Everolimus-eluting versus paclitaxel-eluting stents in coronary artery disease
Gregg W Stone, Ali Rizvi, William Newman, Kourosh Mastali, John C Wang, Ronald Caputo, Julie Doostzadeh, Sherry Cao, Charles A Simonton, Krishnankutty Sudhir, Alexandra J Lansky, Donald E Cutlip, Dean J Kereiakes, SPIRIT IV Investigators, G W Stone, A J Lansky, D E Cutlip, G Johnson, S Fink, G W Stone, K Sudhir, T Engels, W Pierson, J Doostzadeh, L Jonnvithula, J Coe, B Nishimoto, M Harvill, T Lucente, P Patel, M Plaunt, M Mirgoli, X Su, D E Cutlip, A J Lansky, E Cristea, R Piana, D Rizik, J Saczyinski, D Mego, M Ashcraft, M Buchbinder, J Logan, R Fortuna, S Weaver, D Shavelle, C Mayoralago, M Chang, S Bordash, P Coleman, J Willson, J Greenberg, S West, A Doing, S Kaczkowski, L Satler, D Sawyer, F Fleischhauer, J Lehman, S Culp, J Kelley, J Hermiller, A Rizvi, L Burkert, S Gallagher, S Shaikh, D Richardson, M Tannenbaum, C Noyes, M Wiley, C Jones, J McClaymont, W Skinner, J Hamilton, N Xenopoulos, P Adkisson, M Kellett, J Burgess, J Resar, K Citro, J Wang, J Raqueno, S Hearne, K Fiddler, M Turco, K Gray, K Mastali, E Shlian, L Mauri, A Connors, E Ramsaran, P Siegel, D Fisher, S Ball, W Felten, D Lee, V Blitzer, S Dabbous, J Gugudis, D Wohns, K Postema, T Fischell, S Wilson, C D'Haem, T Zambon, L Cannon, J LaLonde, E Hockstad, P Wyman, J Grantham, R Gans, J Maddux, B Krininger, D Netz, C Godfrey, A Kaplan, L Martel, C Hirsch, C Kunz, A Masud, L Delzoppo, R Caputo, J Riley, M Collins, A Hill-Boyd, M Kamanda-Kosseh, S Wong, D Reynolds, L Gruberg, J Kidd, J Williams, B Carroll, A Maganares, W Tan, D Bembridge, J Harris, W Newman, S Darden, J Patterson, B Coleman, R Applegate, T Young, D Kereiakes, D White, S Yakubov, G Robb, T Terry, N Farhat, A Giunta, T Caulfield, E Johnson, K Skelding, A Temple, A Smith, L Baxendell, P Gordon, L DeSimone, D Williams, J Muratori, C Nielsen, C Vaughn, P Hall, T Gonter, J Sheriod-Scott, J Cebe, S Harrelson, J McPherson, L Blair-Anton, L Walder, S Williams, B Raybuck, M Dang, D Eich, C Zulick, H Dauerman, F Straight, P Bernstein, S Oxborough, Gregg W Stone, Ali Rizvi, William Newman, Kourosh Mastali, John C Wang, Ronald Caputo, Julie Doostzadeh, Sherry Cao, Charles A Simonton, Krishnankutty Sudhir, Alexandra J Lansky, Donald E Cutlip, Dean J Kereiakes, SPIRIT IV Investigators, G W Stone, A J Lansky, D E Cutlip, G Johnson, S Fink, G W Stone, K Sudhir, T Engels, W Pierson, J Doostzadeh, L Jonnvithula, J Coe, B Nishimoto, M Harvill, T Lucente, P Patel, M Plaunt, M Mirgoli, X Su, D E Cutlip, A J Lansky, E Cristea, R Piana, D Rizik, J Saczyinski, D Mego, M Ashcraft, M Buchbinder, J Logan, R Fortuna, S Weaver, D Shavelle, C Mayoralago, M Chang, S Bordash, P Coleman, J Willson, J Greenberg, S West, A Doing, S Kaczkowski, L Satler, D Sawyer, F Fleischhauer, J Lehman, S Culp, J Kelley, J Hermiller, A Rizvi, L Burkert, S Gallagher, S Shaikh, D Richardson, M Tannenbaum, C Noyes, M Wiley, C Jones, J McClaymont, W Skinner, J Hamilton, N Xenopoulos, P Adkisson, M Kellett, J Burgess, J Resar, K Citro, J Wang, J Raqueno, S