Background: Treatment of lesions in small coronary arteries by percutaneous transluminal coronary intervention is limited by a high recurrence rate. We assessed the use of a paclitaxel-coated balloon in this indication.
Methods: One-hundred eighteen patients with stenoses in small coronary vessels were treated by a paclitaxel-coated balloon (3 microg/mm(2)). The main inclusion criteria encompassed diameter stenosis of > or =70% and < or =22 mm in length with a vessel diameter of 2.25-2.8 mm. Follow-up angiography was performed at scheduled 6-month post-intervention or whenever driven by clinical or electrocardiographic signs of ischemia. The primary endpoint was angiographic in-segment late lumen loss.
Results: Eighty-two of 118 patients (70%) with a vessel diameter of 2.35 +/- 0.19 mm were treated with the drug-coated balloon only, while 32 patients required additional stent deployment. The mean in-segment late lumen loss was 0.28 +/- 0.53 mm. In patients treated with the drug-coated balloon only, the in-segment late lumen loss was 0.16 +/- 0.38 mm. At 12 months, the rate of major adverse cardiac events was 15% which was primarily due to the need for target lesion revascularization in 14 patients (12%). In those with additional bare metal stent implantation geographical mismatch between coated-balloon dilatation and stent implantation was significantly associated with the occurrence of restenosis.
Conclusion: Treatment of coronary stenosis in small coronary vessels with the paclitaxel-coated balloon was well tolerated. It may offer an alternative to the implantation of a drug-eluting stent (ClinicalTrials.gov Identifier: NCT00404144).