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Updated: Jan 24, 2026
Primary Outcome Assessment in a Pig Model of Acute Myocardial Infarction
Published on: October 14, 2016
Clinical Outcomes of Using Drug-Coated Balloons During Primary Percutaneous Coronary Intervention for ST-Elevation
Ahmed Darwish1, Saleh M Khouj2, Abdallah Alzoobiy2
1Cardiac Centre, King Abdullah Medical City, Makkah, Saudi Arabia; Department of Cardiology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Insights
Drug-coated balloons (DCB) show comparable safety and efficacy to drug-eluting stents (DES) for ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention (PCI). Caution is advised for DCB use in large vessels and cases of in-stent thrombosis.
Area of Science:
- Cardiology
- Interventional Cardiology
- Biomedical Engineering
Background:
- ST-elevation myocardial infarction (STEMI) remains a leading global cause of mortality.
- Primary percutaneous coronary intervention (PPCI) with drug-eluting stents (DES) is the current standard of care.
- Stent-free approaches, such as drug-coated balloons (DCB), are emerging to mitigate stent-related complications.
Purpose of the Study:
- To evaluate the efficacy and safety of DCB compared to DES in STEMI patients undergoing primary PCI.
- To assess major adverse cardiac events (MACE) at in-hospital and six-month follow-up periods.
Main Methods:
- A comparative study of 128 STEMI patients treated with DCB versus 128 matched patients treated with DES between 2019 and 2023.
- Analysis of in-hospital and six-month MACE, including reinfarction and repeat revascularization.
- Subgroup analysis to identify specific lesion subsets where DCB efficacy might differ.
Main Results:
- No significant difference in in-hospital or six-month MACE between DCB and DES groups.
- DCB group showed numerically lower, though not statistically significant, rates of MACE, reinfarction, and repeat revascularization at six months.
- Higher in-hospital MACE and reinfarction rates were observed with DCB use in large vessels (> 3 mm) and in cases of in-stent thrombosis.
Conclusions:
- DCB demonstrate non-inferiority to DES for primary PCI in STEMI patients, including in major epicardial arteries.
- DCB can be considered a viable alternative to DES, offering comparable outcomes.
- Careful consideration of lesion characteristics, particularly large vessels and in-stent thrombosis, is recommended when utilizing DCB.
Objective:
ST-elevation myocardial infarction (STEMI) is one of the leading causes of mortality worldwide. Current guidelines recommend primary percutaneous coronary intervention (PPCI) using drug-eluting stents as the standard management for these patients. Stent-free percutaneous coronary intervention (PCI) using drug-coated balloons (DCB) has been suggested as a novel approach to avoid stent-related complications. This study aimed to assess the efficacy and safety of using DCB in STEMI patients.
Method:
We compared STEMI patients who presented during the period between 2019 and 2023 and underwent primary PCI using DCB to those treated with drug-eluting stents (DES) in terms of in-hospital and six-month major adverse cardiac events (MACE).
Results:
A total of 128 STEMI patients who underwent primary PCI using DCB were compared to 128 matched patients managed using DES. Small-vessel culprit lesions (< 3 mm) and distal lesions were significantly more frequent in the DCB group compared to the DES group. DCBs were used in major epicardial vessels in around 55% of patients and in side branches in almost 45% of cases. Regarding MACE, either in-hospital or within six months, there was no significant difference between the two groups. Moreover, at six-month follow-up, MACE, reinfarction, and repeat revascularization were numerically lower but statistically non-significant in the DCB group. Subgroup analysis showed that in-hospital MACE and reinfarction rates were statistically significantly higher when DCBs were applied to large vessels (> 3 mm) and in cases of in-stent thrombosis (P = 0.014 and 0.001, respectively).
Conclusion:
Drug-coated balloons appear non-inferior to DES during primary PCI in terms of MACE, including mortality and reinfarction, even in major epicardial coronaries. However, it should be used cautiously in certain lesion subsets, especially large vessels (> 3 mm) and in-stent thrombosis.
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