Predictors of Favorable Angiographic Outcomes After Drug-Coated Balloon Use for de novo Small Vessel Coronary Disease (DCB-ONLY)

Angiology ◽  
2021 ◽  
pp. 000331972110155
Author(s):  
Woong Chol Kang ◽  
Sang Min Park ◽  
Albert Youngwoo Jang ◽  
Pyung Chun Oh ◽  
Eun-Seok Shin ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Small Vessel ◽  
Luminal Diameter ◽  
Minimal Luminal Diameter ◽  
Late Luminal Loss ◽  
Drug Coated Balloon

We evaluated the angiographic parameter and clinical outcomes of drug-coated balloon (DCB) to assess the optimal angiographic criteria in de novo small vessel disease (SVD). Patients (n = 424, mean age: 64.4 ± 11.2 years, men: 69.8%) at 20 sites in Korea were prospectively enrolled. The primary end point was late luminal loss (LLL) at 9-month follow-up angiography. Secondary end points included restenosis rates, target lesion failure (TLF), and DCB-related thrombosis during the 12-month follow-up period. We included 403 patients for analysis excluding 21 patients who required bailout stenting. Baseline mean reference vessel .diameter was 2.52 ± 0.39 mm and mean minimal luminal diameter (MLD) was 0.71 ± 0.40 mm. The mean MLD was 1.54 ± 0.37 mm after DCB. Late luminal loss was −0.01 ± 0.43 mm and restenosis was noted in 26 patients (12.2%). Minimal luminal diameter >1.6 mm and % diameter stenosis (DS ) <45% after DCB was associated maintenance of MLD without LLL at 9-months. Multivariate analysis demonstrated that %DS at baseline and post-MLD was associated with the restenosis. During 12-month follow-up, TLF was 2.6% including 1 cardiac death, 1 myocardial infarction, and 10 ischemia-driven target lesion revascularizations. Drug-coated balloon showed a low restenosis and lower LLL despite high in-segment DS. Post-MLD and % DS may be helpful to get optimal results in de novo SVD after DCB.

scholarly journals Drug-Coated Balloon-Only Angioplasty Outcomes in Diabetic and Nondiabetic Patients with De Novo Small Coronary Vessels Disease

2021 ◽  
Vol 2021 ◽  
pp. 1-9
Author(s):  
Botey Katamu Benjamin ◽  
Wenjie Lu ◽  
Zhanying Han ◽  
Liang Pan ◽  
Xi Wang ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Independent Predictor ◽  
Coronary Vessels ◽  
Target Lesion ◽  
Target Lesion Revascularization ◽  
Vessel Disease ◽  
One Year ◽  
Target Lesion Failure ◽  
Drug Coated Balloon

Background. The revascularization of small vessels using drug-eluting stents remains challenging. The use of the drug-coated balloon is an attractive therapeutic strategy in de novo lesions in small coronary vessels, particularly in the diabetic group. This study aimed to assess the outcomes of DCB-only angioplasty in small vessel disease. Methods. A total of 1198 patients with small vessel disease treated with DCB-only strategy were followed. Patients were divided into the diabetic and nondiabetic groups. Clinical and angiographical follow-up were organized at 12 months. The primary endpoints were target lesion failure and secondary major adverse cardiac events. Results. There was a significantly higher rate of target lesion failure among diabetic patients compared to nondiabetic [17 (3.9%) vs. 11 (1.4%), P = 0.006 ], taken separately, the rate of target lesion revascularization significantly differed between groups with a higher rate observed in the diabetic group [9 (2%) vs. 4 (0.5%), P = 0.014 ]. Diabetes mellitus remained an independent predictor for TLF (HR: 2.712, CI: 1.254–5.864, P = 0.011 ) and target lesion revascularization (HR: 3.698, CI: 1.112–12.298, P = 0.033 ) after adjustment. However, no significant differences were observed between groups regarding the target vessel myocardial infarction (0.6% vs. 0.1%, P = 0.110 ) and MACE [19 (4.4%) vs. 21 (2.7%), P = 0.120 ]. Conclusion. Drug-coated balloon-only treatment achieved lower incidence rates of TLF and MACE. Diabetes is an independent predictor for target lesion failure and target lesion revascularization at one year following DCB treatment in small coronary vessels. We observed no significant differences between groups regarding MACE in one year.

