Bioresorbable scaffold implantation in STEMI patients: 5 years imaging subanalysis of PRAGUE-19 study

Abstract

Background: Bioresorbable scaffold (BRS) Absorb ™ clinical use has been stopped due to higher rate of device thrombosis. Scaffold struts persist longer than 2 years in the vessel wall. Second generation devices are being developed. This study evaluates long-term invasive imaging in STEMI patients.Methods: PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with intention to implant Absorb ™ BRS. A total of 83 STEMI patients between December 2012 and March 2014 fulfilled entry criteria. Coronary angiography and optical coherence tomography at 5 year follow-up was performed in 25 patients.Results: Primary combined clinical endpoint (death, myocardial infarction or target vessel revascularization) occurred in 12.6% during the five-year follow-up with overall mortality 6.3%. Definite scaffold thrombosis occurred in 2 patients in the early phase after BRS implantation. Quantitative coronary angiography after 5 years demonstrated low late lumen loss of 0.11 ± 0.35 mm with binary restenosis rate of 0%. Optical coherence tomography demonstrated complete resorption of scaffold struts and mean lumen diameter of 3.25 ± 0.30 and 3.22 ± 0.49 (P = 0.73) at baseline and after 5 years, respectively. Three patients developed small coronary artery aneurysm in the treated segment. Conclusion:Invasive imaging results 5 years after BRS implantation in STEMI showed complete resorption of scaffold struts and stable lumen vessel diameter.Trial registration ISRCTN43696201 (retrospectivelly registred, June 7th, 2019). https ://www.isrct n.com/ISRCT N4369 6201.

Bioresorbable scaffolds vs. drug-eluting stents for patients with myocardial infarction: A systematic review and meta-analysis of randomized clinical trials

“…And the physiological advantages of BRS, such as late lumen enlargement and vasomotion, are particularly appealing for coronary revascularization. However, evidence on the safety and efficacy of BRS vs. DES in patients with myocardial infarction is inconsistent; some trials (12)(13)(14) showed that BRS was similar to or better than DES on a device-oriented endpoint, while other trials reported that BRS was associated with higher risk TLR (15,16). Therefore, we conducted this systematic review and meta-analysis to compare the efficacy and safety of BRS vs. DES in patients with myocardial infarction undergoing percutaneous coronary interventions (PCI).…”

Performance Analysis of Hexagonal Unit Cell Stent Design and Single-Layered Manufacturability With FDM

“…Polimer malzeme teknolojisinin gelişmesiyle, yeni nesil stent üretimleri ve klinik çalışmaları başlamıştır [3,4]. Birinci nesil biyobozunur polimer esaslı stent tasarımları açık birim hücre modeline göre üretilmektedir.…”

Comparison of a Bioresorbable, Magnesium-Based Sirolimus-Eluting Stent with a Permanent, Everolimus-Eluting Metallic Stent for Treating Patients with Acute Coronary Syndrome: the PRAGUE-22 Study

“…However, the Absorb stent (Abbott Vascular, Santa Clara, CA, USA) was associated with a higher risk of target lesion revascularization and stent thrombosis compared with drug-eluting metallic stents in randomized trials [ 1 , 2 ] and in an acute myocardial infarction setting [ 3 ]. Furthermore, resorption only took place more than 3 years after implantation, being complete at 5 years [ 4 , 5 ]. Magnesium-based bioresorbable stents represent different technology with quicker resorption process and are sometimes viewed as second-generation bioresorbable stents.…”