Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents
Background. Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-establi...
Saved in:
| Main Authors: | , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Wiley
2021-01-01
|
| Series: | Journal of Diabetes Research |
| Online Access: | http://dx.doi.org/10.1155/2021/8636050 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832558471664369664 |
|---|---|
| author | Piotr Rola Adrian Włodarczak Mateusz Barycki Marek Szudrowicz Magdalena Łanocha Jan Jakub Kulczycki Karol Turkiewicz Katarzyna Woźnica Maciej Lesiak Adrian Doroszko |
| author_facet | Piotr Rola Adrian Włodarczak Mateusz Barycki Marek Szudrowicz Magdalena Łanocha Jan Jakub Kulczycki Karol Turkiewicz Katarzyna Woźnica Maciej Lesiak Adrian Doroszko |
| author_sort | Piotr Rola |
| collection | DOAJ |
| description | Background. Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. Results. There were no significant differences between the diabetic and nondiabetic populations in the primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. Conclusion. Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results. |
| format | Article |
| id | doaj-art-a477f207c7f6406facfd41e17210f966 |
| institution | Kabale University |
| issn | 2314-6753 |
| language | English |
| publishDate | 2021-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Diabetes Research |
| spelling | doaj-art-a477f207c7f6406facfd41e17210f9662025-02-03T01:32:19ZengWileyJournal of Diabetes Research2314-67532021-01-01202110.1155/2021/8636050Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting StentsPiotr Rola0Adrian Włodarczak1Mateusz Barycki2Marek Szudrowicz3Magdalena Łanocha4Jan Jakub Kulczycki5Karol Turkiewicz6Katarzyna Woźnica7Maciej Lesiak8Adrian Doroszko9Department of CardiologyDepartment of CardiologyDepartment of CardiologyDepartment of CardiologyAdalbert’s HospitalDepartment of CardiologyDepartment of CardiologyFaculty of Mathematics and Information Science1st Department of CardiologyDepartment of Internal MedicineBackground. Cardiovascular disease (CVD) with significant involvement of coronary artery disease (CAD) remains a major cause of death and disability among the diabetic population. Although percutaneous coronary intervention (PCI) continues to evolve, type 2 diabetes mellitus (T2DM) is a well-established marker of poor clinical prognosis after PCI, which is mainly attributed to the rapid progression of atherosclerosis requiring recurrent revascularizations. Hence, the use of bioresorbable materials could provide some solution to this problem. Material and Methods. The study was divided into two arms. For the first one, we qualified 169 patients with NSTE-ACS treated with PCI who received the drug-eluting stent (DES) coated with a biodegradable polymer Ultimaster (Terumo, Tokyo, Japan). The second arm was composed of 193 patients with ACS who underwent PCI with a magnesium bioresorbable scaffold Magmaris (Biotronik, Berlin, Germany). Both arms were divided into two subsequent groups: the T2DM (59 and 72) and the non-DM (110 and 121, respectively). The primary outcomes were cardiovascular death, myocardial infarction, and in-stent thrombosis. The main secondary outcomes included target lesion failure (TLF) and were recorded at a 1-year-follow-up. Results. There were no significant differences between the diabetic and nondiabetic populations in the primary endpoints or main secondary endpoints (TLF, scaffold restenosis, death from any reason, and other cardiovascular events) either in the Ultimaster or Magmaris group. At a 1-year follow-up, the primary endpoint in the DM t.2 population was recorded in 2.7% Ultimaster vs. 5.1% Magmaris, respectively. Conclusion. Both, Ultimaster and Magmaris revealed relative safety and efficiency at a one-year follow-up in the diabetic population in ACS settings. The observed rates of TLF were low, which combined with a lack of in-stent thrombosis suggests that both investigated devices might be an interesting therapeutic option for diabetics with ACS. Nevertheless, further large randomized clinical trials are needed to confirm fully our results.http://dx.doi.org/10.1155/2021/8636050 |
| spellingShingle | Piotr Rola Adrian Włodarczak Mateusz Barycki Marek Szudrowicz Magdalena Łanocha Jan Jakub Kulczycki Karol Turkiewicz Katarzyna Woźnica Maciej Lesiak Adrian Doroszko Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents Journal of Diabetes Research |
| title | Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents |
| title_full | Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents |
| title_fullStr | Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents |
| title_full_unstemmed | Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents |
| title_short | Biodegradable Polymer DES (Ultimaster) vs. Magnesium Bioresorbable Scaffold (BRS Magmaris) in Diabetic Population with NSTE-ACS: A One-Year Clinical Outcome of Two Sirolimus-Eluting Stents |
| title_sort | biodegradable polymer des ultimaster vs magnesium bioresorbable scaffold brs magmaris in diabetic population with nste acs a one year clinical outcome of two sirolimus eluting stents |
| url | http://dx.doi.org/10.1155/2021/8636050 |
| work_keys_str_mv | AT piotrrola biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT adrianwłodarczak biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT mateuszbarycki biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT marekszudrowicz biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT magdalenałanocha biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT janjakubkulczycki biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT karolturkiewicz biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT katarzynawoznica biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT maciejlesiak biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents AT adriandoroszko biodegradablepolymerdesultimastervsmagnesiumbioresorbablescaffoldbrsmagmarisindiabeticpopulationwithnsteacsaoneyearclinicaloutcomeoftwosirolimuselutingstents |