Gorenoi Vitali, Dintsios Charalabos-Markos, Schönermark Matthias P, Hagen Anja
Medizinische Hochschule Hannover, Abteilung für Epidemiologie, Sozialmedizin und Gesundheitssystemforschung, Hannover, Deutschland.
GMS Health Technol Assess. 2008 Dec 9;4:Doc13.
Coronary artery bypass graft (CABG) and percutaneous revascularisations with implantation of drug-eluting stents (DES) are important treatment methods in coronary heart disease (CHD).
The evaluation addresses questions on medical efficacy, health economic parameters as well as ethic, social and legal implications in the use of DES vs. CABG in CHD patients.
A systematic literature search was conducted in December 2006 in the most important electronic databases beginning from 2004. Register data and controlled clinical studies were included in the evaluation. Additionally, a health economic modelling was conducted.
MEDICAL EVALUATION : The literature search yielded 2,312 hits. 14 publications about six controlled clinical studies and five publications about two registers were included into the evaluation. Register data showed low mortality (0.2% to 0.7%) and low rates of myocardial infarction (0.5% to 1.4%) during hospital stay. In patients with stenosis of the left anterior descending coronary artery one study showed in several analyses a significantly higher rate of reinterventions and a significantly higher rate of repeated angina pectoris for DES up to two years after the implantation (16.8% vs. 3.6% and 35% vs. 8%). In patients with left main coronary artery stenosis two studies revealed a significantly higher survival without myocardial infarction and stroke for DES up to one year (96% vs. 79% and 95% vs. 91%) and two studies a significantly higher rate of revascularisations up to two years (20% vs. 4% and 25% vs. 5%) after the primary intervention. In patients with multivessel disease, one study found a significantly higher mortality and myocardial infarction rate for CABG at one year (2.7% vs. 1.0% and 4.2% vs. 1.3%). The rate of revascularisations was significantly higher in two studies up to two years after DES implantation (8.5% vs. 4.2% and 14.2% vs. 5.3%). The rate at repeated angina pectoris was significantly higher in one study in DES patients during two-years follow-up (28% vs. 12%). HEALTH ECONOMIC EVALUATION: The one-year total costs per patient after CABG were calculated to be 13,373 euro and after DES 10,443 euro, leading to a difference of 2,930 euro in favour of DES implantation. The three-year total costs per patient after CABG were estimated to be 13,675 euro and after DES 10,989 euro, showing a cost difference of 2,686 euro in favour of DES implantation. In the performed sensitivity analyses no break even point was reached.
Existing data should be viewed only as limited evidence for possible medical and health economic effects.
There is limited evidence for the possible advantage of DES vs. CABG with respect to mortality and the rate of myocardial infarction in some indications as well as disadvantages with regard to the rate of revascularisations and the rate of repeated angina pectoris. Moreover there is also a limited evidence for possible economic advantage of DES vs. CABG in multivessel disease. Existing data should be proven in long-term follow-up and in randomised studies.
冠状动脉旁路移植术(CABG)和药物洗脱支架(DES)植入的经皮血管重建术是冠心病(CHD)的重要治疗方法。
该评估涉及冠心病患者使用DES与CABG的医学疗效、健康经济参数以及伦理、社会和法律影响等问题。
2006年12月在最重要的电子数据库中从2004年开始进行了系统的文献检索。评估纳入了注册数据和对照临床研究。此外,还进行了健康经济建模。
医学评估:文献检索共获得2312条结果。14篇关于六项对照临床研究的出版物和5篇关于两个注册研究的出版物被纳入评估。注册数据显示住院期间死亡率较低(0.2%至0.7%),心肌梗死发生率较低(0.5%至1.4%)。在左前降支冠状动脉狭窄患者中,一项研究在多项分析中显示,DES植入后两年内再次干预率显著更高,反复心绞痛发生率也显著更高(16.8%对3.6%,35%对8%)。在左主干冠状动脉狭窄患者中,两项研究显示DES植入后一年内无心肌梗死和中风的生存率显著更高(96%对79%,95%对91%),两项研究显示初次干预后两年内血管重建率显著更高(20%对4%,25%对5%)。在多支血管病变患者中,一项研究发现CABG术后一年死亡率和心肌梗死发生率显著更高(2.7%对1.0%,4.2%对1.3%)。两项研究显示DES植入后两年内血管重建率显著更高(8.5%对4.2%,14.2%对5.3%)。一项研究显示DES患者在两年随访期间反复心绞痛发生率显著更高(28%对12%)。健康经济评估:CABG术后每位患者一年的总成本计算为13373欧元,DES术后为10443欧元,DES植入术节省2930欧元。CABG术后每位患者三年的总成本估计为13675欧元,DES术后为10989欧元,成本差异为2686欧元,DES植入术节省成本。在进行的敏感性分析中未达到收支平衡点。
现有数据仅应视为可能的医学和健康经济影响的有限证据。
关于DES与CABG相比在某些适应症的死亡率和心肌梗死发生率方面可能的优势以及在血管重建率和反复心绞痛发生率方面的劣势,证据有限。此外,关于DES与CABG在多支血管病变中可能的经济优势证据也有限。现有数据应在长期随访和随机研究中得到验证。