Compassionate use of a paclitaxel coated balloon in patients with refractory recurrent coronary in-stent restenosis.

OBJECTIVE: Treatment of coronary in-stent restenosis (ISR) remains a challenge in interventional cardiology, especially after drug eluting stent (DES)-ISR. Drug coated balloons (DCB) provide a new therapeutic option in the treatment of ISR. In patients with multiple layers of stents due to refractory ISR and exclusion criteria for revascularization by coronary artery bypass grafting, DCB may be a last therapy option. This paper presents DCB therapy as compassionate use treatment before the balloons were available in Europe. PATIENTS: Compassionate use of DCB was approved by the local ethical committee. Fifteen patients with refractory ISR in 28 lesions were prospectively enrolled between 12/2006 and 04/2009. The frequency of prior ISR was 3.0 ± 1.1. Nine patients presented with coronary three-vessel disease and six patients with one- or two-vessel disease. Thirteen patients had DES-ISR, two patients with contraindication for prolonged dual anti-platelet therapy repeated BMS-ISR. Two or three layers of metal were present in eleven patients. Four patients had prior coronary artery bypass grafting.
RESULTS: All lesions were treated with DCB (SeQuent™ Please, B.Braun, Germany). Angiographic follow-up was obtained in 14 patients. Clinical follow-up was available in all patients after 3.2 ± 0.8 years (maximum 4.8 years). Target lesion revascularization was done in 2 of 28 lesions (7.1 %), one patient with ischemic cardiomyopathy died after 1.5 years. No further MACE occurred.
CONCLUSION: DCB appear to be safe and clinically useful in the treatment of ISR. DCB is a new promising option for high-risk patients with refractory ISR.