Outcomes of biodegradable polymer sirolimus-eluting PROLIM stent in patients with coronary artery disease. Results of 12-month follow-up of prospective registry.
BACKGROUND
Data from clinical trials suggested that biodegradable-polymer-based drug-eluting stents (DES) might improve long-term clinical outcomes. PROLIM (Balton, Warsaw, Poland) DES is based on a stainless steel platform with a closed cell design releasing sirolimus from biodegradable copolymer (lactic and glycolic acid) in eight weeks.


OBJECTIVE
In the present study the safety and the efficacy of a PROLIM stent was assessed in patients with de novo coronary lesions in 12-month clinical follow-up.


METHODS
It was a single-centre, observational, prospective registry to assess the safety and efficacy of a PROLIM stent implantation in all consecutive patients with de novo coronary artery lesions treated with percutaneous coronary intervention (PCI). The primary study endpoint was a composite safety (cardiac death, non-fatal myocardial infarction), and the second study endpoint was the efficacy of PROLIM implantation-clinically driven target vessel revascularisation (TVR) assessed at 12-month follow-up.


RESULTS
One hundred patients were enrolled into the study and 118 PROLIM stents were implanted. Thirty-two (32%) patients had diabetes, 46 (46%) patients were prior PCI, and 17 (17%) patients had coronary artery bypass grafting. 67% of stented lesions were complex ones (B2/C) and 17% were bifurcations. During the 12-month follow-up primary study endpoints occurred in five (5%) patients. Two (2%) cardiac deaths were reported and three (3%) TVRs were performed, of which one was related to in-PROLIM stent restenosis.


CONCLUSIONS
PCI with biodegradable-polymer PROLIM DES seems to be safe and effective in 12-month follow-up. A larger trial is warranted to assess clinical outcomes post PROLIM stent implantation.
3rd Department of Cardiology, Medical University of Silesia, Katowice, Poland. tomaszroleder@gmail.com.
Tomasz
T
Roleder
Grzegorz
G
Smolka
Ewa
E
Podolecka
Jolanta
J
Chudek
Sebastian
S
Dworowy
Katarzyna
K
Żelazowska
Wojciech
W
Wojakowski
Andrzej
A
Ochała
D000368:Aged; D003324:Coronary Artery Disease / Q000188:drug therapy / Q000601:surgery*; D054855:Drug-Eluting Stents; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D062645:Percutaneous Coronary Intervention / Q000379:methods*; D011446:Prospective Studies; D012042:Registries; D020123:Sirolimus / Q000627:therapeutic use*; D016896:Treatment Outcome
D020123:Sirolimus
biodegradable polymer; drug-eluting stents; sirolimus