A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial
Gregg W Stone, Paul S Teirstein, Ian T Meredith, Bruno Farah, Christophe L Dubois, Robert L Feldman, Joseph Dens, Nobuhisa Hagiwara, Dominic J Allocco, Keith D Dawkins, PLATINUM Trial Investigators, Bruno Farah, Frederic Petit, Christophe Dubois, Gina van Oosterwijck, Robert Feldman, Deb McIntyre, Joseph Dens, Caroline Swijsen, Alain Bouchard, Wesley Wade, Didier Carrié, Jacqueline Cahuzac, Helge Moellmann, Cornelia Kisselbach, Keith Oldroyd, Joanne Kelly, Jack Hall, Marylynn Burkert, Robert Stoler, Lucy Kang, Nobuhisa Hagiwara, Miyoko Naganuma, Abram Rabinowitz, Susan Meier, Ameer Kabour, Michelle Hickam, Vincent Pompili, Luba Mazanec, Thomas Stuckey, Donna Ricks, Nicholas Curzen, Zoe Nicholas, Gregory Mishkel, Jennifer Jones, Robin Swinford, Andrejs Erglis, Alona Grave, Shigeru Saito, Izumi Kobayashi, Gilles Levy, Chrystel Leperchois, François Schiele, Gerald Sergent, Thomas Downes, Scott Kaczkowski, Dean Kereiakes, Ersela McGary, Tift Mann, Sarah Mulkey, Maurice Buchbinder, Heather Nielsen, Ryuta Asano, Tomoko Tajima, Michael Foster, Jacqueline Sheriod-Scott, Dariusz Dudek, Elzbieta Kolny, Henry Lui, Pam Gibbons, Paul Vermeersch, Nancy Aerts, Robert Whitbourn, John Gough, Jenny Wilson, Michael Mooney, Holly MacDonald, Andrew Taussig, Delores Barnes, Mark Dorogy, Carrie Knott, Matti Niemelä, Eija Niemelae, Paul Teirstein, Divina Fanning, Sven Moebius-Winkler, Carola Doehnert, Hans Bauer, Donna Palazzo, Michael Ring, Sharon Fulton, Jacek Kubica, Louis Cannon, Jennifer LaLonde, Timothy Grady, Jeff Kaliebe, Tommy Lee, Jenny Marsh, Jacques Koolen, Linda van Leur, John Radcliffe, Adrian Banning, Bernadette Moreby, Carey Kimmelstiel, Vilma Castaneda, Gert Richardt, Daniela Schuermann-Kuchenbrandt, Mirle Kellett, Claire Berg, Joseph Burchenal, Wayne Batchelor, Patty Knap, Barry Bertolet, Terri Tutor, Mary Soltau, Amish Desai, Lauren Braam, Juhani Airaksinen, Tuija Vasankari, Keiichi Igarashi, Yukiko Oshima, Jeffrey Breall, Judy Foltz, Toshiya Muramatsu, Yoshie Kanbe, Junji Yajima, Kazumi Matsuda, Roger Gammon, Mary Robison, Thomas Hovasse, Marion Baudry, Emerson Perin, Gilberto DeFreitas, Reginald Low, Janine Carlson, Warwick Jaffe, Mary-Anne Lindesay, Ian Summerscales, Philip Huber, Jillian Ciccarello, Mark De Belder, Gill Smith, Hiroyoshi Yokoi, Keiko Inoue, Joseph Kozina, Christie Hogan, Krzysztof Reczuch, Ian Meredith, Mauro Baldi, Julie Plunkett, Thomas McGarry, Stacie Hanes, Henning Kelbaek, Lene Kloevgaard, Maarten Suttorp, Conny Maarten, Yves Taeymans, Patrick Verdegem, Michael Laule, Claudia Kuhn, Mark Turco, Denise Pond, Magdi Ghali, Heather Barnes, Steven Martin, Corey Godfrey, Todd Caulfield, Ellen Muir, Masato Nakamura, Yoshiko Mori, Michael Kutcher, Teresa Young, Thomas Neunteufl, Markus Vertesich, David Mego, Melody Thomas, Adam Witkowski, Kui Hian Sim, Danny Day Dudu, Leif Thuesen, Lars Joergensen, Jeroen Vos, Monique de Craen-de Moor, Jeffrey Moses, John Kim, Charles O'Shaughnessy, Amy Walton, Gurpreet Sandhu, Rebekah Herrmann, Kenshi Fujii, Motoko Uehara, Alan Zajarias, Michelle Myers, Scott