Key result
A paclitaxel-coated balloon after bare-metal stent implantation in STEMI patients showed a trend toward reduced long-term clinical events compared to BMS alone (HR 0.300; 95% CI 0.083-1.090; P=0.052).
Why the study?
Although a paclitaxel-drug-coated balloon after bare-metal stent implantation showed superior short-term angiographic and clinical results compared to bare-metal stent alone in STEMI, its long-term safety and efficacy remained uncertain.
Does a paclitaxel-drug-coated balloon after a bare-metal stent improve long-term clinical outcomes in STEMI patients compared to a bare-metal stent alone?
RCT
randomly assigned
Does a paclitaxel-drug-coated balloon after a bare-metal stent improve long-term clinical outcomes in STEMI patients compared to a bare-metal stent alone?
Hazard Ratio: 0.3 (95% CI 0.083–1.09)
p-value: p=0.052
A paclitaxel-coated balloon after bare-metal stent implantation in STEMI patients demonstrates sustained safety and low rates of very late stent thrombosis and revascularization at 8 years.
Sustained TVR reduction and absent very late ST with DCB after BMS at 8 years support its consideration in STEMI; extends short-term RCT superiority to very long-term data.
Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. Results: 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. Trial Registration: ClinicalTrials.gov; identifier: NCT01839890.
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García‐Touchard et al. (2023) conducted an RCT in ST-elevation myocardial infarction (STEMI). Paclitaxel-drug-coated balloon (DCB) after bare-metal stent (BMS) implantation vs. BMS only was evaluated on In-stent late luminal loss (LLL) at 9-month follow-up (original); long-term clinical outcomes including death, re-infarction, revascularization, and stent thrombosis at 8 years (HR 0.300, 95% CI 0.083-1.090, p=0.052). A paclitaxel-coated balloon after bare-metal stent implantation in STEMI patients showed a trend toward reduced long-term clinical events compared to BMS alone (HR 0.300; 95% CI 0.083-1.090; P=0.052).
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