Jon A Kobashigawa1, Daniel F Pauly2, Randall C Starling3, Howard Eisen4, Heather Ross5, Shoei-Shen Wang6, Bernard Cantin7, James A Hill2, Patricia Lopez8, Gaohong Dong9, Stephen J Nicholls3. 1. Cedars-Sinai Heart Institute, Cedars-Sinai Medical Center, Los Angeles, California. Electronic address: Kobashigawaj@cshs.org. 2. Division of Cardiovascular Medicine, University of Florida College of Medicine, Gainesville, Florida. 3. Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio. 4. Division of Cardiology, Drexel University College of Medicine, Philadelphia, Pennsylvania. 5. Division of Experimental Therapeautics, Toronto Medical Hospital, Toronto, Ontario, Canada. 6. Department of Cardiovascular Surgery, National Taiwan University Hospital, Taipei, Taiwan. 7. Lipid Research Center, Laval University Medical Center, Quebec, Canada. 8. Novartis Pharma AG, Basel, Switzerland. 9. Novartis Pharmaceuticals Corporation, East Hanover, New Jersey.
Abstract
OBJECTIVES: A pre-planned substudy of a larger multicenter randomized trial was undertaken to compare the efficacy of everolimus with reduced-dose cyclosporine in the prevention of cardiac allograft vasculopathy (CAV) after heart transplantation to that of mycophenolate mofetil (MMF) with standard-dose cyclosporine. BACKGROUND:CAV is a major cause of long-term mortality following heart transplantation. Everolimus has been shown to reduce the severity and incidence of CAV as measured by first year intravascular ultrasound (IVUS). MMF, in combination with cyclosporine, has also been shown to have a beneficial effect in slowing the progression of CAV. METHODS:Study patients were a pre-specified subgroup of the 553-patientEverolimus versus mycophenolate mofetilin heart transplantation: a randomized, multicenter trial who underwent heart transplantation and were randomized to everolimus 1.5 mg or MMF 3 g/day. IVUS was performed at baseline and at 12 months. Evaluable IVUS data were available in 189 patients (34.6%). RESULTS: Increase in average maximal intimal thickness (MIT) from baseline to month 12 was significantly smaller in the everolimus 1.5 mg group compared with the MMF group (0.03 mm vs. 0.07 mm, p < 0.001). The incidence of CAV, defined as an increase in MIT from baseline to month 12 of greater than 0.5 mm, was 12.5% with everolimus versus 26.7% with MMF (p = 0.018). These findings remained irrespective of sex, age, diabetic status, donor disease, and across lipid categories. CONCLUSIONS:Everolimus was significantly more efficacious than MMF in preventing CAV as measured by IVUS among heart-transplant recipients after 1 year, a finding, which was maintained in a range of patient subpopulations. CV surgery: transplantation, ventricular assistance, cardiomyopathy.
RCT Entities:
OBJECTIVES: A pre-planned substudy of a larger multicenter randomized trial was undertaken to compare the efficacy of everolimus with reduced-dose cyclosporine in the prevention of cardiac allograft vasculopathy (CAV) after heart transplantation to that of mycophenolate mofetil (MMF) with standard-dose cyclosporine. BACKGROUND: CAV is a major cause of long-term mortality following heart transplantation. Everolimus has been shown to reduce the severity and incidence of CAV as measured by first year intravascular ultrasound (IVUS). MMF, in combination with cyclosporine, has also been shown to have a beneficial effect in slowing the progression of CAV. METHODS: Study patients were a pre-specified subgroup of the 553-patientEverolimus versus mycophenolate mofetil in heart transplantation: a randomized, multicenter trial who underwent heart transplantation and were randomized to everolimus 1.5 mg or MMF 3 g/day. IVUS was performed at baseline and at 12 months. Evaluable IVUS data were available in 189 patients (34.6%). RESULTS: Increase in average maximal intimal thickness (MIT) from baseline to month 12 was significantly smaller in the everolimus 1.5 mg group compared with the MMF group (0.03 mm vs. 0.07 mm, p < 0.001). The incidence of CAV, defined as an increase in MIT from baseline to month 12 of greater than 0.5 mm, was 12.5% with everolimus versus 26.7% with MMF (p = 0.018). These findings remained irrespective of sex, age, diabetic status, donor disease, and across lipid categories. CONCLUSIONS:Everolimus was significantly more efficacious than MMF in preventing CAV as measured by IVUS among heart-transplant recipients after 1 year, a finding, which was maintained in a range of patient subpopulations. CV surgery: transplantation, ventricular assistance, cardiomyopathy.
Authors: Travis B DeSa; Muhannad A Abbasi; Julie A Blaisdell; Kai Lin; Jeremy D Collins; James C Carr; Michael Markl Journal: Clin Imaging Date: 2019-12-19 Impact factor: 1.605
Authors: Miguel Hernandez Pampaloni; Uttam M Shrestha; Maria Sciammarella; Youngho Seo; Grant T Gullberg; Elias H Botvinick Journal: J Nucl Cardiol Date: 2017-01-30 Impact factor: 5.952