BACKGROUND Direct stenting without pre-dilation or post-dilation has been advocated for saphenous vein graft percutaneous coronary intervention to decrease the incidence of distal embolization, periprocedural myocardial infarction, and target lesion revascularization. METHODS We performed a post hoc analysis of patients enrolled in the DIVA (Drug-Eluting Stents Versus Bare Metal Stents in Saphenous Vein Graft Angioplasty; NCT01121224) prospective, double-blind, randomized controlled trial. Patients were stratified into stent-only and balloon-stent groups. Primary end point was 12-month incidence of target vessel failure (defined as the composite of cardiac death, target vessel myocardial infarction, or target vessel revascularization). Secondary end points included all-cause death, stent thrombosis, myocardial infarction, and target lesion revascularization during follow-up. RESULTS Of the 575 patients included in this substudy, 185 (32%) patients underwent stent-only percutaneous coronary intervention. Patients in the stent-only versus balloon-stent group had similar baseline characteristics and similar incidence of target vessel failure at 12-months (15% versus 19%; hazard ratio, 1.34 [95% CI, 0.86-2.08]; P=0.19). During long-term follow-up (median of 2.7 years), the incidence of definite stent thrombosis (1% versus 5%; hazard ratio, 9.20 [95% CI, 1.23-68.92]; P=0.0085), the composite of definite or probable stent thrombosis (5% versus 11%; hazard ratio, 2.52 [95% CI, 1.23-5.18]; P=0.009), and target vessel myocardial infarction (8% versus 14%; hazard ratio, 1.92 [95% CI, 1.08-3.40]; P=0.023) was lower in the stent-only group. Multivariable analysis showed that a higher number of years since coronary artery bypass grafting and >1 target saphenous vein graft lesions were associated with increased target vessel failure during entire follow-up, while preintervention Thrombolysis in Myocardial Infarction-3 flow was protective. CONCLUSIONS In patients undergoing percutaneous coronary intervention of de novo saphenous vein graft lesions, there was no difference in target vessel failure at 12 months and long-term follow-up in the stent-only versus the balloon-stent group; however, the incidence of stent thrombosis was lower in the stent-only group, as was target vessel myocardial infarction. Registration: URL: https://www.clinicaltrials.gov. Unique identifier: NCT01121224.

中文翻译：

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大隐静脉移植物经皮冠状动脉介入的仅支架与辅助球囊血管成形术：来自DIVA试验的见解。

背景技术已提倡不进行预扩张或后扩张的直接支架术用于大隐静脉移植物经皮冠状动脉介入治疗，以减少远端栓塞，术中心肌梗塞和靶病变血运重建的发生率。方法我们对前瞻性，双盲，随机对照试验中的DIVA（药物洗脱支架与大隐静脉移植血管成形术中的裸金属支架对比； NCT01121224）的患者进行了事后分析。将患者分为仅支架组和球囊支架组。主要终点是目标血管衰竭（定义为心源性死亡，目标血管心肌梗塞或目标血管血运重建的总和）的12个月发生率。次要终点包括全因死亡，支架血栓形成，心肌梗塞，并在随访期间进行目标病变血运重建。结果在该亚研究的575例患者中，有185例（32％）患者仅接受了支架式经皮冠状动脉介入治疗。仅支架与气囊支架组的患者在12个月时具有相似的基线特征和相似的目标血管衰竭发生率（15％比19％；危险比1.34 [95％CI，0.86-2.08]； P = 0.19 ）。在长期随访（中位值为2.7年）期间，明确的支架内血栓形成发生率（1％比5％；危险比为9.20 [95％CI，1.23-68.92]； P = 0.0085），确定为复合物或可能的支架内血栓形成（5％对11％；危险比，2.52 [95％CI，1.23-5.18]； P = 0.009）和目标血管心肌梗塞（8％对14％；危险比，1.92 [95％CI ，1.08-3.40]； P ＝ 0.023）在仅支架组中较低。多变量分析显示，自从冠状动脉搭桥术和> 1例大隐静脉移植病变以来，更长的年限与整个随访过程中靶血管衰竭的增加相关，而在心肌梗塞3血流中进行干预前溶栓治疗具有保护作用。结论在接受从头大隐静脉移植病变的经皮冠状动脉介入治疗的患者中，仅使用支架的患者与气囊支架组相比，在12个月时的靶血管衰竭和长期随访中无差异。然而，仅支架的组中支架血栓形成的发生率较低，靶血管性心肌梗塞的发生率也较低。注册：URL：https：//www.clinicaltrials.gov。唯一标识符：NCT01121224。在整个随访过程中，有1个目标隐性大隐静脉移植物病变与目标血管衰竭增加有关，而在心肌梗塞3血流中的介入前溶栓治疗具有保护作用。结论在接受从头大隐静脉移植病变的经皮冠状动脉介入治疗的患者中，仅使用支架的患者与气囊支架组相比，在12个月时的靶血管衰竭和长期随访中无差异。然而，仅支架的组中支架血栓形成的发生率较低，靶血管性心肌梗塞的发生率也较低。注册：URL：https：//www.clinicaltrials.gov。唯一标识符：NCT01121224。在整个随访过程中，有1个目标大隐静脉移植物病变与目标血管衰竭增加相关，而在心肌梗塞3血流中进行干预前溶栓治疗具有保护作用。结论在接受从头大隐静脉移植病变的经皮冠状动脉介入治疗的患者中，仅使用支架的患者与气囊支架组相比，在12个月时的靶血管衰竭和长期随访中无差异。然而，仅支架的组中支架血栓形成的发生率较低，靶血管性心肌梗塞的发生率也较低。注册：URL：https：//www.clinicaltrials.gov。唯一标识符：NCT01121224。结论在接受从头大隐静脉移植病变的经皮冠状动脉介入治疗的患者中，仅使用支架的患者与气囊支架组相比，在12个月时的靶血管衰竭和长期随访中无差异。然而，仅支架的组中支架血栓形成的发生率较低，靶血管性心肌梗塞的发生率也较低。注册：URL：https：//www.clinicaltrials.gov。唯一标识符：NCT01121224。结论在接受从头大隐静脉移植病变的经皮冠状动脉介入治疗的患者中，仅使用支架的患者与气囊支架组相比，在12个月时的靶血管衰竭和长期随访中无差异。然而，仅支架的组中支架血栓形成的发生率较低，靶血管性心肌梗塞的发生率也较低。注册：URL：https：//www.clinicaltrials.gov。唯一标识符：NCT01121224。