| Paclitaxel-coated balloon versus drug-eluting stent during PCI of small coronary vessels, a prospective randomised clinical trial. The PICCOLETO study. | |
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MedLine Citation:
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PMID: 20659948 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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BACKGROUND: Percutaneous coronary intervention (PCI) of small vessels is limited by an increased risk of restenosis and adverse outcome, even when drug-eluting stents (DES) are employed. In recent years, the paclitaxel-coated balloon (PCB) has been shown to reduce neointimal proliferation and the need for target lesion revascularization (TLR) in an in-stent restenosis setting. The impact of a PCB during PCI of small coronary vessels was evaluated and compared to one of the most widely used DES. METHODS: In the PICCOLETO randomised clinical trial, patients with stable or unstable angina undergoing PCI of small coronary vessels (< or = 2.75 mm) were randomised to Dior PCB (28 patients) or Taxus DES (29 patients). The primary study end point was per cent diameter stenosis at 6-month angiographic follow-up (non-inferiority), secondary end points were angiographic binary restenosis and occurrence of major adverse cardiac events (MACE: death, Q-wave myocardial infarction, TLR) at 9 month follow-up. RESULTS: The two groups were not dissimilar regarding clinical and angiographic characteristics. Study was interrupted after enrolment of two-thirds of patients due to a clear superiority of one study group. The primary end point was not met, because the PCB group showed higher per cent diameter stenosis (43.6% vs 24.3%, p=0.029); angiographic restenosis was higher as well (32.1 vs 10.3%, p=0.043), whereas MACE were 35.7% in the PCB group and 13.8% in the DES group (p=0.054). CONCLUSIONS: Dior PCB failed to show equivalence to Taxus DES regarding angiographic end points during PCI of small coronary arteries. CLINICAL TRIAL REGISTRATION NUMBER (EUDRACT CODE): 2009-012268-15. |
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Authors:
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Bernardo Cortese; Andrea Micheli; Andrea Picchi; Amelia Coppolaro; Loria Bandinelli; Silva Severi; Ugo Limbruno |
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Publication Detail:
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Type: Journal Article; Randomized Controlled Trial |
Journal Detail:
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Title: Heart (British Cardiac Society) Volume: 96 ISSN: 1468-201X ISO Abbreviation: Heart Publication Date: 2010 Aug |
Date Detail:
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Created Date: 2010-07-27 Completed Date: 2010-08-19 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9602087 Medline TA: Heart Country: England |
Other Details:
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Languages: eng Pagination: 1291-6 Citation Subset: AIM; IM |
Affiliation:
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Interventional Cardiology Unit, Cardiovascular Department, Ospedale della Misericordia, Grosseto, Italy. bcortese@gmail.com |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Aged Angioplasty, Transluminal, Percutaneous Coronary / adverse effects, instrumentation* Cardiovascular Agents / administration & dosage* Coronary Restenosis / prevention & control, radiography Coronary Stenosis / drug therapy, therapy* Drug Delivery Systems / instrumentation* Drug-Eluting Stents* / adverse effects Equipment Design Female Follow-Up Studies Humans Male Middle Aged Paclitaxel / administration & dosage* Prospective Studies Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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0/Cardiovascular Agents; 33069-62-4/Paclitaxel |
| Comments/Corrections | |
Comment In:
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Heart. 2010 Aug;96(16):1257-8
[PMID:
20659942
]
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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