Ulrich Speck

Two year follow-up after treatment of coronary in-stent restenosis with a paclitaxel-coated balloon catheter

BACKGROUNDnWe are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2 years.nnnMETHODSnHundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3 microg/mm(2) balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of >or=70% and <30 mm length with a vessel diameter of 2.5-3.5 mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE).nnnRESULTSnQuantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81 +/- 0.79 mm in the uncoated balloon group vs. 0.11 +/- 0.45 mm (P < 0.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (P < 0.001). Until 12 months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (P = 0.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group.nnnCONCLUSIONnTreatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).BackgroundWe are presenting an extension of a previously published trial on the efficacy and safety of a paclitaxel-coated balloon in coronary ISR in a larger patient population and after a complete follow-up of 2xa0years.MethodsHundred eight patients were enrolled in two separately randomized, double-blind multicenter trials on efficacy and safety using an identical protocol. Patients were treated by the paclitaxel-coated (3xa0µg/mm2 balloon surface; Paccocath) or an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥70% and <30xa0mm length with a vessel diameter of 2.5–3.5xa0mm. The primary endpoint was angiographic late lumen loss in-segment. Secondary endpoints included binary restenosis rate and major adverse cardiovascular events (MACE).ResultsQuantitative coronary angiography revealed no differences in baseline parameters. After six months in-segment late lumen loss was 0.81xa0±xa00.79xa0mm in the uncoated balloon group vs. 0.11xa0±xa00.45xa0mm (Pxa0<xa00.001) in the drug-coated balloon group resulting in a binary restenosis rate of 25/49 vs. 3/47 (Pxa0<xa00.001). Until 12xa0months post procedure 20 patients in the uncoated balloon group compared to two patients in the coated balloon group required target lesion revascularization (Pxa0=xa00.001). Between 12 and 24 only two MACE were recorded, a stroke in the uncoated and a target lesion revascularization in the coated balloon group.ConclusionTreatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2xa0years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).

Long-Term Follow-Up After Treatment of Coronary In-Stent Restenosis With a Paclitaxel-Coated Balloon Catheter

OBJECTIVESnThis study presents long-term clinical follow-up, including binary restenosis rate and major adverse cardiovascular events, of the PACCOCATH-ISR (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons) I and II trial.nnnBACKGROUNDnThe PACCOCATH-ISR trial was a first-in-human study with a drug-coated balloon catheter and the first study for the treatment of coronary ISR with a drug-coated balloon. So, far no long-term follow-up data have been presented.nnnMETHODSnThis study enrolled 108 patients in a randomized, double-blinded multicenter trial on the efficacy and safety of a paclitaxel-coated balloon (3 μg/mm(2) balloon surface; PACCOCATH [Bayer AG, Germany]) compared with an uncoated balloon. The main inclusion criteria were a diameter stenosis of ≥ 70% and <30-mm length with a vessel diameter of 2.5 to 3.5 mm. The primary endpoint was angiographic late lumen loss in-segment after 6 months. Combined antiplatelet therapy was continued only for 1 month followed by treatment with aspirin alone.nnnRESULTSnDuring a follow-up of 5.4 ± 1.2 years, the clinical event rate was significantly reduced in patients treated with the drug-coated balloon (major adverse cardiovascular events: 59.3% vs. 27.8%, p = 0.009), which was mainly driven by the reduction of target lesion revascularization from 38.9% to 9.3% (p = 0.004).nnnCONCLUSIONSnTreatment of coronary ISR with paclitaxel-coated balloon catheters is safe and persistently reduces repeat revascularization during long-term follow-up. The initial results were sustained over the 5-year period. (Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR I]; NCT00106587. Treatment of In-Stent Restenosis by Paclitaxel Coated PTCA Balloons [PACCOCATH ISR II]; NCT00409981).

Angioplasty of Femoral-Popliteal Arteries With Drug-Coated Balloons: 5-Year Follow-Up of the THUNDER Trial

