01 abril 2013

JACC: CARDIOVASCULAR INTERVENTIONS. The “Final” 5-Year Follow-Up From the ENDEAVOR IV Trial Comparing a Zotarolimus-Eluting Stent With a Paclitaxel-Eluting Stent

Ajay J. Kirtane, MD, SM; Martin B. Leon, MD; Michael W. Ball, MD; Harpaul S. Bajwa, MD; Michael H. Sketch, MD; Patrick S. Coleman, MD; Robert C. Stoler, MD; Stylianos Papadakos, MD; Donald E. Cutlip, MD; Laura Mauri, MD, MSc; David E. Kandzari, MD

Objectives: This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions.

01 abril 2012

CIRCULATION. Short- Versus Long-Term Duration of Dual-Antiplatelet Therapy After Coronary Stenting

Background—The optimal duration of dual-antiplatelet therapy and the risk-benefit ratio for long-term dual-antiplatelet therapy after coronary stenting remain poorly defined. We evaluated the impact of up to 6 versus 24 months of dual-antiplatelet therapy in a broad all-comers patient population receiving a balanced proportion of Food and Drug Administration–approved drug-eluting or bare-metal stents.

01 abril 2013

JACC: CARDIOVASCULAR INTERVENTIONS. The REMEDEE Trial. A Randomized Comparison of a Combination Sirolimus-Eluting Endothelial Progenitor Cell Capture Stent With a Paclitaxel-Eluting Stent

Michael Haude, MD, PhD; Stephen W.L. Lee, MD; Stephen G. Worthley, MBBS, PhD; Sigmund Silber, MD, PhD; Stefan Verheye, MD, PhD; Sandra Erbs, MD; Mohd Ali Rosli, MD; Roberto Botelho, MD, PhD; Ian Meredith, MBBS, PhD; Kui Hian Sim, MBBS; Pieter R. Stella, MD, PhD; Huay-Cheem Tan, MBBS; Robert Whitbourn, MBBS; Sukumaran Thambar, MBBS; Alexandre Abizaid, MD, PhD; Tian Hai Koh, MBBS; Peter Den Heijer, MD, PhD; Helen Parise, ScD; Ecaterina Cristea, MD; Akiko Maehara, MD; Roxana Mehran, MD

Objectives: This study sought to compare the efficacy and safety results after coronary implantation of a combined sirolimus-eluting CD34 antibody coated Combo stent (OrbusNeich Medical, Ft. Lauderdale, Florida) with the paclitaxel-eluting Taxus Liberté stent (PES) (Boston Scientific, Natick, Massachusetts). This report summarizes the first-in-man randomized, controlled multicenter REMEDEE trial (Randomized study to Evaluate the safety and effectiveness of an abluMinal sirolimus coatED bio-Engineered StEnt) angiographic, intravascular ultrasound, and clinical results up to 12 months.

01 abril 2013

JACC: CARDIOVASCULAR INTERVENTIONS. Analysis of Stroke Occurring in the SYNTAX Trial Comparing Coronary Artery Bypass Surgery and Percutaneous Coronary Intervention in the Treatment of Complex Coronary Artery Disease

Michael J. Mack, MD; Stuart J. Head, MSc; David R. Holmes, MD; Elisabeth Ståhle, MD; Ted E. Feldman, MD; Antonio Colombo, MD; Marie-Claude Morice, MD; Felix Unger, MD; Andrejs Erglis, MD; Robert Stoler, MD; Keith D. Dawkins, MD; Patrick W. Serruys, MD, PhD; Friedrich W. Mohr, MD, PhD; A. Pieter Kappetein, MD, PhD

Objectives: This study sought to analyze stroke rates in the SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) trial s randomized and registry cohorts of patients being treated with coronary artery bypass grafting (CABG) or percutaneous coronary intervention (PCI) for treatment of complex coronary artery disease.

15 abril 2012

CIRCULATION. Late Results of Percutaneous Mitral Commissurotomy up to 20 Years. Development and Validation of a Risk Score Predicting Late Functional Results From a Series of 912 Patients

Claire Bouleti, MD; Bernard Iung, MD; Cédric Laouénan, MD; Dominique Himbert, MD; Eric Brochet, MD; David Messika-Zeitoun, MD, PhD; Delphine Détaint, MD; Eric Garbarz, MD; Bertrand Cormier, MD; Pierre-Louis Michel, MD; France Mentré, MD, PhD; Alec Vahanian, MD

Background—Long-term follow-up after percutaneous mitral commissurotomy enables predictive factors of late results to be identified.

