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Latest Paper:
Bimmer E Claessen,
Marcel A Beijk,
Victor Legrand,
Witold Ruzyllo,
Antonio Manari,
Olivier Varenne,
Maarten J Suttorp,
Jan G P Tijssen,
Karine Miquel-Hebert,
Susan Veldhof,
Jose P S Henriques,
Patrick W Serruys,
Jan J Piek
Department of Cardiology, Academic Medical Center, University of Amsterdam, The Netherlands; C.H.U. de Liege Sart Tilman, Liege, Belgium; National Institute of Cardiology in Warsaw, Warsaw, Poland; Azienda Ospedaliera Santa Maria Nuova, Reggio Emilia, Italy; Hopital Cochin, Paris, France; St. Antonius Ziekenhuis, Nieuwegein, The Netherlands; Abbott Vascular, Diegem, Belgium; and Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
BACKGROUND: This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial. METHODS AND RESULTS: This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion. Clinical follow-up was planned at 2 years in all patients. A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years. After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (P=0.31). At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group. However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed. There were no significant differences between EES and PES for in-stent late loss (EES, 0.33+/-0.37 mm versus PES, 0.34+/-0.34 mm; P=0.84) and percentage volume obstruction (EES, 5.18+/-6.22% versus PES, 5.80+/-6.31%; P=0.65) at 2 years. The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%). CONCLUSIONS: Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up. There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.
Nicolas Marque,
Arnaud Jégou,
Olivier Varenne,
Emmanuel Salengro,
Philippe Allouch,
Olivier Margot,
Christian Spaulding
Service de cardiologie, hôpital Cochin, 27, rue du Faubourg-Saint-Jacques, 75014 Paris, France.
BACKGROUND: Operator radiation exposure is high during coronary procedures. The radial access decreases the rate of local vascular complications but increases operator radiation exposure. As the X-ray exposure is related to the distance between the operator and the radiation source, the use of an extension tube between the proximal part of the coronary catheter and the 'injection device' might decrease operator radiation exposure. AIMS: To demonstrate that the use of an extension tube during coronary procedures performed through the radial approach decreases operator radiation. METHODS: Overall, 230 patients were included consecutively and randomized to procedures performed with or without an extension tube. Radiation exposure measures were obtained using two electronic dosimeters, one under the lead apron and the other exposed on the physician's left arm. RESULTS: A non-significant trend towards lower left-arm operator exposure was noted in the extension tube group (28.7+/-31.0muSv vs 38.4+/-44.2muSv, p=0.0739). No significant difference was noted according to the type of procedure. Radiation levels were low compared with the series published previously and decreased for each operator during the study. CONCLUSION: The use of an extension tube did not reduce operator radiation exposure during procedures performed through the radial approach. However, physician awareness was increased during the study due to the use of an exposed electronic dosimeter. The use of exposed electronic dosimeters could therefore be recommended to allow operators to improve their protection techniques.
Erasmus Medical Center, Rotterdam, The Netherlands.
Background: Randomised studies have demonstrated the beneficial effect of drug-eluting stents in reducing repeat revascularisation at one year. However, they were individually underpowered to assess long-term safety endpoints such as death and myocardial infarction. The long-term safety of drug-eluting stents has been recently questioned.Methods and results: We performed a pooled analysis of 2,797 patients included in four randomised trials to assess the safety of slow-release paclitaxel-eluting stents as compared with bare metal stents. Patient level data were obtained and analysed by two independent academic statistical institutions. The primary safety endpoint was survival at four years. Secondary endpoints were myocardial infarction and stent thrombosis. Heterogeneities in treatment effect were tested in subgroups.Survival at four years was 93.4% in the paclitaxel-eluting stent group versus 93.0% in the bare-metal stent group (Hazard ratio for survival 0.95; 95% confidence interval [CI] 0.96 - 1.30; P=0.75). Myocardial infarction occurred at a similar rate between both treatment groups. Whereas the total rates of stent thrombosis were equal between the two groups, there was a trend towards a higher rate of stent thrombosis occurring after repeat target lesion revascularisation in the bare-metal stent group. No heterogeneity of treatment effect was found in the subgroups, including diabetic patients and complex lesions.Conclusions: In a pooled analysis of four trials comparing paclitaxel-eluting stents with bare metal stents, no significant differences were found in the rates of death, myocardial infarction or stent thrombosis.
