01 junio 2013

JACC: CARDIOVASCULAR INTERVENTIONS. Risk Factors for Thrombus Formation on the Amplatzer Cardiac Plug After Left Atrial Appendage Occlusion

Bjoern Plicht, MD; Thomas F.M. Konorza, MD; Philipp Kahlert, MD; Fadi Al-Rashid, MD; Hagen Kaelsch, MD; Rolf Alexander Jánosi, MD; Thomas Buck, MD; Hagen S. Bachmann, MD; Winfried Siffert, MD; Gerd Heusch, MD; Raimund Erbel, MD

Objectives: This study sought to identify risk factors for thrombus formation on the Amplatzer Cardiac Plug (ACP) (St. Jude Medical, St. Paul, Minnesota) after left atrial appendage occlusion.

01 mayo 2013

CIRCULATION. Predictors of Mortality and Outcomes of Therapy in Low-Flow Severe Aortic Stenosis

Howard C. Herrmann, MD; Philippe Pibarot, PhD; Irene Hueter, PhD; Zachary M. Gertz, MD; William J. Stewart, MD; Samir Kapadia, MD; E. Murat Tuzcu, MD; Vasilis Babaliaros, MD; Vinod Thourani, MD; Wilson Y. Szeto, MD; Joseph E. Bavaria, MD; Susheel Kodali, MD; Rebecca T. Hahn, MD; Mathew Williams, MD; D. Craig Miller, MD; Pamela S. Douglas, MD; Martin B. Leon, MD

Background—The prognosis and treatment of patients with low-flow (LF) severe aortic stenosis are controversial.

01 junio 2013

JACC: CARDIOVASCULAR INTERVENTIONS. The New York State Risk Score for Predicting In-Hospital/30-Day Mortality Following Percutaneous Coronary Intervention

Edward L. Hannan, PhD; Louise Szypulski Farrell, MS; Gary Walford, MD; Alice K. Jacobs, MD; Peter B. Berger, MD; David R. Holmes, MD; Nicholas J. Stamato, MD; Samin Sharma, MD; Spencer B. King, MD

Objectives: This study sought to develop a percutaneous coronary intervention (PCI) risk score for in-hospital/30-day mortality.

01 mayo 2013

CIRCULATION. Histopathology of Embolic Debris Captured During Transcatheter Aortic Valve Replacement

Nicolas M. Van Mieghem, MD; Marguerite E.I. Schipper, MD; Elena Ladich, MD; Elham Faqiri, MSc; Robert van der Boon, MSc; Abas Randjgari, MD; Carl Schultz, MD, PhD; Adriaan Moelker, MD, PhD; Robert-Jan van Geuns, MD, PhD; Fumiyuki Otsuka, MD; Patrick W. Serruys, MD, PhD; Renu Virmani, MD; Peter P. de Jaegere, MD, PhD

Background—Recent transcatheter aortic valve replacement studies have raised concerns about adverse cerebrovascular events. The etiopathology of the embolized material is currently unknown.

01 abril 2013

CIRCULATION. Mechanisms of Tissue Uptake and Retention in Zotarolimus-Coated Balloon Therapy

Vijaya B. Kolachalama, PhD; Stephen D. Pacetti, MS; Joseph W. Franses, PhD; John J. Stankus, PhD; Hugh Q. Zhao, PhD; Tarek Shazly, PhD; Alexander Nikanorov, MD, PhD; Lewis B. Schwartz, MD; Abraham R. Tzafriri, PhD; Elazer R. Edelman, MD, PhD

Background—Drug-coated balloons are increasingly used for peripheral vascular disease, and, yet, mechanisms of tissue uptake and retention remain poorly characterized. Most systems to date have used paclitaxel, touting its propensity to associate with various excipients that can optimize its transfer and retention. We examined zotarolimus pharmacokinetics.

01 mayo 2013

STROKE. Risk of Stroke or Systemic Embolism in Atrial Fibrillation Patients Treated With Warfarin. A Systematic Review and Meta-analysi

Ida Ehlers Albertsen, BSc; Lars Hvilsted Rasmussen, MD, PhD; Thure Filskov Overvad, BSc; Tina Graungaard, MSc; Torben Bjerregaard Larsen, MD, PhD; Gregory Y.H. Lip, MD

Background and Purpose—Although oral anticoagulants (OACs) are highly effective in reducing stroke risk in atrial fibrillation, some patients still sustain stroke despite being on an OAC. Our aim was to identify the risk factors that contribute to stroke risk in atrial fibrillation, although patients were taking OACs in a clinical trial setting.

