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This study sought to compare the efficacy of drug-eluting balloon (DEB) with sirolimus-eluting stent (SES) for the treatment of in-stent restenosis (ISR) in the Chinese Han population.
Patients with ISR located in a native coronary artery treated with DEB or SES in Beijing Anzhen Hospital between September 2014 and June 2015 were consecutively enrolled in this study. The patients were assigned to the DEB group or the SES group according to the therapeutic strategies they accepted. Major adverse cardiovascular events (MACEs) during hospital stay were recorded and patients were followed by telephone or hospital visit at 12 months. MACE was defined as a composite of all-cause death, nonfatal myocardial infarction (MI), and target vessel revascularization (TVR).
In summary, 166 patients were enrolled, including 63 patients in the DEB group and 103 patients in the SES group. There were 116 patients with drug-eluting stent (DES) ISR which was composited of 44 patients in the DEB group and 72 patients in the SES group. According to the Mehran classification, 33 patients with focal lesions and 133 patients with nonfocal lesions were included. No MACE occurred during hospital stay. Overall, there was 2 nonfatal MIs, while TVR occurred in 5 patients in the DEB group. In terms of the SES group, there were 3 all-cause deaths and 7 TVRs. At 13-month clinical follow-up (follow-up rate: 96.4%), MACE in the DEB group was comparable to that of the SES group (9.7% vs. 9.2%, P = 0.92), while treatment with DEB was not noninferior to SES in terms of the event-free survival (90.3% vs. 90.8%, P non-inferiority = 0.23). Furthermore, no statistical difference was found between the two groups in patients with DES-ISR regarding the rate of MACE (7.0% vs. 10.3%, P = 0.74), whereas DEB was not noninferior to SES in terms of the event-free survival (93.0% vs. 89.7%, P non-inferiority = 0.09). With regard to nonfocal restenosis, the cumulative incidence in the DEB group was similar to that in the SES group (10.4% vs. 8.6%, P = 0.76). Nonetheless, DEB was not noninferior to SES regarding the event-free survival in patients with nonfocal restenosis (89.6% vs. 91.4%, P non-inferiority = 0.34). On the multivariate analysis, use of DEB or SES was not the predictor of MACE (P = 0.20).
Treatment of coronary in-stent restenosis with DEB was as efficacious as SES in the Chinese Han population. Furthermore, treatment with PEB was comparable to SES in patients with DES-ISR and nonfocal restenosis. Obviously, DEB angioplasty offers an effective treatment for in-stent restenosis without implanting additional metal layers.