Percutaneous coronary intervention (PCI) with paclitaxel-eluting balloons (PEB) was found to be safe and effective to treat patients with in-stent restenosis (ISR) and de novo coronary lesions, particularly small vessel disease (SVD), according to a study published in Angiology.
Researchers sought to evaluate the prognosis of PCI using a second-generation PEB in real-world patients. All cases of PCI using PEB in de novo or ISR coronary lesions performed in their unit between 2009 and 2019 were included. After a median follow-up of 42 months, a composite of major adverse cardiovascular events (MACE) was assessed.
A total of 320 consecutive patients (mean age, 66.9 ± 12 years; 75.3% men) with 386 lesions were included. Clinical presentation was stable coronary artery disease in 46.9% of participants and acute coronary syndromes in 53.1%; 52.6% of the lesions were ISR and 47.3% were de novo lesions with a mean diameter of 2.4±0.5 mm. A bare metal stent was implanted in 6.7% of patients and a drug-eluting stent in 8.5% of patients.
The cumulative MACE rate was 8%, with 13 cases (3.4%) of nonfatal myocardial infarction, 16 cases (4.1%) of target lesion revascularization, and 10 cardiovascular deaths (2.6%). The all-cause death rate was 5.2%, and no cases of thrombosis were observed.
“The main finding of this study is that PCI with PEB in a real-world population with heterogeneous clinical and angiographic presentation appears to be safe and effective and provides favorable results after 42 months of follow-up,” the investigators commented.
Study limitations include its single-center, prospective, and observational nature, the fact that enrollment was not randomized and that and operators included cases selectively, which may have led to selection bias. Also, the analysis lacked a comparison with a cohort involving PCI with drug-eluting stents.
“An additional stent after PEB due to dissection was needed in a small percentage of patients, especially in de novo diffuse lesions, bifurcations, and chronic total occlusions,” noted the study authors. “In our opinion, PCI with PEB should be strongly considered for ISR and in SVD and may be a new benchmark comparator in these situations. For bifurcated lesions, appropriately powered studies are needed before recommending routine PEB use.”
Sanchez-Perez IC, Abellan-Huerta J, Jurado-Roman A, et al. Long-term follow-up of percutaneous coronary intervention with paclitaxel-eluting balloon [published online December 17, 2020]. Angiology. doi: 10.1177/0003319720979246