PRAGUE-19 Supports BVS Implantation During Primary PCI for STEMI Patients

December 7, 2015—One-year clinical and computed tomography angiography outcomes from the PRAGUE-19 trial were published by Petr Widimsky, MD, et al online ahead of print in Circulation: Cardiovascular Interventions. 

PRAGUE-19 is an investigation of bioresorbable vascular scaffold (BVS) implantation during primary percutaneous coronary intervention (PCI) for ST-segment elevation myocardial infarction (STEMI). The prospective, multicenter single-arm study enrolled consecutive STEMI patients undergoing primary PCI with intention-to-implant BVS at the University Hospital Kralovske Vinohrady in Prague, Czech Republic.

The investigators concluded that the PRAGUE-19 data demonstrated that BVS implantation in STEMI is feasible, safe, and offers excellent 1-year clinical and angiographic outcomes.

As summarized in Circulation: Cardiovascular Interventions, 343 STEMI patients were screened during the 15-month enrollment period. There were 70 patients (mean age, 58.6 ± 10.3; 74% males) who fulfilled entry criteria; BVS were 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. 

The investigators found that three events were potentially related to BVS: one in-stent restenosis (treated 7 months after primary PCI with drug-eluting balloon), one stent thrombosis (treated 2 weeks after primary PCI by balloon dilatation—this patient stopped all medications after primary PCI), and one sudden death at home 9 months after primary PCI. Four other patients had events definitely unrelated to BVS. 

Overall, 1-year mortality was 2.9%. Computed tomography angiography after 1 year was performed in 59 patients. All BVS were widely patent, and the binary restenosis rate was 2% (the only restenosis event mentioned above). Mean in-scaffold minimal luminal area was 7.8 ± 2.6 mm², area stenosis was 20.1% ± 16.3%, minimal luminal diameter was 3.0 ± 0.6 mm, and diameter stenosis was 12.8% ± 11.1%, reported the investigators in Circulation: Cardiovascular Interventions.