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Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients : Design of the randomized controlled EVOLVD trial

Broch, Kaspar ; Gude, Einar ; Karason, Kristjan ; Dellgren, Göran ; Rådegran, Göran LU ; Gjesdal, Grunde LU ; Gustafsson, Finn ; Eiskjær, Hans ; Lommi, Jyri and Pentikäinen, Markku , et al. (2020) In Clinical Transplantation 34(9).
Abstract

Background: Cardiac allograft vasculopathy (CAV) is characterized by diffuse thickening of the arterial intima. Statins reduce the incidence of CAV, but despite the use of statins, CAV remains one of the leading causes of long-term death after heart transplant. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients. Methods: The Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients (EVOLVD) trial (ClinicalTrials.gov Identifier: NCT03734211) is a randomized, double-blind trial designed to test the effect of the PCSK9 inhibitor evolocumab on coronary intima thickness... (More)

Background: Cardiac allograft vasculopathy (CAV) is characterized by diffuse thickening of the arterial intima. Statins reduce the incidence of CAV, but despite the use of statins, CAV remains one of the leading causes of long-term death after heart transplant. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients. Methods: The Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients (EVOLVD) trial (ClinicalTrials.gov Identifier: NCT03734211) is a randomized, double-blind trial designed to test the effect of the PCSK9 inhibitor evolocumab on coronary intima thickness in heart transplant recipients. Adults who have received a cardiac transplant within the past 4-8 weeks are eligible. Exclusion criteria include an estimated glomerular filtration rate < 20 mL/min/1.73 m2, renal replacement therapy, or contraindications to coronary angiography with intravascular ultrasound. 130 patients will be randomized (1:1) to 12-month treatment with evolocumab or matching placebo. The primary endpoint is the coronary artery intima thickness as measured by intravascular ultrasound. Conclusion: The EVOLVD trial is a randomized clinical trial designed to show whether treatment with the PCSK9 inhibitor evolocumab can ameliorate CAV over the first year after heart transplant.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
cardiac allograft vasculopathy, cholesterol, heart transplant, randomized controlled trial
in
Clinical Transplantation
volume
34
issue
9
article number
e13984
publisher
Wiley-Blackwell
external identifiers
  • scopus:85089024952
  • pmid:32445429
ISSN
0902-0063
DOI
10.1111/ctr.13984
language
English
LU publication?
yes
id
b8769ccc-7b2f-4b50-bce5-0fc203925ff7
date added to LUP
2020-08-13 14:28:15
date last changed
2024-06-13 21:23:35
@article{b8769ccc-7b2f-4b50-bce5-0fc203925ff7,
  abstract     = {{<p>Background: Cardiac allograft vasculopathy (CAV) is characterized by diffuse thickening of the arterial intima. Statins reduce the incidence of CAV, but despite the use of statins, CAV remains one of the leading causes of long-term death after heart transplant. Inhibitors of proprotein convertase subtilisin-kexin type 9 (PCSK9) substantially reduce cholesterol levels but have not been tested in heart transplant recipients. Methods: The Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients (EVOLVD) trial (ClinicalTrials.gov Identifier: NCT03734211) is a randomized, double-blind trial designed to test the effect of the PCSK9 inhibitor evolocumab on coronary intima thickness in heart transplant recipients. Adults who have received a cardiac transplant within the past 4-8 weeks are eligible. Exclusion criteria include an estimated glomerular filtration rate &lt; 20 mL/min/1.73 m<sup>2</sup>, renal replacement therapy, or contraindications to coronary angiography with intravascular ultrasound. 130 patients will be randomized (1:1) to 12-month treatment with evolocumab or matching placebo. The primary endpoint is the coronary artery intima thickness as measured by intravascular ultrasound. Conclusion: The EVOLVD trial is a randomized clinical trial designed to show whether treatment with the PCSK9 inhibitor evolocumab can ameliorate CAV over the first year after heart transplant.</p>}},
  author       = {{Broch, Kaspar and Gude, Einar and Karason, Kristjan and Dellgren, Göran and Rådegran, Göran and Gjesdal, Grunde and Gustafsson, Finn and Eiskjær, Hans and Lommi, Jyri and Pentikäinen, Markku and Lemström, Karl B. and Andreassen, Arne K. and Gullestad, Lars}},
  issn         = {{0902-0063}},
  keywords     = {{cardiac allograft vasculopathy; cholesterol; heart transplant; randomized controlled trial}},
  language     = {{eng}},
  number       = {{9}},
  publisher    = {{Wiley-Blackwell}},
  series       = {{Clinical Transplantation}},
  title        = {{Cholesterol lowering with EVOLocumab to prevent cardiac allograft Vasculopathy in De-novo heart transplant recipients : Design of the randomized controlled EVOLVD trial}},
  url          = {{http://dx.doi.org/10.1111/ctr.13984}},
  doi          = {{10.1111/ctr.13984}},
  volume       = {{34}},
  year         = {{2020}},
}