Author + information
- Joshua P. Loh1,
- Pieter R. Stella2,
- Giuseppe Sangiorgi3,
- Sigmund Silber4,
- Stefanic Stahnke5,
- Rembert Pogge von Strandmann5,
- Zhenyi Xue1,
- Rebecca Torguson1 and
- Ron Waksman1
In the Valentines I trial, treatment of coronary in-stent restenosis was effective and safe with the second-generation DIOR® paclitaxel drug-coated balloon (DCB). We analyzed the effect of DCB treatment on patients with drug-eluting stent (DES) restenosis.
Valentines I trial prospectively enrolled 250 patients with ISR. Of these, 74 patients (29.6%) had DES restenosis. Patients underwent balloon angioplasty followed by DCB treatment. Clinical outcomes of patients with paclitaxel DES restenosis (34 patients with 41 lesions) and -limus (sirolimus, everolimus and zotarolimus) DES restenosis (42 patients with 43 lesions) treated with DIOR® DCB were compared.
Baseline characteristics were similar in both groups. There were more diffuse pattern of restenosis in paclitaxel DES compared to -limus DES restenosis (50% vs. 26.8%, p=0.032). Number of DCB used per patient (1.07 each group), mean DCB diameter (2.95mm vs. 3.02mm), mean DCB length (26.7mm vs. 22.5mm) and bailout stenting (2.6% vs. 4.7%) were similar in both groups (p=NS). At mean follow-up of 231 ± 43 days, major adverse cardiac events was 0% in the paclitaxel DES restenosis and 23.8% in the -limus DES restenosis (p=0.002), the difference contributed mainly by less target vessel revascularization (0 vs. 18.6%, p=0.006) (Table).
In the Valentines I trial, the use of paclitaxel DCB was more effective in patients with paclitaxel DES restenosis compared to -limus DES restenosis, achieving better mid-term clinical outcomes. This suggests the efficacy of localized paclitaxel delivery to overcome paclitaxel resistance but not -limus resistance due to different mechanisms of DES failure.
- 2013 American College of Cardiology Foundation