The deflated balloon-facilitated direct stenting (DBDS) technique significantly increased the overall rate of direct stenting to 74% compared to 32% without the technique in patients with STEMI.
Observational (n=454)
No
Does direct stenting facilitated by a deflated balloon technique improve procedural feasibility and reduce 30-day MACE compared to pre-dilatation in patients with STEMI?
The deflated balloon-facilitated direct stenting technique is feasible and safe in STEMI patients with totally occluded arteries, potentially reducing procedural complications, time, and 30-day MACE compared to routine pre-dilatation.
Absolute Event Rate: 74% vs 32%
p-value: p=<0.0001
BACKGROUND: Several studies and meta-analyses have shown that direct stenting (DS) may improve clinical outcomes in patients with acute ST-elevation myocardial infarction (STEMI). But in most cases, the thrombolysis in myocardial infarction (TIMI) flow remains ≤ 1 after wire placement. We used deflated balloon to facilitate DS in patients with totally occluded culprit arteries. The aim of this study was to evaluate the feasibility, safety and outcomes of this novel technique in patients with STEMI in real-world clinical practice. METHODS: This was a prospective, observational, single-center pilot study. From September 2016 to June 2018, 454 patients were enrolled in the study. DS was performed when the culprit vessel was visualized with at least TIMI flow grade 1. Patients with complete occlusion of the vessel after wire placement were subjected to deflated balloon-facilitated DS technique (DBDS technique) and DS was done wherever possible. RESULTS: DS was done in 74% (n = 336) of the patients and 26% (n = 118) patients received stenting after pre-dilatation (PD). DBDS technique to facilitate DS was successful in 68% patients (211/309). Final TIMI 3 flow was achieved more frequently in the DS group as compared to PD group (96.7% versus 92.3%, P = 0.04). The procedural complications were also significantly lower in DS group (0.6% versus 7.6%, P 50% after percutaneous coronary intervention (PCI) were significantly higher in the DS group (85.7% versus 71.1%, P < 0.001). At 30 days, the major adverse cardiac event (MACE) rate was significantly lower in the DS group (2.4% versus 9.3%, P = 0.02), mainly driven by lower rates of target lesion revascularization (TLR) (0.9% versus 4.2%, P = 0.01). CONCLUSION: This cost-effective technique appears to be simple, feasible and safe and is associated with superior clinical outcomes. It helps in maximizing DS and could offer an alternative to PD and aspiration thrombectomy in total occlusion. However, larger studies with longer follow up are required before a wider application of this technique.
Verma et al. (2018) conducted an observational in ST-elevation myocardial infarction (STEMI) (n=454). Deflated balloon-facilitated direct stenting (DBDS technique) vs. Standard procedure without DBDS (Pre-dilatation) was evaluated on Feasibility of the procedure (overall direct stenting rate) (p=<0.0001). The deflated balloon-facilitated direct stenting (DBDS) technique significantly increased the overall rate of direct stenting to 74% compared to 32% without the technique in patients with STEMI.