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Coronary artery disease
Original article
Five-year clinical performance of a biodegradable polymer-coated biolimus-eluting stent in unselected patients
  1. Gian Battista Danzi1,
  2. Raffaele Piccolo1,2,
  3. Bernard Chevalier3,
  4. Philip Urban4,
  5. Farzin Fath-Ordoubadi5,
  6. Didier Carrie6,
  7. Marcus Wiemer7,8,
  8. Antonio Serra9,
  9. William Wijns10,
  10. Petr Kala11,
  11. Amerigo Stabile12,
  12. Javier Goicolea Ruigomez13,
  13. Dragan Sagic14,
  14. Peep Laanmets15,
  15. Gerhard Strupp16,
  16. Nick West17
  17. on behalf of Nobori 2 Investigators
  1. 1Division of Cardiology, Ospedale Santa Corona, Pietra Ligure, Italy
  2. 2Bern University Hospital, Bern, Switzerland
  3. 3Institut Cardiovasculaire Paris Sud, Massy/Quincy, France
  4. 4Hôpital de la Tour, Geneva, Switzerland
  5. 5Royal Infirmary, Manchester, UK
  6. 6Centre Hospitalier Universitaire Rangueil, Toulouse, France
  7. 7Herz-und Diabeteszentrum North-Rhine Westphalia, Bad Oeynhausen, Germany
  8. 8Department of Cardiology and Intensive Care Medicine, Johannes Wesling Hospital Minden, Minden, Germany
  9. 9Hospital de la Sta. Creu i St. Pau, Barcelona, Spain
  10. 10Cardiovascular Research Center OLV Hospital, Aalst, Belgium
  11. 11University Hospital Brno, Brno, Czech Republic
  12. 12A.R.N.A.S. Ospedale Civico, Palermo, Italy
  13. 13Hospital Puerta de Hierro, Madrid, Spain
  14. 14Institute for Cardiovascular Disease Dedinje, Belgrade, Serbia
  15. 15North-Estonia Regional Hospital, Tallinn, Estonia
  16. 16Klinikum Fulda AG, Fulda, Germany
  17. 17Papworth Hospital, Cambridge, UK
  1. Correspondence to Gian Battista Danzi, Division of Cardiology, Ospedale Santa Corona, Pietra Ligure (SV), Italy; gbdanzi{at}tin.it

Abstract

Objective To evaluate the long-term follow-up of the unrestricted use of a biodegradable polymer-coated drug-eluting stent in patients undergoing percutaneous coronary intervention (PCI).

Methods The Nobori 2 study was a prospective, multicentre, observational registry evaluating the safety and the efficacy of the biodegradable polymer biolimus-eluting stent (BP-BES) among 3067 patients recruited at 125 international sites. The primary combined endpoint was a composite of cardiac death, myocardial infarction and target-lesion revascularisation (TLR).

Results Five-year follow-up was available in 2738 (89.3%) patients. The combined endpoint occurred in 268 patients (10%, 95% CIs 8.9% to 11.3%) at 5 years, with 3.9% of events during the first year and 6.2% during years 1–5 of follow-up. Cumulative rates of TLR and definite/probable stent thrombosis were 5.3% (95% CI 4.5% to 6.3%) and 1.1% (95% CI 0.8% to 1.6%), respectively. Between 1 and 5 years, TLR and very late stent thrombosis rates were 3.5% (95% CI 2.8% to 4.4%) and 0.6% (95% CI 0.3% to 1.1%), respectively. Previous PCI (HR, 2.05, 95% CI 1.68 to 2.50), moderate-to-severe renal disease (HR, 1.89, 95% CI 1.30 to 2.74) and peripheral vascular disease (HR, 1.86, 95% CI 1.38 to 2.52) were the three most powerful independent predictors of the combined endpoint at 5 years.

Conclusions The final 5-year follow-up of the Nobori 2 registry demonstrates the safety and effectiveness of the BP-BES in an unselected, broadly inclusive cohort of PCI patients, highlighting the excellent performance of this coronary stent technology after polymer biodegradation.

Trial registration number ISRCTN81649913; Results.

https://doi.org/10.1136/heartjnl-2016-309283

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    Footnotes

    • Contributors All the authors contributed to the conception, design, analysis and interpretation of the data. GBD and RP drafted the first version of manuscript.

    • Funding The study was funded by Terumo. Terumo is a global company that manufactures and distributes a broad range of medical devices for use in therapeutics areas interventional cardiology, interventional oncology, peripheral interventions and access, with its headquarters located in Tokyo, Japan.

    • Competing interests RP has received a research grant from the Veronesi Foundation. WW has received institutional research grants from several device companies including Biosensors and Terumo (in relation to this work). He is non-executive Board member and shareholder of Argonauts, Celyad and Genae Inc.

