Paclitaxel-eluting stents versus bare-metal stents in acute myocardial infarction
Gregg W Stone, Alexandra J Lansky, Stuart J Pocock, Bernard J Gersh, George Dangas, S Chiu Wong, Bernhard Witzenbichler, Giulio Guagliumi, Jan Z Peruga, Bruce R Brodie, Dariusz Dudek, Martin Möckel, Andrzej Ochala, Alison Kellock, Helen Parise, Roxana Mehran, HORIZONS-AMI Trial Investigators, G W Stone, B R Brodie, D A Cox, C L Grines, B D Rutherford, D Bhatt, G Dangas, F Feit, M Ohman, H Bonnier, A Colombo, E Garcia, E Grube, G Guagliumi, A Kastrati, P Serruys, H Suryapranata, H Bonnier, H Suryapranata, A Colombo, G Guagliumi, E Garcia, E Grube, A Kastrati, Y Almagor, A Banning, J Belardi, L Grinfeld, D Dudek, K Huber, D Nilsen, G Olivecrona, L Rasmussen, S C Wong, M Farkouh, M Attubato, G Dangas, F Feit, R Mehran, D Winsted, R Mehran, L Gambone, I Bihl, H Parise, B J Gersh, D Faxon, S King, S J Pocock, D O Williams, A J Lansky, E Cristea, J Reiffel, G Mintz, Oscar A Mendiz, Jose Amadeo Alvarez, Jose Alvarez, Diego David Grinfeld, Miguel Angel Riccitelli, Daniel Berrocal, Jorge Belardi, Anibal Agustin Damonte, Guillermo Cugat, A Rodriguez, Ernesto M Torresani, Hugo F Londero, Dietmar Glogar, Kurt Huber, George Gaul, Johann Altenberger, Othmar Pachinger, Hans-Georg Olbrich, Bernhard Witzenbichler, Martin Moeckel, Wolfgang Rutsch, Eberhard Grube, Gert Richardt, Klaus Pethig, Martin Desaga, Gerald Werner, Johannes Brachmann, Helmut Kuecherer, Rainer Hoffmann, Franz Hartmann, Stefan Willems, Jochen Wöhrle, Adnan Kastrati, Ricardo Krakover, Uri Rosenschein, Basil S Lewis, Morris Mosseri, Ran Petach-Tikva Kornowski, Luis Gruberg, Yaron Almagor, Victor Guetta, Ariel Finkelstein, Yoseph Rozenman, Giulio Guagliumi, Antonio Colombo, Hans Bonnier, Harry Suryapranata, Peter Smits, Jan Erik Nordrehaug, Dennis Nilsen, Witold Ruzyllo, Adam Witkowski, Dariusz Dudek, Andrzej Rynkiewicz, Jan Z Peruga, Andrzej Ochala, Krzysztof Zmudka, Robert Gil, Pascual Bordes, Adrian Banning, Daniel Blackman, Magdi El-Omar, Adam De Belder, Ever Grech, Bernard Prendergast, Sarah Johnson, Brent McLaurin, Tommy Lee, Duane S Pinto, Joe Choo, Ronald Karlsberg, Louis A Cannon, Trilok Sharma, James Ritter, Leroy Rabbani, Pierre P Leimgruber, Ofsman Quintana, Joseph McGarvey Jr, Oscar Aguilar, Henry Liberman, Jim Blankenship, Ali Razavi, Rajesh Dave, John Rashid, Joseph F Stella, Edmund Finkinski, Matthew Bach, Bruce Brodie, Mirle A Kellett Jr, Ofsman Quintana, Ron Waksman, Robert Iwaoka, Gregory M Eaton, Keith Atassi, Michael Attubato, Raj Chandwaney, Bradley Evans, Oscar Aguilar, Henry Lui, David Rizik, David Rizik, John Griffin, Jason O Hall, Michael C Foster, Jorge A Hernandez, Noel Camba, Thomas LaLonde, Mahesh Bikkina, Barry Rutherford, Vibhuti Singh, John McPherson, Richard B Zelman, James B Hermiller, Kenneth S Korr, Christopher Metzger, Paul Gordon, Cary Hirsch, Venkatraman Srinivasan, Kalim Habet, Mark A Turco, Douglas Ebersole, Cindy L Grines, Gregg W Stone, Alexandra J Lansky, Stuart J Pocock, Bernard J Gersh, George Dangas, S Chiu Wong, Bernhard Witzenbichler, Giulio Guagliumi, Jan Z Peruga, Bruce R Brodie, Dariusz Dudek, Martin Möckel, Andrzej Ochala, Alison Kellock, Helen Parise, Roxana Mehran, HORIZONS-AMI Trial Investigators, G W Stone, B R Brodie, D A Cox, C L Grines, B D Rutherford, D Bhatt, G Dangas, F Feit, M Ohman, H Bonnier, A Colombo, E Garcia, E Grube, G Guagliumi, A Kastrati, P Serruys, H Suryapranata, H Bonnier, H Suryapranata, A Colombo, G Guagliumi, E Garcia, E Grube, A Kastrati, Y Almagor, A Banning, J Belardi, L Grinfeld, D Dudek, K Huber, D Nilsen, G Olivecrona, L Rasmussen, S C Wong, M Farkouh, M Attubato, G Dangas, F Feit, R Mehran, D Winsted, R Mehran, L Gambone, I Bihl, H Parise, B J Gersh, D Faxon, S King, S J Pocock, D O Williams, A J Lansky, E Cristea, J Reiffel, G Mintz, Oscar A Mendiz, Jose Amadeo Alvarez, Jose Alvarez, Diego David Grinfeld, Miguel Angel Riccitelli, Daniel Berrocal, Jorge Belardi, Anibal Agustin Damonte, Guillermo Cugat, A Rodriguez, Ernesto M Torresani, Hugo F Londero, Dietmar Glogar, Kurt Huber, George Gaul, Johann