Bioresorbable scaffold implantation in STEMI patients: 5\xa0years imaging subanalysis of PRAGUE-19 study

Viktor Kočka,Martin Kozel,Tomáš Buděšínský,Andrea Buono,Martin Malý,Petr Toušek,Martin Hajšl,Libor Lisa,Petr Widimský

doi:10.1186/s12967-020-02230-1

Abstract

BackgroundBioresorbable 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.MethodsPRAGUE-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.ResultsPrimary 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.ConclusionInvasive 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.isrctn.com/ISRCTN43696201.

Highlights

Bioresorbable scaffold (BRS) AbsorbTM clinical use has been stopped due to higher rate of device thrombosis
The originally planned coronary angiography with optical coherence tomography (OCT) at three-year follow-up was postponed to five years after analysis of three-year results demonstrating incomplete resorption of the AbsorbTM BRS device [10]; study protocol was amended and invasive assessment was approved for the first 25 patients by all ethics committees again
Two patients suffered of reinfarction and three patients of target vessel revascularization (TVR) during the first 12 months

Summary

Introduction

Bioresorbable scaffold (BRS) AbsorbTM clinical use has been stopped due to higher rate of device thrombosis. This study evaluates long-term invasive imaging in STEMI patients. Bioresorbable scaffolds (BRS) were developed to provide mechanical support and anti-restenotic properties in the short term and undergo resorption, avoiding. The recently published largest randomized ABSORB IV study of AbsorbTM BRS (not included in the above cited meta-analyses) with optimal implantation technique and careful patient selection resulted in non-inferior target lesion failure at 1 year [5]. The discussion about safety and effectivity of BRS technology continues It is vital for the possible future development of generation BRS devices to demonstrate safety and efficacy after the completion of resorption. We sought to study 5 year invasive imaging data of patients with BRS implantation in the setting of ST-elevation myocardial infarction (STEMI)

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Discussion

Conclusion