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Observational Study
. 2017 Dec;40(12):1197-1204.
doi: 10.1002/clc.22837. Epub 2017 Dec 16.

Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study

Dirk Westermann  1   2 , Shaun G Goodman  3 , José C Nicolau  4 , Gema Requena  5 , Andrew Maguire  5 , Ji Yan Chen  6 , Christopher B Granger  7 , Richard Grieve  8 , Stuart J Pocock  8 , Stefan Blankenberg  1   2 , Ana Maria Vega  9 , Satoshi Yasuda  10 , Tabassome Simon  11 , David Brieger  12 ; TIGRIS Study Investigators
Affiliations
Observational Study

Rationale and design of the long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study

Dirk Westermann et al. Clin Cardiol. 2017 Dec.

Abstract

The long-term progression of coronary artery disease as defined by the natural disease course years after a myocardial infarction (MI) is an important but poorly studied area of clinical research. The long-Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post-myocardial infarction patients (TIGRIS) study was designed to address this knowledge gap by evaluating patient management and clinical outcomes following MI in different regions worldwide. TIGRIS (ClinicalTrials.gov Identifier: NCT01866904) is a multicenter, observational, prospective, longitudinal study enrolling patients with history of MI 1 to 3 years previously and high risk of developing atherothrombotic events in a general-practice setting. The primary objective of TIGRIS is to evaluate clinical events (time to first occurrence of any event from the composite cardiovascular endpoint of MI, unstable angina with urgent revascularization, stroke, or death from any cause), and healthcare resource utilization associated with hospitalization for these events (hospitalization duration and procedures) during follow-up. Overall, 9225 patients were enrolled between June 2013 and November 2014 and are being followed in 369 different centers worldwide. This will allow for the description of regional differences in patient characteristics, risk profiles, medical treatment patterns, clinical outcomes, and healthcare resource utilization. Patients will be followed for up to 3 years. Here we report the rationale, design, patient distribution, and selected baseline characteristics of the TIGRIS study. TIGRIS will describe real-world management, quality of life (self-reported health), and healthcare resource utilization for patients with stable coronary artery disease ≥1 year post-MI.

Keywords: Coronary artery disease; Healthcare resource utilization; Observational; Trial design; myocardial infarction < Ischemic heart disease.

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Conflict of interest statement

Dirk Westermann reports speaker/consulting honoraria and/or research grant support from AstraZeneca, Bayer, Berlin‐Chemie, Biotronik, and Novartis. Shaun G. Goodman reports speaker/consulting honoraria and/or research grant support from Amgen Inc., Amilyn, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‐Myers Squibb, Eli Lilly, Ferring Pharmaceuticals, GlaxoSmithKline, Matrizyme, Merck, Novartis, Pfizer, Regeneron, Revalesio, Sanofi, Servier, and Tenax Pharmaceuticals. José C. Nicolau reports speaker/consulting honoraria and/or research grant support from Amgen, AstraZeneca, Bayer, BMS, Boehringer Ingelheim, GlaxoSmithKline, Merck, Novartis, Pfizer, and Sanofi. Gema Requena and Andrew Maguire are employed by Oxon Epidemiology Ltd. (which has received funding from AstraZeneca). Christopher B. Granger reports consulting honoraria and/or research grant support from Armetheon, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‐Myers Squibb, Daiichi Sankyo, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann‐La Roche, Janssen Pharmaceuticals, Medtronic, Pfizer, Salix Pharmaceuticals, Sanofi, Takeda, and The Medicines Company. Stuart Pocock reports statistical consulting honoraria from AstraZeneca. Stefan Blankenberg reports speaker/consulting honoraria and/or research grant support from Abbott, Abbott Diagnostics, AstraZeneca, Bayer, Boehringer Ingelheim, Medtronic, Novartis, Pfizer, Roche, Siemens, Siemens Diagnostics, and Thermo Fisher Scientific. Tabassome Simon reports speaker/consulting honoraria and/or research grant support from Astellas, Amgen Inc., AstraZeneca, Bayer, Boehringer Ingelheim, Eli Lilly, GlaxoSmithKline, Merck, Novartis, Pfizer, and Sanofi. Satoshi Yasuda reports speaker/consulting honoraria and/or research grant support from Takeda, Daiichi‐Sankyo, AstraZeneca, Boehringer Ingelheim, and Bristol‐Myers Squibb. Ana Maria Vega is employed by AstraZeneca. David Brieger reports speaker/consulting honoraria and/or research grant support from Amgen Inc., AstraZeneca, Bayer, Boehringer Ingelheim, Bristol‐Myers Squibb, Eli Lilly, Merck, and Sanofi. The authors declare no other potential conflicts of interest.

Figures

Figure 1
Figure 1
Study design. Abbreviations: MI, myocardial infarction; QoL, quality of life (self‐reported health status)
Figure 2
Figure 2
Patient enrollment in long‐Term rIsk, clinical manaGement, and healthcare Resource utilization of stable coronary artery dISease in post–myocardial infarction patients (TIGRIS) by country and region. Abbreviations: UK, United Kingdom; USA, United States of America
See this image and copyright information in PMC

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