A new-generation drug-coated balloon outperformed an everolimus-eluting stent for the treatment of small vessel coronary artery disease lesions in an open-label, multicenter, randomized clinical trial, the results of which were published in the JACC: Cardiovascular Interventions.

In the PICCOLETO II trial (ClinicalTrials.gov Identifier NCT03899818), patients (N=232) hospitalized for stable coronary artery disease (n=127) or acute coronary syndrome (n=105) requiring percutaneous coronary intervention (PCI) were recruited from 5 centers in Europe between 2015 and 2018. Patients were randomly assigned in a 1:1 ratio to receive Xience everolimus-eluting stent (n=114) or Elutax SV/Emperor drug-coated balloon (n=118) for the treatment of 1 lesion. Angiographic success was defined as final stenosis greater than 20% for the everolimus-eluting stent and less than 30% for the drug-coated balloon recipients. Patients were assessed for major adverse cardiovascular events through 1 year.

At baseline, groups were well balanced for demographic and comorbid characteristics except for instance of renal failure, which was elevated among the patients in the everolimus-eluting stent device group (10.6% vs 3.3%; P =.03). Some patients were lost to follow-up of refused to participate (n=10 and 13 in the stent and balloon groups, respectively).


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Prior to the procedure, patient lesions differed significantly among the treatment groups for lesion pre-dilation (69% vs 84%; P =.007), lesion post-dilation (59.4% vs 3.3%; P =.001), average number of devices used (1.12 vs 1.03; P =.004), length of device used (18.3±6.9 mm vs 21.8±8.2 mm; P =.006), inflation pressure (13.7±2.5 atm vs 11.4±3.3 atm; P =.03), and inflation time (21.4±11.8 vs 49.2±14.5 s; P =.002) among drug-eluting stent and drug-coated balloon recipients, respectively.

Following the procedure, the groups differed significantly for mean in-lesion acute gain in which stent recipients had higher gain (1.47±0.3 mm) compared with balloon recipients (0.99±0.4 mm; P =.03).

After a median of 189 days, late lumen loss was lower among balloon (0.04±0.28 mm) than among stent (0.17±0.39 mm) recipients which was both statistically noninferior (P =.001) and superior (P =.03). In-lesion binary restenosis (P =.98) and percent diameter stenosis (P =.37) did not differ between groups.

After a median of 348 days, major adverse cardiovascular events were observed among 7.5% of the stent group and 5.6% of the balloon group (P =.55). The elevated pre-dilation observed among the balloon group did not appear to have a significant effect on clinical success (P =.31).

These results may not be generalizable to other centers as the 5 procedure centers had strong leadership in the use of drug-coated balloons.

“The PICCOLETO II trial for the first time shows the angiographic superiority in terms of [late lumen loss]…of a novel [drug-coated balloon] over one of the best-in-class [drug-eluting stents] for the treatment of de novo coronary lesions in small vessels,” the researchers concluded.

Reference

Cortese B, Di Palma G, Guimaraes M G, et al. Drug-coated balloon versus drug-eluting stent for small coronary vessel disease. PICCOLETO II randomized clinical trial.JACC Cardiovasc Interv. Published online November 19, 2020. doi:10.1016/j.jcin.2020.08.035