Collet J.-P.,Institut Universitaire de France |
Silvain J.,Institut Universitaire de France |
Barthelemy O.,Institut Universitaire de France |
Range G.,Les Hopitaux de Chartres |
And 20 more authors.
The Lancet | Year: 2014
Background: Optimum duration of dual antiplatelet treatment (DAPT) after coronary stenting remains uncertain, with an unknown efficacy to safety ratio of extended treatment leading to discrepancies between international guidelines and clinical practice. We assessed whether DAPT continuation beyond 1 year after coronary stenting is beneficial. Methods: This analysis was a planned extension of the previously published ARCTIC-Monitoring trial, in which we randomly allocated 2440 patients to a strategy of platelet function testing with antiplatelet treatment adjustment or a conventional strategy after coronary stenting with drug-eluting stent (DES). We recruited patients (aged 18 years or older) scheduled for planned DES implantation at 38 centres in France. After 1 year of follow-up, patients without contraindication to interruption of DAPT were eligible for a second randomisation to this second phase of the study (ARCTIC-Interruption). Using a computer-generated randomisation sequence (1:1; stratified by centre), we allocated patients to a strategy of interruption of DAPT where the thienopyridine was interrupted and single aspirin antiplatelet treatment was maintained (interruption group) or a strategy of DAPT continuation for 6-18 months (continuation group). The primary endpoint was the composite of death, myocardial infarction, stent thrombosis, stroke, or urgent revascularisation, analysed by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00827411. Findings: Between Jan 4, 2011, and March 3, 2012, 1259 eligible patients were randomly allocated to treatment in ARCTIC-Interruption: 624 to the interruption group and 635 to the continuation group. After a median follow-up of 17 months (IQR 15-18), the primary endpoint occurred in 27 (4%) patients in the interruption group and 24 (4%) patients in the continuation group (hazard ratio [HR] 1·17 [95% CI 0.68-2.03]; p=0.58). STEEPLE major bleeding events occurred more often in the continuation group (seven [1%] patients) compared with the interruption group (one [<0.5%] patient; HR 0.15 [0.02-1.20]; p=0.073). Major or minor bleedings were also more common in the continuation group compared with the interruption group (12 [2%] patients vs three [1%] patients; HR 0.26 [0.07-0.91]; p=0.04). Interpretation: Our finding suggests no apparent benefit but instead harm with extension of DAPT beyond 1 year after stenting with DES when no event has occurred within the first year after stenting. No conclusion can be drawn for high-risk patients who could not be randomised. The consistency between findings from all trials of such interruption suggests the need for a reappraisal of guidelines for DAPT after coronary stenting towards shorter duration of treatment. Funding: Allies in Cardiovascular Trials Initiatives and Organized Networks (ACTION Study Group), Fondation de France, Sanofi-Aventis, Cordis, Medtronic, Boston Scientific, Fondation SGAM.
Modine T.,CHRU de Lille |
Obadia J.F.,CHRU de Lyon |
Choukroun E.,CHRU de Bordeaux |
Rioufoul G.,CHRU de Lyon |
And 3 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2011
Objective: Retrograde transfemoral artery catheterization is the most common way of implanting a percutaneous aortic valve. But in some cases, this access cannot be used and the subclavian artery access may represent an alternative to the femoral route, even offering certain advantages. This article describes prosthetic aortic valve implantation using the subclavian arterial approach and reports the findings. Methods: The valve prosthesis is a self-expandable, nitinol-based device (CoreValve; Medtronic Inc. Minneapolis, Minn). The axillary or subclavian artery was exposed with a small incision. Rapid ventricular pacing was used to reduce cardiac output while a routine aortic balloon valvuloplasty was performed. Then, an 18F sheath was inserted into the axillary artery down into the ascending aorta. By using this method, a prosthesis was implanted in 17 patients (aged 71 ± 11 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications. Results: Subclavian arterial injury did not occur in any patient. The postprocedural aortic valve area increased from 0.6 ± 0.3 cm 2 to 1.44 ± 0.35 cm2. A transient ischemic attack occurred in 1 patient. Two patients experienced transitory brachial plexus deficit. There were no intraprocedural deaths. Two deaths occurred in the 30-day follow-up period. Conclusions: This initial experience suggests that subclavian transarterial aortic valve implantation, in selected high-risk patients, is feasible and safe with satisfactory short-term outcomes. Copyright © 2011 by The American Association for Thoracic Surgery.
Modine T.,CHRU de Lille |
Sudre A.,CHRU de Lille |
Collet F.,Clinque Clairval |
Delhaye C.,CHRU de Lille |
And 3 more authors.
