K. Teeuwen , S. Hubbers , Jan G.P. Tijssen , J.A.S. Van Der Heyden , B.J.W.M. Rensing , M.J. Suttorp
{"title":"Experiences with the Absorb everolimus-eluting bioresorbable vascular scaffold in all comers: The St. Antonius hospital single centre registry","authors":"K. Teeuwen , S. Hubbers , Jan G.P. Tijssen , J.A.S. Van Der Heyden , B.J.W.M. Rensing , M.J. Suttorp","doi":"10.1016/j.ctrsc.2015.09.004","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>Data on procedural and clinical outcomes of the everolimus-eluting bioresorbable vascular scaffold (BVS, Abbott) in percutaneous coronary intervention in a real-world setting is limited. Early and mid-term clinical outcomes of the BVS in a real-world population were investigated in this single centre study.</p></div><div><h3>Methods</h3><p>Patients treated with the BVS in the St. Antonius Hospital from April 2012 to February 2015 were included in a prospective single centre registry. Procedural success defined as <<!--> <!-->20% residual restenosis and 30-day and 6-month clinical outcome were investigated. Cumulative event rates were expressed using Kaplan<!--> <!-->−<!--> <!-->Meier method.</p></div><div><h3>Results</h3><p>A total of 108 patients were included in the study, including patients with ST-segment elevation myocardial infarction (STEMI) 18.5%, non-STEMI 22.2% and unstable angina 9.3%. In total 125 lesions were treated with the BVS, of which 48.8% B2/C type lesions including 19.2% bare metal or drugs-eluting in-stent restenosis. Procedural angiographic success was achieved in 99.2% of all patients. Clinical follow-up rate was 100% at 30-day and 87% at 6-month. The rate of cardiac death, target vessel revascularization and definite stent thrombosis was 0%, 0.9% and 0.9% at 30-day and 0.9%, 5.6% and 1.9% at 6-month. The composite end point of target lesion failure (Cardiac death, target lesion myocardial infarction MI and target lesion revascularization) was 1.9% at 30-day and 5.6% at 6-month, respectively.</p></div><div><h3>Conclusions</h3><p>The use of the BVS in a real-world setting demonstrated excellent procedural success and acceptable mid-term clinical outcomes. The rate of definite scaffold thrombosis was not dissimilar to other BVS registries.</p></div>","PeriodicalId":91232,"journal":{"name":"Clinical trials and regulatory science in cardiology","volume":"10 ","pages":"Pages 1-6"},"PeriodicalIF":0.0000,"publicationDate":"2015-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1016/j.ctrsc.2015.09.004","citationCount":"3","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical trials and regulatory science in cardiology","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2405587515300123","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 3
Abstract
Background
Data on procedural and clinical outcomes of the everolimus-eluting bioresorbable vascular scaffold (BVS, Abbott) in percutaneous coronary intervention in a real-world setting is limited. Early and mid-term clinical outcomes of the BVS in a real-world population were investigated in this single centre study.
Methods
Patients treated with the BVS in the St. Antonius Hospital from April 2012 to February 2015 were included in a prospective single centre registry. Procedural success defined as < 20% residual restenosis and 30-day and 6-month clinical outcome were investigated. Cumulative event rates were expressed using Kaplan − Meier method.
Results
A total of 108 patients were included in the study, including patients with ST-segment elevation myocardial infarction (STEMI) 18.5%, non-STEMI 22.2% and unstable angina 9.3%. In total 125 lesions were treated with the BVS, of which 48.8% B2/C type lesions including 19.2% bare metal or drugs-eluting in-stent restenosis. Procedural angiographic success was achieved in 99.2% of all patients. Clinical follow-up rate was 100% at 30-day and 87% at 6-month. The rate of cardiac death, target vessel revascularization and definite stent thrombosis was 0%, 0.9% and 0.9% at 30-day and 0.9%, 5.6% and 1.9% at 6-month. The composite end point of target lesion failure (Cardiac death, target lesion myocardial infarction MI and target lesion revascularization) was 1.9% at 30-day and 5.6% at 6-month, respectively.
Conclusions
The use of the BVS in a real-world setting demonstrated excellent procedural success and acceptable mid-term clinical outcomes. The rate of definite scaffold thrombosis was not dissimilar to other BVS registries.