Publications by authors named "Thomas Hovasse"

85 Publications

The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN).

Eur Heart J 2021 May 18. Epub 2021 May 18.

Institute Cardiovasculaire Paris Sud, Massy, France.

Background: Patients with non-left-main coronary bifurcation lesions are usually best treated with a stepwise provisional approach. However, patients with true left main stem bifurcation lesions have been shown in one dedicated randomized study to benefit from systematic dual stent implantation.

Methods And Results: Four hundred and sixty-seven patients with true left main stem bifurcation lesions requiring intervention were recruited to the EBC MAIN study in 11 European countries. Patients were aged 71 ± 10 years; 77% were male. Patients were randomly allocated to a stepwise layered provisional strategy (n = 230) or a systematic dual stent approach (n = 237). The primary endpoint (a composite of death, myocardial infarction, and target lesion revascularization at 12 months) occurred in 14.7% of the stepwise provisional group vs. 17.7% of the systematic dual stent group (hazard ratio 0.8, 95% confidence interval 0.5-1.3; P = 0.34). Secondary endpoints were death (3.0% vs. 4.2%, P = 0.48), myocardial infarction (10.0% vs. 10.1%, P = 0.91), target lesion revascularization (6.1% vs. 9.3%, P = 0.16), and stent thrombosis (1.7% vs. 1.3%, P = 0.90), respectively. Procedure time, X-ray dose and consumables favoured the stepwise provisional approach. Symptomatic improvement was excellent and equal in each group.

Conclusions: Among patients with true bifurcation left main stem stenosis requiring intervention, fewer major adverse cardiac events occurred with a stepwise layered provisional approach than with planned dual stenting, although the difference was not statistically significant. The stepwise provisional strategy should remain the default for distal left main stem bifurcation intervention.

Study Registration: http://clinicaltrials.gov NCT02497014.
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http://dx.doi.org/10.1093/eurheartj/ehab283DOI Listing
May 2021

Clinical Outcomes of Proximal Optimization Technique (POT) in Bifurcation Stenting.

EuroIntervention 2021 May 11. Epub 2021 May 11.

Ramsay Générale de Santé, ICPS, Hôpital Jacques Cartier, Massy, France.

Background: Optimal deployment of coronary stents in a bifurcation lesion remains a matter of debate.

Aims: We sought to capture the daily practice of bifurcation stenting by means of a worldwide registry and to investigate how the post-implantation deployment techniques influence the clinical outcomes.

Methods: Data from the e-ULTIMASTER registry were used to perform an analysis of 4395 patients undergoing percutaneous coronary intervention for bifurcation lesions. Inverse probability of treatment weights (IPTW) propensity score methodology was used to adjust for any baseline differences. The primary outcome of interest was target lesion failure (TLF) at 1-year (follow-up rate 96.2%).

Results: Global one-year TLF rate was low: 5.1%. Proximal optimization technique was used in 33.9 % of cases and was associated with a reduction in adjusted TLF rate [4.0 (95% confidence interval:3.0-5.1)% versus 6.0(5.1-6.9)%, p<0.01] due to a reduction of all components of this composite endpoint, except for cardiac death. Stent thrombosis was also positively impacted [0.4(0.04-0.7)% versus 1.3(0.8-1.7)%, p<0.01]. POT benefit was uniform across subgroups. Conversely, the use of kissing balloon technique (36.5%) did not influence the adjusted TLF rate.

Conclusions: Despite a low one-year failure rate in this large bifurcation stenting cohort, proximal optimization technique was associated with a further reduction in the event rate and a uniform benefit across subgroups suggesting systematic use of this deployment technique regardless of the bifurcation anatomy and stenting technique.
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http://dx.doi.org/10.4244/EIJ-D-20-01393DOI Listing
May 2021

Long-term prognostic value of stress perfusion cardiovascular magnetic resonance in patients without known coronary artery disease.

J Cardiovasc Magn Reson 2021 04 8;23(1):43. Epub 2021 Apr 8.

CMR Department, Institut Cardiovasculaire Paris Sud, Cardiovascular Magnetic Resonance Laboratory, Hôpital Privé Jacques CARTIER, Ramsay Santé, 6 Avenue du Noyer Lambert, 91300, Massy, France.

Background: To assess the incremental long-term prognostic value of vasodilator stress perfusion cardiovascular magnetic resonance (CMR) in patients without known coronary artery disease (CAD).

Methods: Between 2010 and 2011, consecutive patients with cardiovascular risk factors without known CAD referred for stress CMR were followed for the occurrence of major adverse cardiac events (MACE), defined by cardiovascular mortality or recurrent non-fatal myocardial infarction (MI). Uni- and multivariable Cox regressions were performed to determine the prognostic value of ischemia and unrecognized MI defined by sub-endocardial or transmural late gadolinium enhancement (LGE).

Results: Among 2,295 patients without known CAD, 2058 (89.7%) (71.2 ± 12.5 years; 37.5% males) completed the follow-up (median [IQR]: 8.3 [7.3-8.7] years), and 203 had MACE (9.9%). Using Kaplan-Meier analysis, ischemia and unrecognized MI were associated with MACE (hazard ratio, HR: 4.64 95% CI: 3.69-6.17 and HR: 2.88; 95% CI: 2.08-3.99, respectively; both p < 0.001). In multivariable stepwise Cox regression, ischemia and unrecognized MI were independent predictors of MACE (HR = 3.71; 95% CI 2.73-5.05, p < 0.001 and HR = 1.73; 95% CI 1.22-2.45, p = 0.002; respectively) and cardiovascular mortality (HR: 3.13; 95% CI: 2.17-4.51, p < 0.001 and HR = 1.73; 95% CI 1.15-2.62, p = 0.009; respectively). The addition of ischemia and unrecognized MI led to an improved model discrimination for MACE (change in C statistic from 0.61 to 0.72; NRI = 0.431; IDI = 0.053).

Conclusions: Inducible ischemia and unrecognized MI identified by stress CMR have incremental long term prognostic value for the incidence of MACE in patients without known CAD over traditional risk factors and left ventricular ejection fraction.
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http://dx.doi.org/10.1186/s12968-021-00737-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8028337PMC
April 2021

Prognostic value of stress cardiovascular magnetic resonance in asymptomatic patients with known coronary artery disease.

J Cardiovasc Magn Reson 2021 03 8;23(1):19. Epub 2021 Mar 8.

