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

Scheller, Bruno; Clever, Yvonne P.; Kelsch, Bettina; Hehrlein, Christoph; Bocksch, Wolfgang; Rutsch, Wolfgang; Haghi, Dariush; Dietz, Ulrich; Speck, Ulrich; Böhm, Michael; Cremers, Bodo

doi:10.1016/j.jcin.2012.01.008

Cited by 215 publications

(96 citation statements)

References 24 publications

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“…Specifically, DCB compared to DES show a significant benefit in the treatment of ISR,5, 6, 7, 8, 9, 10, 11, 12 and current guidelines recommend the use of DCB for patients with coronary ISR (class I, level of evidence A) 13. However, there are other potential indications such as coronary small vessel disease and bifurcation lesions 14, 15.…”

Section: Introductionmentioning

confidence: 99%

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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The treatment of coronary small vessel disease (SVD) remains an unresolved issue. Drug‐eluting stents (DES) have limited efficacy due to increased rates of instent‐restenosis, mainly caused by late lumen loss. Drug‐coated balloons (DCB) are a promising technique because native vessels remain structurally unchanged. Basel Stent Kosten‐Effektivitäts Trial: Drug‐Coated Balloons vs. Drug‐Eluting Stents in Small Vessel Interventions (BASKET‐SMALL 2) is a multicenter, randomized, controlled, noninferiority trial of DCB vs DES in native SVD for clinical endpoints. Seven hundred fifty‐eight patients with de novo lesions in vessels <3 mm in diameter and an indication for percutaneous coronary intervention such as stable angina pectoris, silent ischemia, or acute coronary syndromes are randomized 1:1 to angioplasty with DCB vs implantation of a DES after successful initial balloon angioplasty. The primary endpoint is the combination of cardiac death, nonfatal myocardial infarction, and target‐vessel revascularization up to 1 year. Secondary endpoints include stent thrombosis, Bleeding Academic Research Consortium (BARC) type 3 to 5 bleeding, and long‐term outcome up to 3 years. Based on clinical endpoints after 1 year, we plan to assess the noninferiority of DCB compared to DES in patients undergoing primary percutaneous coronary intervention for SVD. Results will be available in the second half of 2018. This study will compare DCB and DES regarding long‐term safety and efficacy for the treatment of SVD in a large all‐comer population.

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Section: Introductionmentioning

confidence: 99%

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Gilgen

Farah

Scheller

et al. 2018

Clinical Cardiology

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“…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]. Subsequent trials compared a second-generation iopromide-matrix-coated PTCA catheter (SeQuent TM Please) with the Taxus™ stent in the treatment of bare metal stent restenosis (PEPCAD II [43]) or investigated the same device in drug-eluting stent restenosis [46,47] [48].…”

Section: üBersicht 353mentioning

confidence: 75%

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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“…Studies with at least 80% angiographic and 90% clinical follow-up were considered at low risk for attrition bias. On the basis of these criteria, the study by Scheller et al 29 and 3 other studies 21,25,30 were not considered low risk for attrition bias for clinical and angiographic end points, respectively. The risk of bias summary of the included studies is shown in Figure IV …”

Section: Study Quality Assessmentmentioning

confidence: 99%

Efficacy of Various Percutaneous Interventions for In-Stent Restenosis

Sethi

Malhotra

Singh

et al. 2015

Circ: Cardiovascular Interventions

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Background— In-stent restenosis (ISR) remains a difficult problem in interventional cardiology. The relative efficacy and safety of available interventions is not clear. We aimed to perform a network meta-analysis using both direct evidence and indirect evidence to compare all available interventions. Methods and Results— We systematically searched electronic databases for randomized trials comparing ≥2 treatments for ISR. A network meta-analysis was performed using a Bayesian approach. Eleven treatments were compared in 31 studies with 8157 patient-years follow-up. Compared with balloon angioplasty, everolimus-eluting stent (hazard ratio [95% credibility interval], 0.13 [0.048–0.35]), paclitaxel-eluting balloon (0.32 [0.20–0.49]), paclitaxel-eluting cutting balloon (0.054 [0.0017–0.5]), paclitaxel-eluting stent (0.39 [0.24–0.62]), and sirolimus-eluting stent (0.32 [0.18–0.50]) are associated with lower target vessel revascularization. Balloon angioplasty is not different from cutting balloon (0.73 [0.31–1.5]), excimer laser (0.89 [0.29–2.7]), rotational atherectomy (0.96 [0.53–1.7]), and vascular brachytherapy (0.60 [0.35–1.0]). In drug-eluting stent ISR, balloon angioplasty was inferior to everolimus-eluting stent (0.19 [0.049–0.76]), paclitaxel-eluting balloon (0.43 [0.18–0.80]), paclitaxel-eluting stent (0.35 [0.13–0.76]), and sirolimus-eluting stent (0.36 [0.11–0.86]) for target vessel revascularization. There was no difference between treatments in probable or definitive stent thrombosis. The results of binary restenosis and target lesion revascularization were similar. Paclitaxel-eluting cutting balloon, everolimus-eluting stent, and paclitaxel-eluting balloon have the highest probability of being in the top 3 treatments based on low target lesion revascularization, but there was no statistical significant difference between them. Conclusions— Balloon angioplasty is inferior to all drug-eluting treatments for ISR, including drug-eluting stent ISR. Drug-eluting stent, particularly everolimus-eluting stent, or paclitaxel-eluting cutting balloon and paclitaxel-eluting balloon should be preferred for treating ISR.

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

Cited by 215 publications

References 24 publications

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Drug‐coated balloons for de novo lesions in small coronary arteries: rationale and design of BASKET‐SMALL 2

Drug-Coated Balloons for Restenosis Prophylaxis

Efficacy of Various Percutaneous Interventions for In-Stent Restenosis

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