TY - JOUR
T1 - The INVICTUS rheumatic heart disease research program
T2 - Rationale, design and baseline characteristics of a randomized trial of rivaroxaban compared to vitamin K antagonists in rheumatic valvular disease and atrial fibrillation
AU - INVICTUS Investigators
AU - Karthikeyan, Ganesan
AU - Connolly, Stuart J.
AU - Ntsekhe, Mpiko
AU - Benz, Alexander
AU - Rangarajan, Sumathy
AU - Lewis, Gayle
AU - Yun, Yan
AU - Sharma, Sanjib Kumar
AU - Maklady, Fathi
AU - Elghamrawy, Alaa Eldin
AU - Kazmi, Khawar
AU - Cabral, Tantchou T.J.
AU - Dayi, Hu
AU - Changsheng, Ma
AU - Gitura, Bernard M.
AU - Avezum, Alvaro
AU - Zuhlke, Liesl
AU - Lwabi, Peter
AU - Haileamlak, Abraham
AU - Ogah, Okechukwu
AU - Chillo, Pilly
AU - Paniagua, Maria
AU - ElSayed, Ahmed
AU - Dans, Antonio
AU - Gondwe-Chunda, Lillian
AU - Molefe-Baikai, Onkabetse Julia
AU - Gonzalez-Hermosillo, Jesus A.
AU - Hakim, James
AU - Damasceno, Albertino
AU - Kamanzi, Emmanuel R.
AU - Musuku, John
AU - Davletov, Kairat
AU - Connolly, Katherine
AU - Mayosi, Bongani M.
AU - Yusuf, Salim
N1 - Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/7
Y1 - 2020/7
N2 - Background: Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need. Methods: The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD. Conclusion: INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.
AB - Background: Rheumatic heart disease (RHD) is a neglected disease affecting 33 million people, mainly in low and middle income countries. Yet very few large trials or registries have been conducted in this population. The INVICTUS program of research in RHD consists of a randomized-controlled trial (RCT) of 4500 patients comparing rivaroxaban with vitamin K antagonists (VKA) in patients with RHD and atrial fibrillation (AF), a registry of 17,000 patients to document the contemporary clinical course of patients with RHD, including a focused sub-study on pregnant women with RHD within the registry. This paper describes the rationale, design, organization and baseline characteristics of the RCT and a summary of the design of the registry and its sub-study. Patients with RHD and AF are considered to be at high risk of embolic strokes, and oral anticoagulation with VKAs is recommended for stroke prevention. But the quality of anticoagulation with VKA is poor in developing countries. A drug which does not require monitoring, and which is safe and effective for preventing stroke in patients with valvular AF, would fulfill a major unmet need. Methods: The INVestIgation of rheumatiC AF Treatment Using VKAs, rivaroxaban or aspirin Studies (INVICTUS-VKA) trial is an international, multicentre, randomized, open-label, parallel group trial, testing whether rivaroxaban 20 mg given once daily is non-inferior (or superior) to VKA in patients with RHD, AF, and an elevated risk of stroke (mitral stenosis with valve area ≤2 cm2, left atrial spontaneous echo-contrast or thrombus, or a CHA2DS2VASc score ≥2). The primary efficacy outcome is a composite of stroke or systemic embolism and the primary safety outcome is the occurrence of major bleeding. The trial has enrolled 4565 patients from 138 sites in 23 countries from Africa, Asia and South America. The Registry plans to enroll an additional 17,000 patients with RHD and document their treatments, and their clinical course for at least 2 years. The pregnancy sub-study will document the clinical course of pregnant women with RHD. Conclusion: INVICTUS is the largest program of clinical research focused on a neglected cardiovascular disease and will provide new information on the clinical course of patients with RHD, and approaches to anticoagulation in those with concomitant AF.
UR - http://www.scopus.com/inward/record.url?scp=85085397329&partnerID=8YFLogxK
U2 - 10.1016/j.ahj.2020.03.018
DO - 10.1016/j.ahj.2020.03.018
M3 - Article
C2 - 32474206
AN - SCOPUS:85085397329
SN - 0002-8703
VL - 225
SP - 69
EP - 77
JO - American Heart Journal
JF - American Heart Journal
ER -