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

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.