TY - JOUR
T1 - Long-term clinical outcomes with use of an angiotensin-converting enzyme inhibitor early after heart transplantation
T2 - ACE-I after Heart Transplantation
AU - Arashi, Hiroyuki
AU - Sato, Takuma
AU - Kobashigawa, Jon
AU - Luikart, Helen
AU - Kobayashi, Yuhei
AU - Okada, Kozo
AU - Sinha, Seema
AU - Honda, Yasuhiro
AU - Yeung, Alan C.
AU - Khush, Kiran
AU - Fearon, William F.
N1 - Funding Information:
Dr Fearon has received research support from Abbott Vascular and Medtronic; and has minor stock options with HeartFlow. Dr Kobayashi has received an institutional fellowship grant from Boston Scientific. All authors have reported that they have no relationships relevant to the contents of this paper to disclose.
Publisher Copyright:
© 2020 Elsevier Inc.
PY - 2020/4
Y1 - 2020/4
N2 - Background: The safety and efficacy of angiotensin converting enzyme inhibition (ACEI) after heart transplantation (HT) is unknown. This study examined long-term clinical outcomes after ACEI in HT recipients. Methods: The ACEI after HT study was a prospective, randomized trial that tested the efficacy of ACEI with ramipril after HT. In this study, long-term clinical outcomes were assessed in 91 patients randomized to either ramipril or placebo (median, 5.8 years). The primary endpoint was a composite of death, retransplantation, hospitalization for rejection or heart failure, and coronary revascularization. Results: The primary endpoint occurred in 10 of 45 patients (22.2%) in the ramipril group and in 14 of 46 patients (30.4%) in the placebo group (Hazard ratio (HR), 0.68; 95% CI, 0.29-1.51; P = .34). When the analysis was restricted to comparing patients who remained on a renin-angiotensin system inhibitor beyond 1 year with those who did not, there was a trend to improved outcomes (HR, 0.54; 95% CI, 0.22-1.28, P = .16). There was no significant difference in creatinine, blood urea nitrogen, and potassium at 3 years after randomization. The cumulative incidence of the primary endpoint was significantly higher in patients in whom the index of microcirculatory resistance increased from baseline to 1 year compared with those in whom it did not (39.1 vs 17.4%, HR: 3.36; 95% CI, 1.07-12.7; P = .037). Conclusion: The use of ramipril after HT safely lowers blood pressure and is associated with favorable long-term clinical outcomes. Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT01078363.
AB - Background: The safety and efficacy of angiotensin converting enzyme inhibition (ACEI) after heart transplantation (HT) is unknown. This study examined long-term clinical outcomes after ACEI in HT recipients. Methods: The ACEI after HT study was a prospective, randomized trial that tested the efficacy of ACEI with ramipril after HT. In this study, long-term clinical outcomes were assessed in 91 patients randomized to either ramipril or placebo (median, 5.8 years). The primary endpoint was a composite of death, retransplantation, hospitalization for rejection or heart failure, and coronary revascularization. Results: The primary endpoint occurred in 10 of 45 patients (22.2%) in the ramipril group and in 14 of 46 patients (30.4%) in the placebo group (Hazard ratio (HR), 0.68; 95% CI, 0.29-1.51; P = .34). When the analysis was restricted to comparing patients who remained on a renin-angiotensin system inhibitor beyond 1 year with those who did not, there was a trend to improved outcomes (HR, 0.54; 95% CI, 0.22-1.28, P = .16). There was no significant difference in creatinine, blood urea nitrogen, and potassium at 3 years after randomization. The cumulative incidence of the primary endpoint was significantly higher in patients in whom the index of microcirculatory resistance increased from baseline to 1 year compared with those in whom it did not (39.1 vs 17.4%, HR: 3.36; 95% CI, 1.07-12.7; P = .037). Conclusion: The use of ramipril after HT safely lowers blood pressure and is associated with favorable long-term clinical outcomes. Clinical Trial Registration—URL: https://www.clinicaltrials.gov. Unique identifier: NCT01078363.
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U2 - 10.1016/j.ahj.2020.01.003
DO - 10.1016/j.ahj.2020.01.003
M3 - Article
C2 - 32007823
AN - SCOPUS:85078530814
VL - 222
SP - 30
EP - 37
JO - American Heart Journal
JF - American Heart Journal
SN - 0002-8703
ER -