right balance between suitable scaffolding and loss of radial strength soon after endothelium restoration is still an unmet need. The present article reports on the First-in-Man trial of a drug-free bioresorbable stent based on a lactic acid stereocopolymer composed of 98% l-lactyl units selected to release stress shielding earlier than in the case of homopoly(l-lactic acid). Thirty patients with single coronary lesions were included in the trial. The fate of scaffolds was monitored by clinical and imaging follow-ups to assess rate of adverse events, acute recoil, late luminal loss, and late lumen recovery. There was no death, no myocardial infarction, and no stent thrombosis observed over the 36 months trial. Dismantling occurred about 3 months after implantation. Bioresorption was almost completed at 2 years. The late lumen loss observed at the end of the first year was partly compensated one year later by enlarging remodeling. At one year, a neointimal hyperplasia slightly greater than for drug-eluting metallic and bioresorbable stents was shown using optical coherence tomography. The excess of hyperplasia was discussed relative to struts thickness, absence of anti-proliferative drug, and release of degradation by-products.
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http://dx.doi.org/10.1080/09205063.2021.1910919DOI Listing
April 2021

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

Symptomatic giant coronary artery aneurysm treated with covered stents.

Coron Artery Dis 2020 11;31(7):658-659

Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse.

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http://dx.doi.org/10.1097/MCA.0000000000000854DOI Listing
November 2020

First Report of Peripheral Balloon-Expandable Stent Underexpansion Treated by Intravascular Lithotripsy.

JACC Cardiovasc Interv 2020 02 11;13(4):530-531. Epub 2019 Dec 11.

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

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http://dx.doi.org/10.1016/j.jcin.2019.09.055DOI Listing
February 2020

Safety and Effectiveness of Coronary Intravascular Lithotripsy for Treatment of Severely Calcified Coronary Stenoses: The Disrupt CAD II Study.

Circ Cardiovasc Interv 2019 10 25;12(10):e008434. Epub 2019 Sep 25.

Structural Interventional Cardiology, Careggi University Hospital, Florence, Italy (C.D.M.).

Background: The feasibility of intravascular lithotripsy (IVL) for modification of severe coronary artery calcification (CAC) was demonstrated in the Disrupt CAD I study (Disrupt Coronary Artery Disease). We next sought to confirm the safety and effectiveness of IVL for these lesions.

Methods: The Disrupt CAD II study was a prospective multicenter, single-arm post-approval study conducted at 15 hospitals in 9 countries. Patients with severe CAC with a clinical indication for revascularization underwent vessel preparation for stent implantation with IVL. The primary end point was in-hospital major adverse cardiac events (cardiac death, myocardial infarction, or target vessel revascularization). An optical coherence tomography substudy was performed to evaluate the mechanism of action of IVL, quantifying CAC characteristics and calcium plaque fracture. Independent core laboratories adjudicated angiography and optical coherence tomography, and an independent clinical events committee adjudicated major adverse cardiac events.

Results: Between May 2018 and March 2019, 120 patients were enrolled. Severe CAC was present in 94.2% of lesions. Successful delivery and use of the IVL catheter was achieved in all patients. The post-IVL angiographic acute luminal gain was 0.83±0.47 mm, and residual stenosis was 32.7±10.4%, which further decreased to 7.8±7.1% after drug-eluting stent implantation. The primary end point occurred in 5.8% of patients, consisting of 7 non-Q-wave myocardial infarctions. There was no procedural abrupt closure, slow or no reflow, or perforations. In 47 patients with post-percutaneous coronary intervention optical coherence tomography, calcium fracture was identified in 78.7% of lesions with 3.4±2.6 fractures per lesion, measuring 5.5±5.0 mm in length.

Conclusions: In patients with severe CAC who require coronary revascularization, IVL was safely performed with high procedural success and minimal complications and resulted in substantial calcific plaque fracture in most lesions.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03328949.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.119.008434DOI Listing
October 2019

Interventional cardiology 2018: the year in review.

EuroIntervention 2019 Apr 5;14(18):e1861-e1878. Epub 2019 Apr 5.

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

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http://dx.doi.org/10.4244/EIJ-D-19-00040DOI Listing
April 2019

Percutaneous coronary interventions with the Absorb Bioresorbable vascular scaffold in real life: 1-year results from the FRANCE ABSORB registry.

Arch Cardiovasc Dis 2019 Feb 7;112(2):113-123. Epub 2019 Jan 7.

