Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease

Seeger, Julia; Markovic, Sinisa; Birkemeyer, Ralf; Rittger, Harald; Jung, Werner; Brachmann, Johannes; Rottbauer, Wolfgang; Wöhrle, Jochen

doi:10.1097/mca.0000000000000314

Cited by 13 publications

(14 citation statements)

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“…Data regarding an a priori strategy of BMS + PCB in de novo coronary artery stenoses are still of the PERfECT trial, a randomized study of BMS/ /PCB vs. BMS in de novo stenoses showed superiority for an adjunctive delivery of paclitaxel by a coated balloon for clinical endpoints [10]. O the contrary, another recently published randomized study found an increased stent thrombosis rate for the concept of BMS + PCB compared to the investigating the course of vessel healing after a BMS + PCB approach using QCA and OCT. *1 patient had only an angiographic follow-up without OCT imaging; # 7 lesions (7 patients) were included in both groups due to sequential follow-up and 1 patient was included with 2 study lesions; ISA -incomplete stent apposition; MLD -minimal lumen diameter; OCT -optical coherence tomography; QCA -quantitative coronary angiography; RLD -reference lumen diameter Figure 2.…”

Section: Discussionmentioning

confidence: 99%

“…Previous studies have shown inconsistent results regarding the antiproliferative strength of such an adjunctive procedure [5][6][7][8][9][10]. Yet, no data about the time course of arterial vessel response and stent coverage after such a procedure is available.…”

Section: Introductionmentioning

confidence: 97%

“…Furthermore, the reversibility of the observed positive remodeling after a BMS/PCB procedure. It has been shown that there is a delayed arterial healing for ISA depths ≥ of paclitaxel via a polymer-stent-matrix seems to induce different or rather alleviated focal vessel effects [10]. PCB induce a much higher paclitaxel 24], and dose-dependent positive vessel remodeling with reversible effects at long-term follow-up have been observed [25][26][27][28].…”

Section: Incomplete Stent Apposition and Positive Vessel Remodelingmentioning

confidence: 99%

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Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

et al. 2016

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 97%

Section: Incomplete Stent Apposition and Positive Vessel Remodelingmentioning

confidence: 99%

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Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

et al. 2016

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“…Therefore, it cannot be considered a true BMS. However, the PERfECT stent study [24, 25] showed that DEB in combination with an EPC stent was better than EPC stent alone; however, these findings were not supported by the PEGASUS study [26]. However, when DEB + BMS are compared to DES, at best similar results have been reported [27], but most studies have found the combination of DEB + BMS inferior to DES.…”

Section: Drug-eluting Balloonsmentioning

confidence: 99%

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

2016

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Drug-eluting balloons (DEBs) have emerged as a new application in percutaneous coronary intervention. DEBs have proven successful in the treatment of in-stent restenosis, but their role in de novo lesions is less clear. This paper provides a review of the current studies where DEBs have been used in coronary de novo lesions, either as part of a DEB-only strategy or in combination with another device, mainly a bare metal stent (BMS). By searching Pubmed and Embase we were able to identify 52 relevant studies, differing in design, intervention, and clinical setting, including patients with small vessel disease, bifurcation lesions, complex long lesions, acute myocardial infarction, diabetes mellitus, and elderly. In 23 studies, a DEB was combined with a BMS, 25 studies used a DEB-only strategy with only provisional BMS implantation, and four studies combined a DEB with a drug-eluting stent (DES). In the vast majority of studies, DEB in combination with BMS does not seem to improve clinical or angiographic outcome compared with DES, whereas a DEB-only strategy seems promising, especially when predilatation and geographical mismatch are taken into account. A lower risk of recurrent thrombosis with DEB compared with DES is not evident from the current studies. In conclusion, the main indication for DEB seems to be small vessel disease, especially in clinical scenarios in which a contraindication to dual antiplatelet therapy exists. The main approach should be a DEB-only strategy with only provisional bailout stenting, which has shown interesting results in different clinical scenarios. In general, larger randomized controlled studies with prolonged follow-up comparing DEB with best in class DES are warranted. Technical developments of DEBs including the use of different drugs might potentially improve the efficacy of such treatment.Electronic supplementary materialThe online version of this article (doi:10.1007/s40119-016-0064-4) contains supplementary material, which is available to authorized users.

