Alfonso Fernando, Cuesta Javier, Ojeda Soledad, Camacho-Freire Santiago, García Del Blanco Bruno, Vaquerizo Beatriz, Zueco Javier, Trillo Ramiro, Mauri Josepa, Velázquez Maite, Córdoba-Soriano Juan G, Serra Antonio, Navarro Felipe, Pan Manuel, Díaz José, Otaegui Imanol, Salvatella Neus, De la TorreHernandez Jose M, Val David Del, Bastante Teresa, Rivero Fernando
Hospital Universitario de la Princesa, IIS-IP, CIBER-CV, Madrid, Spain.
Hospital Universitario de la Princesa, IIS-IP, CIBER-CV, Madrid, Spain.
Am J Cardiol. 2022 Jan 1;162:31-40. doi: 10.1016/j.amjcard.2021.09.027.
Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, n = 309) and RIBS V (BMS - ISR, n = 189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, p = 0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, p = 0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).
目前，药物洗脱支架（DES）和药物洗脱球囊均被推荐用于金属支架置入术后再狭窄（ISR）的患者。然而，生物可吸收血管支架（BVS）再狭窄患者重复干预的临床结果仍未明确。我们试图评估BVS-ISR患者与DES和裸金属支架（BMS）ISR患者干预的结果。再狭窄支架内：生物可吸收血管支架再狭窄的治疗（RIBS VII）是一项前瞻性多中心研究（23个西班牙中心），纳入了117例连续接受BVS-ISR治疗的患者。纳入/排除标准与既往RIBS研究相似。RIBS IV（DES-ISR，n = 309）和RIBS V（BMS-ISR，n = 189）随机试验中的患者用作对照。大多数BVS-ISR患者接受了DES治疗（76%）。BVS-ISR患者比DES-ISR和BMS-ISR患者更年轻，血管更大，干预后节段内残余直径狭窄更高（分别为19±13%、15±11%、15±12%，p<0.001）。在1年临床随访（100%患者获得）时，靶病变血运重建（6%）与DES-ISR和BMS-ISR患者相似（8.7%和3.7%，p = 0.32）。无死亡、心肌梗死和靶血管血运重建（主要临床终点）为8.5%，也与DES-ISR和BMS-ISR患者相似（14.2%和7.4%，p = 0.09）。当仅比较每组中接受DES治疗的患者时结果也相似，在调整基线特征中的潜在混杂因素后保持不变。发生BVS-ISR的时间不影响血管造影或临床结果。本研究证明了冠状动脉介入治疗BVS-ISR患者的安全性和有效性。这些患者的1年临床结果与金属支架ISR患者相似（ClinicalTrials.gov标识符：NCT03167424）。
