Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels

Liu, Wenjie; Zhu, Yongjian; Han, Zhanying; Sun, Guoju; Qin, Xuda; Wang, Zhengbin; Liu, Guanghui; Wang, Xi; Wang, Xule; Liang, Pan; Qiu, Chunguang

doi:10.1016/j.jjcc.2018.07.008

Cited by 22 publications

(17 citation statements)

References 26 publications

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“…Two patients (1.6%) underwent bailout stenting and 4 (3.4%) received TLR at 12 months, but no cardiac deaths, MIs, or TVRs occurred. Similarly, two other prospective studies reported TLR and MACE rates of 3.9% [ 24 ] and 4.3% [ 10 ] respectively, with no MIs or deaths. The BASKET-SMALL2 randomized multi-center clinical trial (758 patients) showed that the Sequent Please® DCB was noninferior to first-/second-generation DES (Taxus, Xience Prime) in the treatment of de novo SVD (RVD <3 mm) [ 6 ].…”

Section: Discussionmentioning

confidence: 62%

“…The 10-month angiographic follow-up showed LLL of (−0.17) ± 0.53 mm, with a TLR rate of 0.4% [ 8 ]. Two recent prospective observational studies reported 8-month LLL after DCB intervention for LVD of (−0.02) ± 0.49mm [ 10 ] and 0.01 ± 0.52 mm [ 24 ] respectively, suggesting that DCB is efficacious in de novo lesions. Nishiyama et al [ 11 ] randomized 60 patients to DCB or DES after acceptable pre-dilation, but observed no significant difference in MLD and LLL at 8 months.…”

Section: Discussionmentioning

confidence: 99%

“…Our previous data showed that treatment of large coronary de novo lesions (reference vessel diameter (RVD) >2.8 mm) with DCB only was as safe and effective as using for SVD [8]. However, limited and inconsistent data are available for DCB in de novo lesions [9][10][11]. We conducted this study to determine DCB is non-inferior to the newgeneration DES for de novo lesions in terms of angiographic late lumen loss (LLL).…”

Section: Introductionmentioning

confidence: 99%

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A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Wang

et al. 2021

Cardiovasc Drugs Ther

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Background Drug-coated balloon (DCB) has been proved efficacy for coronary small vessel disease, but data regarding outcomes of DCB in common de novo lesions (including reference vessel diameter more than 3.0mm) compared with new-generation drug-eluting stent (DES) are lacking. We hypothesized that a DCB-only strategy for coronary de novo lesions would be non-inferior to DES treatment on angiographic outcomes. Methods In this randomized controlled trial, we compared the effect of DCB with DES on late lumen loss (LLL) at 9-month angiographic follow-up and 12-month major adverse cardiac events (MACEs), including death, non-fatal myocardial infarction, target lesion revascularization (TLR), and target vessel revascularization (TVR). Results From July 2017 to July 2018, 288 consecutive patients with reference vessel diameter (RVD) between 2.25 and 4.0mm were screened. After proper pre-dilation, 170 patients were enrolled and randomized to the DCB and the DES groups at 1:1 ratio. Seven patients withdrew the consent forms during hospital stay (1 in DCB group, 6 in DES group). Two patients in DCB group underwent bailout stenting due to severe dissection after DCB release. The primary endpoint of 9-month LLL was −0.19±0.49mm with the DCB versus 0.03±0.64mm with the DES. The one-sided 97.5% upper confidence limit of the difference was −0.04mm, achieving non-inferiority of the DCB compared with the DES (P=0.019). The 12-month cumulative MACE rate was similar in the DCB and DES groups (2.44% vs. 6.33%, P=0.226). Conclusions In this prospective study, the DCB only strategy for de novo lesion was non-inferior to the new-generation DES in terms of 9-month late lumen loss.

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Section: Discussionmentioning

confidence: 62%

Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Wang

et al. 2021

Cardiovasc Drugs Ther

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“…TLR and TVR at 12 months follow-up were 3.4 and 5.1%, respectively, with no cardiac death or MI ( 13 ). Similarly, another prospective study reported TLR and major adverse cardiac event (MACE) rates of 4.3%, with no MI or death ( 14 ). Interestingly, a retrospective study analyzed 222 patients with RVD ≥2.8 mm, and there was no TLR and MACE at an average of 10 months of follow-up ( 7 ).…”

Section: Discussionmentioning

confidence: 95%

Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in de novo Lesions of Large Coronary Arteries

Shang

et al. 2022

Front. Cardiovasc. Med.

