Publications by authors named "Grégoire Range"

37 Publications

Increased Exposure to X-Rays During Coronary Angiography and Percutaneous Coronary Interventions Associated with Fractional Flow Reserve Measurement and Endocoronary Imaging Techniques.

Radiat Prot Dosimetry 2021 May 6. Epub 2021 May 6.

Cardiology Department, Les Hôpitaux de Chartres, 28630 Le Coudray, France.

Growing use of fractional flow reserve (FFR) and intracoronary imaging techniques by optical coherence tomography or intravascular ultrasound has raised concerns about additional exposure during coronary angiography and percutaneous coronary interventions (PCIs). Using data from the prospective CRAC-France PCI Prospective Multicentre registry, we sought to evaluate the effect of these new techniques on the radiation dose to patients undergoing coronary procedures. Data on Kerma Area Product (PKA), total air kerma (KAr) and fluoroscopy time from 42 182 coronary procedures were retrospectively compared, using multivariable linear regression, according to whether they included FFR and intracoronary imaging. In coronary angiography, FFR was associated with longer fluoroscopy time and higher PKA (21.0 vs. 18.9 Gy.cm2) and KAr (372 vs. 299 mGy) (all p < 0.001). Intracoronary imaging was associated with longer fluoroscopy time, higher contrast volume (both p < 0.001), lower PKA (18.3 vs. 19.0 Gy.cm2, p = 0.02) and similar KAr. In PCI, FFR was associated with a moderate increase in KAr (682 vs. 626 mGy, p < 0.01) but not PKA (35.9 vs. 33.7 Gy.cm2, p = 0.34). For intracoronary imaging, there were no differences between groups, except for contrast volume. Increased patient exposure associated with FFR and intracoronary imaging is moderate in diagnostic coronary angiography and minimal or none in PCI, provided optimization techniques are used. It should not be a limitation on the use of these techniques given the important additional information they provide.
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http://dx.doi.org/10.1093/rpd/ncab065DOI Listing
May 2021

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

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

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

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

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

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

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

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

Incidence, delays, and outcomes of STEMI during COVID-19 outbreak: Analysis from the France PCI registry.

J Am Coll Emerg Physicians Open 2020 Nov 23. Epub 2020 Nov 23.

Cardiology Department Centre Hospitalier Universitaire de Clermont-Ferrand Clermont-Ferrand France.

Objectives: The aim of this study was to assess the impact of the coronavirus disease 2019 (COVID-19) outbreak on incidence, delays, and outcomes of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PPCI) in France.

Methods: We analyzed all patients undergoing PPCI <24 hours STEMI included in the prospective France PCI registry. The 2 groups were compared on mean monthly number of patients, delays in the pathway care, and in-hospital major adverse cardiac events (MACE: death, stent thrombosis, myocardial infarction, unplanned coronary revascularization, stroke, and major bleeding).

Results: From January 15, 2019 to April 14, 2020, 2064 STEMI patients undergoing PPCI were included: 1942 in the prelockdown group and 122 in the lockdown group. Only 2 cases in the lockdown group were positive for COVID-19. A significant drop (12%) in mean number of STEMI/month was observed in the lockdown group compared with prelockdown (139 vs 122, < 0.04). A significant increase in "symptom onset to first medical contact" delay was found for patients who presented directly to the emergency department (ED) (238 minutes vs 450 minutes; = 0.04). There were higher rates of in-hospital MACE (7.7% vs 12.3%; = 0.06) and mortality (4.9% vs 8.2%; = 0.11) in the lockdown group but the differences were not significant.

Conclusion: According to the multicenter France PCI registry, the COVID-19 outbreak in France was associated with a significant decline in STEMI undergoing PPCI and longer transfer time for patients who presented directly to the ED. Mortality rates doubled, but the difference was not statistically significant.
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http://dx.doi.org/10.1002/emp2.12325DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7753646PMC
November 2020

National French Registry of Spontaneous Coronary Artery Dissections: Prevalence of Fibromuscular Dysplasia and Genetic Analyses.

EuroIntervention 2020 12 15. Epub 2020 Dec 15.

Department of Cardiology, CHU Clermont-Ferrand, CNRS, Université Clermont Auvergne, Clermont-Ferrand, France.

Aims: Obtain European data on SCAD, determine the prevalence of FMD and enable genetic analyses in this population.

Methods And Results: Data from a national French registry of SCAD cases, were analysed prospectively and retrospectively. Clinical and angiographic data and management strategy were collected. Major adverse cardiovascular events (MACE) were analysed after one-year follow-up. Subjects were screened for fibromuscular dysplasia (FMD) and blood was collected for DNA extraction. From June 2016 to August 2018, 373 SCAD cases were confirmed by the core lab. Mean age was 51.5 years. Patients were mostly women (90.6%) and 54.7% of cases had less than two cardiovascular risk factors. At 1 year, 295 patients (79.1%) were treated conservatively and the MACE rate was 12.3%, and no case of mortality. Recurrence rate of SCAD was 3.3%. FMD was found at ³ 1 arterial site in 45.0% of cases. We also confirmed the genetic association between the PHACTR1 locus and SCAD (odds ratio=1.66, P=7.08×10 -8 ).

Conclusions: Here we describe the largest European SCAD cohort where FMD was found in 45% of cases and the genetic association with PHACTR1 was confirmed. This nationwide cohort is a valuable resource for future clinical and genetic investigation to understand SCAD aetiology.
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http://dx.doi.org/10.4244/EIJ-D-20-01046DOI Listing
December 2020

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

EuroIntervention 2020 Nov 24. Epub 2020 Nov 24.

