Gennaro Giustino1, Usman Baber1, Melissa Aquino1, Samantha Sartori1, Gregg W Stone2, Martin B Leon2, Philippe Genereux3, George D Dangas1, Jaya Chandrasekhar1, Takeshi Kimura4, Olga Salianski1, Giulio G Stefanini5, P Gabriel Steg6, Stephan Windecker7, William Wijns8, Patrick W Serruys9, Marco Valgimigli10, Marie-Claude Morice11, Edoardo Camenzind12, Giora Weisz13, Pieter C Smits14, David E Kandzari15, Soren Galatius16, Clemens Von Birgelen17, Robert Saporito17, Raban V Jeger18, Ghada W Mikhail19, Dipti Itchhaporia20, Laxmi Mehta21, Rebecca Ortega22, Hyo-Soo Kim23, Adnan Kastrati24, Alaide Chieffo25, Roxana Mehran26. 1. The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York. 2. Division of Cardiology, Columbia University Medical Center, New York, New York. 3. Cardiovascular Research Foundation, New York, New York; Division of Cardiology, Columbia University Medical Center, New York, New York; Division of Cardiology, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada. 4. Department of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan. 5. Division of Clinical and Interventional Cardiology, Humanitas Research Hospital, Rozzano, Milan, Italy. 6. Département Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France. 7. Department of Cardiology, Bern University Hospital, Bern, Switzerland. 8. Cardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium. 9. Department of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands. 10. Department of Cardiology, University of Ferrara, Ferrara, Italy. 11. Department of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France. 12. Department of Cardiology, Institut Lorrain du Coeur et des Vaisseaux University Hospital Nancy, Brabois Vandoeuvre-lès-Nancy, France. 13. Division of Cardiology, Columbia University Medical Center, New York, New York; Department of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel. 14. Department of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands. 15. Department of Cardiology, Piedmont Heart Institute, Atlanta, Georgia. 16. Gentofte University Hospital, Hellerup, Denmark. 17. Department of Cardiology, Thoraxcentrum Twente, Enschede, the Netherlands. 18. Department of Cardiology, University Hospital Basel, Basel, Switzerland. 19. Department of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom. 20. Department of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California. 21. Department of Cardiology, Ohio State University Medical Center, Columbus, Ohio. 22. Duke Clinical Research Institute, Center for Educational Excellence, Durham, North Carolina. 23. Department of Cardiology, Seoul National University Main Hospital, Seoul, Korea. 24. Department of Cardiology, Herzzentrum, Munich, Germany. 25. Cardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy. 26. The Zena and Michael A. Wiener Cardiovascular Institute, Interventional Cardiovascular Research and Clinical Trials Center, Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: Roxana.Mehran@mountsinai.org.
Abstract
OBJECTIVES: The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). BACKGROUND: Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. METHODS: We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. RESULTS: Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. CONCLUSIONS: Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.
OBJECTIVES: The purpose of this study was to investigate the safety and efficacy of new-generation drug-eluting stents (DES) versus early-generation DES in women undergoing complex percutaneous coronary intervention (CPCI). BACKGROUND: Whether the benefits of new-generation DES are preserved in women undergoing complex percutaneous revascularization is unknown. METHODS: We pooled patient-level data from women enrolled in 26 randomized trials of DES. Study population was categorized according to the presence or absence of CPCI, which was defined as the composite of total stent length >30 mm, ≥2 stents implanted, ≥2 lesions treated, or bifurcation lesion as target vessel. The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause mortality, myocardial infarction, or target lesion revascularization at 3 years of follow-up. RESULTS: Of 10,241 women included in the pooled database, 4,629 (45%) underwent CPCI. Compared with non-CPCI, women who underwent CPCI had a higher 3-year risk of MACE (adjusted hazard ratio [HR]: 1.63; 95% confidence interval [CI]: 1.45 to 1.83; p < 0.0001). In women who underwent CPCI, use of new-generation DES was associated with significantly lower 3-year risk of MACE (adjusted HR: 0.81; 95% CI: 0.68 to 0.96), target lesion revascularization (adjusted HR: 0.74; 95% CI: 0.57 to 0.95), and definite or probable stent thrombosis (ST) (adjusted HR: 0.50; 95% CI: 0.30 to 0.83). The benefit of new-generation DES on efficacy and safety outcomes was uniform between CPCI and non-CPCI groups, without evidence of interaction. By landmark analysis, new-generation DES were associated with low rates (≤0.4%) of very-late ST irrespective of procedural complexity. CONCLUSIONS:Women undergoing CPCI remain at higher risk of adverse events. The long-term ischemic benefits of new-generation DES platforms are uniform among complex and non-complex percutaneous revascularization procedures in women.
Authors: Gennaro Giustino; Rafael Harari; Usman Baber; Samantha Sartori; Gregg W Stone; Martin B Leon; Stephan Windecker; Patrick W Serruys; Adnan Kastrati; Clemens Von Birgelen; Takeshi Kimura; Giulio G Stefanini; George D Dangas; William Wijns; P Gabriel Steg; Marie-Claude Morice; Edoardo Camenzind; Giora Weisz; Pieter C Smits; Sabato Sorrentino; Madhav Sharma; Serdar Farhan; Michela Faggioni; David Kandzari; Soren Galatius; Raban V Jeger; Marco Valgimigli; Dipti Itchhaporia; Laxmi Mehta; Hyo-Soo Kim; Alaide Chieffo; Roxana Mehran Journal: JAMA Cardiol Date: 2017-08-01 Impact factor: 14.676
Authors: Rayyan Hemetsberger; Mohammad Abdelghani; Ralph Toelg; Hector M Garcia-Garcia; Serdar Farhan; Nader Mankerious; Karim Elbasha; Abdelhakim Allali; Stephan Windecker; Thierry Lefèvre; Shigeru Saito; David Kandzari; Ron Waksman; Gert Richardt Journal: Clin Res Cardiol Date: 2022-02-25 Impact factor: 5.460
Authors: Anna Franzone; Serge Zaugg; Raffaele Piccolo; Maria Grazia Modena; Ghada W Mikhail; Josepa Mauri Ferré; Ruth Strasser; Liliana Grinfeld; Dik Heg; Peter Jüni; Stephan Windecker; Marie-Claude Morice Journal: PLoS One Date: 2017-08-10 Impact factor: 3.240