Clinical Trial: In-stent Restenosis in Patients With Patent Previous Bare Metal Stent
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: The Rate of In-stent Restenosis Within Bare Metal Stents as Compared to Drug Eluting Stents in Patients With Patent Previously Deployed Bare Metal Stent
Brief Summary:
Intra-coronary stents deployment reduces the rate of angiographic restenosis as compared to Balloon angioplasty. in-stent restenosis, usually defined as ≥50 percent diameter stenosis within previously deployed stent, is most often becoming clinically evident within the first 6 to 12 months after the stent was deployed. Several risk factors are predictors for the development of in-stent restenosis. These can be generally calcified as either clinical, angiographic or procedural related factors. However it is difficult to estimate to what extent In stent re-stenosis is influenced by these various components.
Drug eluting stent, as compared to bare metal stents, markedly reduced the incidence of angiographic in-stent restenosis. However this benefit must be weighed against a suggested increased risk of late and very late stent thrombosis, a catastrophic event often leading to myocardial infarction and death. Often in patients with existing risk factors for in-stent restenosis, drug eluting stents will be deployed even in cases where patency of a previously deployed bare metal stent have been demonstrated.
Therefore the researchers sought to investigate whether in patients with previously deployed bare metal stent and no evidence of in-stent re-stenosis there will be a significant difference in the rates of in-stent between drug eluting stents and bare metal stents deployed within de-novo stenotic lesions.
Detailed Summary:
Intra-coronary stents deployment reduces the rate of angiographic restenosis and clinically-driven repeat target lesion revascularization (TLR) compared to percutaneous transluminal coronary angioplasty (PTCA) alone. Angiographic binary in-stent restenosis (ISR) is usually defined as ≥50 percent diameter stenosis within previously deployed intra-coronary stent. in-stent restenosis is most often becoming clinically evident within the first 6 to 12 months after the stent was deployed. Although there is an increase in neointimal tissue with subsequent reduction in the minimal luminal diameter (MLD) during the first six months after stent deployment, there may be no further reduction in luminal diameter, or even regression, at one year and a further increase in diameter at later time points. Hence, after one year recurrent ischemia is more likely to be due to new or progressive disease at another site rather than due to ISR.
Several risk factors are predictors for the development of ISR. These can be generally calcified as clinical related factors, angiographic related factors and procedural related factors:
clinical related factors- higher rates of ISR are seen in female patients, hypertensive or diabetic patients , patients suffering from multivessel disease or renal dysfunction and stenting performed in the setting of acute coronary syndrome (ACS).
angiographic related factors -higher rates of ISR are seen in some lesion types, such as smaller reference artery diameter, Smaller pretreatment MLD, longer lesion length, complex lesions, ostial lesions, ISR in a companion lesion or stenting of multiple lesions and bifurcation lesions and treatment of in-stent restenosis.
procedural related factors- lower rates of ISR are se
Sponsor: Rambam Health Care Campus
Current Primary Outcome: The rate of angiographic in-stent restenosis of a stent deployed within de-novo lesions [ Time Frame: one year after the stent was deployed ]
Original Primary Outcome: Same as current
Current Secondary Outcome: all cause mortality all cause mortality [ Time Frame: one year after the stent was deployed ]
Original Secondary Outcome: Same as current
Information By: Rambam Health Care Campus
Dates:
Date Received: February 13, 2011
Date Started: January 2000
Date Completion:
Last Updated: February 14, 2011
Last Verified: February 2011
