Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial
Por:
Bermejo, J, Yotti, R, Garcia-Orta, R, Sanchez-Fernandez, PL, Castano, M, Segovia-Cubero, J, Escribano-Subias, P, San Roman, JA, Borras, X, Alonso-Gomez, A, Botas, J, Crespo-Leiro, MG, Velasco, S, Bayes-Genis, A, Lopez, A, Munoz-Aguilera, R, de Teresa, E, Gonzalez-Juanatey, JR, Evangelista, A, Mombiela, T, Gonzalez-Mansilla, A, Elizaga, J, Martin-Moreiras, J, Gonzalez-Santos, JM, Moreno-Escobar, E, Fernandez-Aviles, F
Publicada:
14 abr 2018
Resumen:
Aims We aimed to determine whether treatment with sildenafil improves outcomes of patients with persistent pulmonary hypertension (PH) after correction of valvular heart disease (VHD).
Methods and results The sildenafil for improving outcomes after valvular correction (SIOVAC) study was a multricentric, randomized, parallel, and placebo-controlled trial that enrolled stable adults with mean pulmonary artery pressure >= 30 mmHg who had undergone a successful valve replacement or repair procedure at least 1 year before inclusion. We assigned 200 patients to receive sildenafil (40 mg three times daily, n = 104) or placebo (n = 96) for 6 months. The primary endpoint was the composite clinical score combining death, hospital admission for heart failure (HF), change in functional class, and patient global self-assessment. Only 27 patients receiving sildenafil improved their composite clinical score, as compared with 44 patients receiving placebo; in contrast 33 patients in the sildenafil group worsened their composite score, as compared with 14 in the placebo group [odds ratio 0.39; 95% confidence interval (Cl) 0.22-0.67; P < 0.001]. The Kaplan-Meier estimates for survival without admission due to HF were 0.76 and 0.86 in the sildenafil and placebo groups, respectively (hazard ratio 2.0, 95% Cl = 1.0-4.0; log-rank P = 0.044). Changes in 6-min walk test distance, natriuretic peptides, and Doppler-derived systolic pulmonary pressure were similar in both groups.
Conclusion Treatment with sildenafil in patients with persistent PH after successfully corrected VHD is associated to worse clinical outcomes than placebo. Off-label usage of sildenafil for treating this source of left heart disease PH should be avoided.
Filiaciones:
Bermejo, J:
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Fac Med, Inst Invest Sanitaria Gregorio Marano,Dept Cardio, Dr Esquerdo 46, Madrid 28007, Spain
CIBERCV, Dr Esquerdo 46, Madrid 28007, Spain
Yotti, R:
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Fac Med, Inst Invest Sanitaria Gregorio Marano,Dept Cardio, Dr Esquerdo 46, Madrid 28007, Spain
CIBERCV, Dr Esquerdo 46, Madrid 28007, Spain
Garcia-Orta, R:
Hosp Virgen Nieves, Granada, Spain
Sanchez-Fernandez, PL:
Univ Salamanca, Hosp Clin, Salamanca, Spain
CIBERCV Salamanca, Salamanca, Spain
Castano, M:
Hosp Univ Leon, Leon, Spain
Segovia-Cubero, J:
Hosp Puerta Hierro Majadahonda, Majadahonda, Spain
CIBERCV, Majadahonda, Spain
Escribano-Subias, P:
Hosp 12 Octubre, Madrid, Spain
CiberCV, Madrid, Spain
San Roman, JA:
Hosp Clin Valladolid, Valladolid, Spain
CIBERCV, Valladolid, Spain
Borras, X:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
CIBERCV, Barcelona, Spain
Alonso-Gomez, A:
Hosp Univ Araba Txagorritxu, Vitoria, Spain
Botas, J:
Hosp Univ Fdn Alcorcon, Alcorcon, Spain
Crespo-Leiro, MG:
Complejo Hosp Univ A Coruna, La Coruna, Spain
CIBERCV, La Coruna, Spain
Velasco, S:
Hosp Galdakao Usansolo, Usansolo, Spain
Bayes-Genis, A:
Hosp Badalona Germans Trias & Pujol, Badalona, Spain
CIBERCV, Badalona, Spain
Lopez, A:
Hosp Univ Reina Sofia, Cordoba, Spain
Munoz-Aguilera, R:
Hosp Infanta Leonor, Madrid, Spain
de Teresa, E:
Hosp Virgen Victoria, Malaga, Spain
CIBERCV, Malaga, Spain
Gonzalez-Juanatey, JR:
Hosp Clin Santiago de Compostela, Santiago De Compostela, Spain
CIBERCV, Santiago De Compostela, Spain
Evangelista, A:
CIBERCV, Barcelona, Spain
Hosp Univ Vall Hebron, Barcelona, Spain
Mombiela, T:
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Fac Med, Inst Invest Sanitaria Gregorio Marano,Dept Cardio, Dr Esquerdo 46, Madrid 28007, Spain
CIBERCV, Dr Esquerdo 46, Madrid 28007, Spain
Gonzalez-Mansilla, A:
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Fac Med, Inst Invest Sanitaria Gregorio Marano,Dept Cardio, Dr Esquerdo 46, Madrid 28007, Spain
CIBERCV, Dr Esquerdo 46, Madrid 28007, Spain
Elizaga, J:
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Fac Med, Inst Invest Sanitaria Gregorio Marano,Dept Cardio, Dr Esquerdo 46, Madrid 28007, Spain
CIBERCV, Dr Esquerdo 46, Madrid 28007, Spain
Martin-Moreiras, J:
Univ Salamanca, Hosp Clin, Salamanca, Spain
CIBERCV Salamanca, Salamanca, Spain
Gonzalez-Santos, JM:
Univ Salamanca, Hosp Clin, Salamanca, Spain
CIBERCV Salamanca, Salamanca, Spain
Moreno-Escobar, E:
Hosp Univ San Cecilio, Granada, Spain
Fernandez-Aviles, F:
Univ Complutense Madrid, Hosp Gen Univ Gregorio Maranon, Fac Med, Inst Invest Sanitaria Gregorio Marano,Dept Cardio, Dr Esquerdo 46, Madrid 28007, Spain
CIBERCV, Dr Esquerdo 46, Madrid 28007, Spain
Green Published, Hybrid Gold
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