Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty
Status:
Completed
Trial end date:
2016-12-31
Target enrollment:
Participant gender:
Summary
Patients who have undergone coronary bypass surgery have had a vein removed from the leg and
implanted in the chest to "bypass" blockages in the coronary arteries. These veins are called
saphenous vein grafts or SVGs. SVGs often develop blockages that can cause chest pain and
heart attacks. SVG blockages can be opened by using small balloons and stents (metal coils
that keep the artery open). Two types of stents are currently used: bare metal stents (BMS)
and drug-eluting stents (DES). Both BMS and DES are made of metal. DES are also coated with a
drug that releases into the wall of the blood vessel to prevent scar tissue from forming and
re-narrowing the vessel. Both stents have advantages and disadvantages: DES require taking
special blood thinners (called thienopyridines, such as clopidogrel or prasugrel) longer than
bare metal stent and could have more bleeding but are also less likely to renarrow. Both BMS
and DES are routinely being used in SVGs, but it is not known which one is better. Neither
bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in
SVGs. The purpose of CSP#571 is to compare the outcomes after DES vs. BMS use in SVGs.
In CSP#571 patients who need stenting of SVG blockages will be randomized to receive DES or
BMS in a 1:1 ratio. Per standard practice, patients will receive 12 months of an open label
thienopyridine if they have acute coronary syndrome (ACS), or if they have another clinical
reason for needing the medication. Patients without ACS who receive DES also need to take 12
months of a thienopyridine whether or not they are in the study, but non-ACS patients who
receive a BMS do not. In order to make sure patients do not know which stent they received,
non-ACS patients who received BMS will receive 1 month of open label thienopyridine followed
by 11 months of blinded placebo, while those who received DES will receive 1 month of open
label thienopyridine followed by 11 months of blinded clopidogrel, which is a thienopyridine.
All study patients will be followed in the clinic for at least 1 year after their stenting
procedure to see if there is a difference in the rate of cardiac death, heart attack, or any
procedure that is required in order to increase the flow of blood to and from the heart
between the BMS and DES groups.