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

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

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

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

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

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

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

Background: Percutaneous coronary intervention (PCI)-related myonecrosis is frequent and can affect the long-term prognosis of patients. To our knowledge, ticagrelor has not been evaluated in elective PCI and could reduce periprocedural ischaemic complications compared with clopidogrel, the currently recommended treatment. The aim of the ALPHEUS study was to examine if ticagrelor was superior to clopidogrel in reducing periprocedural myocardial necrosis in stable coronary patients undergoing high-risk elective PCI.

Methods: The ALPHEUS study, a phase 3b, randomised, open-label trial, was done at 49 hospitals in France and Czech Republic. Patients with stable coronary artery disease were eligible for the study if they had an indication for PCI and at least one high-risk characteristic. Eligible patients were randomly assigned (1:1) to either ticagrelor (180 mg loading dose, 90 mg twice daily thereafter for 30 days) or clopidogrel (300-600 mg loading dose, 75 mg daily thereafter for 30 days) by use of an interactive web response system, and stratified by centre. The primary outcome was a composite of PCI-related type 4 (a or b) myocardial infarction or major myocardial injury and the primary safety outcome was major bleeding, both of which were evaluated within 48 h of PCI (or at hospital discharge if earlier). The primary analysis was based on all events that occurred in the intention-to-treat population. The trial was registered with ClinicalTrials.gov, NCT02617290.

Findings: Between Jan 9, 2017, and May 28, 2020, 1910 patients were randomly assigned at 49 sites, 956 to the ticagrelor group and 954 to the clopidogrel group. 15 patients were excluded from the ticagrelor group and 12 from the clopidogrel group. At 48 h, the primary outcome was observed in 334 (35%) of 941 patients in the ticagrelor group and 341 (36%) of 942 patients in the clopidogrel group (odds ratio [OR] 0·97, 95% CI 0·80-1·17; p=0·75). The primary safety outcome did not differ between the two groups, but minor bleeding events were more frequently observed with ticagrelor than clopidogrel at 30 days (105 [11%] of 941 patients in the ticagrelor group vs 71 [8%] of 942 patients in the clopidogrel group; OR 1·54, 95% CI 1·12-2·11; p=0·0070).

Interpretation: Ticagrelor was not superior to clopidogrel in reducing periprocedural myocardial necrosis after elective PCI and did not cause an increase in major bleeding, but did increase the rate of minor bleeding at 30 days. These results support the use of clopidogrel as the standard of care for elective PCI.

Funding: ACTION Study Group and AstraZeneca.
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http://dx.doi.org/10.1016/S0140-6736(20)32236-4DOI Listing
November 2020

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

Catheter Cardiovasc Interv 2020 Oct 21. Epub 2020 Oct 21.

Cardiology Department, Rangueil University Hospital, Toulouse, France.

Objectives: To evaluate the rate of procedural success and long-term outcomes of the PK Papyrus (PKP) covered stent (CS).

Background: CS are essential in the treatment of coronary artery perforation (CAP). They have also been used to treat coronary artery aneurysms. Limited evidence is available on clinical outcomes with the PKP.

Methods: This was a multicenter, observational, retrospective, and prospective study. Consecutive patients undergoing intentional PKP implantation in 22 centers in France were included. The primary endpoint was the rate of procedural success. Secondary endpoints included rates of death, myocardial infarction (MI), target lesion revascularization (TLR), in-stent restenosis (ISR), and stent thrombosis (ST).

Results: Data from 130 patients were analyzed (mean age 72.5 ± 10.5 years; 71% men). The main indication for PKP was CAP, in 84 patients (65%). Delivery success was achieved in 95% and procedural success in 91%. During the in-hospital stay, 15 patients died (12%) and 7 (5%) presented with ST. Data from 127 patients were available at 19.2 ± 12.8 month follow-up. Thirty-three patients died (26%), 15 (12%) had an MI and 21 (17%) presented with TLR. TLR was due to ISR in 12 patients (9%), 10 had definite ST (8%) and 1 patient for stent under-expansion.

Conclusions: The principal indication for PKP was CAP. PKP had high rates of delivery and procedural success. At long-term follow-up, there was a high rate of TLR, mainly due to ISR and ST. These results are consistent with previously reported data in these clinical settings.
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http://dx.doi.org/10.1002/ccd.29328DOI Listing
October 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Where have the ST-segment elevation myocardial infarctions gone during COVID-19 lockdown?

Eur Heart J Qual Care Clin Outcomes 2020 Jul;6(3):223-224

Cardiology Department, Centre Hospitalo-Universitaire de Clermont-Ferrand, 58 Rue Montalembert, 63000, Clermont-Ferrand, France.

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http://dx.doi.org/10.1093/ehjqcco/qcaa034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7197594PMC
July 2020

Reasons for the Failure of Platelet Function Testing to Adjust Antiplatelet Therapy: Pharmacodynamic Insights From the ARCTIC Study.

Circ Cardiovasc Interv 2019 11 7;12(11):e007749. Epub 2019 Nov 7.

Sorbonne University, ACTION Study Group, INSERM UMRS 1166, Cardiology Institute, Pitié-Salpêtrière (AP-HP) University Hospital, Paris, France (B.L., J.S., Y.Y., G.M., J.-P.C.).

Background: In the ARCTIC trial (Assessment by a Double Randomization of a Conventional Antiplatelet Strategy Versus a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation and of Treatment Interruption Versus Continuation One Year After Stenting), treatment adjustment following platelet function testing failed to improve clinical outcomes. However, high-on-treatment platelet reactivity (HPR) is considered as a predictor of poor ischemic outcome. This prespecified substudy evaluated clinical outcomes according to the residual platelet reactivity status after antiplatelet therapy adjustment.

Methods: We analyzed the 1213 patients assigned to the monitoring arm of the ARCTIC trial in whom platelet reactivity was evaluated by the VerifyNow P2Y test before percutaneous coronary intervention and during the maintenance phase (at 14 days). HPR was defined as platelet reaction unit≥235U. The primary ischemic end point, a composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization and the safety end point of major bleeding were assessed according to the platelet reactivity status.

