Efficacy and safety of drug-coated balloons in the treatment of acute myocardial infarction: a meta-analysis of randomized controlled trials

This meta-analysis included 5 RCTs involving 528 patients with AMI who underwent DCB-only or stent implantation. The results showed that DCB had no significant difference in MACEs, cardiac death, MI, and TLR for AMI compared to stents, while LLL was less in the DCB group. We performed a subgroup analysis and observed that in STEMI patients, the incidence of MACE in the DCB group was similar to that in the stented group. Thus, these data suggested that DCB could represent a promising avenue for AMI.

In recent years, more and more studies on DCB have been carried out. In the treatment of ISR, a meta-analysis of 10 RCTs from the DAEDALUS study showed that the combined incidence of all-cause death, myocardial infarction, or target lesion thrombosis was similar with DCB treatment versus re-stenting, but moderately higher with DES-repeat stenting was more effective than DCB angioplasty in reducing the need for a TLR at 3 years15. In a meta-analysis on the treatment of small vessel disease, the use of DCB was associated with comparable outcomes of MACE compared to DES16. Similarly, the use of DCB in patients with de novo coronary lesions is associated with comparable clinical outcomes as TLR versus DES17. DCB has been shown to be safe and effective in treating various types of coronary lesions and has stimulated consideration of its use in AMI.

AMI is a common cardiac emergency that can result in severe morbidity and mortality. The management of AMI has improved and evolved dramatically over the past three decades18. In contrast to the treatment of elderly AMI patients, the increased prevalence of AMI in younger people forces us to pay attention to the long-term risks after stenting, such as lifelong medication, bleeding, etc19. Without a metal support, DCB can locally deliver antiproliferative drugs, thereby directly inhibiting the process of endothelial proliferation and negative remodeling. The advantages of treatment with DCB dilatation over DES implantation include a lower incidence of restenosis, a shorter DAPT time to reduce the risk of bleeding, and the ability to promote further restoration of endothelial function without leaving metallic material in the vessels20.

In this study, lower LLL and even extensive lumen enlargement was noted in the DCB group. It seems to suggest that DCB can result in positive coronary remodeling. Positive remodeling after DCB in de novo lesions has also been reported in several studies21,22,23. The exact mechanism of late lumen enlargement is currently unknown and may be related to the long-term antiproliferative effects of drugs such as paclitaxel. Of course, the determination of lumen diameter in studies is mostly based on the results of coronary angiography, and in the future a more detailed and accurate assessment of lumen size and plaque regression by intraluminal imaging such as intravascular ultrasound or optical coherence tomography is needed21. Longer follow-up observations are needed to further confirm this conclusion.

DCB as an attractive leave-nothing strategy can be safe and effective for the treatment of AMI. From another angle, we should be careful when it comes to the bailout stent rate, which ranges from 5.7% to 18%. This is often due to insufficient pre-dilation of the lesion, resulting in elastic retraction or severe dissection of the vessel wall after DCB angioplasty, necessitating the use of stenting. It should be emphasized that the use of DCB for AMI is based on the safe and effective pre-stretching of the culprit lesion. To get the maximum benefit from DCB, appropriate pre-dilation, particularly in calcified lesions, is essential to maximize the contact area between the balloon and the vessel wall24.

Coronary calcification is an important factor affecting the prognosis of patients with CHD, and the occurrence of calcification is associated with factors such as advanced age, chronic kidney disease and diabetes25.26. Excessive calcification leads to a reduced stent expansion rate, is more likely to trigger ISR and TLR, and is associated with MACEs26,27,28. Treatment strategies for calcified lesions require careful consideration. The studies included in this meta-analysis lacked data on the treatment of calcified lesions. Devices such as cutting and incising balloons, rotational atherectomy, coronary laser atherectomy are used to treat severe calcified lesions and the study also showed that there was no significant difference in 1-year MAEs between DCB and DES after rotational atherectomy29. However, rotational atherectomy and coronary laser atherectomy may result in increased operative time. It may be more appropriate to pretreat the lesion with an ordinary balloon or a cut-and-cut balloon to achieve coronary reperfusion in MI patients in a short time26. The treatment strategy of MI complicated by calcified lesions needs further investigation.

In addition, the RCTs included in this study indicated that thrombus aspiration was performed in lesions with large thrombotic burden. Although routine thrombus aspiration did not affect mortality in the studies30the investigators found that optimizing the preparation of lesions is of great value in improving the homogeneous delivery of antiproliferative drugs8th.

In general, adequate lesion preparation, including thrombus aspiration and adequate balloon dilatation, is essential for DCB or stent therapy. For lesions with less than 30% residual stenosis or type A or B dissection, either DCB or DES can be used. DCB may be beneficial for younger patients with STEMI or patients at increased risk of bleeding and those intolerant to DAPT. Bailout stenting was recommended for residual stenosis of the treated lesion of > 50% after dilations with sufficiently large balloons or a coronary dissection greater than or equal to type C resulting in vascular occlusion8th.

Our meta-analysis has several limitations. First, the follow-up for the five included studies ranged from 6 to 12 months. The shorter follow-up time does not provide a good indication of the benefits of a DCB strategy that does not require long-term antiplatelet therapy, nor does it demonstrate its long-term safety. Although the results of the 5-year follow-up study demonstrated the safety of DCB for the treatment of de novo coronary artery disease, the long-term efficacy of DCB for AMI needs further investigation31.

Second, the sample size may be too small. However, we conducted a very extensive literature search to include all articles that met the criteria. On the other hand, our study can also provide theoretical support for more researchers to conduct such studies in the future.

Third, we observed heterogeneity in lifelong learning statistics. As per the study design, we used a random effects model to estimate the effect rather than a fixed effects model because the former measures provided more conservative results32. The same result was obtained after sensitivity analysis.

Overall, this is the first meta-analysis of RCTs comparing DCB angioplasty to stenting in AMI, which may provide some interventional practitioners with new ideas and thoughts on how to treat AMI in the future, encourage the development of interventional techniques, and improve long-term prognosis of AMI patients . Further extensive research should support our results.

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