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

Abstract

Objectives: 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).

Background: 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.

Methods: 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.

Results: 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.

Conclusions: 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).

Keywords: coronary artery disease; drug-eluting stent(s); percutaneous coronary intervention; stent design.

Copyright © 2017 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

Figures

FIGURE 1. Primary Endpoint in the Randomized PLATINUM Trial

The primary endpoint was target lesion failure (TLF), a composite of cardiac death related to the target vessel, MI related to the target vessel or ischemia-driven target lesion revascularization. (A) Five-year time-to-event curves. (B) Landmark analysis of event rates before and after 1 year of follow-up. CI = confidence interval; CoCr-EES = cobalt-chromium everolimus-eluting stent(s); HR = hazard ratio; MI = myocardial infarction; PLATINUM = PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions; PtCr-EES = platinum-chromium everolimus-eluting stent(s).

FIGURE 2. Major Secondary Endpoints at 5 Years in the Main PLATINUM Trial

Five-year time-to-event curves for (A) target vessel (TV)-related cardiac death, (B) target vessel-related myocardial infarction (TV-MI), (C) ischemia-driven target lesion revascularization (ID-TLR), and (D) definite or probable stent thrombosis (ST). Abbreviations as in Figure 1.

FIGURE 3. Subgroup Analyses for the Primary Outcome at 5 Years in the Randomized PLATINUM Trial

Interaction effects between stent type and baseline findings were determined for TLF at 5 years. Diamonds indicate relative risk, and bars indicate 95% CIs. Abbreviations as in Figure 1.

FIGURE 4. 5-Year Endpoints in the PLATINUM Substudies

Five-year time-to-event curves for the primary and major secondary outcomes in the small vessel substudy (A and B) and long lesion substudy (C and D). Abbreviations as in Figures 1 and 2.