Comprehensive Meta-Analysis on Drug-Eluting Stents versus Bare-Metal Stents during Extended Follow-up
Abstract
Background
Several observational reports have documented both increased and decreased cardiac mortality or Q-wave myocardial infarction with drug-eluting stents compared with bare-metal stents.
Methods
We sought to evaluate the safety and efficacy of drug-eluting stents compared with bare-metal stents early after intervention (<1 year) and late (>1 year) among a broad population of patients, using a meta-analysis of randomized clinical trials.
Results
We identified 28 trials with a total of 10,727 patients and a mean follow-up of 29.6 months. For early outcomes (<1 year), all-cause mortality for drug-eluting stents versus bare-metal stents was 2.1% versus 2.4% (risk ratio [RR] 0.91, [95% confidence interval (CI), 0.70-1.18]; P=.47), non-Q-wave myocardial infarction was 3.3% versus 4.4% (RR 0.78 [95% CI, 0.61-1.00]; P=.055), target lesion revascularization was 5.8% versus 18.4% (RR 0.28 [95% CI, 0.21-0.38]; P <.001), and stent thrombosis was 1.1% versus 1.3% (RR 0.87 [95% CI, 0.60-1.26]; P=.47). For late outcomes (>1 year), all-cause mortality for drug-eluting stents versus bare-metal stents was 5.9% versus 5.7% (RR 1.03 [95% CI, 0.83-1.28]; P=.79), target lesion revascularization was 4.0% versus 3.3% (RR 1.22 [95% CI, 0.92-1.60]; P=.16), non-Q-wave myocardial infarction was 1.6% versus 1.2% (RR 1.36 [95% CI, 0.74-2.53]; P=.32) and stent thrombosis was 0.7% versus 0.1% (RR 4.57 [95% CI, 1.54-13.57]; P=.006).
Conclusions
There was no excess mortality with drug-eluting stents. Within 1 year, drug-eluting stents appear to be safe and efficacious with possibly decreased non-Q-wave myocardial infarction compared with bare-metal stents. After 1 year, drug-eluting stents still have similar mortality, despite increased stent thrombosis. The reduction in target lesion revascularization with drug-eluting stents mainly happens within 1 year, but is sustained thereafter.
aDepartment of Cardiovascular Medicine, University of Minnesota, Minneapolis
bDivision of Cardiovascular Medicine, University of Florida, Gainesville
cDepartment of Internal Medicine, Cleveland Clinic, Cleveland, Ohio
dDepartment of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
eCardiovascular Institute, Loyola University Medical Center, Maywood, Ill
fVA Boston Healthcare System and Brigham and Women's Hospital, Boston, Mass
Requests for reprints should be addressed to Deepak L. Bhatt, MD, MPH, VA Boston Healthcare System, Integrated Interventional Cardiovascular Program, Brigham and Women's Hospital and the VA Boston Healthcare System, TIMI Study Group, Harvard Medical School, 75 Francis St., PBB-146, Boston, MA, 02115
Funding: None.
Conflicts of interest: Dr. Deepak Bhatt discloses the following relationships: Research Grants (directly to the institution): Bristol Myers Squibb, Eisai, Ethicon, Heartscape, Sanofi Aventis, The Medicines Company; Honoraria (donated to non-profits for >2 years): Astra Zeneca, Bristol Myers Squibb, Centocor, Daiichi-Sankyo, Eisai, Eli Lilly, Glaxo Smith Kline, Millennium, Paringenix, PDL, Sanofi Aventis, Schering Plough, The Medicines Company, tns Healthcare; Speaker's bureau (>2 years ago): Bristol Myers Squibb, Sanofi Aventis, The Medicines Company; Consultant/Advisory Board (waived or donated to non-profits for >2 years): Arena, Astellas, Astra Zeneca, Bristol Myers Squibb, Cardax, Centocor, Cogentus, Daiichi-Sankyo, Eisai, Eli Lilly, Glaxo Smith Kline, Johnson & Johnson, McNeil, Medtronic, Millennium, Molecular Insights, Otsuka, Paringenix, PDL, Philips, Portola, Sanofi Aventis, Schering Plough, Scios, Takeda, The Medicines Company, tns Healthcare, Vertex; Expert testimony about clopidogrel (>2 years ago; the compensation was donated to a non-profit organization).
Dr. Anthony Bavry discloses the following relationships: Honoraria from Access Closure and Boston Scientific.
Authorship: All authors had access to the data and a role in writing.
ABSTRACT
