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BACKGROUND: A series of studies have shown that both drug-eluting balloons and drug-eluting stents are better than the other treatments for drug-eluting in-stent restenosis lesions, but both of them have limitations. OBJECTIVE: To evaluate the long-term therapeutic efficacy of drug-eluting balloons and drug-eluting stents in the treatment of coronary in-stent restenosis. METHODS: A total of 63 patients with in-stent restenosis who received treatment in the First Affiliated Hospital of Inner Mongolia Medical University between January 2016 and December 2017 were included in this study. Among these patients, 32 patients received treatment with drug-eluting balloons (drug-eluting balloon group) and 31 patients were treated with drug-eluting stents (drug-eluting stent group). Coronary artery status before and immediately after surgery, coronary angiography 1 year after surgery, adverse events, and the risk factors of in-stent restenosis were recorded in both groups. The study was approved and supported by the Medical Ethics Committee of Inner Mongolia Medical University. RESULTS AND CONCLUSION: All patients were followed up for 1 year. There were no significant differences in minimum in-stent diameter, target vessel diameter, in-stent lumen loss in the late period between patients receiving treatment with drug-eluting balloons and patients receiving drug-eluting stents (all P > 0. 05). There were no significant differences in secondary restenosis rate (18% vs. 16%, P=0. 216), target lesion revascularization rate (6% vs. 6%, P=0. 513), and incidence of adverse events (9% vs. 10%, P=0. 334) between drug-eluting balloon and drug-eluting stent groups. There were two cases of gastrointestinal bleeding in the drug-eluting stent group, and no gastrointestinal bleeding occurred in the drug-eluting balloon group. Significant difference in gastrointestinal bleeding occurred between these two groups (P < 0. 01). Multi-factor analysis showed that smoking, diabetes and hyperhomocysteinemia are the risk factors of in-stent restenosis. These results suggest that both drug-eluting balloons and drug-eluting stents are the ideal treatments of in-stent restenosis. In clinical practice, individualized treatment options should be considered based on multiple factors.
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<p><b>Background</b>Currently, drug-eluting balloon (DEB) appears to be an attractive alternative option for the treatment of in-stent restenosis (ISR). Nevertheless, the clinical outcomes of DEB have seldom been compared to those of new-generation drug-eluting stent (DES). Thus, this meta-analysis aimed to evaluate the safety and efficacy of DEB compared to those of new-generation DES in the treatment of ISR.</p><p><b>Methods</b>A comprehensive search of electronic databases including PubMed, EMBASE, and Cochrane Library up to November 2, 2017 was performed to identify pertinent articles comparing DEB to new-generation DES for the treatment of ISR. In addition, conference proceedings for the scientific sessions of the American College of Cardiology, American Heart Association, European Society of Cardiology, Transcatheter Cardiovascular Therapeutics, and EuroPCR were also searched. The primary endpoint was target lesion revascularization (TLR) at the longest follow-up. Dichotomous variables were presented as risk ratios (RR s) with 95% confidence intervals (CI s), while the overall RR s were estimated using the Mantel-Haenszel random-effects model.</p><p><b>Results</b>Five randomized controlled trials (RCTs) and eight observational studies involving 2743 patients were included in the present meta-analysis. Overall, DEB was comparable to new-generation DES in terms of TLR (RR = 1.24, 95% CI: 0.89-1.72, P = 0.21), cardiac death (RR = 1.55, 95% CI: 0.89-2.71, P = 0.12), major adverse cardiovascular event (RR = 1.21, 95% CI: 0.98-1.48, P = 0.07), myocardial infarction (RR = 1.12, 95% CI: 0.72-1.76, P = 0.62), and stent thrombosis (RR = 0.95, 95% CI: 0.38-2.42, P = 0.92). However, DEB was associated with higher risk of all-cause mortality than new-generation DES (RR = 1.65, 95% CI: 1.09-2.50, P = 0.02). This was especially true in the real-world observational studies (RR = 1.79, 95% CI: 1.12-2.88, P = 0.02). In RCTs, however, no significant difference was found between the two treatment strategies in the risk of all-cause mortality.</p><p><b>Conclusions</b>The current meta-analysis showed that DEB and new-generation DES had comparable safety and efficacy for the treatment of ISR in RCTs. However, treatment with DEB was associated with higher risk of all-cause mortality in the real-world nonrandomized studies.</p>
