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Objective:To compare the effect of prognosis between drug-coated balloon (DCB) and drug eluting stent (DES) interventional therapy in patients with coronary heart disease.Methods:The clinical data of 346 coronary heart disease patients underwent interventional therapy because of small vessel lesion, in-stent restenosis and bifurcation lesion in Xuanwu Hospital, Capital Medical University from December 2018 to July 2021 were retrospectively analyzed. Among them, 179 patients were treated with DES (DES group), including small vessel lesion 81 cases, in-stent restenosis 35 cases, and bifurcation lesion 63 cases; 167 patients were treated with DCB (DCB group), including small vessel lesion 69 cases, in-stent restenosis 62 cases, and bifurcation lesion 36 cases. The major adverse cardiac and cerebrovascular event (MACCE) within 1 year after discharge was compared between two groups. Non-inferiority was analyzed, and non-inferiority margin was set to be 4%.Results:There was no statistical difference in the incidence of MACCE between DCB group and DES group: 3.59% (6/167) vs. 7.26% (13/179), P>0.05. There were no statistical differences in the incidences of MACCE in patients with small vessel lesion, in-stent restenosis and bifurcation lesion between DCB group and DES group: 1.45% (1/69) vs. 4.94% (4/81), 8.06% (5/62) vs. 14.29% (5/35) and 0 vs. 6.35% (4/63); P>0.05. Non-inferiority analysis result showed that DCB was non-inferior to DES on the prognosis in patients with coronary heart disease (95% CI - 8.41% to 1.07%). Conclusions:Non-inferiority of DCB versus DES is shown in coronary heart disease patients with small vessel lesion, in-stent restenosis and bifurcation lesion.
RESUMO
Objective:To evaluate the safety, feasibility and efficacy of drug-coated balloon (DCB) in the treatment of in-stent restenosis (ISR) of the vertebrobasilar artery.Methods:Twenty-one patients with ISR of the vertebrobasilar artery treated with DCB at the Zhengzhou University People′s Hospital from January 2018 to December 2020 were retrospectively included. There were 22 lesions with ISR, of which 8 were located in the initial segments of vertebral artery, 12 were located in the V4 segment of the vertebral artery, and 2 were located in the basilar artery. The clinical prognosis was evaluated by modified Rankin Scale (mRS), and the target vessel restenosis was evaluated by DSA, CTA or MRA. The safety, feasibility and effectiveness of DCB in the treatment of vertebrobasilar artery ISR were analyzed by perioperative complications, technical success rate and follow-up.Results:All 21 patients with ISR underwent successful interventional surgery. No stroke, TIA and death occurred in perioperative period. During the operation, two cases (9.5%) were treated with Apollo stent due to the residual stenosis>50% after DCB dilation. The technical success rate was 90.5%. The mean stenosis of the target vessel was improved immediately from preoperative (78.1±11.3)% to postoperative (22.1±8.3)%. All the 21 patients were followed up. As of the last follow-up in September 2021, the median clinical follow-up period was 19 (12, 33.5) months, and there were no stroke, TIA and death caused by the corresponding artery. The mRS score was 0 in 18 patients 1 in 2 patients and 2 in 1 patient. Imaging follow-up was available in 13 cases (61.9%) with a median follow-up time of 7(5.5, 19) months, and the target vessel restenosis rate was 7.7% (1/13).Conclusions:This preliminary study has shown that DCB in the treatment of ISR of the vertebrobasilar artery is safe and feasible, with a high technical success rate and low restenosis rate, which provides clinical application evidence, but the long-term effect needs further follow-up observation.