Institut Cardiovasculaire Paris Sud, Cardiovascular Magnetic Resonance Laboratory, Hôpital Privé Jacques CARTIER, Ramsay Santé, 6 Avenue du Noyer Lambert, 91300, Massy, France.

Background: Several studies have established the prognostic value of vasodilator stress cardiovascular magnetic resonance (CMR) in broad population of patients with suspected or known coronary artery disease (CAD), but this specific population of asymptomatic patients with known CAD have never been formally evaluated. To assess the long-term prognostic value of vasodilator stress perfusion CMR in asymptomatic patients with obstructive CAD.

Methods: Between 2009 and 2011, consecutive asymptomatic patients with obstructive CAD referred for vasodilator stress CMR were followed for the occurrence of major adverse cardiovascular events (MACE), defined by cardiovascular mortality or recurrent non-fatal myocardial infarction (MI). Uni- and multivariable Cox regressions were performed to determine the prognostic value of myocardial ischemia and myocardial infarction defined by late gadolinium enhancement (LGE) with ischemic pattern.

Results: Among 1529 asymptomatic patients with obstructive CAD, 1342 (87.8%; 67.7 ± 10.5 years, 82.0% males) completed the follow-up (median 8.3 years), and 195 had MACE (14.5%). Patients without stress-induced myocardial ischemia had a low annualized rate of MACE (2.4%), whereas the annualized rate of MACE was higher for patients with mild, moderate, or severe ischemia (7.3%, 16.8%, and 42.2%, respectively; p < 0.001). Using Kaplan-Meier analysis, myocardial ischemia and LGE were associated with MACE (hazard ratio, HR 2.52; 95% CI 1.90-3.34 and HR 2.04; 95% CI 1.38-3.03, respectively; both p < 0.001). In multivariable stepwise Cox regression, myocardial ischemia and LGE were independent predictors of MACE (HR 2.80 95% CI 2.10-3.73, p < 0.001 and HR 1.51; 95% CI 1.01-2.27, p = 0.045; respectively). The addition of myocardial ischemia and LGE led to improved model discrimination for MACE (change in C statistic from 0.61 to 0.68; NRI = 0.207; IDI = 0.021).

Conclusions: Vasodilator stress CMR-induced myocardial ischemia and LGE are good long-term predictors for the incidence of MACE in asymptomatic patients with obstructive CAD.
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http://dx.doi.org/10.1186/s12968-021-00721-8DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7938489PMC
March 2021

Prognostic value of vasodilator stress perfusion CMR in patients with previous coronary artery bypass graft.

Eur Heart J Cardiovasc Imaging 2020 Dec 13. Epub 2020 Dec 13.

The Institut Cardiovasculaire Paris Sud, Department of Cardiovascular Magnetic Resonance, Hôpital Privé Jacques CARTIER, Ramsay Santé, 6 Avenue du Noyer Lambert, 91300 Massy, France.

Aims : The accuracy and prognostic value of stress perfusion cardiac magnetic resonance (CMR) are established in coronary artery disease (CAD) patients. Because myocardial contrast kinetics may be altered after coronary artery bypass graft (CABG), most studies excluded CABG patients. This study aimed to assess the prognostic value of vasodilator stress perfusion CMR in CABG patients.

Methods And Results : Consecutive CABG patients referred for stress CMR were retrospectively included and followed for the occurrence of major adverse cardiovascular events (MACE) including cardiovascular (CV) death or non-fatal myocardial infarction (MI). Cox regression analyses were performed to determine the prognostic association of inducible ischaemia and late gadolinium enhancement (LGE) by CMR. Of 866 consecutive CABG patients, 852 underwent the stress CMR protocol and 771 (89%) completed the follow-up [median (interquartile range) 4.2 (3.3-6.2) years]. There were 85 MACE (63 CV deaths and 22 non-fatal MI). Using Kaplan-Meier analysis, the presence of inducible ischaemia identified the occurrence of MACE [hazard ratio (HR) 3.52, 95% confidence interval (CI): 2.27-5.48; P < 0.001] and CV death (HR 2.55, 95% CI: 1.52-4.25; P < 0.001). In a multivariable stepwise Cox regression including clinical characteristics and CMR indexes, the presence of inducible ischaemia was an independent predictor of a higher incidence of MACE (HR 3.22, 95% CI: 2.06-5.02; P < 0.001) and CV death (HR 2.15, 95% CI: 1.28-3.62; P = 0.003), and the same was observed for LGE (both P = 0.02).

Conclusion : Stress CMR has a good discriminative prognostic value in patients after CABG, with a higher incidence of MACE and CV death in patients with inducible ischaemia and/or LGE.
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http://dx.doi.org/10.1093/ehjci/jeaa316DOI Listing
December 2020

Predictive value of early cardiac magnetic resonance imaging functional and geometric indexes for adverse left ventricular remodelling in patients with anterior ST-segment elevation myocardial infarction: A report from the CIRCUS study.

Arch Cardiovasc Dis 2020 Nov 5;113(11):710-720. Epub 2020 Nov 5.

Inserm 1407, Clinical Investigation Centre and Heart Failure Department, Cardiovascular Hospital Louis-Pradel, hospices civils de Lyon, université Claude-Bernard Lyon 1, 69677 Bron, France. Electronic address:

Background: Postinfarction adverse left ventricular (LV) remodelling is strongly associated with heart failure events. Conicity index, sphericity index and LV global functional index (LVGFI) are new LV remodelling indexes assessed by cardiac magnetic resonance (CMR).

Aim: To assess the predictive value of the new indexes for 1-year adverse LV remodelling in patients with anterior ST-segment elevated myocardial infarction (STEMI).

Methods: CMR studies were performed in 129 patients with anterior STEMI (58±12 years; 78% men) from the randomized CIRCUS trial (CMR substudy) treated with primary percutaneous coronary intervention and followed for the occurrence of major adverse cardiovascular events (MACE) (death or hospitalization for heart failure). Conicity index, sphericity index, LVGFI, infarct size and microvascular obstruction (MVO) were assessed by CMR performed 5±4 days after coronary reperfusion. Adverse LV remodelling was defined as an increase in LV end-diastolic volume of ≥15% by transthoracic echocardiography at 1 year.