Hervé Gouya,
Olivier Varenne,
Ludovic Trinquart,
Emmanuel Touzé,
Olivier Vignaux,
Christian Spaulding,
Jean-Louis Mas,
Jean-Louis Sablayrolles
Departments of Radiology and Cardiology, University René Descartes Paris V, Hôpital Cochin, 27 rue du Faubourg Saint Jacques, 75679 Paris Cedex 14, France; Department of Neurology, University René Descartes Paris V, Hôpital Saint Anne, Paris, France; Epidemiology and Clinical Research Unit, INSERM CIE4, Hôpital Européen Georges Pompidou, Paris, France.
Purpose: To assess the diagnostic accuracy of multisection (64-section) computed tomography (CT) versus coronary angiography in detection of and assignment of grades for coronary artery stenoses in a high-risk population and to investigate causes for discordance between the two. Materials and Methods: The protocol was approved by the local ethics committee. Patients gave informed consent. The study included 114 patients (103 men, 11 women; mean age, 63 years +/- 8.2 [standard deviation]) with potential myocardial ischemia. Multisection CT images were interpreted independently by two radiologists with unequal experience in reading coronary CT angiograms. Diagnostic performance of 64-section CT in detection of stenoses of 50% or more was assessed per patient, per artery, and per segment. Interrater agreement was assessed by using the Cohen kappa coefficient. Agreement between 64-section CT and coronary angiography for assigning grades to stenoses was assessed by using Bland-Altman analysis. Results: Sixty-eight percent of patients had stenoses of 50% or more. Good interrater agreement was found, with kappa values of 0.77-0.85. For the most experienced radiologist, the sensitivity, specificity, positive likelihood ratio, and negative likelihood ratio were 73.4%, 95.0%, 14.7, and 0.28 per segment, 95.2%, 94.7%, 18.0, and 0.05 per artery, and 100%, 89.2%, 9.26, and zero per patient, respectively. Discordance between 64-section CT and coronary angiography was related to either under- or overestimation of the degree of stenosis, anatomic misclassification, and coronary artery segments that were not assessable at 64-section CT. Bland-Altman analysis showed poor agreement, especially for intermediate stenosis (mean bias, 1.3%; 95% limits of agreement:-27.3%, 29.9%). Conclusion: Despite excellent sensitivity and negative likelihood ratios in a per-patient or per-vessel analysis, some coronary artery stenosis remained misdiagnosed with 64-section CT, resulting in limited sensitivity on a per-segment basis owing to anatomic discordance and failure to accurately quantify intermediate stenosis.(c) RSNA, 2009.
Cardiology Department, Cochin Hospital, Paris Descartes University, Paris, France.
Keywords:
Claude Le Feuvre,
Aude Healy-Brucker,
Gérard Helft,
Jacques Monségu,
Olivier Varenne,
Christian Spaulding,
Jean P Collet,
Farzin Beygui,
Olivier Barthélémy,
Rémi Choussat,
Gilles Montalescot,
Jean Philippe Metzger
Cardiology Department, Pitié-Salpêtrière Hospital, 47 et 83 Bd de l'Hôpital, 75651 Paris cedex 13, France.
BACKGROUND: Limited data is available on the long-term outcome after sirolimus-eluting stent (SES) implantation for in-stent restenosis. METHODS: In 3 centers, consecutive patients (n=100) with percutaneous coronary intervention (PCI) for in-stent restenosis (n=110) were treated with SES: 28 lesions were focal, 40 diffuse, 17 proliferative, and 15 totally occluded (reference vessel diameter: 3.0+/-0.2 mm, lesion length: 13.8+/-5.7 mm). RESULTS: SES implantation was successful in all patients. The mean follow-up was 50+/-12 months. The main univariate predictive factor of definite (4%) or probable (4%) SES thrombosis was revascularization without SES in a non-target site during the initial procedure (p<0.01). Repeated target lesion revascularization (TLR) was performed in 8 patients (8%) at 1 year, in 10 patients (10%) at 4 years. A cardiac event related to the SES occurred in 14 patients (14%) at one year, 17 patients (17%) at 4 years, and were associated with unstable angina (p<0.05), multivessel disease (p<0.02) and revascularization without SES in another site of the target vessel during the initial procedure (p<0.01). CONCLUSIONS: SESs are effective at 4 years in the treatment of high risk patients with complex in-stent restenosis, with a low risk of TLR but a high risk of stent thrombosis. Most of cardiac events related to the target vessel occur during the first year, and are associated to a revascularization without SES in another site during the first procedure.