Neointimal Healing Evaluated by Optical Coherence Tomography after Drug-Eluting Absorbable Metal Scaffold Implantation in de novo Native Coronary Lesions: Rationale and Design of the Magmaris-OCT Study

Cardiology ◽  
2017 ◽  
Vol 137 (4) ◽  
pp. 225-230 ◽  
Author(s):  
Pasi Karjalainen ◽  
Tuomas Paana ◽  
Jussi Sia ◽  
Wail Nammas
Keyword(s):  
Optical Coherence Tomography ◽  
De Novo ◽  
Quantitative Coronary Angiography ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Lesion Length ◽  
Optical Coherence ◽  
Flow Reserve ◽  
Coronary Lesions

Objectives: We sought to explore neointimal healing assessed by optical coherence tomography (OCT) following implantation of the Magmaris sirolimus-eluting absorbable metal scaffold. Methods: The Magmaris-OCT is a prospective, multicenter, single-arm observational clinical study, intended to enrol 60 consecutive patients with up to 2 de novo native coronary lesions, each located in different major epicardial vessels, with a reference vessel diameter of 2.5-3.5 mm, and a maximum lesion length of 20 mm. Patients will undergo Magmaris scaffold implantation in the target lesion, according to the standard practice. Clinical follow-up will take place at 30 days, and at 3, 6, 9, and 12 months. For invasive-imaging follow-up, patients will be classified into 3 groups: cohort A will be scheduled for follow-up at 3 months, cohort B at 6 months, and cohort C at 12 months. Invasive imaging will include quantitative coronary angiography, OCT evaluation, and coronary flow reserve measurement. The primary end point will be the percentage of uncovered scaffold struts assessed by OCT at the prespecified follow-up. Conclusions: This study will provide insight into the short- and mid-term healing properties following Magmaris scaffold implantation, with special emphasis on the neointimal coverage of scaffold struts.

Drug-Coated Balloon Angioplasty in Atherosclerosis Patients With Popliteal Artery Involvement

2018 ◽  
Vol 25 (5) ◽  
pp. 581-587 ◽  
Author(s):  
Tomoharu Dohi ◽  
Andrej Schmidt ◽  
Dierk Scheinert ◽  
Yvonne Bausback ◽  
Daijiro Kabata ◽  
...  
Keyword(s):  
Popliteal Artery ◽  
De Novo ◽  
Vessel Diameter ◽  
Primary Patency ◽  
Lesion Length ◽  
Endovascular Interventions ◽  
Long Term Follow Up ◽  
Drug Coated Balloon

Purpose: To investigate outcomes of drug-coated balloon (DCB) angioplasty in endovascular interventions including or restricted to the popliteal artery. Methods: A retrospective analysis was conducted of 266 patients [median age 72 years, interquartile range (IQR) 62, 78; 166 men] treated with DCB angioplasty in 281 de novo lesions including the popliteal artery between December 2011 and January 2015 at a single center. The median lesion length was 270 mm (IQR 150, 373). The study outcomes were primary patency and predictors of restenosis [reported as the hazard ratio (HR) with 95% confidence interval (CI)]. Results: The primary patency was 77.4% at a median 12.2 months (IQR 5.7, 18.8). Independent variables associated with restenosis included baseline Rutherford category (HR 1.36, 95% CI 1.05 to 1.77, p=0.02), reference vessel diameter (HR 0.77, 95% CI 0.63 to 0.95, p=0.02), dissection (HR 1.69, 95% CI 1.022.79, p=0.04), and standard nitinol stent use (HR 2.08, 95% CI 1.14 to 3.79, p=0.02). Conclusion: Outcomes after DCB angioplasty in lesions including the popliteal artery were acceptable compared with previous studies. Further investigation with long-term follow-up is needed to confirm these results.

scholarly journals Effect of Drug-Coated Balloon in Side Branch Protection for de novo Coronary Bifurcation Lesions: A Systematic Review and Meta-Analysis

2021 ◽  
Vol 8 ◽  
Author(s):  
Yawei Zheng ◽  
Jie Li ◽  
Lingzhun Wang ◽  
Peng Yu ◽  
Haibo Shi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Outcomes ◽  
De Novo ◽  
Meta Analysis ◽  
Treatment Strategies ◽  
Target Lesion ◽  
Side Branch ◽  
Significant Difference ◽  
Drug Coated Balloon

