Rationale and design of the DEAR-OLD trial: Randomized evaluation of routinely Deferred versus EARly invasive strategy in elderly patients of 75 years or OLDer with non-ST-elevation myocardial infarction
Wen-Xiu Leng, Jingang Yang, Wei Li, Yang Wang, Yue-Jin Yang, DEAR-OLD investigators, Wen-Xiu Leng, Jingang Yang, Wei Li, Yang Wang, Yue-Jin Yang, DEAR-OLD investigators
Abstract
Background: Comparing with conservative strategy, early invasive approach has been shown to be beneficial for initially stabilized patients with non-ST-elevation myocardial infarction (NSTEMI). However, concerns of increased risk of bleeding and other complications associated with early revascularization in patients aged ≥75 years persist. A routinely deferred invasive strategy aiming to facilitate revascularization after stabilizing the culprit lesion predominates across China.
Aim: The aim was to compare efficacy and safety of deferred invasive strategy versus guideline-recommended early invasive strategy in initially stabilized Chinese patients aged ≥75 years with NSTEMI.
Methods: Twenty qualified centers from 10 different provinces throughout mainland China will contribute to the study. Eligible patients will be central randomized to a routine deferred invasive approach or an early invasive approach (coronary angiography >72 hours or <24 hours of admission and appropriate revascularization). Patients meeting the inclusion criteria but not randomized for any reason will be registered. The primary end point of the present study is a composite of all-cause mortality, nonlethal (re) MI, ischemic stroke, and urgent revascularization at 1 year. Noninferiority design is used, and the inferiority margin was set to be 5%. The goal is to enroll 696 patients with expected primary end point rates of 30%, 2-tailed α of .05, power of 80%, and dropout rate of 5%.
Conclusions: The DEAR-OLD trial is a prospective, nationwide, multicenter, noninferiority-designed, open-label randomized clinical trial evaluating efficacy and safety of routinely deferred invasive strategy compared with early invasive strategy in Chinese elderly patients with NSTEMI.
Trial registration: ClinicalTrials.gov NCT02900001.
Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.
Source: PubMed