Release date: 2007-08-23
What is the history of CABG in the era of drug stents? Since the beginning of the last century, people have been making unremitting efforts to cure coronary heart disease, and constantly create safer, more effective and less traumatic treatments. The emergence of the "drug-support era" is in full compliance with the laws of clinical medicine. So, how do we correctly understand and treat the relationship between drug-eluting stents (DES) and coronary artery bypass grafting (CABG)?
Opinion 1 DES mainly replaces BMS rather than CABG Before the advent of CABG, drugs have been the main means of treatment for coronary heart disease. In the 1960s, CABG became an effective treatment for coronary heart disease. A large number of clinical trials have confirmed that surgical treatment of coronary heart disease three-vessel disease, left main disease and diabetes mellitus is more advantageous than simple drug therapy. In the 1970s, percutaneous coronary balloon dilatation was introduced. Because of its clear effect and small trauma, it quickly became popular and quickly exceeded the number of surgical treatments. However, the extremely high restenosis rate (30% to 60%) has limited application, and the subsequent bare metal stent (BMS) has not solved this problem well, and the restenosis rate is still around 20%. The researchers developed DES for the problem of a high rate of restenosis in BMS. Early clinical studies have shown that DES can maintain a zero or very low restenosis rate, so excellent results are very exciting, so some people claim that "the 'drug support era' has arrived!" and "CABG is about to withdraw from the historical stage!". However, in reality, the emergence of DES is mainly to replace the BMS. Recently, some clinical evidences show that "the long-term safety of DES is not clear"; "Indication of DES may increase the incidence of stent thrombosis, myocardial infarction and even death." The emergence of such evidence prompted people to begin to re-examine the safety and indications of DES.
Opinion 2 DES safety and long-term efficacy remain controversial It is undeniable that early DES clinical trials have achieved encouraging results, many doctors and patients are eagerly awaiting. However, as time went on, some problems gradually emerged, and DES security was questioned and became the focus of academic debate. Delayed re-endothelialization of DES, local vascular hypersensitivity and inflammatory response caused by polymer coating, and poor stent attachment in the late stage may increase late thrombotic events and cause disasters. At the same time, it must be noted that short-term clinical trial results do not indicate long-term clinical significance. Drug trials usually last for 5 years, but most DES trials only have 9 months of data. Moreover, the good test results of DES are based on carefully selected cases. In other words, the current evidence is far from proven to be safe and effective for all patients with coronary heart disease. At the very least, the current clinical research and practice for DES is still in the “processâ€, far from the moment of conclusion. At the end of 2006, the US FDA held a hearing on many issues such as the safety of DES, and the meeting warned about the use of DES outside the license. Experts agreed that the use of DES for indications, the risk of stent thrombosis, and increased myocardial infarction and death. However, the current use of DES without compliance with indications accounts for the vast majority (60% to 75%). Some experts point out that patients with very high risk of restenosis and prone to stent thrombosis should limit the use of DES.
In addition, costs are an important issue that must be considered. According to a US survey, the national medical budget is increased by at least 1 percentage point in consideration of the replacement of the current BMS by DES. It can be seen that the investment in the widespread use of DES is very high, which is worthy of careful consideration in China, where medical resources are relatively limited. Opinion 3 Both have their own scope of application and indications. The ARTS-I trial published in 1999 compared the efficacy of BMS and CABG on multivessel disease. The results showed that CABG was superior to BMS, and the 1-year event-free survival rate was 89. % and 75%. In 2003, the results of the ARTS-II trial comparing DES with CABG for multivessel disease were published. The 1-year event-free survival rate of DES was higher than CABG (95% vs. 90%), which is the most frequently cited proof of DES. Clinical evidence superior to CABG. However, the study was a non-randomized and non-synchronous comparison, ie, the DES group in ARTS-II was compared with the CABG group in ARTS-I, and there were differences in baseline characteristics (in the ARTS-I and ARTS-II groups, diabetic patients) They were 26.2% vs. 18.2%, three lesions 54% vs. 28%, and C lesions 13.9% vs. 7.5%. These factors affected the accuracy of the results analysis.
The application of DES in diabetic patients is also not optimistic. Rao et al reported that the proportion of diabetic patients who need revascularization after receiving DES is 10% to 15%, which is much higher than that of CABG patients. Results from Macaya et al showed that the target vessel revascularization rate (TVR) was 12.6% in diabetic patients receiving DES, compared with 4.2% in the CABG group. There was no difference in 1-year mortality between the two groups of patients with multivessel disease (8% versus 10%, P = 0.6), but the incidence of major adverse cardiac events (MACE) was significantly lower in the CABG group than in the DES group (12% vs. 27%, P=0.006), and the rate of revascularization was also lower than that of the DES group (3% vs. 20%, P < 0.001). CABG also has advantages in left main and/or multivessel lesions. Matthew et al reported that 47 patients with left main and/or multivessel disease had an average of DES for 276 days, 21 had lesional vascular stenosis (42%), and often involved circumflex openings, and 19 required revascularization ( 38%). Preliminary results of the ongoing SYNTAX trial showed that 74% of patients with multivessel disease admitted to the centres in Europe and the Americas within 3 months were treated with CABG, with 71% of the three lesions and 29% of the left main lesions. In the United States, only 18% of patients with left main and/or three-vessel disease choose stent placement, which is 29% in Europe.
The above data fully demonstrate that CABG still dominates in complex lesion revascularization. Currently, three large-scale randomized controlled trials are being conducted internationally to evaluate the efficacy of PCI and CABG in the treatment of complex lesions: 1FREDOOM: DES (Cypher or TAXUS) versus CABG in patients with multivessel disease and diabetes; 2SYNTAX: left DES (TAXUS) versus CABG in the main and/or multivessel disease; 3COMBAT: DES (Cypher) versus CABG in the left main and/or multivessel disease. It is believed that the above findings will help to clarify the respective strengths and indications of CABG and DES. In short, the pattern of drug therapy, interventional therapy and surgical treatment for coronary heart disease has not changed fundamentally. After more than 40 years of clinical application, CABG has not only become more mature but also continues to move toward minimally invasive and safe. ——Midi Medical Network
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