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Background and ObjectivesUse of drug-coated balloon (DCB)-only strategy for revascularization of native large coronary artery lesions is on the rise. The long-term efficacy of this approach for bifurcation and non-bifurcation lesions remains unknown. We aim to assess the long-term clinical outcomes of DCB-only strategy for the treatment of de novo bifurcation and non-bifurcation lesions in large coronary arteries.MethodsThis multicenter, prospective, observational study enrolled 119 patients with de novo coronary lesions in vessels ≥2.75 mm. The primary end point was the rate of clinically driven target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction, and clinically driven target lesion revascularization (TLR). Patients were followed up for a median of 2 years.ResultsOf 119 patients with 138 lesions, 66 patients (75 lesions) had bifurcation and 53 patients (63 lesions) had non-bifurcation lesions. Average reference vessel diameter was 3.1 ± 0.3 mm, and there was no difference in bifurcation and non-bifurcation group (3.0 ± 0.3 vs. 3.1 ± 0.3mm; p = 0.27). At 2-year follow-up, the TLF occurred in five (4.2%), TLR in four (3.4%), and target vessel revascularization (TVR) in five (4.2%) cases. The frequency of TLR and TVR was higher in the non-bifurcation group (p = 0.04 and 0.02, respectively), but there were no differences in TLF between the two groups (p = 0.17). The cumulative incidence of TLF (Kaplan–Meier estimates) was also not different in the two groups (log-rank p = 0.11).ConclusionDCB-only strategy for de novo lesions in large coronary arteries appears to be safe and effective for both bifurcation and non-bifurcation lesions. Further randomized clinical trials are warranted to confirm the value of DCB-only strategy in de novo bifurcation lesions of large vessels.

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“…Drug-coated balloon (DCB) is effective in treating instent restenosis (ISR) [7,8]. Various clinical studies have revealed its effectiveness against de novo coronary lesions [9][10][11], especially in small vessel disease. Differences in study results are mainly due to differences in study approach, which may use the "DCB-only" or "hybrid" strategy.…”

Section: Introductionmentioning

confidence: 99%

Clinical Outcomes of Drug-Coated Balloon in Coronary Patients with and without Diabetes Mellitus: A Multicenter, Propensity Score Study

Pan

Liu

Han

et al. 2021

Journal of Diabetes Research

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Background. Relative to nondiabetic patients, percutaneous coronary intervention (PCI) in patients with diabetes mellitus (DM) is associated with inferior clinical outcomes. We aimed to evaluate the outcomes of drug-coated balloon (DCB) in diabetic versus nondiabetic patients. Methods and Results. In this observational, prospective, multicenter study, we compared the outcomes of patients with and without DM after undergoing PCI with DCBs. Target lesion failure (TLF) was analyzed as primary endpoint. Secondary endpoints were the rates of target lesion revascularization (TLR), major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), and any revascularization. Propensity score matching was used to assemble a cohort of patients with similar baseline characteristics. Among 2,306 eligible patients, 578 with DM and 578 without DM had similar propensity scores and were included in the analyses. During follow-up ( 366 ± 46 days), compared with DM patients, patients without DM were associated with a lower yearly incidence of TLF (2.77% vs. 5.36%; OR, 1.991; 95% CI, 1.077 to 3.681; P = 0.025 ) and TLR (1.90% vs. 4.15%; OR, 2.233; 95% CI, 1.083 to 4.602; P = 0.026 ). No significant differences were observed with regards to rates of MACE (OR: 1.580, 95% CI: 0.912-2.735; P = 0.100 ), cardiac death (OR: 1.608, 95% CI: 0.523-4.946; P = 0.403 ), MI (OR: 4.042, 95% CI: 0.855-19.117; P = 0.057 ), and any revascularization (OR: 1.534, 95% CI: 0.983-2.393; P = 0.058 ). Conclusions. Diabetic patients experience higher TLF and TLR rates following DCB angioplasty without substantial increase in the risk of MACE, cardiac death, MI, or revascularization.

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Short-term outcomes from drug-coated balloon for coronary de novo lesions in large vessels

Cited by 22 publications

References 26 publications

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

A Non-inferiority, Randomized Clinical Trial Comparing Paclitaxel-Coated Balloon Versus New-Generation Drug-Eluting Stents on Angiographic Outcomes for Coronary De Novo Lesions

Long-Term Clinical Outcomes After Percutaneous Coronary Intervention With Drug-Coated Balloon-Only Strategy in de novo Lesions of Large Coronary Arteries

Clinical Outcomes of Drug-Coated Balloon in Coronary Patients with and without Diabetes Mellitus: A Multicenter, Propensity Score Study

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