Abstract 2771: Comparison of Everolimus-Eluting Stents with Paclitaxel-Eluting Stents in De Novo Native Coronary Artery Lesions: Intravascular Ultrasound Results From the SPIRIT III Trial

Circulation ◽  
2007 ◽  
Vol 116 (suppl_16) ◽  
Author(s):  
Masao Yamasaki ◽  
Ichizo Tsujino ◽  
Ryota Sakurai ◽  
Katsuhisa Waseda ◽  
Takao Hasegawa ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Intravascular Ultrasound ◽  
De Novo ◽  
Volume Index ◽  
Chromium Alloy ◽  
Lumen Area ◽  
Coronary Artery Lesions ◽  
Post Intervention ◽  
Native Coronary Artery

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.

Abstract 2557: The Appraisal-Trial: Evaluating RESTEN-MPTM in Patients with Bare Metal Stent de novo Native Coronary Artery Lesions

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Sebastian Philipp ◽  
Dirk Böse ◽  
Igor Kordish ◽  
Johannes Brachmann ◽  
Klinikum Coburg ◽  
...  
Keyword(s):  
Coronary Artery ◽  
Intravascular Ultrasound ◽  
De Novo ◽  
Neointimal Hyperplasia ◽  
Bare Metal Stent ◽  
Coronary Artery Lesions ◽  
Cardiac Events ◽  
Late Lumen Loss ◽  
Vessel Lumen

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.

Abstract 5995: Efficacy Of The Everolimus-eluting Stent in Diabetic Patients: Comparison With The Paclitaxel-eluting Stent

Circulation ◽  
2008 ◽  
Vol 118 (suppl_18) ◽  
Author(s):  
Hiromasa Otake ◽  
Junya Ako ◽  
Masao Yamasaki ◽  
Ichizo Tsujino ◽  
Takao Shimohama ◽  
...  
Keyword(s):  
De Novo ◽  
Neointimal Hyperplasia ◽  
Multicenter Trial ◽  
Volume Index ◽  
Diabetic Patients ◽  
Lumen Area ◽  
Post Intervention ◽  
Cross Sectional ◽  
Incomplete Stent Apposition

Background: In the diabetic subgroup of the Spirit III trial (randomized, multicenter trial comparing Everolimus-eluting XIENCE ™ V stent (EES) to Paclitaxel-eluting Taxus ™ stent (PES) in de novo native coronary artery lesions), PES showed a trend toward fewer major adverse cardiac event compared with EES during 1 year follow-up in patients with diabetes despite lower observed late loss with EES at 8 months. Methods: The Stanford University IVUS Core Laboratory database was queried to evaluate the efficacy of EES in diabetics compared with PES. A total of 113 lesions treated with EES (n=58) and PES (n=55) undergoing 8 or 9 months follow up 3-D intravascular ultrasound (IVUS) were enrolled. Volume index (volume/length) was calculated for vessel (VVI), peri-plaque (PVI), neointima (NIV), and lumen (LVI). %NIV was calculated as neointimal volume / stent volume × 100. Cross-sectional narrowing (CSN) was defined as neointimal area divided by stent area (%). Late lumen area loss was calculated as minimum lumen area (MLA) at post-intervention (Post) minus MLA at follow-up (FUP). Late incomplete stent apposition (LISA) was defined as separation of at least 1 strut from the vessel wall with blood speckle behind the strut, where Post IVUS revealed well apposition. Results: Average stent length was significantly longer in EES. EES showed less neointimal hyperplasia and smaller LVI loss than PES (Table ), whereas no statistical interactions were observed between EES and serial changes for VVI and PVI. PES showed a significant increase in PVI (Post: 7.6±3.1, FUP: 8.4±3.1; p=0.049) and a trend toward increase in VVI (Post: 14.8±5.5, FUP: 15.5±4.2; p=0.07) between Post and FUP. One case with LISA was observed in EES group. Conclusions: EES demonstrated significant suppression of neointimal hyperplasia in diabetic patients without vessel expansion compared with PES up to 8 months follow up. Figure 1 Intra Individual matched In-Stent Late Luminal Loss[mm]

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