Altenberger, Othmar Pachinger, Hans-Georg Olbrich, Bernhard Witzenbichler, Martin Moeckel, Wolfgang Rutsch, Eberhard Grube, Gert Richardt, Klaus Pethig, Martin Desaga, Gerald Werner, Johannes Brachmann, Helmut Kuecherer, Rainer Hoffmann, Franz Hartmann, Stefan Willems, Jochen Wöhrle, Adnan Kastrati, Ricardo Krakover, Uri Rosenschein, Basil S Lewis, Morris Mosseri, Ran Petach-Tikva Kornowski, Luis Gruberg, Yaron Almagor, Victor Guetta, Ariel Finkelstein, Yoseph Rozenman, Giulio Guagliumi, Antonio Colombo, Hans Bonnier, Harry Suryapranata, Peter Smits, Jan Erik Nordrehaug, Dennis Nilsen, Witold Ruzyllo, Adam Witkowski, Dariusz Dudek, Andrzej Rynkiewicz, Jan Z Peruga, Andrzej Ochala, Krzysztof Zmudka, Robert Gil, Pascual Bordes, Adrian Banning, Daniel Blackman, Magdi El-Omar, Adam De Belder, Ever Grech, Bernard Prendergast, Sarah Johnson, Brent McLaurin, Tommy Lee, Duane S Pinto, Joe Choo, Ronald Karlsberg, Louis A Cannon, Trilok Sharma, James Ritter, Leroy Rabbani, Pierre P Leimgruber, Ofsman Quintana, Joseph McGarvey Jr, Oscar Aguilar, Henry Liberman, Jim Blankenship, Ali Razavi, Rajesh Dave, John Rashid, Joseph F Stella, Edmund Finkinski, Matthew Bach, Bruce Brodie, Mirle A Kellett Jr, Ofsman Quintana, Ron Waksman, Robert Iwaoka, Gregory M Eaton, Keith Atassi, Michael Attubato, Raj Chandwaney, Bradley Evans, Oscar Aguilar, Henry Lui, David Rizik, David Rizik, John Griffin, Jason O Hall, Michael C Foster, Jorge A Hernandez, Noel Camba, Thomas LaLonde, Mahesh Bikkina, Barry Rutherford, Vibhuti Singh, John McPherson, Richard B Zelman, James B Hermiller, Kenneth S Korr, Christopher Metzger, Paul Gordon, Cary Hirsch, Venkatraman Srinivasan, Kalim Habet, Mark A Turco, Douglas Ebersole, Cindy L Grines
Abstract
Background: There is no consensus regarding the safety and efficacy of drug-eluting stents, as compared with bare-metal stents, in patients with ST-segment elevation myocardial infarction who are undergoing primary percutaneous coronary intervention (PCI).
Methods: We randomly assigned, in a 3:1 ratio, 3006 patients presenting with ST-segment elevation myocardial infarction to receive paclitaxel-eluting stents (2257 patients) or otherwise identical bare-metal stents (749 patients). The two primary end points of the study were the 12-month rates of target-lesion revascularization for ischemia (analysis powered for superiority) and a composite safety outcome measure of death, reinfarction, stroke, or stent thrombosis (powered for noninferiority with a 3.0% margin). The major secondary end point was angiographic evidence of restenosis at 13 months.
Results: Patients who received paclitaxel-eluting stents, as compared with those who received bare-metal stents, had significantly lower 12-month rates of ischemia-driven target-lesion revascularization (4.5% vs. 7.5%; hazard ratio, 0.59; 95% confidence interval [CI], 0.43 to 0.83; P=0.002) and target-vessel revascularization (5.8% vs. 8.7%; hazard ratio, 0.65; 95% CI, 0.48 to 0.89; P=0.006), with noninferior rates of the composite safety end point (8.1% vs. 8.0%; hazard ratio, 1.02; 95% CI, 0.76 to 1.36; absolute difference, 0.1 percentage point; 95% CI, -2.1 to 2.4; P=0.01 for noninferiority; P=0.92 for superiority). Patients treated with paclitaxel-eluting stents and those treated with bare-metal stents had similar 12-month rates of death (3.5% and 3.5%, respectively; P=0.98) and stent thrombosis (3.2% and 3.4%, respectively; P=0.77). The 13-month rate of binary restenosis was significantly lower with paclitaxel-eluting stents than with bare-metal stents (10.0% vs. 22.9%; hazard ratio, 0.44; 95% CI, 0.33 to 0.57; P<0.001).
Conclusions: In patients with ST-segment elevation myocardial infarction who were undergoing primary PCI, implantation of paclitaxel-eluting stents, as compared with bare-metal stents, significantly reduced angiographic evidence of restenosis and recurrent ischemia necessitating repeat revascularization procedures. No safety concerns were apparent at 1 year. (ClinicalTrials.gov number, NCT00433966.)
2009 Massachusetts Medical Society
Source: PubMed