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

Otto, Sylvia; Gassdorf, Johannes; Nitsche, Kristina; Gutiérrez‐Chico, Juan Luis; Kryvanos, Aleh; Goebel, Björn; Figulla, Hans R.; Poerner, Tudor C.

doi:10.5603/cj.a2016.0018

Cited by 6 publications

(6 citation statements)

References 23 publications

(31 reference statements)

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“…This could also explain the similar outcomes observed in our patients with or without dissection. A similar study on the time course of vascular response after implantation of bare‐metal stents after DCB dilation showed transient, severe, incomplete strut apposition after the procedure . A meta‐analysis comparing the outcomes of bare‐metal stent implantation after DCB with DES treatment also suggested that bail‐out stenting may be a predictor of poor late lumen loss and MACE .…”

Section: Discussionmentioning

confidence: 82%

“…12 Briefly, the RESTORE SVD China study was a prospective, randomized, open-label, multicenter trial in which 230 eligible patients with visually-estimated reference vessel diameter (RVD) ≥2. 25 and ≤2.75 mm were randomized to undergo PCI with RESTORE DCB (Cardionovum, Bonn, Germany) or RESO-LUTE Integrity DES (Medtronic, Minneapolis, Minnesota) implantation in a 1:1 ratio stratified by diabetes and the number of lesions treated.…”

Section: Methodsmentioning

confidence: 99%

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Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

Tian

Tang

Qiao

et al. 2020

Cathet Cardio Intervent

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Objectives To report the clinical outcomes of the RESTORE drug‐coated balloon (DCB; Cardionovum, Bonn, Germany) for treatment of de novo small vessel disease (SVD) beyond 1 year. Background Previous reports have demonstrated the noninferiority of the RESTORE DCB to the RESOLUTE Integrity drug‐eluting stent (DES; Medtronic, Minneapolis, Minnesota) in terms of 9‐month in‐segment percent diameter stenosis. Methods In the prospective, multicenter, noninferiority RESTORE SVD China trial, 230 patients with visually‐estimated reference vessel diameter (RVD) ≥2.25 and ≤2.75 mm were randomized to DCB or DES in a 1:1 ratio stratified by diabetes and number of lesions treated. Furthermore, 32 patients with RVD ≥2.00 and <2.25 mm were enrolled in a nested very small vessel (VSV) registry. Clinical follow‐up were performed at 2 years to evaluate target lesion failure (TLF) in both groups and the VSV cohort. Results Overall, 256 (97.7%) patients (115 and 109 in the DCB and DES groups, respectively, and 32 in the VSV cohort) completed 2 years of follow‐up. There was no significant difference in TLF between the DCB and DES groups (5.2 vs. 3.7%, p = .75). Target lesion revascularization was acceptable at 1 month, 1 year, and 2 years, and did not differ significantly with DCB from that in the DES group (0.9 vs. 0%, p = 1.0, 4.4 vs. 2.6%, p = .72, 5.2 vs. 2.8%, p = .50, respectively). Conclusions Compared to the second‐generation DES, the RESTORE DCB did not increase the risk of clinical outcomes. Late catch‐up phenomen requiring revascularization was not significant in this study.

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Section: Discussionmentioning

confidence: 82%

Section: Methodsmentioning

confidence: 99%

Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

Tian

Tang

Qiao

et al. 2020

Cathet Cardio Intervent

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“…The OCTOPUS trial, which used optical coherence tomography, reported that DCB + BMS was associated with more pronounced neointimal proliferation than DES. [23,34] The IVUS study used intravascular ultrasound also showed more pronounced neointimal hyperplasia in the DCB + BMS group, leading to more revascularization than that in the DES group. [35] The reason for this finding is not yet satisfactorily explained.…”

