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This prospective study designed to assess the safety and short and intermediate term efficacy of drug eluting balloon (DEB) in the treatment of de-novo, in-stent restenosis and bifurcation coronary artery disease (CAD) in Saudi Arabic Population.
Total of 64 patients so far enrolled in a prospective registry using a Be Brown Paclitaxel-coated balloon (DEB) at our hospital, 61 patients were studied for short and intermediate term outcomes (6 to 12 months). All patients with symptomatic CAD requiring percutaneous intervention (PCI) with DEB were included. Clinical follow-up was conducted at 6 to 12 months. Coronary angiography (CAG) or SPECT Scan were done in 70% of patients during this period. Primary outcome was a composite of target vessel revascularization and mortality.
Procedural success was achieved in 96% of the patients. Two patients were failed due to failed DEB to cross heavily calcified vessel. Mean age was 60.8±30 years. 47 patients (77%) presented with stable angina and 9 patients 15% with acute coronary syndrome (ACS). 25 patients (41%) had triple vessel CAD. Sixty percent were classified as having ACC/AHA B-2 or type coronary arteries including bailout stenting post DEB required in 8 patients %.
Immediate result mean diameter stenosis was 80%±8 decrease to 5%±9 post DEB dilatation and the diameter stenosis reached 15%±20 with coronary angiography follow up at 6 to 12 months. 7 patients (11%) have restenosis (5 patients have PCI and 2 patients have CABG). 37 patients (59%) who were followed by either re-cath (17 patients) or SPECT Scan (20 patients) showed no evidence of restenosis. The remaining 17 patients (30 %) were followed clinically and showed no Angina. One patient died from cancer one month after PCI. Two patients failed because of inability to cross the lesion. There was no cerebrovascular accident and no major bleeding.
Be Brown Pacilitaxel-coated balloon (DEB) can be used safely with good and successful intermediate result with target vessel restenosis of 7 patients (11.3) % and non cardiac mortality of 1.6%.
- 2013 American College of Cardiology Foundation