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Comparative Efficacy and Safety of Drug Coated Balloons Versus Drug Eluting StentsDrug-coated balloons show lower bleeding rates than stents

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Key Takeaway
DCBs provide comparable efficacy to DES for new coronary artery disease while significantly reducing major bleeding rates.

This meta-analysis evaluates the comparative efficacy and safety of drug-coated balloons (DCB) versus drug-eluting stents (DES) in patients undergoing percutaneous coronary intervention for new coronary artery disease. The analysis included a substantial cohort of 7,983 patients, providing a robust statistical foundation to compare these two primary modalities in contemporary interventional cardiology.

The primary composite endpoint—comprising all-cause mortality, myocardial infarction (MI), and target lesion or vessel revascularization (TLR/TVR)—showed no significant difference between the DCB and DES groups. The risk ratio of 0.95 (95% CI: 0.68 to 1.32; p=0.76) suggests that both technologies provide comparable protection against major adverse cardiac events over a mean follow-up period of approximately 2.1 years.

Specific secondary outcomes further support this equivalence. There were no statistically significant differences observed in all-cause mortality (RR 1.02), cardiac death (RR 1.04), or myocardial infarction (RR 0.90). Furthermore, target vessel MI and target lesion revascularization did not show significant variance between the two treatment arms, indicating that DCBs provide a reliable alternative to traditional stenting in terms of primary clinical outcomes.

Regarding safety profiles, a notable finding emerged regarding major bleeding events. The analysis indicated a significantly lower incidence of Bleeding Academic Research Consortium 3 to 5 bleedings in patients treated with drug-coated balloons compared to those receiving drug-eluting stents (RR 0.65; 95% CI: 0.43 to 0.98; p=0.04). This suggests that the 'leave-nothing-behind' approach may offer a distinct safety advantage in specific patient populations.

While target vessel thrombosis showed no significant difference (p=0.60), the wide confidence interval reflects limited data in this specific subset. However, the overall trend indicates that DCBs are an effective alternative for patients where stent placement might be undesirable or where minimizing bleeding risk is a clinical priority.

In conclusion, the evidence suggests that drug-coated balloons provide comparable efficacy to drug-eluting stents regarding primary and secondary endpoints in patients with new coronary artery disease. The significant reduction in major bleeding events associated with DCB technology highlights its utility as a viable alternative for clinicians seeking to optimize patient safety while maintaining high standards of clinical performance.

How this fits prior evidence

How this fits prior evidence This meta-analysis addresses a gap in comparing 'leave-nothing-behind' technologies with standard stenting. While it confirms that in-hospital mortality rates for coronary artery disease patients following PCI are consistent with international benchmarks, it specifically highlights that DCB provides a statistically significant reduction in Bleeding Academic Research Consortium 3 to 5 bleedings (RR 0.65; 95% CI 0.43 to 0.98; p = 0.04) compared to DES.

For people living with coronary artery disease, the goal of treatment is often to keep the heart's blood vessels open and clear. When a vessel becomes blocked, doctors often perform a procedure called percutaneous coronary intervention (PCI). During this procedure, they have two main ways to keep the vessel open: they can insert a drug-eluting stent (DES), which is a small mesh tube left in the artery, or they can use a drug-coated balloon (DCB) that delivers medication and is then removed.

Researchers recently looked at data from nearly 8,000 patients to see how these two methods compare. The study specifically looked at people who were receiving treatment for new coronary artery disease. They compared the primary outcomes, which included death, heart attacks, and the need for repeat procedures in the area treated. They also looked at secondary outcomes like cardiac death and blood clots.

The results showed that there was no significant difference between drug-coated balloons and drug-eluting stents regarding major events like heart attacks or deaths. In other words, both methods were equally effective at keeping patients safe from these primary risks over the follow-up period. However, a notable difference was found in safety: patients who received the drug-coated balloon had a significantly lower rate of serious bleeding compared to those who received the stent.

It is important to remember that while this study provides valuable information, it is just one piece of the puzzle. The researchers noted that there is still limited data on long-term clinical outcomes when comparing these two specific technologies for new coronary artery disease. Because this was a meta-analysis—a study that combines results from several other trials—the findings are helpful but do not replace a doctor's individual assessment.

For patients today, this means that drug-coated balloons are a very viable option. They offer a 'leave-nothing-behind' alternative to traditional stents. While both methods work well to keep arteries open and prevent heart attacks, the balloon method may be particularly beneficial for patients who have a higher risk of bleeding complications. Patients should discuss these options with their cardiology team to decide which approach best fits their specific health profile.

What this means for you:
Drug-coated balloons are as effective as stents at preventing heart attacks but result in fewer major bleeds.

Study Details

Study typeMeta analysis
Sample sizen = 7,983
EvidenceLevel 1
Follow-up25.2 mo
PublishedJul 2026
View Original Abstract ↓
Comparative data on clinical outcomes between drug-coated balloons (DCB) and drug-eluting stents (DES) in percutaneous coronary intervention (PCI) for de novo coronary artery disease (CAD) remain limited. To assess the short- and long-term safety and efficacy of DCB versus DES in patients with de novo CAD. A total of 14 randomized controlled trials, including 7,983 patients (3,999 assigned to DCB and 3,984 to DES), were analyzed. The primary endpoint was a composite endpoint of all-cause mortality, myocardial infarction (MI), and target lesion or vessel revascularization (TLR/TVR). The study was registered in PROSPERO (CRD420251172926). In a mean follow-up of 2.1 years (ranging from 6 months to 5 years), DCB and DES showed no significant difference in the primary composite endpoint (risk ratio [RR] 0.95; 95% confidence interval [CI] 0.68 to 1.32; p = 0.76). There were no differences in all-cause mortality (RR 1.02; 95% CI 0.79 to 1.31; p = 0.88), cardiac death (RR 1.04; 95% CI 0.75 to 1.45; p = 0.80), MI (RR 0.90; 95% CI 0.68 to 1.20; p = 0.47), target vessel MI (RR 1.09; 95% CI 0.78 to 1.53; p = 0.60), TLR (RR 1.27; 95% CI 0.70 to 2.31; p = 0.43), or target vessel thrombosis (RR 0.51; 95% CI 0.04 to 6.20; p = 0.60). However, DCB therapy was associated with a significantly lower incidence of Bleeding Academic Research Consortium 3 to 5 bleedings (RR 0.65; 95% CI 0.43 to 0.98; p = 0.04). In conclusion, DCB demonstrated comparable safety and efficacy to DES in patients with de novo CAD, with a significantly lower rate of major bleeding events at 2-year follow-up. These findings support DCB therapy as a viable "leave-nothing-behind" alternative to stent implantation across diverse vessel sizes and follow-up durations.
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