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Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty
Not Recruiting
Trial ID: NCT01121224
Purpose
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bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in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.
Official Title
CSP #571 - Drug-eluting Stents vs. Bare Metal Stents in Saphenous Vein Graft Angioplasty (DIVA)
Stanford Investigator(s)
Eligibility
Inclusion Criteria:
- Age 18 years
- Need for percutaneous coronary intervention of a 50-99% de novo SVG lesion that is
between 2.25 and 4.5 mm in diameter and that is considered to cause clinical or
functional ischemia
- Intent to use a distal embolic protection device
- Agrees to participate and to take prescribed medications as instructed
- Has provided informed consent and agrees to participate
Exclusion Criteria:
- Planned non-cardiac surgery within the following 12 months
- Presentation with an ST-segment elevation acute myocardial infarction
- Target SVG is the last remaining vessel or is the "left main" equivalent
- Any previous percutaneous treatment of the target lesion (with balloon angioplasty,
stent, intravascular brachytherapy etc)
- Any previous percutaneous treatment of the target vessel (of a lesion different than
the target lesion) within the prior 12 months
- Hemorrhagic diatheses, or refusal to receive blood transfusions
- Warfarin administration required for the next 12 months and patient considered to be
at high risk of bleeding with triple anticoagulation/antiplatelet therapy
- Recent positive pregnancy test, breast-feeding, or possibility of a future pregnancy
(defined as no prior hysterectomy or as <5 years elapsing since last menstrual period)
- Coexisting conditions that limit life expectancy to less than 12 months
- History of an allergic reaction or significant sensitivity to drugs such as sirolimus,
paclitaxel, zotarolimus, or everolimus included in various DES. History of an allergic
reaction or significant sensitivity to L-605 cobalt chromium alloy (cobalt, silicon,
chromium, tungsten, manganese, iron, nickel), F562 cobalt chromium alloy (cobalt,
chromium, nickel), 316L surgical stainless steel (iron, chromium, nickel, and
molybdenum), or MP35N cobalt-based alloy (cobalt, nickel, chromium, molybdenum,
titanium, iron, silicon, and manganese), or components of the platinum chromium alloy
stent.
- Allergy to clopidogrel in patients who do not present with an acute coronary syndrome
(ACS), where ACS is defined as cardiac ischemic symptoms occurring at rest and 1 of
the following 3 criteria: electrocardiographic changes suggestive of ischemia
(ST-segment elevation or depression 1 mm in 2 contiguous leads, or new left bundle
branch block, or posterior myocardial infarction); positive biomarker indicating
myocardial necrosis (troponin I or T or creatine kinase-MB greater than the upper
limit of normal); or coronary revascularization performed during hospitalization
triggered by the cardiac ischemic symptoms
- Participating in another interventional randomized trial (required condition for all
CSP studies) for which dual enrollment with DIVA is not approved
Intervention(s):
device: Bare Metal Stent
device: Drug-Eluting Stent
drug: Blinded clopidogrel
drug: Placebo
drug: Thienopyridine (open-label)
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Todd Wagner
6504935000