Cuculi Florim, Bossard Matthias, Zasada Wojciech, Moccetti Federico, Voskuil Michiel, Wolfrum Mathias, Malinowski Krzysztof Piotr, Toggweiler Stefan, Kobza Richard
Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.
Krakow Cardiovascular Research Institute (KCRI), Krakow, Poland.
Open Heart. 2020 Jan 23;7(1):e001204. doi: 10.1136/openhrt-2019-001204. eCollection 2020.
Stent underexpansion is a predictor of in-stent-restenosis and stent thrombosis. Semi-compliant balloons (SCBs) are generally used for lesion preparation. It remains unknown whether routine predilatation using non-compliant balloons (NCBs) improves stent expansion in ordinary coronary lesions.
The PREdilatation by high-pressure NC balloon catheter for better vessel preparation and Optimal lesion preparation with non-compliant balloons for the implantation of bioresorbable vascular scaffolds studies randomised patients presenting with stable coronary artery disease or non-ST-elevation myocardial infarction requiring stent implantation to lesion preparation using NCBs versus SCBs. Stent expansion index (SEI-minimal luminal area/mean luminal area on optical coherence tomography) and periprocedural complications were compared.
We enrolled 104 patients: 53 patients (54 lesions) vs 51 patients (56 lesions) to the NCB and SCB groups, respectively. Predilatation pressure was higher in the NCB group (24±7 atmospheres (atm) vs 14±3 atm, p<0.0001). Postdilatation using NCBs was performed in 41 (76%) lesions vs 46 (82%) lesions pretreated with NCBs versus SCBs (p=0.57). Similar pressures were used for postdilatation with NCB in both groups (23±8 atm vs 23±9 atm, p=0.65). SEI after stent implantation was 0.88±0.13 in the NCB vs 0.85±0.14 in the SCB group (p=0.18). After postdilatation, SEI increased to 0.94±0.13 in the NCB group vs 0.88±0.13 in the SCB group (p=0.02). No relevant complications occurred.
In simple coronary lesions, predilatation/postdilatation with NCBs at high pressures appears to result in better scaffold and stent expansion. Using SCBs only for predilatation might lead to inadequate stent expansion and postdilatation with NCBs might only partially correct this. Predilatation and postdilatation using NCBs at high pressure is safe.
ClinicalTrials.gov no. NCT03518645.
支架扩张不足是支架内再狭窄和支架血栓形成的一个预测因素。半顺应性球囊（SCB）通常用于病变预处理。对于普通冠状动脉病变，使用非顺应性球囊（NCB）进行常规预扩张是否能改善支架扩张情况尚不清楚。
高压NC球囊导管预扩张以更好地进行血管预处理及使用非顺应性球囊进行最佳病变预处理以植入生物可吸收血管支架研究，将患有稳定型冠状动脉疾病或非ST段抬高型心肌梗死且需要植入支架的患者随机分为使用NCB或SCB进行病变预处理组。比较支架扩张指数（SEI——光学相干断层扫描上的最小管腔面积/平均管腔面积）和围手术期并发症。
我们纳入了104例患者：NCB组53例患者（54处病变），SCB组51例患者（56处病变）。NCB组的预扩张压力更高（24±7个大气压（atm）对14±3 atm，p<0.0001）。41处（76%）病变使用NCB进行后扩张，而使用NCB与SCB预处理的病变分别为46处（82%）（p=0.57）。两组使用NCB进行后扩张的压力相似（23±8 atm对23±9 atm，p=0.65）。NCB组支架植入后的SEI为0.88±0.13，SCB组为0.85±0.14（p=0.18）。后扩张后，NCB组的SEI增至0.94±0.13，SCB组为0.88±0.13（p=0.02）。未发生相关并发症。
在简单冠状动脉病变中，使用NCB进行高压预扩张/后扩张似乎能使支架和生物可吸收血管支架扩张得更好。仅使用SCB进行预扩张可能导致支架扩张不足，而使用NCB进行后扩张可能只能部分纠正这一情况。使用NCB进行高压预扩张和后扩张是安全的。
ClinicalTrials.gov编号：NCT03518645。
