Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty
Condition: Saphenous Vein Graft Atherosclerosis
MeSH terms: Atherosclerosis
Intervention: Bare Metal Stent; Drug-Eluting Stent; Blinded clopidogrel; Placebo; Thienopyridine (open-label)
Intervention description: Patients receive one or more bare metal stents in the saphenous vein graft target lesion.; Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.; For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.; For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.; For ACS patients who receive BMS or DES in their saphenous vein graft or patients for whom there is another clinical indication for open-label thienopyridine. Also for patients who receive a DES in a non-target lesion.
Intervention MeSH terms: Clopidogrel
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Enrollment: 597.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Saphenous vein graft; Percutaneous coronary intervention; Stents

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      bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in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.
    

Eligibility criteria:

        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