Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry
Robert W Yeh, Matthew J Czarny, Sharon-Lise T Normand, Dean J Kereiakes, David R Holmes Jr, Ralph G Brindis, W Douglas Weaver, John S Rumsfeld, Matthew T Roe, Sunghee Kim, Priscilla Driscoll-Shempp, Laura Mauri, Robert W Yeh, Matthew J Czarny, Sharon-Lise T Normand, Dean J Kereiakes, David R Holmes Jr, Ralph G Brindis, W Douglas Weaver, John S Rumsfeld, Matthew T Roe, Sunghee Kim, Priscilla Driscoll-Shempp, Laura Mauri
Abstract
Background: The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed.
Methods and results: Within the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2% versus 42.6%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease.
Conclusions: Within the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained.
Clinical trial registration url: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.
Keywords: clinical trial; coronary disease; methods; stents.
Conflict of interest statement
Disclosures
Dr. Yeh receives funding from the Harvard Clinical Research Institute
Dr. Czarny has no disclosures or conflicts of interest to report.
Dr. Normand is the Director of the Massachusetts Data Analysis Center, contracted by the Massachusetts Department of Public Health, and is funded to collect, validate, analyze, and disseminate evidence of quality of cardiovascular care at acute care non-federal hospitals in Massachusetts.
Dr. Kereiakes has the following disclosures: Consulting fees: Modest: Harvard Clinical Research Institute; Significant: Boston Scientific, Abbott Vascular
Dr. Holmes has no disclosures or conflicts of interest to report.
Dr. Brindis is Senior Medical Officer, External Affairs of the National Cardiovascular Data Registry
Dr. Weaver has the following disclosures: Consulting for Data Safety and Monitoring Committees for Boston Scientific Corporation and for Biotronik Corporation.
Dr. Rumsfeld is Chief Scientific Officer for the National Cardiovascular Data Registry.
Dr. Roe has the following disclosures: Research funding: Eli Lilly, Revalesio, Sanofi-Aventis, American College of Cardiology, American Heart Association, Familial Hypercholesterolemia Foundation; consulting or honoraria: Astra Zeneca, Sanofi-Aventis, Janssen Pharmaceuticals, Merck, Regeneron, and Daiichi-Sankyo. All conflicts of interest are listed at www.dcri.org.
Ms. Lee has no disclosures.
Ms. Driscoll-Shempp is an employee of the Harvard Clinical Research Institute.
Dr. Mauri receives institutional research support from Abbott, Boston Scientific, Cordis, Medtronic, Eli Lilly, Daiichi Sankyo, Bristol Myers Squibb, Sanofi-Aventis; and has consulted for Cordis, Medtronic, Boston Scientific and Biotronik.
© 2014 American Heart Association, Inc.
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Source: PubMed