OBJECTIVESnThe purpose of this study was to evaluate the 5-year follow-up (FU) data of the THUNDER (Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries).nnnBACKGROUNDnThe THUNDER trial was the first study to investigate the treatment of femoropopliteal arteries with a paclitaxel-coated balloon (PCB).nnnMETHODSnIn 154 patients, femoropopliteal arteries were treated with PCB, with angioplasty with paclitaxel in contrast medium, or no paclitaxel (control). The primary endpoint was 6-month late lumen loss (LLL). Secondary endpoints included freedom from target lesion revascularization (TLR), binary restenosis rate, and amputation. The 5-year FU compares outcomes in patients treated with PCB and control subjects. Additionally, LLL at 6 months and TLR up to 5-year FU were analyzed in terms of sex and lesion length.nnnRESULTSnOver the 5-year period, the cumulative number of patients with TLR remained significantly lower in the PCB group (21%) than in the control group (56%, p = 0.0005). In the small group of patients with angiographic and duplex sonographic follow-up, PCB was associated with a lower rate of binary restenosis (17% vs. 54%; p = 0.04). No signs of aneurysm formation or constrictive fibrosis were detected. Whereas LLL at 6-month FU did not differ between men and women in the PCB group, the TLR rate was lower in men than in women at 5-year FU. A benefit of PCB treatment in terms of LLL and TLR was seen independent of lesion length.nnnCONCLUSIONSnThe reduced TLR rate following PCB treatment was maintained over the 5-year FU period. No signs of drug-related local vessel abnormalities were detected. (Thunder Trial-Local Taxan With Short Time Contact for Reduction of Restenosis in Distal Arteries [THUNDER]; NCT00156624).

High-Grade, Non-Flow-Limiting Dissections Do Not Negatively Impact Long-term Outcome After Paclitaxel-Coated Balloon Angioplasty: An Additional Analysis From the THUNDER Study

Purpose: To investigate the impact of using paclitaxel-coated balloons (PCB) on outcome after post-angioplasty dissection in femoropopliteal arteries. Methods: The angiograms obtained in the THUNDER study ( ClinicalTrials.gov identifier NCT00156624) were analyzed to compare degrees of dissection and angiographic parameters between the control (uncoated balloons, n=43) and treatment (PCBs, n=43) groups before and after the intervention and at 6-month follow-up. Furthermore, target lesion revascularizations (TLR) were documented up to 2 years. Results: In each group, 24 (56%) patients had a dissection after the intervention. At the 6-month follow-up, patients with dissection of any grade after treatment with PCBs had significantly less late lumen loss (0.4 mm) than patients with dissection after treatment with uncoated balloons (1.9 mm, p=0.001) and a lower degree of stenosis (20% vs. 51%, respectively; p=0.003). Patients with severe dissection (grades C, D, or E) especially seemed to benefit from the PCBs, with late lumen loss of 0.4 mm vs. 2.4 mm for controls (p=0.05). The binary restenosis rate was also markedly lower in the PCB group (20%) than in the uncoated group (55%, p=0.02). In the 2-year follow-up, TLR was performed in 56% of patients in the control group compared to 10% of patients in the PCB group (p=0.002). Conclusion: The results of this subgroup analysis suggest that patients with dissection following treatment with a paclitaxel-coated balloon have a very acceptable outcome and stent implantation is not necessary as long as the dissection does not result in acute flow limitation.

Three-dimensional gradient-echo imaging for percutaneous MR-guided laser therapy of liver metastasis.

To evaluate the use of three‐dimensional (3D) gradient‐echo (GRE) magnetic resonance imaging (MRI) for percutaneous MR‐guided catheter placement for laser therapy of liver metastases.

A novel drug‐coated scoring balloon for the treatment of coronary in‐stent restenosis: Results from the multi‐center randomized controlled PATENT‐C first in human trial

Scoring balloons produce excellent acute results in the treatment of in‐stent restenosis (ISR), fibro‐calcific and bifurcation lesions but have not been shown to affect the restenosis rate. A novel paclitaxel‐coated scoring balloon (SB) was developed and tested to overcome this limitation.

Treatment of a coronary bifurcation lesion with drug-coated balloons: lumen enlargement and plaque modification after 6 months.

We report a male with a coronary bifurcation lesion in the mid circumflex artery (CX). After predilatation, the lesion was treated with two drug-coated balloons (DCB). Primary success in the posterolateral branch was good; however the CX lesion had a residual stenosis including a non-flow-limiting type A dissection. After 6xa0months, angiography showed slight lumen enlargement in both branches of the bifurcation. Intravascular ultrasound identified about 35xa0% atherosclerotic plaque load within the inner area of the bifurcation but more than 50xa0% concentric atherosclerotic plaque burden in the vessel areas proximal and distal to the DCB-treated area.