Results: Before percutaneous coronary intervention, 35.7% of patients displayed HPR (n=419). During the acute phase, between percutaneous coronary intervention and the 14-day platelet function testing, ischemic (adjusted hazard ratio, 0.94 [95% CI, 0.74-1.18]; =0.58) and safety outcomes (hazard ratio, 1.28 [95% CI, 0.22-7.59]; =0.78) were similar in HPR and non-HPR patients. During the maintenance phase, the proportion of HPR patients (n=186, 17.4%) decreased by 56%. At 1-year, there was no difference for the ischemic end point (5.9% versus 6.0%; adjusted hazard ratio, 0.79 [95% CI, 0.40-1.58]; =0.51) and a nonsignificant higher rate of major bleedings (2.7% versus 1.0%, hazard ratio, 2.83 [95% CI, 0.96-8.41]; =0.06) in HPR versus non-HPR patients.

Conclusions: The proportion of HPR was halved after platelet function testing and treatment adjustment but without significant ischemic benefit at 1 year. HPR seems more as a modifiable risk marker than a risk factor of ischemic outcome.

Clinical Trial Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00827411.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.118.007749DOI Listing
November 2019

Regression of Q waves and clinical outcomes following primary PCI in anterior STEMI.

J Electrocardiol 2019 Oct 20. Epub 2019 Oct 20.

Hopital Cardiovasculaire Louis Pradel, Hospices Civils de Lyon, Lyon, France, Centre d'Investigation Clinique de Lyon, Université Claude Bernard Lyon 1, France. Electronic address:

Background: Pathological Q waves are correlated with infarct size, and Q-wave regression is associated with left ventricular ejection fraction improvement. There are limited data regarding the association of Q-wave regression and clinical outcomes. Our main objective was to assess the association of pathological Q wave evolution after reperfusion with clinical outcomes after anterior STEMI.

Methods: Standard 12-lead electrocardiograms (ECGs) were recorded in 780 anterior STEMI patients treated with primary percutaneous coronary intervention (PCI) from the CIRCUS trial. ECGs were recorded before and 90 min following PCI, as well as at hospitalization discharge and 12 months of follow-up. The number of classic ECG criteria Q waves was scored for each ECG. Patients were classified in the Q wave regression group if they had regression of at least one Q wave between the post-PCI, the discharge and/or one year ECGs. Patients were classified in the Q wave persistent group if they had the same number or greater between the post-PCI, the discharge and/or 1 and one year ECGs. All-cause death and heart failure events were assessed for all patients at one year.

Results: There were 323(43%) patients with persistent Q waves (PQ group), 378(49%) patients with Q wave regression (RQ group) and 60(8%) patients with non-Q wave MI (NQ group). Infarct size as measured by the peak creatine kinase was significantly greater in the PQ group compared to the RQ and NQ groups (4633 ± 2784 IU/l vs. 3814 ± 2595 IU/l vs. 1733 ± 1583 IU/l respectively, p < 0.0001). At one year, there were 22 deaths (7%) in the PQ-group, 15 (4%) in the RQ-group and none in the NQ-group (p = 0.04). There was a 4-fold increase in the risk of death or heart failure in the PQ compared to the NQ group (HR 4.7 [1.1; 19.3]; p = 0.03), but there was no significant difference between NQ and RQ groups (HR 3.3 [0.8; 13.8]; p = 0.09).

Conclusion: In a population of anterior STEMI patients, persistent Q waves defined according to the classic ECG criteria after reperfusion was associated with a 4-fold increase in the risk of heart failure or death compared to non-Q-wave MI, while Q-wave regression was associated with significantly lower risk of events.
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http://dx.doi.org/10.1016/j.jelectrocard.2019.09.022DOI Listing
October 2019

Does helicopter transport delay prehospital transfer for STEMI patients in rural areas? Findings from the CRAC France PCI registry.

Eur Heart J Acute Cardiovasc Care 2020 Dec 31;9(8):958-965. Epub 2019 Aug 31.

Cardiology Department, Les Hôpitaux de Chartres, France.

Aims: The aim of this study was to analyse delays in emergency medical system transfer of ST-segment elevation myocardial infarction (STEMI) patients to percutaneous coronary intervention (PCI) centres according to transport modality in a rural French region.

Methods And Results: Data from the prospective multicentre CRAC / France PCI registry were analysed for 1911 STEMI patients: 410 transferred by helicopter and 1501 by ground transport. The primary endpoint was the percentage of transfers with first medical contact to primary percutaneous coronary intervention within the 90 minutes recommended in guidelines. The secondary endpoint was time of first medical contact to primary percutaneous coronary intervention. With helicopter transport, time of first medical contact to primary percutaneous coronary intervention in under 90 minutes was less frequently achieved than with ground transport (9.8% vs. 37.2%; odds ratio 5.49; 95% confidence interval 3.90; 7.73; <0.0001). Differences were greatest for transfers under 50 km (13.7% vs. 44.7%; <0.0001) and for primary transfers (22.4% vs. 49.6%; <0.0001). The median time from first medical contact to primary percutaneous coronary intervention and from symptom onset to primary percutaneous coronary intervention (total ischaemic time) were significantly higher in the helicopter transport group than in the ground transport group (respectively, 137 vs. 103 minutes; <0.0001 and 261 vs. 195 minutes; <0.0001). There was no significant difference in inhospital mortality between the helicopter and ground transport groups (6.9% vs. 6.6%; =0.88).

Conclusions: Helicopter transport of STEMI patients was five times less effective than ground transport in maintaining the 90-minute first medical contact to primary percutaneous coronary intervention time recommended in guidelines, particularly for transfer distances less than 50 km.
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http://dx.doi.org/10.1177/2048872619848976DOI Listing
December 2020

Factors associated with delay in transfer of patients with ST-segment elevation myocardial infarction from first medical contact to catheterization laboratory: Lessons from CRAC, a French prospective multicentre registry.