Service de cardiologie et maladies vasculaires, CIC-IT 804, hôpital Pontchaillou, CHU de Rennes, 35033 Rennes, France; Inserm U1099, laboratoire de traitement du signal et de l'image, université de Rennes 1, 35000 Rennes, France.

Background: Several randomized studies have shown that bioresorbable vascular scaffold (BVS) technology is associated with an increased risk of stent thrombosis.

Aim: This study aimed to assess the rates of adverse outcomes at 1 year in patients treated with the Absorb BVS (Abbott Vascular, Santa Clara, CA, USA), using data from a large nationwide prospective multicentre registry (FRANCE ABSORB).

Methods: All patients receiving the Absorb BVS in France were included prospectively in the study. Predilatation, optimal sizing and postdilatation were recommended systematically. The primary endpoint was a composite of cardiovascular death, myocardial infarction and target lesion revascularization at 1 year. Secondary endpoints were scaffold thrombosis and target vessel revascularization at 1 year.

Results: A total of 2072 patients at 86 centres were included: mean age 55±11 years; 80% men. The indication was acute coronary syndrome (ACS) in 49% of cases. Predilatation and postdilatation were done in 93% and 83% of lesions, respectively. At 1 year, the primary endpoint occurred in 3.9% of patients, the rate of scaffold thrombosis was 1.5% and the rate of target vessel revascularization was 3.3%. In a multivariable analysis, diabetes and total Absorb BVS length>30mm were independently associated with the occurrence of the primary endpoint, whereas oral anticoagulation and total Absorb BVS length>30mm were independently associated with occurrence of scaffold thrombosis.

Conclusions: The Absorb BVS was implanted in a relatively young population, half of whom had ACS. Predilatation and postdilatation rates were high, and 1-year outcomes were acceptable.
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http://dx.doi.org/10.1016/j.acvd.2018.09.007DOI Listing
February 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

Evaluating the importance of sham-controlled trials in the investigation of medical devices in interventional cardiology.

EuroIntervention 2018 Aug;14(6):708-715

Deutsches Herzzentrum München, Technische Universität München, Munich, Germany.

Cardiovascular medicine is one of the specialties that has relied most heavily on evidence from randomised clinical trials in determining best practice for the management of common disease conditions. When comparing treatment approaches, trials incorporating random allocation are the most appropriate method for protecting against treatment allocation bias. In order to protect against performance and ascertainment bias, trial designs including placebo control are preferable where feasible. In contrast to testing of medicines, treatments based on procedures or use of medical devices are more challenging to assess, as sham procedures are necessary to facilitate blinding of participants. However, in many cases, ethical concerns exist, as individual patients allocated to sham procedure are exposed only to risk without potential for benefit. Accordingly, the potential benefits to the general patient population must be carefully weighed against the risks of the exposed individuals. For this reason, trial design and study conduct are critically important to ensure that the investigation has the best chance of answering the study question at hand. In the current manuscript, we aim to review issues relating to the conduct of sham-controlled trials and discuss a number of recent examples in the field of interventional cardiology.
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http://dx.doi.org/10.4244/EIJ-D-18-00481DOI Listing
August 2018

Management of left main disease: an update.

Eur Heart J 2019 05;40(18):1454-1466

Columbia University Medical Center, New York-Presbyterian Hospital, Cardiovascular Research Foundation, New York, NY, USA.

A severe narrowing of the left main coronary artery (LMCA), usually due to atherosclerosis, jeopardizes a large area of myocardium and increases the risk of major adverse cardiac events. Management strategies for LMCA disease include coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI). In general, PCI offers more rapid recovery and a lower early adverse event rate, whereas CABG offers a more durable procedure. The largest of six LMCA trials comparing PCI with CABG recently reported that in patients with site-reported low or intermediate anatomical complexity PCI was non-inferior to CABG with respect to the composite of death, stroke, or myocardial infarction at 3 years. This result was obtained on a background of contemporary PCI standards, including safer and more effective stents, intravascular imaging and physiology assessment. This review updates on the current management of LMCA disease, with an emphasis on clinical data and procedural knowledge supporting the use of PCI in a growing proportion of patients.
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http://dx.doi.org/10.1093/eurheartj/ehy238DOI Listing
May 2019

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

Optical Coherence Tomography Characterization of Coronary Lithoplasty for Treatment of Calcified Lesions: First Description.

JACC Cardiovasc Imaging 2017 08;10(8):897-906

Clinique Pasteur, Toulouse, France.

Objectives: This study sought to determine the mechanistic effects of a novel balloon-based lithoplasty system on heavily calcified coronary lesions and subsequent stent placement using optical coherence tomography (OCT).

