Journal ArticleDOI
A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease
Gregg W. Stone,Stephen G. Ellis,David A. Cox,James B. Hermiller,Charles O'Shaughnessy,James Tift Mann,Mark Turco,Ronald P. Caputo,Patrick Bergin,Joel Greenberg,Jeffrey J. Popma,Mary E. Russell +11 more
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TLDR
As compared with bare-metal stents, the slow-release, polymer-based, paclitaxel-eluting stent is safe and markedly reduces the rates of clinical and angiographic restenosis at nine months.Abstract:
Background Restenosis after coronary stenting necessitates repeated percutaneous or surgical revascularization procedures. The delivery of paclitaxel to the site of vascular injury may reduce the incidence of neointimal hyperplasia and restenosis. Methods At 73 U.S. centers, we enrolled 1314 patients who were receiving a stent in a single, previously untreated coronary-artery stenosis (vessel diameter, 2.5 to 3.75 mm; lesion length, 10 to 28 mm) in a prospective, randomized, double-blind study. A total of 652 patients were randomly assigned to receive a bare-metal stent, and 662 to receive an identical-appearing, slow-release, polymer-based, paclitaxel-eluting stent. Angiographic follow-up was prespecified at nine months in 732 patients. Results In terms of base-line characteristics, the two groups were well matched. Diabetes mellitus was present in 24.2 percent of patients; the mean reference-vessel diameter was 2.75 mm, and the mean lesion length was 13.4 mm. A mean of 1.08 stents (length, 21.8 mm) were...read more
Citations
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Journal ArticleDOI
Clinical End Points in Coronary Stent Trials A Case for Standardized Definitions
Donald E. Cutlip,Stephan Windecker,Roxana Mehran,Ashley B Boam,David J. Cohen,Gerrit-Anne van Es,P. Gabriel Steg,Marie-Angèle Morel,Laura Mauri,Pascal Vranckx,Eugene P. McFadden,Alexandra J. Lansky,Martial Hamon,Mitchell W. Krucoff,Patrick W. Serruys +14 more
TL;DR: Criteria for assessment of death, myocardial infarction, repeat revascularization, and stent thrombosis were developed and provide consistency across studies that can facilitate the evaluation of safety and effectiveness of these devices.
Journal ArticleDOI
Guidelines on myocardial revascularization: The Task Force on Myocardial Revascularization of the European Society of Cardiology (ESC) and the European Association for Cardio-Thoracic Surgery (EACTS)
William Wijns,Philippe Kolh,Nicolas Danchin,Volkmar Falk,Stefan James,Miodrag Ostojic,Massimo F. Piepoli,Charles Pirlet,José L. Pomar,Flavio Ribichini,Martin J. Schalij,Paul Sergeant,Patrick W. Serruys,Sigmund Silber,David P. Taggart +14 more
TL;DR: Guidelines and Expert Consensus Documents summarize and evaluate all available evidence to assist physicians in selecting the best management strategy for an individual patient suffering from a given condition, taking into account the impact on outcome and the risk–benefit ratio of diagnostic or therapeutic means.
Journal ArticleDOI
Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents.
Ioannis Iakovou,Thomas Schmidt,Erminio Bonizzoni,Lei Ge,Giuseppe Sangiorgi,Goran Stankovic,Flavio Airoldi,Alaide Chieffo,Matteo Montorfano,Mauro Carlino,Iassen Michev,Nicola Corvaja,Carlo Briguori,Ulrich Gerckens,Eberhard Grube,Antonio Colombo +15 more
TL;DR: The cumulative incidence of stent thrombosis 9 months after successful drug-eluting stent implantation in consecutive "real-world" patients was substantially higher than the rate reported in clinical trials.
Journal ArticleDOI
Pathology of Drug-Eluting Stents in Humans: Delayed Healing and Late Thrombotic Risk
Michael Joner,Aloke V. Finn,Andrew Farb,Erik Mont,Frank D. Kolodgie,Elena Ladich,Robert Kutys,Kristi Skorija,Herman K. Gold,Renu Virmani +9 more
TL;DR: The Cypher and Taxus DES result in delayed arterial healing when compared with BMS of similar implant duration, and the cause of DES LST is multifactorial with delayed healing in combination with other clinical and procedural risk factors playing a role.
