Mitchell W Krucoff1, Philip Urban2, Jean-François Tanguay3, Thomas McAndrew4, Yiran Zhang4, Sunil V Rao1, Marie-Claude Morice5, Matthew J Price6, David J Cohen7, Mohamed Abdel-Wahab8, Shamir R Mehta9, Benjamin Faurie10, Brent McLaurin11, Corie Diaz12, Hans-Peter Stoll13, Stuart Pocock14, Martin B Leon15. 1. Duke Clinical Research Institute, Duke University School of Medicine, Durham, NC (M.W.K., S.V.R.). 2. Hôpital de la Tour, Geneva, Switzerland (P.U.). 3. Department of Medicine, Montreal Heart Institute, Québec, Canada (J.-F.T.). 4. Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (T.M., Y.Z.). 5. Générale de Santé, Institut Cardiovasculaire Paris Sud, Massy, France (M.-C.M.). 6. Scripps Clinic, La Jolla, CA (M.J.P.). 7. University of Missouri-Kansas City (D.J.C.). 8. Segeberger Kliniken GmbH, Bad Segeberg, Germany (M.A.-W.). 9. McMaster University and Hamilton Health Sciences, Ontario, Canada (S.R.M.). 10. Department of Cardiology, Groupe Hospitalier Mutualiste de Grenoble, France (B.F.). 11. AnMed Health, Anderson, SC (B.M.). 12. Syntactx, New York, NY (C.D.). 13. Biosensors Clinical Research, Morges, Switzerland (H.-P.S.). 14. Department of Medical Statistics, London School of Hygiene & Tropical Medicine, Keppel Street, United Kingdom (S.P.). 15. Columbia University Medical Center/New York-Presbyterian Hospital (M.B.L.).
Abstract
BACKGROUND: High bleeding risk (HBR) patients undergoing percutaneous coronary intervention have been widely excluded from randomized device registration trials. The LF study (LEADERS FREE) reported superior outcomes of HBR patients receiving 30-day dual antiplatelet therapy after percutaneous coronary intervention with a polymer-free drug-coated stent (DCS). LFII was designed to assess the reproducibility and generalizability of the benefits of DCS observed in LF to inform the US Food and Drug Administration in a device registration decision. METHODS: LFII was a single-arm study using HBR inclusion/exclusion criteria and 30-day dual antiplatelet therapy after percutaneous coronary intervention with DCS, identical to LF. The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls. RESULTS: A total of 1203 LFII patients were enrolled with an average 1.7 HBR criteria per patient, including 60.7% >75 years of age, 34.1% on anticoagulants, and 14.7% with renal failure. Propensity-adjusted 365-day clinically indicated target lesion revascularization was significantly lower with DCS (7.2% versus 9.2%; hazard ratio, 0.72 [95% CI, 0.52-0.98]; P=0.0338 for superiority), as was the primary safety (cardiac death and myocardial infarction) composite (9.3% versus 12.4%; hazard ratio, 0.72 [95% CI, 0.55-0.94]; P=0.0150 for superiority). Stent thrombosis rates were 2.0% DCS and 2.2% bare metal stent. Major bleeding at 1 year occurred in 7.2% DCS patients and 7.2% bare metal stent. CONCLUSIONS: LFII reproduces the results of the DCS arm of LF in an independent, predominantly North American cohort of HBR patients.
BACKGROUND:High bleeding risk (HBR) patients undergoing percutaneous coronary intervention have been widely excluded from randomized device registration trials. The LF study (LEADERS FREE) reported superior outcomes of HBR patients receiving 30-day dual antiplatelet therapy after percutaneous coronary intervention with a polymer-free drug-coated stent (DCS). LFII was designed to assess the reproducibility and generalizability of the benefits of DCS observed in LF to inform the US Food and Drug Administration in a device registration decision. METHODS: LFII was a single-arm study using HBR inclusion/exclusion criteria and 30-day dual antiplatelet therapy after percutaneous coronary intervention with DCS, identical to LF. The 365-day rates of the primary effectiveness (clinically indicated target lesion revascularization) and safety (composite cardiac death and myocardial infarction) end points were reported using a propensity-stratified analysis compared with the LF bare metal stent arm patients as controls. RESULTS: A total of 1203 LFII patients were enrolled with an average 1.7 HBR criteria per patient, including 60.7% >75 years of age, 34.1% on anticoagulants, and 14.7% with renal failure. Propensity-adjusted 365-day clinically indicated target lesion revascularization was significantly lower with DCS (7.2% versus 9.2%; hazard ratio, 0.72 [95% CI, 0.52-0.98]; P=0.0338 for superiority), as was the primary safety (cardiac death and myocardial infarction) composite (9.3% versus 12.4%; hazard ratio, 0.72 [95% CI, 0.55-0.94]; P=0.0150 for superiority). Stent thrombosis rates were 2.0% DCS and 2.2% bare metal stent. Major bleeding at 1 year occurred in 7.2% DCS patients and 7.2% bare metal stent. CONCLUSIONS: LFII reproduces the results of the DCS arm of LF in an independent, predominantly North American cohort of HBR patients.
Entities:
Keywords:
United States; drug-eluting stents; humans; polymers; stents
Authors: Davide Capodanno; Deepak L Bhatt; C Michael Gibson; Stefan James; Takeshi Kimura; Roxana Mehran; Sunil V Rao; Philippe Gabriel Steg; Philip Urban; Marco Valgimigli; Stephan Windecker; Dominick J Angiolillo Journal: Nat Rev Cardiol Date: 2021-08-23 Impact factor: 32.419
Authors: David E Kandzari; Ajay J Kirtane; Stephan Windecker; Azeem Latib; Elvin Kedhi; Roxana Mehran; Matthew J Price; Alexandre Abizaid; Daniel I Simon; Stephen G Worthley; Azfar Zaman; James W Choi; Ronald Caputo; Mihir Kanitkar; Brent McLaurin; Srinivasa Potluri; Timothy Smith; Douglas Spriggs; Thaddeus Tolleson; Tamim Nazif; Maria Parke; Lilian C Lee; Te-Hsin Lung; Gregg W Stone Journal: Circ Cardiovasc Interv Date: 2020-11-10 Impact factor: 6.546
Authors: Franz R Eberli; Hans-Peter Stoll; Philip Urban; Marie-Claude Morice; Philippe Brunel; Luc Maillard; Janus Lipiecki; Stephane Cook; Jacques Berland; Thomas Hovasse; Didier Carrie; Diana Schütte; Sara Sadozai Slama; Philippe Garot Journal: Catheter Cardiovasc Interv Date: 2021-07-09 Impact factor: 2.585