The proportion of patients treated with coronary angioplasty who are at a high risk for bleeding is increasing. In this population, extended dual antithrombotic therapy increases the risk of bleeding. The 1-year randomized Onyx one study has demonstrated the non-inferiority of zotarolimus-eluting stents (ZES) vs. biolimus-coated polymer-free stent BioFreedom (DCS). Patients received dual-antiplatelet therapy (DAPT)…
Using Biolimus-Coated Balloons for Treating Small-Vessel Disease Yields Promising Results
Drug-eluting balloons have demonstrated safety and effectiveness in the treatment of small-vessel coronary artery disease and in-stent restenosis. However, randomized studies were performed using paclitaxel. Several studies have shown that using biolimus, a semisynthetic analog of sirolimus, optimizes drug delivery in both stents and balloons. The aim of this randomized, multicenter study was to evaluate…
TCT 2018 | ReCre8 Trial: Permanent Polymer and Zotarolimus vs. Polymer-Free Amphilimus
Polymer-free amphilimus-eluting stents are a novel technology combining sirolimus and long-chained fatty acids. This enhances the uptake of antiproliferative agents and may be associated with lower restenosis, particularly among patients with diabetes. The new device includes abluminal reservoirs filled with the drug; in consequence, there is no need for polymer. This work compares this new…
TCT 2018 | SORT OUT IX: Polymer-Free DES with Ultra-Thin Struts vs. Bioresorbable Polymer- Based DES
Polymer persistence in 1st and 2nd generation DES meant to allow drug release has been associated with a chronic inflammatory response that might be associated to restenosis, neo atherosclerosis and stent thrombosis. This is the rationale behind the development of polymer free and bioresorbable polymer-based DES. They have both been compared against permanent polymer DES,…
TCT 2018 | LEADERS FREE II: Polymer-Free DES in Patients at High Risk for Bleeding with 1 Month of Antiplatelet Therapy
This study was aimed at gaining device registration from the US Food and Drug Administration (FDA) for a polymer-free biolimus A9 drug-coated stent (BioFreedom, Biosensors). The study had two purposes: on the one hand, it meant to reproduce the results of the LEADERS FREE trial (published in 2015) in terms of safety and efficacy with…
Zotarolimus with Durable Polymer vs. Biolimus with Biodegradable Polymer
The present work compared the safety and efficacy of the permanent polymer zotarolimus eluting stent vs. the biodegradable polymer biolimus eluting stent in unselected coronary artery disease patients. The biodegradable polymer biolimus eluting stent resulted superior to the first generation durable polymer stent in long term randomized studies. However, little evidence supports this superiority…
Polymer-Free Biolimus Coated Stent: 5 Year Outcomes
Original Title: Polymer-Free Biolimus A9-Coated Stents in the Treatment of De Novo Coronary Lesions4- and 12-Month Angiographic Follow-Up and Final 5-Year Clinical Outcomes of the Prospective, Multicenter BioFreedom FIM Clinical Trial CME. Reference: Ricardo A. Costa et al. J Am Coll Cardiol Intv. 2016;9(1):51-64. The purpose of this study was to assess the efficacy and long…
Polymer Free Drug Coated Stent in High Bleeding Risk Patients with Only One Month DAPT
Original Title: Polymer-free Drug-Coated Coronary Stents in Patients at High Bleeding Risk Reference: Philip Urban et al. N Engl J Med. 2015 Oct 14. [Epub ahead of print]. High bleeding risk patients undergoing PCI usually receive conventional bare metal stents (BMS) to allow the shortest possible DAPT (dual antiplatelet therapy), usually a month long. This…