Markovic Sinisa, Kugler Christine, Rottbauer Wolfgang, Wöhrle Jochen
Department of Internal Medicine II, University of Ulm, Ulm, Germany.
J Interv Cardiol. 2017 Aug;30(4):325-330. doi: 10.1111/joic.12392. Epub 2017 Jun 1.
We evaluated clinical results up to 36 months after implantation of Absorb BVS using PSP-technique and compared the outcome of patients with and without diabetes mellitus.
Absorb II demonstrated that interventional treatment of coronary artery disease with bioresorbable vascular scaffolds (BVS) without proper PSP-technique (pre-dilation, proper sizing, and post-dilation) is associated with an increased thrombotic risk, even in simple lesions.
In this prospective study 319 patients with 420 lesions were enrolled and treated with the Absorb BVS. Pre-dilation was mandatory and post-dilation with a high-pressure balloon was performed in patients with a scaffold length >12 mm. Patients were clinically followed up to 3 years. Primary outcome measure was the device-oriented endpoint (DoCE) defined as cardiac death, myocardial infarction not clearly related to a non-target vessel and target lesion revascularization.
DoCE was 5.0%, 7.1%, and 10.0% after 12, 24, and 36 months for the total population. Rate of scaffold thrombosis was 0.5%, 0.8%, and 1.4% after 12, 24, and 36 months. Rate of DoCE was higher in the diabetic subgroup with 9.1%, 12.6%, and 12.9% after 12, 24, and 36 months compared with 4.0% (P = 0.13), 5.6% (P = 0.05), and 9.9% (P = 0.20) in patients without diabetes mellitus.
Patients treated with the Absorb BVS using the PSP-technique show good results up to 3 years with a low rate of scaffold thrombosis. Patients suffering from diabetes mellitus have an increased rate of DoCE compared with non-diabetic patients.
clinicaltrials.gov_NCT02162056.
我们评估了采用PSP技术植入Absorb生物可吸收血管支架（BVS）后36个月内的临床结果，并比较了糖尿病患者和非糖尿病患者的治疗结果。
Absorb II研究表明，即使在简单病变中，使用生物可吸收血管支架（BVS）对冠状动脉疾病进行介入治疗时，如果没有适当的PSP技术（预扩张、合适的尺寸选择和后扩张），血栓形成风险也会增加。
在这项前瞻性研究中，纳入了319例患者的420处病变，并采用Absorb BVS进行治疗。预扩张是必需的，对于支架长度>12 mm的患者，使用高压球囊进行后扩张。对患者进行了长达3年的临床随访。主要结局指标是器械导向终点（DoCE），定义为心源性死亡、与非靶血管无明确关联的心肌梗死以及靶病变血运重建。
总体人群在12、24和36个月时的DoCE分别为5.0%、7.1%和10.0%。支架血栓形成率在12、24和36个月时分别为0.5%、0.8%和1.4%。糖尿病亚组的DoCE率在12、24和36个月时分别为9.1%、12.6%和12.9%，高于非糖尿病患者的4.0%（P = 0.13）、5.6%（P = 0.05）和9.9%（P = 0.20）。
采用PSP技术使用Absorb BVS治疗的患者在长达3年的时间里显示出良好的结果，支架血栓形成率较低。与非糖尿病患者相比，糖尿病患者的DoCE率更高。
clinicaltrials.gov_NCT02162056。
