Deflated Balloon-Facilitated Direct Stenting in Primary Angioplasty (The DBDS Technique): A Pilot Study

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 < 0.001). DS group had significantly lower procedure time (33 ± 19 min versus 41 ± 17 min, P < 0.001), fluoroscopy time (6.2 ± 3.4 min versus 7.8 ± 32 min, P < 0.001), required lesser contrast volume (112 ± 16 mL versus 123 ± 18 mL, P < 0.001) and had lower procedural cost (310 ± 45$ versus 402 ± 56$, P < 0.001). ST-segment resolution > 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.