01 agosto 2015

JACC. Impact of Dual Lipid-Lowering Strategy With Ezetimibe and Atorvastatin on Coronary Plaque Regression in Patients With Percutaneous Coronary Intervention. The Multicenter Randomized Controlled PRECISE-IVUS Trial

Kenichi Tsujita, MD, PhD∗; Seigo Sugiyama, MD, PhD†; Hitoshi Sumida, MD, PhD‡; Hideki Shimomura, MD, PhD§; Takuro Yamashita, MD, PhD‖; Kenshi Yamanaga, MD∗; Naohiro Komura, MD, PhD∗; Kenji Sakamoto, MD, PhD∗; Hideki Oka, MD, PhD¶; Koichi Nakao, MD, PhD#; Sunao Nakamura, MD, PhD∗∗; Masaharu Ishihara, MD, PhD††; Kunihiko Matsui, MD, PhD‡‡; Naritsugu Sakaino, MD, PhD§§; Natsuki Nakamura, MD, PhD‖‖; Nobuyasu Yamamoto, MD, PhD¶¶; Shunichi Koide, MD, PhD##; Toshiyuki Matsumura, MD, PhD∗∗∗; Kazuteru Fujimoto, MD, PhD†††; Ryusuke Tsunoda, MD, PhD‡‡‡; Yasuhiro Morikami, MD, PhD§§§; Koushi Matsuyama, MD, PhD‖; Shuichi Oshima, MD, PhD‡; Koichi Kaikita, MD, PhD∗; Seiji Hokimoto, MD, PhD∗; Hisao Ogawa, MD, PhD∗

Background: Despite standard statin therapy, a majority of patients retain a high “residual risk” of cardiovascular events.

01 agosto 2015

JACC. 10-Year Mortality Outcome of a Routine Invasive Strategy Versus a Selective Invasive Strategy in Non–ST-Segment Elevation Acute Coronary Syndrome. The British Heart Foundation RITA-3 Randomized Trial

Robert A. Henderson, DM∗; Christopher Jarvis, MSc†; Tim Clayton, MSc†; Stuart J. Pocock, PhD†; Keith A.A. Fox, MB, ChB‡

Background: The RITA-3 (Third Randomised Intervention Treatment of Angina) trial compared outcomes of a routine early invasive strategy (coronary arteriography and myocardial revascularization, as clinically indicated) to those of a selective invasive strategy (coronary arteriography for recurrent ischemia only) in patients with non–ST-segment elevation acute coronary syndrome (NSTEACS). At a median of 5 years’ follow-up, the routine invasive strategy was associated with a 24% reduction in the odds of all-cause mortality.

01 julio 2015

JACC. Plaque Characterization by Coronary Computed Tomography Angiography and the Likelihood of Acute Coronary Events in Mid-Term Follow-Up

Sadako Motoyama, MD, PhD∗; Hajime Ito, MD, PhD∗; Masayoshi Sarai, MD, PhD∗; Takeshi Kondo, MD, PhD∗; Hideki Kawai, MD, PhD∗; Yasuomi Nagahara, MD∗; Hiroto Harigaya, MD, PhD∗; Shino Kan, MD∗; Hirofumi Anno, MD, PhD§; Hiroshi Takahashi, BSc‖; Hiroyuki Naruse, MD, PhD∗; Junichi Ishii, MD, PhD∗; Harvey Hecht, MD†; Leslee J. Shaw, PhD¶; Yukio Ozaki, MD, PhD∗; Jagat Narula, MD, PhD†

Background: Coronary computed tomography angiography (CTA)-verified positive remodeling and low attenuation plaques are considered morphological characteristics of high-risk plaque (HRP) and predict short-term risk of acute coronary syndrome (ACS).

01 julio 2015

JACC. Presentation, Diagnosis, and Outcomes of Acute Aortic Dissection. 17-Year Trends From the International Registry of Acute Aortic Dissection

Linda A. Pape, MD∗; Mazen Awais, MD†; Elise M. Woznicki, BS†; Toru Suzuki, MD, PhD§; Santi Trimarchi, MD, PhD‖; Arturo Evangelista, MD¶; Truls Myrmel, MD, PhD#; Magnus Larsen, MD#; Kevin M. Harris, MD∗∗; Kevin Greason, MD††; Marco Di Eusanio, MD, PhD‡‡; Eduardo Bossone, MD, PhD§§; Daniel G. Montgomery, BS†; Kim A. Eagle, MD†; Christoph A. Nienaber, MD‖‖; Eric M. Isselbacher, MD¶¶; Patrick O´Gara, MD##

Background: Diagnosis, treatment, and outcomes of acute aortic dissection (AAS) are changing.

