Two-Year Clinical, Angiographic, and Intravascular Ultrasound Follow-Up of the XIENCE V Everolimus-Eluting Stent in the Treatment of Patients With De Novo Native Coronary Artery Lesions: The SPIRIT II Trial

Background-This article reports the 2-year clinical, angiographic, and intravascular ultrasound outcomes of the everolimus-eluting stent (EES) compared with the paclitaxel-eluting stent (PES) in the randomized SPIRIT II trial.Methods and Results-This was a prospective, single-blind clinical trial in which a total of 300 patients with de novo native coronary artery lesions were randomized to either EES or PES in a 3:1 fashion.Clinical follow-up was planned at 2 years in all patients.A subset of 152 patients underwent serial angiographic and intravascular ultrasound analyses at 6 months and 2 years.After 2 years, target lesion failure (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization) rates were 6.6% and 11% in EES and PES, respectively (Pϭ0.31).At 6 months, a significant reduction in angiographic in-stent late loss and percentage volume obstruction measured by intravascular ultrasound was observed in the EES group.However, at 2-year follow-up, a late increased intimal hyperplasia growth after implantation of an EES was observed.There were no significant differences between EES and PES for in-stent late loss (EES, 0.33Ϯ0.37mm versus PES, 0.34Ϯ0.34mm; Pϭ0.84) and percentage volume obstruction (EES, 5.18Ϯ6.22%versus PES, 5.80Ϯ6.31%;Pϭ0.65) at 2 years.The incidence of stent thrombosis was low and comparable in both groups (EES, 0.9%; PES, 1.4%).Conclusions-Although the previously reported angiographic and clinical superiority of the EES has vanished over time, this report confirms and extends the previously demonstrated noninferiority in terms of in-stent late loss of the EES when compared with the PES up to 2-year follow-up.There were no significant differences between EES and PES in clinical, angiographic and intravascular ultrasound outcomes at 2 years.(Circ Cardiovasc Intervent.2009;2:339-347.)Key Words: stents Ⅲ angioplasty Ⅲ IVUS S tenting of de novo lesions in native coronary arteries is an established and effective treatment of coronary narrowing due to atherosclerosis.However, long-term efficacy of bare metal stents (BMS) has been hampered by the development of restenosis, resulting in rehospitalization for percutaneous or surgical revascularization in 10% to 20% of patients. 1Drug-eluting stents (DES) have been shown to be effective against restenosis by reducing neointimal hyperplasia after vascular injury, when compared with BMS. 2