TY - JOUR
T1 - 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
AU - Claessen, Bimmer E.
AU - Beijk, Marcel A.
AU - Legrand, Victor
AU - Ruzyllo, Witold
AU - Manari, Antonio
AU - Varenne, Olivier
AU - Suttorp, Maarten J.
AU - Tijssen, Jan G. P.
AU - Miquel-Hebert, Karine
AU - Veldhof, Susan
AU - Henriques, Jose P. S.
AU - Serruys, Patrick W.
AU - Piek, Jan J.
PY - 2009
Y1 - 2009
N2 - 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 (P = 0.31). 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, 0.33 +/- 0.37 mm versus PES, 0.34 +/- 0.34 mm; P = 0.84) and percentage volume obstruction (EES, 5.18 +/- 6.22% versus PES, 5.80 +/- 6.31%; P = 0.65) 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.)
AB - 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 (P = 0.31). 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, 0.33 +/- 0.37 mm versus PES, 0.34 +/- 0.34 mm; P = 0.84) and percentage volume obstruction (EES, 5.18 +/- 6.22% versus PES, 5.80 +/- 6.31%; P = 0.65) 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.)
U2 - https://doi.org/10.1161/CIRCINTERVENTIONS.108.831800.108.831800
DO - https://doi.org/10.1161/CIRCINTERVENTIONS.108.831800.108.831800
M3 - Article
C2 - 20031737
SN - 1941-7640
VL - 2
SP - 339
EP - 347
JO - Circulation. Cardiovascular interventions
JF - Circulation. Cardiovascular interventions
IS - 4
ER -