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Long-term follow-up after bioresorbable vascular scaffold implantation in STEMI patients: PRAGUE-19 study update
Petr Toušek1, Viktor Kočka, Martin Malý
1Cardiocenter, Third Faculty of Medicine, Charles University in Prague and University Hospital Kralovske Vinohrady, Prague, Czech Republic.
Insights
Long-term follow-up of bioresorbable vascular scaffolds (BVS) in ST-elevation myocardial infarction (STEMI) patients shows encouraging clinical and imaging results. No late scaffold thrombosis was observed, with struts remaining well-apposed and covered after three years.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials Science
Background:
- Bioresorbable vascular scaffolds (BVS) offer a potential alternative to permanent metallic stents.
- Early outcomes with BVS in ST-elevation myocardial infarction (STEMI) are promising, but long-term data are limited.
Purpose of the Study:
- To evaluate the long-term clinical and imaging outcomes of BVS implantation in patients with STEMI.
- To assess scaffold thrombosis, target vessel revascularization, and scaffold healing over an extended follow-up period.
Main Methods:
- Prospective academic study (PRAGUE-19) enrolling consecutive STEMI patients undergoing BVS implantation.
- Clinical endpoints assessed over a mean follow-up of 730±275 days.
- Quantitative coronary angiography and optical coherence tomography used for three-year imaging follow-up in a subset of patients.
Main Results:
- The primary endpoint (death, reinfarction, or target vessel revascularization) occurred in 11.5% of patients.
- Overall mortality was 4.4%.
- Two cases of early definite scaffold thrombosis occurred; no late thrombosis was observed. Three-year imaging showed minimal late lumen loss and good scaffold coverage with struts still visible and well-apposed.
Conclusions:
- Clinical and imaging results of BVS implantation in STEMI patients remain encouraging during long-term follow-up.
- BVS demonstrate a favorable safety profile regarding late scaffold thrombosis.
- Scaffold healing and integration appear satisfactory at three years post-implantation.
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 mm2 and neointimal hyperplasia area of 2.9±0.48 mm2. 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.
