Stable Angina Clinical Trial
Official title:
Comparison of the Vasomotor Function and Myocardial Flow in Patients Treated
Background: A total of 25-50% of patients with stable coronary atherosclerosis treated with
metallic stent implantation remain with effort angina despite optimal medical treatment and
absence of stent restenosis at 1 year. The most plausible cause of persistent effort angina
after stent implantation is microcirculatory dysfunction. Coronary circulation matches the
myocardial blood supply and oxygen consumption. Metallic stent implantation has been related
with endothelial dysfunction and impaired coronary blood flow reserve (relation between
coronary blood flow at rest and maximal hyperemia) of the treated vessel at 1 year.
Bioresorbable Vascular Scaffold (BVS) has been shown to improve the endothelial function and
to improve the angina symptoms at 1 year. However, the coronary blood flow of BVS has never
been tested.
Main objective: To determine differences in the blood average peak velocity at maximal
hyperemia with adenosine infusion between patients treated with bioresorbable and metallic
coronary stents at 1 year after stent implantation.
Methodology: A total of 70 patients are 1:1 randomized to everolimus-eluting metallic stent
(EES) versus everolimus-eluting BVS implantation in patients with stable coronary disease. At
1 year, patients undergo to invasive coronary angiography prior cessation of vasomotor drugs.
A pressure/Doppler wire is advanced distally to the "treated segment" and the endothelial
(acetylcholine) and non-endothelial (adenosine and nitroglycerine) vasomotor function is
assessed with quantitative coronary angiography and pressure and Doppler measurements. Angina
test questionnaires are obtained at different time-points of the study.
Expected results: A difference between patients treated with BVS and EES of 12.0 cm/sc in the
maximal average peak velocity (APV) under maximal hyperemia (with adenosine administration)
is expected, as assessed by Doppler measurements, at 1 year after stent implantation. The
study is powered to assess superiority in terms of maximal APV favoring patients treated with
BVS.
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