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

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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.

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