Arch Cardiovasc Dis 2019 Jan 14;112(1):3-11. Epub 2019 Jan 14.

Unité régionale d'épidémiologie hospitalière (UREH), 37044 Tours, France.

Background: It is critical to minimize the time between the first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

Aims: To identify factors associated with a delay of>120min between first medical contact and primary percutaneous coronary intervention in patients with ST-segment elevation myocardial infarction.

Methods: Data were analysed from a regional French registry of patients undergoing coronary angioplasty for ST-segment elevation myocardial infarction<24h after symptom onset. Patients (n=2081) were grouped according to transfer times from first medical contact to primary percutaneous coronary intervention:>120min; or≤120min. Independent predictors of delay were identified by univariate and multivariable analyses.

Results: The median transfer time from first medical contact to primary percutaneous coronary intervention was 112min; 892 patients (42.9%) had a transfer time>120min. A delay of>120min was significantly associated with:≥75km distance from interventional cardiology centre at symptom onset (odds ratio 7.9); more than one medical practitioner involved before interventional cardiology centre (odds ratio 4.5); first admission to a hospital without an interventional cardiology centre (odds ratio 2.9); absence of emergency call (odds ratio 1.6); ≥90min between symptom onset and first medical contact (odds ratio 1.3); Killip class at admission>1 (odds ratio 1.8); lateral ischaemia (odds ratio 1.8); diabetes mellitus (odds ratio 1.6); and hypertension (odds ratio 1.3).

Conclusions: In ST-segment elevation myocardial infarction, a transfer time from first medical contact to primary percutaneous coronary intervention of>120min was associated with geographic, systemic and comorbid factors, several of which appear reasonably actionable.
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http://dx.doi.org/10.1016/j.acvd.2018.04.008DOI Listing
January 2019

Current indications for the intra-aortic balloon pump: The CP-GARO registry.

Arch Cardiovasc Dis 2018 Dec 13;111(12):739-748. Epub 2018 Jun 13.

Université Rennes, Department of cardiology, CHU Rennes, Inserm, LTSI-UMR 1099, 35000 Rennes, France; EA4324, département de cardiologie, optimisation des régulations physiologiques (ORPhy), UFR sciences et techniques, CHU de Brest, 29200 Brest, France; L'institut du Thorax, CHU Nantes, service de cardiologie, 44093 Nantes, France. Electronic address:

Background: Intra-aortic balloon pumps (IABPs) have been used routinely since the 1970s. Recently, large randomized trials failed to show that IABP therapy has meaningful benefit, and international recommendations downgraded its place, particularly in cardiogenic shock.

Aims: The aim of this registry was to describe the contemporary use of IABP therapy, in light of these new data.

Methods: This prospective multicentre registry included 172 patients implanted with an IABP in 19 French cardiac centres in 2015. Baseline characteristics, aetiologies leading to IABP use, and IABP-related and disease-related complications were assessed. In-hospital and 1-year mortality rates were studied.

Results: A total of 172 patients were included (mean age 65.5±12.0 years; 118 men [68.6%]). The reasons for IABP implantation were mainly haemodynamic (n=107; 62.2%), followed by bridge to revascularization (n=34; 19.8%) and four other "rare" aetiologies (n=29 patients; 16.8%). In-hospital and 1-year mortality rates were 40.7% and 45.8%, respectively. Fourteen patients (8.1%) experienced ischaemic or haemorrhagic complications, which were directly related to the IABP in seven patients (4.1%).

Conclusions: Despite current international guidelines regarding the place of IABPs in ischaemic cardiogenic shock without mechanical complications, this aetiology remains the leading cause for its utilization in the contemporary era.
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http://dx.doi.org/10.1016/j.acvd.2018.03.011DOI Listing
December 2018

Characteristics of stent thrombosis in bifurcation lesions analysed by optical coherence tomography.

EuroIntervention 2018 04 6;13(18):e2174-e2181. Epub 2018 Apr 6.

Cardiology Department, Institut Mutualiste Montsouris, Paris, France.

Aims: This work aimed to investigate a cohort of patients presenting with stent thrombosis (ST) explored by optical coherence tomography (OCT) to identify the underlying mechanical abnormalities in case of bifurcation lesions.

Methods And Results: The PESTO study was a prospective national registry involving 29 French catheterisation facilities. Patients with acute coronary syndromes were prospectively screened for presence of definite ST and analysed by OCT after culprit lesion reopening. The cohort involved 120 subjects, including 21 patients (17.5% of the global PESTO group; median age: 62.6 yrs; 76% male) with bifurcation lesions. The clinical presentation was acute or subacute ST in 34%, late ST in 5% and very late ST in 62% of the patients. The main underlying mechanisms were strut malapposition in 33%, stent underexpansion in 19% and isolated strut uncoverage in 19% of the cases. The proximal main branch was involved in 71%, distal main branch in 52% and jailed side branch in 5% of the patients.

Conclusions: In this cohort, bifurcation lesions represented a limited number of all ST cases. Different sections of the bifurcation could be involved. Although the underlying mechanisms were various, strut malapposition was the most frequently observed cause.
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http://dx.doi.org/10.4244/EIJ-D-17-00794DOI Listing
April 2018

Smartphones to Assess Cardiac Function: Novelty Blindness or Fresh Perspectives?

Crit Care Med 2017 11;45(11):e1199-e1201

MiCo, Denens, Switzerland; Department of Cardiology, Les hôpitaux de Chartres, Chartres, France; Department of Anesthesia and Critical Care, Pellegrin Hospital, Bordeaux, France.

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http://dx.doi.org/10.1097/CCM.0000000000002638DOI Listing
November 2017

Antiplatelet Drug Regimen in Patients With Stent Thrombosis - Insights From the PESTO French Optical Coherence Tomography Registry.

