Clinical Outcomes of Using Drug-Coated Balloons During Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction Patients – Insights from High-Risk Groups: A Single-Center Experience-Uncorrected Proof

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.

Keywords: Drug-coated balloons, drug-eluting stents, primary percutaneous coronary intervention, ST-elevation myocardial infarction