NewYork Presbyterian Hospital, Columbia University Medical Center, New York, New York; Cardiovascular Research Foundation, New York, New York.
Catheter Cardiovasc Interv. 2013 Sep 1;82(3):352-9. doi: 10.1002/ccd.24630. Epub 2013 Mar 9.
The provisional approach for bifurcation stenting with side-branch balloon angioplasty is associated with dissections and suboptimal results requiring kissing balloon techniques or bailout stenting. We hypothesized that using a scoring balloon for the side branch and a drug-eluting stent for the main vessel might improve outcomes of true bifurcation lesions.
A total of 93 patients with complex bifurcations were enrolled in a multicenter, single-arm, prospective clinical trial. A drug-eluting stent was deployed in the main vessel following dilatation of the side-branch stenosis with a scoring balloon. The overall angiographic success rate was 93.5%, and procedural success rate was 91.4%. The final diameter stenosis was 13.9% ± 7.2% for the main vessel and 33.3% ± 22.9% for the side branch. Crossover to stent deployment in the side branch was required in 10.8%. The postscoring balloon dissection rate was 8.2% and 6% (all ≤ class C) for the main vessel and side branch respectively, which was reduced to 1.1 and 2.1% poststenting. At 9-month follow-up, the composite MACE rate [cardiac death, myocardial infarction, or target lesion revascularization (TLR)] was 5.4%, including a TLR rate of 3.3% (1.1% from hospital discharge to 9 months).
The 9-month results of the AGILITY trial support a simple provisional strategy for treating complex true bifurcation lesions with deployment of a drug-eluting stent in the main vessel after dilatation of the side-branch vessel with a scoring balloon. This strategy was associated with excellent and safe procedural results, a low rate of crossover to side-branch stenting, and favorable outcomes.
采用边支球囊血管成形术的分叉支架置入术的临时方法与夹层和不理想的结果相关，需要采用对吻球囊技术或挽救性支架置入术。我们假设，使用边支的切割球囊和主血管的药物洗脱支架可能会改善真正分叉病变的结果。
共纳入 93 例复杂分叉病变患者，进行了一项多中心、单臂、前瞻性临床试验。边支狭窄采用切割球囊扩张后，在主血管内置入药物洗脱支架。总的血管造影成功率为 93.5%，手术成功率为 91.4%。主血管的最终直径狭窄率为 13.9%±7.2%，边支为 33.3%±22.9%。10.8%的患者需要边支支架置入。主血管和边支的 postscoring balloon 夹层发生率分别为 8.2%和 6%（均为 ≤ C 类），支架置入后分别降低至 1.1%和 2.1%。9 个月随访时，复合终点事件（MACCE）发生率为 5.4%，包括 3.3%的靶病变血运重建（TLR）（1.1%的患者从出院到 9 个月）。
AGILITY 试验的 9 个月结果支持一种简单的临时策略，即采用切割球囊扩张边支血管后，在主血管内置入药物洗脱支架治疗复杂的真性分叉病变。该策略具有出色且安全的手术结果、较低的边支支架置入率和良好的预后。
