Author + information
- Received September 23, 2015
- Revision received December 3, 2015
- Accepted December 7, 2015
- Published online April 11, 2016.
- Gennaro Giustino, MDa,
- Usman Baber, MD, MSca,
- Melissa Aquino, MSca,
- Samantha Sartori, PhDa,
- Gregg W. Stone, MDb,
- Martin B. Leon, MDb,
- Philippe Genereux, MDc,d,e,
- George D. Dangas, MD, PhDa,
- Jaya Chandrasekhar, MBBSa,
- Takeshi Kimura, MDf,
- Olga Salianskia,
- Giulio G. Stefanini, MD, PhDg,
- P. Gabriel Steg, MD, PhDh,
- Stephan Windecker, MD, PhDi,
- William Wijns, MDj,
- Patrick W. Serruys, MD, PhDk,
- Marco Valgimigli, MD, PhDl,
- Marie-Claude Morice, MDm,
- Edoardo Camenzind, MDn,
- Giora Weisz, MDb,o,
- Pieter C. Smits, MDp,
- David E. Kandzari, MDq,
- Soren Galatius, MDr,
- Clemens Von Birgelen, MDs,
- Robert Saporitos,
- Raban V. Jeger, MDt,
- Ghada W. Mikhail, MDu,
- Dipti Itchhaporia, MDv,
- Laxmi Mehta, MDw,
- Rebecca Ortega, MHAx,
- Hyo-Soo Kim, MDy,
- Adnan Kastrati, MDz,
- Alaide Chieffo, MDaa and
- Roxana Mehran, MDa,∗ ()
- aThe 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
- bDivision of Cardiology, Columbia University Medical Center, New York, New York
- cCardiovascular Research Foundation, New York, New York
- dDivision of Cardiology, Columbia University Medical Center, New York, New York
- eDivision of Cardiology, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada
- fDepartment of Cardiology, Kyoto University Graduate School of Medicine, Kyoto, Japan
- gDivision of Clinical and Interventional Cardiology, Humanitas Research Hospital, Rozzano, Milan, Italy
- hDépartement Hospitalo Universitaire Fibrose, Inflammation et REmodelage, Assistance Publique-Hôpitaux de Paris, Université Paris Diderot, INSERM U114, Paris, France
- iDepartment of Cardiology, Bern University Hospital, Bern, Switzerland
- jCardiovascular Center Aalst, Onze-Lieve-Vrouwziekenhuis Ziekenhuis, Aalst, Belgium
- kDepartment of Cardiology, Erasmus Medical Center, Rotterdam, the Netherlands
- lDepartment of Cardiology, University of Ferrara, Ferrara, Italy
- mDepartment of Cardiology and Cardiovascular Surgery, Institut Cardiovasculaire Paris Sud, France
- nDepartment of Cardiology, Institut Lorrain du Coeur et des Vaisseaux University Hospital Nancy, Brabois Vandoeuvre-lès-Nancy, France
- oDepartment of Cardiology, Shaare Zedek Medical Center, Jerusalem, Israel
- pDepartment of Cardiology, Maasstad Hospital, Rotterdam, the Netherlands
- qDepartment of Cardiology, Piedmont Heart Institute, Atlanta, Georgia
- rGentofte University Hospital, Hellerup, Denmark
- sDepartment of Cardiology, Thoraxcentrum Twente, Enschede, the Netherlands
- tDepartment of Cardiology, University Hospital Basel, Basel, Switzerland
- uDepartment of Cardiology, Imperial College Healthcare NHS Trust, London, United Kingdom
- vDepartment of Cardiology, Hoag Memorial Hospital Presbyterian, Newport Beach, California
- wDepartment of Cardiology, Ohio State University Medical Center, Columbus, Ohio
- xDuke Clinical Research Institute, Center for Educational Excellence, Durham, North Carolina
- yDepartment of Cardiology, Seoul National University Main Hospital, Seoul, Korea
- zDepartment of Cardiology, Herzzentrum, Munich, Germany
- aaCardiothoracic Department, San Raffaele Scientific Institute, Milan, Italy
- ↵∗Reprint requests and correspondence:
Dr. Roxana Mehran, The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, One Gustave L. Levy Place, Box 1030, New York, New York 10029.
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.
The Gender Data Forum was sponsored by the Women in Innovation Initiative of the Society of Cardiovascular Angiography and Interventions. Dr. Dangas' spouse has relationships with AstraZeneca, Bayer, CSL Behring, Jannsen Pharmaceuticals Inc., Merck & Co. Inc., Osprey Medical Inc., Regado Biosciences Inc., The Medicines Company, Watermark Consulting, Abbott Laboratories, Boston Scientific Corp., Covidien, sanofi-aventis, Elixir Medical Corp., and Claret Medical Inc. Dr. Stefanini has received speaker/consultant fees from Abbott Vascular, AstraZeneca, BBraun, Biotronik, and The Medicines Company. Dr. Steg has received a research grant (to INSERM U1148) from Sanofi and Servier; speaking or consulting fees from Amarin, AstraZeneca, Bayer, Boehringer-Ingelheim, Bristol-Myers Squibb, CSL-Behring, Daiichi-Sankyo, GlaxoSmithKline, Janssen, Lilly, Novartis, Pfizer, Regeneron, Roche, Sanofi, Servier, and The Medicines Company; and is a stockholder for Aterovax. Dr. Windecker has received research grants to his institution from Abbott Vascular, Biotronik, Boston Scientific, Medtronic, Edwards, and St. Jude Medical. Dr. Wijns has received institutional research grants from St. Jude Medical, Abbott Vascular, MiCell, Stentys and Boston Scientific; and is a non-executive board member and shareholder of Genae and Cardio3BioSciences. Dr. Smits has received institutional research grants form Abbott Vascular, Terumo, and St. Jude Medical. Dr. Kandzari has received research/grant support from Abbott Vascular, Biotronik, Boston Scientific, Medtronic CardioVascular, and Medinol; and consulting honoraria from Boston Scientific and Medtronic CardioVascular. Dr. von Birgelen is the PI on several randomized stent trials; has received lecture fees from AstraZeneca and MSD; is a consultant (advisory board member) to Abbott Vascular, Boston Scientific, and Medtronic; and his institution has received research grants from Abbott Vascular, AstraZeneca, Biotronik, Boston Scientific, and Medtronic to fund investigator-initiated, multi-center, randomized controlled trials and large registries. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Received September 23, 2015.
- Revision received December 3, 2015.
- Accepted December 7, 2015.
- American College of Cardiology Foundation