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Objective To compare the safety and effectiveness of drug-eluting balloon (DEB) with paclitaxel and drug eluting stent (DES) in treating in-stent restenosis (ISR).Methods The clinical data of a total of 76 patients with ISR,who were admitted to authors' hospital to receive stem implantation during the period from January 2012 to September 2014,were retrospectively analyzed.According to the therapeutic means,the patients were divided into paclitaxel DEB group (n=32) and paclitaxel DES group (n=44).The general clinical information and coronary artery angiography findings were collected.The patients were followed up for one year;the all-cause mortality,cardiac death,myocardial infarction,in-stent thrombosis,target lesion revascularization,target vessel revascularization,and major adverse cardiac events were documented.Results No obvious difference in the general data of patients existed between group DEB and group DES (P＞0.05).The incidences of left anterior descending artery ISR in DEB group and in DES group were 43.75％ and 47.73％ respectively.The ISR target vessel types of the two groups were quite similar (P＞0.05).No statistically significant differences in ISR type,ISR lesion type and characteristics of in-stent restenosis existed between the two groups (P＞0.05).One-year following-up examinations indicated that no statistically significant differences in all-cause mortality,cardiac death,myocardial infarction,in-stent thrombosis,target lesion revascularization,target vessel revascularization,and major adverse cardiac events existed between the two groups (P＞0.05).Further analysis revealed that no significant difference in event-free survival existed between the two groups (P＞0.05).Conclusion For the treatment of ISR,the use of paclitaxel DEB is safe and feasible,its curative effect is not less than DES.
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Objective To evaluated the safety and feasibility of excimer laser atherectomy (ELA) combined with drug-eluting balloon angioplasty in treating chronic ischemia of lower limbs.Methods ELA combined with paclitaxel-eluting balloon angioplasty was adopted to treat chronic ischemia of lower limbs caused by arteriosclerosis occlusive disease of lower extremity in three patients.All three patients had arteriosclerosis occlusive disease of superficial femoral artery;in two of them the disease was primary occlusive lesion and in another patient the disease was in-stent re-occlusion lesion after sten implantation.Results After the treatment,the blood flow in the diseased arteries was unobstructed,the blood supply of the lower limbs was obviously improved.No procedure-related complications occurred.Two weeks after the treatment,no recurrence of ischemic symptoms was observed,the blood flow in superficial femoral artery kept unobstructed.The patients recovered smoothly.Conclusion For the treatment of chronic ischemia of lower limbs,which are caused by the primary arteriosclerosis occlusive disease of lower extremity or by the in-stent re-occlusion lesion after sten implantation,ELA combined with paclitaxel-eluting balloon angioplasty is clinically safe and feasible,although its long-term effect needs to be clarified with more studies.
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The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15–0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option. This was a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT01539603; http://www.clinicaltrials.gov/ct2/show/NCT01539603).
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Humans , Angiography , Coronary Angiography , Coronary Artery Disease , Coronary Vessels , Drug-Eluting Stents , Follow-Up Studies , Prospective Studies , StentsABSTRACT
Objective To investigate the possible inhibition effect of a domestic novel drug-eluting balloon(DEB), such as controlling the vascular stenosis and reducing the intimal hyperplasia, on obstructive peripheral arterial disease (PAD) of lower extremity. Methods Male New Zealand rabbits (weighted 2.5-3.0 kg) were used for this study. Mustang bare metal stents (BMS) were separately implanted at both the proximal and distal site of abdominal aorta to establish the PAD models in rabbits. Bare balloon (PTA group) or drug-eluting balloon (DEB group) was separately used to dilate the stent segment of the aorta. The animals were sacrificed 28 days after the treatment. The aorta stent specimens were collected and sent for pathologic examination. Using Masson staining method the degree of intimal hyperplasia was estimated and the expression level of paclitaxel-targeted β-tubulin was determined with immunohistochemical method. The results were compared between the two groups. Results Morphologically, both the degree of intimal hyperplasia and the vascular stenosis rate in DEB group were significantly lower than those in PTA group. Meanwhile, immunohistochemical examination of paclitaxel-targeted β-tubulin indicated that its expression level in DEB group was obviously higher than that in PTA group. Conclusion This experimental study indicates that the domestic novel DEB has potential inhibition effect in respect of controlling the loss of lumen as well as reducing the intimal hyperplasia. This novel DEB carries excellent property, suggesting the possibility to use DEB in clinical treatment of PAD.