01 julio 2015

JACC. Outcomes of Percutaneous Coronary Intervention Performed at Offsite Versus Onsite Surgical Centers in the United Kingdom

Scot Garg, MBChB, PhD∗; Simon G. Anderson, PhD, MPhil, MBBCh†; Keith Oldroyd, MBChB, MD§; Colin Berry, MBChB, BSc§; Connor A. Emdin, HBSc‡; Sanne A.E. Peters, PhD‡; Nick E.J. West, MA, MD¶; Damian Kelly, MBChB, MD#; Kanarath Balachandran, MBBS, MD, PhD∗; John McDonald, MBBS, BSc∗; Ravi Singh, MBBS, MD∗; Sen Devadathan, MBBS∗∗; Simon Redwood, MD††; Peter F. Ludman, MA, MD‡‡; Kazem Rahimi, DM, MPH‡; Mark Woodward, PhD‡

Background: Percutaneous coronary intervention (PCI) is increasingly being performed at centers with offsite surgical support. Strong guideline endorsement of this practice has been lacking, in part because outcome data are limited to modest-size populations with short-term follow-up.

01 julio 2015

JACC. The Incidence and Predictors of Early- and Mid-Term Clinically Relevant Neurological Events After Transcatheter Aortic Valve Replacement in Real-World Patients

Johan Bosmans, MD, PhD∗; Sabine Bleiziffer, MD†; Ulrich Gerckens, MD‡; Peter Wenaweser, MD§; Stephen Brecker, MD‖; Corrado Tamburino, MD, PhD¶; Axel Linke, MD#

Background: Transcatheter aortic valve replacement (TAVR) enables treatment of high-risk patients with symptomatic aortic stenosis without open-heart surgery; however, the benefits are mitigated by the potential for neurological events.

01 julio 2015

JACC. Revisiting Sex Equality With Transcatheter Aortic Valve Replacement Outcomes. A Collaborative, Patient-Level Meta-Analysis of 11,310 Patients

Stephen A. O’Connor, MD, MB∗; Marie-Claude Morice, MD∗; Martine Gilard, MD†; Martin B. Leon, MD‡; John G. Webb, MD§; Danny Dvir, MD§; Josep Rodés-Cabau, MD‖; Corrado Tamburino, MD¶; Davide Capodanno, MD¶; Fabrizio D’Ascenzo, MD#; Philippe Garot, MD∗; Bernard Chevalier, MD∗; Ghada W. Mikhail, MD∗∗; Peter F. Ludman, MBBChir, MD††

Background There has been conflicting clinical evidence as to the influence of female sex on outcomes after transcatheter aortic valve replacement.

01 julio 2015

JACC. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 1: Clinical Trial Design Principles. A Consensus Document From the Mitral Valve Academic Research Consortium

Gregg W. Stone, MD∗; Alec S. Vahanian, MD‡; David H. Adams, MD§; William T. Abraham, MD‖; Jeffrey S. Borer, MD¶; Jeroen J. Bax, MD, PhD#; Joachim Schofer, MD∗∗; Donald E. Cutlip, MD††; Mitchell W. Krucoff, MD‡‡; Eugene H. Blackstone, MD§§; Philippe Généreux, MD∗; Michael J. Mack, MD¶¶; Robert J. Siegel, MD##; Paul A. Grayburn, MD¶¶; Maurice Enriquez-Sarano, MD∗∗∗; Patrizio Lancellotti, MD, PhD†††; Gerasimos Filippatos, MD‡‡‡; Arie Pieter Kappetein, MD, PhD§§§

Abstract: Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

01 julio 2015

JACC. Clinical Trial Design Principles and Endpoint Definitions for Transcatheter Mitral Valve Repair and Replacement: Part 2: Endpoint Definitions. A Consensus Document From the Mitral Valve Academic Research Consortium

Gregg W. Stone, MD∗; David H. Adams, MD‡; William T. Abraham, MD§; Arie Pieter Kappetein, MD, PhD‖; Philippe Généreux, MD∗; Pascal Vranckx, MD, PhD#; Roxana Mehran, MD†; Karl-Heinz Kuck, MD∗∗; Martin B. Leon, MD∗; Nicolo Piazza, MD, PhD††; Stuart J. Head, PhD‖; Gerasimos Filippatos, MD‡‡; Alec S. Vahanian, MD§§

