Author + information
- Received March 9, 2017
- Revision received June 1, 2017
- Accepted June 29, 2017
- Published online December 4, 2017.
- Christopher R. Kelly, MDa,
- Paul S. Teirstein, MDb,
- Ian T. Meredith, AM, MBBS, PhDc,
- Bruno Farah, MDd,
- Christophe L. Dubois, MD, PhDe,
- Robert L. Feldman, MDf,
- Joseph Dens, MD, PhDg,
- Nobuhisa Hagiwara, MDh,
- Abram Rabinowitz, MDi,
- Didier Carrié, MDj,
- Vincent Pompili, MDk,
- Alain Bouchard, MDl,
- Shigeru Saito, MDm,
- Dominic J. Allocco, MDn,
- Keith D. Dawkins, MDn and
- Gregg W. Stone, MDa,∗ ()
- aColumbia University Medical Center/New York-Presbyterian Hospital and the Cardiovascular Research Foundation, New York, New York
- bScripps Clinic, La Jolla, California
- cMonashHEART, Southern Health, Monash Medical Centre, Clayton, Victoria, Australia
- dClinique Pasteur–Toulouse, Toulouse, France
- eUniversity Hospital Leuven, Leuven, Belgium
- fMediquest Research at Munroe Regional Medical Center, Ocala, Florida
- gDepartment of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium
- hTokyo Women’s Medical University Hospital, Shinjuku, Tokyo, Japan
- iTexSan Heart Hospital, San Antonio, Texas
- jUniversité Paul Sabatier, Centre Hospitalier Universitaire Rangueil, Toulouse, France
- kUniversity of Nebraska Medical Center, Omaha, Nebraska
- lBaptist Medical Center–Princeton, Birmingham, Alabama
- mShonan Kamakura General Hospital, Kanagawa, Japan
- nBoston Scientific Corporation, Marlborough, Massachusetts
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Columbia University Medical Center, The Cardiovascular Research Foundation, 1700 Broadway, 8th Floor, New York, New York 10019.
Objectives The authors sought to evaluate the final 5-year safety and effectiveness of the platinum-chromium everolimus-eluting stent (PtCr-EES) in the randomized trial, as well as in 2 single-arm substudies that evaluated PtCr-EES in small vessels (diameter <2.5 mm; n = 94) and long lesions (24 to 34 mm; n = 102).
Background In the multicenter, randomized PLATINUM (PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions), the PtCr-EES was noninferior to the cobalt-chromium everolimus-eluting stent (CoCr-EES) at 1 year in 1,530 patients undergoing percutaneous coronary intervention.
Methods Patients with 1 or 2 de novo coronary artery lesions (reference vessel diameter 2.50 to 4.25 mm, length ≤24 mm) were randomized 1:1 to PtCr-EES versus CoCr-EES. All patients in the substudies received PtCr-EES. The primary endpoint was target lesion failure (TLF), a composite of target vessel-related cardiac death, target vessel-related myocardial infarction, or ischemia-driven target lesion revascularization.
Results In the randomized trial, the 5-year TLF rate was 9.1% for PtCr-EES and 9.3% for CoCr-EES (hazard ratio [HR]: 0.97; p = 0.87). Landmark analysis demonstrated similar TLF rates from discharge to 1 year (HR: 1.12; p = 0.70) and from 1 to 5 years (HR: 0.90; p = 0.63). There were no significant differences in the rates of cardiac death, myocardial infarction, target lesion or vessel revascularization, or stent thrombosis. PtCr-EES had 5-year TLF rates of 7.0% in small vessels and 13.6% in long lesions.
Conclusions PtCr-EES demonstrated comparable safety and effectiveness to CoCr-EES through 5 years of follow-up, with low rates of stent thrombosis and other adverse events. The 5-year event rates were also acceptable in patients with small vessels and long lesions treated with PtCr-EES. (The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions [PLATINUM]; NCT00823212; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of De Novo Coronary Artery Lesions in Small Vessels [PLATINUM SV]; NCT01498692; The PLATINUM Clinical Trial to Assess the PROMUS Element Stent System for Treatment of Long De Novo Coronary Artery Lesions [PLATINUM LL]; NCT01500434)
Funded by Boston Scientific Corp. Dr. Teirstein has been a speaker for and received consulting fees from Boston Scientific, Abbott, and Medtronic. Dr. Meredith is an employee and shareholder of Boston Scientific. Dr. Dubois serves on Boston Scientific’s scientific advisory board. Dr. Feldman has received honoraria from Boston Scientific; is stockholder of Boston Scientific; and serves on their scientific advisory board. Dr. Dens is a consultant for and has received a research grant from Boston Scientific. Dr. Saito is a consultant for and has received honoraria from Abbott Vascular, Boston Scientific, Medtronic, and Terumo. Drs. Allocco and Dawkins are employees and shareholders of Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received March 9, 2017.
- Revision received June 1, 2017.
- Accepted June 29, 2017.
- 2017 American College of Cardiology Foundation