Survival advantage in medicare patients receiving drug-eluting stents compared with bare metal stents: Real or artefactual?

Catheterization and Cardiovascular Interventions

Volumn 71, Issue 5, 2008, Pages 636-643

  Fen, Wei Wang ^a   Uretsky, Barry F ^a,d   Freeman, Jean L ^a,b   Zhang, Dong ^a   Giordano, Sharon H ^c   Goodwin, James S ^a,b  

^a University of Texas Medical Branch School of Medicine   (United States)

^b UNIVERSITY OF TEXAS MEDICAL BRANCH   (United States)

^c UNIVERSITY OF TEXAS MD ANDERSON CANCER CENTER   (United States)

^d NONE   (United States)

Author keywords

Coronary intervention; Drug eluting stents; Mortality; Observational data; Outcome

Indexed keywords

PACLITAXEL; RAPAMYCIN;

ADULT; AFRICAN AMERICAN; AGED; ANGIOGRAPHY; ARTERY DISEASE; ARTICLE; COMORBIDITY; CONTROLLED STUDY; DIABETES MELLITUS; DRUG ELUTING STENT; FEMALE; HEART FAILURE; HUMAN; MAJOR CLINICAL STUDY; MALE; MEDICARE; RESTENOSIS; REVASCULARIZATION; STENT; SURVIVAL RATE; THROMBOSIS;

AGED; AGED, 80 AND OVER; ANGIOPLASTY, TRANSLUMINAL, PERCUTANEOUS CORONARY; CARDIOVASCULAR AGENTS; CARDIOVASCULAR DISEASES; CORONARY ARTERY DISEASE; CORONARY RESTENOSIS; DRUG-ELUTING STENTS; FEMALE; HUMANS; KAPLAN-MEIERS ESTIMATE; MALE; MEDICARE; METALS; PROPORTIONAL HAZARDS MODELS; PROSTHESIS DESIGN; REPRODUCIBILITY OF RESULTS; RESEARCH DESIGN; RISK ASSESSMENT; SELECTION BIAS; SIROLIMUS; STENTS; TIME FACTORS; TREATMENT OUTCOME; UNITED STATES;

EID: 42249094732     PISSN: 15221946     EISSN: 1522726X     Source Type: Journal    
DOI: 10.1002/ccd.21417     Document Type: Article

References (29)

