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Does Carbofilm coating affect in-stent intimal proliferation? A randomized trial comparing Rx multi-link penta and Tecnic Carbostent Stents: SIROCCO Trial.

Abstract : OBJECTIVES:To compare the volume of in-stent neointimal proliferation, assessed by intravascular ultrasound (IVUS), at 6-month follow-up after implantation of a coronary Carbofilm-coated stent (Tecnic Carbostent, Sorin Biomedica Cardio, Saluggia, Italy) versus a conventional 316 L stent (Rx Multi-Link Penta, Abbott Laboratories, Abbott Park, IL). BACKGROUND:Many trials suggest that stent characteristics and coating could be important determinants of restenosis. METHODS:From October 2004 to May 2005, 63 patients were randomized to Tecnic (T, n = 30) or Penta (P, n = 33). The primary end-point was in-stent volume of neointimal hyperplasia (NIH) measured by IVUS at 6 months. The secondary end-points included binary restenosis, minimal luminal diameter (MLD), target lesion revascularization, and major adverse cardiac events. RESULTS:There were no significant differences between T and P as to mean age, male gender, clinical status, complexity of the lesion, lesion length, reference vessel diameter before percutaneous coronary intervention (PCI), MLD pre-PCI, and stent-to-artery ratio. However, MLD poststenting was greater in P group than T group (2.81 +/- 0.45 mm vs. 2.49 +/- 0.33 mm, P < 0.002). At 6 months, angiographic late lumen loss (0.61 +/- 0.51 mm vs. 0.92 +/- 0.61 mm, P < 0.043), in-stent obstruction (25.86 +/- 16.48% vs. 38.33 +/- 19.56%, P = 0.021), and in-stent late loss volume (31.62 +/- 29.75 mm(3) vs. 57.28 +/- 37.16 mm(3), P = 0.016) were significantly lower in T group than in P group. CONCLUSION:Penta stent appears to offer a better deployment and a larger MLD post-PCI than Carbofilm-coated stent. However, a thicker NIH was observed on Penta stent at 6-month follow-up, when compared to Tecnic.
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https://www.hal.inserm.fr/inserm-00409564
Contributor : Marie Francoise Simon <>
Submitted on : Monday, August 10, 2009 - 3:17:05 PM
Last modification on : Wednesday, July 8, 2020 - 3:01:28 AM

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Didier Carrié, Thierry Lefevre, Rhizlan Cherradi, Pierre Dumas, Meyer Elbaz, et al.. Does Carbofilm coating affect in-stent intimal proliferation? A randomized trial comparing Rx multi-link penta and Tecnic Carbostent Stents: SIROCCO Trial.. Journal of Interventional Cardiology, Wiley-Blackwell, 2007, 20 (5), pp.381-8. ⟨10.1111/j.1540-8183.2007.00281.x⟩. ⟨inserm-00409564⟩

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