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- Title
Treatment of Small Vessel Disease With the Paclitaxel Drug-Eluting Balloon: 6-Month Angiographic and 1-Year Clinical Outcomes of the Spanish Multicenter Registry.
- Authors
Vaquerizo, Beatriz; Miranda‐Guardiola, Faustino; Fernández, Eduardo; Rumoroso, José Ramón; Gómez‐Hospital, Josep Antoni; Bossa, Francisco; Iñiguez, Andrés; Oategui, Imanol; Serra, Antonio
- Abstract
<bold>Background: </bold>Small vessel disease (SMD) remains a major challenge because of the increased risk of restenosis. We sought to assess the efficacy and safety of a paclitaxel-eluting balloon (PEB) in patients with SMD.<bold>Methods and Results: </bold>One-hundred and four patients with native coronary lesions in small vessels treated by using a PEB were included in this prospective multicenter registry. In each case, after regular balloon dilatation, a larger PEB was inflated for a minimum of 45-60 seconds. Patients were 65 ± 10 years old, 43% diabetic, and 58% presented acutely. Angiographic success was 93% (7% bailout BMS implantation due to coronary dissection). The rate of major adverse cardiac events (MACE) at 12 months was 4.8% (1.9% cardiac death, 1.0% MI, and 2.9% TLR). One definite stent thrombosis was reported at 6 months in a patient with bailout BMS implantation. At 7 months, late loss was 0.31 ± 0.2 mm. Bail-out BMS after DEB use, was an independent predictor of MACE, HR 18.74, 95%CI (2.58-135.84) and TLR, HR 30.99, 95%CI (2.79-344.07).<bold>Conclusion: </bold>The use of this PEB for the treatment of SMD provides excellent 1-year outcomes with only 4.8% MACE. The need for a bailout BMS was a strong predictor of MACE and TLR.
- Subjects
SPAIN; TREATMENT of vascular diseases; DRUG-eluting stents; PACLITAXEL; HEALTH outcome assessment; CLINICAL trials; ANTINEOPLASTIC agents; CORONARY restenosis prevention; COMPARATIVE studies; CORONARY arteries; LONGITUDINAL method; RESEARCH methodology; MEDICAL cooperation; MYOCARDIAL revascularization; RESEARCH; TIME; CORONARY restenosis; TRANSLUMINAL angioplasty; EVALUATION research; TREATMENT effectiveness; ACQUISITION of data; KAPLAN-Meier estimator; CORONARY angiography; EQUIPMENT &; supplies
- Publication
Journal of Interventional Cardiology, 2015, Vol 28, Issue 5, p430
- ISSN
0896-4327
- Publication type
journal article
- DOI
10.1111/joic.12227