Compassionate use of a paclitaxel coated balloon in patients with refractory recurrent coronary in-stent restenosis

ObjectiveTreatment of coronary in-stent restenosis (ISR) remains a challenge in interventional cardiology, especially after drug eluting stent (DES)-ISR. Drug coated balloons (DCB) provide a new therapeutic option in the treatment of ISR. In patients with multiple layers of stents due to refractory ISR and exclusion criteria for revascularization by coronary artery bypass grafting, DCB may be a last therapy option. This paper presents DCB therapy as compassionate use treatment before the balloons were available in Europe.PatientsCompassionate use of DCB was approved by the local ethical committee. Fifteen patients with refractory ISR in 28 lesions were prospectively enrolled between 12/2006 and 04/2009. The frequency of prior ISR was 3.0xa0±xa01.1. Nine patients presented with coronary three-vessel disease and six patients with one- or two-vessel disease. Thirteen patients had DES-ISR, two patients with contraindication for prolonged dual anti-platelet therapy repeated BMS-ISR. Two or three layers of metal were present in eleven patients. Four patients had prior coronary artery bypass grafting.ResultsAll lesions were treated with DCB (SeQuent™ Please, B.Braun, Germany). Angiographic follow-up was obtained in 14 patients. Clinical follow-up was available in all patients after 3.2xa0±xa00.8xa0years (maximum 4.8xa0years). Target lesion revascularization was done in 2 of 28 lesions (7.1xa0%), one patient with ischemic cardiomyopathy died after 1.5xa0years. No further MACE occurred.ConclusionDCB appear to be safe and clinically useful in the treatment of ISR. DCB is a new promising option for high-risk patients with refractory ISR.

Paclitaxel-Coated Balloons: Investigation of Drug Transfer in Healthy and Atherosclerotic Arteries – First Experimental Results in Rabbits at Low Inflation Pressure

PurposeBeyond antiproliferative properties, paclitaxel exhibits anti-inflammatory activity, which might be beneficial in the local treatment of nonocclusive coronary artery disease. Paclitaxel release and tissue concentrations after paclitaxel-coated balloon treatment using different pressures have not been investigated so far. The aim of the study was to investigate in an atherosclerotic rabbit model whether drug transfer from paclitaxel-coated balloons into the vessel wall is affected by the presence of atherosclerotic lesions and to which extent it depends on the inflation pressure used.MethodsPaclitaxel-coated balloons (3.5xa0μg/mm2 paclitaxel) were inflated with pressures of 1, 2, or 6xa0atm (60s) in healthy (nxa0=xa039) and atherosclerotic (nxa0=xa022) arteries of New Zealand White Rabbits. Paclitaxel content in arterial walls (10xa0min after interventions) and paclitaxel remaining on balloons after treatment were analyzed using high-performance liquid chromatography.ResultsMedian paclitaxel tissue concentrations were 829.3xa0μg/g (IQR 636.5–1487xa0μg/g) in healthy and 375.7xa0μg/g (IQR 169.8–771.6xa0μg/g) in atherosclerotic arteries (pxa0=xa00.0002). The paclitaxel tissue concentration was dependent on inflation pressure (1xa0atm vs. 2xa0atm vs. 6xa0atm) in atherosclerotic arteries (pxa0=xa00.0106) but not in healthy arteries (pxa0≥xa00.05).ConclusionsAtherosclerotic lesions impede the transfer of paclitaxel into arterial walls. Higher inflation pressures resulted in an increased paclitaxel transfer in atherosclerotic but not in healthy arteries. However, it is assumed that the tissue concentrations achieved with an inflation pressure of 2xa0atm are potentially effective in this model.

Laser Ablation of Lung Metastases: Technique and Results after 21 Treatments

Summary A thin-caliber applicator system was developed for laser ablation of lung metastases. Feasibility of lung metastases ablation as well as the complication rate and clinical results were evaluated. We calibrated the miniaturized applicator system in non-perfused bovine liver for maximum energy supply and necessary flow of the cooling saline solution in reference to a commercially available system (Power laser applicator kit, Somatex, Teltow, Germany). The size of heat coagulation in bovine liver was 24 ± 2 ml with the miniaturized system in comparison to a size of 29 ± 7 ml for the existing applicator. 15 W were applied for 20 min and a saline flow of 40 ml/h with the miniaturized applicator and 30 W, 20 min, 60 ml/min with the standard applicator. 21 patients with 32 lung metastases were then treated and the results as well as minor and major complications were evaluated. Ablation was technically successful in all but 2 patients. 14 patients were considered to be effectively treated. Their metastases showed a marked reduction of volume. Volume reduction took several months to develop. Successful treatment had either a ground-glass appearance of the treated site or a cystic defect as a morphological correlate. We conclude that successful ablation of lung metastases is possible with a miniaturized applicator.