Paclitaxel coated balloon fibroplasty: A more effective treatment for chronic symptomatic lead/catheter related central venous obstruction?

Central venous occlusion is a common complication following transvenous lead or therapeutic catheter placement that can present either acutely or chronically.     

Inhibition of neo‐intimal hyperplasia in porcine coronary arteries utilizing a novel paclitaxel‐coated scoring balloon catheter

Objective: Scoring balloons are particularly useful in the acute treatment of fibro‐calcific, bifurcation and in‐stent restenosis lesions but have not been shown to affect the restenosis rate. Conventional balloons coated with paclitaxel have recently been shown to reduce restenosis rates in certain lesion subsets, but are associated with suboptimal acute results. A novel paclitaxel‐coated scoring balloon was developed to overcome these limitations. Design: AngioSculpt^® scoring balloons (SB) were coated with paclitaxel admixed with a specific excipient. Setting and Interventions: Four in vitro and in vivo studies were performed: (a) loss of the drug during passage to the lesion, (b) transfer of the drug to the vessel wall; (c) inhibition of neo‐intimal proliferation in porcine coronary arteries as compared to uncoated SB and the Paccocath?, and (d) evaluation of the dose‐response to 1.5–12 μg of paclitaxel/mm². Main outcome measures and Results: Drug loss during delivery to the lesion was 17% ± 8%, and transfer to the vessel wall was 9% ± 4% of dose on unused balloons. The paclitaxel‐coated SB resulted in a lower late lumen loss of 0.27 ± 0.24 mm compared to 1.4 ± 0.7 mm with the uncoated SB (P = 0.001). Histomorphometry revealed larger luminal areas of 6.8 ± 1.6 mm² (paclitaxel‐coated SB) and 5.8 ± 1.7 mm² (Paccocath) as compared to the uncoated SB (2.3 ± 1.5 mm²; P = 0.001). No coating related adverse effects were observed on follow‐up angiography or histologic examination at the treatment site or downstream myocardium. Conclusion: A novel paclitaxel‐coated SB leads to a significant inhibition of neointimal proliferation in the porcine coronary model. © 2013 Wiley Periodicals, Inc.     

Outcomes after drug‐coated balloon treatment for patients with calcified coronary lesions

Objectives

To investigate the efficacy of drug‐coated balloon (DCB) for calcified coronary lesions.

Background

Calcified coronary lesions is associated with poor clinical outcomes after revascularization. Recently, DCB is emerging as an alternative strategy for de novo coronary lesions. However, reports describing the efficacy of DCB for calcified coronary lesions are limited.

Methods

A total of 81 patients (96 lesions) who electively underwent DCB treatment for de novo coronary lesions were enrolled: 46 patients (55 lesions) in the calcified group and 35 patients (41 lesions) in the non‐calcified group. Angiographic follow‐up data and clinical outcomes after the procedure were evaluated.

Results

The diameter of the DCB used was 2.5 ± 0.5 mm. No bail‐out stenting was observed after DCB treatment. Rotational atherectomy was used in 82% of lesions in the calcified group. Follow‐up angiography (median, 6.5 months after intervention) was performed for 59 patients (30 in the calcified group and 29 in the non‐calcified group). Late lumen loss and rates of restenosis were comparable between the groups (0.03 mm in the calcified group vs ?0.18 mm in the non‐calcified group, P = 0.093 and 13.9% vs 3.03%, P = 0.095, respectively). The survival rates for target lesion revascularization free survival and major adverse cardiac events at 2 years were comparable between the groups (85.3% vs 93.4%, P = 0.64 and 81.4% vs 88.5%, P = 0.57, respectively).

Conclusion

Calcified coronary lesions might dilute the effect of DCB. However, clinical outcomes in the calcified group were similar to those in the non‐calcified group.

     

Drug‐coated balloon: Long‐term outcome from a real world three‐center experience

Objectives

In‐stent restenosis (ISR) and diffuse small vessel disease still represent challenging subsets for percutaneous coronary interventions, also in the new‐generation DES era. We aim at reporting on the long‐term clinical outcome of drug‐coated balloons (DCB) in all‐comers population.

