Raffaele Piccolo, MD; Giuseppe Gargiulo, MD; Anna Franzone, MD; Andrea Santucci, MD; Sara Ariotti, MD; Andrea Baldo, MD; Carlo Tumscitz, MD; Aris Moschovitis, MD; Stephan Windecker, MD; Marco Valgimigli, MD, PhD
Acknowledgment: The authors thank Dik Heg, PhD, from the Institute of Social and Preventive Medicine and the Department of Clinical Research, Clinical Trials Unit Bern, for providing statistical support.
Disclosures: Dr. Piccolo reports a research grant from the Veronesi Foundation. Dr. Gargiulo reports research grant support from the CardioPath PhD program of Federico II University of Naples outside the submitted work. Dr. Windecker reports grants from Biotronik, Boston Scientific, Bracco Pharmaceuticals, Edwards Lifesciences, Medtronic, Terumo, and St. Jude Medical and personal fees from Boston Scientific and Daiichi Sankyo outside the submitted work. Dr. Valgimigli reports grants from Terumo Medical, AstraZeneca, and Medicure; personal fees from AstraZeneca, Bayer, and Terumo Medical; and lecture fees from AstraZeneca outside the submitted work. Authors not named here have disclosed no conflicts of interest. Disclosures can also be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=M16-2389.
Editors' Disclosures: Christine Laine, MD, MPH, Editor in Chief, reports that she has no financial relationships or interests to disclose. Darren B. Taichman, MD, PhD, Executive Deputy Editor, reports that he has no financial relationships or interests to disclose. Cynthia D. Mulrow, MD, MSc, Senior Deputy Editor, reports that she has no relationships or interests to disclose. Deborah Cotton, MD, MPH, Deputy Editor, reports that she has no financial relationships or interest to disclose. Jaya K. Rao, MD, MHS, Deputy Editor, reports that she has stock holdings/options in Eli Lilly and Pfizer. Sankey V. Williams, MD, Deputy Editor, reports that he has no financial relationships or interests to disclose. Catharine B. Stack, PhD, MS, Deputy Editor for Statistics, reports that she has stock holdings in Pfizer and Johnson & Johnson.
Reproducible Research Statement:Study protocol: Available from Dr. Valgimigli (e-mail, email@example.com). Statistical code: Available from Dr. Piccolo (e-mail, firstname.lastname@example.org). Data set: Not available.
Requests for Single Reprints: Marco Valgimigli, MD, PhD, Department of Cardiology, Bern University Hospital, University of Bern, Freiburgstrasse 4, 3010 Bern, Switzerland.
Current Author Addresses: Drs. Piccolo, Gargiulo, Franzone, Santucci, Ariotti, Baldo, Moschovitis, Windecker, and Valgimigli: Department of Cardiology, Bern University Hospital, University of Bern, Freiburgstrasse 4, 3010 Bern, Switzerland.
Dr. Tumscitz: Department of Cardiology, Ferrara University Hospital, Via Aldo Moro 8, 44100 Ferrara, Italy.
Author Contributions: Conception and design: R. Piccolo, A. Santucci, C. Tumscitz, M. Valgimigli.
Analysis and interpretation of the data: R. Piccolo, G. Gargiulo, M. Valgimigli.
Drafting of the article: R. Piccolo, A. Franzone, M. Valgimigli.
Critical revision of the article for important intellectual content: R. Piccolo, G. Gargiulo, S. Ariotti, A. Baldo, S. Windecker, M. Valgimigli.
Final approval of the article: R. Piccolo, G. Gargiulo, A. Franzone, A. Santucci, S. Ariotti, A. Baldo, C. Tumscitz, A. Moschovitis, S. Windecker, M. Valgimigli.
Statistical expertise: R. Piccolo.
Obtaining of funding: S. Windecker.
Administrative, technical, or logistic support: S. Windecker, M. Valgimigli.
Collection and assembly of data: G. Gargiulo, M. Valgimigli.
The dual-antiplatelet therapy (DAPT) score was developed to identify patients more likely to derive harm (score <2) or benefit (score ≥2) from prolonged DAPT after percutaneous coronary intervention (PCI).
To evaluate the safety and efficacy of DAPT duration according to DAPT score.
Retrospective assessment of DAPT score–guided treatment duration in a randomized clinical trial. (ClinicalTrials.gov: NCT00611286)
1970 patients undergoing PCI.
DAPT (aspirin and clopidogrel) for 24 versus 6 months.
Primary efficacy outcomes were death, myocardial infarction, or cerebrovascular accident. The primary safety outcome was type 3 or 5 bleeding according to the Bleeding Academic Research Consortium definition. Outcomes were assessed between 6 and 24 months.
884 patients (44.9%) had a DAPT score of at least 2, and 1086 (55.1%) had a score less than 2. The reduction in the primary efficacy outcome with 24- versus 6-month DAPT was greater in patients with high scores (risk difference [RD] for score ≥2, −2.05 percentage points [95% CI, −5.04 to 0.95 percentage points]; RD for score <2, 2.91 percentage points [CI, −0.43 to 6.25 percentage points]; P = 0.030). However, the difference by score for the primary efficacy outcome varied by stent type; prolonged DAPT with high scores was effective only in patients receiving paclitaxel-eluting stents (RD, −7.55 percentage points [CI, −12.85 to −2.25 percentage points]). The increase in the primary safety outcome with 24- versus 6-month DAPT was greater in patients with low scores (RD for score ≥2, 0.20 percentage point [CI, −1.20 to 1.60 percentage points]; RD for score <2, 2.58 percentage points [CI, 0.71 to 4.46 percentage points]; P = 0.046).
Retrospective calculation of the DAPT score.
Prolonged DAPT resulted in harm in patients with low DAPT scores undergoing PCI but reduced risk for ischemic events in patients with high scores receiving paclitaxel-eluting stents. Whether prolonged DAPT benefits patients with high scores treated with contemporary drug-eluting stents requires further study.
Piccolo R, Gargiulo G, Franzone A, et al. Use of the Dual-Antiplatelet Therapy Score to Guide Treatment Duration After Percutaneous Coronary Intervention. Ann Intern Med. 2017;167:17–25. [Epub ahead of print 13 June 2017]. doi: 10.7326/M16-2389
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Published: Ann Intern Med. 2017;167(1):17-25.
Published at www.annals.org on 13 June 2017
Cardiology, Coronary Heart Disease, Percutaneous Coronary Intervention.
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Print ISSN: 0003-4819 | Online ISSN: 1539-3704
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