Harding, Diane Middleditch, Akil Loli, Hope Mangum, Sanford Gips, Nancy Markiewicz, David Dobies, Sandra Watt, Steven Burstein, Cecile Mayoralgo, Martyn Thomas, Karen Wilson, Ian Gilchrist, Patricia Frey, Charles Barth 3rd, Cheryl Rutherford, Paul Mahoney, Melinda Bullivant, Darren Walters, Lee Clement, David Wolford, Dogan Temizer, Deborah Kathman, Thomas Nygaard, Wyvonia Harris, Joyce White, Sean Janzer, Catherine Pensyl, Johannes de Swart, Yvonne van der Meij, Aaron Wong, Ding Ying Law, Rajesh Dave, Stephanie McMullen, Ehtisham Mahmud, Cecilia Judd, Marc Schweiger, Judy Fleurent, Marcus Wiemer, Carola Pape, Alan Niederman, Sandra Vujanic, Robaayah Zambahari, Sabian Intan Safarinaz, Nicholaos Xenopoulos, Nancy McDonald, A R Zaki Masud, Theresa Giambra, Robert Frankel, Annapoorna Kini, Michael Fusilero, Clark McKenzie, Stuart Higano, Cathy Castner, Steven Yakubov, Tammy Terry, Jamie Rankin, Clare Venn-Edmonds, Albert Deibele, Christine Leone, Takaaki Isshiki, Katsumasa Misawa, John Wang, Judith Raqueno, Kari Niemelä, Hannaleena Nappila, Wolfgang Rottbauer, Christiane Selter, Olivier Darremont, Laetitia Reuter, Rui Teles, Paulo Simao, Douglas Scott, Diane Caveney, Ganesh Manoharan, Bernie Smith, David Wohns, Jeanine Holens, Richard Shlofmitz, Elizabeth Haag, Thaddeus Tolleson, Cheryl Rasor, Simon Dixon, Dorothy Richardson, Gregg W Stone, Paul S Teirstein, Ian T Meredith, Bruno Farah, Christophe L Dubois, Robert L Feldman, Joseph Dens, Nobuhisa Hagiwara, Dominic J Allocco, Keith D Dawkins, PLATINUM Trial Investigators, Bruno Farah, Frederic Petit, Christophe Dubois, Gina van Oosterwijck, Robert Feldman, Deb McIntyre, Joseph Dens, Caroline Swijsen, Alain Bouchard, Wesley Wade, Didier Carrié, Jacqueline Cahuzac, Helge Moellmann, Cornelia Kisselbach, Keith Oldroyd, Joanne Kelly, Jack Hall, Marylynn Burkert, Robert Stoler, Lucy Kang, Nobuhisa Hagiwara, Miyoko Naganuma, Abram Rabinowitz, Susan Meier, Ameer Kabour, Michelle Hickam, Vincent Pompili, Luba Mazanec, Thomas Stuckey, Donna Ricks, Nicholas Curzen, Zoe Nicholas, Gregory Mishkel, Jennifer Jones, Robin Swinford, Andrejs Erglis, Alona Grave, Shigeru Saito, Izumi Kobayashi, Gilles Levy, Chrystel Leperchois, François Schiele, Gerald Sergent, Thomas Downes, Scott Kaczkowski, Dean Kereiakes, Ersela McGary, Tift Mann, Sarah Mulkey, Maurice Buchbinder, Heather Nielsen, Ryuta Asano, Tomoko Tajima, Michael Foster, Jacqueline Sheriod-Scott, Dariusz Dudek, Elzbieta Kolny, Henry Lui, Pam Gibbons, Paul Vermeersch, Nancy Aerts, Robert Whitbourn, John Gough, Jenny Wilson, Michael Mooney, Holly MacDonald, Andrew Taussig, Delores Barnes, Mark Dorogy, Carrie Knott, Matti Niemelä, Eija Niemelae, Paul Teirstein, Divina Fanning, Sven Moebius-Winkler, Carola Doehnert, Hans Bauer, Donna Palazzo, Michael Ring, Sharon Fulton, Jacek Kubica, Louis Cannon, Jennifer LaLonde, Timothy Grady, Jeff Kaliebe, Tommy Lee, Jenny Marsh, Jacques Koolen, Linda van Leur, John Radcliffe, Adrian Banning, Bernadette Moreby, Carey Kimmelstiel, Vilma Castaneda, Gert Richardt, Daniela Schuermann-Kuchenbrandt, Mirle Kellett, Claire Berg, Joseph Burchenal, Wayne