Background: The Shockwave Coronary Rx Lithoplasty System (Shockwave Medical, Fremont, California) delivers localized, lithotripsy-enhanced disruption of calcium within the target lesion (i.e., lithoplasty) for vessel preparation before stent implantation.

Methods: We analyzed OCT findings in 31 patients in whom lithoplasty was used to treat severely calcified stenotic coronary lesions.

Results: After lithoplasty, intraplaque calcium fracture was identified in 43% of lesions, with circumferential multiple fractures noted in >25%. The frequency of calcium fractures per lesion increased in the most severely calcified plaques (highest tertile vs. lowest tertile; p = 0.009), with a trend toward greater incidence of calcium fracture (77.8% vs. 22.2%; p = 0.057). Post-lithoplasty, mean acute area gain was 2.1 mm, which further increased with stent implantation, achieving a minimal stent area of 5.94 ± 1.98 mm and mean stent expansion of 112.0 ± 37.2%. Deep dissections, as part of the angioplasty effect, occurred in 13% of cases and were successfully treated with stent implantation without incidence of acute closure, slow flow/no reflow, or perforation.

Conclusions: High-resolution imaging by OCT delineated calcium modification with fracture as a major mechanism of action of lithoplasty in vivo and demonstrated efficacy in the achievement of significant acute area gain and favorable stent expansion.
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http://dx.doi.org/10.1016/j.jcmg.2017.05.012DOI Listing
August 2017

Value-based healthcare, innovation and the future of interventional medicine: defining our place at the centre of the debate.

EuroIntervention 2017 08 4;13(5):e508-e512. Epub 2017 Aug 4.

SAVI(partners), Montgaillard de Salies, France.

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http://dx.doi.org/10.4244/EIJV13I5A80DOI Listing
August 2017

Diagnostic Accuracy of Coronary CT Angiography for the Evaluation of Bioresorbable Vascular Scaffolds.

JACC Cardiovasc Imaging 2018 05 19;11(5):722-732. Epub 2017 Jul 19.

Erasmus Medical Center, Rotterdam, the Netherlands.

Objectives: The purpose of this study was to assess the diagnostic accuracy of coronary computed tomography angiography (CTA) for bioresorbable vascular scaffold (BVS) evaluation.

Background: Coronary CTA has emerged as a noninvasive method to evaluate patients with suspected or established coronary artery disease. The diagnostic accuracy of coronary CTA to evaluate angiographic outcomes after BVS implantation has not been well established.

Methods: In the ABSORB II (A Bioresorbable Everolimus-Eluting Scaffold Versus a Metallic Everolimus-Eluting Stent II) study, patients were randomized either to receive treatment with the BVS or everolimus-eluting metallic stent. At the 3-year follow-up, 238 patients (258 lesions) treated with BVS underwent coronary angiography with intravascular ultrasound (IVUS) evaluation and coronary CTA. The diagnostic accuracy of coronary CTA was assessed by the area under the receiver-operating characteristic curve with coronary angiography and IVUS as references.

Results: The mean difference in coronary CTA-derived minimal luminal diameter was -0.14 mm (limits of agreement -0.88 to 0.60) with quantitative coronary angiography as reference, whereas the mean difference in minimal lumen area was 0.73 mm (limits of agreement -1.85 to 3.30) with IVUS as reference. The per-scaffold diagnostic accuracy of coronary CTA for detecting stenosis based on coronary angiography diameter stenosis of ≥50% revealed an area under the receiver-operating characteristic curve of 0.88 (95% confidence interval [CI]: 0.82 to 0.92) with a sensitivity of 80% (95% CI: 28% to 99%) and a specificity of 100% (95% CI: 98% to 100%), whereas diagnostic accuracy based on IVUS minimal lumen area ≤2.5 mm showed an area under the receiver-operating characteristic curve of 0.83 (95% CI: 0.77 to 0.88) with a sensitivity of 71% (95% CI: 44% to 90%) and a specificity of 82% (95% CI: 75% to 87%). The diagnostic accuracy of coronary CTA was similar to coronary angiography in its ability to identify patients with a significant lesion based on the IVUS criteria (p = 0.75).

Conclusions: Coronary CTA has good diagnostic accuracy to detect in-scaffold luminal obstruction and to assess luminal dimensions after BVS implantation. Coronary angiography and coronary CTA yielded similar diagnostic accuracy to identify the presence and severity of obstructive disease. Coronary CTA might become the method of choice for the evaluation of patients treated with BVS.
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http://dx.doi.org/10.1016/j.jcmg.2017.04.013DOI Listing
May 2018

Arterial Remodeling After Bioresorbable Scaffolds and Metallic Stents.

