Seabra-Gomes R, Farto eAbreu P, Marques A L, Pereira H, da Cunha J A, Carvalho H, Ribeiro V G, Garcia L M, Mourão L, dos Santos L P, Providência L, Figueiredo L, Almeida M, Cavaco D
Instituto do Coração Av. Prof. Reynaldo dos Santos, 27 Carnaxide-2795-523 Linda-a-Velha Portugal.
Rev Port Cardiol. 2001 Sep;20(9):819-37.
Stents are being used with increasing frequency in percutaneous transluminal coronary angioplasty (PTCA) but their use in small vessels is still controversial, due to the possibility of excessively high rates of adverse events and restenosis.
To assess the safety and clinical efficacy of ACS RX Multi-Link (ML) 2.5 mm stents, in "de novo" coronary stenosis.
Prospective Registry, with 6 months clinical follow-up, involving all Portuguese centers of Interventional Cardiology.
Between April 7 and November 20 1998, 102 patients were enrolled, 82 male and with ages ranging from 30 to 86 years (average 58 +/- 11). Clinical presentation for PTCA was stable angina in 53%, unstable angina in 36% and silent ischemia in 11%. There was a history of previous myocardial infarction in 29% of patients. The main risk factors were hypertension (58%), hyperlipidemia (57%), smoking (25%) and diabetes (20%). Multivessel coronary artery disease was present in 46% of patients and left ventricular function was normal in 89%. Of the 217 existing lesions, 188 (87%) were treated: 35 with balloon angioplasty and 153 with stent implantation, 114 of which were ML 2.5 mm: 79 of 15 mm in length and 35 of 25 mm.
Angiographic success with ML stent implantation and major adverse cardiac events (MACE)--myocardial infarction (MI), coronary artery bypass graft (CABG), new target vessel revascularizations and death--were evaluated during hospital stay, and at 1 and 6 months clinical follow-up.
Angiographic success was 97.4%. In one patient it was not possible to cross the lesion, in another there was stent migration and in a third distal coronary flow after stenting was TIMI grade 1. Clinical success was 96.1% and there were no cases of death, Q-wave MI or urgent CABG. Two patients had non-Q wave MI and two required urgent repeat angioplasty. Subacute stent thrombosis occurred in 1 patient. There were no additional MACE at 1 month follow-up. At 6-month follow-up (in 97% of patients) MACE had occurred in 14.1%: 2 deaths (one non-cardiac), 3 MI (one non-Q) and 14 new PTCA (one in a non-ML stent). There was no need for CABG in any patient. Six-month survival rate was 97.9%, 94.9% were free of infarction and 84.8% were free of infarction and new revascularization.
Multi-Link 2.5 mm stent implantation appears to be safe and efficient with a low incidence of immediate and 6-month adverse events in the range of centers and operators of the Registry.
在经皮腔内冠状动脉成形术（PTCA）中，支架的使用频率越来越高，但由于不良事件和再狭窄发生率可能过高，其在小血管中的应用仍存在争议。
评估ACS RX多链接（ML）2.5毫米支架在“初发”冠状动脉狭窄中的安全性和临床疗效。
前瞻性登记研究，进行6个月的临床随访，纳入了葡萄牙所有介入心脏病学中心。
1998年4月7日至11月20日期间，共纳入102例患者，其中82例为男性，年龄在30至86岁之间（平均58±11岁）。PTCA的临床表现为稳定型心绞痛占53%，不稳定型心绞痛占36%，无症状性心肌缺血占11%。29%的患者有既往心肌梗死病史。主要危险因素为高血压（58%）、高脂血症（57%）、吸烟（25%）和糖尿病（20%）。46%的患者存在多支冠状动脉疾病，89%的患者左心室功能正常。在217处现有病变中，188处（87%）接受了治疗：35处采用球囊血管成形术，153处采用支架植入术，其中114处植入的是ML 2.5毫米支架：79处长度为15毫米，35处长度为25毫米。
在住院期间以及1个月和6个月的临床随访中，评估ML支架植入的血管造影成功率和主要不良心脏事件（MACE）——心肌梗死（MI）、冠状动脉旁路移植术（CABG）、新的靶血管血运重建和死亡情况。
血管造影成功率为97.4%。1例患者无法穿过病变，另1例出现支架移位，第3例患者支架置入后远端冠状动脉血流为TIMI 1级。临床成功率为96.1%，无死亡、Q波心肌梗死或紧急冠状动脉旁路移植术病例。2例患者发生非Q波心肌梗死，2例需要紧急重复血管成形术。1例患者发生亚急性支架血栓形成。1个月随访时无其他MACE事件。在6个月随访时（97%的患者），MACE发生率为14.1%：2例死亡（1例非心脏原因），3例心肌梗死（1例非Q波），14例新的PTCA（1例在非ML支架）。所有患者均无需进行冠状动脉旁路移植术。6个月生存率为97.9%，94.9%的患者无梗死，84.8%的患者无梗死且无新的血运重建。
在登记研究的中心和操作人员范围内，多链接2.5毫米支架植入术似乎是安全有效的，即刻和6个月不良事件发生率较低。
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