Background: At present, there are a variety of treatment strategies for percutaneous coronary intervention. The role of drug-coated balloon (DCB) in the treatment of side branch for de novo coronary bifurcated lesions (CBL) is unclear.Objective: To examine the effect of DCB in side branch protection for de novo CBL.Methods: Electronic databases, including Pubmed, Embase, the Web of science, Cochrance library, CNKI, CBM, WanFang Data and VIP were searched for studies that compared DCB with non-drug-coated balloon (NDCB) in side branch protection for de novo CBL from inception through July 7th, 2021. The primary outcome was target lesion revascularization (TLR). Secondary clinical outcomes included myocardial infarction (MI), cardiac death (CD). The angiographic outcomes included side branch late lumen loss (LLL), minimum lumen diameter (MLD), diameter stenosis (DS) and binary restenosis (BR). The target lesion failure (TLF) was also analyzed.Results: A total of 10 studies, including 5 randomized controlled trials and 5 non-randomized observational studies, with 934 patients were included. Meta-analysis results of angiographic outcomes suggested that DCB group had the less LLL, DS and BR and the higher MLD compared with NDCB group at follow-up (P &lt; 0.05). Meta-analysis results of clinical outcomes suggested that the significant difference in the TLR, MI and CD between DCB group and NDCB group has not been found yet (P &gt; 0.05). However, the MACE of DCB group was significantly less than that of NDCB group at 9-month follow-up [OR = 0.21, 95%CI (0.05, 0.84), P = 0.03] and 12-month follow-up [OR = 0.45, 95%CI (0.22, 0.90), P = 0.02]. In addition, there was no significant difference in TLF between DCB group and NDCB group (P &gt; 0.05).Conclusions: DCB had great effect in side branch protection for de novo CBL at short and medium-term follow-up with no reduction in the procedural success rate.Systematic Review Registration:https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=267426, PROSPERO [Identifier: CRD42021267426].

scholarly journals Does the use of scoring balloon prior to drug coated balloons improve clinical outcomes in de Novo coronary lesions?

2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A M Fawzy ◽  
B H Loku Waduge ◽  
H Kalkat ◽  
A M Saif ◽  
S Athulorala ◽  
...  
Keyword(s):  
Clinical Outcomes ◽  
Cardiac Death ◽  
De Novo ◽  
Target Lesion ◽  
Drug Uptake ◽  
Target Vessel ◽  
Funding Sources ◽  
Scoring Balloon ◽  
Drug Coated Balloon

Abstract Aims The use of scoring balloon prior to drug coated balloon has been proven to be effective in restenotic lesions. However, their effect in de novo lesions has not been tested. Logic tells that the use of scoring balloons should enhance the drug uptake into the vessel wall. In this study, we evaluated this concept of scoring balloon prior to DCB in de novo lesions and compared to those who were treated with a conventional approach (semi-compliant and/or non-compliant balloons). Methods and results We evaluated all de novo lesions treated with DCB between March 2018 and October 2020 at our centre. The results are reported as cardiac death, target vessel myocardial infarction (TVMI), target lesion revascularisation (TLR) and MACE (combination of cardiac death, target vessel MI and TLR). During the study period 348 patients with de novo lesions were treated with DCB. Of those, 49 were predilated with scoring balloon prior to use of DCB and the remaining 299 were predilated with non-scoring balloons (semi-compliant and/or non-compliant). The majority of the baseline characteristics had no statistically significant differences (table 1), with the exception of the mean diameter of the lesions were larger in the scoring balloon group than non-scoring balloon group: 2.7±0.5 vs. 2.49±0.4; p=0.003 and mean length of lesions were longer in the non-scoring balloon group: 26±8.8 vs. 23±7.7; p=0.02. During the median follow-up of 660 days, clinical outcomes between the scoring and non-scoring balloons were; cardiac death: 0 vs. 8 (3%); p=0.5, TVMI: 2 (4%) vs. 8 (3%); p=0.9, TLR: 3 (6%) vs. 25 (8.4%); p=0.8, MACE: 4 (8%) vs. 34 (11%) p=0.7 Conclusion There were no differences in the clinical outcomes between the two groups indicating that use of scoring balloon prior to DCB may not offer additional benefit, although this needs to be confirmed in a larger patient group. FUNDunding Acknowledgement Type of funding sources: None.

