| Objective: Arterial Sclerosis Occlusion(ASO), a common vascular arteriosclerotic disease in the middle-aged and elder patients, has a vital effect on the patients’ quality of life. Peripheral percutaneous transluminal angioplasty(PTA) can effectively improve the symptoms of lower limb ischemia, however, it’s such a big challenge to deal with the vascular restenosis after operation. To reduce the incidence of vascular restenosis, the drug-eluting balloon has been found。The aim of this paper was to prove the superiority of the DEB by comparing the efficacy and safety between the paclitaxel drug-eluting balloon(DEB) and the ordinal uncoated balloon in patients who had been undergone the femoral-popliteal percutaneous transluminal angioplasty.Methods: In this study, 12 patients were chosen in our hospital from 2013-11 to 2014-8, and randomly divided into 2 groups----the DEB group(DEB group) and the uncoated balloon group(control group). All the patients had the operation of the femoral-popliteal percutaneous transluminal angioplasty. Several changes of major indicators in the period from pre-operation to 6 months later were required to record, such as the minimum lumen diameter(MLD) of target lesion, late lumen loss at 6 months, ankle brachial index(ABI), Rutherford class, target lesion revascularization, presence of amputation and adverse events, and then compared the differences of these indicators between the two groups.Results: All the patients had the operation of the femoral-popliteal percutaneous transluminal angioplasty without loss in follow-up.1 The change in MLD and LLL: there is no obvious difference in statistics before and immediately after the operation between the two groups(P>0.05), while 6 months later the MLD of DEB group(2.28±0.69) is higher than that of the control group(1.10±0.97) which is significant on 5%-class in statistics(p =0.036). Also the DEB group(0.08±0.60)has a much smaller LLL than the control group(1.32±0.80)(p =0.013).2 The change in ABI value: there is no difference in statistics before the operation, the ABI value of DEB group is higher than the control group both in period of postoperative 1 week and 6 months, so does the increase of ABI value of each group. The analysis of variance revealed significant differences between the groups(p<0.05) except for the increase of ABI value in the period of postoperative 6 months(p =0.132).3 The change in Rutherford classification: the difference in constituent ratio between two groups is not statistically significant before the operation(P=0.733). All patients are at class 1 after the operation except that only one of them was still in class 5. After 3 and 6 months, there are 5 patients in class 1 and the other one is in class 5 in DEB group. While there is a raising trend in control group with time gone by. Only 1 remain in class 1 at last. There is a significant difference in constituent ratio between these two groups 3 months after the operation(P=0.02), but 6 months after the operation the change is not statistically significant(P=0.086).4 The incident rate of vascular restenosis and the PTA retreatment: the incident rate of control group(50%) is much higher than the DEB group(0), there are 3 patients get PTA retreatment, and 2 of them have stents implantation operation.5 Adverse events: 2 adverse events in control group---one is a hematoma happened at the puncture point, the other one is arterial thrombosis formed below the knee. 2 adverse events in DEB group---one of them is that lower limb arteriorrhagia, and the other one is new knee lesion. No amputation and other complications.6 Major laboratory indicators: there are no significant change on the result of blood and urine routine tests, the blood biochemical test and any other tests both in pre-operation and post-operation between two groups.Conclusion: the result of preliminary stage about DEB clinic application in our hospital: a drug-eluting balloon(DEB) is safe and effective to patients suffering from the femoral-popliteal artery ischemic disease. The DEB reduces the area loss rate of the target vessel and the possibility to stents implantation, avoids some subsequent complications. In addition, it postpones the process of restenosis, and most importantly, the life quality of patients get improved. |
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