Results: Adverse LV remodelling occurred in 27% of patients at 1 year. Infarct size and MVO were significantly predictive of adverse LV remodelling: odds ratio [OR] 1.03, 95% confidence interval [CI] 1.01-1.05 (P<0.001) and OR 1.12, 95% CI 1.05-1.22 (P<0.001), respectively. Among the newly tested indexes, only LVGFI was significantly predictive of adverse LV remodelling (OR 1.10, 95% CI 1.03-1.16; P=0.001). In multivariable analysis, infarct size remained an independent predictor of adverse LV remodelling at 1 year (OR 1.05, 95% CI 1.02-1.08; P<0.001). LVGFI and infarct size were associated with occurrence of MACE: OR 1.21, 95% CI 1.08-1.37 (P<0.001) and OR 1.02, 95% CI 1.00-1.04 (P=0.018), respectively. Conicity and sphericity indexes were not associated with MACE.

Conclusions: LVGFI was associated with adverse LV remodelling and MACE 1 year after anterior STEMI.
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http://dx.doi.org/10.1016/j.acvd.2020.05.024DOI Listing
November 2020

Feasibility and Prognostic Value of Vasodilator Stress Perfusion CMR in Patients With Atrial Fibrillation.

JACC Cardiovasc Imaging 2021 02 28;14(2):379-389. Epub 2020 Oct 28.

Institut Cardiovasculaire Paris Sud, Cardiovascular Magnetic Resonance Laboratory, Hôpital Privé Jacques CARTIER, Ramsay Santé, Massy, France. Electronic address:

Objectives: The aim of this study was to assess the feasibility and prognostic value of vasodilator stress perfusion cardiovascular magnetic resonance (CMR) in patients with atrial fibrillation (AF).

Background: Because most studies have excluded arrhythmic patients, the prognostic value of stress perfusion CMR in patients with AF is unknown.

Methods: Between 2008 and 2018, consecutive patients with suspected or stable chronic coronary artery disease and AF referred for vasodilator stress perfusion CMR were included and followed for the occurrence of major adverse cardiovascular event(s) (MACE), defined as cardiovascular death or nonfatal myocardial infarction. The diagnosis of AF was defined by 12-lead electrocardiography before and after CMR. Univariate and multivariate Cox regressions were performed to determine the prognostic value of inducible ischemia or late gadolinium enhancement (LGE) by CMR.

Results: Of 639 patients (mean age 72 ± 9 years, 77% men), 602 (94%) completed the CMR protocol, and 538 (89%) completed follow-up (median 5.1 years); 80 had MACE. Using Kaplan-Meier analysis, the presence of ischemia (hazard ratio [HR]: 7.56; 95% confidence interval [CI]: 4.86 to 11.80) or LGE (HR: 2.41; 95% CI: 1.55 to 3.74) was associated with the occurrence of MACE (p < 0.001 for both). In a multivariate Cox regression including clinical and CMR indexes, the presence of ischemia (HR: 5.98; 95% CI: 3.68 to 9.73) or LGE (HR: 2.61; 95% CI: 1.89 to 3.60) was an independent predictor of MACE (p < 0.001 for both).

Conclusions: In patients with AF, stress perfusion CMR is feasible and has good discriminative prognostic value to predict the occurrence of MACE.
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http://dx.doi.org/10.1016/j.jcmg.2020.07.041DOI Listing
February 2021

Safety and Prognostic Value of Vasodilator Stress Cardiovascular Magnetic Resonance in Patients With Heart Failure and Reduced Ejection Fraction.

Circ Cardiovasc Imaging 2020 09 2;13(9):e010599. Epub 2020 Sep 2.

Cardiovascular Magnetic Resonance Laboratory, Institut Cardiovasculaire Paris Sud (ICPS), Hôpital Privé Jacques CARTIER, Ramsay Santé, Massy, France (T.P., F.S., M.K., V.L., P.G., T.H., T.U., S.C., Y.L., M.C.M., J.G.).

Background: Patients with heart failure with reduced ejection fraction (HFrEF; heart failure with reduced left ventricular ejection fraction <40%) referred for stress cardiovascular magnetic resonance (CMR) may have a less optimal hemodynamic response to intravenous vasodilator. The aim was to assess the prognostic value of vasodilator stress perfusion CMR in patients with HFrEF.

Methods: Between 2008 and 2018, consecutive patients with HFrEF defined by left ventricular ejection fraction <40% prospectively referred for vasodilator stress perfusion CMR were followed for the occurrence of major adverse cardiovascular events (MACE), defined by cardiovascular death or nonfatal myocardial infarction. Univariable and multivariable Cox regressions were performed to determine the prognostic value of inducible ischemia or late gadolinium enhancement by CMR.

Results: Of 1053 patients with HFrEF (65±11 years, median [interquartile range] left ventricular ejection fraction 38.7% [37.2-39.0]), 1018 (97%) completed the CMR protocol and 950 (93%) completed the follow-up (median [interquartile range], 5.6 [3.6-7.3] years); 117 experienced a MACE (12.3%). Stress CMR was well tolerated without any adverse events. Patients without ischemia or late gadolinium enhancement experienced a lower annual event rate of MACE (1.8%) than those with both ischemia and late gadolinium enhancement (12.0%; <0.001). Using Kaplan-Meier analysis, inducible ischemia and late gadolinium enhancement were significantly associated with the occurrence of MACE (hazard ratio, 2.46 [95% CI, 1.69-3.60]; and hazard ratio, 2.92 [95% CI, 1.77-4.83], respectively, both <0.001). In multivariable Cox regression, inducible ischemia was an independent predictor of a higher incidence of MACE (hazard ratio, 2.26 [95% CI, 1.52-3.35]; <0.001).

Conclusions: Stress CMR is safe and has a good discriminative prognostic value to predict the occurrence of MACE in patients with HFrEF.
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http://dx.doi.org/10.1161/CIRCIMAGING.120.010599DOI Listing
September 2020

Two-year outcomes after percutaneous coronary intervention with drug-eluting stents or bare-metal stents in elderly patients with coronary artery disease.

Catheter Cardiovasc Interv 2021 Apr 6;97(5):E607-E613. Epub 2020 Aug 6.

Cardiology Department Hôpital Cochin, Assistance Publique-Hôpitaux de Paris and, Université de Paris, Paris, France.

Objectives: Report the results at 2 years of the patients included in the SENIOR trial.

