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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

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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 mm3 vs. 57.28 ± 37.16 mm3, 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.

(J Interven Cardiol 2007;20:381–388)
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Document Type: Research Article

Affiliations: 1: Cardiology Department, Rangueil Hospital, Toulouse, France 2: Institut Hospitalier J. Cartier, Massy, France 3: Hôpital Louis Pradel, Lyon, France

Publication date: 2007-10-01

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