Circ J 2017 Sep 23;81(10):1469-1476. Epub 2017 May 23.

Cardiology Department, CHU Clermont-Ferrand.

Background: Stent thrombosis (ST) may be triggered by different phenomena, including underlying device abnormalities and modification of the antiplatelet therapy (APT) regimen. This work investigated the characteristics of APT regimens and their relationships with ST mechanisms among a large cohort of patients evaluated by optical coherence tomography (OCT).Methods and Results:A prospective multicenter registry was screened for patients with confirmed ST. OCT was performed after the initial intervention to the culprit lesion. ST was classified as acute (AST), subacute (SAST), late (LST) and very late (VLST). OCT records were analyzed in a central core laboratory. A total of 120 patients (median age 62 years, 89% male) were included in the study. VLST was the clinical presentation in 75%, LST in 6% and SAST+AST in 19% of the patients. Single APT (SAPT) was given in 61%, double APT (DAPT) in 27% and no APT in 12% of the cases at the time of the ST. A recent (≤15 days) APT modification was reported in 22% of the patients. An underlying mechanical abnormality was identified by OCT in 96.7% of the cases. Ruptured neoatherosclerotic lesions were significantly more frequent in patients without APT compared with the others.

Conclusions: ST mostly occurs in patients receiving DAPT or SAPT. Any underlying mechanical abnormality of ST can be involved, irrespective of the APT regimen.
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http://dx.doi.org/10.1253/circj.CJ-17-0181DOI Listing
September 2017

Mechanical abnormalities associated with first- and second-generation drug-eluting stent thrombosis analyzed by optical coherence tomography in the national PESTO French registry.

Int J Cardiol 2017 Jan 9;227:161-165. Epub 2016 Nov 9.

Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand, France.

Background And Objectives: DES thrombosis may be triggered by different mechanisms that are difficult to identify by angiography alone. This work aimed to investigate and compare the characteristics of stent thrombosis (ST) between 1st- and 2nd-generation drug-eluting stents (DES) among a large cohort of patients explored by optical coherence tomography (OCT).

Methods And Results: The PESTO study was a prospective national registry involving 29 French catheterization facilities. Patients with acute coronary syndromes were prospectively screened for presence of definite ST and analyzed by OCT after culprit lesion deocclusion. The analysis involved 71 subjects including 34 patients with 1st-generation DES (DES1G) and 35 patients with 2nd-generation DES (DES2G). Most patients (80%) presented with very late stent thrombosis. The median time between initial PCI and ST was longer in DES1G than DES2G patients (3.8 [2.6-6.5] years vs. 1.1 [0.04-2.3] years, p<0.0001). OCT identified an underlying morphological abnormality in 96% of the cases. Significant malapposition was the main abnormality observed either in DES1G (26%) or DES2G patients (35%). Ruptured neoatherosclerotic lesions were more frequently observed with DES1G than with DES2G (26% vs. 3%, p=0.008). There was no significant difference in percentage of malapposed struts and uncovered struts between groups.

Conclusions: In this registry, DES thrombosis mainly occurred ≥1year after initial PCI. OCT identified a mechanical abnormality in the vast majority of the cases. Similar causes were observed between DES1G and DES2G, but neoatherosclerotic lesions were more common in DES1G.
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http://dx.doi.org/10.1016/j.ijcard.2016.11.084DOI Listing
January 2017

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

Lancet 2016 Oct 28;388(10055):2015-2022. Epub 2016 Aug 28.

Sorbonne Université-Paris 06, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (AP-HP), Paris, France.

Background: Elderly patients are at high risk of ischaemic and bleeding events. Platelet function monitoring offers the possibility to individualise antiplatelet therapy to improve the therapeutic risk-benefit ratio. We aimed to assess the effect of platelet function monitoring with treatment adjustment in elderly patients stented for an acute coronary syndrome.

Methods: We did this multicentre, open-label, blinded-endpoint, randomised controlled superiority study at 35 centres in France. Patients aged 75 years or older who had undergone coronary stenting for acute coronary syndrome were randomly assigned (1:1), via a central interactive voice-response system based on a computer-generated permuted-block randomisation schedule with randomly selected block sizes, to receive oral prasugrel 5 mg daily with dose or drug adjustment in case of inadequate response (monitoring group) or oral prasugrel 5 mg daily with no monitoring or treatment adjustment (conventional group). Randomisation was stratified by centre. Platelet function testing was done 14 days after randomisation and repeated 14 days after treatment adjustment in patients in the monitoring group. Study investigators and patients were not masked to treatment allocation, but allocation was concealed from an independent clinical events committee responsible for endpoint adjudication. The primary endpoint was a composite of cardiovascular death, myocardial infarction, stroke, stent thrombosis, urgent revascularisation, and Bleeding Academic Research Consortium-defined bleeding complications (types 2, 3, or 5) at 12 months' follow-up. We did analysis by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01538446.

Findings: Between March 27, 2012, and May 19, 2015, we randomly assigned 877 patients to the monitoring group (n=442) or the conventional group (n=435). The primary endpoint occurred in 120 (28%) patients in the monitoring group compared with 123 (28%) patients in the conventional group (hazard ratio [HR], 1·003, 95% CI 0·78-1·29; p=0·98). Rates of bleeding events did not differ significantly between groups.

Interpretation: Platelet function monitoring with treatment adjustment did not improve the clinical outcome of elderly patients treated with coronary stenting for an acute coronary syndrome. Platelet function testing is still being used in many centres and international guidelines still recommend platelet function testing in high-risk situations. Our study does not support this practice or these recommendations.

Funding: Eli Lilly and Company, Daiichi Sankyo, Stentys, Accriva Diagnostics, Medtronic, and Fondation Coeur et Recherche.
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http://dx.doi.org/10.1016/S0140-6736(16)31323-XDOI Listing
October 2016

Comparison of Immediate With Delayed Stenting Using the Minimalist Immediate Mechanical Intervention Approach in Acute ST-Segment-Elevation Myocardial Infarction: The MIMI Study.

