Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry
Objective To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).Methods National, prospective, multicentre, single-arm, all-come...
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BMJ Publishing Group
2019-10-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/9/10/e026578.full |
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| author | Scot Garg Nikhil Patel Anirban Choudhury Jamie Smith Andrew Sharp Sergio Nabais de Araujo Anoop Chauhan Benjamin Wrigley Sudipta Chattopadhyay Azfar G Zaman |
| author_facet | Scot Garg Nikhil Patel Anirban Choudhury Jamie Smith Andrew Sharp Sergio Nabais de Araujo Anoop Chauhan Benjamin Wrigley Sudipta Chattopadhyay Azfar G Zaman |
| author_sort | Scot Garg |
| collection | DOAJ |
| description | Objective To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).Methods National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months—overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE—composite of cardiac death, MI, emergent or repeat revascularisation).Results At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).Conclusions The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI. |
| format | Article |
| id | doaj-art-084aaf18dca846f0934a19f809bb1a1d |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2019-10-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-084aaf18dca846f0934a19f809bb1a1d2024-12-14T03:50:08ZengBMJ Publishing GroupBMJ Open2044-60552019-10-0191010.1136/bmjopen-2018-026578Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registryScot Garg0Nikhil Patel1Anirban Choudhury2Jamie Smith3Andrew Sharp4Sergio Nabais de Araujo5Anoop Chauhan6Benjamin Wrigley7Sudipta Chattopadhyay8Azfar G Zaman92 Department of Cardiology, Royal Blackburn Hospital, Blackburn, UKmedical student1 Department of Cardiology, Cardiff and Vale University Health Board, Cardiff, UK3 Department of Cardiology, Raigmore Hospital, Inverness, UKCentre for Women`s Health Research, Department of Women`s and Children`s Health, Institute of Life Course and Medical Sciences, University of Liverpool, Liverpool, UK1Salisbury NHS Foundation Trust, Odstock Road, Salisbury SP2 8BJ, Salisbury District Hospital, Salisbury, WIL SP2 8BJ, UK6 Department of Cardiology and Institute of Cellular Medicine, Blackpool Victoria Hospital, Blackpool, UK8 Department of Cardiology, The Heart and Lung Centre, Wolverhampton, UK9 Department of Cardiology, Milton Keynes University Hospital NHS Foundation Trust, Milton Keynes, UK10 Freeman Hospital, Newcastle Upon Tyne, UKObjective To prospectively evaluate safety and efficacy of the ultrathin strut biodegradable polymer-coated Supraflex sirolimus-eluting stent (S-SES) in ‘real world’ patient population requiring percutaneous coronary intervention (PCI).Methods National, prospective, multicentre, single-arm, all-comers, observational registry of 469 patients treated with S-SES from July 2015 and November 2016 in 11 centres in UK. Primary endpoint was target lesion failure (TLF) at 12 months (cardiac death, target vessel myocardial infarction (MI) or clinically driven target lesion revascularisation (TLR)). Secondary endpoints included safety and performance outcomes at 12 months—overall stent thrombosis (ST), all-cause mortality, any MI, target vessel failure (TVF) and major adverse cardiac events (MACE—composite of cardiac death, MI, emergent or repeat revascularisation).Results At 12 months, the primary endpoint occurred in 11 (2.4%) of 466 patients, consisting of 4 (0.9%) cardiac deaths, 3 (0.6%) target vessel MI and 7 (1.5%) TLR. Secondary endpoints findings included all-cause mortality in 6 (1.3%), TVF of 14 (3%), no definite ST, 1 (0.2%) probable ST and 3 (0.6%) possible ST. Overall MACE was observed in 18 (3.9%).Conclusions The S-FLEX UK registry showed that the S-SES is safe with a low incidence of TLF in routine clinical practise in patients with coronary artery disease being treated by PCI.https://bmjopen.bmj.com/content/9/10/e026578.full |
| spellingShingle | Scot Garg Nikhil Patel Anirban Choudhury Jamie Smith Andrew Sharp Sergio Nabais de Araujo Anoop Chauhan Benjamin Wrigley Sudipta Chattopadhyay Azfar G Zaman Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry BMJ Open |
| title | Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry |
| title_full | Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry |
| title_fullStr | Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry |
| title_full_unstemmed | Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry |
| title_short | Prospective evaluation of an ultrathin strut biodegradable polymer-coated sirolimus-eluting stent: 12 months’ results from the S-FLEX UK registry |
| title_sort | prospective evaluation of an ultrathin strut biodegradable polymer coated sirolimus eluting stent 12 months results from the s flex uk registry |
| url | https://bmjopen.bmj.com/content/9/10/e026578.full |
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