CORPAL-II - CORPAL-II – Presented at AHA 2006
The goal of the trial was to evaluate percutaneous coronary intervention (PCI) using the tacrolimus-eluting stent (TES) compared with the sirolimus-eluting stent (SES) among patients with long diffuse coronary lesions.
Patients Enrolled: 108
Mean Follow Up: 15 months
Mean Patient Age: Mean age 62 years
Mean Ejection Fraction: Mean 54% at baseline
Symptomatic patients with long diffuse lesions >20 mm in length
Late loss at 6-month angiographic follow-up
Patients were randomized to TES (n = 52) or SES (n = 56). Repeat angiography and intravascular ultrasound (IVUS) were performed at 6 months.
Unstable angina was present at baseline in 56% of patients and 9% had a chronic total occlusion. Culprit artery was the left anterior descending in 54% of patients. Mean stenosis was 73%. Overlapping stents were placed in 43% of cases. Glycoprotein IIb/IIIa inhibitors were used in 12% of cases.
Repeat angiographic follow-up at 6 months was performed in 65% of patients. There was no significant difference in the primary endpoint of late lumen loss (0.48 mm for SES vs. 0.78 mm for TES, p = NS) or in minimum lumen diameter (2.13 mm for SES vs. 1.81 mm for TES, p = NS). Likewise, there was no difference in percent diameter stenosis (30% vs. 40%) or binary restenosis (18% vs. 22%). On IVUS, lumen area was smaller in the TES group compared with the SES group (3.1 mm2 vs. 4.2 mm2, p = 0.05).
At 15-month clinical follow-up, there was no difference in target lesion revascularization (11% vs. 15%). There was one myocardial infarction and one death in the TES group, and none in the SES group. Late stent occlusion occurred in 2% of each group.
Among symptomatic patients with long diffuse coronary lesions undergoing PCI, use of TES was not associated with a difference in late loss at 6 months compared with SES.
In addition to no difference on angiographic parameters, there was also no difference in clinical events, although the overall event rate was low and the trial was small and underpowered to detect a difference in events. Results are consistent with the JUPITER 2 trial, which showed no difference in late loss with the TES compared with bare-metal stent. With this stent design, the drug is delivered without the use of a polymer.
Presented by Dr. Antonio Delgado at the American Heart Association Annual Scientific Sessions, Chicago, IL, November 2006.
Keywords: Coronary Artery Disease, Myocardial Infarction, Drug-Eluting Stents, Polymers, Constriction, Pathologic, Sirolimus, Tacrolimus, Percutaneous Coronary Intervention
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