Methods

Consecutive patients treated with DCB between January 2011 and December 2014 were retrospectively studied in three centers of northern Italy. The measured end‐points were cardiac death, myocardial infarction (MI), target lesion revascularization (TLR), and major adverse cardiac events (MACE) defined as combination of cardiac death, MI, and TLR.

Results

We included 143 patients. Of the 167 lesions treated, 41 (24.5%) were de novo lesions in small coronary vessels (<2.5 mm) and 126 (75.4%) were ISR. Among ISR lesions, 78.5% were DES‐ISR, 32.5% were focal, 15.8% multifocal, 30.1% diffuse, 18.2% proliferative, and 3.1% were total occlusions. Procedural success was achieved in 94.6% of cases. Overall survival free from MACEs was 91.6% at 12 months, and 75.3% at 48 months, with a total of 3 cardiac deaths, 8 MI, and 27 TLR. No thrombotic event occurred in the treated segments. There were no differences in MACESs between the ISR and de novo lesions groups. At multivariate analysis, acute coronary syndromes, previous MI, previous surgical revascularization, peripheral arterial disease and diabetes were independent predictors of MACEs at long‐term follow‐up.

Conclusions

DCB proved a valid revascularization strategy in an all‐comers population of patients with ISR and de novo lesions in small vessels, with an acceptable rate of cardiac events up to 48 months follow‐up.

     

The Paclitaxel-eluting PTCA-balloon in combination with a cobalt-chromium stent in two different sequences to treat de novo coronary artery lesions: An angiographic follow up study

IntroductionThe paclitaxel-coated balloon catheter (DCB) based on the PACCOCATH^® technology has yielded angiographic and clinical results superior to drug-eluting stents (DES) in situations like in-stent restenosis (ISR) and a trend towards superior results in small coronary vessels and side branches of coronary bifurcations. Using the DCB followed by cobalt–chromium stent (CoCr) deployment or with a reverse sequence may yield different outcomes in terms of late loss.Methods97 patients with de-novo coronary stenosis (55.6 ± 10.7 years, 79.4% male, ≥70%, length: ≤25 mm, vessel diameter: 2.5–4.0 mm) were randomly treated with the DCB (3 μg/mm²) followed by a CoCr-stent or stent first and DCB later. Six-month angiographic and one-year clinical follow-up intention-to-treat analyses were performed.ResultsAngiographic and demographic baseline data was comparable between the two groups. When comparing balloon first versus stent first technique, the primary outcome variables were not statistically different for mean in-segment (0.51 ± 0.56 mm vs. 0.36 ± 0.55 mm, p = 0.23) and in-stent (0.52 ± 0.55 mm vs. 0.46 ± 0.52 mm, p = 0.65) late lumen loss. The lesion related 12-month MACE rates were 5/49 (10.2%) and 2/48 (4.2%) (p = 0.44). Lesion related thrombotic events occurred in three patients in balloon first and in one patient in stent first group, two of which were associated with early discontinuation of continuous dual anti-platelet therapy, two with suboptimal PCI, and one each were performed in a thrombotic lesion and a bifurcation type 1.1.0.ConclusionDrug-coated balloon first followed by cobalt chromium stent deployment versus a reverse sequence is not associated with statistically significantly different 6-month angiographic or 12-month clinical outcomes.     

单纯药物涂层球囊策略治疗冠状动脉分叉病变分支血管的临床观察

目的观察单纯应用药物涂层球囊治疗冠状动脉分叉病变的安全性及有效性。方法入选我院心内科31例分叉病变患者(主支狭窄50%,分支开口狭窄70%;分支血管参考直径≥2mm),单纯应用药物涂层球囊处理分支血管,观察手术成功率、分支血管血流情况及并发症发生率,术后9个月行冠状动脉造影检查,记录随访过程中不良心血管事件(MACE)的发生情况。结果 31例患者33个分叉病变中位于前降支/对角支占57.58%,回旋支/钝缘支占30.30%,右冠状动脉/后降支或左室后支占12.12%。31例患者均成功完成分叉病变介入治疗,手术成功率100%,并且全部患者均经桡动脉途径完成。其中2列患者出现分支血管夹层(1例TIMI血流2级)进行补救性药物洗脱支架植入。围手术期及术后临床随访(门诊或电话随访),无死亡或心肌梗死等主要心脏不良事件发生。74.19%的患者完成了冠状动脉造影复查,仅1例行靶病变再次血运重建(TLR)。分支晚期管腔丢失(LLL)为(0.13±0.25)mm。结论单独药物涂层球囊策略处理冠状动脉分叉病变分支血管是安全有效的。     