Batchelor, Patty Knap, Barry Bertolet, Terri Tutor, Mary Soltau, Amish Desai, Lauren Braam, Juhani Airaksinen, Tuija Vasankari, Keiichi Igarashi, Yukiko Oshima, Jeffrey Breall, Judy Foltz, Toshiya Muramatsu, Yoshie Kanbe, Junji Yajima, Kazumi Matsuda, Roger Gammon, Mary Robison, Thomas Hovasse, Marion Baudry, Emerson Perin, Gilberto DeFreitas, Reginald Low, Janine Carlson, Warwick Jaffe, Mary-Anne Lindesay, Ian Summerscales, Philip Huber, Jillian Ciccarello, Mark De Belder, Gill Smith, Hiroyoshi Yokoi, Keiko Inoue, Joseph Kozina, Christie Hogan, Krzysztof Reczuch, Ian Meredith, Mauro Baldi, Julie Plunkett, Thomas McGarry, Stacie Hanes, Henning Kelbaek, Lene Kloevgaard, Maarten Suttorp, Conny Maarten, Yves Taeymans, Patrick Verdegem, Michael Laule, Claudia Kuhn, Mark Turco, Denise Pond, Magdi Ghali, Heather Barnes, Steven Martin, Corey Godfrey, Todd Caulfield, Ellen Muir, Masato Nakamura, Yoshiko Mori, Michael Kutcher, Teresa Young, Thomas Neunteufl, Markus Vertesich, David Mego, Melody Thomas, Adam Witkowski, Kui Hian Sim, Danny Day Dudu, Leif Thuesen, Lars Joergensen, Jeroen Vos, Monique de Craen-de Moor, Jeffrey Moses, John Kim, Charles O'Shaughnessy, Amy Walton, Gurpreet Sandhu, Rebekah Herrmann, Kenshi Fujii, Motoko Uehara, Alan Zajarias, Michelle Myers, Scott Harding, Diane Middleditch, Akil Loli, Hope Mangum, Sanford Gips, Nancy Markiewicz, David Dobies, Sandra Watt, Steven Burstein, Cecile Mayoralgo, Martyn Thomas, Karen Wilson, Ian Gilchrist, Patricia Frey, Charles Barth 3rd, Cheryl Rutherford, Paul Mahoney, Melinda Bullivant, Darren Walters, Lee Clement, David Wolford, Dogan Temizer, Deborah Kathman, Thomas Nygaard, Wyvonia Harris, Joyce White, Sean Janzer, Catherine Pensyl, Johannes de Swart, Yvonne van der Meij, Aaron Wong, Ding Ying Law, Rajesh Dave, Stephanie McMullen, Ehtisham Mahmud, Cecilia Judd, Marc Schweiger, Judy Fleurent, Marcus Wiemer, Carola Pape, Alan Niederman, Sandra Vujanic, Robaayah Zambahari, Sabian Intan Safarinaz, Nicholaos Xenopoulos, Nancy McDonald, A R Zaki Masud, Theresa Giambra, Robert Frankel, Annapoorna Kini, Michael Fusilero, Clark McKenzie, Stuart Higano, Cathy Castner, Steven Yakubov, Tammy Terry, Jamie Rankin, Clare Venn-Edmonds, Albert Deibele, Christine Leone, Takaaki Isshiki, Katsumasa Misawa, John Wang, Judith Raqueno, Kari Niemelä, Hannaleena Nappila, Wolfgang Rottbauer, Christiane Selter, Olivier Darremont, Laetitia Reuter, Rui Teles, Paulo Simao, Douglas Scott, Diane Caveney, Ganesh Manoharan, Bernie Smith, David Wohns, Jeanine Holens, Richard Shlofmitz, Elizabeth Haag, Thaddeus Tolleson, Cheryl Rasor, Simon Dixon, Dorothy Richardson
Abstract
Objectives: We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI).
Background: Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance.
Methods: A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority.
Results: The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00).
Conclusions: In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI.
Trial registration: ClinicalTrials.gov NCT00823212.
Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
Source: PubMed