Treatment of small vessel disease with the paclitaxel drug-eluting balloon: 6-month angiographic and 1-year clinical outcomes of the Spanish multicenter registry

Background: 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. Methods and results: one-hundred and four patients with native coronary lesions in sma...

Full description

Bibliographic Details
Authors: Vaquerizo, Beatriz, Miranda-Guardiola, Faustino, Fernández, Eduardo, Rumoroso, José Ramón, Gómez Hospital, Josep Antoni, Bossa, Francisco, Iñiguez Romo, Andres, Oategui, Imanol, Serra, Antonio
Format: article
Status:Published version
Publication Date:2015
Country:España
Institution:Universidad de Barcelona
Repository:Dipòsit Digital de la UB
OAI Identifier:oai:diposit.ub.edu:2445/177231
Online Access:https://hdl.handle.net/2445/177231
Access Level:Open access
Keyword:Efectes secundaris dels medicaments
Malalties coronàries
Pròtesis de Stent
Ús terapèutic
Drug side effects
Coronary diseases
Stents (Surgery)
Therapeutic use
Description
Summary:Background: 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. Methods and results: 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). Conclusion: 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.