Seiler Thomas, Attinger-Toller Adrian, Cioffi Giacomo Maria, Madanchi Mehdi, Teufer Mario, Wolfrum Mathias, Moccetti Federico, Toggweiler Stefan, Kobza Richard, Bossard Matthias, Cuculi Florim
Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland.
Cardiology Division, Heart Center, Luzerner Kantonsspital, Luzern, Switzerland; Medical School, University of Zurich, Zurich, Switzerland.
Cardiovasc Revasc Med. 2023 Jan;46:29-35. doi: 10.1016/j.carrev.2022.08.018. Epub 2022 Aug 20.
Treatment of in-stent restenosis (ISR) is challenging and treatment failure rate remains high. Correction of stent under-expansion and neointimal compression using the twin-layer OPN™ highly non-compliant balloon (NCB) at high pressure (>30 atm) may lead to increased luminal gain and thus better clinical outcomes. We evaluated periprocedural safety and clinical long-term outcomes after ISR treatment using the OPN™ NCB in a real-world population.
From an ongoing registry, consecutive ISR patients treated with the OPN™ NCB at a tertiary cardiology center in Switzerland were analyzed. We evaluated procedural efficacy, periprocedural complications, target lesion/vessel failure (TLF/TVF), and major adverse cardiovascular events (MACE).
Totally, 208 ISR lesions were treated in 188 patients (mean age 68 ± 13 years, 78 % males). Most lesions were moderately to heavily calcified (89 %), the majority (70.2 %) had complex lesion characteristics (AHA Type B2/C lesions) and 50.5 % were non-focal ISR lesions. After ISR treatment using high pressure pre- and post-dilatation (mean pressure 33 ± 6 atm) with the OPN™ NCB device, the rate of major complications was low (0.96 % coronary perforation, 4 % major dissections, 1.9 % no-reflow and 0.5 % acute vessel closure). At 1-year follow-up, MACE occurred in 19.7 %; 15.4 % patients had TVF; MI and stent thrombosis was found in 5.9 % and 2.1 % of all patients, respectively; and 5 patients died.
For ISR treatment, using the super non-compliant OPN™ balloon at very high pressures is safe. Moreover, its use might lead to a low rate of TLF/TVF during long-term follow-up, but this requires further evaluation in dedicated comparative trials.
支架内再狭窄（ISR）的治疗具有挑战性，治疗失败率仍然很高。使用双层OPN™高度非顺应性球囊（NCB）在高压（>30个大气压）下纠正支架扩张不足和新生内膜受压可能会导致管腔增益增加，从而带来更好的临床结果。我们在真实世界人群中评估了使用OPN™ NCB治疗ISR后的围手术期安全性和临床长期结果。
从一个正在进行的登记研究中，分析了瑞士一家三级心脏病中心连续接受OPN™ NCB治疗的ISR患者。我们评估了手术疗效、围手术期并发症、靶病变/血管失败（TLF/TVF）和主要不良心血管事件（MACE）。
总共对188例患者（平均年龄68±13岁，78%为男性）的208处ISR病变进行了治疗。大多数病变为中度至重度钙化（89%），大多数（70.2%）具有复杂病变特征（美国心脏协会B2/C型病变），50.5%为非局灶性ISR病变。在使用OPN™ NCB装置进行高压预扩张和后扩张（平均压力33±6个大气压）治疗ISR后，主要并发症发生率较低（冠状动脉穿孔0.96%，严重夹层4%，无复流1.9%，急性血管闭塞0.5%）。在1年随访时，MACE发生率为19.7%；15.4%的患者发生TVF；心肌梗死和支架血栓形成分别在所有患者中的发生率为5.9%和2.1%；5例患者死亡。
对于ISR治疗，在极高压力下使用超非顺应性OPN™球囊是安全的。此外，其使用可能会导致长期随访期间TLF/TVF发生率较低，但这需要在专门的对照试验中进一步评估。