J Am Coll Cardiol 2017 Jul;70(1):60-74

ThoraxCenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Background: Although previous observational studies have documented late luminal enlargement and expansive remodeling following implantation of a bioresorbable vascular scaffold (BVS), no comparison with metallic stents has been conducted in a randomized fashion.

Objectives: This study sought to compare vessel remodeling patterns after either Absorb BVS or Xience metallic drug-eluting stent (DES) implantation (Abbott Vascular, Santa Clara, California) and determine the independent predictors of remodeling.

Methods: In the ABSORB II randomized trial, 383 lesions (n = 359) were investigated by intravenous ultrasound both post-procedure and at 3-year follow-up. According to vessel and lumen area changes over 3 years, we categorized 9 patterns of vessel remodeling that were beyond the reproducibility of lumen and vessel area measurements.

Results: The relative change in mean vessel area was significantly greater with the BVS compared to the DES (6.7 ± 12.6% vs. 2.9 ± 11.5%; p = 0.003); the relative change in mean lumen area was significantly different between the 2 arms (1.4 ± 19.1% vs. -1.9 ± 10.5%, respectively; p = 0.031). Multivariate analysis indicated that use of the BVS, female sex, balloon-artery ratio >1.25, expansion index ≥0.8, previous percutaneous coronary intervention, and higher level of low-density lipoprotein cholesterol were independent predictors of expansive remodeling. Furthermore, in the BVS arm, necrotic core pre-procedure was an independent determinant of expansive remodeling.

Conclusions: Expansive vessel wall remodeling was more frequent and intense with the BVS than the metallic DES and could be determined by patient baseline characteristics and periprocedural factors. The clinical effect of the observed lumen and vessel remodeling must be investigated in further large clinical studies to optimize the clinical outcome of patients and lesions treated by bioresorbable scaffolds. (ABSORB II Randomized Controlled Trial; NCT01425281).
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http://dx.doi.org/10.1016/j.jacc.2017.05.028DOI Listing
July 2017

Drug-coated versus bare-metal stents for elderly patients: A predefined sub-study of the LEADERS FREE trial.

Int J Cardiol 2017 Sep 25;243:110-115. Epub 2017 Apr 25.

Hôpital de La Tour, Geneva, Switzerland.

Background: The randomized, LEADERS FREE trial showed superior safety and efficacy of a polymer-free DCS vs. a bare metal stent in high-bleeding risk patients with only one month dual antiplatelet treatment. We report characteristics and outcomes of the pre-specified group of elderly patients (aged ≥75).

Methods: Age >75 was one of the trial's inclusion criteria. The main additional criteria were: need for oral anticoagulants, recent bleeding, anemia, chronic renal failure and cancer. All patients received 1month DAPT only. Both primary endpoints (efficacy: clinically driven TLR and safety: composite of cardiac death, MI and stent thrombosis) as well as bleeding were recorded up to 390days.

Results: 1564 elderly patients (63.4% of the population) were enrolled with a mean of 2 inclusion criteria/patient. The primary safety endpoint was reached less frequently in DCS than BMS patients (10.7 vs. 14.3%, p=0.03), as was the primary efficacy endpoint (5.8 vs. 10.8% p=0.0003). Major bleeding rates were high and similar in both groups (7.3 vs. 8.2%, p=0.55). For the 562 (23.4%) patients with age as sole entry criterion, trends were similar for DCS and BMS patients respectively: safety endpoint (7.3%vs.11.4% p=0.10) and Cd TLR (4.7 vs. 13.2% p=0.0003), but for both groups, major bleeding occurred less frequently than for elderly patients with more comorbid conditions (3.6%vs. 2.8%).

Conclusion: Compared to a BMS, use of a DCS together with a short one-month DAPT course was associated with significant safety and efficacy benefits for the elderly patients enrolled in LEADERS FREE.
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http://dx.doi.org/10.1016/j.ijcard.2017.04.079DOI Listing
September 2017

Baseline characteristics and outcomes after transcatheter aortic-valve implantation in patients with or without previous balloon aortic valvuloplasty: Insights from the FRANCE 2 registry.

Arch Cardiovasc Dis 2017 Oct 3;110(10):534-542. Epub 2017 May 3.

