Efficacy and safety of drug-coated balloon for de novo lesions of large coronary arteries: Systematic review and...

Area of Science:

• Interventional Cardiology
• Cardiovascular Research
• Medical Device Technology

Background:

• Drug-coated balloons (DCB) offer an alternative to stenting, potentially avoiding stent-related complications.
• DCB have demonstrated effectiveness in treating in-stent restenosis and small vessel disease.
• The role of DCB in treating de novo lesions within large coronary arteries remains less established.

Purpose of the Study:

• To compare the efficacy and safety of drug-coated balloons versus stents for de novo lesions in large coronary arteries.
• To evaluate key safety and efficacy endpoints, including major adverse cardiovascular events and late lumen loss.

Main Methods:

• A systematic literature search was conducted up to April 2023.
• Included 10 randomized controlled trials (RCTs) comparing DCB and stents.
• Safety assessed via MACE, cardiac death, mortality, MI, TLR, bleeding; efficacy via LLL, MLD.

Main Results:

• DCB demonstrated significantly lower late lumen loss compared to stents (MD = -0.19, P = 0.003).
• No significant differences in overall safety indicators between DCB and stents.
• DCB showed lower target lesion revascularization compared to bare-metal stents.

Conclusions:

• Drug-coated balloons represent a viable alternative for de novo lesions in large coronary arteries.
• DCB exhibit favorable efficacy and safety profiles, outperforming bare-metal stents and matching drug-eluting stents.
• A trend towards reduced late lumen loss suggests potential long-term benefits of DCB therapy.