Department of Cardiology, Ulsan University Hospital, University of Ulsan College of Medicine, Ulsan, South Korea.
Department of Cardiology, Chungnam National University Hospital, Chungnam National University School of Medicine, Daejeon, South Korea.
Clin Cardiol. 2020 Jun;43(6):606-613. doi: 10.1002/clc.23355. Epub 2020 Mar 16.
There are limited data on the clinical value of routine postdilatation using noncompliant balloons after contemporary drug-eluting stent implantation.
Additional postdilatation using noncompliant balloons after everolimus-eluting stent implantation could provide better clinical outcomes.
We randomly assigned 1774 patients with coronary artery disease to undergo additional high-pressure postdilatation using noncompliant balloons and moderate-pressure dilatation using stent balloons after everolimus-eluting stent implantation. The primary endpoint was a composite of death, myocardial infarction (MI), stent thrombosis, and target vessel revascularization (TVR) 2 years after randomization.
The study was discontinued early owing to slow enrollment. In total, 810 patients (406 patients in the high pressure group and 404 in the moderate pressure group) were finally enrolled. At 2 years, the primary endpoint occurred in 3.6% of patients in the high pressure group and in 4.4% of those in the moderate pressure group (P = .537). In addition, no significant differences were observed between the two groups in the occurrence of an individual end point of death (0.8% in the high pressure group vs 1.5% in the moderate group, P = .304), MI (0.2% vs 0.5%, P = .554), stent thrombosis (0% vs 0.2%, P = .316), or TVR (2.8% vs 2.6%, P = .880).
The strategy of routine postdilatation using noncompliant balloons after everolimus-eluting stent implantation did not provide incremental clinical benefits.
在当代药物洗脱支架置入后，使用顺应性差的球囊进行常规后扩张的临床价值数据有限。
在依维莫司洗脱支架置入后使用顺应性差的球囊进行额外的后扩张可能会提供更好的临床结果。
我们随机将 1774 例冠心病患者分为两组，一组在依维莫司洗脱支架置入后使用顺应性差的球囊进行高压后扩张，另一组使用支架球囊进行中压扩张。主要终点是随机分组后 2 年时死亡、心肌梗死（MI）、支架血栓形成和靶血管血运重建（TVR）的复合终点。
由于入组缓慢，研究提前终止。最终共有 810 例患者（高压组 406 例，中压组 404 例）入组。2 年后，高压组患者的主要终点发生率为 3.6%，中压组为 4.4%（P =.537）。此外，两组之间各终点事件的发生率也没有显著差异，包括死亡（高压组 0.8% vs 中压组 1.5%，P =.304）、MI（0.2% vs 0.5%，P =.554）、支架血栓形成（0% vs 0.2%，P =.316）和 TVR（2.8% vs 2.6%，P =.880）。
在依维莫司洗脱支架置入后使用顺应性差的球囊进行常规后扩张的策略并未提供额外的临床益处。