Journal of Thoracic and Cardiovascular Surgery | Year: 2012
Objective: Both retrograde femoral and subclavian artery catheterization techniques have been described as the most common methods for the implantation of the Medtronic CoreValve percutaneous aortic valve (Medtronic Inc, Minneapolis, Minn). The subclavian artery has been shown to be a safe and effective alternative access route in patients with unfavorable femoral access. Of the patients who are identified as candidates for subclavian artery access, a subset possess a patent left internal thoracic artery to left anterior descending artery. This patent left internal thoracic artery presents an additional anatomic and clinical variable that must be taken into consideration to ensure procedural safety and efficacy. We describe the Medtronic CoreValve percutaneous aortic valve implantation using the subclavian arterial approach in patients with a patent left internal thoracic artery and report our study's findings. Methods: The CoreValve percutaneous aortic valve is a self-expandable nitinol-based frame with a porcine pericardial valve. The subclavian access was created by a small infraclavicular surgical incision to expose the artery. Rapid ventricular pacing was used to reduce cardiac output to perform the balloon aortic valvuloplasty via a 12F sheath inserted into the subclavian artery. An 18F sheath was then inserted into the artery down into the ascending aorta and used for introduction of the delivery catheter and implantation of the percutaneous aortic valve. Results: With the use of this method, 19 patients (76 ± 13 years) whose surgical risk was deemed excessive because of severe comorbidity and in whom transfemoral catheterization was considered unfeasible or at risk of severe complications have received implants. Subclavian artery or left internal thoracic artery injury did not occur in any patient. Two deaths occurred. One patient died of right coronary artery occlusion during the procedure, and one patient died 48 hours after the procedure as the result of a tamponade after the temporary pacemaker wire ablation. Conclusions: This initial experience suggests that subclavian transarterial aortic valve implantation in patients with a patent left internal thoracic artery to left anterior descending artery is feasible and safe with satisfactory short-term outcomes. Copyright © 2012 by The American Association for Thoracic Surgery.
Dimopoulos M.A.,National and Kapodistrian University of Athens |
Beksac M.,Ankara University |
Benboubker L.,Center Regional Of Cancerologie |
Roddie H.,Western General Hospital |
And 6 more authors.
Haematologica | Year: 2013
This phase II study is the first prospective evaluation of bortezomib-dexamethasone as second-line therapy for relapsed/refractory multiple myeloma. A total of 163 patients were enrolled to receive four cycles of bortezomibdexamethasone. Patients were investigator-assessed for response at cycle 5 Day 1, then treated as follows: responding patients received another four cycles of bortezomib-dexamethasone, while patients with stable disease were subsequently randomized to sequential treatment with a further four cycles of bortezomib-dexamethasone alone or with added cyclophosphamide or lenalidomide. The primary end point was response to sequential therapy; however, this could not be evaluated because investigator-assessed response rates to bortezomib-dexamethasone after four cycles were high, and an insufficient number of patients were randomized to sequential treatment per protocol. Among all 163 patients, validated best confirmed response rate was 66%, including 37% complete/very good partial responses; median response duration was 9.7 months. After a median follow up of 16.9 months, median time to progression and progression-free survival were 9.5 and 8.6 months, respectively; estimated 1-year overall survival was 81%. Median glomerular filtration rate improved from baseline during treatment. Among 58 patients with baseline glomerular filtration rate below 50 mL/min, 24 had renal responses. Grade 3/4 adverse events included: thrombocytopenia (17%), anemia (10%), constipation (6%), peripheral sensory neuropathy (5%), and polyneuropathy (5%). Overall, 57% of neuropathy events improved/resolved; median time to improvement was 2.1 months. These findings suggest bortezomib-dexamethasone represents an active, feasible second-line treatment option for patients with relapsed/refractory myeloma.. © 2013 Ferrata Storti Foundation.
Zeymer U.,Herzzentrum Ludwigshafen |
Zeymer U.,Institute Fr Herzinfarktforschung Ludwigshafen |
Margenet A.,CHU Henri Mondor |
Haude M.,Lukas Krankenhaus Neuss |
And 9 more authors.