A novel ultrasound controlled paclitaxel releasing balloon catheter versus plain balloon catheter in the treatment of small coronary vessel stenosis: study protocol of a randomized controlled clinical trial (Vasoguard I Trial)

2020 ◽  
Author(s):  
Yueyi Pan ◽  
Feng Zhang ◽  
Jingpu Wang ◽  
Ji'e Yang ◽  
Li Shen ◽  
...  
Keyword(s):  
Small Vessel Disease ◽  
Balloon Catheter ◽  
Target Lesion ◽  
Small Vessel ◽  
Controlled Clinical Trial ◽  
Efficacy And Safety ◽  
Randomized Controlled Clinical Trial ◽  
Vessel Disease ◽  
Randomized Controlled ◽  
Drug Coated Balloon

Abstract Background The optimal intervention strategy remains controversial in small vessel disease which is a very common kind of coronary artery lesions. For now, balloon-only percutaneous coronary intervention is the major percutaneous revascularization method in these patients, but the restenosis rate is still at a high level. Drug coated balloon is designed to deliver paclitaxel to target vessel to inhibit the proliferation of vascular endothelial cells, it aims at restraining the stenosis process after intervention so as to reduce the rate of restenosis. Ultrasound controlled paclitaxel releasing balloon catheter (Vasoguard TM ) is a newly designed drug coated balloon, expected to promote the drug release process via external ultrasound intervention so as to improve drug bioavailability. The current trial was designed to assess the efficacy and safety of Vasoguard in the treatment of small vessel coronary disease.Methods A prospective, multicenter, randomized, controlled clinical trial has been designed to compare the safety and efficacy of Vasoguard with plain balloon angioplasty in the treatment of small vessel coronary disease. 230 patients will be included in this trial, the primary endpoint is late lumen loss of target lesion at 9 months post operation measured by quantitative coronary angiography. Secondary endpoints include angiographic findings such as device success rate, operation success rate, in-segment restenosis, clinical outcomes such as target lesion revascularization, target vessel revascularization, device oriented composite endpoint and thrombotic events.Discussion This trial will evaluate the efficacy and safety of Vasoguard in the treatment of small vessel coronary disease by comparing to plain balloon angioplasty. It will clarify the practicability of the newly designed balloon and may lend more credence to the role of drug coated balloon in the treatment of small vessel disease.

scholarly journals Drug-coated Balloons for Small Coronary Vessel Interventions: A Literature Review

2019 ◽  
Vol 14 (3) ◽  
pp. 131-136 ◽  
Author(s):  
Thomas Nestelberger ◽  
Raban Jeger
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Bare Metal Stents ◽  
Standard Of Care ◽  
Target Lesion ◽  
Small Vessel ◽  
Current Evidence ◽  
Metal Stents ◽  
Vessel Disease ◽  
Stent Restenosis

Newer-generation drug-eluting stents (DES) are the standard of care for the treatment of symptomatic coronary artery disease. However, some lack of efficacy has been reported in small coronary arteries based on higher rates of target lesion restenosis, thrombosis and MI resulting in repeated interventions. Drug-coated balloons (DCBs) are an established treatment option for in-stent restenosis in both bare metal stents and DES and they can deliver an anti-proliferative drug into the vessel wall without implanting a stent. DCBs are a promising technique for selected de novo coronary lesions, especially in small vessel disease. In this article, the current evidence for the treatment of small vessel disease with DCBs will be reviewed.

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

2021 ◽  
Author(s):  
Xue Yu ◽  
Xinyue Wang ◽  
Fusui Ji ◽  
Wenduo Zhang ◽  
Chenguang Yang ◽  
...  
Keyword(s):  
De Novo ◽  
Small Vessel Disease ◽  
Controlled Trial ◽  
Vessel Diameter ◽  
Target Lesion ◽  
Drug Eluting Stent ◽  
Cardiac Events ◽  
Late Lumen Loss ◽  
Drug Eluting ◽  
New Generation

Abstract 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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