Background: Patients above 75 years of age represent a fast-growing population in the cathlab. In the SENIOR trial, patients treated by percutaneous coronary intervention (PCI) with drug eluting stent (DES) and a short duration of P2Y12 inhibitor (1 and 6 months for stable and unstable coronary syndromes, respectively) compared with bare metal stents (BMS) was associated with a 29% reduction in the rate of all-cause mortality, myocardial infarction (MI), stroke, and ischaemia-driven target lesion revascularization (ID-TLR) at 1 year. The results at 2 years are reported here.

Methods And Results: We randomly assigned 1,200 patients (596[50%] to the DES group and 604[50%] to the BMS group). At 2 years, the composite endpoint of all-cause mortality, MI, stroke and ID-TLR had occurred in 116 (20%) patients in the DES group and 131 (22%) patients in the BMS group (RR 0.90 [95%CI 0.72-1.13], p = .37). IDTLR occurred in 14 (2%) patients in the DES group and 41 (7%) patients in the BMS group (RR 0.35 [95%CI 0.16-0.60], p = .0002). Major bleedings (BARC 3-5) occurred in 27(5%) patients in both groups (RR 1.00, [95%CI 0.58-1.75], p = .99). Stent thrombosis rates were low and similar between DES and BMS (0.8 vs 1.3%, (RR 0.52 [95%CI 0.01-1.95], p = .27).

Conclusion: Among elderly PCI patients, a strategy combining a DES together with a short duration of DAPT is associated with a reduction in revascularization up to 2 years compared with BMS with very few late events and without any increased in bleeding complications or stent thrombosis.
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http://dx.doi.org/10.1002/ccd.29159DOI Listing
April 2021

Prognostic value of dipyridamole stress perfusion cardiovascular magnetic resonance in elderly patients >75 years with suspected coronary artery disease.

Eur Heart J Cardiovasc Imaging 2020 Aug 5. Epub 2020 Aug 5.

Department of Cardiology Cardiovascular Magnetic Resonance Laboratory, The Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques CARTIER, Ramsay Santé, 91300 Massy, France.

Aims : There are only very few data on the prognostic value of stress cardiovascular magnetic resonance (CMR) in elderly people, while life expectancy of the general population is steadily increasing. Therefore, this study aims to assess the prognostic value of vasodilator stress perfusion CMR in elderly >75 years.

Methods And Results : Between 2008 and 2017, we included consecutive elderly >75 years without known coronary artery disease (CAD) referred for dipyridamole stress CMR. They were followed for the occurrence of major adverse cardiovascular events (MACE) including cardiac death or non-fatal myocardial infarction. Univariate and multivariate analyses were performed to determine the prognostic value of ischaemia or late gadolinium enhancement. Of 754 elderly individuals (82.0 ± 3.9 years, 48.4% men), 659 (87.4%) completed the follow-up with median follow-up of 4.7 years. Using Kaplan-Meier analysis, the presence of myocardial ischaemia was associated with the occurrence of MACE [hazard ratio (HR) 5.38, 95% confidence interval (CI): 3.56-9.56; P < 0.001]. In a multivariable Cox regression including clinical characteristics and CMR indexes, inducible ischaemia was an independent predictor of a higher incidence of MACE (HR 4.44, 95% CI: 2.51-7.86; P < 0.001). In patients without ischaemia, the occurrence of MACE was lower in women when compared with men (P < 0.01).

Conclusion : Stress CMR is safe and has discriminative prognostic value in elderly, with a significantly lower event rate of future cardiovascular event or death in subjects without ischaemia or infarction.
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http://dx.doi.org/10.1093/ehjci/jeaa193DOI Listing
August 2020

Sinus of Valsalva Thrombosis Following Transcatheter Aortic Valve Replacement in a Bicuspid Aortic Valve.

JACC Cardiovasc Interv 2020 08 10;13(15):1828-1830. Epub 2020 Jun 10.

Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France. Electronic address:

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http://dx.doi.org/10.1016/j.jcin.2020.03.051DOI Listing
August 2020

Cost-Effectiveness of Drug-Eluting Stents in Elderly Patients With Coronary Artery Disease: The SENIOR Trial.

Value Health 2019 12 29;22(12):1355-1361. Epub 2019 Aug 29.

AP-HP URC Eco IdF, Unité de recherche clinique en économie de la santé d'Ile de France, Paris, France.

Background: Elderly patients receive bare metal stents instead of drug-eluting stents (DES) to shorten the duration of dual antiplatelet therapy (DAPT). The SENIOR trial compared outcomes between these 2 types of stents combined with a short duration of DAPT. A significant decrease in the number of patients with at least 1 major adverse cardiac and cerebrovascular event (MACCE) was noted in the DES group.

Objectives: The objective of this article was to perform an economic evaluation of the SENIOR trial.

Methods: This evaluation was performed separately in 5 participating countries using pooled patient-level data from all study patients and country-specific unit costs and utility values. Costs, MACCEs, and quality-adjusted life-years (QALYs) were calculated in both arms at 1 year, and an incremental cost-effectiveness ratio was estimated. Uncertainty was explored by probabilistic bootstrapping.

Results: A total of 1200 patients underwent randomization. The average total cost per patient was higher in the DES group. The number of MACCEs and average QALYs were not statistically different between the 2 groups. The 1-year incremental cost-effectiveness ratio for each country of reference ranged from €13 752 to €20 511/MACCE avoided and from €42 835 to €68 231/QALY gained. The scatter plots found a wide dispersion, reflecting a large uncertainty surrounding the results. But in each country studied, 90% of the bootstrap replications indicated a higher cost for greater effectiveness for the DES group. Assuming a willingness to pay of €50 000/QALY, there was between a 40% and 50% chance that the use of DES was cost-effective in 4 countries.

Conclusion: The use of DES instead of bare metal stents combined with a short duration of DAPT in elderly patients induced higher cost for greater effectiveness in each of the 5 countries studied.
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http://dx.doi.org/10.1016/j.jval.2019.07.008DOI Listing
December 2019

Safety and effectiveness of a transaortic approach for TAVI: procedural and midterm outcomes of 265 consecutive patients in a single centre.

Interact Cardiovasc Thorac Surg 2020 03;30(3):400-407

Department of Cardiac Surgery, Policlinico S. Donato Hospital, S. Donato Milanese, Milan, Italy.