L'UNAM université, service de cardiologie, Angers, France; Laboratoire cardioprotection, remodelage et thrombose, service de cardiologie, CHU d'Angers, institut MITOVASC, 49045 Angers, France.

Background: Some patients who are at high surgical risk because of multiple co-morbidities undergo balloon aortic valvuloplasty (BAV) as a bridge therapy towards transcatheter aortic-valve implantation (TAVI).

Aim: The aim of this study was to compare the clinical course of patients with or without previous BAV who underwent TAVI and were included in the FRANCE 2 registry.

Methods: From January 2010 to December 2011, 3953 patients underwent TAVI. Survival analysis was done by multivariable regression and propensity-score analysis to adjust for confounders.

Results: Patients in the previous BAV group (n=664, 16.8%) were older than patients in the primary TAVI group. The logistic EuroSCORE I and the rates of co-morbidities and symptoms were higher in the previous BAV group. Procedural success was similar in both groups, as was postprocedural aortic regurgitation grade≥2/4. The 1-month mortality rates from all causes were 12.5 and 8.7%, respectively, in the previous BAV and primary TAVI groups (P=0.001). The 1-month to 1-year mortality rates were similar in both groups. Previous BAV was not an independent predictor of 1-month mortality (hazard ratio 1.44, 95% confidence interval 0.90-2.34; P=0.14) or 1-month to 1-year mortality.

Conclusions: Crude 1-month mortality was higher in patients with previous BAV. Nevertheless, precarious preoperative status, but not previous BAV, was associated with mortality, and is the only marker that should be considered as detrimental at the time of preTAVI reassessment.
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http://dx.doi.org/10.1016/j.acvd.2016.12.012DOI Listing
October 2017

Computing Methods for Composite Clinical Endpoints in Unprotected Left Main Coronary Artery Revascularization: A Post Hoc Analysis of the DELTA Registry.

JACC Cardiovasc Interv 2016 11;9(22):2280-2288

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands.

Objectives: The study sought to investigate the impact of different computing methods for composite endpoints other than time-to-event (TTE) statistics in a large, multicenter registry of unprotected left main coronary artery (ULMCA) disease.

Background: TTE statistics for composite outcome measures used in ULMCA studies consider only the first event, and all the contributory outcomes are handled as if of equal importance.

Methods: The TTE, Andersen-Gill, win ratio (WR), competing risk, and weighted composite endpoint (WCE) computing methods were applied to ULMCA patients revascularized by percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) at 14 international centers.

Results: At a median follow-up of 1,295 days (interquartile range: 928 to 1,713 days), all analyses showed no difference in combinations of death, myocardial infarction, and cerebrovascular accident between PCI and CABG. When target vessel revascularization was incorporated in the composite endpoint, the TTE (p = 0.03), Andersen-Gill (p = 0.04), WR (p = 0.025), and competing risk (p < 0.001) computing methods showed CABG to be significantly superior to PCI in the analysis of 1,204 propensity-matched patients, whereas incorporating the clinical relevance of the component endpoints using WCE resulted in marked attenuation of the treatment effect of CABG, with loss of significance for the difference between revascularization strategies (p = 0.10).

Conclusions: In a large study of ULMCA revascularization, incorporating the clinical relevance of the individual outcomes resulted in sensibly different findings as compared with the conventional TTE approach. In particular, using the WCE computing method, PCI and CABG were no longer significantly different with respect to the composite of death, myocardial infarction, cerebrovascular accident, or target vessel revascularization at a median of 3 years.
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http://dx.doi.org/10.1016/j.jcin.2016.08.025DOI Listing
November 2016

Twelve-month results of a prospective, multicentre trial to assess the everolimus-eluting coronary stent system (PROMUS Element): the PLATINUM PLUS all-comers randomised trial.

EuroIntervention 2017 Jan;12(13):1595-1604

Clinique Pasteur, Toulouse, France.

Aims: The aim of the study was to compare the safety and efficacy of the platinum-chromium-based everolimus-eluting stent (EES) with a cobalt-chromium EES.

