Publications

Background SYNTAX is a randomized controlled trial comparing percutaneous coronary intervention (PCI) using drug-eluting stents with coronary artery bypass graft surgery (CABG) in patients (pts) with 3 vessel and/or left main disease. We will analyze health economic data associated with CABG and PCI in the subset of France compared with select countries in the EU (Germany, Italy and UK). Methods Costs will be estimated using 1-year resource utilization data including procedural resource use (stents, guidewires etc.), hospitalizations major procedures and work days lost. Estimates are based on French patterns of resource utilization, number of hospital days and break down of those in intensive care, or ward days. Where data did not allow reliable French estimate, a Bayesian statistical model was applied combining the observed resource utilization with priors based on data on less rare events. Effects are measured in terms of MACCE-free survival. Results In France, 105 pts were randomized to CABG and 103 to PCI in the SYNTAX trial. There were 156 hospitalizations in the first year in CABG pts compared with 139 in PCI pts. Overall, CABG pts in France spent 23.3 days (d) in hospital (see Table). PCI pts spent 9.2 d in hospital. After the index procedure, pts in the CABG arm spent 9.1 d in hospital whereas PCI pts spent 5.7 d. Economic data comparing short- and long-term medical care costs for pts with left main and/or 3-vessel CAD treated with either DES or CABG will be available at time of presentation. Conclusions Additional analyses of the procedural resources utilized and costs associated with the procedures will be presented as a comparison between the French subset and countries in the EU. Mean Total Days in Hospital Per Patient * Mean Days in Hospital During Follow-up CABG PCI CABG PCI Intensive Care Unit (ICU) 8.8 4.3 1.8 1.3 General Ward 10.7 3.7 6.7 4.2 Other Wards 2.5 0.9 0.6 0.2 Total Days 23.3 9.2 9.1 5.7 * Total days in hospital includes days spent during index procedure

No abstract is provided for this article.

No abstract is provided for this article.

Objectives We sought to determine the risk of late stent thrombosis (ST) during long-term follow-up beyond 3 years, searched for predictors, and assessed the impact of ST on overall mortality. Background Late ST was reported to occur at an annual rate of 0.6% up to 3 years after drug-eluting stent (DES) implantation. Methods A total of 8,146 patients underwent percutaneous coronary intervention with a sirolimus-eluting stent (SES) (n = 3,823) or paclitaxel-eluting stent (PES) (n = 4,323) and were followed up to 4 years after stent implantation. Dual antiplatelet treatment was prescribed for 6 to 12 months. Results Definite ST occurred in 192 of 8,146 patients with an incidence density of 1.0/100 patient-years and a cumulative incidence of 3.3% at 4 years. The hazard of ST continued at a steady rate of 0.53% (95% confidence interval [CI]: 0.44 to 0.64) between 30 days and 4 years. Diabetes was an independent predictor of early ST (hazard ratio [HR]: 1.96; 95% CI: 1.18 to 3.28), and acute coronary syndrome (HR: 2.21; 95% CI: 1.39 to 3.51), younger age (HR: 0.97; 95% CI: 0.95 to 0.99), and use of PES (HR: 1.67; 95% CI: 1.08 to 2.56) were independent predictors of late ST. Rates of death and myocardial infarction at 4 years were 10.6% and 4.6%, respectively. Conclusions Late ST occurs steadily at an annual rate of 0.4% to 0.6% for up to 4 years. Diabetes is an independent predictor of early ST, whereas acute coronary syndrome, younger age, and PES implantation are associated with late ST.

Objectives This study sought to evaluate inter–core lab variability in quantitative coronary angiography (QCA) analysis of bifurcation lesions. Background QCA of bifurcation lesions is challenging. To date there are no data available on the inter–core lab variability of bifurcation QCA analysis. Methods The randomized Tryton IDE (Tryton Pivotal IDE Coronary Bifurcation Trial) compared the Tryton Side Branch Stent (Tryton Medical, Durham, North Carolina) with balloon angioplasty as side branch treatment. QCA was performed in an angiographic subcohort (n = 326) at 9-month follow-up. Inter-core lab variability of QCA analysis between the Cardiovascular Research Foundation and the Cardialysis core labs was evaluated before and after alignment of the used QCA methodology using angiographic data derived from this angiographic follow-up cohort. Results In the original analysis, before alignment of QCA methodology, the mean difference between the core labs (bias) was large for all QCA parameters with wide 95% limits of agreement (1.96 × SD of the bias), indicating marked variability. The bias of the key angiographic endpoint of the Tryton trial, in-segment percentage diameter stenosis (%DS) of the side branch, was 5.5% (95% limits of agreement: –26.7% to 37.8%). After reanalysis, the bias of the in-segment %DS of the side branch reduced to 1.8% (95% limits of agreement: –16.7% to 20.4%). Importantly, after alignment of the 2 core labs, there was no longer a difference between both treatment groups (%DS of the side branch: treatment group A vs. group B: 34.4 ± 19.4% vs. 32.4 ± 16.1%, p = 0.340). Conclusions Originally, a marked inter–core lab variability of bifurcation QCA analysis was found. After alignment of methodology, inter–core lab variability decreased considerably and impacted angiographic trial results. This latter finding emphasizes the importance of using the same methodology among different core labs worldwide. (Tryton Pivotal Prospective, Single Blind, Randomized Controlled Study to Evaluate the Safety & Effectiveness of the Tryton Side Branch Stent Used With DES in Treatment of de Novo Bifurcation Lesions in the Main Branch & Side Branch in Native Coronaries [TRYTON]; NCT01258972)