Service de cardiologie, hôpital Cochin, 75674 Paris cedex, France. olivier.varenne@cch.aphp.fr
Interventional cardiology has dramatically developed since its introduction in 1977. Angioplasty represents the first choice for coronary reperfusion during acute myocardial infarction with thromboaspiration and stenting of the culprit lesion. In acute coronary syndroms and stable angina or silent ischemia despite optimal medical treatment, angioplasty is today an excellent option for coronary revascularization which includes a technologic offer adapted to various clinical and anatomical situations (specific guidewires, rotative atherectomy, distal protection devices and drug eluting stents that reduce the risk of coronary reintervention after initial angioplasty). For patient with severe ischemic left ventricular dysfunction, interventional rythmology can improve patient prognosis by a limitation of lethal ventricular fibrillation. Despite the hope that intracoronary cell transplantation could save myocardial cells, several randomized control trials have given various and disappointing results concerning the potential improvement of left ventricular function. Interventional cardiology nowadays offers global technical solutions for more and more patients suffering from ischemic cardiomyopathy.
Department of Neurology, Hôpital Sainte-Anne, 1 rue Cabanis 75674 Paris, Cedex 14, Cedex, France. e.touze@ch-sainte-anne.fr
BACKGROUND: The risk of coronary artery disease (CAD) is traditionally considered high in patients who had an ischemic stroke or a transient ischemic attack (TIA). However, few studies have specifically assessed the absolute risk of coronary events in those patients and predictors of such events are not well known. SUMMARY OF REVIEW: The overall risks of myocardial infarction and nonstroke vascular death are each around 2% per year. However, those risks are only about 1% per year in patients without CAD (i.e. the only ones who are likely to benefit from specific additional strategies). The prevalence of asymptomatic CAD ranges from 15% to 60%. Although potentially higher, the risk of CAD in patients with stroke/TIA related to atherosclerosis also seems to vary widely depending on the extent of the disease. Given the relatively low CAD risk, a simple systematic reinforcement of medical treatment in all patients may be not relevant. Up to now, there have been only limited ways to stratify the CAD risk in stroke/TIA patients. High-risk patients may be identified using the traditional cardiac scoring systems, but their validity has never been specifically assessed in stroke populations. The relative influence of traditional risk factors may be altered after a first vascular event. Stroke patients could also be screened for asymptomatic CAD. However, there is no simple and valid screening test for asymptomatic CAD that could be applied to all patients. Finally, there is still uncertainty about the potential benefits of treating asymptomatic CAD. Therefore, should the identification of patients with asymptomatic CAD requiring revascularization become feasible, the relevance of this strategy would remain to be evaluated by a randomized clinical trial. CONCLUSION: The absolute risk of CAD in stroke/TIA patients is moderately high. More research is needed to identify high risk patients who could benefit from specific strategies.
Since their advent, drug eluting stents have been used extensively exceeding the restrictive framework of the pilot studies which validated their effectiveness and safety. In some countaies the penetzation rate is over 80. A recent controversy has very seriously questioned their long term safety. What are, according to the currently available scientific data, the limits of drug eluting stents?
Adnan Kastrati,
Alban Dibra,
Christian Spaulding,
Gerrit J Laarman,
Maurizio Menichelli,
Marco Valgimigli,
Emilio Di Lorenzo,
Christoph Kaiser,
Ilkka Tierala,
Julinda Mehilli,
Melchior Seyfarth,
Olivier Varenne,
Maurits T Dirksen,
Gianfranco Percoco,
Attilio Varricchio,
Undine Pittl,
Mikko Syvänne,
Maarten J Suttorp,
Roberto Violini,
Albert Schömig
Aims To compare the efficacy and safety of drug-eluting stents vs. bare-metal stents in patients with acute ST-segment elevation myocardial infarction. Methods and results We performed a meta-analysis of eight randomized trials comparing drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) with bare-metal stents in 2786 patients with acute ST-segment elevation myocardial infarction. All patients were followed up for a mean of 12.0-24.2 months. Individual data were available for seven trials with 2476 patients. The primary efficacy endpoint was the need for reintervention (target lesion revascularization). The primary safety endpoint was stent thrombosis. Other outcomes of interest were death and recurrent myocardial infarction. Drug-eluting stents significantly reduced the risk of reintervention, hazard ratio of 0.38 (95% CI, 0.29-0.50), P < 0.001. The overall risk of stent thrombosis: hazard ratio of 0.80 (95% CI, 0.46-1.39), P = 0.43; death: hazard ratio of 0.76 (95% CI, 0.53-1.10), P = 0.14; and recurrent myocardial infarction: hazard ratio of 0.72 (95% CI, 0.48-1.08, P = 0.11) was not significantly different for patients receiving drug-eluting stents vs. bare-metal stents. Conclusion The use of drug-eluting stents in patients with acute ST-segment elevation myocardial infarction is safe and improves clinical outcomes by reducing the risk of reintervention compared with bare-metal stents.
