Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial

Byrne, Robert A.; Neumann, Franz‐Josef; Mehilli, Julinda; Pinieck, Susanne; Wolff, Britta; Tiroch, Klaus; Schulz, Stefanie; Fusaro, Massimiliano; Ott, Ilka; Ibrahim, Tareq; Hausleiter, Jörg; Valina, Christian; Pache, Jürgen; Laugwitz, Karl‐Ludwig; Maßberg, Steffen; Kastrati, Adnan

doi:10.1016/s0140-6736(12)61964-3

Cited by 356 publications

(239 citation statements)

References 31 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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“…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]. In these studies beneficial effects of the drug were shown with respect to the restenosis rate and target lesion revascularization.…”

Section: üBersicht 353mentioning

confidence: 79%

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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“…The SeQuentPlease World Wide Registry (26) was a large-scale, prospective registry study in which the TLR rate was significantly lower in patients who underwent a PCB angiography for BMS-ISR compared with that in patients who underwent a PCB angiography for DES-ISR (3.8 vs. 9.6%, P<0.001). In 5 studies (10,12,13,15,18) in the present meta-analysis, the restenosis type being treated was DES-ISR, and a comparison between PCB and control (UCB or DES) treatments was made. The clinical and angiographic results reported for the PCB treatment were considered to be comparable to those for the control treatments; therefore, we consider PCB to be an attractive optimal treatment strategy for DES and BMS restenosis, despite the effect of PCBs on DES restenosis being shown to be relatively inferior to that on BMS restenosis (26).…”

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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Paclitaxel-eluting balloons, paclitaxel-eluting stents, and balloon angioplasty in patients with restenosis after implantation of a drug-eluting stent (ISAR-DESIRE 3): a randomised, open-label trial

Cited by 356 publications

References 31 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

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

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