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. (December 2015)

• Record Type: Journal Article
• Authors: Widimsky, Petr; Petr, Robert; Tousek, Petr; Maly, Martin; Linkova, Hana; Vrana, Jiri; Hajsl, Martin; Budesinsky, Tomas; Lisa, Libor; Kocka, Viktor
• Is Part Of: Circulation. Volume 8:Number 12(2015)
• Publication Date: 2015-12
• Subjects: bioresorbable scaffold -- computed tomography -- myocardial infarction -- restenosis -- stent -- stent thrombosis; Cardiovascular system -- Surgery -- Periodicals; Cardiovascular system -- Diseases -- Treatment -- Periodicals; 616.105
• DOI: 10.1161/CIRCINTERVENTIONS.115.002933
• Languages: English
• ISSNs: 1941-7640

Abstract

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 58.6±10.3 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 dilatation—this 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.