01 mayo 2013

JACC. Outcomes After Cardioversion and Atrial Fibrillation Ablation in Patients Treated With Rivaroxaban and Warfarin in the ROCKET AF Trial

Jonathan P. Piccini, MD, MHS; Susanna R. Stevens, MS; Yuliya Lokhnygina, PhD; Manesh R. Patel, MD; Jonathan L. Halperin, MD; Daniel E. Singer, MD; Graeme J. Hankey, MD; Werner Hacke, MD, PhD; Richard C. Becker, MD; Christopher C. Nessel, MD; Kenneth W. Mahaffey, MD; Keith A.A. Fox, MB, ChB; Robert M. Califf, MD; Günter Breithardt, MD

Objectives: This study sought to investigate the outcomes following cardioversion or catheter ablation in patients with atrial fibrillation (AF) treated with warfarin or rivaroxaban.

03 abril 2013

JACC: CARDIOVASCULAR INTERVENTIONS. Clinical Outcome of Patients With and Without Diabetes Mellitus After Percutaneous Coronary Intervention With the Resolute Zotarolimus-Eluting Stent

Sigmund Silber, MD, PhD; Patrick W. Serruys, MD, PhD; Martin B. Leon, MD; Ian T. Meredith, MBBS, PhD; Stephan Windecker, MD; Franz-Josef Neumann, MD, PhD; Jorge Belardi, MD; Petr Widimsky, MD, DRSc; Joe Massaro, PhD; Victor Novack, MD, PhD; Alan C. Yeung, MD; Shigeru Saito, MD; Laura Mauri, MD, MSc

Objectives: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes.

16 abril 2012

CIRCULATION. Long-Term (>10 Years) Clinical Outcomes of First-in-Human Biodegradable Poly-l-Lactic Acid Coronary Stents. Igaki-Tamai Stents

Soji Nishio, MD; Kunihiko Kosuga, MD, PhD, FJCC; Keiji Igaki, PhD; Masaharu Okada, MD, PhD; Eisho Kyo, MD; Takafumi Tsuji, MD; Eiji Takeuchi, MD, PhD; Yasutaka Inuzuka, MD, PhD; Shinsaku Takeda, MD; Tatsuhiko Hata, MD, PhD; Yuzo Takeuchi, MD, PhD; Yoshitaka Kawada, MD; Takeshi Harita, MD; Junya Seki, MD; Shunji Akamatsu, ME; Shinichi Hasegawa, ME; Nico Bruining, PhD; Salvatore Brugaletta, MD; Sebastiaan de Winter, BSc; Takashi Muramatsu, MD; Yoshinobu Onuma, MD; Patrick W. Serruys, MD, PhD; Shigeru Ikeguchi, MD, PhD

Background—The purpose of this study was to evaluate the long-term safety of the Igaki-Tamai stent, the first-in-human fully biodegradable coronary stent made of poly-l-lactic acid.

01 mayo 2013

JACC. Pre-Procedural Estimate of Individualized Bleeding Risk Impacts Physicians Utilization of Bivalirudin During Percutaneous Coronary Intervention

Seshu C. Rao, MD; Adnan K. Chhatriwalla, MD; Kevin F. Kennedy, MS; Carole J. Decker, RN, PhD; Elizabeth Gialde, RN, MSN; John A. Spertus, MD, MPH; Steven P. Marso, MD

Objectives: This study sought to assess whether incorporation of routine bleeding risk estimates affected the utilization of bivalirudin during percutaneous coronary intervention (PCI).

01 abril 2013

JACC: CARDIOVASCULAR INTERVENTIONS. Randomized Comparison of Clinical Outcomes Between Intravascular Ultrasound and Angiography-Guided Drug-Eluting Stent Implantation for Long Coronary Artery Stenoses

Jung-Sun Kim, MD; Tae-Soo Kang, MD; Gary S. Mintz, MD; Byoung-Eun Park, MD; Dong-Ho Shin, MD, MPH; Byeong-Keuk Kim, MD; Young-Guk Ko, MD; Donghoon Choi, MD; Yangsoo Jang, MD; Myeong-Ki Hong, MD

Objectives: This study sought to assess the impact of intravascular ultrasound (IVUS) guidance on clinical outcomes following drug-eluting stent implantation when treating long lesions.

01 mayo 2012

CIRCULATION. Risk Score for Predicting Long-Term Mortality After Coronary Artery Bypass Graft Surgery

Chuntao Wu, MD, PhD; Fabian T. Camacho, MS; Andrew S. Wechsler, MD; Stephen Lahey, MD; Alfred T. Culliford, MD; Desmond Jordan, MD; Jeffrey P. Gold, MD; Robert S.D. Higgins, MD; Craig R. Smith, MD; Edward L. Hannan, PhD

Background—No simplified bedside risk scores have been created to predict long-term mortality after coronary artery bypass graft surgery.

