Effect of vessel diameter on the clinical benefits of drug-coated balloon angioplasty: Insights from paclitaxel-coated balloon and polymer-free sirolimus-eluting stent studies.

background20 years ago, drug coated balloon (DCB) angioplasty was introduced into the interventionalist's toolbox initially to treat in-stent restenosis. Since then, considerable clinical evidence was generated in patients with de novo lesions. Whether drug-eluting stents (DES) or DCB angioplasty are associated with better clinical outcomes for de novo lesion treatment is still a matter of debate.

objectiveThe objective of this post-hoc analysis was to assess the impact of vessel diameter in a real-world, unselected patient population treated with either paclitaxel-coated balloon (PCB) angioplasty or polymer-free sirolimus-eluting stent (PF-SES) implantation based on patient-level data.

methodsFour all-comers observational studies based on similar protocols were pooled and vessel-diameter matched to study the clinical outcomes following revascularization with either PCB or PF-SES. The primary endpoint in all studies was the accumulated clinically driven target lesion revascularization (TLR) rate at 9-12 months complemented with secondary endpoints such as the rates for major adverse cardiac events (MACE), myocardial infarction (MI) and cardiac death.

resultsIn the unmatched patient population, 3035 patients received either PCB (1614 patients) or PF-SES (1421 patients). The 'unmatched' TLR and MACE rates were low with 2.5% (PCB) vs. 2.0% (PF-SES, p = 0.319) and 4.5% (PCB) vs. 5.0% (PF-SES, p = 0.493), respectively. In the large vessel group (≥ 3 mm), 253 patient pairs were matched with reference diameters of 3.19 ± 0.27 mm (PCB) and 3.18 ± 0.27 mm (PF-SES, p = 0.787), and lesion lengths of 17.5 ± 9.8 mm (PCB) and 17.3 ± 7.1 mm (PF-SES, p = 0.839). The accumulated TLR rates were not significantly different (PCB 2.0% vs. PF-SES 2.8%, p = 0.786). Likewise, MACE rates in this large vessel subgroup were similar (5.6% vs. 6.4%, p = 0.723). In the small vessel group (< 3 mm), 420 patient pairs were matched with reference diameters of 2.49 ± 0.18 mm (PCB) and 2.49 ± 0.18 mm (PF-SES, p = .995), and lesion lengths of 16.0 ± 9.0 mm (PCB) and 16.7 ± 7.1 mm (PF-SES, p = 0.665). The accumulated TLR rates were not significantly different (PCB 1.9% vs. PF-SES 2.2%, p = 0.810). Likewise, MACE rates in the small vessel subgroup were similar (4.4% vs. 5.8%, p = 0.346). Individual clinical event rates were low and not significantly different between patients with small and large vessels.

conclusionsIn this real-world experience PCB and PF-SES angioplasty were associated with low clinical event rates. There was no difference in clinical efficacy between PCB and PF-SES in large and small vessel PCI in terms of clinically driven TLR and MACE. Previously reported higher rates for clinical events after DCB angioplasty in large coronary vessels ≥ 3 mm could not be observed.