Circ Cardiovasc Interv 2016 Mar;9(3):e003388

From the Departments of Cardiology and Radiology, Centre Hospitalier Annecy-Genevois, Annecy, France (L. Belle, L.M., A.M.); Department of Cardiology, University Hospital of Clermont-Ferrand, Clermont-Ferrand, France (P.M., G.S.); Department of Cardiology, Les Hôpitaux de Chartres, Eure-et-Loir, France (G.R.); Department of Cardiology, Centre Hospitalier de Vichy, Vichy, France (X.M., N.F.); Department of Cardiology, Centre Hospitalier St Luc St Joseph, Lyon, France (O.D.); Department of Cardiology, Centre Hospitalier de Cannes, Cannes, France (G.Z.); Department of Cardiology, Institut Mutualiste Monsouris, Paris, France (C.C., N.A.); Department of Cardiology, Hopital Nord, University hospital of Saint-Étienne, Saint-Étienne, France (K.I.); Department of Cardiology, Centre Hospitalier Universitaire de La Croix Rousse, Lyon, France (R.D.); Department of Cardiology, Clinique Saint Hilaire, Rouen, France (R.K.); Department of Cardiology, Clinique Convert, Bourg en Bresse, France (C.R.); Cardiovascular Institute, Groupe Hospitalier Mutualiste, Grenoble, France (B.F.); Department of Cardiology, Centre Hospitalier Universaitaire Marseille Nord, France (L. Bonello); Department of Cardiology, Hôpital de Valence, Valence, France (S.C.); Department of Cardiology, Hôpital Cardiologique, Lille university hospital, Lille, France (C.D.); Department of Cardiology, Hospital of Macon, Macon, France (F.C.); Department of Cardiology, Clinical Investigation Center, INSERM 1407, Hôpital Cardiovasculaire Louis Pradel, Lyon, France (N.M.); Clinical Investigation Centre, University Hospital of Grenoble, Grenoble, France (C.G., J.L.B.); and Department of Radiology, Hôpital Nord, University Hospital of Saint-Étienne, Saint-Étienne, France (M.V., P.C.).

Background: Delayed stent implantation after restoration of normal epicardial flow by a minimalist immediate mechanical intervention aims to decrease the rate of distal embolization and impaired myocardial reperfusion after percutaneous coronary intervention. We sought to confirm whether a delayed stenting (DS) approach (24-48 hours) improves myocardial reperfusion, versus immediate stenting, in patients with acute ST-segment-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

Methods And Results: In the prospective, randomized, open-label minimalist immediate mechanical intervention (MIMI) trial, patients (n=140) with ST-segment-elevation myocardial infarction ≤12 hours were randomized to immediate stenting (n=73) or DS (n=67) after Thrombolysis In Myocardial Infarction 3 flow restoration by thrombus aspiration. Patients in the DS group underwent a second coronary arteriography for stent implantation a median of 36 hours (interquartile range 29-46) after randomization. The primary end point was microvascular obstruction (% left ventricular mass) on cardiac magnetic resonance imaging performed 5 days (interquartile range 4-6) after the first procedure. There was a nonsignificant trend toward lower microvascular obstruction in the immediate stenting group compared with DS group (1.88% versus 3.96%; P=0.051), which became significant after adjustment for the area at risk (P=0.049). Median infarct weight, left ventricular ejection fraction, and infarct size did not differ between groups. No difference in 6-month outcomes was apparent for the rate of major cardiovascular and cerebral events.

Conclusions: The present findings do not support a strategy of DS versus immediate stenting in patients with ST-segment-elevation infarction undergoing primary percutaneous coronary intervention and even suggested a deleterious effect of DS on microvascular obstruction size.

Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01360242.
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http://dx.doi.org/10.1161/CIRCINTERVENTIONS.115.003388DOI Listing
March 2016

Clinical Outcome of First- vs Second-Generation DES According to DAPT Duration: Results of ARCTIC-Generation.

Clin Cardiol 2016 Apr 16;39(4):192-200. Epub 2016 Feb 16.

Univ Paris 06 (UPMC), ACTION Study Group, Institut de Cardiologie, Hôpital Pitié-Salpêtrière (APHP), Paris, France.

There is an apparent benefit with extension of dual antiplatelet therapy (DAPT) beyond 1 year after implantation of drug-eluting stents (DES). Assessment by a Double Randomization of a Conventional Antiplatelet Strategy vs a Monitoring-Guided Strategy for Drug-Eluting Stent Implantation, and of Treatment Interruption vs Continuation One Year After Stenting (ARCTIC)-Generation assessed whether there is a difference of outcome between first- vs second-generation DES and if there is an interaction with DAPT duration in the ARCTIC-Interruption study. ARCTIC-Interruption randomly allocated 1259 patients 1 year after stent implantation to a strategy of interruption of DAPT (n = 624), in which aspirin antiplatelet treatment only was maintained, or DAPT continuation (n = 635) for 6 to 18 additional months. The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization. A total of 520 and 722 patients received a first- and a second-generation DES, respectively. After a median follow-up of 17 months (interquartile range, 15-18 months) after randomization, the primary endpoint occurred in 32 (6.2%) and 19 (2.6%) patients with first- and second-generation DES, respectively (hazard ratio: 2.31, 95% confidence interval: 1.31-4.07, P = 0.004). This was observed irrespective of the strategy of interruption or continuation of DAPT and timing of study recruitment. Major bleeding events occurred in 4 (0.8%) and 3 patients (0.4%) with first- and second-generation DES, respectively (hazard ratio: 1.79, 95% confidence interval: 0.40-8.02, P = 0.44). Results did not change after multiple adjustments for potential confounding variables. ARCTIC-Generation showed worse clinical outcome with first- vs second-generation DES, a difference that appeared to persist even with prolonged DAPT.
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http://dx.doi.org/10.1002/clc.22512DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6490771PMC
April 2016

Mechanisms of stent thrombosis analysed by optical coherence tomography: insights from the national PESTO French registry.

