Aspects on efficacy in endovascular treatment with drug eluting stents and balloons in the repair of stenotic vessel lesions with special reference to local drug therapy
Fransson, Torbjörn LU
(2024)
In Lund University, Faculty of Medicine Doctoral Dissertation Series
- Abstract
Abstract:
Background:The need for vascular procedures for certain disease-specific causes is a majorissue for health care today. This thesis will focus on endovascular treatmentfor PAD and malfunctioning haemodialysis access. Although many other vasculardiseases and anatomic regions sometimes need to be managed with endovascularprocedures, PAD and haemodialysis access together account for a significantpart of the daily vascular operative production. The incidence of PAD isheavily increasing in society due to the ageing population and lifestyleissues, and an essential part of this pathological and metabolic issue is theincreasing burden of diabetes... (More)
Abstract:
Background:The need for vascular procedures for certain disease-specific causes is a majorissue for health care today. This thesis will focus on endovascular treatmentfor PAD and malfunctioning haemodialysis access. Although many other vasculardiseases and anatomic regions sometimes need to be managed with endovascularprocedures, PAD and haemodialysis access together account for a significantpart of the daily vascular operative production. The incidence of PAD isheavily increasing in society due to the ageing population and lifestyleissues, and an essential part of this pathological and metabolic issue is theincreasing burden of diabetes mellitus in developed countries around the world.Also, the need for haemodialysis is increasing, partly due to the same reasonsdiscussed earlier. For the last decades, the treatment of both PAD andmalfunctioning haemodialysis access is increasingly being performed byinterventional methods, which come with an increasing burden of handlingintimal hyperplasia and other adverse treatment effects. These lead to earlyrestenosis that significantly impairs the clinical results of the performedprocedures as well as the patient’s quality of life. New drug adjunctiveangioplasty methods have been developed to deal with these postangioplastyproblems. Studies are needed to evaluate their efficacy and safety compared tostandard procedures.
Methods:Three RCTs and one retrospective observational cohort study were performed, allcomparing drug eluting endovascular therapy with standard endovascular therapyin specified settings. The aim was to clarify an acceptable safety profile andpossibly demonstrate superior treatment results with drug eluting technology.
I. Randomisationof 50+50 subjects in a single blinded, parallel group, clinical trial,comparing drug eluting angioplasty against conventional angioplasty whentreating malfunctional haemodialysis access in the upper extremity.
II. Randomisationof 100+100 subjects in a single blinded, parallel group, clinical trial,comparing drug eluting stenting against standard bare metal stenting whentreating arterial lesions in the superficial femoral artery or the poplitealartery in subjects with chronic limb threatening ischemia.
III. Nationwideobservational cohort study, with data from SWEDVASC and NDR, analysing andcomparing the results of drug eluting therapy in endovascular treatment oflower limb ischemia in subjects with and without diabetes mellitus.
IV. Randomisationof 35+35 subjects in a single blinded, parallel group, clinical trial,comparing drug eluting angioplasty against conventional angioplasty whentreating complex crural arterial lesions in subjects with chronic limbthreatening ischemia.
Results:Studies I and II did not completely fulfil the prestudy enrolment criteria.They were analysed and could not show any safety issues or superior resultswith drug eluting technology. Study III showed that subjects with diabetesmellitus and chronic limb threatening ischemia, treated with drug elutingmethods, had superior amputation-free survival (HR 0.712 [CI 0.562-0.901],p=0.005). Study IV did not show any differences in primary outcome variables atone-year follow-up. However, amputation-free survival as a secondary outcomevariable was significantly better among subjects treated with drug coatedballoons (OR 0.31[CI 0.10-0.96], p=0.042).
Conclusion: The aggregated results signal a possible positivetreatment effect with drug eluting technology compared to standard treatment.Unfortunately, two of the performed trials became underpowered and could notsupport a conclusion in favour of drug eluting technology. More and largerrandomised studies are needed to clarify the role of drug eluting technologiesin the treatment of vascular diseases.
(Less)
- author
- Fransson, Torbjörn
LU
- supervisor
- opponent
-
- Associate Professor Sigvant, Birgitta, Department of Surgical Sciences, Uppsala University, and Centre for Clinical Research and Education, Region Värmland.
- organization
- publishing date
- 2024
- type
- Thesis
- publication status
- published
- subject
- keywords
- Drug eluting, Drug coated, Angioplasty, Endovascular, Stent, Paclitaxel, Chronic limb threatening ischemia, Haemodialysis access, Diabetes Mellitus, Randomized trial.
- in
- Lund University, Faculty of Medicine Doctoral Dissertation Series
- issue
- 2024:81
- pages
- 204 pages
- publisher
- Lund University, Faculty of Medicine
- defense location
- Agardh föreläsningssal, CRC, Jan Waldenströms gata 35, Skånes Universitetssjukhus i Malmö
- defense date
- 2024-06-14 13:00:00
- ISSN
- 1652-8220
- ISBN
- 978-91-8021-576-3
- language
- English
- LU publication?