Late lumen enlargement induced by drug coated balloon in the patient with PTFE‐covered stent restenosis

We report a case of percutaneous coronary intervention with drug coated balloon (DCB) for the in‐stent restenosis of polytetrafluoroethylene‐covered stent. One year follow‐up angiography was excellent and in‐stent lumen enlargement compared with the postprocedure and 6‐months follow‐up was demonstrated by optical coherent tomography. This case suggested the utility of DCB as a therapeutic option for covered‐stent restenosis.     

Drug-coated balloon angioplasty versus balloon angioplasty for treating patients with in-stent restenosis in the femoropopliteal artery: A meta-analysis

Background:The introduction of endovascular surgery has led to frequent stent use, although in-stent restenosis (ISR) remains a challenging issue. Drug-coated balloon (DCB) and conventional balloon angioplasty (BA) are common endovascular procedures for addressing ISR in the femoropopliteal artery. However, there is controversy regarding which procedure provides the greatest benefit to patients.Methods:The PubMed, EMBASE, and Cochrane Central Register of Controlled Trials databases were searched for prospective controlled trials that compared DCB and BA for patients with ISR in the femoropopliteal artery. The study has been approved by Ethics Committee of Wuhan Central Hospital.Results:The meta-analysis included 6 prospective trials with 541 patients. We found that DCB use was associated with significant reductions in binary restenosis at 6 months (relative risk [RR]: 0.45, 95% confidence interval [CI]: 0.33–0.63; P < .00001), binary restenosis at 1 year (RR: 0.44, 95% CI: 0.34–0.57; P < .00001), target lesion revascularization (TLR) at 6 months (RR: 0.36, 95% CI: 0.20–0.65; P = .0006), and TLR at 1 year (RR: 0.38, 95% CI: 0.27–0.54; P < .00001). The DCB group also had significantly better clinical improvement (RR: 1.39, 95% CI: 1.13–1.71; P = .002), although we did not detect inter-group differences in terms of death, target vessel thrombosis, or ipsilateral amputation. The brand of DCB may a cause of heterogeneity.Conclusion:Relative to BA, DCB use increases the durability of treatment for ISR in the femoropopliteal artery, based on significant reductions in binary restenosis and TLR at 6–12 months after the procedure. Furthermore, DCB use was associated with better clinical improvement. However, additional randomized controlled trials are needed to validate these findings.     

Cost effectiveness analysis of drug coated balloon only angioplasty for de novo coronary artery disease

Aims

We aimed to perform a cost analysis of drug coated balloon (DCB)-only angioplasty versus drug eluting stent (DES), for de novo disease of all vessel sizes and all clinical indications.

Background

DCB angioplasty is an emergent technology for the treatment of coronary artery disease. There is lack of data regarding the cost-effectiveness of DCB-only angioplasty for treatment of de novo coronary artery disease as compared with second generation DES.

Methods

We compared total costs of patients treated with DCB or DES for first presentation of ST-elevation myocardial infarction, non-ST-elevation myocardial infarction, or stable angina due to de novo disease between January 1, 2018 and November 15, 2019. We defined total cost as the sum of (1) procedural devices-cost, (2) procedural staff-cost, (3) post-percutaneous coronary intervention hospital stay cost, and (4) antiplatelet regime cost. A cost minimization analysis was performed to compare the costs of DCB and DES.

Results

We present 1952 all-comer, consecutive patients; 902 (1064 lesions) treated with DCB and 1050 (1236 lesions) treated with DES for de novo coronary artery disease. The cost per patient was estimated to be £9.02 more expensive in the DCB group (£3153.00 vs. £3143.98). However, the cost per lesion treated was calculated to be £15.51 cheaper in the DCB group (£3007.56 vs. £3023.07). The results were consistent irrespective of duration of long-term antiplatelet medications.

