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MONOGRAFÍAS


Stens coronarios con polímeros biodegradables

01 octubre 2012

JACC. Randomized comparison of Biolimus-eluting (Nobori) and Everolimus-eluting (Xience/Promus) stents in patients with multivessel coronary artery disease: 12-month follow-up data from COMPARE II study

TCT-573 - Peter Smits; A.J. van Boven; Mariano Valdes; Antonio Serra; Jean-Jacques Goy; V. Voudris; Ramiro Trillo; J.M. Vazquez; Peter den Heijer; Ton Slagboom; A.G. Vuillomenet

Background: The role of percutaneous coronary intervention (PCI) in the treatment of multivessel coronary artery disease (CAD) is still controversial and widely discussed. More liberal use of drug-eluting stents (DES) increased proportion of those patients undergoing PCI procedure, raising a need for more clinical evidence. The recent reported COMPARE II trial showed similar results of Biolimus-eluting Nobori stent (BES) and Everolimus-eluting Xience/Promus stent (EES) at 1-year in an all comers population. We aim to compare safety and efficacy outcomes in patients with multivessel CAD (a pre-specified study subset) treated with BES and EES in COMPARE II trial.

01 octubre 2012

JACC. COMPARE II – 1 Year Outcomes of a large randomized all-comers study

TCT-577 - Peter Smits; A.J. van Boven; Mariano Valdes; Antonio Serra; Jean-Jacques Goy; V. Voudris; J.M. Vazquez; Ramiro Trillo; A.G. Vuillomenet; Ton Slagboom; Peter den Heijer

Background: The newer generation drug eluting stents (DES) have shown advantages over first generation DES, particularly relating to long term safety. However, comparative data for contemporary DES are still insufficient. We aim to compare safety and efficacy between Nobori DES, eluting Biolimus A9 from an abluminal biodegradable polymer (BES) and Xience/Promus DES eluting everolimus from a permanent polymer (EES)

01 octubre 2012

JACC. COMPARE II: 1 Year Clinical Data of the Treatment of Long Lesions (>20mm)

TCT-580 - Peter Smits; A.J. van Boven; Mariano Valdes; Antonio Serra; Jean-Jacques Goy; V. Voudris; J.M. Vazquez; Ramiro Trillo; A.G. Vuillomenet; Ton Slagboom; Peter den Heijer

Background: Treatment of long lesions (LL) remains a challenge in interventional cardiology, with a high propensity to restenosis. Our aim was to evaluate the clinical outcomes of the patients with LL treated with a Nobori biolimus eluting stent (BES) versus patients treated with an everolimus eluting stent (EES) in a real world / all-comer situation as an substudy of COMPARE II trial.

01 octubre 2012

JACC. COMPARE II: One year Clinical Data for the treatment of small vessels (<2.75mm)

TCT-576 - COMPARE II: One year Clinical Data for the treatment of small vessels (<2.75mm)

Background: Small coronary vessels (reference diameter <2.75mm) are often associated with diabetic and female patients and remain an important challenge in interventional cardiology. We performed a pre-specified substudy on outcome in patients with small vessel treatment within the all-comer COMPARE II trial.

29 agosto 2012

JAMA. Effect of Biolimus-Eluting Stents With Biodegradable Polymer vs Bare-Metal Stents on Cardiovascular Events Among Patients With Acute Myocardial Infarction. The COMFORTABLE AMI Randomized Trial

Lorenz Räber, MD; Henning Kelbæk, MD; Miodrag Ostojic, MD; Andreas Baumbach, MD; Dik Heg, PhD; David Tüller, MD; Clemens von Birgelen, MD, PhD; Marco Roffi, MD; Aris Moschovitis, MD; Ahmed A. Khattab, MD; Peter Wenaweser, MD; Robert Bonvini, MD; Giovanni Pedrazzini, MD; Ran Kornowski, MD; Klaus Weber, MD; Sven Trelle, MD; Thomas F. Lüscher, MD; Masanori Taniwaki, MD; Christian M. Matter, MD; Bernhard Meier, MD; Peter Jüni, MD; Stephan Windecker, MD; for the COMFORTABLE AMI Trial Investigators

Context: The efficacy and safety of drug-eluting stents compared with bare-metal stents remains controversial in patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Objective: To compare stents eluting biolimus from a biodegradable polymer with bare-metal stents in primary PCI.

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.

01 mayo 2012

EURO INTERVENTION. Two-year clinical and safety outcomes of the e-BioMatrix PMS registry

Oficial Journal of Euro PCR

Aims: The specific benefits of biolimus-eluting stents (BES) with a biodegradable polymer have been recently demonstrated during the long term follow-up of the LEADERS all-comers randomised trial. It is thus of interest to determine whether the long-term follow-up of patients treated with the BioMatrix™ stent system in routine clinical practice is associated with a similarly low rate of late adverse events. We present the 2-year results of the 1123 patient e-BioMatrix Post Market Surveillance (PMS) registry, and focus on the safety and efficacy of the stent in the very late phase (>1 year) by performing a landmark analysis according to a pre-specified 12 months time-point.

01 mayo 2012

EURO INTERVENTION. Optical coherence tomography assessment for biolimus-eluting stents and everolimus-eluting stents in the very early period

Oficial Journal of Euro PCR

Aims: New generation drug-eluting stents, biolimus-eluting stents (BES), and everolimus-eluting stents (EES), are expected to provide minimal inflammatory reaction and good neointimal coverage. However, there is no data regarding vessel response in the very early period after BES and EES implantation. The aim of this study was to assess detailed response at 1-month after BES and EES implantation using optical coherence tomography (OCT).