1. Tung R, Kaul S, Diamond GA, Shah PK. Narrative review: Drug-eluting stents for the management of restenosis: A critical appraisal of the evidence. Ann Intern Med 2006;144:913-919.
2. Rao SV, Shaw RE, Brindis RG, Klein LW, Weintraub WS, Krone RJ, Peterson ED. Patterns and outcomes of drug-eluting coronary stent use in clinical practice. Am Heart J 2006;152:321-326.
3. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R; RAVEL Study Group. Randomized study with the sirolimus-coated Bx Velocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346:1773-1780.
4. Holmes DR, Leon MB, Moses JW, Popma JJ, Cutlip D, Fitzgerald PJ, Brown C, Fischell T, Wong SC, Midei M, Snead D, Kuntz RE. Analysis of 1-year clinical outcomes in the SIRIUS trial - A randomized trial of a sirolimus-eluting stent versus a standard stent in patients at high risk for coronary restenosis. Circulation 2004;109:634-640.
5. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME; TAXUS-IV Investigators. One-year clinical results with the slow-release polymer-based, paclitaxel-eluting TAXUS stent. Circulation 2004;109:1942-1947.
6. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME, TAXUS V Investigators. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: A randomized controlled trial. JAMA 2005;294:1215-1223.
7. Win HK, Caldera AE, Maresh K, Lopez J, Rihal CS, Parikh MA, Granada JF, Marulkar S, Nassif D, Cohen DJ, Kleiman NS, Event Registry Invesigators. Clinical outcomes and stent thrombosis following off-label use of drug eluting stents. JAMA 2007;297:2001-2009.
8. Muni NI, Gross TP. Problems with drug-eluting coronary stents - The FDA perspective. N Engl J Med 2004;351:1593-1595.
9. Shuchman M. Trading restenosis for thrombosis'? New questions about drug-eluting stents. N Engl J Med 2006;355:1949-1952.
10. Maisel WH. Unanswered questions - Drug-eluting stents and the risk of late thrombosis. N Engl J Med 2007;356:981-984.
11. Malenka DJ, Kaplan AV, Sharp SM, Wennberg JE. Postmarketing surveillance of medical devices using Medicare claims. Health Aff (Millwood) 2005;24:928-937.
12. Singh M, Rihal CS, Lennon RJ, Garratt KN, Holmes DR Jr. A critical appraisal of current models of risk stratification for percutaneous coronary interventions. Am Heart J 2005;149:753-760.
13. D'Agostinom RB Jr. Propensity score methods for bias reduction in comparison of a treatment to a non-randomized control group. Stat Med 1998;17:2265-2281.
14. Greenland S. Basic methods for sensitivity analysis and external adjustment. In: Rothman KJ, Greenland S, editors. Modern Epidemiology, 2nd ed. Philadephia: Lippincott-Raven; 1998. pp 343-357.
15. Du XL, Key CR, Osborne C, Mahnken JD, Goodwin JS. Discrepancy between consensus recommendations and actual community use of adjuvant chemotherapy in women with breast cancer. Ann Intern Med 2003;138:90-97.
16. Williams DO, Abbott DA, Kip KE. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents report of the DEScover registry. Circulation 2006;114:2154-2162.
17. Applegate RJ, Sacrinty MT, Kutcher MA, Baki TT, Gandhi SK, Santos RM, Little WC. Comparison of drug-eluting versus bare metal stents on later frequency of acute myocardial infarction and death. Am J Cardiol 2007;99:333-338.
18. Kastrati A, Mehilli J, Pache J, Kaiser C, Valgimigli M, Kelbæk H, Menichelli M, Sabaté M, Suttorp M, Baumgart D, Seyfarth M, Pfisterer M, Schömig A. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 2007;356:1030-1039.
19. Jensen LO, Maeng M, Kaltoft A, Thayssen P, Hansen HHT, Bottcher M, Lassen JF, Krussel LR, Rasmussen K, Hansen KN, Pedersen L, John SP, Soerensen HF, Thuesen L. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions. J Am Coll Cardiol 2007;50:463-470.
20. Lagerqvist B, James SK, Stenestrand U, Lindbäck J, Nilsson T, Wallentin L. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 2007;356:1009-1019.
21. James S, Carlsson J, Lindback J, Nilsson T, Stenestrand U, Wallentin L, Lagerqvist B for the SCAAR Study Group. Long-term outcome with drug eluting stents vs. bare metal stents in Sweden-one additional year of follow-up. Presented at the European Society of Cardiology, Vienna, Austria, September 3, 2007. Reported on mgibson@clinicaltrialresults.org, Sept 4. 2007.
22. Iakovou I, Schmidt T, Bonizonni F, Sangiogi G, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Brigouri C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA 2005;293:2126-2130.
23. Babapulle MN, Joseph L, Belisle P, Brophy JM, Eisenberg MJ. A hierarchical Bayesian meta-analysis of randomized clinical trials of drug-eluting stents. Lancet 2004;364:583-591.
24. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized controlled trials comparing drug-eluting vs. bare metal stents in coronary artery disease: A meta-analysis. Eur Heart J 2006;27:2784-2814.
25. Stukel TA, Fisher ES, Wennberg DE, Alter DA, Gottlieb DJ, Vermeulen MJ. Analysis of observational studies in the presence of treatment selection bias: Effects of invasive cardiac management on AMI survival using propensity score and instrumental variable methods. JAMA 2007;297:278-285.
26. Grodstein F, Stampfer MJ, Manson JE, Colditz GA, Willett WC, Rosner B, Speizer FE, Hennekens CH. Postmenopausal estrogen and progestin use and the risk of cardiovascular disease. N Engl J Med 1996;335:453-461.
27. Hulley S, Grady D, Bush T, Furberg C, Herrington D, Riggs B, Vittinghoff E. Randomized trial of estrogen plus progestin for secondary prevention of coronary heart disease in postmenopausal women. JAMA 1998;280:605-613.
28. The Heart Outcomes Prevention Evaluation Study investigators. Vitamin E supplementation and cardiovascular events in high-risk patients. N Engl J Medm 2002;342:154-160.
29. Omenn GS, Goodman GE, Thornquist MD, Balmes J, Cullen MR, Glass A, Keogh JP, Meyskens FL, Valants B, Williams JH, Barnhart S, Hammar S. Effects of a combination of beta carotene and vitamin A on lung cancer and cardiovascular disease. N Engl J Med 1996;334:1150-1155.