Objectives: Transcatheter aortic valve implantation with a transaortic approach (TAo-TAVI) is an alternative to transapical or femoral access. We studied the procedural and midterm efficacy and safety of TAo-TAVI with Edwards Sapien XT and Medtronic CoreValve devices.

Methods: Among 901 patients receiving TAVI since 2006, 265 consecutive patients underwent TAo-TAVI between January 2011 and September 2014. Procedural and midterm results were evaluated according to Valve Academic Research Consortium-2 criteria.

Results: The mean age was 83 ± 5 years. Sapien XT and CoreValve were used in 191 (72.1%) and 74 (27.9%) patients, respectively. Full sternotomy made elective concomitant off-pump coronary artery bypass grafting possible in 38 patients (14.3%) with severe coronary artery disease unsuitable for percutaneous coronary intervention. The device success rate was 95.5%. Postprocedural paravalvular leak  ≥2/4 was observed in 16 patients (6.4%). Emergency open chest surgery was required in 10 patients (3.8%) (3 aortic dissections, 3 valve embolizations, 2 LMCA occlusions, 1 aortic annulus rupture and 1 aortic rupture). Cerebrovascular accidents occurred in 3 patients (1.1%). Transfusions  ≥4 units were required in 36 patients (13.6%). New pacemakers were implanted in 26 patients (9.8%). Thirty-day and 1-year mortality were 8.7% and 16.2%, respectively. Mean follow-up duration was 24 ± 6 months. At 3 years, freedom from all-cause death was 80% ± 4%. New York Heart Association class
Conclusion: The TAo-TAVI approach confirms its safety and effectiveness with satisfactory procedural and midterm outcomes with both currently available devices.
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http://dx.doi.org/10.1093/icvts/ivz269DOI Listing
March 2020

Impact of vascular access on outcome after PCI in patients at high bleeding risk: a pre-specified sub-analysis of the LEADERS FREE trial.

Rev Esp Cardiol (Engl Ed) 2020 Jul 26;73(7):536-545. Epub 2019 Sep 26.

Cardiology Department, Hôpital de la Tour, Geneva, Switzerland. Electronic address:

Introduction And Objectives: The prognostic impact of bleeding in high bleeding risk (HBR) patients depending on the location of bleeding and prognosis in nonaccess site bleeding is unknown. We aimed to assess the impact of vascular access site on bleeding complications after percutaneous coronary interventions for HBR patients at 30-day and 2-year follow-up.

Methods: The LEADERS FREE trial included 2432 HBR PCI patients. A Biolimus A9 drug-coated stent was superior to a bare-metal stent for safety and efficacy. This is a predefined sub-analysis of the LEADERS FREE trial.

Results: Transradial access (TRA) was used in 1454 patients (59.8%) and transfemoral access (TFA) in 978 (40.2%), according to operator preference. The safety and benefits of drug-coated stents over bare-metal stents were independent of vascular access. At 30 days and 2 years, major bleeding had occurred in 2.4% and 7.5% of TRA patients and 4.6% and 10.9% of TFA patients (P=.003), respectively. Most of these events in both groups (2.1% and 7.0% for TRA; 3.2% and 9.4% for TFA, respectively) were nonaccess site-related. TRA was associated with a significant reduction in adjusted rates of major bleeding both at 30 days (HR, 1.98; 95%CI, 1.25-3.11; P=.003) and at 2 years of follow-up (HR, 1.51; 95%CI, 1.14-2.01; P=.003). This difference was driven by both access and nonaccess bleeding.

Conclusions: Operators preferred TRA for most HBR patients, which was associated with a significant reduction in major bleeding events. However, most of these events in this population are unrelated to vascular access.
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http://dx.doi.org/10.1016/j.rec.2019.07.010DOI Listing
July 2020

Is sex associated with adverse outcomes after percutaneous coronary intervention for CTO?

Int J Cardiol 2019 08 11;288:29-33. Epub 2019 Apr 11.

Institut Cardiovasculaire Paris Sud, Hôpital Privé Jacques Cartier, Générale de Santé, Massy, France. Electronic address:

Background: Conflicting results have been reported regarding sex differences in percutaneous coronary intervention (PCI), but their potential influence on clinical outcomes after chronic total coronary occlusion (CTO) PCI remains unknown. We aimed to identify sex-related differences in long-term clinical outcomes after CTO PCI.

Methods And Results: All consecutive patients undergoing CTO PCI between 2004 and 2012 were included in a prospective registry. Baseline, procedural characteristics and clinical outcomes were compared according to sex. Out of 1343 patients, 194 were female (14.4%). Women were older (68.5 ± 9.9 vs 62.3 ± 10.8 years, p < 0.001), more frequently diabetic (33.5% vs 26.4%, p = 0.026) and hypertensive (70.1% vs 57.4%, p < 0,001), whereas males were more frequently smokers (28.5% vs 15.5%, p < 0.001). J-CTO score was similar between both sexes (1.59 ± 0.91 vs 1.51 ± 0.88). The procedural success rate was also similar in men and women (74.0% vs 77.3%, respectively). At 8 years' follow-up, successful CTO PCI was associated with reduced mortality in women (14.8% vs 36.2%, p = 0.003) and men (18.5% vs 29.1%, p < 0.001). In successful CTO PCI cases, no sex-related differences were observed in terms of major adverse cardiac events.

Conclusions: Our study suggests an equal benefit of CTO interventions with a marked reduction in mortality after successful CTO PCI in women and men alike.
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http://dx.doi.org/10.1016/j.ijcard.2019.04.033DOI Listing
August 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

Prognostic Impact of Pre-Transcatheter and Post-Transcatheter Aortic Valve Intervention Troponin: A Large Cohort Study.

