This study sought to compare the efficacy and safety of optical coherence tomography (OCT)-guided PCI with RA vs OA.
The DIRO (To directly compare RA and OA for calcified lesions, a prospective randomized trial) trial was conducted. We enrolled patients with de novo calcified lesions (arc >180°) assessed by OCT or angiographically moderate or severe calcifications if the OCT catheter could not cross the lesion before any intervention. Eligible patients were randomly 1:1 allocated to lesion preparation with RA vs OA. Stent expansion was defined as the minimum stent area divided by the distal reference area multiplied by 100. Tissue modification was assessed using preatherectomy and postatherectomy OCT images. Procedural outcomes including periprocedural myocardial infarctions were evaluated. Furthermore, clinical events and vascular healing evaluated by OCT at 8 months postprocedure were assessed.
The stent expansion was significantly greater in the RA group vs the OA group (99.5% vs 90.6%; P = 0.02). The maximum atherectomy area was significantly larger in the RA group than in the OA group (1.34 [IQR: 1.02-1.89] mm2 vs 0.83 [IQR: 0.59-1.11] mm2; P = 0.004). The procedural outcomes and clinical events at 8 months did not differ between the groups. The vascular healing was sufficient in both groups.
The prospective randomized DIRO trial revealed that RA could produce a more favorable tissue modification, which may lead to a larger stent expansion than OA in heavily calcified lesions.
目的:本研究旨在比较光学相干断层扫描(OCT)引导的PCI与RA和OA的疗效和安全性。
方法:DIRO(直接比较RA和OA的钙化病变,进行了一项前瞻性随机试验)试验。我们招募了通过OCT评估的新生钙化病变(弧>180°)或如果OCT导管在任何干预前无法穿过病变,则血管造影中度或重度钙化的患者。符合条件的患者被随机1:1分配到RA与OA的病变准备中。支架扩张定义为最小支架面积除以远端参考面积乘以100。使用动脉粥样斑块切除术前和动脉粥样斑块切除术后OCT图像评估组织修饰。评估了手术结果,包括围手术期心肌梗塞。此外,术后8个月通过OCT评估临床事件和血管愈合情况.
结果:RA组的支架扩张明显高于OA组(99.5%vs90.6%;P=0.02)。RA组的最大斑块切除面积明显大于OA组(1.34[IQR:1.02-1.89]mm2vs0.83[IQR:0.59-1.11]mm2;P=0.004)。两组之间的手术结果和8个月时的临床事件没有差异。两组血管愈合都足够。
结论:前瞻性随机DIRO试验表明,RA可以产生更有利的组织修饰,在严重钙化的病变中,这可能导致比OA更大的支架扩张。