Serruys Patrick W, Daemen Joost, Morice Marie-Claude, De Bruyne Bernard, Colombo Antonio, Macaya Carlos, Richardt Gert, Fajadet Jean, Hamm Christian, Dawkins Keith D, Vranckx Pascal, Bressers Marco, van Domburg Ron, Schuijer Monique, Wittebols Kristel, Pieters Magdaleen, Stoll Hans Peter
Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands.
EuroIntervention. 2008 Jan;3(4):450-9. doi: 10.4244/eijv3i4a81.
Late stent thrombosis has been documented in on- and off-label populations. Stent thrombosis is more frequently in higher risk patients and there is still scarce data about the impact on late adverse cardiac events. The aim therefore is to determine the 3-year safety and effectiveness of Sirolimus-Eluting Stent (SES) (Cypher(R)) implantation in patients with multivessel disease and to compare outcomes with the historical results of the two arms of the Arterial Revascularisation Therapies Study (ARTS-I).
ARTS-II is a 45 centre, 607 patient single-arm study. Three years outcomes were compared to the outcome of the historical cohorts of ARTS-I using the same inclusion and exclusion criteria and major adverse cardiac and cerebrovascular events (MACCE) definitions. Patients were stratified by clinical site to ensure that at least 1/3 had 3-vessel disease to achieve a number of treated lesions per patient comparable to ARTS-I. Stent thrombosis was re-adjudicated using the ARC definitions. An angiographic coronary score to characterise lesion complexity was applied to allow the identification of patients who might benefit the most from multivessel stenting. In ARTS-II, 46.6% of the patients underwent 3-vessel treatment as compared to 18.0% in ARTS-I percutaneous coronary intervention (PCI) (n=600) with bare metal stents (BMS). Diabetes was present in 26.2% in ARTS-II as compared to 17.3% in ARTS-I. In ARTS-II, patients received on average 3.7 stents resulting in a mean total stented length of 72.5 mm. The 3-year survival rate in ARTS-II was 97.0%, comparable to the 95.6% and 96.0% of the historical surgical (n=605) and PCI cohorts of ARTS-I. The death/cerebrovascular accident (CVA)/myocardial infarction (MI) event free survival rate in ARTS-II was 91.7%, versus 89.1% (p=0.1) and 87.2% (p=0.007) in ARTS-I coronary artery bypass graft (CABG) and PCI cohorts, respectively. Freedom from revascularisation in ARTS-II was 85.5%, lower than in ARTS-I CABG (93.4%; p<0.001) but higher than in ARTS-I PCI (73.7%; p<0.001) cohorts. MACCE free survival was 80.6% in ARTS-II, comparable to ARTS-I CABG (83.8%; p=0.21) but superior to ARTS-I PCI (66.0%; p<0.0001). The incidence of stent thrombosis (ARC any) in ART-II was 6.4% (39/607 patients).
Despite the higher clinical and angiographic risk profile, the overall MACCE rate at three years was lower in ARTS-II than in the ARTS-I PCI and comparable to ARTS-I CABG. However, the re-intervention rate in ARTS-I CABG remained significantly lower than in ARTS-II.
已在适应证内和适应证外人群中记录到晚期支架内血栓形成。支架内血栓形成在高危患者中更为常见，关于其对晚期不良心脏事件影响的数据仍然匮乏。因此，本研究旨在确定西罗莫司洗脱支架（SES，商品名Cypher®）植入多支血管病变患者的3年安全性和有效性，并将结果与动脉血运重建治疗研究（ARTS-I）两组的历史结果进行比较。
ARTS-II是一项在45个中心开展的、纳入607例患者的单臂研究。采用相同的纳入和排除标准以及主要不良心脑血管事件（MACCE）定义，将3年结果与ARTS-I历史队列的结果进行比较。根据临床部位对患者进行分层，以确保至少1/3的患者患有三支血管病变，从而使每位患者的治疗病变数量与ARTS-I相当。采用学术研究联盟（ARC）定义对支架内血栓形成进行重新判定。应用血管造影冠状动脉评分来描述病变复杂性，以便识别可能从多支血管支架置入中获益最大的患者。在ARTS-II中，46.6%的患者接受了三支血管治疗，而在ARTS-I中接受裸金属支架（BMS）经皮冠状动脉介入治疗（PCI）（n = 600）的患者中这一比例为18.0%。ARTS-II中26.2%的患者患有糖尿病，而ARTS-I中这一比例为17.3%。在ARTS-II中，患者平均植入3.7枚支架，平均总支架长度为72.5 mm。ARTS-II的3年生存率为97.0%，与ARTS-I历史队列中外科手术组（n = 605）的95.6%以及PCI组的96.0%相当。ARTS-II中无死亡/脑血管意外（CVA）/心肌梗死（MI）事件生存率为91.7%，而ARTS-I冠状动脉旁路移植术（CABG）组和PCI组分别为89.1%（p = 0.1）和87.2%（p = 0.007）。ARTS-II中无需血运重建的比例为85.5%，低于ARTS-I CABG组（93.4%；p < 0.001）但高于ARTS-I PCI组（73.7%；p < 0.001）。ARTS-II中无MACCE生存率为80.6%，与ARTS-I CABG组（83.8%；p = 0.21）相当但优于ARTS-I PCI组（66.0%；p < 0.0001）。ART-II中支架内血栓形成（ARC任何类型）的发生率为6.4%（39/607例患者）。
尽管ARTS-II患者的临床和血管造影风险特征更高，但其3年总体MACCE发生率低于ARTS-I PCI组且与ARTS-I CABG组相当。然而，ARTS-I CABG组的再次干预率仍显著低于ARTS-II组。
