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Bioresorbable scaffolds for treating coronary artery disease in patients with diabetes mellitus
Published in Yoshinobu Onuma, Patrick W.J.C. Serruys, Bioresorbable Scaffolds, 2017
Ayyaz Sultan, Takashi Muramatsu, Javaid Iqbal
The DESolve® BRS (Elixir Medical, Sunnyvale, CA) is a novel PLLA-based bioresorbable scaffold, eluting antiproliferative metabolite of sirolimus, myolimus in earlier iterations, and novolimus in subsequent devices. The first-in-human trial [78] demonstrated promising initial results for the efficacy and safety of the DESolve BRS in a multicenter, nonrandomized, prospective study of 15 patients (6.7% diabetics) [79]. This led to international enrolment of 126 patients (21% diabetics) for DESolve Nx trial, which showed significant increase in lumen area (5.9 vs. 6.43 mm2; 17%) and scaffold area (5.86 mm vs. 6.78 mm2; 16%) by IVUS examination and 99% coverage of the scaffold struts by OCT examination at 6 months. The MACE incidence was 3.25% including one cardiac death, one target vessel MI, and two TLRs [80]. However, the authors did not discuss outcome results specifically in diabetics.
Current perspectives on bioresorbable scaffolds in coronary intervention and other fields
Published in Expert Review of Medical Devices, 2021
Xinlei Wu, Sijing Wu, Hideyuki Kawashima, Hironori Hara, Masafumi Ono, Chao Gao, Rutao Wang, Mattia Lunardi, Faisal Sharif, William Wijns, Patrick W. Serruys, Yoshinobu Onuma
FANTOM I trial was a pilot study that enrolled seven patients with de novo coronary lesions, treated with 3.0 x 18 mm BRS. The scaffold was successfully implanted in all patients without adverse in-hospital events. At 4-month follow-up in-stent lumen loss was 0.21 mm (no binary restenosis) [81]. Afterward, the FANTOM II trial (n = 240) with single de novo lesions started. This study included the lesions with a reference diameter of 2.5 mm to 3.0 mm and length≤20 mm, while excluding complex lesions. Angiographic follow-up was performed in patient cohort A at 6 months (n = 117) and in cohort B at 9 months (n = 123). The 6-month follow-up results showed MACE in 3 (2.6%) patients and scaffold thrombosis in 1 (0.9%) patient, while the mean in-scaffold LLL was 0.25 ± 0.40 mm [82]. At 9 months, the mean in-scaffold LLL was 0.33 ± 0.36 mm and in-segment binary stenosis occurred in 7.6% of patients [80]. At 12-month follow-up, MACE occurred in 4.2% of patients. No more scaffold thrombosis was reported between 6 and 12 months. Recently, FANTOM STEMI trial was designed to evaluate the safety and efficacy of the device implanted in STEMI patients. The initial results of 10 patients revealed 100% procedural and angiographic success rates with device-oriented composite endpoint at 30 days [83].
The STENTYS self-apposing stent technology in coronary artery disease: literature review and future directions
Published in Expert Review of Medical Devices, 2018
Huangling Lu, Robbert J. De Winter, Karel T. Koch
A smaller real-world, single-center experience with the STENTYS stent from Italy enrolled a total of 109 patients [35]. Both BMS and PES STENTYS were included. A total of 54.1% presented with STEMI, 29.4% with non-STEMI/unstable angina. Mean follow-up was 23.6 ± 12.6 months. MACE, which was a composite of cardiac death, MI, TVR, and stroke, occurred in 5.5%. Definite ST rate was 1.8%. The authors noted that there is a learning curve while using this device to avoid complications, GM, and to achieve good procedural results. A small Italian real-world registry including 40 patients revealed that interventionalists chose the STENTYS device in a selection of angiographic situations, including bifurcation lesions, acute coronary syndrome, and ectatic coronaries. All patients were treated with the STENTYS BMS, acute ST rate was 2.5%, and MACE rate was 15% at 21 ± 13 months follow-up [36]. Comparable high event rates were found in a small Polish real-world registry of 40 patients treated with either BMS or the PES STENTYS, with TLR rate of 7.8% at 12 months follow-up. ST rate was 0% at 12 months follow-up.
Does the novel delivery system for the STENTYS self-apposing coronary stent increase the risk of stent edge dissections? Optical coherence tomography post stent findings
Published in Expert Review of Medical Devices, 2018
Huangling Lu, Deborah N. Kalkman, Maik J. Grundeken, Jan G. P. Tijssen, Joanna J. Wykrzykowska, Robbert J. de Winter, Karel T. Koch
Patients were contacted 1 month post-procedure by telephone to obtain follow-up data. If a patient could not be reached, general practitioners and referring hospitals were contacted to complete follow-up. When a potential clinical event was reported, hospital records and coronary angiograms were reviewed to complete information. Reported clinical outcomes included major adverse cardiac events (MACE) which was the composite of cardiac death, any myocardial infarction (MI), and target vessel revascularization (TVR). Other individual events were all cause death, clinically indicated TLR, non-TVR, and definite/probable ST. Clinical events are defined according to the Academic Research Consortium definition [9].