Track topics on Twitter Track topics that are important to you
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 Neither bare metal (except for an outdated model) nor drug-eluting stents are FDA approved for use in SVGs.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.
VA Cooperative Studies Program #571 is designed to prospectively evaluate the efficacy of drug-eluting stents (DES) in reducing aortocoronary saphenous vein bypass graft (SVG) failure when compared to bare metal stents (BMS) in patients undergoing stenting of de novo SVG lesions.
SVGs often develop luminal stenoses that are most commonly treated with stent implantation. Approximately 60,000-100,000 percutaneous SVG interventions are performed annually in the USA. Two types of coronary stents are currently available: bare metal stents and drug eluting stents. Bare metal stents are the standard of care for the percutaneous treatment of SVG lesions, but are limited by high rates of in-stent restenosis (as high as 51% after 12 months) often leading to repeat percutaneous or surgical SVG treatments. Drug-eluting stents have been shown to significantly reduce in-stent restenosis and the need for repeat target vessel and lesion revascularization in native coronary arteries, yet their efficacy in SVGs is not well studied, with conflicting results from various small studies. The proposed Cooperative Studies Program study will be the first large prospective, randomized, multicenter, blinded clinical trial comparing DES and BMS in SVG lesions. It will provide critical knowledge to assist the cardiac interventionalist in selecting the optimum stent type for these challenging lesions.
Patients undergoing clinically-indicated stenting of de novo SVG lesions will be randomized in a 1:1 ratio to DES or BMS. To ensure blinding to the type of stent used, of the patients who do not present with an acute coronary syndrome and do not require 12 months of dual antiplatelet therapy, those who receive DES will receive 11 months of clopidogrel and those who receive BMS will receive 11 months of matching placebo. After stenting, patients will be followed clinically for a minimum of one year to determine the 12-month incidence of target vessel failure (TVF, primary study endpoint). TVF will be defined as the composite of cardiac death, target vessel myocardial infarction and target vessel revascularization, and is the primary clinical endpoint used in all FDA-approved DES pivotal trials. Coronary angiography and intervention during follow-up will only be performed if clinically-indicated (no mandatory angiographic follow-up). Secondary endpoints include: 1) clinical outcomes other than TVF (procedural success; post-procedural myocardial infarction; post-procedural bleeding; all cause death and cardiac death; follow-up myocardial infarction; stent thrombosis; target lesion revascularization; target vessel revascularization; non-target vessel revascularization; the composite endpoint of death, MI, and target vessel revascularization (patient-oriented composite endpoint according to the FDA guidance document on DES studies); the composite endpoint of cardiac death, target vessel myocardial infarction, and target lesion revascularization (device-oriented composite endpoint for target lesion failure); and stroke); and 2) incremental cost-effectiveness of DES relative to BMS. A tertiary endpoint is in-stent neointima proliferation as measured by intravascular ultrasonography.
Based on published studies, we estimate the 12-month TVF rate in the BMS arm to be 30%. We hypothesize that DES will reduce TVF to 18% (40% relative reduction). Assuming two-year accrual and one interim assessment, a total sample size of about 520 patients will be needed to detect this difference with 90% power, using a two-sided 5% significance level. Assuming an intake rate of 1 patient per month per VAMC, we will need 22 participating sites. However, we will begin the study with 25 sites to protect against a site dropout rate of 10%.
