Drug-eluting balloon (DEB) for de-novo coronary artery disease and in-stent restenosis: immediate and intermediate term results from a prospective registry.
Drug-eluting balloon (DEB) for de-novo coronary artery disease and in-stent restenosis: immediate and intermediate term results from a prospective registry.
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发表时间：
2011-02
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通讯作者：
W. Ahmed;M. A. Shah;A. Thaver;J. Mirza
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作者：
W. Ahmed;M. A. Shah;A. Thaver;J. Mirza
目的探讨药物洗脱球囊（DEB）治疗新生和支架内再狭窄冠心病（CAD）的安全性和中短期疗效。方法：在我院使用紫杉醇包被球囊纳入前瞻性DEB登记的总共100例患者中，对36例患者进行了短期和中期（即12个月的结果）研究。所有伴有症状性冠状动脉疾病（CAD）的患者，包括新生病变或支架内再狭窄（ISR），需要经皮介入治疗（PCI）。分别于3、6、12个月进行临床随访。主要终点是主要心脏不良事件（MACE）的综合结果。结果所有患者（100%）手术成功。平均年龄53.2±12岁，61.1%为急性冠脉综合征（ACS）， 47.2%为三支血管CAD。66%的患者被分类为ACC/AHA B-2或C型冠状动脉，其中22.2%的患者有分叉病变。对新生冠心病患者进行DEB干预的比例为77.7%，对ISR患者进行DEB干预的比例为22.2%。所有的新生病变在DEB扩张后都需要金属支架（BMS）。平均DEB直径为2.73±0.06 mm，平均长度为19.58±0.81 mm。5例患者冠状动脉剥离，并成功地接受了附加支架治疗。在随访3 （n=36）、6 （n=31）和12 （n=31）个月时，未观察到任何患者发生MACE。结论：这项前瞻性DEB登记的短期和中期结果显示，对于新生和ISR病变，靶区血管重建术（TLR）均为0%。
OBJECTIVES To study the safety and short and intermediate term efficacy of drug-eluting balloon (DEB) in the treatment of de-novo and in-stent restenotic coronary artery disease (CAD). METHODS Of the total 100 patients so far enrolled in a prospective DEB registry using a Paclitaxel-coated balloon at our hospital, 36 patients were studied for short and intermediate term i.e. 12 months outcomes. All patients with symptomatic coronary artery disease (CAD) including de-novo lesions or in-stent restenosis (ISR) requiring percutaneous intervention (PCI) with a DEB were included. Clinical follow-up was conducted at 3, 6 and 12 months. Primary outcome was a composite of major adverse cardiac events (MACE). RESULTS Procedural success was achieved in all (100%) patients. Mean age was 53.2 +/- 12 years, 61.1% presented with acute coronary syndrome (ACS) and 47.2% had triple vessel CAD. Sixty six percent were classified as having ACC/AHA B-2 or C type coronary arteries including 22.2% with bifurcation lesions. DEB intervention for de-novo CAD was done in 77.7% patients and 22.2% for ISR. All de-novo lesions required a bare- metal stent (BMS) after DEB dilatation. Mean DEB diameter was 2.73 +/- 0.06 mm and mean length was 19.58 +/- 0.81 mm. Coronary dissections occurred in 5 patients which were successfully treated with additional stents. At 3 (n=36), 6 (n=31) and 12 (n=31) months follow-up, no MACE was observed in any patient. CONCLUSION The short and intermediate term outcomes from this prospective DEB registry showed excellent results with 0% target lesion revascularization (TLR) for both de-novo and ISR lesions.