依维莫司洗脱支架用于裸金属和药物洗脱支架内再狭窄患者：RIBS IV和V试验患者水平汇总分析结果
Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.
作者信息
Alfonso Fernando, Pérez-Vizcayno María José, García Del Blanco Bruno, García-Touchard Arturo, López-Mínguez José-Ramón, Masotti Mónica, Zueco Javier, Melgares Rafael, Mainar Vicente, Moreno Raul, Domínguez Antonio, Sanchís Juan, Bethencourt Armando, Moreu José, Cequier Angel, Martí Vicens, Otaegui Imanol, Bastante Teresa, Gonzalo Nieves, Jiménez-Quevedo Pilar, Cárdenas Alberto, Fernández Cristina
机构信息
From the Hospital Universitario de La Princesa, Madrid, Spain (F.A., T.B.); Hospital Universitario Clínico San Carlos, Madrid, Spain (M.J.P.-V., N.G., P.J.-Q., A. Cárdenas, C.F.); Fundación Interhospitalaria Investigación Cardiovascular, Madrid, Spain (M.J.P.-V.); Hospital Universitario Vall d'Hebron, Barcelona, Spain (B.G.d.B., I.O.); Hospital Universitario Puerta de Hierro-Majadahonda, Madrid, Spain (A.G.-T.); Hospital Universitario Infanta Cristina, Badajoz, Spain (J.-R.L.-M.); Hospital Universitario Clinic de Barcelona, Spain (M.M.); Hospital Universitario Marqués de Valdecilla, Santander, Spain (J.Z.); Hospital Universitario Virgen de las Nieves, Granada, Spain (R. Melgares); Hospital Universitario de Alicante, Spain (V. Mainar); Hospital Universitario La Paz, Madrid, Spain (R. Moreno); Hospital Universitario Virgen de la Victoria, Málaga, Spain (A.D.); Hospital Universitario Clínico de Valencia, Spain (J.S.); Hospital Universitario Son Espases, Palma de Mallorca, Spain (A.B.); Hospital Universitario Virgen de la Salud Toledo, Spain (J.M.); Hospital Universitario de Bellvitge, Barcelona, Spain (A. Cequier); and Hospital Universitario de San Pau, Barcelona, Spain (V. Martí).
出版信息
Circ Cardiovasc Interv. 2016 Jul;9(7). doi: 10.1161/CIRCINTERVENTIONS.115.003479.
BACKGROUND
Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled.
METHODS AND RESULTS
A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group.
CONCLUSIONS
This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR.
CLINICAL TRIAL REGISTRATION
URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.
背景
药物洗脱支架（DES）置入后支架内再狭窄（ISR）患者的治疗比裸金属支架ISR患者更具挑战性。然而，依维莫司洗脱支架（EES）在这些不同情况下的结果仍未明确。
方法与结果
使用患者层面的数据对RIBS IV（药物洗脱支架内再狭窄：紫杉醇洗脱球囊与依维莫司洗脱支架对比）和RIBS V（裸金属支架内再狭窄：紫杉醇洗脱球囊与依维莫司洗脱支架对比）随机试验进行汇总分析，以比较EES在裸金属支架ISR和DES-ISR中的疗效。两项试验的纳入和排除标准相同。将94例接受EES治疗的裸金属支架ISR患者的结果与155例接受EES治疗的DES-ISR患者的结果进行比较。DES-ISR患者的基线特征更差，尽管他们出现较晚且更频繁地表现为局灶性模式。干预后，DES-ISR组的最小管腔直径（2.22±0.5对2.38±0.5 mm，P=0.01）较小且更狭窄。DES-ISR患者的晚期血管造影结果（89.3%的符合条件患者）较差，包括最小管腔直径（2.03±0.7对2.36±0.6 mm，P<0.001）和直径狭窄（23±22对13±17%，P<0.001）。节段内和病变内分析的结果一致。在多元线性回归分析中，DES-ISR患者随访时的最小管腔直径仍显著较小。最后，在1年临床随访（100%的患者）时，DES-ISR组的死亡率（2.6%对0%，P<0.01）和靶血管血运重建需求（8%对2%，P=0.03）更高。
结论
对RIBS IV和RIBS V随机临床试验进行的这项患者层面的汇总分析表明，EES在ISR患者中可提供良好的结果。然而，EES在DES-ISR患者中的结果不如在裸金属支架ISR患者中令人满意。
临床试验注册
网址：http://www.clinicaltrials.gov。唯一标识符：NCT01239953和NCT01239940。
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