VA North Texas Healthcare System, University of Texas Southwestern Medical Center at Dallas, Dallas, Texas 75216, USA.
JACC Cardiovasc Interv. 2010 Jul;3(7):742-50. doi: 10.1016/j.jcin.2010.04.012.
The aim of this study was to examine the incidence of clinical events after implantation of the TAXUS Express (Boston Scientific Corporation, Natick, Massachusetts) paclitaxel-eluting stent in saphenous vein graft (SVG) lesions in an unselected patient population.
Saphenous vein grafts have 1-year occlusion rates of 12% to 20%, with >50% failure by 7 to 10 years. Many diseased SVGs are treated by percutaneous coronary intervention to avoid higher-risk reoperation, but bare-metal stents have 35% to 40% historical SVG restenosis rates by 18 months. Reported outcomes of drug-eluting stents in SVG lesions are limited and mainly retrospective.
The ARRIVE (TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance) program compiled data on 7,492 patients receiving > or =1 TAXUS Express (Boston Scientific) stent, including 474 patients with SVG. All cardiac events were monitored with independent adjudication of end points. Patients enrolled at procedure start with no mandated inclusion/exclusion criteria.
The ARRIVE SVG patient 2-year follow-up was 96% complete (457 of 474). The SVG patients had significantly more baseline comorbidities/complex disease than simple-use patients (n = 2,698) undergoing native coronary intervention or other expanded-use patients (n = 4,320 without SVG patients). They had higher 2-year rates of mortality (10.9% vs. 4.2%, p < 0.001), myocardial infarction (5.3% vs. 2.2%, p < 0.001), and Academic Research Consortium definite/probable stent thrombosis (4.7% vs. 1.4%, p < 0.001) than the simple-use group. They also had higher 2-year adverse event rates, including significantly more mortality (10.9% vs. 7.5%, p = 0.008) than other expanded-use patients.
The ARRIVE SVG patients have significantly different baseline risk and higher clinical risk through 2 years than simple-use and other expanded-use patients. Nonetheless, compared with historical SVG revascularization rates, treatment with paclitaxel-eluting stent seems to offer a reasonable therapeutic option in this high-risk group. (TAXUS ARRIVE: TAXUS Peri-Approval Registry: A Multicenter Safety Surveillance Program; NCT00569491) and (TAXUS ARRIVE 2: A Multicenter Safety Surveillance Program; NCT00569751).
本研究旨在观察在未经选择的患者人群中，紫杉醇洗脱支架在静脉桥（SVG）病变中的应用所导致的临床事件的发生率。
静脉桥 1 年闭塞率为 12%至 20%，7 至 10 年内超过 50%的静脉桥失败。许多患病的 SVG 通过经皮冠状动脉介入治疗来避免高风险的再次手术，但裸金属支架在 18 个月时的 SVG 再狭窄率为 35%至 40%。在 SVG 病变中应用药物洗脱支架的报告结果有限，且主要是回顾性的。
ARRIVE（TAXUS 批准前注册：多中心安全性监测）计划对 7492 例接受>或=1 个 TAXUS Express（波士顿科学公司）支架的患者进行了数据汇编，其中 474 例为 SVG 患者。所有心脏事件均通过独立终点裁决进行监测。患者在开始手术时即入组，无强制性纳入/排除标准。
ARRIVE SVG 患者 2 年随访率为 96%（474 例中的 457 例）。与单纯使用患者（n=2698 例）行冠状动脉介入治疗或其他扩大适应证患者（n=4320 例无 SVG 患者）相比，SVG 患者的基线合并症/复杂疾病明显更多。他们的 2 年死亡率（10.9%比 4.2%，p<0.001）、心肌梗死（5.3%比 2.2%，p<0.001）和学术研究联合会（ARC）明确/可能的支架血栓形成（4.7%比 1.4%，p<0.001）的 2 年发生率更高。与单纯使用组相比，他们的 2 年不良事件发生率也更高，包括死亡率（10.9%比 7.5%，p=0.008）也更高。
与单纯使用组和其他扩大适应证组相比，ARRIVE SVG 患者的基线风险和 2 年临床风险显著不同。尽管如此，与静脉桥再血管化的历史发生率相比，紫杉醇洗脱支架治疗似乎为这一高危人群提供了合理的治疗选择。（TAXUS ARRIVE：TAXUS 批准前注册：多中心安全性监测计划；NCT00569491）和（TAXUS ARRIVE 2：多中心安全性监测计划；NCT00569751）。
