These patients were randomized (2:1 ratio) to treatment with the Orsiro™ (n=884) or the Xience™ stent (n=450). In detail, the BIOFLOW V study recruited 1,334 patients with stable and unstable CAD scheduled for elective or urgent percutaneous coronary intervention in 90 hospitals from 13 countries. In a recent report in The Lancet ( 15) the Orsiro™ stent (Biotronik, Buelach, Switzerland), a second generation DES with an ultrathin cobalt-chromium platform (60 µm strut thickness) and a bioresorbable carrier made of poly-L-lactic acid loaded with sirolimus (1.4 µg/mm 2), demonstrated better clinical outcomes in comparison with the Xience™ stent (Abbott Vascular, Santa Clara, CA, USA), an everolimus-eluting stent with a non-resorbable polymer carrier and a thin cobalt-chromium platform (80 µm strut thickness), currently considered the benchmark for DES comparisons due to the huge number of patients included in its study programme and the excellent clinical results reported ( 16). It is a macrolide with cytostatic rather than cytotoxic properties that impedes advancement from G1 to S in the cell cycle and inhibits the vascular smooth muscle cell migration and proliferation ( 14).įinally, the bio-resorbable polymer influence the rate and completeness of vessel healing limiting the anti-proliferative drug elution to the time frame in which restenosis occurs, without excessive delay in stent endothelialization ( 14). In fact the ancestor of “limus” drugs still represents an ideal choice considering that it acts on the common final pathway of cell division cycle without excessive risks of necrosis induction.
The safety and efficacy of “limus family” DES have been confirmed in several clinical studies ( 1, 3, 5, 13) and in particular sirolimus is associated with the best outcomes in terms of LLL, binary restenosis and late stent thrombosis ( 10). Several studies have confirmed that the rate of restenosis was reduced according to strut thickness ( 8, 9) and LLL showed a significant positive correlation with strut thickness in a meta-regression study ( 10). The strut thickness is a crucial parameter, as it is associated with local inflammation at the lesion site and, when excessive, is a formidable obstacle to stent strut coverage with neo-intima ( 11, 12). Each of these characteristics was demonstrated to be associated with a reduced late lumen loss (LLL) and minimal hazard of thrombus formation, in both clinical studies ( 7- 9) and meta-analyses ( 10). However besides the stent strut thickness, the employ of sirolimus as anti-proliferative drug and of bio-resorbable polymers as drug-eluting carriers represent important features of new generation DES. The biomechanical characteristics of cobalt- and platinum-chromium alloys has allowed the production of even thinner stent struts, with further improvement of DES mechanical performances ( 6). These DES have shown excellent safety and efficacy profiles for the treatment of coronary artery disease (CAD) ( 1- 5), with a consequent widespread diffusion in the daily clinical practice. New generation drug eluting stents (DES), differ mainly from first generation DES due to their metallic scaffolds, with thinner struts (<100 µm).
Ultrathin, bioresorbable polymer sirolimus-eluting stents versus thin, durable polymer everolimus-eluting stents in patients undergoing coronary revascularisation (BIOFLOW V): a randomised trial. Email: or This is an invited Editorial commissioned by the Section Editor Hai-Long Dai (Department of Cardiology, Yan’an Affiliated Hospital of Kunming Medical University, Kunming, China).Ĭomment on: Kandzari DE, Mauri L, Koolen JJ, et al. SOC Cardiologia, Ospedali Riuniti di Domodossola & Verbania, ASL V.C.O., Via Mazzini 117, 28887 Omegna (VB), Italy. Interviews with Outstanding Guest EditorsĬorrespondence to: Dr.Policy of Dealing with Allegations of Research Misconduct.Policy of Screening for Plagiarism Process.
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