Drug-eluting or bare-metal stents forlarge coronary vessel stenting? The BASKET-PROVE (PROspective Validation Examination) trial: Study protocol and design

American Heart Journal

Volumn 155, Issue 4, 2008, Pages 609-614

  Pfisterer, Matthias ^a   Bertel, Osmund ^b   Bonetti, Piero O ^c   Brunner La Rocca, Hans Peter ^a   Eberli, Franz R ^d   Erne, Paul ^e   Galatius, Soeren ^f   Hornig, Burkhard ^g   Kiowski, Wolfgang ^b   Pachinger, Otmar ^h   Pedrazzini, Giovanni ⁱ   Rickli, Hans ^j   De Servi, Stefano ^k   Kaiser, Christoph ^a  

^a UNIVERSITY HOSPITAL BASEL   (Switzerland)

^b Im Park Hospital   (Switzerland)

^c State Hospital   (Switzerland)

^d TRIEMLI HOSPITAL   (Switzerland)

^e State Hospital Lucerne   (Switzerland)

^f GENTOFTE UNIVERSITY HOSPITAL   (Denmark)

^g St Claraspital AG   (Switzerland)

^h UNIVERSITY HOSPITAL INNSBRUCK   (Austria)

ⁱ REGIONAL HOSPITAL OF LUGANO   (Switzerland)

^j Children's Hospital St Gallen   (Switzerland)

^k Ospedale Civile   (Italy)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ACETYLSALICYLIC ACID; ANTITHROMBOCYTIC AGENT; CHROMIUM; CLOPIDOGREL; COBALT;

ADULT; AGED; ARTICLE; BLEEDING; CLINICAL TRIAL; COMORBIDITY; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CORONARY ARTERY DISEASE; CORONARY ARTERY THROMBOSIS; DRUG ELUTING STENT; FEMALE; FOLLOW UP; HEART DEATH; HEART INFARCTION; HUMAN; LOADING DRUG DOSE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; PERCUTANEOUS CORONARY INTERVENTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RESTENOSIS; RISK ASSESSMENT; STATISTICAL ANALYSIS;

ADULT; AGED; CLINICAL PROTOCOLS; CORONARY DISEASE; DRUG-ELUTING STENTS; FEMALE; FOLLOW-UP STUDIES; HUMANS; KAPLAN-MEIERS ESTIMATE; MALE; MIDDLE AGED; MYOCARDIAL INFARCTION; PROSPECTIVE STUDIES; RESEARCH DESIGN; SAMPLE SIZE; STENTS;

EID: 40849137844     PISSN: 00028703     EISSN: 10976744     Source Type: Journal    
DOI: 10.1016/j.ahj.2007.11.011     Document Type: Article

References (26)

1. Pfisterer M., Brunner-La Rocca H.P., Buser P.T., et al. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol 48 (2006) 2584-2591
2. Stone G.W., Moses J.W., Ellis S.G., et al. Safety and efficacy of sirolimus- and paclitaxel-eluting coronary stents. N Engl J Med 356 (2007) 998-1008
3. Kastrati A., Mehilli J., Pache J., et al. Analysis of 14 trials comparing sirolimus-eluting stents with bare-metal stents. N Engl J Med 356 (2007) 1030-1039
4. Lagerqvist B., James S.K., Stenestrand U., et al. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med 356 (2007) 1009-1019
5. Jensen L.O., Maeng M., Kaltoft P., et al. Stent thrombosis, myocardial infarction. J Am Coll Cardiol 50 (2007) 463-470
6. Cutlip D.E., Windecker S., Mehran R., et al. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 115 (2007) 2344-2351
7. Brunner La Rocca H.P., Kaiser C., Pfisterer M., et al. Targeted stent use in clinical practice based on evidence from the BAsel Stent Cost Effectiveness Trial (BASKET). Eur Heart J 28 (2007) 719-725
8. Ardissino D., Cavallini C., Bramucci E., et al. Sirolimus-eluting vs. uncoated stents for prevention of restenosis in small coronary arteries: a randomized trial. JAMA 292 (2004) 2727-2734
9. Lee C.W., Suh J., Lee S.W., et al. Factors predictive of cardiac events and restenosis after sirolimus-eluting stent implantation in small coronary arteries. Catheter Cardiovasc Interv 69 (2007) 821-825
10. Morice M.C., Serruys P.W., Sousa J.E., et al., RAVEL Study Group. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med 346 (2002) 1773-1780
11. Moses J.W., Leon M.B., Popma J.J., et al. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349 (2003) 1315-1323
12. Colombo A., Drzewiecki J., Banning A., et al. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation 108 (2003) 788-794
13. Stone G.W., Ellis S.G., Cannon L., et al. 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 294 (2005) 1215-1223
14. Babapulle M.N., Joseph L., Belisle P., et al. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 364 (2004) 583-591
15. Kaiser C., Brunner-La Rocca H.P., Buser P.T., et al. Incremental cost-effectiveness of drug-eluting stents compared with a third-generation bare-metal stent in a real-world setting: randomised Basel Stent Kosten Effektivitats Trial (BASKET). Lancet 366 (2005) 921-929
16. Stone G.W., Ellis S.G., Colombo A., et al. Offsetting impact of thrombosis and restenosis on the occurrence of death and myocardial infarction after paclitaxel-eluting and bare metal stent implantation. Circulation 115 (2007) 2842-2847
17. Beijk M.A., and Piek J.J. XIENCE V everolimus-eluting coronary stent system: a novel second generation drug-eluting stent. Expert Rev Med Devices 1 (2007) 11-22
18. Myocardial infarction redefined-a consensus document of The Joint European Society of Cardiology/American College of Cardiology Committee for the redefinition of myocardial infarction. Eur Heart J 21 (2000) 1502-1513
19. Anderson R., Cain K.C., and Gelber A.D. Analysis of survival by tumor response. J Clin Oncol 1 (1983) 710-719
20. Eisenstein E.L., Anstrom K.J., Kong F.D., et al. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA 297 (2007) 159-168
21. World Medical Association. Declaration of Helsinki: ethical principles for medical research involving human subjects. Available from:. http://www.wma.net/e/policy/b3.htm (accessed July 2007)
22. Stettler C., Wandel S., Allemann S., et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 370 (2007) 937-948
23. Tu J.V., Bowen J., Chiu M., et al. Effectiveness and safety of drug-eluting stents in Ontario. N Engl J Med 357 (2007) 1393-1402
24. Win H.K., Caldera A.E., Maresh K., et al. Clinical outcomes and stent thrombosis following off-label use of drug-eluting stents. JAMA 297 (2007) 2001-2009
25. Beohar N., Davidson C.J., Kip K.E., et al. Outcomes and complications associated with off-label and untested use of drug-eluting stents. JAMA 297 (2007) 1992-2000
26. Daemen J., and Serruys P.W. Drug-eluting stent update 2007: Part I. Survey of current and future generation drug-eluting stents: meaningful advances or more of the same?. Circulation 116 (2007) 326-328