Clinical and angiographic follow-up in patients with Cypher or Taxus stents in populations with high percentage of trial-excluded lesions.

BACKGROUND: Drug-eluting stents (DESs) are being used in real life in patients with complex lesions usually excluded from the published trials. It is reasonable to think that the results could be worse, and the performance may be different between DES when these complex lesions are included.

METHODS AND MATERIAL: To investigate this issue, we studied our first 82 patients with DES (54 patients with Cypher (C) and 28 patients with Taxus (T) (129 lesions, with 1.57 lesions per patient). Seventy-one complex lesions were treated with C stent, 41 with T stent, and 17 with no DES. It was a high-risk population, as reflected by 64% unstable angina and 40% diabetes mellitus. Of the 112 DES complex lesions treated, 38% would have been excluded from the Sirius and Taxus IV trials.

RESULTS: The main data on intra-segment angiographic measures showed a late luminal loss lower for the C stent than for the T stent (0.17+/-0.45 and 0.44+/-0.6, P=.02, respectively). The restenosis and target lesion revascularization percentages were also lower for the C stent (8.4% vs. 24.4%, P=.07 and 5.6% vs. 17.1%, P<.05, respectively). In the complex lesions without restenosis, 28% would have been excluded from the trials, while in complex lesions with restenosis, there were 53% (P=.05) (with a homogeneous percentage between the C and T groups). The predictor variables of restenosis in the 112 DES-treated complex lesions were length (P=.03, IC=0.97-1.6) and the pre-reference diameter (P=.06).

CONCLUSIONS: In our experience, the C stent is superior to the T stent when treating populations with a high percentage of complex lesions excluded from the trials.