24 marzo 2012

EUROPEAN HEART JOURNAL. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervention

Giulio G. Stefanini, Robert A. Byrne, Patrick W. Serruys, Antoinette de Waha, Bernhard Meier, Steffen Massberg, Peter Jüni, Albert Schömig, Stephan Windecker and Adnan Kastrati

Aims: The efficacy of durable polymer drug-eluting stents (DES) is delivered at the expense of delayed healing of the stented vessel. Biodegradable polymer DES aim to avoid this shortcoming and may potentially improve long-term clinical outcomes, with benefit expected to accrue over time. We sought to compare long-term outcomes in patients treated with biodegradable polymer DES vs. durable polymer sirolimus-eluting stents (SES).

01 febrero 2012

EURO INTERVENTION. Comparison of biolimus eluted from an erodible stent coating with bare metal stents in acute ST-elevation myocardial infarction (COMFORTABLE AMI trial): rationale and design

Oficial Journal of Euro PCR

Aims: Compared with bare metal stents (BMS), early generation drug-eluting stents (DES) reduce the risk of revascularisation in patients with ST-elevation myocardial infarction (STEMI) at the expense of an increased risk of very late stent thrombosis (ST). Durable polymer coatings for controlled drug release have been identified as a potential trigger for these late adverse events and this has led to the development of newer generation DES with durable and biodegradable polymer surface coatings with improved biocompatibility. In a recent all-comers trial, biolimus-eluting stents with a biodegradable polymer surface coating were found to reduce the risk of very late ST by 80% compared with sirolimus-eluting stents with durable polymer, which also translated into a lower risk of cardiac death and myocardial infarction (MI) beyond one year.

28 diciembre 2011

JOURNAL OF CARDIOVASCULAR AND THORACIC RESEARCH. The Twelve-Month Outcome of Biolimus Eluting Stent with Biodegradable Polymer Compared With an Everolimus Eluting Stent with Durable Polymer

Ahmad Separham, Bahram Sohrabi, Naser Aslanabadi, Samad Ghaffari

Introduction: Drug-eluting stents (DES) have significantly decreased the need for repeat coronary revascularization but concerns remain regarding the safety of first and second generation DES. We compared the safety and efficacy of a biolimus-eluting stent (with biodegradable polymer) with an everolimus-eluting stent (with durable polymer) one

01 diciembre 2011

CATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS. In vivo comparison of a polymer-free Biolimus A9-eluting stent with a biodegradable polymer-based Biolimus A9 eluting stent and a bare metal stent

Ron Waksman MD, Rajbabu Pakala PhD, Richard Baffour PhD, Rufus Seabron, David Hellinga MS, Rosanna Chan PhD, Shih-Horng Su PhD, Frank Kolodgie PhD3, Renu Virmani MD

Objectives: To evaluate the effect of a polymer-free Biolimus A9-eluting stent [BioFreedom™ (BF)], compared with that of a biodegradable polymer-based Biolimus A9-eluting stent [BioMatrix Flex™ (BMF)] and a bare metal stent (BMS) in balloon denuded and radiated hypercholesterolemic rabbit iliac arteries. Methods: Rabbits were fed with 1% cholesterol diet (n = 14) for 14 days, both iliac arteries were balloon denuded and radiated, and then rabbits were switched to 0.15% cholesterol diet. After 4 weeks, BF (n = 8), BMF (n = 8), and BMS (n = 8) were deployed in denuded and radiated areas. Four weeks later animals were euthanized, arterial segments were processed for morphometry. Results: The neointimal area in vessels implanted with BF stents was significantly less than that seen in vessels implanted with BMS (0.90 mm2 ± 0.14 vs. 1.29 mm2 ± 0.23, P <0.01). Percent fibrin and fibrin score were higher with BMF stents compared to BMS (P <0.03 and <0.04) and giant cell number was significantly higher with both BMF and BF stents (P < 0.01 for both). Percent endothelialization was significantly higher and % uncovered struts were lower with BMS compared to either BMF or BF stents (P < 0.05 for both). Conclusion: This study demonstrates that compared to BMS, BF stents significantly decreased neointimal hyperplasia. © 2011 Wiley Periodicals, Inc.

01 noviembre 2011

LANCET: Long-term clinical outcomes of biodegradable polymer biolimus-eluting stents versus durable polymer sirolimus-eluting stents in patients with coronary artery disease (LEADERS): 4 year follow-up of a randomised non-inferiority trial

Giulio G Stefanini, Bindu Kalesan, Patrick W Serruys, Dik Heg, Pawel Buszman, Axel Linke, Thomas Ischinger, Volker Klauss, Franz Eberli, William Wijns, Marie-Claude Morice, Carlo Di Mario, Roberto Corti, Diethmar Antoni, Hae Y Sohn, Pedro Eerdmans, Gerrit-Anne van Es, Bernhard Meier, Stephan Windecker, Peter Jüni

Background: The eff ectiveness of durable polymer drug-eluting stents comes at the expense of delayed arterial healing and subsequent late adverse events such as stent thrombosis (ST). We report the 4 year follow-up of an assessment of biodegradable polymer-based drug-eluting stents, which aim to improve safety by avoiding the persistent infl ammatory stimulus of durable polymers

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