超高压球囊与切割球囊预处理重度钙化病变冠状动脉：ISAR-CALC 随机试验
Super high-pressure balloon versus scoring balloon to prepare severely calcified coronary lesions: the ISAR-CALC randomised trial.
机构信息
Klinik für Herz- und Kreislauferkrankungen, Deutsches Herzzentrum München, Munich, Germany.
出版信息
EuroIntervention. 2021 Aug 27;17(6):481-488. doi: 10.4244/EIJ-D-20-01000.
BACKGROUND
The comparative efficacy of balloon-based techniques to prepare severely calcified coronary lesions before stenting remains poorly studied.
AIMS
We sought to compare stent expansion following preparation of severely calcified coronary lesions with either a super high-pressure balloon or a scoring balloon.
METHODS
In this randomised, open-label trial, patients with severely calcified coronary lesions were enrolled at five centres in Germany and Switzerland. After unsuccessful lesion preparation with a standard non-compliant balloon (<30% reduction of baseline diameter stenosis), participants were randomised to predilation with either a super high-pressure balloon or a scoring balloon before drug-eluting stent (DES) implantation. The primary endpoint of the study was stent expansion index as assessed by optical coherence tomography (OCT). The key secondary endpoints included angiographic, strategy and procedural success.
RESULTS
OCT data after DES implantation were available for 70 out of 74 patients (94.6%) enrolled. Lesion preparation with a super high-pressure balloon versus a scoring balloon led to a comparable stent expansion index (0.72±0.12 vs 0.68±0.13; p=0.22). Compared with the scoring balloon, the super high-pressure balloon increased the minimum lumen diameter (2.83±0.34 mm vs 2.65±0.36 mm; p=0.03) and reduced the diameter stenosis (11.6±4.8% vs 14.4±5.6%; p=0.02) without difference in terms of angiographic success (100% vs 97.3%; p>0.99). Strategy success (91.9% vs 83.8%; p=0.48) and procedural success (100% vs 89.2%; p=0.12) were numerically more frequent with the super high-pressure balloon versus the scoring balloon.
CONCLUSIONS
In patients with severely calcified coronary artery lesions, preparation with a super high-pressure balloon versus a scoring balloon was associated with comparable stent expansion on intravascular imaging and a trend towards improved angiographic performance. Visual summary. A ComparIson of Strategies to PrepAre SeveRely CALCified Coronary Lesions: the ISAR-CALC randomised trial.
背景
在支架置入前，球囊为基础的技术处理严重钙化病变的疗效比较仍研究甚少。
目的
我们旨在比较在严重钙化病变预处理时，应用高压力球囊和切割球囊对支架扩张的影响。
方法
在这项随机、开放标签的临床试验中，德国和瑞士的五家中心纳入了严重钙化病变患者。在使用标准非顺应性球囊预处理（狭窄直径减少＜30%）失败后，患者被随机分配到高压力球囊或切割球囊预扩张，然后再行药物洗脱支架（DES）植入。该研究的主要终点是应用光学相干断层成像术（OCT）评估的支架扩张指数。关键次要终点包括血管造影、策略和手术成功率。
结果
共 74 例患者入选，70 例（94.6%）患者术后行 DES 植入并获得 OCT 数据。高压力球囊与切割球囊预处理后的支架扩张指数相当（0.72±0.12 vs 0.68±0.13；p=0.22）。与切割球囊相比，高压力球囊增加了最小管腔直径（2.83±0.34 mm vs 2.65±0.36 mm；p=0.03）和降低了狭窄程度（11.6±4.8% vs 14.4±5.6%；p=0.02），但两组的血管造影成功率无差异（100% vs 97.3%；p＞0.99）。高压力球囊的策略成功率（91.9% vs 83.8%；p=0.48）和手术成功率（100% vs 89.2%；p=0.12）略高于切割球囊。
结论
在严重钙化冠状动脉病变患者中，与切割球囊相比，高压力球囊预处理后支架扩张指数相当，且在血管造影表现上有改善趋势。
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