Does pre-dilatation balloon choice matter? standard versus specialized balloons prior to drug-coated balloon therapy in acute coronary syndrome patients
A Darwish, S Khouj, A Ghabashi, I Alghamdi, A Alzoobiy, S Alhassani, A Taha, M Ismail, A Ujaimi, I Elsawah, A Sheikh, G Shalaby, S KhaledAbstract
Background
Drug-coated balloons (DCBs) have emerged as a promising strategy for stent-free percutaneous coronary intervention (PCI). Nevertheless, despite the growing evidence supporting DCB-based approaches, data remain limited regarding optimal lesion pre-dilatation strategies required to maximize procedural success and clinical outcomes.
Purpose
To compare the clinical outcomes of using standard balloons including semi-compliant and non-compliant (NC) versus specialized balloons including cutting and scoring balloons prior to DCB application to the target lesion in acute coronary syndrome (ACS) patients.
Methods
This retrospective cohort study included 274 consecutive ACS patients treated with DCB between January 2022 and January 2025. Patients were grouped by lesion preparation strategy: standard balloon pre-dilatation (n = 147) and specialized balloon pre-dilatation (n = 127).Cases requiring bail-out drug-eluting stents for flow-limiting dissections were excluded. The primary endpoint was major adverse cardiovascular events (MACE), composite of all-cause mortality, cardiac death, target-vessel myocardial infarction (TV-MI), and target-vessel revascularization (TVR), assessed during hospitalization and at one-year follow-up
Results
Baseline characteristics were comparable between the two groups. Standard balloons were more frequently used in distal lesion compared with specialized balloons (26% vs. 11.8%, P = 0.003). There was no significant difference in balloon type use across different vessel calibres, native, or in-stent lesions. Intravascular ultrasound (IVUS) was employed in approximately 59.4% of cases to ensure the absence of flow-limiting dissection and adequate lumen gain. Regarding the primary outcome, MACE was significantly higher in the standard balloon group compared with the specialized balloon group, both during hospitalization (16.3% vs. 7.9%, P = 0.03) and at 1-year follow-up (19.7% vs. 7.9%, P = 0.003). Compared with specialized balloons, the regular balloon pre-dilatation group had a significantly higher rate of in-hospital TV-MI (8.2% vs. 1.6%, P = 0.016) and a significantly greater incidence of TVR at 1-year follow-up (15.7% vs. 6.4%, P = 0.017). Kaplan–Meier survival analysis showed that one-year post-PCI cumulative MACE rates were lower with specialized balloons compared to standard balloons (P = 0.03). Subgroup analysis showed numerically lower event rates in terms of MACE, mortality, TV-MI, or TVR for non-compliant balloons compared with semi-compliant balloons; however, these differences did not reach statistical significance.
Conclusion
In ACS patients undergoing DCB treatment, specialized balloon pre-dilatation was associated with lower in-hospital and 1-year MACE compared with standard balloons. In contrast, standard balloons, predominantly semi-complaint, were linked to higher rates of in-hospital TV-MI and 1-year TVR and therefore should be discouraged for routine use before DCB.Clinical outcomes comparisonFor image description, please refer to the figure legend and surrounding text.Kaplan–Meier CurveFor image description, please refer to the figure legend and surrounding text.