Twelve months clinical outcome after bioresorbable vascular scaffold implantation in patients with stable angina and acute coronary syndrome. Data from the Polish National Registry.
BACKGROUND
There are limited data describing bioresorbable vascular scaffold (BVS) implantation in complex lesions. Only short-term clinical outcomes are available for patients with acute coronary syndrome (ACS).


OBJECTIVE
To evaluate 12-month clinical outcome, safety and effectiveness of BVS implantation in complex lesions and in stable angina (SA) or ACS.


METHODS
Five hundred ninety-one patients with SA/ACS were enrolled between October 2012 and November 2013 in 30 invasive cardiology centres in Poland. At least one BVS implantation during percutaneous coronary intervention (PCI) was the only inclusion criteria. The clinical endpoint was the occurrence of a major adverse cardiovascular event (MACE) (all-cause death, myocardial infarction (MI), clinically driven target lesion revascularisation (TLR) with urgent PCI or target vessel revascularisation (TVR) with urgent coronary artery bypass grafting (CABG)) and device-oriented composite endpoint (DOCE) (cardiac death, urgent target vessel revascularisation with PCI/CABG, target vessel MI) during 12-month follow-up.


RESULTS
After 12 months TLR with urgent PCI was significantly more often reported in patients with diagnosed UA (4.59%; p < 0.02) in comparison with other PCI indications. No significant differences were found in terms of composite MACE endpoint, cumulative MACE (p = 0.09), stent thrombosis (p = 0.2) or restenosis (p = 0.2). There were no significant differences in cumulative MACE and composite MACE endpoint between patients with no/mild versus moderate/severe tortuosity and no/mild versus moderate/severe calcification of the target vessel. No significant difference was found between groups of patients with or without bifurcation of the target vessel. Device-oriented composite endpoint was significantly more often reported in the ACS group (3.2% vs. 0.47%; p < 0.03), most frequently in patients with diagnosed UA (5.5%).


CONCLUSIONS
Bioresorbable vascular scaffold can be successfully and safely used for ACS treatment and in lesions of higher complexity.
2 Department of Cardiology, Institute of Cardiology, Jagiellonian University, Medical College, Krakow, Poland.
Łukasz
Ł
Rzeszutko
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Zbigniew
Z
Siudak
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Tomasz
T
Tokarek
Krakow Cardiovascular Research Institute, Krakow, Poland.
Krzysztof
K
Plens
Miedziowe Centrum Zdrowia S.A., Lublin, Poland.
Adrian
A
Włodarczak
3 Department and Clinical Unit of Cardiology, Silesian Centre for Heart Diseases, Medical University of Silesia, Zabrze, Poland.
Andrzej
A
Lekston
3 Department of Cardiology, Medical University of Silesia, Katowice, Poland.
Andrzej
A
Ochała
Invasive Cardiology Clinic, Central Clinical Hospital of the Internal Affairs and Administration Ministry, Warsaw, Poland; Institute of Experimental and Clinical Medicine, Polish Academy of Science, Warsaw, Poland.
Robert J
RJ
Gil
2 Department of Cardiology, Ludwik Rydygier Collegium Medicum in Bydgoszcz, Nicolaus Copernicus University in Torun, Poland.
Wojciech
W
Balak
Department of Interventional Cardiology, Institute of Cardiology, Jagiellonian University Medical College, Krakow, Poland.
Dariusz
D
Dudek
bifurcation; calcified; complex lesion; stent; tortuosity