ISSN 2996-8215
International Journal of Cardiology | Vol. 7, No. 11, November 2016 | pp. 81–88
DOI: 10.46882/2016/IJC/000092
Original Research Article
Safety and Efficacy of Second-Generation Everolimus-Eluting Stents in Patients Undergoing Complex Percutaneous Coronary Intervention
Ji-Hoon Kim¹, Min-Soo Park¹, Sung-Hoon Choi²
¹Department of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine, Seoul, South Korea
²Division of Interventional Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea
Abstract:
First-generation drug-eluting stents (DES) significantly limited coronary restenosis but raised long-term concerns regarding late stent thrombosis in complex coronary anatomy due to delayed arterial healing. Second-generation DES incorporate thinner cobalt-chromium struts and highly biocompatible polymers to improve vascular compliance and endothelialization. This randomized, single-blind clinical trial evaluated the 2-year clinical safety and efficacy of second-generation everolimus-eluting stents (EES) compared with first-generation paclitaxel-eluting stents (PES) in patients with highly complex coronary artery lesions. We randomized 340 patients exhibiting complex lesions (classified as type B2 or C according to the ACC/AHA criteria) to undergo percutaneous coronary intervention (PCI) with either EES (n = 170) or PES (n = 170). The primary endpoint was target lesion failure (TLF) at 24 months, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization (TLR). At 2 years, the primary endpoint occurred significantly less frequently in the EES cohort than in the PES group (6.5% vs. 13.5%, p = 0.03), driven by a substantial reduction in TLR (2.9% vs. 8.2%, p < 0.05). Definite or probable stent thrombosis was also significantly lower with EES (0.6% vs. 2.4%, p = 0.04). Multivariable logistic regression identified first-generation PES deployment as an independent predictor of 2-year TLF (odds ratio: 2.24, 95% CI: 1.12–4.48, p = 0.02). Second-generation everolimus-eluting stents demonstrate superior safety and efficacy profiles over first-generation paclitaxel-eluting stents in complex coronary lesions, minimizing target lesion failure and stent thrombosis.
Keywords: Percutaneous coronary intervention, Drug-eluting stents, Everolimus, Paclitaxel, Complex coronary lesions, Stent thrombosis
Received: August 01, 2016; Revised: September 15, 2016; Accepted: October 10, 2016; Published: November 20, 2016