Matthew J Price1, Shigeru Saito2, Richard A Shlofmitz3, Douglas J Spriggs4, Michael Attubato5, Brent McLaurin6, Alexandra Popma Almonacid7, Sandeep Brar8, Minglei Liu8, Elizabeth Moe8, Roxana Mehran9. 1. Department of Cardiovascular Diseases, Scripps Clinic, La Jolla, California. Electronic address: price.matthew@scrippshealth.org. 2. Shonan Kamakura General Hospital, Kamakura, Japan. 3. Saint Francis Hospital, Roslyn, New York. 4. Morton Plant Hospital, Clearwater, Florida. 5. NYU Langone Medical Center, New York, New York. 6. AnMed, Anderson, South Carolina. 7. Beth Israel Deaconess Medical Center, Cardiovascular Imaging Core Laboratory, Boston, Massachusetts. 8. Medtronic, Santa Rosa, California. 9. Department of Cardiology, Mount Sinai Medical Center, New York, New York.
Abstract
OBJECTIVES: The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD). BACKGROUND: Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation. METHODS: This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure. RESULTS: A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%. CONCLUSIONS: In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501).
OBJECTIVES: The aim of this study was to explore the safety and efficacy of a dedicated drug-eluting stent for the treatment of coronary lesions with very small reference vessel diameter (RVD). BACKGROUND: Smaller RVD is associated with increased risk for restenosis and target lesion failure (TLF) after stent implantation. METHODS: This was a prospective, single-arm, multicenter trial of the Resolute Onyx 2.0-mm zotarolimus-eluting stent. The primary endpoint was 12-month TLF, which was compared with a pre-specified performance goal. Subjects with stable or unstable angina or ischemia, target lesions ≤27 mm in length, and RVD ≥2.0 and <2.25 mm were eligible for enrollment. A subset of subjects underwent follow-up angiography at 13 months post-procedure. RESULTS: A total of 101 subjects with 104 lesions were enrolled. The mean age was 67.3 ± 9.6 years, 47% of subjects had diabetes, the mean lesion length was 12.6 ± 6.3 mm, and the mean RVD was 1.91 ± 0.26 mm. The rate of TLF at 12 months was 5.0%, fulfilling the pre-specified performance goal of 19% (p < 0.001). The rates of target lesion revascularization and target vessel myocardial infarction were 2.0% and 3.0%, respectively. There were no episodes of stent thrombosis. In-stent late lumen loss was 0.26 ± 0.48 mm, and the rate of binary restenosis was 12.0%. CONCLUSIONS: In this first report of a drug-eluting stent with a dedicated size to treat lesions with RVD <2.25 mm, the Resolute Onyx 2.0-mm zotarolimus-eluting stent was associated with a low rate of TLF and late lumen loss, without a signal for stent thrombosis. This novel-sized drug-eluting stent appears to be a feasible option for the treatment of coronary lesions in extremely small vessels. (Medtronic Resolute Onyx 2.0 mm Clinical Study; NCT02412501).
Authors: Rosaly A Buiten; Eline H Ploumen; Paolo Zocca; Carine J M Doggen; Liefke C van der Heijden; Marlies M Kok; Peter W Danse; Carl E Schotborgh; Martijn Scholte; Frits H A F de Man; Gerard C M Linssen; Clemens von Birgelen Journal: JAMA Cardiol Date: 2019-07-01 Impact factor: 14.676
Authors: Kyuho Jeong; Jung-Hyun Kim; James M Murphy; Hyeonsoo Park; Su-Jeong Kim; Yelitza A R Rodriguez; Hyunkyung Kong; Chungsik Choi; Jun-Lin Guan; Joan M Taylor; Thomas M Lincoln; William T Gerthoffer; Jun-Sub Kim; Eun-Young Erin Ahn; David D Schlaepfer; Ssang-Taek Steve Lim Journal: Circ Res Date: 2019-05-17 Impact factor: 17.367
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