Journal of the American College of Cardiology | Year: 2010
Objectives: The aim of this study was to compare eptifibatide and abciximab as adjuncts to primary percutaneous coronary intervention (PCI). Background: The glycoprotein (GP) IIb/IIIa receptor inhibitor abciximab as adjunct to primary PCI in patients with ST-segment elevation myocardial infarctions has been shown to reduce ischemic complications and improve clinical outcomes. So far, no trial has been performed to compare the efficacy of another GP IIb/IIIa receptor inhibitor, eptifibatide, and abciximab in primary PCI. Methods: A total of 427 patients with ST-segment elevation myocardial infarctions <12 h and planned primary PCI were randomized to double-bolus eptifibatide (n = 226) followed by a 24-h infusion or single-bolus abciximab (n = 201) followed by a 12-h infusion. In this noninferiority trial, the primary end point was the incidence of complete (<70%) ST-segment resolution (STR) 60 min after PCI, a measure of myocardial reperfusion. The assumption was a 60% complete STR rate in the abciximab group. The noninferiority margin was set to 15%. Results: The incidence of complete STR at 60 min after PCI in the intention-to-treat analysis was 62.6% after eptifibatide and 56.3% after abciximab (adjusted difference: 7.1%; 95% confidence interval: 2.7% to 17.0%). All-cause mortality 6.2% versus 4.5% (p = 0.50); reinfarction 0.4% versus 3.5% (p = 0.03); target vessel revascularization 4.4% versus 6.5% (p = 0.40); the combined end point of death, nonfatal reinfarction, and target vessel revascularization 10.6% versus 10.9% (p = 0.90); stroke 0.5% versus 0.5% (p = 1.00) after 6 months; and Thrombolysis In Myocardial Infarction major bleeding complications 4.0% versus 2.0% (p = 0.20) after 30 days were observed after eptifibatide and abciximab, respectively. Conclusions: Eptifibatide as an adjunct to primary PCI is equally as effective as abciximab with respect to STR. (Efficacy of Eptifibatide Compared to Abciximab in Primary Percutaneous Coronary Intervention [PCI] for Acute ST Elevation Myocardial Infarction [STEMI]; NCT00426751) © 2010 American College of Cardiology Foundation.
Bourgault C.,Orthopedics Unit A |
Vervoort T.,Orthopedics Unit A |
Szymanski C.,Orthopedics Unit A |
Chastanet P.,CHRU de Lille |
Maynou C.,Orthopedics Unit A
Orthopaedics and Traumatology: Surgery and Research | Year: 2014
Introduction: Osteoid osteoma is a painful, benign bone tumor that mainly affects young people. Thermocoagulation is one of the recommended percutaneous treatment methods. This study sought to assess its efficacy and identify risk factors for osteoma recurrence. Methods: Results were analyzed retrospectively for a group of 87 patients treated by thermocoagulation between 2002 and 2011. The recurrence rate was calculated and analyzed relative to patient and tumor characteristics. The treatment efficacy was determined and methods to prevent complications were analyzed. Results: The mean follow-up time was 34 months. The average patient age was 23 years. There were seven complications including three patients with delayed wound healing, mainly at tibial sites. The recurrence rate was 10.4%. The success rate for first-line treatment was 89.6% and it was 97.5% for second-line treatment. Analysis of patient characteristics and tumor locations revealed no risk factors for recurrence. Conclusion: Percutaneous thermocoagulation is a reliable and effective technique that provides fast, long-lasting pain relief. However recurrence can occur even after the nidus is completely resected. These recurrences can be effectively managed by repeat treatment. Recent technical improvements have reduced the risk of thermocoagulation-related complications. Level of evidence: IV. © 2014 Elsevier Masson SAS.
Masson R.,Caen University Hospital Center |
Colas V.,CHRU de Lille |
Parienti J.-J.,Caen University Hospital Center |
Parienti J.-J.,University Paris Diderot |
And 5 more authors.
Resuscitation | Year: 2012
Background: The use of extracorporeal life support (ECLS) as a treatment for severe cardiovascular impairment due to poisoning is unclear. Therefore, we conducted a retrospective cohort analysis to compare survival among critically ill poisoned patients treated with or without ECLS. Methods: All consecutive patients admitted into 2 university hospitals in northwestern France over the past decade for persistent cardiac arrest or severe shock following poisoning due to drug intoxication were included. ECLS was preferentially performed in 1 of the 2 centers. Results: Sixty-two patients (39 women, 23 men; mean age 48 ± 17 years) fulfilled inclusion criteria: 10 with persistent cardiac arrest and 42 with severe shock. Fourteen patients were treated with ECLS and 48 patients with conventional therapies. All subjects received vasopressor and fluid loading. Patients treated with or without ECLS at ICU admission had comparable drug ingestion histories, Simplified Acute Physiology Score (SAPS II score) (66 ± 18), Sequential Organ Failure Assessment (SOFA) score (median: 11 [IQR, 9-13]), Glasgow Coma Scale score (median: 3 [IQR, 3-11]), need for ventilator support (n=56) and extra renal support (n=23). Thirty-five (56%) patients survived: 12/14 (86%) ECLS patients and 23/48 (48%) non-ECLS patients (p=0.02, by Fisher exact test). None of the patients with persistent cardiac arrest survived without ECLS support. Based on admission data, beta-blocker intoxication (p=0.02) was also associated with lower mortality. In multivariate analysis, adjusting for SAPS II and beta-blocker intoxication, ECLS support remained associated with lower mortality [Adjusted Odds Ratio, 0.18; 95% CI, 0.03-0.96; p=0.04]. Conclusion: In the absence of response to conventional therapies, we consider that ECLS may improve survival in critically ill poisoned patients experiencing cardiac arrest and severe shock. © 2012 Elsevier Ireland Ltd.