Eur Heart J 2016 Apr 12;37(15):1208-16. Epub 2016 Jan 12.

Cardiology Department, CHU Clermont-Ferrand, Clermont-Ferrand 63000, France Cardio Vascular Interventional Therapy and Imaging (CaVITI), UMR CNRS 6284, Auvergne University, Clermont-Ferrand, France.

Aims: Angiography has limited value for identifying the causes of stent thrombosis (ST). We studied a large cohort of patients by optical coherence tomography (OCT) to explore ST characteristics and mechanisms.

Methods And Results: A prospective multicentre registry was screened for patients with confirmed ST. Optical coherence tomography was performed after initial intervention to the culprit lesion (in 69% of cases in a deferred procedure). Stent thrombosis was classified as acute (AST), sub-acute (SAST), late (LST), and very late (VLST). Optical coherence tomography records were analysed in a central core lab. The analysis included 120 subjects aged 61.7 [51.4-70.7]; 89% male. Very late ST was the clinical presentation in 75%, LST in 6%, SAST in 15%, and AST in 4% of patients. Bare metal stents (BMS) were used in 39%, drug-eluting stents (DES) in 59% and bioresorbable vascular scaffolds in 2% of the cases. Optical coherence tomography identified an underlying morphological abnormality in 97% of cases, including struts malapposition (34%), neoatherosclerotic lesions (22%), major stent underexpansion (11%), coronary evagination (8%), isolated uncovered struts (8%), edge-related disease progression (8%), and neointimal hyperplasia (4%). Ruptured neoatherosclerotic lesions were more frequent with BMS than with DES (36 vs. 14%, P = 0.005), whereas coronary evaginations were more frequent with DES than with BMS (12 vs. 2%, P = 0.04). LST + VLST were mainly related to malapposition (31%) and neoatherosclerosis (28%), while prominent mechanisms for AST + SAST were malapposition (48%) and underexpansion (26%).

Conclusion: In patients with confirmed ST, OCT imaging identified an underlying morphological abnormality in 97% of cases.
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http://dx.doi.org/10.1093/eurheartj/ehv711DOI Listing
April 2016

Management of Takotsubo cardiomyopathy in non-academic hospitals in France: The Observational French SyndromEs of TakoTsubo (OFSETT) study.

Arch Cardiovasc Dis 2016 Jan 23;109(1):4-12. Epub 2015 Oct 23.

Department of Cardiology, Douai Hospital, 59500 Douai, France.

Background: Takotsubo cardiomyopathy (TTC) is a rare condition characterized by a sudden temporary weakening of the heart. TTC can mimic acute myocardial infarction and is associated with a minimal release of myocardial biomarkers in the absence of obstructive coronary artery disease.

Aims: To provide an extensive description of patients admitted to hospital for TTC throughout France and to study the management and outcomes of these patients.

Methods: In 14 non-academic hospitals, we collected clinical, electrocardiographic, biological, psychological and therapeutic data in patients with a diagnosis of TTC according to the Mayo Clinic criteria.

Results: Of 117 patients, 91.5% were women, mean ± SD age was 71.4 ± 12.1 years and the prevalence of risk factors was high (hypertension: 57.9%, dyslipidaemia: 33.0%, diabetes: 11.5%, obesity: 11.5%). The most common initial symptoms were chest pain (80.5%) and dyspnoea (24.1%). A triggering psychological event was detected in 64.3% of patients. ST-segment elevation was found in 41.7% of patients and T-wave inversion in 71.6%. Anterior leads were most frequently associated with ST-segment elevation, whereas T-wave inversion was more commonly associated with lateral leads, and Q-waves with septal leads. The ratio of peak B-type natriuretic peptide (BNP) or N-terminal prohormone BNP (NT-proBNP) level to peak troponin level was 1.01. No deaths occurred during the hospital phase. After 1 year of follow-up, 3 of 109 (2.8%) patients with available data died, including one cardiovascular death. Rehospitalizations occurred in 17.4% of patients: 2.8% due to acute heart failure and 14.7% due to non-cardiovascular causes. There was no recurrence of TTC.

Conclusions: This observational study of TTC included primarily women with atherosclerotic risk factors and mental stress. T-wave inversion was more common than ST-segment elevation. There were few adverse cardiovascular outcomes in these patients after 1-year follow-up.
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http://dx.doi.org/10.1016/j.acvd.2015.08.004DOI Listing
January 2016

Cyclosporine before PCI in Patients with Acute Myocardial Infarction.

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

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

Background: Experimental and clinical evidence suggests that cyclosporine may attenuate reperfusion injury and reduce myocardial infarct size. We aimed to test whether cyclosporine would improve clinical outcomes and prevent adverse left ventricular remodeling.

Methods: In a multicenter, double-blind, randomized trial, we assigned 970 patients with an acute anterior ST-segment elevation myocardial infarction (STEMI) who were undergoing percutaneous coronary intervention (PCI) within 12 hours after symptom onset and who had complete occlusion of the culprit coronary artery to receive a bolus injection of cyclosporine (administered intravenously at a dose of 2.5 mg per kilogram of body weight) or matching placebo before coronary recanalization. The primary outcome was a composite of death from any cause, worsening of heart failure during the initial hospitalization, rehospitalization for heart failure, or adverse left ventricular remodeling at 1 year. Adverse left ventricular remodeling was defined as an increase of 15% or more in the left ventricular end-diastolic volume.

