In our 鈥榮tentless鈥?approach, the NSE balloon is used for target lesion dilation in patients with low risk factors and simple target lesions. No stenting was performed once an optimal dilatation result was achieved, as evaluated by intravascular ultrasound (IVUS). In a total of 340 lesions in 304 patients, in whom the follow-up study was completed, the 鈥榮tentless鈥?PCI by NSE balloon alone was achieved in 52 lesions (15%). Target lesion revascularization (TLR) was performed for 5 (9.6%) of the 52 鈥榮tentless鈥?lesions. In the comparison between the 52 鈥榮tentless鈥?lesions and the 31 DES lesions selected under the statistical matching of the patient profiles and baseline lesion characteristics, the TLR rate (9.6% vs 6.5%, p = 0.616) and late lumen loss (0.52 卤 0.26 mm vs 0.48 卤 0.21 mm, p = 0.347) were similar. In the 52 鈥榮tentless鈥?lesions, IVUS parameters such as vessel area, minimal lumen area, and plaque area at both before and immediately after PCI were similar between the 5 TLR lesions and the 47 non TLR lesions.
It is believed that the 鈥榮tentless鈥?approach is applicable even in the DES era.