Abstract 2644: A Randomized Comparison of Tacrolimus- and Sirolimus-eluting Stents for Long Diffuse Coronary Lesions. The CORPAL-II Study
BACKGROUND.- New emerging drug-eluting stents need to be compared with those already proven to be effective. In previous comparative studies, sirolimus-eluting stents (SES) has demostrated the lowest late loss. In this study, we randomly compared the Tacrolimus-eluting stent (TES) with SES in symptomatic patients with long diffuse coronary lesions (> 20 mm length).
METHODS.- Between January 2005 and January 2006, 108 patients with long diffuse coronary stenoses were randomly assigned to receive either SES (n=56) or TES (n=52). After treatment, major adverse cardiac events were recorded. In addition, a 6-month follow-up cardiac catheterization was scheduled for late angiographic and intravascular ultrasound assessment.
RESULTS.- There were no significant differences in clinical, angiographic and procedural characteristics between groups. Similarly, primary success and in-hospital course were similar in both groups. Minimal lumen diameter following stent implantation was almost identical in both groups (2.58±0.35 mm for SES vs 2.53±0.43 mm for TES). Post-procedural myocardial injury markers were similar in both groups either (CK 87±6 IU/L for SES vs 103±105 IU/L for TES). There were no in-hospital deaths. At follow-up, 7 patients (6%) had target lesion revascularization (one of them from the SES group −1.7%− and 6 from the TES group −12%−; p<0.04). At late angiographic and ultrasonic assessment, already perfomed in 30 patients (28%), a trend towards lower late loss was observed in SES group (0.6±0.9 mm vs 1.1±0.8 mm; ns). In addition, the neointimal area obtained by ultrasound study at the point of minimal lumen diameter was significantly lower in the SES-treated group (0.9±1.3 mm2 vs 3.2±1.5 mm2 p<0.001). Angiographic and ultrasound evaluation will be updated at the meeting. CONCLUSIONS.- Our preliminary data show that TES does not seem to be as effective as SES in patients with long diffuse coronary lesions.