- Author
-
J. Chandrasekhar
- Title
- Clinical outcomes with the Biodegradable-polymer Dual-therapy COMBO stent in patients with coronary artery disease
- Supervisors
-
R.J. de Winter
R. Mehran - Co-supervisors
-
G.D. Dangas
D.N. Kalkman - Award date
- 3 September 2020
- Number of pages
- 490
- ISBN
- 9789402821659
- Document type
- PhD thesis
- Faculty
- Faculty of Medicine (AMC-UvA)
- Abstract
-
In this thesis, we examined the clinical outcomes in patients treated with a new generation coronary stent – the biodegradable-polymer dual therapy COMBO stent. This stainless-steel stent includes an anti-restenotic layer with antiproliferative drug sirolimus which is eluted from a biodegradable polymer coated on the stent abluminally. In addition, a unique pro-healing circumferential layer of anti-CD34 antibodies attracts circulating endothelial progenitor cells which mature into healthy endothelium. We hypothesized that treatment with this coronary stent would allow for low rates of adverse cardiac outcomes during follow-up in several patient groups. By virtue of a pooled patient level analysis from two large COMBO stent registries (REMEDEE and MASCOT), we were able to explore for differences in outcomes among special high-risk populations from the COMBO collaboration. We found that treatment with COMBO stents was associated with similar 1-year target lesion failure (TLF) rates in men and women, young (≤ 75 years) and elderly (>75 years) patients, small vessel (<3mm) and large vessel (≥3mm) coronary disease. We observed regional differences between patients treated in Asia and Europe 1-year after COMBO stenting, which are likely to be a reflection of variances in patient profiles, and potentially diverse cultural and local governance issues. Chronic kidney disease (CKD) patients experienced worse outcomes than non-CKD patients after PCI with COMBO stents, highlighting the challenges in managing this subgroup despite the availability of novel technologies. Patients at increasing bleeding risk using the PARIS score demonstrated greater risk of ischemic and bleeding events at 1-year after COMBO stenting. We observed that treating physicians tended to stop aspirin and continue P2Y12 inhibitor monotherapy in patients with greater bleeding risk. In propensity matched analyses, COMBO stents were not statistically different to biodegradable polymer Orsiro stents for 1-year TLF in all-comer patients. In long term follow-up, COMBO stents were associated with low risk of events to 5 years, with no very late stent thrombosis events beyond 3 years. These results demonstrate the safety and effectiveness of COMBO stents in real world patients, while data from large randomized trials are presently awaited.
- Persistent Identifier
- https://hdl.handle.net/11245.1/d48e7116-9561-4c34-8408-af98d3c6aff4
- Downloads
-
Thesis (complete)
Front matter
General introduction and outline of this thesis
Chapter 1: Safety and efficacy of the COMBO bio-engineered stent in an all-comer PCI cohort: 1-year final clinical outcomes from the MASCOT post-marketing registry
Chapter 2: 1-year clinical outcomes of all-comer patients treated with dual-therapy combo stent: Primary results of the COMBO collaboration
Chapter 3: Sex-differences in 1-year clinical outcomes after PCI with COMBO stents: From the COMBO collaboration
Chapter 4: Comparison of one-year clinical outcomes in patients >75 versus ≤75 years with coronary artery disease treated with COMBO stents (From the MASCOT registry)
Chapter 5: 1-year results after PCI with the COMBO stent in all-comers in Asia versus Europe: Geographical insights from the COMBO collaboration
Chapter 6: 1-year outcomes with COMBO stents in small vessel coronary disease: Subgroup analysis from the COMBO collaboration
Chapter 7: 1-year clinical outcomes in patients with chronic kidney disease treated with COMBO stents: From the COMBO collaboration
Chapter 8: 1-year COMBO stent outcomes in acute coronary syndrome: From the COMBO collaboration
Chapter 9: 1-year COMBO stent outcomes stratified by the PARIS bleeding prediction score: From the MASCOT registry
Chapter 10: Final five-year results of the REMEDEE registry: Real-world experience with the dual-therapy COMBO stent
Chapter 11: 1-year clinical outcome of all-comers treated with two bioresorbable polymer-coated sirolimus-eluting stents: Propensity score matched comparison of COMBO and ultrathin strut Orsiro stents
Chapter 12: Current evidence for the safety and efficacy of the bio-engineered dual-therapy COMBO stent
Chapter 13: Biodegradable polymer and polymer free drug eluting stents: A review
Chapter 14: Concluding remarks and future directions
Chapter 15: Thesis summary
Dutch summary
Authors and affiliations; List of publications; PhD portfolio; Dankwoord (Acknowledgements); Curriculum vitae
- Supplementary materials
Disclaimer/Complaints regulations
If you believe that digital publication of certain material infringes any of your rights or (privacy) interests, please let the Library know, stating your reasons. In case of a legitimate complaint, the Library will make the material inaccessible and/or remove it from the website. Please Ask the Library, or send a letter to: Library of the University of Amsterdam, Secretariat, Singel 425, 1012 WP Amsterdam, The Netherlands. You will be contacted as soon as possible.