Deutsches Herzzentrum, Technische Universität, Munich Germany.
Heart. 2014 Jan;100(2):153-9. doi: 10.1136/heartjnl-2013-304933. Epub 2013 Nov 22.
Systematic investigation of restenosis after percutaneous coronary intervention (PCI) with bare metal stents (BMS) or first or second generation drug eluting stents (DES) in large scale, broadly inclusive patient populations undergoing follow-up angiography represents a gap in our scientific knowledge. We investigated the incidence of angiographically proven restenosis and its predictors in patients undergoing PCI with stents.
All patients undergoing successful implantation of coronary stents for de novo lesions from 1998 to 2009 and follow-up angiography at 6-8 months at two centres in Munich, Germany were eligible for inclusion. Patients with cardiogenic shock, dialysis dependent renal insufficiency or previous cardiac transplantation were excluded. Data were prospectively collected. The incidence of restenosis, defined as diameter stenosis ≥50% in the in-segment area at follow-up angiography, and its predictors were evaluated.
A total of 12 094 patients met inclusion criteria. Angiographic follow-up was available for 10 004 patients (77.5%) with 15 004 treated lesions. Binary restenosis was detected in 2643 (26.4%) patients. Use of first generation DES versus BMS (OR 0.35, 95% CI 0.31 to 0.39) and second generation DES versus first generation DES (OR 0.67, 95% CI 0.58 to 0.77) were independent predictors of lower rates of restenosis. At multivariate analysis, smaller vessel size (OR 1.59, 95% CI 1.52 to 1.68, for each 0.5 mm decrease), total stented length (OR 1.27, 95% CI 1.21 to 1.33, for each 10 mm increase), complex lesion morphology (OR 1.35, 95% 1.21 to 1.51), presence of diabetes mellitus (OR 1.32, 95% 1.19 to 1.46), and history of bypass surgery (OR 1.38, 95% CI 1.20 to 1.58) were independently associated with restenosis and were similar across the spectrum of stent devices.
In this large cohort of patients with angiographic surveillance we demonstrated the impact of device development on antirestenotic efficacy, with sequentially improved efficacy from BMS to first generation DES to second generation DES. Predictors of restenosis were small vessel size, increased stented length, complex lesion morphology, diabetes mellitus, and prior bypass surgery.
在大规模、广泛纳入接受随访血管造影的患者人群中，系统研究经皮冠状动脉介入治疗（PCI）后使用裸金属支架（BMS）或第一代或第二代药物洗脱支架（DES）的再狭窄情况，这代表了我们科学知识中的一个空白。我们调查了接受支架 PCI 治疗的患者中经血管造影证实的再狭窄的发生率及其预测因素。
在德国慕尼黑的两个中心，所有在 1998 年至 2009 年期间成功植入冠状动脉支架治疗初发病变并在 6-8 个月时进行随访血管造影的患者均符合纳入标准。排除心源性休克、透析依赖的肾功能不全或先前心脏移植的患者。前瞻性收集数据。评估再狭窄的发生率，定义为随访血管造影时节段内的直径狭窄≥50%，及其预测因素。
共有 12094 名患者符合纳入标准。10004 名患者（77.5%）进行了血管造影随访，共治疗了 15004 处病变。2643 名（26.4%）患者检测到再狭窄。第一代 DES 与 BMS 的使用（比值比 0.35，95%置信区间 0.31 至 0.39）和第二代 DES 与第一代 DES 的使用（比值比 0.67，95%置信区间 0.58 至 0.77）是再狭窄发生率较低的独立预测因素。多变量分析显示，血管直径较小（比值比 1.59，95%置信区间 1.52 至 1.68，每减少 0.5mm）、支架总长度（比值比 1.27，95%置信区间 1.21 至 1.33，每增加 10mm）、复杂病变形态（比值比 1.35，95%置信区间 1.21 至 1.51）、存在糖尿病（比值比 1.32，95%置信区间 1.19 至 1.46）和旁路手术史（比值比 1.38，95%置信区间 1.20 至 1.58）与再狭窄独立相关，并且在支架设备的各个谱段中相似。
在这项具有血管造影监测的大型患者队列中，我们证明了器械开发对抗再狭窄效果的影响，从 BMS 到第一代 DES 再到第二代 DES，效果依次提高。再狭窄的预测因素是血管直径较小、支架总长度增加、病变形态复杂、糖尿病和先前的旁路手术。