05 marzo 2013

LANCET. Safety and performance of the drug-eluting absorbable metal scaffold (DREAMS) in patients with de-novo coronary lesions: 12 month results of the prospective, multicentre, first-in-man BIOSOLVE-I trial

Prof Michael Haude MD, Prof Raimund Erbel MD, Prof Paul Erne MD, Stefan Verheye MD, Hubertus Degen MD, Dirk Böse MD, Paul Vermeersch MD, Inge Wijnbergen MD, Neil Weissman MD, Francesco Prati MD, Ron Waksman MD, Jacques Koolen MD

Background: Bioabsorbable vascular scaffolds were developed to overcome limitations of permanent bare-metal or drug-eluting coronary stents—ie, stent thrombosis (despite prolonged dual antiplatelet therapy), the life-long presence of a caged vessel segment that does not allow vasomotion or remodelling, and chronic vessel wall inflammation. We assessed the safety and performance of a new magnesium-based paclitaxel-eluting absorbable metal scaffold in symptomatic patients with de-novo coronary lesions

01 mayo 2012

EURO INTERVENTION. BEACON II - A prospective, multi-centre, observational, real-world registry to assess clinical outcomes of patients after treatment with the BioMatrix™ Stent

Oficial Journal of Euro PCR

Aims: Drug-eluting stents (DES) effectively reduce the rate of target lesion revascularization (TLR) compared with bare metal stents. However, there is concern of an increased incidence of very late stent thrombosis associated with DES potentially related to the durable polymer. The BioMatrix Stent (Biosensors International, Morges, Switzerland) is a Biolimus A9™ eluting stent platform which releases biolimus, from an abluminal biodegradable polymer, polylactic acid (PLA). Polylactic acid is fully absorbed after 6-9 months. The purpose of the Beacon II registry was to assess clinical outcomes in Asian Pacific patients treated with BioMatrix stent in a real world, all-comers population. The goal of this presentation is to present, for the first time, the three year clinical follow-up data of Beacon II registry.

26 febrero 2013

LANCET: Abluminal biodegradable polymer biolimus-eluting stent versus durable polymer everolimus-eluting stent (COMPARE II): a randomised, controlled, non-inferiority trial

Dr Pieter Cornelis Smits MD, Sjoerd Hofma MD, Mario Togni MD, Nicolás Vázquez MD, Prof Mariano Valdés MD, Vassilis Voudris MD, Ton Slagboom MD, Prof Jean-Jaques Goy MD, Andre Vuillomenet MD, Antoni Serra MD, Ramiro Trillo Nouche MD, Peter den Heijer MD, Martin van der Ent MD

Background: Drug-eluting stents with durable biocompatible or biodegradable polymers have been developed to address the risk of thrombosis associated with first-generation drug-eluting stents. We aimed to compare the safety and efficacy of a biodegradable polymer-coated biolimus-eluting stent with a thin-strut everolimus-eluting stent coated with a durable biocompatible polymer.

01 enero 2011

JOURNAL OF CLINICAL PHARMACOLOGY. Randomized, Double-Blind, Placebo-Controlled, Single Intravenous Dose-Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of the Novel Coronary Smooth Muscle Cell Proliferation Inhibitor Biolimus A9

Dr Wolfgang Steudel MD, Dr Colleen Dingmann RN, PhD, Dr Yan-Ling Zhang PhD, Ms Jamie Bendrick-Peart MSc, Dr Claudia Clavijo MD, Mr John Shulze BSc, MBA, Dr Ronald Betts PhD, Dr Uwe Christians MD, PhD

