A narrative overview: Have clinical trials of PCI vs medical therapy addressed the right question?

Doralisa Morrone; Mario Marzilli; Roberta Antonazzo Panico; Paul Kolm; William S Weintraub

doi:10.1016/j.ijcard.2018.03.125

A narrative overview: Have clinical trials of PCI vs medical therapy addressed the right question?

Int J Cardiol. 2018 Sep 15:267:35-40. doi: 10.1016/j.ijcard.2018.03.125.

Authors

Doralisa Morrone¹, Mario Marzilli², Roberta Antonazzo Panico², Paul Kolm³, William S Weintraub³

Affiliations

¹ Christiana Care Health System, Newark, DE, USA; Surgery Pathology, Medical, Molecular and Critic Area Department-Cardiovascular Disease Section, Pisa University, Italy. Electronic address: doralisa.morrone@unipi.it.
² Surgery Pathology, Medical, Molecular and Critic Area Department-Cardiovascular Disease Section, Pisa University, Italy.
³ Christiana Care Health System, Newark, DE, USA.

PMID: 29957261
DOI: 10.1016/j.ijcard.2018.03.125

Abstract

Background: In RCTs about revascularization, the terms "coronary artery disease" and "ischemic heart disease" are sometimes used interchangeably. This can create confusion concerning inclusion and exclusion criteria, which may lead to uncertain results.

Objective: Our purpose is to investigate whether the study populations in randomized controlled trials (RCTs) which compared percutaneous coronary revascularization to medical therapy for stable ischemic heart disease specifically enrolled patients with demonstrable ischemia, and how many patients were included in trials with evidence of coronary atherosclerosis but without evidence of ischemia.

Methods: Trial published data were obtained from ACME I, ACME II, RITA I, RITA II, MASS I, MASS II, AVERT, ACIP, COURAGE and FAME2. Published data were used to calculate the number of patients included in the trials with a negative stress test but significant coronary artery stenosis and the number of patients excluded from the trials with a positive stress test or angina, but without significant coronary artery stenosis at the time of angiography.

Results: A total of 196,433 patients were screened between 1998 and 2011. Overall about 30% of patients were excluded if they did not meet the angiographic criteria, even though the presence of inducible ischemia or angina, and, about 20% of patients were included without inducible ischemia.

Conclusion: RCTs have contributed to the confusion between coronary artery disease and ischemic heart disease. This may limit the ability to interpret the results and apply them in practice.

Keywords: Atherosclerosis; Clinical trials; Stable ischemic heart disease.

Publication types

Review

MeSH terms

Coronary Angiography / methods
Coronary Artery Disease* / complications
Coronary Artery Disease* / diagnosis
Coronary Artery Disease* / therapy
Coronary Stenosis* / diagnosis
Coronary Stenosis* / etiology
Coronary Stenosis* / therapy
Drug Therapy / methods*
Exercise Test / methods
Humans
Myocardial Ischemia* / diagnosis
Myocardial Ischemia* / therapy
Patient Care Management / methods
Patient Selection*
Percutaneous Coronary Intervention / methods*
Randomized Controlled Trials as Topic