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

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• 作者：Luciano Potena MD ; PhD  ; ;   ; ^{luciano.potena2@unibo.it} ; Francesco Grigioni MD ; PhD ; Paolo Ortolani MD ; Gaia Magnani MD ; PhD ; Francesca Fabbri MD ; Marco Masetti MD ; Fabio Coccolo MD ; Francesco Fallani MD ; Antonio Russo MD ; PhD ; Teresa Ionico MD ; Francesco Saia MD ; PhD ; Claudio Rapezzi MD ; Angelo Branzi MD
• 关键词：heart transplantation ; intravascular ultrasound ; cholesterol ; statins ; cardiac allograft vasculopathy ; atherosclerosis
• 刊名：The Journal of Heart and Lung Transplantation
• 出版年：2011
• 出版时间：December 2011
• 年：2011
• 卷：30
• 期：12
• 页码：1305-1311
• 全文大小：546 K

文摘

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.