Promus element

The only BRS used in this study was Absorb. However, several second-generation DES were used: Xience Prime, Xience Xpedition, and Xience Pro X (Abbott Vascular); Promus Premier, Promus Element and Synergy (Boston Scientific, Marlborough, MA); Resolute Integrity and Resolute Onyx (Medtronic, Minneapolis, MN); Nobori and Ultimaster (Terumo, Tokyo, Japan); BioMatrix (Biosensors International, Singapore); Combo (OrbusNeich, Hong Kong); Xposition S (Stentys, Paris, France); and Cre8 (Alvimedica, Istanbul, Turkey).
BRS implantation was performed as recommended by expert consensus (aggressive lesion preparation, appropriate sizing, routine intravascular imaging guidance, and high-pressure postdilatation with noncompliant balloons with a balloon-to-artery ratio of ≈1). 10 (link) DES implantation technique was left at the operator discretion. Figures 1 and2 show examples of CTO PCI with BRS and DES, respectively.

All interventions were performed using standard techniques. Predilation, postdilation, and use of intracoronary imaging (intravascular ultrasound (IVUS) or optical coherence tomography (OCT)) were left to the operator's discretion, as well as the decision to implant a further stent in patients with ESV-confirmed SF. ESV system utilization was mandatory after stent implantation and after postdilation (if it was performed). The following DES were implanted: Xience V or Xience Prime or Xience PRO (Abbott Vascular, Santa Clara, CA, USA), Promus Element or Promus Premier (Boston Scientific, Natick, MA, USA), Biomatrix Flex (Biosensors Europe SA, Morges, Switzerland), and Cre8 (CID and Alvimedica. S.P.A., Saluggia, Italy). After the procedure, all patients were advised to continue dual antiplatelet therapy (DAPT) with aspirin and P2Y12 inhibitor months after 2nd-generation DES implantation in patients with SF-predisposing factors. Secondary endpoints were: (1) any component of the primary endpoint; (2) definite and probable stent thrombosis (ST), and (3) target vessel revascularization (TVR). Finally, as a preliminary analysis, we compared the occurrence of the primary endpoint in patients with SF III-IV stratified according to the implantation (or not) of a further stent. All endpoints were adjudicated by an independent reviewer (R.P.), who was unaware of any data.

Three different devices were implanted. The test device was a thin-strut durable polymer metallic EES (Promus Element; Boston Scientific, Marlborough, MA), 3.0×16 mm, platinum-chromium platform, 81 μm strut thickness, consisting of an inner layer of poly n-butyl methacrylate polymer surrounded by poly (vinylidene fluoride-co-hexafluoropropylene), which is comprised of vinylidene fluoride and hexafluoropropylene monomers as the drug matrix layer containing 100 µg/cm 2 of EVL. It was compared with a thinstrut BMS of the same backbone (OMEGA; Boston Scientific, Marlborough, MA), 3.0×12 mm, n=20 (platinum-chromium platform, 81 μm strut thickness) as control. A custom-made TES, 3.0×16 mm (platinum-chromium platform, 81 μm strut thickness using OMEGA backbone), was manufactured by Boston Scientific by the same techniques used for the EES (poly n-butyl methacrylate primer layer with poly [vinylidene fluoride-co-hexafluoropropylene] plus 100 µg/cm 2 Torin-2 [Selleck Chemicals, Houston, TX] in the external layer). Using this polymer in combination with drug has been shown to release the majority of drug within 3 months. 10