Introduction: Drug-coated balloons (DCB) are being increasingly used in interventional cardiology and are established for the treatment of in-stent restenosis (ISR). It is unclear how effective they are in patients with de novo lesions.
Methods: A prospective registry of patients treated with the In.Pact DCB at our institution was conducted. Patients with ISR and those with planned surgery or contraindication to long-term use of double-antiplatelet therapy were included.
Outcome measures: 12-month rates of clinically driven target-lesion revascularization (TLR). The efficacy of DCB was compared between patients with ISR and de novo lesions and in those with reference vessel diameter (RVD) < and > 2.75 mm.
Results: A total of 139 patients (222 lesions) were followed up for 12 months. The mean age was 69 ± 10 years. Ninety-five patients (68%) had stable angina and 44 patients (32%) had acute coronary syndrome. Clinically driven TLR was performed in 6/126 lesions (4.8%) in the de novo group and in 5/92 lesions (5.4 %) in the ISR group (P=1.0). In the de novo group, TLR rate was 1/45 (2.2%) in patients with vessel diameter >2.75 mm and 5/81 (6.2%) in those with diameter <2.75 (P=.42). In the ISR group, TLR was 3/71 (4.2%) in patients with vessel diameter >2.75 mm and 2/21 (9.5%) in those with diameter <2.75 mm (P=.32).
Conclusions: DCB are a valuable treatment option for patients with ISR offering good rates of TLR. Additionally, DCB can be an alternative to drug-eluting stents, if the use of long-term double antiplatelet medications is not desired.