Overview of Coronary Drug-Coated Balloons

Interventional therapy holds a central position in the treatment of coronary artery disease. With continuous technological advancements and developments in device technology, interventional therapy for coronary artery disease has evolved through three major phases: percutaneous coronary balloon angioplasty, bare metal stents, and drug-eluting stents.
While these technologies have significantly improved outcomes for patients with coronary artery disease, in-stent restenosis remains a global problem. To address this issue, researchers have explored the development of biodegradable stents. However, the inconsistent degradation rates of biodegradable materials increase the risk of long-term thrombosis at the insertion site, limiting their application. Against this backdrop, drug-coated balloons have become a research hotspot. The emergence of this technology marks a new era in interventional coronary artery disease treatment.
DCBs are a stent-free approach designed to overcome the shortcomings of drug-eluting stents. By coating the surface of traditional balloons with an antiproliferative drug, the drug is released into the vessel wall while dilating the blood vessel, inhibiting intimal hyperplasia. A single dose of the drug is rapidly absorbed, resulting in long-term inhibitory effects. The specific function of DCBs requires that the antiproliferative drug they carry achieve the highest possible transport rate and the longest possible intramural retention during release and entry into the vessel wall.

Drug-eluting stent advantages and disadvantages:

Compared to drug-eluting stents, DCB technology offers the following advantages:

① No foreign material is implanted, and the “balloon” contains no metal mesh residue, preserving the opportunity for subsequent treatment;

② Reduces intimal inflammatory response and reduces the risk of thrombosis;

③ Shortens the duration of antiplatelet therapy (only 1-3 months of dual-antiplatelet therapy is required postoperatively), making it a boon for patients who have recently undergone surgery, cannot tolerate dual-antiplatelet therapy, or have gastrointestinal bleeding.

However, DCBs also have significant disadvantages:

1. First, drug-eluting balloons are expensive. After the centralized procurement of stents, both domestically produced and imported drug-eluting stents have become inexpensive, making stent therapy highly cost-effective. Currently, the price of a drug-eluting balloon can approach the cost of 20-30 stents.

2. Caution is advised when using drug-eluting balloons in major or dominant vessels. Any balloon expansion could lead to vascular dissection or rupture. If these can be identified during surgery, stent implantation can be used to remedy the situation. However, vascular damage is sometimes difficult to identify with angiography and can be easily missed. The consequences of acute thrombosis or vascular occlusion after surgery can be catastrophic.
3. Residual stenosis after drug-eluting balloon therapy is higher than with stents. Since drug-eluting balloons only temporarily dilate stenotic lesions and cannot fully dilate and relieve stenosis, residual stenosis is higher than with stents. Stents, on the other hand, have a metal mesh structure that provides permanent support for stenotic vessels after implantation, minimizing residual stenosis. Therefore, stents are the preferred choice for calcified lesions or stenotic plaques.

Scope of Drug-Coated Balloon Applications
1. In-Stent Restenosis
Drug-coated balloons have been widely recognized for their effectiveness in treating ISR lesions. In addition to paclitaxel DCBs, research has also shown the use of sirolimus and its derivatives in DCBs, suggesting that these DCBs are also safe and effective in treating in-stent restenosis.
2. Bifurcation Lesions
Drug-coated balloons have also demonstrated unique advantages in the treatment of bifurcation lesions. DCBs for bifurcation lesions reduce bifurcation ridge deviation, avoid local metal accumulation, and prevent uneven drug distribution, thereby optimizing treatment outcomes.
3. Small Vessel Lesions
The minimum diameter of existing coronary stents is 2.25 mm. For lesions smaller than 2.25 mm, where appropriate stents are unavailable, drug-eluting balloons can be used.
4. Primary Large Vessel Lesions
Multiple studies have demonstrated the efficacy and safety of DCBs alone in primary large vessel coronary lesions. However, large-scale multicenter studies are needed to further validate their safety and efficacy.
5. CTOs and Other Primary Coronary Artery Lesions
A major advantage of DCBs for CTO lesions is that they avoid passive stent malapposition when the CTO lesion returns to its original size. However, clinical data on DCBs for CTO lesions are currently very limited, and large-scale clinical trials are needed to confirm their effectiveness as an effective treatment for CTO lesions. For other primary coronary artery lesions, such as diffuse long lesions, severely calcified lesions, and ostial lesions, hybrid treatment strategies using DCB alone or DCB combined with drug-eluting stents have been tried and explored in some suitable lesions. Currently, it is recommended to use and handle them with caution.

 

 

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