01 abril 2013

JACC: CARDIOVASCULAR INTERVENTIONS: Relationship of Thrombus Characteristics to the Incidence of Angiographically Visible Distal Embolization in Patients With ST-Segment Elevation Myocardial Infarction Treated With Thrombus Aspiration

Kei Yunoki, MD, PhD; Takahiko Naruko, MD, PhD; Takeshi Inoue, MD, PhD; Kenichi Sugioka, MD, PhD; Mayumi Inaba, MD, PhD; Yoko Iwasa, MD, PhD; Ryushi Komatsu, MD, PhD; Akira Itoh, MD, PhD; Kazuo Haze, MD, PhD; Minoru Yoshiyama, MD, PhD; Anton E. Becker, MD, PhD; Makiko Ueda, MD, PhD

Objectives: This study sought to investigate the association between pathological characteristics of aspirated intracoronary thrombi and the incidence of angiographically visible distal embolization (AVDE) during primary percutaneous coronary intervention (p-PCI) in patients with ST-segment elevation myocardial infarction (STEMI) treated with thrombus aspiration.

01 mayo 2012

CIRCULATION. Impact of the Presence and Extent of Incomplete Angiographic Revascularization After Percutaneous Coronary Intervention in Acute Coronary Syndromes The Acute Catheterization and Urgent Intervention Triage Strategy (ACUITY) Trial

Gregg F. Rosner, MD; Ajay J. Kirtane, MD, SM; Philippe Genereux, MD; Alexandra J. Lansky, MD; Ecaterina Cristea, MD; Bernard J. Gersh, MB, ChB, DPhil; Giora Weisz, MD; Helen Parise, ScD; Martin Fahy, MSc; Roxana Mehran, MD; Gregg W. Stone, MD

Background—The clinical significance of incomplete coronary revascularization (ICR) after percutaneous coronary intervention in patients with acute coronary syndromes is unknown.

01 mayo 2012

JACC: CARDIOVASCULAR INTERVENTIONS. Direct Percutaneous Access Technique for Transaxillary Transcatheter Aortic Valve Implantation. “The Hamburg Sankt Georg Approach

Ulrich Schäfer, MD; Yen Ho, MD; Christian Frerker, MD; Dimitry Schewel, MD; Damian Sanchez-Quintana, MD; Joachim Schofer, MD; Klaudija Bijuklic, MD; Felix Meincke, MD; Thomas Thielsen, MD; Felix Kreidel, MD; Karl-Heinz Kuck, MD

Objectives: This study questioned whether transaxillary transcatheter aortic valve implantation (TAVI) is feasible as a true percutaneous approach using percutaneous closure devices.

01 abril 2012

JACC. New Oral Anticoagulants in Atrial Fibrillation and Acute Coronary Syndromes. ESC Working Group on Thrombosis—Task Force on Anticoagulants in Heart Disease Position PapeR

Raffaele De Caterina, MD, PhD; Steen Husted, MD, DSc; Lars Wallentin, MD, PhD; Raffaele De Caterina, MD, PhD; Steen Husted, MD, DSc; Lars Wallentin, MD, PhD; Felicita Andreotti, MD, PhD; Harald Arnesen, MD; Fedor Bachmann, MD; Colin Baigent, MD; Kurt Huber, MD; Jørgen Jespersen, MD, DSc; Steen Dalby Kristensen, MD; Gregory Y.H. Lip, MD; João Morais, MD; Lars Hvilsted Rasmussen, MD, PhD; Agneta Siegbahn, MD, PhD; Freek W.A. Verheugt, MD; Jeffrey I. Weitz, MD

Until recently, vitamin K antagonists were the only available oral anticoagulants, but with numerous limitations that prompted the introduction of new oral anticoagulants targeting the single coagulation enzymes thrombin (dabigatran) or factor Xa (apixaban, rivaroxaban, and edoxaban) and given in fixed doses without coagulation monitoring. Here we review the pharmacology and the results of clinical trials with these new agents in stroke prevention in atrial fibrillation and secondary prevention after acute coronary syndromes, providing perspectives on their future incorporation into clinical practice. In phase III trials in atrial fibrillation, compared with warfarin, dabigatran etexilate 150 mg B.I.D. reduced the rates of stroke/systemic embolism without any difference in major bleeding; dabigatran etexilate 110 mg B.I.D. had similar efficacy with decreased bleeding; apixaban 5 mg B.I.D. reduced stroke, systemic embolism, and mortality as well as major bleeding; and rivaroxaban 20 mg Q.D. was noninferior to warfarin for stroke and systemic embolism without a difference in major bleeding. All these agents reduced intracranial hemorrhage. Edoxaban is currently being evaluated in a further large phase III trial. Apixaban and rivaroxaban were evaluated in phase III trials for prevention of recurrent ischemia in patients with acute coronary syndromes who were mostly receiving dual antiplatelet therapy, with conflicting results on efficacy but consistent results for increased major bleeding. Overall, the new oral anticoagulants are poised to replace vitamin K antagonists for many patients with atrial fibrillation and may have a role after acute coronary syndromes. Although convenient to administer and manage, they present challenges that need to be addressed.