Most systems used for three-dimensional (3-D) of two-dimensional intracoronary ultrasound (ICUS) images are based on an image acquisition with a pull-back device which withdraws the catheter with a constant speed, nor taking account of cardiac motion and coronary dynamics/pulsation. Cyclic changes of the vessel dimensions and the movement of the catheter inside the vessel result in artifacts and inaccuracies of quantitative measurements. This phenomenon limits accuracy and resolution when an attempt of 3-D reconstruction is performed, since images obtained in different phases of the cardiac cycle are compiled. To overcome these limitations the authors developed a custom-designed pull-back device driven by a stepping motor, which is controlled by a steering logic ensuring an ECG-gated image acquisition.

Objectives This study sought to assess the vascular function in patients with chronic total coronary occlusions (CTO) immediately after successful percutaneous recanalization and its relation with the pre-existing collateral circulation. Background CTOs represent a long-acting occlusion of a coronary vessel, in which the progressively developed collateral circulation may limit ischemia and symptoms. However, it is unknown if the coronary segment distal to the occlusion has a preserved vascular function. Methods We prospectively enrolled 19 consecutive patients, after percutaneous coronary intervention of a CTO. Luminal diameter, measured by quantitative coronary angiography, and coronary blood flow at level of epicardial coronary artery distal to the treated CTO was assessed before and after administration of acetylcholine (Ach), adenosine, and nitroglycerin (NTG). Collaterals were assessed angiographically by grading of Rentrop and of collateral connections (CC1: threadlike continuous connection; CC2: side branch–like connection). Results Overall, Ach and adenosine caused coronary artery vasoconstriction (p = 0.001 and p = 0.004, respectively), whereas NTG failed to induce vasodilation (p = 0.084). Coronary blood flow significantly decreased with Ach (p = 0.005), significantly increased with NTG (p = 0.035), and did not change with adenosine (p = 0.470). Patients with CC2 collaterals (n = 8) had less vasoconstriction response and reduction in coronary blood flow after Ach (p = 0.005 and p = 0.008, respectively), and better vasomotor response to NTG (p = 0.029) than patients with CC1 collaterals (n = 11). Conclusions Significant endothelial and smooth muscle dysfunction is present in the distal segments of successfully recanalized CTOs, and that seems to be more pronounced in the presence of a low grading of collateral circulation.

No abstract is provided for this article.

No abstract is provided for this article.

We investigated the potential role of intercellular-adhesion molecule-1 (ICAM-1) in allergen-induced bronchial hyperresponsiveness (BHR) and inflammation in sensitised Brown-Norway rats. Rats were sensitised with ovalbumin (OA) intraperitoneally and 21 days later they were either exposed to 0.9% NaCl or 1% OA aerosol for 15min. Rats exposed to OA aerosol were pretreated either with ICAM-1 antibody (3 mg/kg i.p. and i.v, 45 min prior to OA exposure) or with the diluent for the antibody. Eighteen to twenty-four hours after OA or 0.9% NaCl exposure, rats were anaesthetised, tracheostomised and mechanically ventilated, and airway responsiveness to acetylcholine (ACh) aerosol was measured as the provocative concentration of ACh needed to increase pulmorary resistance by 100% (PC100). Mean––log PC100 was increased in rats exposed to OA but pretreated with diluent (2.75 ± 0.06) compared to rats treated with ICAM-1 antibody (2.51 ± 0.08; < 0.05). However, only the former group showed significantly higher mean––log PC100 compared to the sensitised group exposed to 0.9% NaCl alone (2.22 ± 0.12; p < 0.01). There was a significant increase in eosinophil and lymphocyte counts in bronchoalveolar lavage fluid at 24 h in rats pretreated with diluent compared to saline exposed rats. However, in ICAM-1 antibody-pretreated rats, eosinophil and lymphocyte counts were significantly different from diluent-treated ones. We conclude that ICAM-1 antibody inhibits BHR without reducing the influx of inflammatory cells.