Conclusion

We have compared the cost-effectiveness of DCB-only angioplasty to DES-angioplasty and showed that the per patient and per lesion results were not different and hence cost should not be implicated in the decision to choose DCB or DES.     

Can you score with balloons to enhance outcomes after drug coated balloon angioplasty? Insights from the Paris DCB Registry for in‐stent restenosis

Objectives

The objective of this study was to assess the 12‐month clinical outcomes in patients with drug‐eluting stent in‐stent restenosis (DES‐ISR) who were either pre‐dilated with non‐compliant balloons (NCBA) and with additional scoring balloons (NCBA + SBA) prior to drug coated balloon (DCB) angioplasty.

Methods

This monocentric, retrospective study included patients with DES‐ISR who were routinely treated over a 2‐year time span. Patients with stable angina and documented ischemia or selected forms of unstable angina due to a culprit DES‐ISR lesion were analyzed. The primary endpoint was the clinically driven target‐lesion revascularization (TLR) rate at 12 months. Secondary endpoints included post‐interventional lumen gain and late lumen loss (LLL) at 6 months.

Results

The 12‐month TLR rates in 124 patients who underwent either NCBA + SBA or NCBA only group were not different (17.3%, 9/52 vs 11.6%, 8/69, P = 0.371) and low as compared to other comparable studies. The use of SBA led to equally high post minimal lumen diameters (MLD) in both treatment arms (NCBA 2.21 ± 0.33 vs NCBA + SBA 2.18 ± 0.41, P = 0.868). We did not find a significant difference in late lumen loss (LLL) between both groups (0.50 ± 0.62 mm vs 0.40 ± 0.46 mm, P = 0.468).

Conclusions

Scoring Balloon Angioplasty can safely and effectively prepare DES‐ISR lesions to render them suitable for DCB angioplasty with acceptable TLR and MACE rates.

     

Markedly different tissue types on optical coherence tomography imaging in a patient with multiple lesion drug‐eluting stent in‐stent restenosis

The treatment of in‐stent restenosis after drug‐eluting stent (DES) implantation remains a major clinical challenge. Optical coherence tomography (OCT) imaging at the time of presentation can provide important information on mechanical factors contributing to stent failure as well as on tissue characteristics of the in‐stent neointimal tissue. We report a case of markedly different tissue types—characterized by heterogeneous and homogeneous signal intensity—observed in a patient with multiple lesion DES in‐stent restenosis. Although both lesions were initially successfully treated with drug‐coated balloon angioplasty, the patient presented with recurrent in‐stent restenosis in the lesion with homogeneous tissue characteristics. Future studies should evaluate whether OCT tissue characterization can guide optimal treatment strategy in patients with DES restenosis. © 2016 Wiley Periodicals, Inc.     

Short and long terms clinical outcomes of Paclitaxel drug-eluting balloons applied for de-novo coronary artery lesions in the context of acute coronary syndrome: A real world experience

A single-centre retrospective observational study aimed at observing the outcomes of using DEB in ACS patients. All-comer ninety patients were included with a follow-up of 12–36 months. DEBs were deployed successfully yielding TIMI 3 without significant coronary dissection. MACE was 1.1% and 3.3% for 30 days and 12–36 months respectively.     

How to perform a successful drug-coated balloon angioplasty? Tips and tricks

Drug-coated balloons (DCB) offer an excellent alternative to stents as the antiproliferative drugs are delivered via balloons and hence there is no permanent implant of metal or polymer. This rationale applies perfectly in in-stent restenosis (ISR) as we want to avoid another layer of metal in a previously failed stent. However, their use has also been extended to de novo lesions especially in patients and lesion subsets where stents are not ideal. There is an increased desire toward expanding this further and studies are now being done which are testing DCB in large-caliber vessels. As the use of DCB is escalating, we felt the importance of writing this article whereby we aim to provide important tips and tricks when using DCB especially for the operators who are in the early phase or have the desire of embarking this technology. From our experience, the DCB-angioplasty substantially differs on several aspects from DES-angioplasty. We have provided several case bases examples including algorithm when using DCB in ISR and de novo lesions.