The Leipzig Prospective Drug-Eluting Balloon-Registry – Outcome of 484 Consecutive Patients Treated for Coronary In-Stent Restenosis and De Novo Lesions Using Paclitaxel-Coated Balloons –
Abstract:Circulation Journal Official Journal of the Japanese Circulation Society http://www. j-circ.or.jp in DES is associated with worse outcomes than with ISR in BMS. 13 Currently, there is no clear consensus about the optimal management of ISR. Intracoronary stenting is still the preferred treatment in patients with ISR after DES or BMS implantation. 9,14-16 However, drug-eluting balloons (DEB) provide potential advantages: 17 rapid release of high drug concentrations and homogeneous drug delivery to the vessel wal… Show more
“…16 The incidence of cardiac death was 1.8% in our cohort, which is consistent with DCB safety outcome concluded from other DCB studies. 17,18 Previous DCB trials have reported low MI rates at long period follow-up. 18,19 This is comparable to the 2.4% incidence of MI in the current study.…”
Limited data exist about the effect of intracoronary imaging (ICI)-guided drug-coated balloon (DCB) intervention on clinical end points. In all, 1157 patients with coronary artery disease treated with DCB between December 2014 and December 2017 at Beijing Anzhen Hospital were included in the final analysis in this cohort study. The primary end point was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization, and the key secondary end point was the incidence of cardiac death or target vessel MI. The median follow-up for clinical events was 32.0 months (IQR 25.0-40.0). Intracoronary imaging was used in 90 (7.8%) patients. There was no statistically significant difference in TLF (12.2% vs 12.5%, P = .80) between ICI-guided and angiography-guided group. Cardiac death or target vessel MI rates (1.1% vs 3.7%, P = .17) were numerically lower for the ICI-guided cohort. In the propensity score–based analysis, TLF (10.5% vs 16.2%, P = .19) and cardiac death or target vessel MI rates (1.2% vs 2.3%, P = .51) tended to be lower for the ICI-guided cohort. In this observational study, TLF rate tended to decrease in the ICI-guided DCB treatment group compared with angiography-guided procedures. Larger studies are needed.
“…16 The incidence of cardiac death was 1.8% in our cohort, which is consistent with DCB safety outcome concluded from other DCB studies. 17,18 Previous DCB trials have reported low MI rates at long period follow-up. 18,19 This is comparable to the 2.4% incidence of MI in the current study.…”
Limited data exist about the effect of intracoronary imaging (ICI)-guided drug-coated balloon (DCB) intervention on clinical end points. In all, 1157 patients with coronary artery disease treated with DCB between December 2014 and December 2017 at Beijing Anzhen Hospital were included in the final analysis in this cohort study. The primary end point was the incidence of target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction (MI), and target lesion revascularization, and the key secondary end point was the incidence of cardiac death or target vessel MI. The median follow-up for clinical events was 32.0 months (IQR 25.0-40.0). Intracoronary imaging was used in 90 (7.8%) patients. There was no statistically significant difference in TLF (12.2% vs 12.5%, P = .80) between ICI-guided and angiography-guided group. Cardiac death or target vessel MI rates (1.1% vs 3.7%, P = .17) were numerically lower for the ICI-guided cohort. In the propensity score–based analysis, TLF (10.5% vs 16.2%, P = .19) and cardiac death or target vessel MI rates (1.2% vs 2.3%, P = .51) tended to be lower for the ICI-guided cohort. In this observational study, TLF rate tended to decrease in the ICI-guided DCB treatment group compared with angiography-guided procedures. Larger studies are needed.
“…Twenty-five percent received bailout BMS implantation which was not associated with a less favorable outcome (MACE 7.1% with additional BMS and 9.5% without BMS) [41]. The prospective Leipzig Registry evaluated the clinical outcome in 484 patients treated with a SeQuent Please DEB [42]. De novo vessel disease was seen in 76 patients (15.7%).…”
Section: Drug-eluting Balloonsmentioning
confidence: 99%
“…In de novo lesions, no TLR was seen after 27 months. MACE was defined differently than in other studies and was thus difficult to compare [42]. Being the second largest real world registry, the SeQuent Please Small Vessel “PCB Only” Registry was a prospective multicenter study assessing the safety and efficacy of the SeQuent Please DEB in 447 patients [35].…”
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.
“…Patients with blocked coronary arteries undergoing PCI are given the choice to receive either drug‐eluting stents (DESs) or bare metal stents (BMSs) to restore the normal blood flow. Currently, bare metal stents have ≈30% chance of restenosis occurring within a six‐month period . Long‐term metallic stents may also interfere with computer tomography (CT) and magnetic resonance imaging.…”
Section: Introductionmentioning
confidence: 99%
“…A complete degradation period for polymer based stents including poly‐ l ‐lactic acid (PLLA) and poly‐ l ‐caprolactone (PCL) have been reported as ca. two years while for polyglycolic acid were found to be 6–12 months . An ideal period for stent degradation would finally depend on the targeted disease with requirement of small or longer time interventions.…”
Patients with percutaneous coronary intervention generally receive either bare metal stents or drug-eluting stents to restore the normal blood flow. However, due to the lack of stent production with an individual patient in mind, the same level of effectiveness may not be possible in treating two different clinical scenarios. This study introduces for the first time the feasibility of a patient-specific stenting process constructed from direct 3D segmentation of medical images using direct 3D printing of biodegradable polymer-graphene composite with dual drug incorporation. A biodegradable polymer-carbon composite is prepared doped with graphene nanoplatelets to achieve controlled release of combinatorics as anticoagulation and antirestenosis agents. This study develops a technology prototyped for personalized stenting. An in silico analysis is performed to optimize the stent design for printing and its prediction of sustainability under force exerted by coronary artery or blood flow. A holistic approach covering in silico to in situ-in vivo establishes the structural integrity of the polymer composite, its mechanical properties, drug loading and release control, prototyping, functional activity, safety, and feasibility of placement in coronary artery of swine.
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