Long-Term Safety and Efficacy of Platinum Chromium Everolimus-Eluting Stents in Coronary Artery Disease: 5-Year Results From the PLATINUM Trial

• Published in: JACC. Cardiovascular interventions Vol. 10; no. 23; pp. 2392 - 2400
• Main Authors: Kelly, Christopher R, Teirstein, Paul S, Meredith, Ian T, Farah, Bruno, Dubois, Christophe L, Feldman, Robert L, Dens, Joseph, Hagiwara, Nobuhisa, Rabinowitz, Abram, Carrié, Didier, Pompili, Vincent, Bouchard, Alain, Saito, Shigeru, Allocco, Dominic J, Dawkins, Keith D, Stone, Gregg W
• Format: Journal Article
• Language: English
• Published: United States 11.12.2017
• Subjects: Aged; Asia; Cardiovascular Agents - administration & dosage; Cardiovascular Agents - adverse effects; Chromium Alloys; Coronary Artery Disease - diagnostic imaging; Coronary Artery Disease - mortality; Coronary Artery Disease - therapy; Coronary Thrombosis - etiology; Drug-Eluting Stents; Europe; Everolimus - administration & dosage; Everolimus - adverse effects; Female; Humans; Kaplan-Meier Estimate; Male; Middle Aged; Myocardial Infarction - etiology; Percutaneous Coronary Intervention - adverse effects; Percutaneous Coronary Intervention - instrumentation; Percutaneous Coronary Intervention - mortality; Platinum; Proportional Hazards Models; Prosthesis Design; Risk Factors; Time Factors; Treatment Outcome; United States; coronary artery disease; percutaneous coronary intervention; stent design; drug-eluting stent(s)
• DOI: 10.1016/j.jcin.2017.06.070
• ISSN: 1936-8798

The authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102). In the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention. Patients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization. In the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions. PtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434).