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Comparison between catheter-based delivery of fluid paclitaxel and drug eluting stents (DES) in coronary artery disease patients at high risk for instent restenosis

Thesis

Last updated: 06 Feb 2023

Subjects

-

Tags

Cardiovascular Medicine

Advisors

El-Ramli, Muhammad S., Mahmoud, Hesham B., Mussttafa, Amr H., Abdel-Wahhab, Amir M.

Authors

El-Muqaddem, Mussttafa Usama

Accessioned

2017-07-12 06:42:46

Available

2017-07-12 06:42:46

type

M.D. Thesis

Abstract

Objectives: In a prospective non randomized trial, we compared the safety and efficacy of the new catheter based delivery of fluid paclitaxel with that of drug eluting stents in coronary artery disease patients at high risk for instent restenosis.Background : Drug eluting stents reduce the risk of instent restenosis but delay healing of the vascular wall. Recent data on late and very late stent thrombosis after drug-eluting stent (DES) implantation have raised concerns about the long-term safety and have led to a decline in worldwide use of DES. High lipophilicity of paclitaxel promotes rapid cellular uptake and prolongs its action. Hence, paclitaxel exerts potent and sustained inhibitory effects on smooth muscle cell proliferation and migration in cell culture after single-dose application. This makes paclitaxel a very promising candidate for local drug therapy intended to inhibit the proliferative and migratory processes involved in restenosis following PCIMethods and results:. We conducted a prospective, non randomized trial comparing the local delivery of fluid paclitaxel after bare metal stent implantation (DBB group) with the implantation of drug eluting stent (DES group) in 60 patients at high risk for instent restenosis. The primary end points were in-stent late lumen loss and binary restenosis rate ›50%. Secondary end points were procedure success and a composite clinical end point (major adverse cardiac events and revascularization of the target lesion) 6 months after intervention. At 6 months, angiography showed an in-stent late lumen loss of 1.05+1.3 mm in DDB group versus 0.94+1.3 mm in DES group (P=.743) without statistically significant difference in the cumulative overall rate of major cardiac events between both groups.DES subgroup analysis showed in-stent late lumen loss of 0.09+30 mm in everolimus eluting stent (EES) treated patients that was statistically significant in comparison with DDB group(P=.033) and paclitaxel eluting stent (PES) treated patients (P=.006).Target lesion revascularization was 0% in EES treated patients , 36.7% in DDB group and was 47.7% in PES treated patients (P=.026)Conclusion: Paclitaxel either in fluid form used in drug delivery balloons or polymerized form used in drug eluting stents was safe but ineffective in reducing neointimal proliferation, instent restenosis, and clinical events .EES were much more superior when compared with PES treated patients and catheter based delivery of fluid paclitaxel after bare metal stent implantation regarding primary and secondary end points

Issued

1 Jan 2013

DOI

http://dx.doi.org/10.21473/iknito-space/38374

Details

Type

Thesis

Created At

31 Jan 2023