The multi-modality pattern of coronary heart disease treatment has not changed - thinking from the perspective of "drug-support era"

Release date: 2007-06-28

The multi-modality of coronary heart disease treatment has not changed. The thinking caused by the "drug-support era" has been making unremitting efforts for the treatment of coronary heart disease for many years. From the earliest sympathectomy, thyroidectomy to drug therapy, coronary artery bypass grafting (bridge), percutaneous transluminal balloon dilatation, stent placement, surgical minimally invasive myocardial revascularization, and now The percutaneous coronary lumen is embedded in a drug-sustained stent, and the treatment of coronary heart disease has always been developed in one direction: the pursuit of safer, more effective and less traumatic. As a cardiologist, the relationship between discipline competition and safety and effective medical practice should be viewed scientifically and objectively, and the so-called "drug-support era" coronary heart disease surgical treatment should be correctly recognized and judged.
â– The drug stent still needs practice test
Before the advent of surgical coronary artery bypass graft surgery, drugs are the main treatment for coronary heart disease. In the 1960s, coronary artery bypass grafting became an effective treatment for coronary heart disease. A large number of clinical trials have confirmed that surgical treatment of coronary heart disease with three-vessel disease, left main disease and diabetes has obvious advantages over drug therapy alone. Percutaneous transluminal balloon dilatation in the 1970s was rapidly spread because of its clear effects and small trauma, and soon exceeded the application of surgical treatment, but its incidence of extremely high restenosis (30%~ 60%) limits the application. Although placement of a stent (metal bare stent) after percutaneous balloon inflation in the percutaneous coronary lumen can reduce the incidence of restenosis, the incidence of restenosis is still around 20%. The researchers found that restenosis can be reduced by coating some chemotherapeutic drugs (such as paclitaxel, mitomycin, etc.) on bare metal stents. At the end of the 20th century and the beginning of the 21st century, such drug sustained-release stents were officially used in clinical practice. The US Food and Drug Administration (FDA) approved Cypher and TAXUS sustained-release stents for coronary intervention in April and November 2003.
It is undeniable that clinical trials of early drug-sustained stents have yielded encouraging results, and many heart-centered doctors and patients are eagerly awaiting. However, short-term clinical trial results cannot be used to demonstrate long-term clinical significance. Drug trials usually last for 5 years, but most drug sustained-release stents have only 9 months of trial data, and good clinical delivery of sustained-release stents. The test results 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 least, the current clinical research and practice of drug delivery stents is far from the conclusion.
Some recent clinical evidence refuted the results of earlier studies. "The long-term safety of drug-release stents is not clear." "The use of drug-release stents other than indications may increase stent thrombosis, myocardial infarction, and even death. Incidence rate." This prompted people to begin to re-examine the safety and indications of drug delivery stents. Therefore, it is not the treatment of coronary heart disease that has entered the "drug support era", but only a new treatment technology that has yet to be confirmed by long-term clinical practice. The reality is that although the use of drug-sustained stents is rapidly increasing, it is mainly used to replace the original bare metal stents.
â–  The controversy over drug stents is far from stopped
It is noteworthy that a meta-analysis of two drug-release stents published at the 2006 European Conference of Cardiology (ESC) and the World Congress of Cardiology (WCC) suggests long-term mortality and myocardial myocardial stent delivery. The incidence of infarction is higher than that of bare metal stents, which makes the safety of drug-release stents questionable and has become the focus of academic debate. Studies have found that delayed release of drug delivery stents, 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 serious consequences. At present, the use rate of drug sustained release stents in Sweden has dropped significantly.
A meta-analysis in the March issue of the New England Journal of Medicine also showed that there was no difference in mortality and myocardial infarction rates between the drug-release stent and the bare metal stent (4 years of follow-up). The long-term tracking did not appear, and in the subgroup of diabetic patients, the survival rate of the bare metal stent group was higher than that of the drug sustained-release stent group. Another meta-analysis in the same period also showed that the 4-year follow-up found that the rate of thrombosis in the two drug-releasing stent groups was higher than that in the bare metal stent group. On the European continent, German and Italian study groups were followed up for 21 months at drug center stents at three cardiac centers. The results showed that there was a high rate of thrombosis after drug delivery stent implantation. In 2,229 patients, 29 patients (1.3%) had stent thrombosis after successful drug stent delivery, and 13 patients died. There was no difference in the rate of thrombosis between the two drug-release stents.
