Author + information
- Received January 31, 2020
- Accepted March 17, 2020
- Published online June 15, 2020.
- Paul Guedeney, MDa,b,
- Bimmer E. Claessen, MD, PhDa,
- Roxana Mehran, MDa,c,
- Gary S. Mintz, MDc,
- Mengdan Liu, MSc,
- Sabato Sorrentino, MD, PhDa,
- Gennaro Giustino, MDa,
- Serdar Farhan, MDa,
- Martin B. Leon, MDc,d,
- Patrick W. Serruys, MD, PhDe,f,
- Pieter C. Smits, MDg,
- Clemens von Birgelen, MD, PhDh,i,
- Ziad A. Ali, MD, DPhilc,d,j,
- Philippe Généreux, MD, PhDc,k,l,
- Björn Redfors, MD, PhDc,d,m,
- Mahesh V. Madhavan, MDc,d,
- Ori Ben-Yehuda, MDc,d and
- Gregg W. Stone, MDa,c,∗ ()
- aThe Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York
- bSorbonne Université, ACTION Study Group, INSERM UMRS 1166, Institut de Cardiologie, Pitié-Salpêtrière Hospital (AP-HP), Paris, France
- cClinical Trials Center, Cardiovascular Research Foundation, New York, New York
- dNewYork-Presbyterian Hospital/Columbia University Irving Medical Center, New York, New York
- eDepartment of Cardiology, NUI Galway, National University of Ireland, Galway, Ireland
- fImperial College of Science, Technology and Medicine, London, United Kingdom
- gDepartment of Cardiology, Maasstad Ziekenhuis, Rotterdam, the Netherlands
- hDepartment of Cardiology, Thoraxcentrum Twente, Medisch Spectrum Twente, Enschede, the Netherlands
- iDepartment of Health Technology and Services Research, Technical Medical Centre, University of Twente, Enschede, the Netherlands
- jSt. Francis Hospital, Roslyn, New York
- kGagnon Cardiovascular Institute, Morristown Medical Center, Morristown, New Jersey
- lHôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada
- mDepartment of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden
- ↵∗Address for correspondence:
Dr. Gregg W. Stone, Mount Sinai Health System, Cardiovascular Research Foundation, 1700 Broadway, 8th Floor, New York, New York 10019.
Objectives The aim of this study was to evaluate the long-term impact of coronary artery calcification (CAC) on outcomes after percutaneous coronary intervention and the respective performance of first- and second-generation drug-eluting stents (DES).
Background Whether contemporary DES have improved the long-term prognosis after percutaneous coronary intervention in lesions with severe CAC is unknown.
Methods Individual patient data were pooled from 18 randomized trials evaluating DES, categorized according to the presence of angiography core laboratory–confirmed moderate or severe CAC. Major endpoints were the patient-oriented composite endpoint (death, myocardial infarction [MI], or any revascularization) and the device-oriented composite endpoint of target lesion failure (cardiac death, target vessel MI, or ischemia-driven target lesion revascularization). Multivariate Cox proportional regression with study as a random effect was used to assess 5-year outcomes.
Results A total of 19,833 patients were included. Moderate or severe CAC was present in 1 or more target lesions in 6,211 patients (31.3%) and was associated with increased 5-year risk for the patient-oriented composite endpoint (adjusted hazard ratio [adjHR]: 1.12; 95% confidence interval [CI]: 1.05 to 1.20) and target lesion failure (adjHR: 1.21; 95% CI: 1.09 to 1.34), as well as death, MI, and ischemia-driven target lesion revascularization. In patients with CAC, use of second-generation DES compared with first-generation DES was associated with reductions in the 5-year risk for the patient-oriented composite endpoint (adjHR: 0.88; 95% CI: 0.78 to 1.00) and target lesion failure (adjHR: 0.73; 95% CI: 0.61 to 0.87), as well as death or MI, ischemia-driven target lesion revascularization, and stent thrombosis. The relative treatment effects of second-generation compared with first-generation DES were consistent in patients with and without moderate or severe CAC, although outcomes were consistently better with contemporary devices.
Conclusions In this large-scale study, percutaneous coronary intervention of target lesion moderate or severe CAC was associated with adverse patient-oriented and device-oriented adverse outcomes at 5 years. These detrimental effects were mitigated with second-generation DES.
This investigator-sponsored study was funded by Abbott. Dr. Mehran has received institutional research grants from Abbott Laboratories, AstraZeneca, Bayer, Beth Israel Deaconess, Bristol-Myers Squibb, Cardiovascular European Research Center, Chiesi, Concept Medical, CSL Behring, Daiichi-Sankyo Inc., Medtronic, Novartis Pharmaceuticals, OrbusNeich; has received consultant fees from Abbott Laboratories, Boston Scientific, Janssen Scientific Affairs, Medscape/WebMD, Medtelligence (Janssen Scientific Affairs), Roivant Sciences, Sanofi, Siemens Medical Solutions; has received consultant fees paid to the institution from Abbott Laboratories, Bristol-Myers Squibb; has received advisory board, funding paid to the institution from Spectranetics/Philips/Volcano Corp; spouse has received consultant fees from Abiomed and The Medicines Company; has equity <1% in Claret Medical and Elixir Medical; has received Data and Safety Monitoring Board Membership fees paid to the institution from Watermark Research Partners; has been a consultant (no fee) for Idorsia Pharmaceuticals Ltd. and Regeneron Pharmaceuticals; and is Associate Editor for the ACC and AMA. Dr. Mintz has received honoraria from Boston Scientific, Philips, Terumo, and Medtronic. Dr. Leon has received institutional grant support from Abbott, Boston Scientific, and Medtronic. Dr. Serruys is a consultant for Biosensors, Sinomed, Balton sp, Philips/Volcano, Xeltis, and HeartFlow. Dr. Smits has received institutional research grants from Abbott Vascular, Terumo, and St. Jude Medical; and has received speaking fees from Abbott Vascular, St. Jude Medical, and Terumo. Dr. von Birgelen has received institutional research grants from Abbott Vascular, Biotronik, Boston Scientific, and Medtronic. Dr. Ali has received institutional research grants to Columbia University from Abbott and Cardiovascular Systems; is a consultant to Abbott, Medtronic, Boston Scientific, Opsens, and AstraZeneca. Dr. Généreux has received speaking fees from Abbott Vascular, Edwards Lifesciences, Medtronic, Tryton Medical, Cardinal Health, and Cardiovascular Systems; has received consulting fees from Abbott Vascular, Boston Scientific, Cardiovascular Systems, and Pi-Cardia; has received an institutional research grant from Boston Scientific; and holds equity in SIG.NUM, SoundBite Medical Solutions, Saranas, and Pi-Cardia. Dr. Stone is a consultant to Shockwave. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
The authors attest they are in compliance with human studies committees and animal welfare regulations of the authors’ institutions and Food and Drug Administration guidelines, including patient consent where appropriate. For more information, visit the JACC: Cardiovascular Interventions author instructions page.
- Received January 31, 2020.
- Accepted March 17, 2020.
- 2020 American College of Cardiology Foundation
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