Coronary stenting procedures are among the most common procedures in the United States, with an estimated 1.13 million percutaneous coronary interventions (PCIs) in 2009, the vast majority of which are performed with coronary stents. They also consume a substantial portion of our country's health expenditures, with an estimated $68 billion for hospital charges for PCI procedures. Initially, these procedures were performed using only balloon angioplasty, then primarily with bare-metal stents (BMS), and now drug-eluting stents (DES) are by far the most common type of PCI being used. The newest (second) generation of DES was introduced in 02/08, and includes everolimus-eluting stents (EES) and zotarolimus-eluting stents (ZES). Because there are different types of stents, decisions must be made about which one to use for whom. But, it is not clear which stents are best for patients, particularly given that their high initial cost. Although there have been many randomized controlled trials and several observational studies that have examined coronary stent outcomes, such studies have usually been limited with regard to the length of their follow-up and their ability to examine relative outcomes for numerous high-risk subgroups of patients. Some of the important gaps in knowledge in contemporary practice of coronary stenting include: (1) few studies on longer-term outcomes of DES and BMS, (2) few studies on relative longer-term outcomes of different types of second generation DES, (3) scarcity of studies on relative longer-term outcomes for select groups of patients, including off-label and high-risk patient groups, and (4) scarcity of studies comparing different types of stents for patients who are appropriate for PCI. The objectives of our study are to compare longer-term mortality, myocardial infarction, and subsequent revascularization (PCI or coronary artery bypass graft surgery) for different pairs of coronary stents including BMS and the two generations of DES. For each pair of stents, we will (1) examine relative differences in long- term mortality, myocardial infarction, and subsequent revascularization between patients receiving each of the 2 stents. We will also analyze these comparative outcomes for several types of off-label uses of DES and high-risk patients so that care can be tailored to patients'specific profiles. All studies will also be repeated after limiting patients to those who are deemed appropriate for stenting by the American College of Cardiology/American Heart Association. The findings of the study will have direct impact on medical professionals who manage coronary artery disease and patients who need coronary stents. In particular, the information will enable referring physicians to customize their decisions based on patients'demographic and clinical profiles.

Public Health Relevance

The purposes of this project are to compare longer-term outcomes (mortality, myocardial infarction, and subsequent percutaneous coronary interventions or coronary artery bypass graft surgery) for different types and different generations of coronary stents used for patients with severe coronary artery disease. These comparisons will be made for all patients receiving stents as well as for off-label/high-risk subgroups of patients, and the subset of patients deemed to be appropriate for stenting by the American College of CardiologyAmerican Heart Association.

Agency
National Institute of Health (NIH)
Institute
Agency for Healthcare Research and Quality (AHRQ)
Type
Research Project (R01)
Project #
5R01HS022289-02
Application #
8710024
Study Section
Health Care Quality and Effectiveness Research (HQER)
Program Officer
Zhan, Chunliu
Project Start
2013-08-01
Project End
2016-05-31
Budget Start
2014-06-01
Budget End
2015-05-31
Support Year
2
Fiscal Year
2014
Total Cost
Indirect Cost
Name
State University of New York at Albany
Department
Public Health & Prev Medicine
Type
Schools of Public Health
DUNS #
152652822
City
Albany
State
NY
Country
United States
Zip Code
12222