双导丝聚力球囊预扩张对小血管支架置入术的影响

Effect of dual-wire focused force balloon predilation and drug-eluting stent placement for lesions of small coronary arteries

目的探讨双导丝聚力球囊预扩张较普通球囊能否降低小血管支架置入术围术期并发症及改善支架置入术远期预后。方法连续入选冠状动脉造影显示小血管病变（参考血管直径≤2．75mm）需行冠状动脉介入治疗的患者300例，完全随机分成研究组和对照组，每组150例。研究组：双导丝聚力球囊预扩张后置人支架；对照组：普通球囊预扩张后置人支架。观察冠状动脉介入治疗即刻成功率、血管并发症发生率。9-12个月复查冠状动脉造影，观察靶病变再狭窄发生率，12个月内不良心血管事件（MACE）发生率。结果研究组与对照组冠状动脉介入治疗手术成功率分别为98．7％（148例）与94．7％（142例），手术并发症发生率分别为1．3％（2例）与5．3％（8例），组间差异有统计学意义（均P〈0．05）。9-12个月复查冠状动脉造影，研究组和对照组的MACE发生率分别为3．4％（5／148）和7．O％（10／142），组间差异无统计学意义（P〉0．05）。结论双导丝聚力球囊较普通球囊扩张可降低小血管支架置入术围术期手术并发症，并具有改善支架置入术远期预后的趋势。

Objective To assess the effect of dual-wire focused force balloon predilation followed by drug- eluting stent placement for lesions of small coronary arteries. Methods Through coronary angiography, 300 consec- utive patients with unstable angina（ reference vessel ≤2.75 mm in diameter） were randomly assigned to experimen- tal group （dual-wire focused force balloon predilation group） and control group （balloon predilation group）. Rest- enosis at 9-12 month were followed up through angiography. Clinic improvement and major adverse cardiac event （MACE） at 1 year were assessed. Results Procedural success was achieved in 98.7% （148/150） of patients as- signed to experimental group and in 94.7% （142/150） of patients assigned to control group （P 〈 0.05 ）. Vessels complications in these two groups were 1.3% （2/150） and 5.3% （8/150） respectively （P 〈0.05）. Less patients in experimental group experienced major adverse cardiac event [ 5/148 （ 3.4% ） vs 10/142 （ 7.0% ）, P 〉 0.05 ]. There was no statistical difference between these two groups regarding restenosis and MACE, but the procedural suc- cess rate and vessel complications were different. Conclusion Dual-wire focused force balloon predilation reduced the incidence of perioperatine complications and provided tendency of improving outcomes followed by drug-eluting stent placement in small vessels.