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

Abstract

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, 0.33Ϯ0.37 mm versus PES, 0.34Ϯ0.34 mm; 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.)

2-Year Clinical and Angiographic Outcomes From a Randomized Trial of Polymer-Free Dual Drug-Eluting Stents Versus Polymer-Based Cypher and Endeavor, Drug-Eluting Stents

“…In particular, the rate of ⌬TLR with the Cypher stent (3.5%) was significantly higher than that with both the Dual-DES and ZES. The observation of a small magnitude "catch up" in antirestenotic efficacy with polymer-based DES has previously been described in earlier reports (4,5,16,17).…”

Second- and third-generation drug-eluting coronary stents

“…The SPIRIT II trial demonstrated better clinical efficacy and safety of EES compared to the first-generation Taxus Express 2 PES over 4 years of follow-up; longterm follow-up demonstrated "delayed" restenosis with EES, a phenomenon previously observed with other DES [35]. This finding, however, did not appear to have any adverse effect on clinical outcomes.…”

Optical coherence tomography for evaluating Synergy everolimus-eluting stents with biodegradable polymer and Xience durable polymer everolimus-eluting stents following percutaneous coronary intervention in patients with left main coronary artery stenosis

“…Несмотря на то что стенты с лекарственным пок-рытием заметно снизили частоту рестеноза, длитель-ная персистенция инородного тела в коронарной ар-терии и продолжительное действие лекарственного покрытия препятствуют раннему заживлению сосуда, вызывают локальное воспаление стенки и могут быть причиной позднего рестеноза и тромбоза [30,31]. Так, результаты мультицентрового рандомизированного ис-следования TROfL II trial продемонстрировали лучшие показатели неоинтимального заживления биодегради-руемого стента Absorb, по сравнению с Xience, у паци-ентов с инфарктом миокарда с подъемом сегмента ST через 6 мес.…”