Journal ArticleDOI
ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention-summary article : A report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (ACC/AHA/SCAI Writing Committee to Update the 2001 Guidelines for Percutaneous Coronary Intervention)
Sidney C. Smith,Ted Feldman,John W. Hirshfeld,Alice K. Jacobs,Morton J. Kern,Spencer B. King,Douglass A. Morrison,William W. O'Neill,Hartzell V. Schaff,Patrick L. Whitlow,David O. Williams,Elliott M. Antman,Cynthia D. Adams,Jeffrey L. Anderson,David P. Faxon,Valentin Fuster,Jonathan L. Halperin,Loren F. Hiratzka,Sharon A. Hunt,Rick A. Nishimura,Joseph P. Ornato,Richard L. Page,Barbara Riegel +22 more
TL;DR: The American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions (ACC/AHA/SCAI) 2005 Guideline Update for Percutaneous Coronary Intervention (PCI) contains changes in the recommendations, along with supporting text.
References
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Journal ArticleDOI
A Comparison of Balloon-Expandable-Stent Implantation with Balloon Angioplasty in Patients with Coronary Artery Disease
Patrick W. Serruys,P. de Jaegere,Ferdinand Kiemeneij,Carlos Macaya,Wolfgang Rutsch,Gr. Heyndrickx,H. Emanuelsson,Jean Marco,Victor Legrand,P. Materne +9 more
TL;DR: The clinical and angiographic outcomes were better in patients who received a stent than in those who received standard coronary angioplasty, however, this benefit was achieved at the cost of a significantly higher risk of vascular complications at the access site and a longer hospital stay.
Journal ArticleDOI
A Randomized Comparison of Coronary-Stent Placement and Balloon Angioplasty in the Treatment of Coronary Artery Disease
David L. Fischman,Martin B. Leon,Donald S. Baim,Richard A. Schatz,Michael P. Savage,Ian M. Penn,Katherine D. Detre,Lisa Veltri,Donald R. Ricci,Masakiyo Nobuyoshi,Michael W. Cleman,Richard R. Heuser,David Almond,Paul S. Teirstein,R. David Fish,Antonio Colombo,Jeffrey C. Brinker,Jeffrey Moses,Alex Shaknovich,John N. Hirshfeld,Stephen Bailey,Stephen E. Ellis,Randal Rake,Sheldon Goldberg +23 more
TL;DR: In selected patients, placement of an intracoronary stent, as compared with balloon angioplasty, results in an improved rate of procedural success, a lower rate of angiographically detected restenosis, a similar rate of clinical events after six months, and a less frequent need for revascularization of the original coronary lesion.
Journal ArticleDOI
Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.
Jeffrey W. Moses,Martin B. Leon,Jeffrey J. Popma,Peter J. Fitzgerald,David R. Holmes,Charles O'Shaughnessy,Ronald P. Caputo,Dean J. Kereiakes,David O. Williams,Paul S. Teirstein,Judith Jaeger,Richard E. Kuntz +11 more
TL;DR: In this randomized clinical trial involving patients with complex coronary lesions, the use of a sirolimus-eluting stent had a consistent treatment effect, reducing the rates of restenosis and associated clinical events in all subgroups analyzed.
Journal ArticleDOI
A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary Revascularization
Marie-Claude Morice,Patrick W. Serruys,J. Eduardo Sousa,Jean Fajadet,Ernesto Ban Hayashi,Marco Antonio Perin,Antonio Colombo,Gerhard Schuler,Paul Barragan,Giulio Guagliumi,Ferenc Molnar,Robert Falotico +11 more
TL;DR: As compared with a standard coronary stent, a sirolimus-eluting stent shows considerable promise for the prevention of neointimal proliferation, restenosis, and associated clinical events.
Journal ArticleDOI
Early and sustained dual oral antiplatelet therapy following percutaneous coronary intervention: a randomized controlled trial.
Steven R. Steinhubl,Peter B. Berger,J. Tift Mann,Edward T.A. Fry,Augustin DeLago,Charles Wilmer,Eric J. Topol +6 more
TL;DR: Following PCI, long-term clopidogrel therapy significantly reduced the risk of adverse ischemic events and subgroup analyses suggest that longer intervals between the loading dose and PCI may reduce events.