Results: A total of 395 patients in the cyclosporine group and 396 in the placebo group received the assigned study drug and had data that could be evaluated for the primary outcome at 1 year. The rate of the primary outcome was 59.0% in the cyclosporine group and 58.1% in the control group (odds ratio, 1.04; 95% confidence interval [CI], 0.78 to 1.39; P=0.77). Cyclosporine did not reduce the incidence of the separate clinical components of the primary outcome or other events, including recurrent infarction, unstable angina, and stroke. No significant difference in the safety profile was observed between the two treatment groups.

Conclusions: In patients with anterior STEMI who had been referred for primary PCI, intravenous cyclosporine did not result in better clinical outcomes than those with placebo and did not prevent adverse left ventricular remodeling at 1 year. (Funded by the French Ministry of Health and NeuroVive Pharmaceutical; CIRCUS ClinicalTrials.gov number, NCT01502774; EudraCT number, 2009-013713-99.).
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http://dx.doi.org/10.1056/NEJMoa1505489DOI Listing
September 2015

Genetic and platelet function testing of antiplatelet therapy for percutaneous coronary intervention: the ARCTIC-GENE study.

Eur J Clin Pharmacol 2015 Nov 13;71(11):1315-24. Epub 2015 Aug 13.

ACTION Study Group, Institut de Cardiologie, INSERM_UMRS 1166, Pitié-Salpêtrière Hospital (APHP), Sorbonne Universités UPMC (Paris 6), Paris, France.

Background: The ARCTIC study randomized 2440 patients scheduled for stent implantation to a strategy of platelet function monitoring with drug adjustment in patients who had a poor response to antiplatelet therapy or to a conventional strategy without monitoring and drug adjustment. No significant improvement in clinical outcomes with platelet function monitoring was observed.

Objective: The purpose of this study is to assess the relationships between CYP2C19 genotypes, clopidogrel pharmacodynamic response, and clinical outcome.

Methods And Results: In the ARCTIC-GENE study, 1394 patients were genotyped for loss- and gain-of-function CYP2C19 alleles. Randomization of treatment strategy was well balanced. Slow metabolizers identified as carriers of at least one loss-of-function allele CYP2C19*2 (n = 459) were more likely poor responders at randomization (41.6 vs. 31.6%, p = 0.0112) and 14 days later (23.8 vs. 10.4%, p < 0.0001) and more frequently on prasugrel (11.5 vs. 8.1%, p = 0.039) as compared with rapid metabolizers (n = 935). Intensification of antiplatelet treatment did not differ between slow and rapid metabolizers according to the study algorithm based on platelet function only. The primary study outcome defined as the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularization 1 year after stent implantation did not differ between slow and rapid metabolizers (HR 0.988, 95% CI [0.812;1.202], p = 0.90). Likewise, the primary safety outcome did not differ between rapid and slow metabolizer phenotype.

Conclusions: The genetic clopidogrel profile was a good marker of platelet function response on clopidogrel but was not related to clinical outcome suggesting that the genetic added little to the pharmacodynamic information used in the study to adjust antiplatelet therapy. ClinicalTrials.gov: NCT00827411.
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http://dx.doi.org/10.1007/s00228-015-1917-9DOI Listing
November 2015

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

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

Hôpital de La Cavale Blanche, Brest, France.

Background: Both acute myocardial ischemia and reperfusion contribute to cardiomyocyte death in ST-elevation myocardial infarction (STEMI). The final infarct size is the principal determinant of subsequent clinical outcome in STEMI patients. In a proof-of-concept phase II trial, the administration of cyclosporine prior to primary percutaneous coronary intervention (PPCI) has been associated with a reduction of infarct size in STEMI patients.

Methods: CIRCUS is an international, prospective, multicenter, randomized, double-blinded, placebo-controlled trial. The study is designed to compare the efficacy and safety of cyclosporine versus placebo, in addition to revascularization by PPCI, in patients presenting with acute anterior myocardial infarction within 12 hours of symptoms onset and initial TIMI flow ≤1 in the culprit left anterior descending coronary artery. Patients are randomized in a 1:1 fashion to 2.5 mg/kg intravenous infusion of cyclosporine or matching placebo performed in the minutes preceding PCI. The primary efficacy end point of CIRCUS is a composite of 1-year all-cause mortality, rehospitalization for heart failure or heart failure worsening during initial hospitalization, and left ventricular adverse remodeling as determined by sequential transthoracic echochardiography. Secondary outcomes will be tested using a hierarchical sequence of left ventricular (LV) ejection fraction and absolute measurements of LV volumes. The composite of death and rehospitalization for heart failure or heart failure worsening during initial hospitalization will be further assessed at three years after the initial infarction.

Results: Recruitment lasted from April 2011 to February 2014. The CIRCUS trial has recruited 975 patients with acute anterior myocardial infarction. The 12-months results are expected to be available in 2015.

Conclusions: The CIRCUS trial is testing the hypothesis that cyclosporine in addition to early revascularization with PPCI compared to placebo in patients with acute anterior myocardial infarction reduces the incidence of death, heart failure and adverse LV remodeling at one-year follow-up.
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http://dx.doi.org/10.1016/j.ahj.2015.02.020DOI Listing
June 2015

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

Am Heart J 2014 Nov 7;168(5):674-81. Epub 2014 Aug 7.

Institut de Cardiologie, Hôpital Pitié-Salpêtrière, Paris, France. Electronic address:

Background: Elderly patients are at high risk for both ischemic and bleeding events. Platelet monitoring offers the opportunity to individualized antiplatelet therapy to optimize the therapeutic risk/benefit ratio.

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

Conclusion: ANTARCTIC is a nationwide, prospective, open-label study testing a strategy of platelet function monitoring with dose and drug adjustment to reduce ischemic and bleeding complications in elderly ACS patients undergoing coronary stenting.
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http://dx.doi.org/10.1016/j.ahj.2014.07.026DOI Listing
November 2014