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Articles by M Vorpahl
Total Records ( 2 ) for M Vorpahl
  R Wessely , T Koppara , C Bradaric , M Vorpahl , S Braun , S Schulz , J Mehilli , A Schomig , A Kastrati and for the Contrast Media and Nephrotoxicity Following Coronary Revascularization by Angioplasty (CONTR
 

Background— No clinical trial has yet focused on contrast-mediated nephrotoxicity in patients with chronic renal failure exclusively undergoing percutaneous coronary intervention (PCI). Therefore, the aim of this study was to compare the effect of contemporary contrast media on nephrotoxicity in this high-risk patient population.

Methods and Results— This prospective, randomized, double-blind, comparative clinical trial randomly selected 939 patients with chronic renal failure undergoing coronary angiography with potential PCI to receive either the iso-osmolar contrast medium iodixanol or the low-osmolar contrast medium iomeprol. Of those 939 patients, 615 received diagnostic angiography only and were not included in the primary study analysis, but were followed up in a registry. Three hundred twenty-four patients underwent PCI, of which one-half received iodixanol or iomeprol, respectively, and were included in the primary study analysis. The primary end point was the peak increase in S-creatinine during hospitalization for PCI. Maximum increase in S-creatinine after PCI was lower than expected and thus impaired the power of the study. It was not significantly different between the 2 contrast groups (0.19±0.40 mg/dL for iodixanol and 0.21±0.34 mg/dL for iomeprol; P=0.53). Albeit contrast media-induced nephropathy rates were lower with iodixanol (22.2% compared with 27.8% for iomeprol), this difference was not statistically different (P=0.25). Subgroup analysis suggested a favorable outcome regarding nephrotoxicity in patients who received higher contrast volumes (>340 mL) in the iodixanol group (Pinteraction=0.016).

Conclusions— Routine use of iso-osmolar contrast medium is not associated with a significant reduction of nephrotoxicity compared with low-osmolar contrast medium in patients with chronic renal failure undergoing PCI. However, a positive effect was seen in the iso-osmolar contrast group for patients receiving high amounts of contrast medium, which awaits confirmation of a specifically designed randomized clinical trial.

Clinical Trial Registration— clinicaltrials.gov Identifier: NCT00390585

  J. F Granada , S Inami , M. S Aboodi , A Tellez , K Milewski , D Wallace Bradley , S Parker , S Rowland , G Nakazawa , M Vorpahl , F. D Kolodgie , G. L Kaluza , M. B Leon and R. Virmani
  Background—

We aimed to demonstrate that, by separating endothelial progenitor cell capture from sirolimus delivery through the application of drug to the abluminal surface of the stent, the degree of endothelialization can be enhanced.

Methods and Results—

Stainless steel R Stents, with biodegradable SynBiosys polymer coating with sirolimus abluminally applied and surface modified with anti-CD34 antibody were prepared at 2 dosages (low-dose sirolimus [LD-Combo, 2.5 µg sirolimus/mm] and full-dose sirolimus [Combo, 5 µg sirolimus/mm). These Combo stents and the Cypher stent (10 µg sirolimus/mm) were deployed in 98 normal porcine arteries and harvested for pharmacokinetic analysis at 0.25, 1, 3, 7, 14, 28, and 35 days. The LD-Combo stents showed faster early release (50%total dose in 72 hours) than the Combo and Cypher. At 30 days, drug release was near complete with both Combo stents, whereas 20% of drug remained on the Cypher stents. To assess efficacy, a total of 50 stents (Xience V=8, Cypher=8, Genous bioengineered R stent=6, LD-Combo=14, and Combo=14) were implanted in 18 pigs for 14 and 28 days. Optical coherence tomography was performed, and stents were harvested for histology. At 28 days, there was less neointimal thickness with Combo (0.173±0.088 mm) compared with Cypher (0.358±0.225 mm), LD-Combo (0.316±0.228 mm), and Xience V (0.305±0.252 mm; P<0.00001). Immunohistochemical analysis of endothelialization showed that Genous bioengineered R stent had the highest degree of platelet endothelial cell adhesion molecule expression (87%) followed by the Combo (75%), LD-Combo (65%), and Cypher (58%).

Conclusions—

Both optical coherence tomography and histology demonstrate that anti-CD34 sirolimus-eluting stents promote endothelialization while reducing neointimal formation and inflammation.

 
 
 
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