Objective: To assess the safety and efficacy of the implantation of Paclitaxel Eluting Stents (PES) for de novo, non-flow limiting lesions.
Methods and results: We assessed the 12-month occurrence of major adverse cardiac events (MACE) in 21 patients (4% of the total population treated in a 'real world' registry) with 22 non-significant coronary narrowings treated with PES. The following criteria had to be met: (1) the lesion was de novo; (2) the location was non-ostial, and not a bifurcation lesion; (3) the diameter stenosis by quantitative coronary angiography (QCA) was <50%; (4) there was no visible thrombus and (5) the lesion was not located in an angiographically diffusely diseased segment. Procedural success rate was 100% without any periprocedural myocardial infarction. After a mean follow-up of 407.33+/-53 (range: 344-498) days the overall MACE-free survival was 95.2%. Freedom from target revascularization was 95.2%.
Conclusions: The result of this non-randomized observational study suggests that the implantation of PES for de novo, non-significant lesions appears most probably safe and effective.