Miketic S, Carlsson J, Tebbe U
Department of Cardiology, Klinikum Lippe-GmbH, Detmold, Germany.
Heart. 2002 Dec;88(6):622-6. doi: 10.1136/heart.88.6.622.
To compare in a randomised trial the procedural and clinical outcome and long term patency of conventional angioplasty with optional stent implantation versus direct stenting without predilatation.
Patients undergoing coronary intervention for symptomatic coronary artery disease were randomly assigned to conventional angioplasty with optional stenting or to direct stent implantation without predilatation. The post-stent treatment consisted of antiplatelets. Follow up angiography was performed six months after the initial procedure.
Between December 1998 and August 1999, 181 of 190 eligible patients were randomly assigned to either optional stenting (n = 92) or direct stenting (n = 89). The procedural success was similar in both groups (87 (97.8%) in the optional v 87 (94.6%) in direct stenting group, p = 0.88). There were five cases of crossover from the direct stenting to the optional stenting group. Six patients experienced a Q wave myocardial infarction without further complications (4 in the optional v 2 in the direct stenting group, p = 0.36). One patient in whom coronary angioplasty failed underwent elective bypass surgery. No patients required urgent bypass surgery and no patients died. The reduction in late luminal loss (mean (SD) 1.19 (0.87) mm in the optional v 0.62 (0.69) mm in the direct stenting group, p = 0.004) led to a significant improvement in minimal luminal diameter at follow up (1.87 (0.93) mm in the optional v 2.56 (0.86) mm in the direct stenting group, p = 0.002), resulting in a significant reduction in restenosis rate, defined as > 50% diameter stenosis at follow up 6.5 (2.1) months after the initial procedure (28 (30.4%) in the optional v 14 (15.7%) in the direct stenting group, p = 0.019). Direct stenting significantly reduced the overall procedure and fluoroscopy times, the amount of contrast medium used, and the number of angioplasty catheters needed. The incidence of clinical events during the six month follow up did not differ significantly between the groups. No patient died during follow up.
Direct stent implantation without predilatation significantly reduced late luminal loss, giving a better improvement in minimal luminal diameter and restenosis rate than with optional stenting. There were five patients in whom direct stenting failed who needed predilatation followed by stent implantation. However, in most patients direct stent implantation without predilatation is a feasible treatment option with a favourable long term outcome and a low incidence of complication. The procedure may help to reduce the cost of coronary interventions by reducing overall procedure and fluoroscopy times, the amount of contrast medium used, and the number of angiography catheters needed.
在一项随机试验中比较常规血管成形术加选择性支架植入与直接支架植入（不进行预扩张）的操作和临床结果以及长期通畅率。
因症状性冠状动脉疾病接受冠状动脉介入治疗的患者被随机分配至常规血管成形术加选择性支架植入组或直接支架植入（不进行预扩张）组。支架置入后的治疗包括使用抗血小板药物。在初始操作6个月后进行随访血管造影。
1998年12月至1999年8月期间，190例符合条件的患者中有181例被随机分配至选择性支架植入组（n = 92）或直接支架植入组（n = 89）。两组的操作成功率相似（选择性支架植入组为87例（97.8%），直接支架植入组为87例（94.6%），p = 0.88）。有5例从直接支架植入组交叉至选择性支架植入组。6例患者发生Q波心肌梗死且无进一步并发症（选择性支架植入组4例，直接支架植入组2例，p = 0.36）。1例冠状动脉血管成形术失败的患者接受了择期搭桥手术。无患者需要紧急搭桥手术，也无患者死亡。晚期管腔丢失的减少（选择性支架植入组平均（标准差）为1.19（0.87）mm，直接支架植入组为0.62（0.69）mm，p = 0.004）导致随访时最小管腔直径显著改善（选择性支架植入组为1.87（0.93）mm，直接支架植入组为2.56（0.86）mm，p = 0.002），导致再狭窄率显著降低，再狭窄定义为初始操作后6.5（2.1）个月随访时直径狭窄> 50%（选择性支架植入组为28例（30.4%），直接支架植入组为14例（15.7%），p = 0.019）。直接支架植入显著缩短了总体操作时间和透视时间，减少了造影剂用量以及所需血管成形术导管的数量。两组在6个月随访期间的临床事件发生率无显著差异。随访期间无患者死亡。
直接支架植入（不进行预扩张）显著减少了晚期管腔丢失，与选择性支架植入相比，在最小管腔直径和再狭窄率方面有更好的改善。有5例直接支架植入失败的患者需要进行预扩张然后植入支架。然而，对于大多数患者而言，直接支架植入（不进行预扩张）是一种可行的治疗选择，具有良好的长期结果和低并发症发生率。该操作可通过减少总体操作时间和透视时间、造影剂用量以及所需血管造影导管的数量来帮助降低冠状动脉介入治疗的成本。