Percutaneous treatment of SVG lesions is of particular importance to the VA system because many veterans have undergone and continue to undergo coronary artery bypass graft surgery. Every year, approximately 12-15% of percutaneous coronary interventions performed within the VA system are performed in SVGs, at a cost of approximately $15,000-$20,000 per procedure; DES are currently used in approximately half of SVG interventions. Because of (a) the high prevalence and high cost of SVG stenting, (b) DES cost two- to three- fold more than BMS and often require prolonged ( 12 months) thienopyridine administration to prevent late stent thrombosis, and (c) DES may have increased risk for late and very late stent thrombosis, a catastrophic complication with high mortality, the proposed study will have considerable impact on the clinical practice of SVG lesion stenting, patient satisfaction, and financial burden of health care systems (both within and outside the VA), regardless of whether the results are positive (DES offer significantly superior health benefits to patients than BMS), or negative (DES do not offer significantly superior health benefits to patients than BMS). Due to decreasing profits and increasing competition, DES manufacturers are not planning to ever fund a SVG DES study. The VA system with its Cooperative Studies Program is uniquely suited to conduct the proposed study.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment
Saphenous Vein Graft Atherosclerosis
Bare Metal Stent, Drug-Eluting Stent, Blinded clopidogrel, Placebo, Thienopyridine (open-label)
Southern Arizona VA Health Care System, Tucson
Not yet recruiting
Department of Veterans Affairs
Published on BioPortfolio: 2014-08-27T03:13:47-0400
The investigators hypothesize that patients with Acute ST Elevation Myocardial Infarction may benefit from primary angioplasty with use of a drug eluting balloon/bare metal stent combinati...
The purpose of this study was to determine whether Sirolimus stent implantation is effective in reducing neointimal hyperplasia as compared to Bare metal stent in diabetic patients with de...
The aim of this study is to compare the efficacy of drug-eluting stents and bare metal stents to reduce reblockage of bypass grafts after coronary stenting
The objective of this study is to compare the Cypher Select-TM Sirolimus Eluting Stent (SES) with the SONIC-TM Bare Metal Stent (BMS) in the treatment of Chronic Total Occlusion lesions (C...
The main objective of this study is to assess the safety and effectiveness of the sirolimus coated Bx VELOCITY stent in reducing angiographic in-stent late loss in de novo native coronary ...
This study aimed to perform a systematic review and meta-analysis of current evidence comparing the drug-eluting stent (DES) with the bare-metal stent (BMS) in the treatment of femoropopliteal artery ...
Stent technology has rapidly evolved since the first stainless steel bare metal stents with substantial developments in scaffolding, polymer, drug choice, drug delivery, and elution mechanisms. Most r...
This study sought to evaluate the optimal treatment for in-stent restenosis (ISR) of drug-eluting stents (DESs).
Studies comparing coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) have largely been performed in the bare-metal stent (BMS) and first-generation drug eluting stent (F-...
The new and thickened layer of scar tissue that forms on a PROSTHESIS, or as a result of vessel injury especially following ANGIOPLASTY or stent placement.
Surgical construction of an artificial opening (stoma) for external fistulization of a duct or vessel by insertion of a tube with or without a supportive stent.
Postoperative hemorrhage from an endovascular AORTIC ANEURYSM repaired with endoluminal placement of stent grafts (BLOOD VESSEL PROSTHESIS IMPLANTATION). It is associated with pressurization, expansion, and eventual rupture of the aneurysm.
Stents that are covered with materials that are embedded with chemicals that are gradually released into the surrounding milieu.
A type of surgical portasystemic shunt to reduce portal hypertension with associated complications of esophageal varices and ascites. It is performed percutaneously through the jugular vein and involves the creation of an intrahepatic shunt between the hepatic vein and portal vein. The channel is maintained by a metallic stent. The procedure can be performed in patients who have failed sclerotherapy and is an additional option to the surgical techniques of portocaval, mesocaval, and splenorenal shunts. It takes one to three hours to perform. (JAMA 1995;273(23):1824-30)
Pain is defined by the International Association for the Study of Pain as “an unpleasant sensory and emotional experience associated with actual or potential tissue damage or described in terms of such damage”. Some illnesses can be excruci...
Cardiology is a specialty of internal medicine. Cardiac electrophysiology : Study of the electrical properties and conduction diseases of the heart. Echocardiography : The use of ultrasound to study the mechanical function/physics of the h...