Section: Discussionmentioning

confidence: 99%

Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease

Liu

Zhu²,

Han³

et al. 2017

Medicine

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Background:Studies examining the efficiency of drug-coated balloon (DCB) + bare metal stent (BMS) compared with stents alone for de novo lesions have reported inconsistent results. The present comprehensive meta-analysis of randomized controlled trials (RCTs) assessed and compared the clinical efficacy and safety of DCB + BMS with those of stents alone for de novo coronary artery disease.Methods:We formally searched electronic databases before September 2016 to identify potential studies. All RCTs were eligible for inclusion if they compared DCB + BMS with a control treatment (drug-eluting stent [DES] alone or BMS alone) in patients with de novo coronary artery disease.Results:Eleven RCTs with a total of 2196 patients met the inclusion criteria were included in our meta-analysis. Subgroup analysis indicated DCB plus BMS was associated with poorer outcomes when compared with DES alone in primary endpoint {(in-segment late lumen loss [LLL]: mean difference [MD], 0.19; 95% confidence interval [CI], 0.06–0.32; P = 0.0042) and (major adverse cardiovascular events [MACEs]: risk ratio [RR], 1.88; 95% CI, 1.44–2.45; P < 0.0001)}. However, DCB + BMS had nonsignificantly lower LLL than BMS alone (in-segment LLL: MD, −0.14; 95% CI, −0.33–0.04; P = 0.24), and was more advantageous in reducing MACE incidence, with borderline significance (MACEs: RR, 0.67; 95% CI, 0.45–0.99; P = 0.05).Conclusions:In summary, the present results do not favor the DCB + BMS strategy as an alternative therapeutic method to DES implantation for de novo coronary artery lesions in percutaneous coronary intervention (PCI). Additional well-designed large RCTs with long-follow-up periods are required to clarify the inconsistent results.

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“…However, properties of DCB´s should not be understood as “class effects” [28]. Current evidence for vessel wall expansion is the strongest for paclitaxel and is histologically proven as media wall thinning and cell necrosis in addition to inhibition of smooth muscle cells [18, 29–31]. Out of the available paclitaxel-coated balloons, the Sequent Please™ DCB used in this study has been best investigated.…”

Section: Discussionmentioning

confidence: 99%

“…OCT images were acquired with an automated pullback of 20 mm/s (St. Jude Medical Ilumien™), analyzed offline and blinded to the coronary angiogram. A computational algorithm was applied for dissection and plaque analysis as described before: Plaque morphology was assessed according to the international consensus [17, 18]. Plaques and dissections were manually traced in each cross section, and according volumes were computed through the integral of cross-sectional measurements.…”

Section: Methodsmentioning

confidence: 99%

Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography

et al. 2016

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BackgroundPercutaneous coronary interventions (PCI) with drug-coated balloons (DCB) might be a promising trade-off between balloon angioplasty and drug-eluting stents, since DCB inhibit neointimal proliferation and limit duration of dual antiplatelet therapy. We investigated the safety, feasibility, and 6-month results of fractional flow reserve (FFR)-guided use of the paclitaxel-coated SeQuent Please® balloon without stenting for elective PCI of de novo lesions.Methods and resultsIn 46 patients (54 lesions) with stable symptomatic coronary artery disease (CAD), a FFR-guided POBA (plain old balloon angioplasty) was performed. In case of a sufficient POBA result with residual stenosis < 40 %, FFR > 0.8 and no severe dissection, the target lesion was finally dilated using the DCB. Quantitative coronary angiography (QCA) was performed before and after the index procedure and at 6-month follow-up (f/u) to calculate late lumen loss (LLL) and net luminal gain (NLG). Optical coherence tomography (OCT) was performed at f/u to assess vascular remodeling. DCB-only treatment was applied to 43 patients (51 lesions), while 3 patients (3 lesions) needed provisional stenting. Invasive f/u was completed in 39 patients (47 lesions). At the stenotic site, the lumen diameter showed a trend toward progressive increase at f/u (LLL: −0.13 ± 0.44 mm, n.s.; NLG: 1.10 ± 0.53 mm, p < 0.001) without aneurysm formation or restenosis after DCB-only treatment.ConclusionsFFR-guided DCB-only PCI of de novo lesions appeared feasible and safe in stable CAD with clopidogrel discontinuation after 4 weeks, showing a trend toward positive vessel remodeling without lumen loss at 6 months.Clinical trial registration http://www.clinicaltrials.gov. Unique identifier: NCT02120859Electronic supplementary materialThe online version of this article (doi:10.1007/s00392-016-1019-4) contains supplementary material, which is available to authorized users.

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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

Abstract: Background: An a priori combined therapy of a bare metal stent post-dilated with a paclitaxel--coated balloon (PCB) was investigated with optical coherence tomography (OCT) at p = 0.001; uncovered struts: 14.5 ± 14.8% vs. 2.0 ± 5.3%, p = 0.001 (Cardiol J 2016; 23, 3: 296-306)

Cited by 6 publications

References 23 publications

Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

Two‐year follow‐up of a randomized multicenter study comparing a drug‐coated balloon with a drug‐eluting stent in native small coronary vessels: The RESTORE Small Vessel Disease China trial

Drug-coated balloon in combination with bare metal stent strategy for de novo coronary artery disease

Fractional flow reserve-guided coronary angioplasty using paclitaxel-coated balloons without stent implantation: feasibility, safety and 6-month results by angiography and optical coherence tomography

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