One-Year Clinical and Computed Tomography Angiographic Outcomes After Bioresorbable Vascular Scaffold Implantation During Primary Percutaneous Coronary Intervention for ST-Segment-Elevation Myocardial Infarction The PRAGUE-19 Study
Abstract
Background Bioresorbable vascular scaffolds (BVS) represent promising new technology, but data on their long-term outcomes in ST-segment-elevation myocardial infarction (STEMI) setting are missing. The aim was to analyze 1-year clinical and computed tomographic angiographic outcomes after BVS implantation in STEMI.
Methods and Results PRAGUE-19 is a prospective multicenter single-arm study enrolling consecutive STEMI patients undergoing primary percutaneous coronary intervention (pPCI) with intention-to-implant BVS. A total of 343 STEMI patients were screened during 15 months enrollment period, and 70 patients (mean age 58.610.3 and 74% males) fulfilled entry criteria and BVS was successfully implanted in 96% of them.
All patients were invited for clinical and computed tomographic angiographic control 1 year after BVS implantation. Restenosis was defined as 75% area stenosis within the scaffolded segment.
Three events were potentially related to BVS: 1 in-stent restenosis (treated 7 months after pPCI with drug-eluting balloon), 1 stent thrombosis (treated 2 weeks after pPCI by balloon dilatationthis patient stopped all medications after pPCI), and 1 sudden death at home 9 months after pPCI. Four other patients had events definitely unrelated to BVS.
Overall, 1-year mortality was 2.9%. Computed tomographic angiography after 1 year was performed in 59 patients.
All BVS were widely patent, and binary restenosis rate was 2% (the only restenosis mentioned above). Mean in-scaffold minimal luminal area was 7.8 +/- 2.6 mm(2), area stenosis was 20.1 +/- 16.3%, minimal luminal diameter was 3.0 +/- 0.6 mm, and diameter stenosis was 12.8 +/- 11.1%.
Conclusions BVS implantation in STEMI is feasible and safe and offers excellent 1-year clinical and angiographic outcomes.