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

Scheller, Bruno; Hehrlein, Christoph; Bocksch, Wolfgang; Rutsch, Wolfgang; Haghi, Dariush; Dietz, Ulrich; Böhm, Michael; Speck, Ulrich

doi:10.1007/s00392-008-0682-5

Cited by 230 publications

(147 citation statements)

References 35 publications

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“…Thirty-seven microliters of one of the resulting solutions were then slowly pipetted, for each glass slide (64 mm 2 ) in order to approach a surface load of 9 µg/mm 2 PVP and/or 3 µg/mm 2 PTX. This PTX load has been defined, as it had been shown to be safe and effective in non-clinical [21] and clinical studies [22,23]. Prior to crosslinking, all coatings were dried in a vacuum chamber at 40 °C and 40 mbar overnight.…”

Section: Coating Of Glass Cover Slips With Pvp And/or Ptxmentioning

confidence: 99%

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Petersen¹,

Minrath²,

Kaule³

et al. 2013

Coatings

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Polyvinylpyrrolidone (PVP) is a conventionally applied hydrophilic lubricious coating on catheter-based cardiovascular devices, used in order to ease movement through the vasculature. Its use as drug reservoir and transfer agent on drug-coated balloons (DCB) is therefore extremely promising with regard to the simplification of its approval as a medical device. Here, we developed a PVP-based coating for DCB, containing paclitaxel (PTX) as a model drug, and studied the impact of crosslinking via UV radiation on drug stability, wash off, and transfer during simulated use in an in vitro vessel model. We showed that crosslinking was essential for coating stability and needed to be performed prior to PTX incorporation due to decreased drug bioavailability as a result of photodecomposition and/or involvement in vinylic polymerization with PVP under UV radiation. Moreover, the crosslinking time needed to be carefully controlled. While short radiation times did not provide enough coating stability, associated with high wash off rates during DCB insertion, long radiation times lowered drug transfer efficiency upon balloon expansion. A ten minutes radiation of PVP, however, combined a minimized drug wash off rate of 34% with an OPEN ACCESSCoatings 2013, 3 254 efficient drug transfer of 49%, underlining the high potential of photochemically crosslinked PVP as a coating matrix for DCB.

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Section: Coating Of Glass Cover Slips With Pvp And/or Ptxmentioning

confidence: 99%

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Petersen¹,

Minrath²,

Kaule³

et al. 2013

Coatings

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“…Overall, late lumen loss after 6 months was 0.81 ± 0.79 mm in the control group versus 0.11 ± 0.45 mm (P < 0.001) in the drug-coated balloon group. Over a period of up to 2 years, target lesion revascularization was performed in 21 of 54 patients treated with the uncoated balloons versus 3 of 54 patients treated with the coated balloons [74]. Meanwhile, longterm data up to 6 years confirms the initial finding with no signs of a late catch-up [75].…”

Section: üBersicht 353mentioning

confidence: 75%

“…Randomized treatment comparing uncoated and paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) catheters, participation of 5 centers, best possible blinding of the investigators versus the treatment, and quantitative evaluation of angiograms by an independent core lab were intended to dispel doubts that might arise should these studies prove the effectiveness of drug-coated balloons [39]. Furthermore, reproducibility of the findings was investigated in a second, independently randomized trial with the same study design [74]. Overall, late lumen loss after 6 months was 0.81 ± 0.79 mm in the control group versus 0.11 ± 0.45 mm (P < 0.001) in the drug-coated balloon group.…”