Perini P.,CHRU De Lille |
Sediri I.,CHRU De Lille |
Midulla M.,CHRU De Lille |
Delsart P.,University of Lille Nord de France |
And 3 more authors.
Journal of Endovascular Therapy | Year: 2012
Purpose: To evaluate contrast-enhanced ultrasound (CEUS) as an effective alternative to computed tomographic angiography (CTA) during follow-up after fenestrated endovascular aneurysm repair (EVAR) of juxtarenal aortic aneurysms. Methods: Between January 2008 and April 2011, 62 patients (all men; mean age 72 years) underwent fenestrated EVAR follow-up with both CTA and CEUS. In a retrospective analysis, the first CTA and CEUS postoperative examinations after EVAR were compared for endoleak detection, aneurysm sac diameter, and target vessel patency. The examinations were performed within 30 days of the procedure and the interval between the 2 scans was ≥7 days. Only fenestrated endografts with up to 3 fenestrations (with or without a scallop) were eligible so that the entire implant could be visualized with standard abdominal ultrasound. Results: The mean diameters of the aneurysm sac were 56.58±8.56 mm with CEUS and 57.70±8.59 mm with CTA. The mean difference in aneurysm sac diameter was -1.13±3.19 mm (95% CI -0.34 to -1.92), with CTA measurements tending to be slightly larger. Bland- Altman plots showed good agreement between the imaging modalities with respect to aneurysm sac diameter (Spearman correlation coefficient rs=0.921, p≤0.01). Endoleaks were detected by CTA in 7 (11.3%) of 62 patients and by CEUS in 6 (9.7%). In 59 (95.16%) cases, the tests agreed, and their equivalence was confirmed by binomial distribution testing. There was complete agreement between CEUS and CTA in the assessment of target vessels (144/146 patent target arteries; 1 had a significant stenosis and another was thrombosed). Conclusion: CEUS is as accurate as CTA in endoleak detection, abdominal aortic aneurysm diameter measurement, and the evaluation of target vessels during surveillance of fenestrated stent-grafts. Although it cannot yet be proposed as the only imaging modality during follow-up, CEUS could be usefully employed with the self-evident advantage of reducing lifetime exposure to ionizing radiation. © 2012 by the International Society of Endovascular Specialists.
The surgical treatment of metastases in the appendicular skeleton [Chirurgie des métastases osseuses du bassin et du squelette appendiculaire The surgical treatment of metastases in the appendicular skeleton]
Szymanski C.,CHRU de Lille
Bulletin du Cancer | Year: 2013
The orthopedic surgical treatment of metastases is very important in the treatment of osteophile cancers. The surgical option is always proposed after a multidisciplinary decision. The main risk of the metastases is the pathological fracture. This risk has to be evaluated and a preventive treatment can often be performed. The surgical options are multiple: such as preventive osteosynthesis, pathological fracture treatment, reconstruction with prosthesis, carcinological excision.̇̇ The choice of the treatment is support on the life expectancy and the functional risk of the metastatic bone lesion.
Puech P.,CHRU de Lille |
Sufana Iancu A.,CHRU de Lille |
Renard B.,CHRU de Lille |
Villers A.,CHRU de Lille |
Lemaitre L.,CHRU de Lille
Diagnostic and Interventional Imaging | Year: 2012
Multiparametric MRI of the prostate is an essential examination for the diagnosis, preoperative evaluation and planning of treatment for prostate cancer. This examination can accurately detect cancer foci in the gland so that the most appropriate management can be offered, reduce the risk of over-treatment and also ensure that certain aggressive lesions or unusual locations, which might affect the prognosis, are not ignored. We present here its main indications, focusing on the techniques for interpreting MRI, its performance and its limitations, as well as the recent European recommendations underlining the need for international harmonisation. © 2012 Published by Elsevier Masson SAS on behalf of the Éditions françaises de radiologie.