Five-year clinical outcomes of everolimus-eluting stents from the post marketing study of CoCr-EES (XIENCE V/PROMUS) in Japan
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The Cobalt Chromium Everolimus-Eluting Stent (CoCr-EES) Post Marketing Surveillance (PMS) Japan study is a prospective multicenter registry designed to evaluate the safety and efficacy of XIENCE V/PROMUS everolimus-eluting stents in routine clinical practice at 47 centers representative of the clinical environment in Japan. We enrolled 2010 consecutive patients (2649 lesions) who underwent percutaneous coronary intervention using CoCr-EES. Clinical outcomes were evaluated through 5 years. Mean age was 68.8 years, 41.9% had diabetes, 4.9% received hemodialysis. Five-year clinical follow up was available for 1704 (84.8%) patients. Major adverse cardiovascular events (MACE) occurred in 10.7% of patients, including cardiac death (3.8%), myocardial infarction (1.8%), and clinically driven target lesion revascularization (TLR) (6.0%). Beyond 1 year, annual incidence of clinically driven TLR was 0.5–0.8%. Definite or probable stent thrombosis occurred in 9 (0.5%) patients at 5 years. After 1 year, definite stent thrombosis occurred in only 1 patient. Significant predictors for MACE were dialysis (ODDs ratio 4.58, 95% CI 2.75–7.64), prior cardiac intervention (ODDs ratio 2.47, 95% CI 1.75–3.49), total stent length (ODDs ratio 1.01, 95% CI 1.01–1.02), and number of diseased vessels (ODDs ratio 1.66, 95% CI 1.08–2.55). Five-year clinical outcomes from the CoCr-EES PMS Japan study demonstrated a low incidence of clinical events in the daily practice up to 5 years.
Clinical Trial Registration Information: https://clinicaltrials.gov/ct2/show/NCT01086228.
KeywordsEverolimus Stent Restenosis Thrombosis
The authors thank the members of the cardiac catheterization laboratory and clinical research coordinators at the participating centers.
The XIENCE V/PROMUS PMS was sponsored and funded by Abbott Vascular (ClinicalTrials.gov ID: NCT01086228).
Compliance with ethical standards
Conflict of interest
Ken Kozuma and Kengo Tanabe receive remuneration from Abbott Vascular, Kusano Hajime is an employee of Abbott Vascular and has stocks of Abbott Vascular, Hong Nie is an employee of Abbott Vascular, and Takeshi Kimura receives research and scholar funds from Abbott Vascular. Others have no disclosure related to this manuscript.
- 2.Gada H, Kirtane AJ, Newman W, Sanz M, Hermiller JB, Mahaffey KW, et al. 5-year results of a randomized comparison of XIENCE V everolimus-eluting and TAXUS paclitaxel-eluting stents: final results from the SPIRIT III trial (clinical evaluation of the XIENCE V everolimus eluting coronary stent system in the treatment of patients with de novo native coronary artery lesions). JACC Cardiovasc Interv. 2013;6:1263–6.CrossRefGoogle Scholar
- 3.Smits PC, Vlachojannis GJ, McFadden EP, Royaards KJ, Wassing J, Joesoef KS, et al. Final 5-year follow-up of a randomized controlled trial of everolimus- and paclitaxel-eluting stents for coronary revascularization in daily practice: the COMPARE Trial (a trial of everolimus-eluting stents and paclitaxel stents for coronary revascularization in daily practice). JACC Cardiovasc Interv. 2015;8:1157–65.CrossRefGoogle Scholar
- 5.Iqbal J, Serruys PW, Silber S, Kelbaek H, Richardt G, Morel MA, et al. Comparison of zotarolimus- and everolimus-eluting coronary stents: final 5-year report of the RESOLUTE all-comers trial. Circ Cardiovasc Interv. 2015;8:e002230.Google Scholar
- 6.von Birgelen C, van der Heijden LC, Basalus MW, Kok MM, Sen H, Louwerenburg HW, et al. Five-year outcome after implantation of zotarolimus- and everolimus-eluting stents in randomized trial participants and nonenrolled eligible patients: a secondary analysis of a randomized clinical trial. JAMA Cardiol. 2017;2:268–76.CrossRefGoogle Scholar
- 7.Ikari Y, Kotani J, Kozuma K, Kyo E, Nakamura M, Yokoi H, et al. Assessment of sirolimus-eluting coronary stent implantation with aspirin plus low dose ticlopidine administration: one year results from CYPHER Stent Japan Post-Marketing Surveillance Registry (J-PMS). Circ J. 2009;73:1038–44.CrossRefGoogle Scholar
- 11.Natsuaki M, Morimoto T, Furukawa Y, Nakagawa Y, Kadota K, Yamaji K, et al. Late adverse events after implantation of sirolimus-eluting stent and bare-metal stent: long-term (5–7 years) follow-up of the Coronary Revascularization Demonstrating Outcome study-Kyoto registry Cohort-2. Circ Cardiovasc Interv. 2014;7:168–79.CrossRefGoogle Scholar
- 16.Otsuka F, Cheng Q, Yahagi K, Acampado E, Sheehy A, Yazdani SK, et al. Acute thrombogenicity of a durable polymer everolimus-eluting stent relative to contemporary drug-eluting stents with biodegradable polymer coatings assessed ex vivo in a swine shunt model. JACC Cardiovasc Interv. 2015;8:1248–60.CrossRefGoogle Scholar