At the end of 2006, the FDA discussed a number of issues regarding the safety of drug delivery stents and warned about the use of non-approved indications for drug delivery stents to increase the risk of death and myocardial infarction. It is understood that the current use of drug-release stents without approval of indications accounts for the majority (60% to 75%) of the total use of drug-sustained stents. The discussants agreed that if the drug sustained-release stent was not used as approved, the risk of stent thrombosis and myocardial infarction and death were higher than the approved indications. Some experts point out that patients with a very high risk of restenosis should limit the use of drug-sustained stents. The use of drug-release stents, such as bifurcation, overlapping stents, and vascular thrombosis, tends to increase the risk of stent thrombosis, increase the incidence of thrombotic-related adverse cardiac events, and have statistically significant differences. In early 2007, the FDA issued a statement on the safety of drug delivery stents, indicating that patients treated with drug-release stents may have death and myocardial infarction rates due to stent thrombosis (blood clots in the stent). Significant increase. At the same time, FDA summoned the two major manufacturers of drug delivery stents to conduct a comprehensive review of all possible information related to this issue and to make reasonable recommendations for response. At the same time, it is recommended that patients with more severe and complex lesions (such as diabetes, acute myocardial infarction or multivessel disease, or coronary bifurcation, left main and long-term disease) being treated in the current randomized registration study Long-term follow-up.
Cost is also a very important issue in the use of drug delivery stents. A report from Sweden showed that the half-year medical cost of using a drug-release stent was not reduced because it reduced the rate of restenosis. According to a survey in the United States, the current metal bare stents were replaced by drug-sustained stents, and the national medical care was reduced by 1 percentage point. It can be seen that the investment in the application of drug sustained-release stents is very high, and the widespread use of drug-release stents in China, where medical resources are relatively limited, should be carefully considered.
â–  bracket and bridge can not replace each other
Coronary artery bypass grafting and drug delivery stents are two technologies that cannot be substituted for each other, and both have their own clinical application scope and indications. In 1999, the ARTSI trial compared the efficacy of coronary stenting (common metal stent) with coronary artery bypass grafting for multivessel disease. The results showed that coronary artery bypass grafting was superior to coronary stenting. The 1-year event-free survival rate was 89% and 75%, respectively.
The effect of drug-eluting stents in patients with diabetes is also not optimistic. Rao et al reported that diabetic patients need to re-vascularization rate of 10% to 15% after receiving drug-eluting stents, far less than the benefits obtained by patients undergoing coronary artery bypass graft surgery. The results of ARTSII showed that the revascularization rate was 12.6% in the diabetic subgroup treated with drug-eluting stents, compared with 4.2% in the same period of coronary artery bypass grafting. In patients with diabetic multivessel disease, there was no difference in 1-year mortality between the two groups (8% vs 10%, p=0.6), but the incidence of severe cardiac adverse events was significantly lower in the coronary artery bypass graft group than in the drug release group (12). % vs 27%, p=0.006), the rate of revascularization was also lower than that of the drug-eluting stent group (3% vs. 20%, p<0.001), and the angiography showed that the stent thrombosis rate was 3% after implantation, which was postoperative acute. Independent risk factors for myocardial infarction. These studies fully demonstrate that patients with diabetes should also be cautious and careful when choosing a drug-eluting stent.
In left main and/or multivessel lesions, coronary artery bypass grafting still has advantages. In the United States, only 18% of left main and/or three diseased patients choose stent placement. In Europe, coronary artery bypass grafting still has a dominant advantage in complex lesion revascularization. In addition, three large-scale randomized controlled clinical studies are being conducted internationally to evaluate the efficacy of drug-eluting stents and coronary artery bypass grafting for multi-vessel disease: drug-release stents and coronary artery bypass grafts in patients with multivessel disease and diabetes Comparative study of surgery (FREDOOM); drug-release stent for left main and/or multi-vessel disease and coronary artery bypass graft surgery (SYNTAX); drug release stent for left main and/or multi-vessel disease A comparative study of coronary artery bypass graft surgery (COMBAT). It is believed that these studies will help to clarify the respective strengths and indications of coronary artery bypass graft surgery and drug release stents.
Source: China Medical News

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