Sildenafil for Improving Outcomes after VAlvular Correction - SIOVAC

Jan 10, 2018
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Author/Summarized by Author:
Anthony A. Bavry, MD, MPH, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Instituto de Salud Carlos III, Ministerio de Economía y Competitividad, Spain; EU–European Regional Development Fund; and the Red de Investigación Cardiovascular and CIBERCV.
Date Published:
12/21/2017
Date Updated:
01/10/2018
Original Posted Date:
01/11/2018
References

Contribution To Literature:

The SIOVAC trial showed that sildenafil was associated with unfavorable clinical outcomes compared with placebo.

Description:

The goal of the trial was to evaluate treatment with sildenafil compared with placebo among patients with persistent pulmonary hypertension after valvular replacement or repair.

Study Design

  • Randomized
  • Parallel
  • Placebo

Patients who underwent valve replacement or repair in the last year and had persistent pulmonary hypertension (mean pulmonary artery [PA] pressure ≥30 mm Hg) were randomized to sildenafil 40 mg three times daily (n = 104) versus placebo (n = 96).

  • Total number of enrollees: 200
  • Duration of follow-up: 6 months
  • Mean patient age: 70 years
  • Percentage female: 73%
  • Percentage with diabetes: 30%

Inclusion criteria:

  • >18 years of age
  • Mean PA pressure ≥30 mm Hg (by catheterization) after valve replacement or repair
  • Stable clinical condition

Exclusion criteria:

  • Significant residual valve dysfunction
  • Systolic blood pressure <90 mm Hg
  • Myocardial infarction, stroke, or life-threatening arrhythmia in the last 6 months
  • Severe renal impairment
  • Limited life expectancy

Other salient features/characteristics:

  • Median time from valve surgery: 7.5 years
  • Mitral and aortic valve surgery: 28%
  • Isolated mitral valve surgery: 26%
  • Mitral and tricuspid valve surgery: 25%
  • Isolated aortic valve surgery: 8%

Principal Findings:

The primary outcome, composite clinical score (death, hospitalization for heart failure, change in functional class, and patient global self-assessment) worsened in 33 patients in the sildenafil group versus 14 patients in the placebo group (p < 0.001).

Secondary outcomes:

  • Hospitalization for heart failure: 22% for sildenafil vs. 11% for placebo (p = 0.06)
  • Heart failure or dyspnea: 34% for sildenafil vs. 20% for placebo (p = 0.04) 

Interpretation:

Among patients with persistent pulmonary hypertension after valve replacement or repair (majority mitral ± another valve), the use of sildenafil was not beneficial. Sildenafil was associated with unfavorable clinical outcomes compared with placebo. Unfavorable outcomes were due to a higher incidence of heart failure in the sildenafil group. The use of sildenafil to treat persistent pulmonary hypertension after valve surgery cannot be recommended.

References:

Bermejo J, Yotti R, García-Orta R, et al., on behalf of the Sildenafil for Improving Outcomes after VAlvular Correction (SIOVAC) investigators. Sildenafil for improving outcomes in patients with corrected valvular heart disease and persistent pulmonary hypertension: a multicenter, double-blind, randomized clinical trial. Eur Heart J 2017;Dec 21:[Epub ahead of print].

Keywords: Aortic Valve, Cardiac Surgical Procedures, Catheterization, Dyspnea, Heart Failure, Heart Valve Diseases, Hypertension, Pulmonary, Mitral Valve, Pulmonary Valve, Tricuspid Valve, Treatment Outcome


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