Abstract: Mitral regurgitation (MR) is one of the most prevalent valve disorders and has numerous etiologies, including primary (organic) MR, due to underlying degenerative/structural mitral valve (MV) pathology, and secondary (functional) MR, which is principally caused by global or regional left ventricular remodeling and/or severe left atrial dilation. Diagnosis and optimal management of MR requires integration of valve disease and heart failure specialists, MV cardiac surgeons, interventional cardiologists with expertise in structural heart disease, and imaging experts. The introduction of transcatheter MV therapies has highlighted the need for a consensus approach to pragmatic clinical trial design and uniform endpoint definitions to evaluate outcomes in patients with MR. The Mitral Valve Academic Research Consortium is a collaboration between leading academic research organizations and physician-scientists specializing in MV disease from the United States and Europe. Three in-person meetings were held in Virginia and New York during which 44 heart failure, valve, and imaging experts, MV surgeons and interventional cardiologists, clinical trial specialists and statisticians, and representatives from the U.S. Food and Drug Administration considered all aspects of MV pathophysiology, prognosis, and therapies, culminating in a 2-part document describing consensus recommendations for clinical trial design (Part 1) and endpoint definitions (Part 2) to guide evaluation of transcatheter and surgical therapies for MR. The adoption of these recommendations will afford robustness and consistency in the comparative effectiveness evaluation of new devices and approaches to treat MR. These principles may be useful for regulatory assessment of new transcatheter MV devices, as well as for monitoring local and regional outcomes to guide quality improvement initiatives.

01 julio 2015

JACC. 2-Year Outcomes in Patients Undergoing Surgical or Self-Expanding Transcatheter Aortic Valve Replacement

Michael J. Reardon, MD∗; David H. Adams, MD†; Neal S. Kleiman, MD∗; Steven J. Yakubov, MD‡; Joseph S. Coselli, MD§; G. Michael Deeb, MD‖; Thomas G. Gleason, MD¶; Joon Sup Lee, MD¶; James B. Hermiller, Jr., MD#; Stan Chetcuti, MD‖; John Heiser, MD∗∗; William Merhi, MD∗∗; George L. Zorn, III, MD††; Peter Tadros, MD††; Newell Robinson, MD‡‡; George Petrossian, MD‡‡; G. Chad Hughes, MD§§; J. Kevin Harrison, MD§§; Brijeshwar Maini, MD‖‖; Mubashir Mumtaz, MD‖‖; John V. Conte, MD¶¶; Jon R. Resar, MD¶¶; Vicken Aharonian, MD##; Thomas Pfeffer, MD##; Jae K. Oh, MD∗∗∗; Hongyan Qiao, PhD†††; Jeffrey J. Popma, MD‡‡‡

Background: The U.S. pivotal trial for the self-expanding valve found that among patients with severe aortic stenosis at increased risk for surgery, the 1-year survival rate was 4.9 percentage points higher in patients treated with a self-expanding transcatheter aortic valve bioprosthesis than in those treated with a surgical bioprosthesis.

01 julio 2015

JACC. Late Restenosis After Paclitaxel-Coated Balloon Angioplasty Occurs in Patients With Drug-Eluting Stent Restenosis

Seiji Habara, MD; Kazushige Kadota, MD; Takenobu Shimada, MD; Masanobu Ohya, MD; Hidewo Amano, MD; Yu Izawa, MD; Shunsuke Kubo, MD; Yusuke Hyodo, MD; Suguru Otsuru, MD; Daiji Hasegawa, MD; Takeshi Tada, MD; Hiroyuki Tanaka, MD; Yasushi Fuku, MD; Tsuyoshi Goto, MD; Kazuaki Mitsudo, MD

Background There are currently inadequate data on whether “late restenosis” occurs after paclitaxel-coated balloon (PCB) angioplasty for in-stent restenosis (ISR) lesions.

