Drug-Eluting Stents vs. Bare Metal Stents In Saphenous Vein Graft Angioplasty

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 Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs.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.

Conditions

• Saphenous Vein Graft Atherosclerosis

Interventions

DEVICE

Bare Metal Stent

Patients receive one or more bare metal stents in the saphenous vein graft target lesion.

DEVICE

Drug-Eluting Stent

Patients receive one or more drug-eluting stents in the saphenous vein graft target lesion.

DRUG

Blinded clopidogrel

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive one or more DES in the target lesion.

DRUG

Placebo

For non-ACS patients with no other clinical indication for open-label thienopyridine who receive only BMS.

DRUG

Thienopyridine (open-label)

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.

Sponsors & Collaborators

• VA Office of Research and Development

  lead FED

Principal Investigators

• Emmanouil S Brilakis, MD PhD · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

• Subhash Banerjee, MD · VA North Texas Health Care System Dallas VA Medical Center, Dallas, TX

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-01-11

Primary Completion

2016-12-31

Completion

2016-12-31

FDA Device

Yes

Countries

• United States

Study Locations