Hansen Kirstine Nørregaard, Trøan Jens, Maehara Akiko, Noori Manijeh, Hougaard Mikkel, Ellert-Gregersen Julia, Veien Karsten Tange, Junker Anders, Hansen Henrik Steen, Lassen Jens Flensted, Jensen Lisette Okkels
Department of Cardiology, Odense University Hospital, Denmark (K.N.H., J.T., M.N., M.H., J.E.-G., K.T.V., A.J., H.S.H., J.F.L., L.O.J.).
University of Southern Denmark, Odense (K.N.H., M.N., H.S.H., J.F.L., L.O.J.).
Circ Cardiovasc Interv. 2025 Jan;18(1):e014665. doi: 10.1161/CIRCINTERVENTIONS.124.014665. Epub 2025 Jan 21.
Bioresorbable scaffolds (BRS) were developed to overcome limitations related to late stent failures of drug-eluting stents, but lumen reductions over time after implantation of BRS have been reported. This study aimed to investigate if lesion preparation with a scoring balloon compared with a standard noncompliant balloon minimizes lumen reduction after implantation of a Magmaris BRS assessed with optical coherence tomography and intravascular ultrasound.
Eighty-two patients with stable angina were randomized in a ratio of 1:1 to lesion preparation with a scoring balloon versus a standard noncompliant balloon before implantation of a Magmaris BRS. The primary end point was minimal lumen area at 6-month follow-up.
Following Magmaris BRS implantation, minimal lumen area (6.4±1.6 versus 6.3±1.5 mm; =0.65), mean scaffold area (7.8±1.5 versus 7.5±1.7 mm; =0.37), and mean lumen area (8.0±1.6 versus 7.7±2.1 mm; =0.41) did not differ significantly in patients with lesions prepared with scoring versus standard noncompliant balloon, respectively. Six-month angiographic follow-up with optical coherence tomography and intravascular ultrasound was available in 74 patients. The primary end point, 6-month minimal lumen area, was significantly larger in lesions prepared with a scoring balloon compared with a standard noncompliant balloon (4.7±1.4 versus 3.9±1.9 mm; =0.04), whereas mean lumen area (7.2±1.4 versus 6.8±2.2 mm; =0.35) did not differ significantly. Intravascular ultrasound findings showed no difference in mean vessel area at the lesion site from baseline to follow-up in the scoring balloon group (16.8±2.9 versus 17.0±3.6 mm; =0.62), whereas mean vessel area (17.1±4.4 versus 15.7±4.9 mm; <0.001) was smaller in lesions prepared with a standard noncompliant balloon due to negative remodeling.
Lesion preparation with a scoring balloon before implantation of a Magmaris BRS resulted in a significantly larger minimal lumen area after 6 months due to less negative remodeling compared with lesion preparation with a standard noncompliant balloon.
URL: https://www.clinicaltrials.gov; Unique identifier: NCT04666584.
生物可吸收支架（BRS）的研发是为了克服与药物洗脱支架晚期支架故障相关的局限性，但有报道称BRS植入后管腔会随时间减少。本研究旨在调查与标准非顺应性球囊相比，使用刻痕球囊进行病变预处理是否能在植入Magmaris BRS后通过光学相干断层扫描和血管内超声评估将管腔减少最小化。
82例稳定型心绞痛患者按1:1比例随机分为两组，分别在植入Magmaris BRS前使用刻痕球囊或标准非顺应性球囊进行病变预处理。主要终点是6个月随访时的最小管腔面积。
植入Magmaris BRS后，使用刻痕球囊与标准非顺应性球囊预处理病变的患者，其最小管腔面积（6.4±1.6对6.3±1.5mm²；P = 0.65）、平均支架面积（7.8±1.5对7.5±1.7mm²；P = 0.37）和平均管腔面积（8.0±1.6对7.7±2.1mm²；P = 0.41）均无显著差异。74例患者进行了6个月的光学相干断层扫描和血管内超声血管造影随访。主要终点，即6个月时的最小管腔面积，使用刻痕球囊预处理的病变明显大于使用标准非顺应性球囊预处理的病变（4.7±1.4对3.9±1.9mm²；P = 0.04），而平均管腔面积（7.2±1.4对6.8±2.2mm²；P = 0.35）无显著差异。血管内超声检查结果显示，刻痕球囊组病变部位的平均血管面积从基线到随访无差异（16.8±2.9对17.0±3.6mm²；P = 0.62），而使用标准非顺应性球囊预处理的病变由于负性重塑，平均血管面积（17.1±4.4对15.7±4.9mm²；P < 0.001）较小。
与使用标准非顺应性球囊进行病变预处理相比，在植入Magmaris BRS前使用刻痕球囊进行病变预处理，由于负性重塑较少，6个月后最小管腔面积明显更大。
