Background: Statins are recommended in heart transplantation regardless of lipid levels. However, it remains unknown whether dosing should be maximized or adjusted toward a pre-defined cholesterol threshold. Methods: This pilot, randomized, open-label study compares an early maximal dose of fluvastatin (80 mg/day) with a strategy based on 20 mg/day subsequently titrated to target low-density lipoproteins (LDL) <100 mg/dl. Efficacy outcomes consisted of achieving an LDL level of <100 mg/dl at 12 months after transplant, and change in intracoronary ultrasound parameters. Results: Fifty-two patients were randomized. Overall safety, and efficacy in achieving LDL targets (13 [50%] vs 14 [54%]; p = 0.8) were comparable between study arms, but 17 (65%) patients needed a dose increase in the titrated-dosing arm. Early LDL levels and average LDL burden were lower in the maximal-dosing arm (p < 0.05). Few patients developed an increase in maximal intimal thickness of >0.5 mm, with numerical prevalence in the titrated-dosing arm (3 [12.5%] vs 1 [5%]; p = 0.3). Intimal volume increased in the titrated-dosing (p < 0.01) but not in the maximal-dosing arm (p = 0.1), which accordingly showed a higher prevalence of negative remodeling (p = 0.02). Conclusions: Despite being as effective as the titrated-dosing approach in achieving LDL <100 mg/dl at 12 months after transplant, the maximal-dose approach was associated with a more rapid effect and with potential advantages in preventing pathologic changes in graft coronary arteries.

Safety and efficacy of early aggressive versus cholesterol-driven lipid-lowering strategies in heart transplantation: A pilot, randomized, intravascular ultrasound study / Potena L.; Grigioni F.; Ortolani P.; Magnani G.; Fabbri F.; Masetti M.; Coccolo F.; Fallani F.; Russo A.; Ionico T.; Saia F.; Rapezzi C.; Branzi A.. - In: THE JOURNAL OF HEART AND LUNG TRANSPLANTATION. - ISSN 1053-2498. - ELETTRONICO. - 30:(2011), pp. 1305-1311. [10.1016/j.healun.2011.07.002]

Safety and efficacy of early aggressive versus cholesterol-driven lipid-lowering strategies in heart transplantation: A pilot, randomized, intravascular ultrasound study.

POTENA, LUCIANO;GRIGIONI, FRANCESCO;ORTOLANI, PAOLO;MAGNANI, GAIA;MASETTI, MARCO;RUSSO, ANTONIO;IONICO, TERESA;SAIA, FRANCESCO;RAPEZZI, CLAUDIO;BRANZI, ANGELO
2011

Abstract

Background: Statins are recommended in heart transplantation regardless of lipid levels. However, it remains unknown whether dosing should be maximized or adjusted toward a pre-defined cholesterol threshold. Methods: This pilot, randomized, open-label study compares an early maximal dose of fluvastatin (80 mg/day) with a strategy based on 20 mg/day subsequently titrated to target low-density lipoproteins (LDL) <100 mg/dl. Efficacy outcomes consisted of achieving an LDL level of <100 mg/dl at 12 months after transplant, and change in intracoronary ultrasound parameters. Results: Fifty-two patients were randomized. Overall safety, and efficacy in achieving LDL targets (13 [50%] vs 14 [54%]; p = 0.8) were comparable between study arms, but 17 (65%) patients needed a dose increase in the titrated-dosing arm. Early LDL levels and average LDL burden were lower in the maximal-dosing arm (p < 0.05). Few patients developed an increase in maximal intimal thickness of >0.5 mm, with numerical prevalence in the titrated-dosing arm (3 [12.5%] vs 1 [5%]; p = 0.3). Intimal volume increased in the titrated-dosing (p < 0.01) but not in the maximal-dosing arm (p = 0.1), which accordingly showed a higher prevalence of negative remodeling (p = 0.02). Conclusions: Despite being as effective as the titrated-dosing approach in achieving LDL <100 mg/dl at 12 months after transplant, the maximal-dose approach was associated with a more rapid effect and with potential advantages in preventing pathologic changes in graft coronary arteries.
2011
Safety and efficacy of early aggressive versus cholesterol-driven lipid-lowering strategies in heart transplantation: A pilot, randomized, intravascular ultrasound study / Potena L.; Grigioni F.; Ortolani P.; Magnani G.; Fabbri F.; Masetti M.; Coccolo F.; Fallani F.; Russo A.; Ionico T.; Saia F.; Rapezzi C.; Branzi A.. - In: THE JOURNAL OF HEART AND LUNG TRANSPLANTATION. - ISSN 1053-2498. - ELETTRONICO. - 30:(2011), pp. 1305-1311. [10.1016/j.healun.2011.07.002]
Potena L.; Grigioni F.; Ortolani P.; Magnani G.; Fabbri F.; Masetti M.; Coccolo F.; Fallani F.; Russo A.; Ionico T.; Saia F.; Rapezzi C.; Branzi A.
File in questo prodotto:
Eventuali allegati, non sono esposti

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/105412
 Attenzione

Attenzione! I dati visualizzati non sono stati sottoposti a validazione da parte dell'ateneo

Citazioni
  • ???jsp.display-item.citation.pmc??? 4
  • Scopus 13
  • ???jsp.display-item.citation.isi??? 15
social impact