Using drug-eluting balloons in patients with ST-segment elevation acute coronary syndrome.
The benefits of early reperfusion in ST-segment elevation acute coronary syndromes (STEACS) have not been discussed; compared with fibrinolysis, primary percutaneous coronary intervention (pPCI) has shown benefits in terms of mortality. Despite the constant advancements in stent technology and design, these devices are not free of complications such as stent thrombosis and in-stent restenosis (ISR).
Drug-eluting balloons (DEBs), as they deliver the drug to the affected area, could prevent the complications related to permanent stent implantation. This type of strategy has been useful for its proven safety and efficacy in various scenarios such as ISR, small vessel disease, or patients at high risk of bleeding.
A study was conducted to observe the treatment efficacy of drug-coated balloons (DCBs) vs. latest-generation DEBs in STEACS pPCI (Merinopoulos et al.).
This was a retrospective, single center, paired, propensity-score study. Patients with STEACS were included, while patients with cardiac arrest, intubated, or in cardiogenic shock were excluded. The primary endpoint (PEP) was all-cause mortality and the secondary endpoints (SEPs) were cardiovascular death, acute coronary syndrome (ACS), stroke, major bleeding, and target vessel revascularization. The mean follow-up was 2.9 years.
A total of 452 consecutive patients were treated exclusively with a paclitaxel-coated balloon (24 needed bailout stenting and were excluded from the analysis). The mean age was 66 years old; 74% of patients were male; 13% had diabetes; 4.7% had undergone a prior coronary intervention; the main culprit vessel was the right coronary artery (44%) followed by the anterior descending artery (40%).
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Death rates in the DCB and DEB arms were 10.8% and 9%, respectively (hazard ratio: 0.77; 95% confidence interval: 0.53-1.12; p = 0.18). There were no significant differences in all-cause mortality probability using the Kaplan-Meier Estimator Plot. There were no significant differences in any of the SEPs analyzed. Mortality at 30 days was 2% vs. 1.5 (p = 0.49), and unplanned revascularization was 1.2% vs. 0.7% (p = 0.41) for DCB and DEB, respectively.
After regression analysis, the predictors of mortality were age, history of heart failure, and family history of ischemic heart disease. The propensity score showed no significant differences between the two strategies.
Conclusions
When analyzing the safety of a DCB-exclusive strategy in patients with STEACS compared with pPCI with DES, no significant differences were found in all-cause mortality, both in the overall analysis and after propensity score matching.
Although its retrospective nature does not allow for conclusions to be drawn, this study demonstrates the feasibility of using this strategy, which in a 3-year follow-up did not generate net adverse events.
Dr. Omar Tupayachi.
Member of the Editorial Board of SOLACI.org.
Original Title: Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI.
Reference: Merinopoulos, Ioannis et al. “Assessment of Paclitaxel Drug-Coated Balloon Only Angioplasty in STEMI.” JACC. Cardiovascular interventions vol. 16,7 (2023): 771-779. doi:10.1016/j.jcin.2023.01.380.
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