Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update
Abstract
Aims: Early clinical results after implantation of bioresorbable vascular scaffolds (BVS) in ST-elevation myocardial infarction (STEMI) are encouraging, but long-term data are missing. This study evaluates long-term outcome in STEMI patients with implanted BVS.
Methods and results: The PRAGUE-19 study is an academic study enrolling consecutive STEMI patients with the intention to implant BVS. A total of 580 STEMI patients were screened between December 2012 and March 2015; 117 patients fulfilled entry criteria and BVS was successfully implanted in 114 (97%) of them.
The primary combined clinical endpoint (death, reinfarction or target vessel revascularisation) occurred in 11.5% during the mean follow-up period of 730 +/- 275 days with overall mortality of 4.4%. Definite scaffold thrombosis occurred in two patients in the early phase after BVS implantation; there was no late thrombosis.
Quantitative coronary angiography (10 patients) at three years demonstrated late lumen loss of 0.2 +/- 0.33 mm and optical coherence tomography showed minimal lumen area of 5.3 +/- 1.37 mine and neointimal hyperplasia area of 2.9 +/- 0.48 mm(2). BVS struts were still visible at three years and 99.4% of them were well apposed and covered.
Conclusions: Encouraging clinical and imaging results after BVS implantation in STEMI patients persist during long-term follow-up.