J Am Heart Assoc 2019 03;8(6):e011111

1 Interventional Cardiology Department Ramsay Générale de Santé Institut Cardiovasculaire Paris Sud Massy France.

Background Biomarkers were advocated as prognostic factors in patients undergoing transcatheter aortic valve intervention, with contradictory results concerning prognostic impact of troponin. Our aim was to assess the prognostic impact of preprocedural and postprocedural troponin in transcatheter aortic valve intervention. Methods and Results Preprocedural and postprocedural high-sensitivity troponin levels were measured in all patients undergoing transcatheter aortic valve intervention. Primary end point was 1-year mortality. This study included 1390 patients, with a mean age of 83.4±6.8 years. Patients were divided into 3 tertiles according to preprocedural troponin values: tertile 1: 0.001 to 0.023 μg/L; tertile 2: 0.024 to 1.80 μg/L; and T3: 1.81 to 12.1 μg/L. One-year mortality was higher in patients in tertile 2 (hazard ratio, 2.1; P=0.001) and T3 (hazard ratio, 1.8; P=0.009) compared with those in tertile 1. Myocardial injury was predictive of 1-year mortality (hazard ratio, 1.7; P=0.01). This effect may be stronger in the tertile 1 subgroup (hazard ratio, 5.1; P=0.03 [ P value for interaction: 0.18]). Conclusions Elevated preprocedural troponin and myocardial injury are associated with 1-year mortality after transcatheter aortic valve intervention.
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http://dx.doi.org/10.1161/JAHA.118.011111DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6475053PMC
March 2019

Bicuspid Aortic Valve Anatomy and Relationship With Devices: The BAVARD Multicenter Registry.

Circ Cardiovasc Interv 2019 01;12(1):e007107

Thoraxcenter, Erasmus Medical Center, Rotterdam, the Netherlands (L.v.G., N.M.V.M.).

Background: Sizing for transcatheter aortic valve implantation in bicuspid aortic valves (BAV) remains controversial.

Methods And Results: The aim of the BAVARD (Bicuspid Aortic Valve Anatomy and Relationship With Devices) retrospective registry is to capture the sizing ratios used for transcatheter aortic valve implantation in BAV and analyze the second-generation prostheses geometry postimplantation. About 101 patients with BAV along with available pre- and post-transcatheter aortic valve implantation multidetector computed tomography were compared with 88 tricuspid aortic valves (TAV) patients. Preprocedural multidetector computed tomography diagnosed type 0 and type 1 BAV in, respectively, 12.9% and 86.1 % of BAV. At baseline, the ellipticity index was similar between BAV and TAV patients: 1.2±0.1 versus 1.2±0.1, P=0.09. The mean annular oversizing was, respectively, 1.14±0.04 and 1.04±0.04, P<0.001, in TAV and BAV patients. The mean prosthesis intercommissural distance, ratio was 1.03±0.1. The mean diameter of the prostheses at the annulus matched the mean perimeter-derived diameter of the aortic annulus at baseline with TAV (23.3±2.2 versus 23.6±1.9, P=0.4) and was smaller with BAV (24±2.8 versus 26.8±3.1, P<0.01), confirming 11% underexpansion in BAV. Finally, in situ, prosthesis diameter and ellipticity followed the same pattern, with stable values from the distal edge to 12 mm above, in both groups.

Conclusions: Second-generation prostheses similarly reshape the aortic annulus in TAV and BAV. Prostheses keep consistent diameters from distal edge to 12 mm in TAV and BAV. Prosthesis underexpansion is constantly observed in BAV. Annular-based sizing is accurate in BAV with minimal oversizing. The intercommissural distance, 4 mm above the annulus, could be integrated in gray zones.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov . Unique identifier: NCT03495050.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007107DOI Listing
January 2019

Implementation of the transradial approach as an alternative vascular access for transcatheter aortic valve replacement guidance: Experience from a high-volume center.

Catheter Cardiovasc Interv 2019 06 10;93(7):1367-1373. Epub 2018 Dec 10.

Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, Paris, France.

Objective: This study sought to assess the potential benefits of the transradial approach (TRA) as an alternative vascular access to the classical contralateral femoral approach for transcatheter aortic valve replacement (TAVR).

Background: Vascular and bleeding complications in TAVR have gradually decreased owing to operator experience and downsizing of the delivery system. However, about 1/4 of vascular access site complications are related to the transfemoral (TF) secondary access.

Methods: We compared the outcomes at 30 days according to VARC-2 after TAVR of a prospective cohort of 217 consecutive patients undergoing right or left TRA as the second vascular access (TRA-TF TAVR) and a retrospective cohort of 194 consecutive patients undergoing TF approach as a second vascular access (TF-TF TAVR).

Results: Baseline clinical characteristics and risk scores were well matched in both groups. Procedural success rate was 99.7%. Fluoro time was significantly lower in the TF-TF TAVR group (16.9 ± 7.2 vs. 19.1 ± 7.8 min, P = 0.003); however, there was no significant difference in x-ray exposure, procedure time or amount of contrast used. In the TRA-TF TAVR group, there were no complications related to the TRA access and there were less vascular and bleeding complications (18.0% vs. 9.7%, P = 0.014; 17.0% vs. 9.2%, P = 0.026, respectively), although blood transfusion requirement or hospitalization duration stay were similar in both groups.

Conclusions: TRA approach as alternative secondary vascular access in TAVR is safe and feasible and is associated with a significant decrease in vascular and bleeding complications. Further, large-scale studies are warranted to confirm the potential benefit of this approach.
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http://dx.doi.org/10.1002/ccd.28024DOI Listing
June 2019

Transcatheter Aortic Valve Replacement in the Catheterization Laboratory Versus Hybrid Operating Room: Insights From the FRANCE TAVI Registry.

JACC Cardiovasc Interv 2018 11;11(21):2195-2203

Paris South Cardiovascular Institute, Jacques-Cartier Private Hospital, Ramsay Générale de Santé, Massy, France.

Objectives: This study sought to compare outcomes of patients undergoing transcatheter aortic valve replacement (TAVR) in a catheterization laboratory (cath lab) to those undergoing TAVR in a hybrid operating room (OR).

Background: TAVR can be performed in a cath lab or in a hybrid OR. Comparisons between these locations are scarce.

Methods: All TAVRs performed in 48 centers across France between January 2013 and December 2015 were prospectively included in the FRANCE TAVI (French Transcatheter Aortic Valve Implantation) registry. The primary endpoint of this study was all-cause mortality at 1 year. Secondary endpoints consisted of 30-day complications and 3-year mortality. All analyses were adjusted for baseline and procedural characteristics.

Results: A total of 12,121 patients were included in this study, 62% of which underwent TAVR in a cath lab versus 38% in a hybrid OR. Mean age was 82.9 ± 7.2 years, 48.9% of patients were men, and mean Logistic EuroScore was 17.9% ± 12.3%. Both procedure locations showed similar, below 2% rates of intraprocedural complications. After adjusting for baseline and procedural characteristics, major bleeding and infections were significantly higher in the hybrid OR group (bleeding, 6.3% vs. 4.8%; infection, 6.1% vs. 3.5%; p < 0.05). Adjusted mortality rates at 1 and 3 years did not differ significantly between groups (for cath lab vs. hybrid OR, respectively: 1 year: 16.2% vs. 15.8%; p = 0.91; 3 years: 38.4% vs. 36.4%; p = 0.49).

