AVI与Firebird 2支架在冠心病直接PCI治疗中的疗效比较

The Efficacy of AVI versus Firebird 2 drug eluting stents in primary PCI treatment of coronary disease

目的比较在一支或非复杂二支血管病变患者首次经皮冠状动脉介入治疗(PCI)术中应用三氧化二砷药物涂层支架(AVI)与雷帕霉素洗脱钴基支架(Firebird 2)的临床疗效与安全性。方法采用单盲对照法选取2013年1月至2014年12月接受首次PCI术住院患者160例,根据置入支架不同,分为Firebird 2组112例和AVI组48例,两组在年龄、性别、病变部位和病变长度等方面无明显差异。比较术前、术后即刻和术后6个月冠脉造影最小管腔直径(MLD)、直径狭窄程度(DS),术后6个月再狭窄率(RR)以及住院期间与随访期间主要不良心脏事件(MACE)发生率。结果两组手术成功率均为100%。随访时间Firebird 2组为(311.30±7.50)d,AVI组为(201.41±8.63)d。(1)术中两组最大扩张压力无显著性差异[(13.76±1.62)atm vs(13.78±1.65)atm,P>0.05)];(2)术后即刻MLD:Firebird 2组从术前的(0.33±0.14)mm增加到(2.83±0.35)mm,AVI组从术前的(0.32±0.12)mm增加到(2.80±0.34)mm;Firebird 2组与AVI组早期获得无统计学差异[(2.50±0.35)mm vs(2.49±0.30)mm,P>0.05)]。DS:Firebird 2组从术前的(88.96±4.55)%减少到术后的(5.53±1.41)%(P<0.05),AVI组从术前的(89.38±3.65)%减少到术后的(5.08±1.66)%(P<0.05),但组间差异不显著(P>0.05)。(3)6个月术后冠脉造影结果显示,Firebird 2组与AVI组MLD[(2.70±0.35)mm vs(2.67±0.34)mm]、晚期丢失[(0.14±0.03)mm vs(0.14±0.03)mm]、RR(1.32%vs 1.39%)以及住院期间与随访期间MACE发生率(6.25%vs 5.56%)组间差异均无显著性(P均>0.05),但DS两组间差异显著[(10.62±1.81)%vs(9.78±2.09)%,P=0.011]。(4)住院期间:Firebird 2组死亡1例;AVI组死亡1例,1例于术后第3天出现AMI,经再次冠脉造影证实为亚急性支架内血栓形成。随访期间:Firebird 2组有2例心绞痛发作,AVI组有3例心绞痛发作,两组均有1例因再狭窄形成再次置入药物支架治疗。结论 AVI支架与Firebird 2支架PCI中应用的近中期疗效和安全性无明显差异,但AVI支架中期预防再狭窄的疗效优于Firebird 2支架。

Objective To compare the efficacy and safety of arsenic trioxide eluting stent( AVI) and rapamycin eluting stent( Firebird 2) in primary percutaneous coronary intervention( PCI) for the patients with one or two vessels non-complex lesions. Methods Using single-blind controlled method,160 patients underwent primary PCI between January 2013 and December 2014 were selected as research objects. The patients were divided into Firebird 2 group( n = 112) and AVI group( n = 48) according to types of implanted stents. There were no significant differences in age,gender of patients,diseased region and lesion length between two groups. The minimal lumen diameter( MLD) and the degree of diameter stenosis( DS) displayed by coronary angiography before procedure,instant after surgery and 6 months after procedure,the restenosis rate( RR) 6 months after procedure and the incidence of major adverse cardiac events( MACE) in hospital stay and follow-up period were compared in two groups. Results The PCI success rate was all 100% in both two groups. The follow-up time was( 311. 30 ± 7. 50) days in Firebird 2 group and( 201. 41 ± 8. 63) days in AVI group.( 1) There was no significant difference in maximum dilation pressure in procedure between Firebird group and AVI group[( 13. 76 ± 1. 62) atm vs( 13. 78 ± 1. 65) atm,P > 0. 05) ].( 2) Compared with MLD before procedure,the MLDs of instant after procedure in both Firebird2 group[( 2. 83 ± 0. 35) mm vs( 0. 33 ± 0. 14) mm] and AVI group[( 2. 80 ± 0. 34) mm vs( 0. 32 ± 0. 12) mm] increased significantly,so there were no significant difference in early gains of MLD in two groups [( 2. 50 ± 0. 35) mm vs( 2. 49 ± 0. 30) mm,P > 0. 05) ]. Compared with DSs before procedure,the DSs of instant after procedure in both Firebird 2group [( 88. 96 ± 4. 55) % vs( 5. 53 ± 1. 41) %,P < 0. 05) ] and AVI group [( 89. 38 ± 3. 65) % vs( 5. 08 ± 1. 66) %,P < 0. 05) ] decreased significantly,but there was no significant difference in the improvement of DS between two groups( P > 0. 05).( 3) Coronary angiography 6 months after procedure in Firebird 2 group and AVI group showed that there were no significant differences in MLD [( 2. 70 ± 0. 35) mm vs( 2. 67 ± 0. 34) mm],late luminal loss( 0. 14 ± 0. 03) mm vs( 0. 14 ± 0. 03) mm,RR( 1. 32% vs 1. 39%) and the incidence of MACE in hospital stay and follow-up period( 6. 25% vs5. 56%)( all P < 0. 05),while there was significant difference in DS [( 10. 62 ± 1. 81) % vs( 9. 78 ± 2. 09) %,P <0. 05].( 4) MACE in hospital stay and follow-up period was follows: during hospital stay,one case died in Firebird 2 group( 0. 89%),and one case died in AVI group( 2. 1%); at the third day after procedure,acute myocardial infarction occurred in one case in AVI group who was confirmed as sub-acute stent thrombosis by coronary angiography again; in follow-up period,angina pectoris attacks were two cases in Firebird 2 group and three cases in AVI group,and there was one case needed to implant drug eluting stents again in each group. Conclusion The short-term and mid-term therapeutic effects and safety of AVI stent and Firebird 2 stent are similar for PCI treatment of coronary disease,but AVI stent is superior to Firebird 2stent in preventing mid-term re-stenosis.