- yes
- id
- 8f7fec35-961e-43cb-8172-5e96ec03368f
- date added to LUP
- 2024-05-06 19:25:24
- date last changed
- 2024-05-21 14:11:27
@phdthesis{8f7fec35-961e-43cb-8172-5e96ec03368f,
abstract = {{<p class="tabeltext" style="margin-bottom:1.0pt"><b>Abstract:</b></p><p class="tabeltextintabel">Background:The need for vascular procedures for certain disease-specific causes is a majorissue for health care today. This thesis will focus on endovascular treatmentfor PAD and malfunctioning haemodialysis access. Although many other vasculardiseases and anatomic regions sometimes need to be managed with endovascularprocedures, PAD and haemodialysis access together account for a significantpart of the daily vascular operative production. The incidence of PAD isheavily increasing in society due to the ageing population and lifestyleissues, and an essential part of this pathological and metabolic issue is theincreasing burden of diabetes mellitus in developed countries around the world.Also, the need for haemodialysis is increasing, partly due to the same reasonsdiscussed earlier. For the last decades, the treatment of both PAD andmalfunctioning haemodialysis access is increasingly being performed byinterventional methods, which come with an increasing burden of handlingintimal hyperplasia and other adverse treatment effects. These lead to earlyrestenosis that significantly impairs the clinical results of the performedprocedures as well as the patient’s quality of life. New drug adjunctiveangioplasty methods have been developed to deal with these postangioplastyproblems. Studies are needed to evaluate their efficacy and safety compared tostandard procedures.</p><p class="tabeltextintabel">Methods:Three RCTs and one retrospective observational cohort study were performed, allcomparing drug eluting endovascular therapy with standard endovascular therapyin specified settings. The aim was to clarify an acceptable safety profile andpossibly demonstrate superior treatment results with drug eluting technology.</p><p class="tabeltextintabel" style="margin-left:18.45pt;text-indent:-18.45pt; mso-list:l0 level1 lfo1">I. Randomisationof 50+50 subjects in a single blinded, parallel group, clinical trial,comparing drug eluting angioplasty against conventional angioplasty whentreating malfunctional haemodialysis access in the upper extremity.</p><p class="tabeltextintabel" style="margin-left:18.45pt;text-indent:-18.45pt; mso-list:l0 level1 lfo1">II. Randomisationof 100+100 subjects in a single blinded, parallel group, clinical trial,comparing drug eluting stenting against standard bare metal stenting whentreating arterial lesions in the superficial femoral artery or the poplitealartery in subjects with chronic limb threatening ischemia.</p><p class="tabeltextintabel" style="margin-left:18.45pt;text-indent:-18.45pt; mso-list:l0 level1 lfo1">III. Nationwideobservational cohort study, with data from SWEDVASC and NDR, analysing andcomparing the results of drug eluting therapy in endovascular treatment oflower limb ischemia in subjects with and without diabetes mellitus.</p><p class="tabeltextintabel" style="margin-left:18.45pt;text-indent:-18.45pt; mso-list:l0 level1 lfo1">IV. Randomisationof 35+35 subjects in a single blinded, parallel group, clinical trial,comparing drug eluting angioplasty against conventional angioplasty whentreating complex crural arterial lesions in subjects with chronic limbthreatening ischemia.</p><p class="tabeltextintabel">Results:Studies I and II did not completely fulfil the prestudy enrolment criteria.They were analysed and could not show any safety issues or superior resultswith drug eluting technology. Study III showed that subjects with diabetesmellitus and chronic limb threatening ischemia, treated with drug elutingmethods, had superior amputation-free survival (HR 0.712 [CI 0.562-0.901],p=0.005). Study IV did not show any differences in primary outcome variables atone-year follow-up. However, amputation-free survival as a secondary outcomevariable was significantly better among subjects treated with drug coatedballoons (OR 0.31[CI 0.10-0.96], p=0.042).</p><p class="tabeltextintabel">Conclusion: The aggregated results signal a possible positivetreatment effect with drug eluting technology compared to standard treatment.Unfortunately, two of the performed trials became underpowered and could notsupport a conclusion in favour of drug eluting technology. More and largerrandomised studies are needed to clarify the role of drug eluting technologiesin the treatment of vascular diseases.</p>}},
author = {{Fransson, Torbjörn}},
isbn = {{978-91-8021-576-3}},
issn = {{1652-8220}},
keywords = {{Drug eluting, Drug coated, Angioplasty, Endovascular, Stent, Paclitaxel, Chronic limb threatening ischemia, Haemodialysis access, Diabetes Mellitus, Randomized trial.}},
language = {{eng}},
number = {{2024:81}},
publisher = {{Lund University, Faculty of Medicine}},
school = {{Lund University}},
series = {{Lund University, Faculty of Medicine Doctoral Dissertation Series}},
title = {{Aspects on efficacy in endovascular treatment with drug eluting stents and balloons in the repair of stenotic vessel lesions with special reference to local drug therapy}},
url = {{https://lup.lub.lu.se/search/files/183029322/Avhandling_Torbj_rn_Fransson_LUCRIS.pdf}},
year = {{2024}},
}