Journal of Invasive Cardiology

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

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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.