Conclusions: Midterm mortality after TAVR was similar between the cath lab and the hybrid OR. These findings support the performance of TAVR in either location, which has important implications on health care organization and costs.
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http://dx.doi.org/10.1016/j.jcin.2018.06.043DOI Listing
November 2018

Double Anomalous Aortic Origin of a Coronary Artery With Intramural Course.

JACC Cardiovasc Interv 2018 10 12;11(19):e153-e155. Epub 2018 Sep 12.

Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.

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http://dx.doi.org/10.1016/j.jcin.2018.07.009DOI Listing
October 2018

Radial Versus Femoral Approach for Percutaneous Coronary Intervention: MACE Outcomes at Long-Term Follow-up.

J Invasive Cardiol 2018 07;30(7):262-268

Hôpital Rangueil, CHU Toulouse, 1 Avenue Jean Poulhès, 31059 Toulouse, France.

Objective: To compare the main outcomes of radial versus femoral access at long-term follow-up.

Background: Little is known about the long-term major cardiovascular events and bleeding complications of patients undergoing percutaneous coronary intervention (PCI) with radial vs femoral approach.

Methods: A total of 1107 patients from the CENTURY II trial were included. To minimize baseline differences between radial and femoral groups, we applied propensity-score matching for this comparison.

Results: In this multicenter study, the radial approach was used in 73.4% of patients. After propensity-score matching, baseline and procedural characteristics were comparable between both groups. Procedural success was high and similar in radial and femoral approaches (98.2% vs 97.5%; P=.47) while radial access was associated with a shorter hospital stay (1.69 ± 1.92 days vs 2.08 ± 1.98 days; P<.01). The short-term bleeding and vascular complication rates were significantly lower in the radial group (1.7% vs 6.2% [P<.001 in-hospital] and 2.7% vs 9.6% [P<.001 at 1-month follow-up]). At 3-year follow-up, radial access was associated with lower rates of all-cause mortality (3.9 vs 6.9%; P=.04) and cardiovascular death (2.1 vs 4.9%; P=.02). The composite of all-cause mortality, myocardial infarction, and revascularization showed no differences between groups (18.2 vs 21.1%; P=.29).

Conclusions: Compared to the femoral approach, the radial approach is associated with significantly lower long-term all-cause mortality rate as well as lower in-hospital and short-term bleeding rates. These results suggest additional long-term benefits of radial access for PCI, but should be interpreted within the context of the current study and further verified in future studies.
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July 2018

A randomized multicentre trial to compare revascularization with optimal medical therapy for the treatment of chronic total coronary occlusions.

Eur Heart J 2018 07;39(26):2484-2493

Institut Jacques Cartier, 6 avenue Noyer Lambert, Massy, France.

Aims: The clinical value of percutaneous coronary intervention (PCI) for chronic coronary total occlusions (CTOs) is not established by randomized trials. This study should compare the benefit of PCI vs. optimal medical therapy (OMT) on the health status in patients with at least one CTO.

Method And Results: Three hundred and ninety-six patients were enrolled in a prospective randomized, multicentre, open-label, and controlled clinical trial to compare the treatment by PCI with OMT with a 2:1 randomization ratio. The primary endpoint was the change in health status assessed by the Seattle angina questionnaire (SAQ) between baseline and 12 months follow-up. Fifty-two percent of patients have multi-vessel disease in whom all significant non-occlusive lesions were treated before randomization. An intention-to-treat analysis was performed including 13.4% failed procedures in the PCI group and 7.3% cross-overs in the OMT group. At 12 months, a greater improvement of SAQ subscales was observed with PCI as compared with OMT for angina frequency [5.23, 95% confidence interval (CI) 1.75; 8.71; P = 0.003], and quality of life (6.62, 95% CI 1.78-11.46; P = 0.007), reaching the prespecified significance level of 0.01 for the primary endpoint. Physical limitation (P = 0.02) was also improved in the PCI group. Complete freedom from angina was more frequent with PCI 71.6% than OMT 57.8% (P = 0.008). There was no periprocedural death or myocardial infarction. At 12 months, major adverse cardiac events were comparable between the two groups.

Conclusion: Percutaneous coronary intervention leads to a significant improvement of the health status in patients with stable angina and a CTO as compared with OMT alone.

Trial Registration: NCT01760083.
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http://dx.doi.org/10.1093/eurheartj/ehy220DOI Listing
July 2018

Serial Assessment of Strut Coverage of Biodegradable Polymer Drug-Eluting Stent at 1, 2, and 3 Months After Stent Implantation by Optical Frequency Domain Imaging: The DISCOVERY 1TO3 Study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months).

Circ Cardiovasc Interv 2017 Dec;10(12)

From the Ramsay Générale de Santé, Interventional Cardiology Department, Institut Cardiovasculaire Paris Sud, Massy, France (B.C., F.J.S., T.H.); Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands (P.C.S., A.O.K., G.J.V.); Department of Cardiology, CHU Rangueil, Toulouse, France (D.C.); Department of Cardiology, Munich University Clinic, LMU Munich and Munich Heart Alliance, DZHK, Germany (J.M.); Department of Cardiology, Medisch Centrum Leeuwarden, the Netherlands (A.J.V.B.); The Thoraxcenter, Erasmus MC, Rotterdam, the Netherlands (E.R.); and Department of Invasive Cardiology, Institute Dante Pazzanese of Cardiology, Cardiovascular Research Center, Sao Paulo, Brazil (D.C.).

Background: To assess the vessel-healing pattern of Ultimaster drug-eluting stent using optical frequency domain imaging. Our hypothesis is that biodegradable polymer-based drug-eluting technology allows complete very early strut coverage.

