scholarly journals Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions

Author(s):  
Bimmer E. Claessen ◽  
Marcel A. Beijk ◽  
Victor Legrand ◽  
Witold Ruzyllo ◽  
Antonio Manari ◽  
...  
Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Masao Yamasaki ◽  
Ichizo Tsujino ◽  
Ryota Sakurai ◽  
Katsuhisa Waseda ◽  
Takao Hasegawa ◽  
...  

Background : SPIRIT III is a pivotal, multicenter, 2:1 randomized, controlled trial comparing Everolimus-eluting cobalt-chromium alloy XIENCE™ V stents (EES) to Paclitaxel-eluting Taxus ™ stents (PES) in de novo native coronary artery lesions. Intravascular ultrasound (IVUS) was performed in a subset of Spirit III to further investigate the safety and efficacy profiles of EES. Methods : The SPIRIT III IVUS study enrolled 305 patients who received 359 stents (244 EES in 205 patients; 115 PES in 100 patients). Serial IVUS imaging was performed post-intervention and at 8 months follow-up. Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention minus MLA at follow-up. Volume index, defined as volume data divided by stent length, was obtained for vessel (VVI), stent (SVI), lumen (LVI), plaque (PVI), and neointima (NVI). Results : At baseline, the incidence of tissue prolapse, edge dissections, and incomplete stent apposition (ISA) were not significantly different between EES and PES (15.6 vs 19.7%, 1.3 vs 2.8%, and 31.8 vs 28.2%, respectively). At follow-up, edge dissections and late-acquired ISA were not significantly different between EES and PES (1.4 vs 3.1%, 1.7 vs 4.1%, respectively). EES showed significantly less neointimal hyperplasia and a trend toward larger follow-up lumen than PES (Table ), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in VVI and PVI between post-intervention and follow-up. Reference segment analysis showed no unfavorable edge effect adjacent to either EES or PES. Conclusion : Detailed IVUS analysis confirmed significantly greater neointimal suppression with EES, with no apparent adverse vessel response, as compared to PES. Additional drug-eluting stent trials in more complex lesions are warranted to further validate the clinical utility of these new technologies.


Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sebastian Philipp ◽  
Dirk Böse ◽  
Igor Kordish ◽  
Johannes Brachmann ◽  
Klinikum Coburg ◽  
...  

Background: Although the use of drug-eluting stents has been shown to limit neointimal hyperplasia, currently available DES may adversely affect re-endothelialization, possibly precipitating late cardiac events. The aim of this study was to evaluate the efficacy and safety of a microbubble delivery of c-myc antisense peptide in preventing restenosis after coronary stenting in de novo stenosis with intravascular ultrasound. Methods: A BMS was implanted in de novo coronary artery lesions (RD ≥ 2.5- ≤4.0mm; TL ≥ 15- ≤ 30mm in length). Serial intravascular ultrasound analysis were performed in 25 lesions. A dose of 16mg RESTEN-MPTM (AVI BioPharma/Global Therapeutics LLC) was intravenously administered after stenting and again 24 hours later. Results: A total of 50 patients were enrolled, 34 in Essen, 13 in Coburg and 3 in Heidelberg. Before stenting, the MLD and length of stenosis was determined by QCA. 18 Patients had a LAD lesion, 21 LCX, 12 RCA. 84% (43/51) of the lesions were either Type B2 or C lesions. At six month follow-up, angiography with a QCA was performed. Generally the neointimal proliferation was minor and open vessel lumen could be demonstrated during follow-up. Of the 30 patients currently studied at six-months in the IVUS sub-study, six patients required TLR. Late lumen loss by QCA was 0.47±0.09mm. Volume stenosis by IVUS was 26 ± 4 %. Generally the neointima proliferation was minor and open vessel lumen could be demonstrated during follow-up. Summary: Microbubble delivery of c-myc antisense seems to be effective in reducing neointimal tissue proliferation without the problem of late stent thrombosis, because the proliferation seems to be attenuated but not fully blocked.


2007 ◽  
Vol 3 (3) ◽  
pp. 315-320 ◽  
Author(s):  
Peter Ruygrok ◽  
Martin Desaga ◽  
Franck Van Den Branden ◽  
Klaus Rasmussen ◽  
Harry Suryapranata ◽  
...  

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