Culprit-Lesion Drug-Coated-Balloon Percutaneous Coronary Intervention in Patients Presenting with ST-Elevation
Jorge Sanz-Sánchez1,2, Andrea Teira Calderón1, David Neves3
1Hospital Universitari i Politecnic La Fe, 46026 Valencia, Spain.
Insights
Drug-coated balloons (DCBs) show promise for ST-elevation myocardial infarction (STEMI) treatment, offering low complication rates in a retrospective study. Further randomized trials are needed to confirm DCB-primary percutaneous coronary intervention (pPCI) efficacy in STEMI patients.
Area of Science:
- Cardiovascular Medicine
- Interventional Cardiology
- Biomaterials in Medical Devices
Background:
- Drug-eluting stents (DESs) are standard for ST-elevation myocardial infarction (STEMI) but carry risks like stent thrombosis and restenosis.
- Drug-coated balloons (DCBs) present a potential alternative, yet clinical data in STEMI patients remain limited.
Purpose of the Study:
- To assess the safety and efficacy of drug-coated balloon (DCB) culprit-lesion primary percutaneous coronary intervention (pPCI) in STEMI patients.
- To evaluate the impact of DCB-pPCI on the microcirculatory territory in STEMI.
Main Methods:
- An observational, retrospective study involving 118 patients across six European centers.
- Patients underwent DCB culprit-lesion pPCI for STEMI.
- Analysis included clinical outcomes and, in a subgroup, angiographic microvascular resistance (AMR).
Main Results:
- Low rates of target lesion failure (3.4%) and target lesion revascularization (1.8%) were observed.
- Overall mortality was 7%, with only 1.8% cardiac-related deaths.
- Microvascular resistance was higher in the stent thrombosis group compared to the native coronary group (p=0.038).
Conclusions:
- DCB-pPCI appears to be a safe alternative treatment for STEMI patients, associated with few long-term adverse cardiac events.
- The study highlights the need for large, randomized clinical trials with robust outcome measures to define DCB-PCI's role in STEMI management.
Abstract:
Background/Objectives: Drug-eluting stents (DESs) remain the standard of treatment for patients with ST-elevation myocardial infarction (STEMI). However, complications such as stent thrombosis and in-stent restenosis still pose significant risks. Drug-coated balloons (DCBs) have emerged as a promising alternative, but data for this clinical scenario are still scarce. The objective was to evaluate the safety and efficacy of DCB culprit-lesion primary percutaneous coronary intervention (pPCI) in patients presenting with STEMI and to evaluate its impact on the microcirculatory territory. Methods: An observational retrospective study was conducted across six European centers. Results: In total, 118 patients were included. Of these, 82.2% were male, with a median age of 67 years (IQR 36-92); 28% patients presented with stent thrombosis and most of them (94%) underwent paclitaxel-DCB-pPCI. The median follow-up was 23.2 months (IQR 6.7-77.3). Target lesion failure (TLF) rates were low (3.4%), with no differences between patients presenting with native coronary vessel and stent thrombosis (4.7% vs. 0%; p = 0.205). Overall mortality rates at follow-up were 7%, with only 1.8% attributed to cardiac causes. A target lesion revascularization (TLR) rate of 1.8% was observed, with no target vessel myocardial infarction reported. A subgroup of patients (42; 35.6%) underwent an adenosine-free angiographic microvascular resistance (AMR) analysis. The median AMR was 4.7 (3.9-5.5) and was greater in the stent thrombosis group than in the native coronary group (5.1 vs. 4.6; p = 0.038) with no clinical differences between patients based on the AMR. Conclusions: DCB-pPCI has emerged as an alternative potential treatment for patients presenting with STEMI, with few long-term adverse cardiac events. Despite the encouraging outcomes, these findings underscore the need for a large randomized clinical trial powered by a relevant clinical outcome in order to elucidate the role of DCB-PCI in patients presenting with STEMI.
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