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“…However, bifurcation, in-stent restenosis, and small vessel lesions remain challenging subsets even in the DES era, and DEB angioplasty with bailout stenting has been suggested as an alternative treatment strategy. In this issue of the Journal, the PERFECT (Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease) Stent study investigators compared paclitaxelcoated balloon angioplasty plus bare-metal stenting with bare-metal stenting alone in 120 patients with native coronary artery disease [5]. At 5 years of follow-up, the rate of target lesion revascularization was 15 versus 23.2%, respectively (P = 0.26).…”

mentioning

confidence: 99%

Drug-eluting balloon

Lee

Park²

2016

Coronary Artery Disease

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Drug-eluting stents (DES) have been used as the mainstream device for percutaneous coronary intervention. However, the permanent metallic stents have inherent pitfalls, such as late stent failure, loss of physiologic vessel function, and precluding future bypass surgery. Drug-eluting balloon (DEB) was introduced as a promising therapeutic modality to overcome these limitations for patients with coronary and peripheral artery disease [1]. The potential advantages of DEB may include a drug release without polymer, the potential of reducing restenosis and duration of dual antiplatelet therapy, and absence of a permanent implant. Currently, several DEBs are available for clinical use [2], and have been studied in a particular clinical setting. Early trials have shown promising results for DEB technology, but most of the studies were relatively small [3,4].Conventional balloon angioplasty is limited by acute closure and late restenosis, evolving to current DES technology. DES placement is used widely as an accepted strategy for the treatment of coronary artery disease. However, bifurcation, in-stent restenosis, and small vessel lesions remain challenging subsets even in the DES era, and DEB angioplasty with bailout stenting has been suggested as an alternative treatment strategy. In this issue of the Journal, the PERFECT (Prospective, Randomized Trial Evaluating a Paclitaxel-Eluting Balloon in Patients Treated with Endothelial Progenitor Cell Capturing Stents for De Novo Coronary Artery Disease) Stent study investigators compared paclitaxelcoated balloon angioplasty plus bare-metal stenting with bare-metal stenting alone in 120 patients with native coronary artery disease [5]. At 5 years of follow-up, the rate of target lesion revascularization was 15 versus 23.2%, respectively (P = 0.26). There was no late catchup phenomenon between 6 and 60 months, supporting the long-term efficacy of DEB plus bare-metal stents. There was certainly a nonsignificant trend toward lower repeat revascularization in the DEB plus bare-metal stent group. However, this approach may be no longer valid in contemporary percutaneous coronary intervention. The superiority of newer-generation DES over previous DES is now well-established in terms of efficacy and safety, and it is even safer than bare-metal stents [6].DES restenosis is a growing problem with the routine use of DES and more complex procedures. A variety of treatment options including plain balloon angioplasty, DEB angioplasty, and DES implantation have been studied, with no definitive answers. Plain balloon angioplasty is associated with a high risk of re-restenosis. Additional DES implantation reduces the risk of rerestenosis compared with balloon angioplasty, but multiple layers of stent struts may be a drawback of this approach. DEB angioplasty appears to be attractive to avoid additional layers of metal within the stents. Small studies have shown that DEB angioplasty reduces rerestenosis below 10%. However, the largest RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Dru...

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Paclitaxel-coated balloon plus bare-metal stent for de-novo coronary artery disease

Abstract: PCB angioplasty plus BMS was superior to BMS alone for the treatment of de-novo lesions. The combined clinical endpoint was lower with PCB plus BMS at 6 months and remained lower after 5 years. There was no late catch-up phenomenon (http://www.clinicaltrials.gov; NCT 00732953).

Cited by 13 publications

References 19 publications

Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

Time course of vascular response after an a priori strategy of bare metal stent implantation post-dilated with a paclitaxel-coated balloon: Implementation of a three-dimensional analysis algorithm with optical coherence tomography

Drug-Eluting Balloons in the Treatment of Coronary De Novo Lesions: A Comprehensive Review

Drug-eluting balloon

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