01 julio 2015

JACC. A Prospective Randomized Trial of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis of Drug-Eluting Stents. The RIBS IV Randomized Clinical Trial

Fernando Alfonso, MD∗; María Jose Pérez-Vizcayno, MD†; Alberto Cárdenas, MD†; Bruno García del Blanco, MD‡; Arturo García-Touchard, MD§; José Ramón López-Minguéz, MD‖; Amparo Benedicto, MD∗; Mónica Masotti, MD¶; Javier Zueco, MD#; Andrés Iñiguez, MD∗∗; Maite Velázquez, MD††; Raúl Moreno, MD‡‡; Vicente Mainar, MD§§; Antonio Domínguez, MD‖‖; Francisco Pomar, MD¶¶; Rafael Melgares, MD##; Fernando Rivero, MD∗; Pilar Jiménez-Quevedo, MD†; Nieves Gonzalo, MD†; Cristina Fernández, MD†; Carlos Macaya, MD†

Background: Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge.

01 mayo 2015

JACC. Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Valve Stenosis. 1-Year Results From the All-Comers NOTION Randomized Clinical Trial

Hans Gustav Hørsted Thyregod, MD∗; Daniel Andreas Steinbrüchel, MD, DMSc∗; Nikolaj Ihlemann, MD, PhD†; Henrik Nissen, MD, PhD‡; Bo Juel Kjeldsen, MD, PhD§; Petur Petursson, MD‖; Yanping Chang, MS¶; Olaf Walter Franzen, MD†; Thomas Engstrøm, MD, DMSc†; Peter Clemmensen, MD, DMSc†; Peter Bo Hansen, MD#; Lars Willy Andersen, MD, DMSc#; Peter Skov Olsen, MD, DMSc∗; Lars Søndergaard, MD, DMSc†

Background: Transcatheter aortic valve replacement (TAVR) is an option in certain high-risk surgical patients with severe aortic valve stenosis. It is unknown whether TAVR can be safely introduced to lower-risk patients.

01 mayo 2015

JACC. Randomized Trial of Stents Versus Bypass Surgery for Left Main Coronary Artery Disease. 5-Year Outcomes of the PRECOMBAT Study

Jung-Min Ahn, MD∗; Jae-Hyung Roh, MD∗; Young-Hak Kim, MD∗; Duk-Woo Park, MD∗; Sung-Cheol Yun, PhD†; Pil Hyung Lee, MD∗; Mineok Chang, MD∗; Hyun Woo Park, MD∗; Seung-Whan Lee, MD∗; Cheol Whan Lee, MD∗; Seong-Wook Park, MD∗; Suk Jung Choo, MD∗; CheolHyun Chung, MD∗; JaeWon Lee, MD∗; Do-Sun Lim, MD‡; Seung-Woon Rha, MD§; Sang-Gon Lee, MD‖; Hyeon-Cheol Gwon, MD¶; Hyo-Soo Kim, MD#; In-Ho Chae, MD∗∗; Yangsoo Jang, MD††; Myung-Ho Jeong, MD‡‡; Seung-Jea Tahk, MD§§; Ki Bae Seung, MD‖‖; Seung-Jung Park, MD∗

Background: In a previous randomized trial, we found that percutaneous coronary intervention (PCI) was not inferior to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis at 1 year.

01 junio 2015

JACC. Retrograde Recanalization of Chronic Total Occlusions in Europe. Procedural, In-Hospital, and Long-Term Outcomes From the Multicenter ERCTO Registry

Alfredo R. Galassi, MD∗; Georgios Sianos, MD, PhD†; Gerald S. Werner, MD‡; Javier Escaned, MD, PhD§; Salvatore D. Tomasello, MD∗; Marouane Boukhris, MD∗; Marine Castaing, MSc∗; Joachim H. Büttner, MD¶; Alexander Bufe, MD#; Artis Kalnins, MD∗∗; James C. Spratt, MD††; Roberto Garbo, MD‡‡; David Hildick-Smith, MD§§; Simon Elhadad, MD‖‖; Andrea Gagnor, MD¶¶; Bernward Lauer, MD‖; Leszek Bryniarski, MD, PhD∗∗∗; Evald H. Christiansen, MD, PhD†††; Leif Thuesen, MD, DMSc†††; Markus Meyer-Geßner, MD‡‡‡; Omer Goktekin, MD§§§; Mauro Carlino, MD‖; Yves Louvard, MD¶¶¶; Thierry Lefèvre, MD¶¶¶; Aigars Lismanis, MD###; Valery L. Gelev, MD∗∗∗∗; Antonio Serra, MD, PhD††††; Francesco Marzà, MD∗; Carlo Di Mario, MD‡‡‡‡; Nicolaus Reifart, MD, PhD§§§§

Background: A retrograde approach improves the success rate of percutaneous coronary interventions (PCIs) for chronic total occlusions (CTOs).