Initial experience with the Presillion stent in an unselected population: immediate and six-month outcomes.

INTRODUCTION

The release of a new bare metal stent (BMS), the Presillion stent, whose main innovative feature is its reduced strut thickness, has created expectations that it may reduce neointimal proliferation and consequently lower the restenosis rate.

OBJECTIVE

To evaluate the efficacy and safety profile of Presillion stent implantation in an unselected population referred for coronary revascularization with BMS.

METHODS

This was a prospective study of the first 20 consecutive patients undergoing implantation of at least one Presillion stent. We performed a descriptive analysis of the study population in terms of demographics, clinical context, angiographic characteristics of coronary lesions before and after angioplasty, and clinical outcome. After discharge, patients were followed up and assessed clinically at 3 and 6 months for the occurrence of MACE (cardiovascular death, myocardial infarction, stroke or revascularization). The statistical analysis consisted of calculation of means and standard deviation for continuous variables and relative proportions for categorical variables.

RESULTS

The study population was predominantly male (65%), with a mean age of 68.8 years. The indication for cardiac catheterization was acute coronary syndrome in 90% and heart failure in 10% of cases. Half the patients had multivessel disease, and 34 stents, of which 26 were Presillion stents, were implanted in 29 coronary lesions. According to the ACC/AHA classification, the coronary lesions treated with Presillion stents were classified as type A in 0% of cases, type B1 in 27% and type B2 or C in 73%; 27% of these had moderate to severe calcification. The percentage of stenosis and minimal luminal diameter (MLD) before and after angioplasty were respectively 88.5 +/- 9.7% (MLD = 0.65 +/- 0.40 mm) and 10.6 +/- 4.3% (MLD = 2.58 +/- 0.36 mm). The success rate of Presillion implantation was 100%, with no significant drop in hemoglobin, additional elevation of cardiac biomarkers or deterioration in renal function after the procedure. No MACE occurred before hospital discharge. At 6-month follow-up all patients were alive, none had had stroke, two patients (10%) had had acute myocardial infarction in territories not dependent on previously treated arteries and two patients had undergone a new revascularization, but not of the target vessel.

CONCLUSION

This initial experience with Presillion stents showed a high efficacy rate and an excellent safety profile that was maintained over 6 months of follow-up. Their effectiveness compared to other BMS should be demonstrated in larger-scale comparative studies.