Ignite Creation Date:
2024-05-05 @ 10:32 PM
Last Modification Date:
2024-10-26 @ 10:19 AM
Study NCT ID:
NCT01121224
Status:
COMPLETED
Last Update Posted:
2022-07-26
First Post:
2010-05-07
Brief Title:
Drug-Eluting Stents vs Bare Metal Stents In Saphenous Vein Graft Angioplasty
Sponsor:
VA Office of Research and Development
Organization:
VA Office of Research and Development
Study Overview
Official Title:
CSP 571 - Drug-eluting Stents vs Bare Metal Stents in Saphenous Vein Graft Angioplasty DIVA
Status:
COMPLETED
Status Verified Date:
2022-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIVA
Brief 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BMS and DES are routinely being used in SVGs but it is not known which one is better Neither bare metal except for an outdated model nor drug-eluting stents are FDA approved for use in SVGs The purpose of CSP571 is to compare the outcomes after DES vs BMS use in SVGs
In CSP571 patients who need stenting of SVG blockages will be randomized to receive DES or BMS in a 11 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
In CSP571 patients who need stenting of SVG blockages will be randomized to receive DES or BMS in a 11 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
Detailed Description:
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 60000-100000 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 11 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 myocardial infarction 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 the investigators estimate the 12-month TVF rate in the BMS arm to be 30 The investigators 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 VA Medical Center the investigators will need 22 participating sites However the investigators 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 15000-20000 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
SVGs often develop luminal stenoses that are most commonly treated with stent implantation Approximately 60000-100000 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 11 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 myocardial infarction 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 the investigators estimate the 12-month TVF rate in the BMS arm to be 30 The investigators 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 VA Medical Center the investigators will need 22 participating sites However the investigators 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 15000-20000 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None