Methods And Results: The DISCOVERY 1TO3 study (Evaluation With OFDI of Strut Coverage of Terumo New Drug Eluting Stent With Biodegradable Polymer at 1, 2, and 3 Months) is a prospective, single-arm, multicenter study. A total of 60 patients with multivessel disease requiring staged procedure at 1 month were treated with Ultimaster. Optical frequency domain imaging was acquired at baseline, 1, 2, and 3 months. The primary end point is optical frequency domain imaging-assessed strut coverage at 3 months. Mean age of patients was 67.2±9.9 years, and 73.3% were male, and 36.7% presented with acute coronary syndrome. A total of 132 lesions were treated, with average 1.4 lesions per patient treated at baseline and 1.1 lesions treated at 1 month. Strut coverage at 3 months of single implanted stents (n=71, primary end point) was 95.2±5.2% and of combined single and overlapped stents was 95.4±4.9%. Strut coverage of combined single and overlapped stents at 1 (n=49) and 2 months (n=38) was 85.1±12.7% and 87.9±10.8%, respectively. The median neointimal hyperplasia thickness was 0.04, 0.05, and 0.06 mm, whereas mean neointimal hyperplasia obstruction was 4.5±2.4%, 5.2±3.4%, and 6.6±3.3% at 1, 2, and 3 months, respectively.

Conclusions: Nearly complete strut coverage was observed in this complex population very early after implantation of Ultimaster drug-eluting stent.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01844843.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.116.004801DOI Listing
December 2017

Drug-eluting stents in elderly patients with coronary artery disease (SENIOR): a randomised single-blind trial.

Lancet 2018 01 1;391(10115):41-50. Epub 2017 Nov 1.

Department of Cardiovascular Medicine, University Hospitals Leuven, Leuven, Belgium.

Background: Elderly patients regularly receive bare-metal stents (BMS) instead of drug-eluting stents (DES) to shorten the duration of double antiplatelet therapy (DAPT). The aim of this study was to compare outcomes between these two types of stents with a short duration of DAPT in such patients.

Methods: In this randomised single-blind trial, we recruited patients from 44 centres in nine countries. Patients were eligible if they were aged 75 years or older; had stable angina, silent ischaemia, or an acute coronary syndrome; and had at least one coronary artery with a stenosis of at least 70% (≥50% for the left main stem) deemed eligible for percutaneous coronary intervention (PCI). Exclusion criteria were indication for myocardial revascularisation by coronary artery bypass grafting; inability to tolerate, obtain, or comply with DAPT; requirement for additional surgery; non-cardiac comorbidities with a life expectancy of less than 1 year; previous haemorrhagic stroke; allergy to aspirin or P2Y inhibitors; contraindication to P2Y inhibitors; and silent ischaemia of less than 10% of the left myocardium with a fractional flow reserve of 0·80 or higher. After the intended duration of DAPT was recorded (1 month for patients with stable presentation and 6 months for those with unstable presentation), patients were randomly allocated (1:1) by a central computer system (blocking used with randomly selected block sizes [two, four, eight, or 16]; stratified by site and antiplatelet agent) to either a DES or similar BMS in a single-blind fashion (ie, patients were masked), but those assessing outcomes were masked. The primary outcome was to compare major adverse cardiac and cerebrovascular events (ie, a composite of all-cause mortality, myocardial infarction, stroke, or ischaemia-driven target lesion revascularisation) between groups at 1 year in the intention-to-treat population, assessed at 30 days, 180 days, and 1 year. This trial is registered with ClinicalTrials.gov, number NCT02099617.

Findings: Between May 21, 2014, and April 16, 2016, we randomly assigned 1200 patients (596 [50%] to the DES group and 604 [50%] to the BMS group). The primary endpoint occurred in 68 (12%) patients in the DES group and 98 (16%) in the BMS group (relative risk [RR] 0·71 [95% CI 0·52-0·94]; p=0·02). Bleeding complications (26 [5%] in the DES group vs 29 [5%] in the BMS group; RR 0·90 [0·51-1·54]; p=0·68) and stent thrombosis (three [1%] vs eight [1%]; RR 0·38 [0·00-1·48]; p=0·13) at 1 year were infrequent in both groups.

Interpretation: Among elderly patients who have PCI, a DES and a short duration of DAPT are better than BMS and a similar duration of DAPT with respect to the occurrence of all-cause mortality, myocardial infarction, stroke, and ischaemia-driven target lesion revascularisation. A strategy of combination of a DES to reduce the risk of subsequent repeat revascularisations with a short BMS-like DAPT regimen to reduce the risk of bleeding event is an attractive option for elderly patients who have PCI.

Funding: Boston Scientific.
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http://dx.doi.org/10.1016/S0140-6736(17)32713-7DOI Listing
January 2018

Simultaneous TAVR and Left Main "Chimney" Stenting in a Patient With Low Left Main Height.

JACC Cardiovasc Interv 2017 10 27;10(20):e185-e187. Epub 2017 Sep 27.

Interventional Cardiology Department, Ramsay Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France.

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http://dx.doi.org/10.1016/j.jcin.2017.06.047DOI Listing
October 2017

Polymer-Free Drug-Coated Coronary Stents Are Cost-Effective in Patients at High Bleeding Risk: Economic Evaluation of the LEADERS FREE Trial.

EuroIntervention 2018 02;13(14):1688-1695

Assistance Publique Hopitaux de Paris, URCEco & Santé publique, Hôpital Henri Mondor, Créteil, France.

Aims: In patients at high risk of bleeding who undergo PCI the biolimus A9 polymer-free drug coated stent (DCS) has superior efficacy and safety compared to a bare metal stent (BMS). We estimated the cost effectiveness of DCS vs. BMS.

Methods And Results: The Leaders FREE-based economic evaluation estimated service use and quality of life data collected prospectively. The entire trial population was analysed using cost-weights from England, France, Germany, Italy, Scotland and Spain. Country-specific QALYs were derived from EQ-5D scores. We estimated cost per event averted and per QALY gained. DCS use resulted in -0.095 cardiac deaths, target vessel MI, stent thrombosis and revascularization per patient (0.152 vs. 0.237;p<0.001). One-year QALYs were non-significantly higher in the DCS group. Total costs for the index admission were similar between groups. One-year costs using cost-weights from each of the 6 countries, including the additional €300 per DCS stent, ranged from €4,664-8,593 for DCS and €4,845-9,742 for BMS and were lower in the DCS group (England:€-428, France:€-137, Germany:€-33, Italy:€-522, Scotland:€-298, Spain:€-854).

Conclusions: The probability that DCS dominated BMS was >50% in all countries. At a threshold of €10,000 per event averted DCS had a 98% probability of being cost-effective in all 6 countries.
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http://dx.doi.org/10.4244/EIJ-D-17-00286DOI Listing
February 2018

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