Balducelli M, Varani E, Vecchi G, Paloscia L, Manari A, Santarelli A, Cappi B, Shoeib A, Valenti S, Maresta A
Cardiology Department, Catheterization Laboratory, S. Maria delle Croci Hospital, Ravenna, Italy.
Minerva Cardioangiol. 2007 Jun;55(3):281-9.
The aim of this study was to assess the safety of direct coronary stenting, its influence on costs, duration of the procedure, radiation exposure, clinical outcome and the incidence of periprocedural myocardial damage as assessed by enzyme release determination.
We randomized 103 patients (109 lesions) to direct stent implant or stent implant following balloon predilatation. Patients with heavily calcified lesions, bifurcations, total occlusions, left main lesions and very tortuous vessels were excluded. Three samples of blood were drawn; before, 12 and 24 h after the procedure and total CK, CK MB mass and troponin I determination was carried out in a single centralized laboratory.
Direct stenting was successful in 62/62 lesions (100%). No single loss or embolization of the stent occurred. All stents in the group with predilatation were effectively deployed. The immediate post procedure angiographic results were similar with both techniques. Contrast media consumption and procedural time were significantly lower in direct stenting (150+/-82 cc and 30+/-13 min) than in pre-dilated stenting (184+/-85 cc and 36+/-14 min) (P=0.04 and P=0.036 respectively) while fluoroscopy time was similar (9.1+/-12 vs 9.19+/-15 min, P=0.97). The incidence of enzyme release was similar in the groups with only three non Q MI all in the pre-dilated group (P=0.149). Any elevation of CK MB and troponin I occurred in 7% of direct stent vs 12% of pre-dilated group (P=0.66), isolated troponin I elevation in 21% of both groups. Major adverse cardiac events during hospitalization were 0 in direct and 3 in pre-dilated stenting (P=0.66), but there were no significant differences at follow-up at 1, 6 and 12 months between the 2 groups (target lesion revascularization at 12 months 11 vs 14% in the 2 groups respectively).
Direct stenting is as safe as pre-dilated stenting in selected coronary lesions. Acute results and myocardial damage as assessed by enzyme release determination are similar, but procedural costs (as measured by resource consumption) and duration of the procedure are lower in direct stenting. Overall success rate and mid-term clinical outcome are similar with both techniques.
本研究旨在评估直接冠状动脉支架置入术的安全性、其对费用、手术时长、辐射暴露、临床结局的影响以及通过酶释放测定评估的围手术期心肌损伤发生率。
我们将103例患者（109处病变）随机分为直接支架植入组或球囊预扩张后支架植入组。排除重度钙化病变、分叉病变、完全闭塞病变、左主干病变和血管极度迂曲的患者。采集三份血样；分别在术前、术后12小时和24小时采集，总肌酸激酶（CK）、肌酸激酶同工酶质量（CK MB mass）和肌钙蛋白I的测定在单一集中实验室进行。
直接支架置入术在62/62处病变（100%）中成功。未发生支架的丢失或栓塞。预扩张组的所有支架均有效置入。两种技术术后即刻血管造影结果相似。直接支架置入术的造影剂用量和手术时间（分别为150±82毫升和30±13分钟）显著低于预扩张支架置入术（分别为184±85毫升和36±14分钟）（P分别为0.04和0.036），而透视时间相似（9.1±12分钟对9.19±15分钟，P = 0.97）。酶释放的发生率在两组中相似，仅3例非Q波心肌梗死均在预扩张组（P = 0.149）。CK MB和肌钙蛋白I升高的情况在直接支架组为7%，预扩张组为12%（P = 0.66），两组中仅肌钙蛋白I升高的情况均为21%。住院期间直接支架组主要不良心脏事件为0例，预扩张支架组为3例（P = 0.66），但两组在1、6和12个月随访时无显著差异（12个月时两组靶病变血运重建率分别为11%和14%）。
在选定的冠状动脉病变中，直接支架置入术与预扩张支架置入术一样安全。通过酶释放测定评估的急性结果和心肌损伤相似，但直接支架置入术的手术费用（以资源消耗衡量）和手术时长更低。两种技术的总体成功率和中期临床结局相似。