Section: üBersicht 353mentioning

confidence: 99%

Drug-Coated Balloons for Restenosis Prophylaxis

Speck

Scheller

Hamm

2013

Fortschr Röntgenstr

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Drug-coated balloons for restenosis prophylaxis provide a high local drug concentration with minimal or no systemic adverse effects. Their development was both delayed and facilitated by the introduction of drug-eluting stents: delayed because sustained release kinetics from stent platforms seemed to be essential and facilitated because prior experience with stents allowed selection of testing methods and drugs. Currently, a variety of drug-coated balloons are available, basically consisting of a coating containing paclitaxel at a dose of about 3??g/mm? balloon surface, and different additives influencing the adherence and release of the drug, e.?g., contrast agent, urea, or various amphiphilic compounds. The drug is almost completely released during a single inflation of 30???60 seconds. Studies in animals and several independent randomized clinical trials in coronary and peripheral arteries demonstrate effective reduction of neointimal proliferation, restenosis, and revascularization persisting for at?least 2 years or 5 years according to one study in coronary arteries. Drug-coated balloons are preferably used for treating coronary in-stent restenosis and de novo and restenotic lesions in peripheral vessels. No coating-related adverse events have been observed in clinical trials. Persistent efficacy may be explained by the long residence time of paclitaxel in tissue or inhibition of an essential first step in the chain of events leading to neointimal proliferation. Citation Format: ??Speck U., Scheller B., Hamm B. Drug-Coated Balloons for Restenosis Prophylaxis. Fortschr R?ntgenstr 2014; 186: 348???358

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“…In addition, the pooled estimates demonstrated a clear superiority of PCB in the 6-to 12-month follow-up clinical results (TLR, MACEs and TM), and PCBs proved more effective than UCBs in reducing the incidence of MI (4/423 vs. 8/317) and ST (2/369 vs. 4/263); however the difference was non-significant. We hypothesized that this lack of significance may have been due to the small sample size and the lack of ST data in the PACCOCATH-ISR I/II trial (11). In the other subgroup, 5 trials (4 RCTs and 1 NRCT) that compared PCBs and DESs in the treatment of ISR were included.…”

Section: Before Procedures (Mm) Follow-up (N) ------------------------mentioning

confidence: 99%

Paclitaxel-coated balloons for the treatment of patients with in-stent restenosis: A meta-analysis of angiographic and clinical data

Liu

et al. 2015

Experimental and Therapeutic Medicine

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Abstract. Paclitaxel-coated balloons (PCBs) have become attractive alternative treatment options for patients with in-stent restenosis (ISR); however, the safety and efficacy of PCBs in comparison with those of conventional therapies are less well defined. The aim of this meta-analysis was to systematically review the efficacy and safety of PCBs for patients with ISR using comparisons with control groups. Electronic databases, such as MEDLINE, Embase and the Cochrane Central Register of Controlled Trials, were searched, and eligible studies that compared PCBs with uncoated balloons (UCBs) or drug-eluting stents (DESs) in patients with ISR were considered. Subgroup analyses were performed with different control groups. Nine studies (1,488 patients, 1,608 lesions) were included in the meta-analysis. Compared with patients who underwent UCB angioplasty, those who underwent PCB angioplasty exhibited a clear superiority in late lumen loss (LLL) [weighted mean difference (WMD), -0.46; 95% confidence interval (CI), (-0.59)-(-0.34); P<0.00001] and major adverse cardiac events (MACEs) [odds ratio (OR), 0.21; 95% CI, 0.13-0.33; P<0.00001]. The OR for myocardial infarction (MI) (OR, 0.46; 95% CI, 0.15-1.47; P=0.19) did not reach statistical significance. PCBs were associated with similar outcomes when compared with DESs with regard to LLL (WMD, -0.04; 95% CI, -0.18-0.10; P= 0.57), MACEs (OR, 0.74; 95% CI, P= 0.42) and the ORs for all endpoints, including total mortality, target lesion revascularization, MI, stent thrombosis and binary restenosis, and no statistically significant differences were found. This meta-analysis showed that PCBs are associated with superior outcomes when compared with UCBs in the management of ISR, and are at least as efficacious and as well tolerated as DESs.

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

Abstract: Treatment of coronary ISR with paclitaxel-coated balloon catheters persistently reduces repeat restenosis up to 2 years. (ClinicalTrials.gov Identifier: NCT00106587, NCT00409981).

Cited by 230 publications

References 35 publications

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Development and in Vitro Characterization of Photochemically Crosslinked Polyvinylpyrrolidone Coatings for Drug-Coated Balloons

Drug-Coated Balloons for Restenosis Prophylaxis

Paclitaxel-coated balloons for the treatment of patients with in-stent restenosis: A meta-analysis of angiographic and clinical data

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