Clinical impact of drug-coated balloon inflation time: a nationwide analysis from SCAAR

Background Drug-coated balloons (DCBs) are frequently used in percutaneous coronary intervention (PCI). A typical inflation time of 30 seconds is commonly applied in clinical practice; however, recommendations vary between 30 and 60 seconds, and uncertainties persist regarding the clinical efficacy of longer or shorter inflation durations. Purpose The aim of this study was to assess the clinical efficacy of a standard inflation time (28-32 s) compared with a short inflation time (<28 s) and a long inflation time (>32 s). Methods We conducted an observational retrospective nationwide analysis using the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). SCAAR collects data on all patients undergoing PCI in any of the 29 hospitals in Sweden that provide acute cardiac care. For this study, SCAAR was used to include all patients undergoing PCI with DCB. Key exclusion criteria comprised patients presenting with cardiogenic shock or cardiac arrest, left main lesion, segment treated with stent implantation and use of multiple DCB in the same segment. Three groups were defined according to DCB inflation time: Short (<28 s), Standard (28-32 s) and Long (>32 s). Outcome was assessed using unadjusted Kaplan-Meier estimates together with adjusted Cox proportional regression analysis after 1 year. The primary outcome was the composite of target lesion revascularization (TLR), target vessel myocardial infarction (TV-MI) and all-cause mortality. Results A total of 12,648 patients with 14,051 treated segments with DCB were eligible, including 458 segments treated with Short inflation time, 11,884 with Standard inflation time and 1,709 with long inflation time. For patients with Short-, Standard- and Long inflation time, the mean age was 69.0 vs 68.5 vs 68.3 and 72.3% vs 76.5% vs 76.1% were male. The proportion of previous PCI and previous myocardial infarction was higher in the Short inflation time group (62.7% vs 56.8% vs 58.7% and 53.1% vs 46.5% vs 48.4%). After 1 year, compared to Short inflation time, Standard inflation time was associated with lower rates of the primary composite outcome (12.3% vs 7.3%, adjusted hazard ratio (aHR): 1.66 [95% confidence interval (CI): 1.22-2.27], p≤0.001), TLR (6.7% vs 3.0%, aHR: 2.35 [95% CI: 1.56-3.54], p≤0.001) and TV-MI (4.7% vs 1.9%, aHR: 2.48 [95% CI: 1.50-4.11], p≤0.001). No difference was observed for all-cause mortality. When comparing Standard inflation time with Long inflation time, no difference was observed for the primary outcome or its components. Conclusion In this large nationwide analysis including 12,648 patients undergoing PCI with DCB, an inflation time of 28-32 seconds was associated with improved outcome compared to a shorter inflation time. The results were driven by lower rates of repeat revascularizations and incidence of myocardial infarctions. However, compared to a long inflation time, no difference in clinical outcome was observed.FIgure 1.Primary outcome FIgure 2.Secondary outcome