Biolimus A9 (BA9) is a novel proliferation inhibitor of coronary smooth muscle cells that has been specifically designed for coating drug-eluting stents. The goals of this study were to identify the highest safe intravenous dose of BA9, to evaluate the dose-dependent pharmacokinetics of BA9 after intravenous administration in humans, and to characterize early clinical symptoms of BA9 toxicity in healthy subjects. This phase 1 trial in healthy subjects was designed as a double-blind, placebo-controlled, randomized, ascending single-dose study. After screening and randomization, 28 volunteers received either placebo (n = 7) or BA9 (n = 21) in a double-blinded fashion. Doses from 0.0075 mg/kg were escalated to 0.25 mg/kg in 4 cohorts. BA9 concentrations were measured using liquid chromatography-tandem mass spectrometry. BA9 doses up to 0.075 mg/kg were well tolerated. Only the highest BA9 dose of 0.25 mg/kg produced reversible drug-related adverse events. The most frequent adverse events were headache, nausea, and mouth ulcers, most likely due to immunosuppression. Exposure to BA9 did not result in electrocardiographic or clinical laboratory changes. BA9 had a terminal half-life of 90.0 ± 40.0 hours (all n = 21, mean ± standard deviation), an apparent clearance from blood of 0.96 ± 1.07 L/kg/h, and a volume of distribution of 96.5 ± 72.6 L/kg.

23 febrero 2013

LANCET: Biolimus-eluting biodegradable polymer-coated stent versus durable polymer-coated sirolimus-eluting stent in unselected patients receiving percutaneous coronary intervention (SORT OUT V): a randomised non-inferiority trial

Dr Evald Hoj Christiansen PhD, Lisette Okkels Jensen DMS, Per Thayssen DMS, Hans-Henrik Tilsted MD, Lars Romer Krusell MD, Knud Norregaard Hansen MD, Anne Kaltoft PhD, Michael Maeng PhD, Prof Steen Dalby Kristensen DMS, Prof Hans Erik Botker DMS, Christian Juhl Terkelsen DMS, Anton Boel Villadsen MD, Jan Ravkilde DMS, Jens Aaroe MD, Morten Madsen MS, Leif Thuesen DMS, Jens Flensted Lassen PhD, for the Scandinavian Organization for Randomized Trials with Clinical Outcome (SORT OUT) V investigators

Background: Third-generation biodegradable polymer drug-eluting stents might reduce the risk of stent thrombosis compared with first-generation permanent polymer drug-eluting stents. We aimed to further investigate the effects of a biodegradable polymer biolimus-eluting stent compared with a durable polymer-coated sirolimus-eluting stent in a population-based setting.

01 junio 2011

EURO INTERVENTION. Implantation of the biodegradable polymer biolimus-eluting stent in patients with high SYNTAX score is associated with decreased cardiac mortality compared to a permanent polymer sirolimus-eluting stent: two year follow-up.

Oficial Journal of Euro PCR

Background: The SYNTAX score (SXscore) has been shown to be an effective predictor of clinical outcomes in patients undergoing percutaneous coronary intervention (PCI).

01 marzo 2011

EURO INTERVENTION. The outcome of bifurcation lesion stenting using a biolimuseluting stent with a bio-degradable polymer compared to a sirolimus-eluting stent with a durable polymer

Oficial Journal of Euro PCR

Aims: This study investigated the differences in clinical outcomes between patients with bifurcation lesions (BL) treated with a biolimus-eluting stent (BES) with a biodegradable polymer, and a sirolimus-eluting stent (SES) with a durable polymer

01 abril 2013

CIRCULATION: CARDIOVASCULAR INTERVENTIONS. Stroke After Primary Percutaneous Coronary Intervention in Patients With ST-Segment Elevation Myocardial Infarction

Jeffrey T. Guptill, MD, MA, Rajendra H. Mehta, MD, MS, Paul W. Armstrong, MD, John Horton, MS, Daniel Laskowitz, MD, MHS, Stefan James, MD, PhD, Christopher B. Granger, MD and Renato D. Lopes, MD, PhD

Background—Stroke is a rare but potentially devastating complication of acute myocardial infarction. Little is known about stroke timing, characteristics, and clinical outcomes in patients with ST-segment elevation myocardial infarction treated with primary percutaneous coronary intervention (PCI).

01 abril 2013

CIRCULATION: CARDIOVASCULAR INTERVENTIONS. Fractional Flow Reserve Assessment of Left Main Stenosis in the Presence of Downstream Coronary Stenoses

Andy S.C. Yong, MBBS, PhD, David Daniels, MD, Bernard De Bruyne, MD, PhD, Hyun-Sook Kim, MD, Fumiaki Ikeno, MD, Jennifer Lyons, RVT, Nico H.J. Pijls, MD, PhD and William F. Fearon, MD

Background—Several studies have shown that fractional flow reserve (FFR) measurement can aid in the assessment of left main coronary stenosis. However, the impact of downstream epicardial stenosis on left main FFR assessment with the pressure wire in the nonstenosed downstream vessel remains unknown.