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DCB use a safe and feasible strategy for PCI procedures
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Utilization of a drug-coated balloon was deemed noninferior compared with a drug-eluting stent in primary PCI for STEMI, according to findings presented at EuroPCR.
The DCB procedure also appears to be a safe and feasible strategy in PCI.
In the study, which was simultaneously published in JACC: Cardiovascular Interventions, Nicola S. Vos, MD, and colleagues sought to assess the efficacy and safety of a DCB in STEMI.
“Considering the absence of superiority with regard to hard clinical endpoints and the potential short- and long-term disadvantages of stent implantation, angioplasty with a drug-coated balloon may well serve as a therapeutic strategy of choice in STEMI if coronary flow is restored and no significant stenosis persists after balloon dilatation,” Vos, a cardiologist at OLVG Hospital in the Netherlands, and colleagues wrote.
The researchers analyzed data of 120 patients from the single-center REVELATION trial comparing a DCB (Pantera Lux, Biotronik) with DES (Orsiro, Biotronik; Xience, Abbott) in patients with STEMI.
Patients with de novo, nonseverely calcified culprit lesion in a native coronary artery and residual stenosis of less than 50% after predilatation were stratified to the DCB or DES groups, Vos and colleagues wrote.
The endpoint was fractional flow reserve at 9 months to allow for functional measurement of infarct-related lesion.
Nine months after enrollment, the mean FFR value in the DCB group (n = 35) was 0.92 ± 0.05 compared with 0.91 ± 0.55 in the DES group (P = .27), the researchers reported.
One abrupt vessel closure that required treatment occurred after treatment with DCB, Vos and colleagues wrote. Up to the follow-up point, two patients, one in each group, required nonurgent target lesion revascularization.
“This may represent a valuable alternative strategy by which the purpose of truly leaving nothing behind can be accomplished without comprising results,” the researchers wrote. “Strict patient selection and sufficient culprit lesion preparation are mandatory to optimize results and prevent bailout stenting.”
In a related editorial, Omeed Neghabat, a PhD student, and Niels Ramsing Holm, MD, a cardiology fellow at Aarhus University Hospital in Denmark, wrote, “While these results are promising for use of DCB, the findings should be interpreted with the necessary caution due to the high percentage of cases lost to follow-up both for FFR and event recording.” – by Earl Holland Jr.
References:
Vos NS, et al. Trials and registries – Clinical outcomes after interventions with drug-coated balloons. Presented at: EuroPCR; May 21-24, 2019; Paris.
Neghabat O, et al. JACC Cardiovasc Interv. 2019;doi:10.106/j.jcin.2019.05.004.
Vos NS, et al. JACC Cardiovasc Interv. 2019;doi:10.106/j.jcin.2019.04.016.
Disclosures: Vos and Neghabat report no relevant financial disclosures. Holm reports receiving research grants and speaker fees from Abbott, Biotronik and Boston Scientific. Please see the study for all other authors’ relevant financial disclosures.