Safety and efficacy of polymer-free biolimus-eluting stents in all-comer patients: the RUDI-FREE study

• Published in: EuroIntervention Vol. 14; no. 7; pp. 772 - 779
• Main Authors: Sardella, Gennaro, Stefanini, Giulio G, Briguori, Carlo, Tamburino, Corrado, Fabbiocchi, Franco, Rotolo, Francesco, Tomai, Fabrizio, Paggi, Anita, Lombardi, Mario, Gioffrè, Gaetano, Sclafani, Rocco, Rolandi, Andrea, Sciahbasi, Alessandro, Scardaci, Francesco, Signore, Nicola, Calcagno, Simone, Mancone, Massimo, Chiarito, Mauro, Giordano, Arturo
• Format: Journal Article
• Language: English
• Published: France 01.09.2018
• ISSN: 1774-024X; 1969-6213
• DOI: 10.4244/EIJ-D-18-00148

Polymer-free biolimus-eluting stents (PF-BES) have been shown to be superior to bare metal stents in high bleeding risk (HBR) patients treated with one-month dual antiplatelet therapy (DAPT). However, limited evidence is available on PF-BES in non-HBR patients. We aimed to evaluate the safety and efficacy of PF-BES in all-comer patients undergoing percutaneous coronary intervention (PCI). Patients with stable coronary artery disease or acute coronary syndromes (ACS) undergoing PCI with PF-BES in routine clinical practice were included in a multicentre, prospective registry. DAPT duration was left to the discretion of the operator. The primary endpoint was the composite of cardiovascular death, myocardial infarction (MI), and definite/probable stent thrombosis (ST) at one year. Overall, 1,104 consecutive patients treated with PF-BES were included at 16 Italian centres. Mean age was 68.7±11.2 years, 77.2% of patients were male, 30% had diabetes, 15.1% had chronic kidney disease, and 40.5% had ACS at baseline. Mean CRUSADE score was 24.1±13.1, and 83.7% of patients did not have high bleeding risk features. At one year, the primary endpoint occurred in 4.1% of patients, cardiovascular death in 2.4%, MI in 1.8%, and definite/probable ST in 1.1%. With respect to efficacy, target lesion revascularisation occurred in 1.2% of patients. This is the first study providing clinical evidence on the use of PF-BES in all-comer patients irrespective of HBR status. Our findings suggest that PF-BES has a favourable safety and efficacy profile in a real-world clinical setting. Further investigation in randomised clinical trials against new-generation DES is warranted.