Safety and Efficacy of Drug-Eluting Balloons in the Treatment of Drug-Eluting In-Stent Restenosis: Experience of a Tertiary Care Hospital
- Volume 24 - Issue 7 - July 2012
- Posted on: 6/29/12
- 0 Comments
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Abstract: Background. The advent of drug-eluting balloons (DEBs) is a promising development for coronary revascularization procedures, especially for in-stent restenosis (ISR). This study aims to highlight our experience with DEBs in the treatment of drug-eluting ISR at a tertiary care hospital in Pakistan. Methods. All patients presenting to our institution from August 2008 to February 2011 with significant drug-eluting instent restenosis (DES-ISR) who were eligible to receive treatment via DEB were included in the analysis. Patient baseline characteristics and angiographic data about the lesion characteristics were obtained. Postprocedural and follow-up endpoints, including cardiac death, myocardial infarction, and repeat revascularization, ie, major adverse cardiovascular events (MACE), were included in the analysis. Results. A total of 26 patients received treatment with DEB in the study period, with a significant number having major predisposing factors for the development of ischemic heart disease (IHD; 46% diabetics; 92% hypertensives). The culprit lesion was most commonly identified in the left anterior descending (31%), with presence of American College of Cardiology/American Heart Association lesion type C in 68% of patients. The SeQuent Please paclitaxel-eluting balloon (B. Braun) was used for revascularization. Patients were followed for a median of 16 months. Only 5 patients (19%) developed MACE during this period. Conclusion. Our experience demonstrates the effectiveness of DEBs in the treatment of drug-eluting ISR, especially in complex lesions with patients having significant risk factors for development of IHD. However, further studies are needed to define their indications in this role.
J INVASIVE CARDIOL 2012;24(7):335-338
Key words: drug-eluting balloon, SeQuent Please balloon
The drug-eluting balloon (DEB) was designed1 to address the incumbent issues of neointimal proliferation and stent thrombosis, which are the banes of the established technology of the bare-metal stent (BMS) and drug-eluting stent (DES).2,3 Theoretically, this device could deliver the drug evenly to the vessel wall, limiting neointimal proliferation and at the same time reducing dependency on long-term anti-platelet therapy for vessel patency.4 This concept tested favorably in preclinical studies, with adequate delivery of drug from balloon (~90% in 1 minute of inflation),1 and significant reduction in areas of neointimal proliferation,1,5,6 diameter stenosis, and late luminal loss.7 Clinical studies following them are limited; however, they clearly demonstrate a favorable reduction in late luminal loss, restenosis rates, and major adverse cardiovascular events (MACE) in de novo8 and bifurcation lesions.9 However, their efficacy in lesions with in-stent restenosis (ISR) is the most promising,10,11 and as such, needs further research to define the adequate place of the DEB in the interventionalist’s armament.12 Hence, this registry aims to determine the safety and efficacy of the use of DEBs in patients with drug-eluting ISR at a tertiary care hospital in Pakistan.