Hearne, K Fiddler, M Turco, K Gray, K Mastali, E Shlian, L Mauri, A Connors, E Ramsaran, P Siegel, D Fisher, S Ball, W Felten, D Lee, V Blitzer, S Dabbous, J Gugudis, D Wohns, K Postema, T Fischell, S Wilson, C D'Haem, T Zambon, L Cannon, J LaLonde, E Hockstad, P Wyman, J Grantham, R Gans, J Maddux, B Krininger, D Netz, C Godfrey, A Kaplan, L Martel, C Hirsch, C Kunz, A Masud, L Delzoppo, R Caputo, J Riley, M Collins, A Hill-Boyd, M Kamanda-Kosseh, S Wong, D Reynolds, L Gruberg, J Kidd, J Williams, B Carroll, A Maganares, W Tan, D Bembridge, J Harris, W Newman, S Darden, J Patterson, B Coleman, R Applegate, T Young, D Kereiakes, D White, S Yakubov, G Robb, T Terry, N Farhat, A Giunta, T Caulfield, E Johnson, K Skelding, A Temple, A Smith, L Baxendell, P Gordon, L DeSimone, D Williams, J Muratori, C Nielsen, C Vaughn, P Hall, T Gonter, J Sheriod-Scott, J Cebe, S Harrelson, J McPherson, L Blair-Anton, L Walder, S Williams, B Raybuck, M Dang, D Eich, C Zulick, H Dauerman, F Straight, P Bernstein, S Oxborough
Abstract
Background: Previous studies have established the superiority of coronary everolimus-eluting stents over paclitaxel-eluting stents with respect to angiographic findings. However, these trials were not powered for superiority in clinical end points.
Methods: We randomly assigned 3687 patients at 66 U.S. sites to receive everolimus-eluting stents or paclitaxel-eluting stents without routine follow-up angiography. The primary end point was the 1-year composite rate of target-lesion failure (defined as cardiac death, target-vessel myocardial infarction, or ischemia-driven target-lesion revascularization).
Results: Everolimus-eluting stents were superior to paclitaxel-eluting stents with respect to the primary end point of target-lesion failure (4.2% vs. 6.8%; relative risk, 0.62; 95% confidence interval, 0.46 to 0.82; P=0.001). Everolimus-eluting stents were also superior with respect to the major secondary end point of the 1-year rate of ischemia-driven target-lesion revascularization (P=0.001) and were noninferior with respect to the major secondary end point of the 1-year composite rate of cardiac death or target-vessel myocardial infarction (P<0.001 for noninferiority; P=0.09 for superiority). The 1-year rates of myocardial infarction and stent thrombosis were also lower with everolimus-eluting stents than with paclitaxel-eluting stents (1.9% vs. 3.1%, P=0.02 for myocardial infarction; 0.17% vs. 0.85%, P=0.004 for stent thrombosis). Target-lesion failure was consistently reduced with everolimus-eluting stents as compared with paclitaxel-eluting stents in 12 prespecified subgroups, except in the subgroup of patients with diabetes (6.4% vs. 6.9%, P=0.80).
Conclusions: Everolimus-eluting stents, as compared with paclitaxel-eluting stents, resulted in reduced rates of target-lesion failure at 1 year, results that were consistent in all patients except those with diabetes, in whom the results were nonsignificantly different. (ClinicalTrials.gov number, NCT00307047.)
2010 Massachusetts Medical Society
Source: PubMed