Methods And Results: We performed a prospective, multicentre, single-blind non-inferiority all-comers study randomising patients with stable or unstable coronary artery disease (2:1) to treatment with the platinum-chromium EES (n=1,952) or the control cobalt-chromium EES (n=1,028) in Europe (PLATINUM PLUS trial). The primary endpoint was target vessel failure (TVF) at 12 months, a composite of target vessel-related cardiac death, myocardial infarction (MI), and ischaemia-driven target vessel revascularisation (TVR). Among 2,980 patients, 33% presented with acute coronary syndromes, and 48% with multivessel disease. At 12 months, the intention-to-treat analysis determined that the platinum-chromium EES was non-inferior to the cobalt-chromium EES for the primary endpoint (86 [4.6%] patients vs. 32 [3.2%], absolute difference 1.4%, 95% confidence interval [CI]: -0.1-2.9; upper limit of the one-sided 95% CI: 2.57%; non-inferiority p=0.012; superiority analysis: hazard ratio [HR] 1.44, 95% CI: 0.96-2.16, p=0.08). In the per protocol analysis, however, the primary endpoint was significantly more common in the platinum-chromium EES (HR 1.64, 95% CI: 1.05-2.55, p=0.03). There were no significant differences in the rates of cardiac death (1.1% vs. 1.0%, p=0.78), MI (1.6% vs. 0.8%, p=0.09), or ischaemia-driven TLR (2.0% vs. 1.6%, p=0.49). The rates of ARC definite or probable stent thrombosis were comparable between platforms (0.8% vs. 0.5%, p=0.44).

Conclusions: At one year, the platinum-chromium EES satisfied the pre-specified criteria for non-inferiority relative to the control cobalt-chromium EES in this all-comers trial.
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http://dx.doi.org/10.4244/20150112-07DOI Listing
January 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

Transcatheter aortic valve implantation: there is still much to know.

EuroIntervention 2016 Sep;12(Y):Y21

Cardio-Thorax-Vascular and Transplant Department, University of Catania, Catania, Italy.

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http://dx.doi.org/10.4244/EIJV12SYA5DOI Listing
September 2016

Magmaris preliminary recommendation upon commercial launch: a consensus from the expert panel on 14 April 2016.

EuroIntervention 2016 Sep;12(7):828-33

Department of Interventional Cardiology, Clinique Pasteur, Toulouse, France.

Bioresorbable scaffolds represent an exciting milestone in the development of coronary stent technology with the potential to substantially improve the management of patients with coronary artery disease. In an attempt to provide first recommendations for the technology, experienced experts involved in the first-in-man studies met in Zurich on the 14 April 2016 in order to reach consensus on a responsible market introduction. This document will be updated regularly as new information from clinical trials becomes available and should be understood as a review of current data, opportunities, expectations, advice, and recommendations for future investigations.
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http://dx.doi.org/10.4244/EIJV12I7A137DOI Listing
September 2016

Long-term clinical outcomes after percutaneous coronary intervention versus coronary artery bypass grafting for acute coronary syndrome from the DELTA registry: a multicentre registry evaluating percutaneous coronary intervention versus coronary artery bypass grafting for left main treatment.

EuroIntervention 2016 Aug 5;12(5):e623-31. Epub 2016 Aug 5.

Contilia Heart and Vascular Center, Elisabeth-Krankenhaus Essen, Essen, Germany.

Aims: Our aim was to compare, in a large unprotected left main coronary artery (ULMCA) all-comer registry, the long-term clinical outcome after percutaneous coronary intervention (PCI) with first-generation drug-eluting stents (DES) versus coronary artery bypass grafting (CABG) in patients with acute coronary syndrome (ACS).

Methods And Results: Of a total of 2,775 patients enrolled in the Drug Eluting Stents for Left Main Coronary Artery Disease (DELTA) multicentre registry, 379 (13.7%) patients with ACS treated with PCI (n=272) or CABG (n=107) were analysed. Baseline demographics were considerably different in the two groups before propensity matching. No significant differences emerged for the composite endpoint of all-cause death, myocardial infarction (MI), and cerebrovascular accident (HR 1.11, 95% CI: 0.63-1.94; p=0.727), all-cause death (HR 1.26, 95% CI: 0.68-2.32; p=0.462), the composite endpoint of all-cause death and MI (HR 1.02, 95% CI: 0.56-1.84; p=0.956), and major adverse cardiac and cerebrovascular events (HR 0.82, 95% CI: 0.50-1.36; p=0.821). However, a higher incidence of target vessel revascularisation (HR 4.67, 95% CI: 1.33-16.47; p=0.008) was observed in the PCI compared with the CABG group, which was confirmed in the propensity score-matched analysis.

Conclusions: In the DELTA all-comer, multinational registry, PCI for ACS in ULMCA is associated with comparable clinical outcomes to those observed with CABG at long-term follow-up, despite the use of first-generation DES.
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http://dx.doi.org/10.4244/EIJV12I5A102DOI Listing
August 2016