    • Ethics approval National Research Ethics Services, London, UK; Comité de Protection de Patients, Paris, France; OLV Ziekenhuis Campus, Aalst, Belgium; ZOL Campus St Jan, Genk, Belgium; Catharina Ziekenhuis, Eindhoven, The Netherlands; Odense Hospital, Odense, Denmark; North-Estonia Regional Hospital, Tallinn, Estonia; Satakunta Central Hospital, Pori, Finland; Uppsala Akademiska Sjukhus, Uppsala, Sweden; Vaasa Central Hospital, Vaasa, Finland; Riga University Hospital, Riga, Latvia; Klinik Im Park, Zurich, Zwitzerland; C.H.U. Vaudois, Lausanne, Switzerland; University Hospital, Basel, Switzerland; Hirslanden Klinik, Zurich, Switzerland; Kantonsspital, Aarau, Switzerland; Hospital General de Navarra, Madrid, Spain; Hospital Puerta de Hierro, Madrid, Spain; Hospital Virgen de la Salud, Toledo, Spain; Hospital, Guadalajara, Spain; Hospital de Torrevieja, Alicante, Spain; Hospital del Mar, Barcelona, Spain; Hospital Universitario Miguel Servet, Zaragoza, Spain; Hospital Universitari Germans Trias I Pujol, Badalona, Spain; Hospital Clinico Universitario de Vigo, Spain; Hospital Clinico Universitario Santiago de Compostela, Spain; Hospital Joan XXIII, Tarragona, Spain; C. H. Torrecardenas, Almeria, Spain; Hospital General Yagüe, Burgos, Spain; Clinica Moncloa, Madrid, Spain; Hospital Infanta Cristina, Badajoz, Spain; Angiocor, Barcelona, Spain; Hospital do Meixoeiro, Vigo, Spain; Maggiore Policlinico-UOS Emodinamica, Milano, Italy; Ospedale S. Maria Nuova Reggio, Emilia, Italy; Policlinico S. Orsola-Malpighi, Bologna, Italy; Ospedale Maggiore (Azienda USL di Bologna), Bologna, Italy; Nuovo Ospedale di Modena, Baggiovara, Italy; A.O.V. Cervello, Palermo, Italy; Ospedale San Paolo, Savona, Italy; Azienda Ospedaliera Senese-Policlinico Le Scotte, Siena, Italy; Azienda Ospedaliera Villa Sofia, Palermo, Italy; A.R.N.A.S Civico , Palermo, Italy; Ospedale Sirai ASL 7, Carbonia, Italy; Policlinico A. Gemelli Università Cattolica del Sacro Cuore, Toma, Italy; Loreto Mare, Napoli, Italy; Ospedale Civile di, Mirano, Italy; Policlinico Universitario ‘Mater Domini', Catanzaro, Italy; Azienda Ospedaliera Pugliese-Ciaccio, Catanzaro, Italy; Ospedale C.G. Mazzoni Ascoli, Piceno, Italy; Azienda Unita Sanitaria Locale di Rimini, Italy; Policlinico Universitario di Tor Vergata, Roma, Italy; University Hospital Rio-Patras, Greece; Onassis Cardiac Surgery Center, Athens, Greece; Ozel Antalya Yasam Hospital, Sokak, Turkey; Şifa Hospital, Izmir, Turkey; Acibadem Hospital, Istanbul, Turkey; Istanbul University-Cardiology Institute, Istanbul, Turkey; National Heart Centre, Singapore, Malaysia; Kiang Wu Hospital, Macau, China; Medistra Hospital, Jakarta, Indonesia; Vietnam Heart Institute, Hanoi, Vietnam; Siriraj Hospital, Bangkok, Thailand; Heart Institute of HCMC, Ho Chi Minh, Vietnam; Freiburger Ethik-Kommission, Freiburg, Germany; University Hospital BRNO, Brno, Czech Republic; Rambam Hospital, Haifa, Israel; Wolfson Medical Center, Holon, Israel; Department of CV Surgery, Semmelweis University, Budapest, Hungary; State Hospital for Cardiology, Balatonfüred, Hungary; Hadassah Medical Organization, Jerusalem, Israel; Meir Medical Center, Kfar-Saba, Israel; Rabin Medical Centre, Petah-Tikva, Israel; Krajska Nemocnice Liberec a.s., Liberec, Czech Republic; Clinical Center Kragujevac, Kragujevac, Serbia; State Research Institute of Circulation Pathology, Novosibirsk, Russia; Republican Research and Scientific Center of Cardiology, Minsk, Belarus; Institute for CVD, Dedinje, Belgrade, Serbia; Clinical Center, Belgrade, Serbia; University Clinical Center, Nis, Serbia; Sanz Medical Center—Laniado Hospital, Netanya, Israel.

    • Provenance and peer review Not commissioned; externally peer reviewed.

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