Fractional flow reserve‐guided paclitaxel‐coated balloon treatment for de novo coronary lesions

Shin, Eun‐Seok; Ann, Soe Hee; Singh, Gillian Balbir; Lim, Kyung Hun; Kleber, Franz X.; Koo, Bon‐Kwon

doi:10.1002/ccd.26257

Cited by 50 publications

(33 citation statements)

References 22 publications

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“…To the best of our knowledge, this is the first prospective, officially registered study with a dedicated, predefined procedural protocol that investigates the feasibility of elective DCB-only PCI in all-comers and provides a nearly completed 6-month invasive and clinical f/u in all patients. Earlier studies of DCB-only angioplasty of de novo stenoses showed a high conversion rate to stenting (11.9–32.8 %), or investigated a preselected study population [20, 21, 23]. Contrary, bail-out stenting in our study was necessary only in 6 % of cases.…”

Section: Discussioncontrasting

confidence: 56%

“…3a–c). Our results on positive vessel remodeling are in agreement with previous studies also showing luminal gain at variable f/u times (Scheller 2013: LLL −0.25 to −0.18 mm; Kleber 2015: late lumen increase in 69 % of the lesion, Her 2016: LLL: −0.12 ± 0.30 mm; Shin 2015: LLL 0.05 ± 0.27 mm; Ann 2016: LLL 0.02 ± 0.27 mm) [14, 19, 21–23]. Only the Valentine´s II trial showed a LLL of 0.38 ± 0.39 mm at 6–9 months f/u.…”

Section: Discussionmentioning

confidence: 99%

“…Contrary to the consensus on DCB treatment, the mean b / a ratio of 1.27 in this study was considerably higher than recommended (0.8–1.0), but is in line with values reported by other studies (1.15–1.18). Thus, oversizing seems of crucial importance to achieve sufficient acute and long-term results [14, 21, 22]. …”

Section: Discussionmentioning

confidence: 99%

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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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Section: Discussioncontrasting

confidence: 56%

Section: Discussionmentioning

confidence: 99%

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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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“…In the present study, we demonstrated that PCB treatment for de novo coronary disease in patients who were unable to receive long-term dual antiplatelet therapy is promising in better tackling PMI than DES implantation. In terms of the safety and efficacy of PCB treatment for de novo coronary lesions, we have already shown that fractional flow reserve guided PCB treatment is safe and effective with good anatomical and physiological patency at follow-up 29. Therefore, we hope that PCB treatment will be used in a broader patient population with de novo coronary disease, thus reducing PMI post-PCI.…”

Section: Discussionmentioning

confidence: 98%

A Comparison of Peri-Procedural Myocardial Infarction between Paclitaxel-Coated Balloon and Drug-Eluting Stent onDe NovoCoronary Lesions

et al. 2017

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PurposeThis study compared the impact of paclitaxel-coated balloons (PCB) or drug eluting stents (DES) on peri-procedural myocardial infarction (PMI) on de novo coronary lesion in stable patients.Materials and MethodsIn this observational study, we compared the incidence of PMI amongst patients with single vessel de novo coronary lesions who underwent treatment with a PCB or DES. Propensity score-matching analysis was used to assemble a cohort of patients with similar baseline characteristics. PMI was classified as myocardial infarction occurring within 48 hours after percutaneous coronary intervention with a threshold of 5 x the 99th percentile upper reference limit of normal for creatine kinase-myocardial band (CK-MB) or troponin T (TnT).ResultsOne hundred four patients (52 receiving PCB and 52 receiving DES) were enrolled in this study. The peak mean values of CK-MB and TnT were significantly higher in the DES group. There was a significantly higher rate of PMI in the DES group (23.1% vs. 1.9%, p=0.002). Total occlusion of the side-branch occurred in two patients treated with DES, while no patients treated with PCB. In multivariable analysis, DES was the only independent predictor of PMI compared with PCB (odds ratio 42.85, 95% confidence interval: 3.44–533.87, p=0.004).ConclusionTreatment with a PCB on de novo coronary lesion might be associated with a significant reduction in the risk of PMI compared to DES.

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“…Finally, Shin et al (27) presented the similar efficacy and safety of DEB vs. second generation DES in treatment of de novo coronary stenosis even without additional BMS implantation. They emphasized the perfect lesion preparation with predilation to obtain fractional flow reserve (FFR) > 0.85.…”

Section: Discussionmentioning

confidence: 99%

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial

et al. 2017

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The combined use of a drug-eluting balloon (DEB) and a bare metal stent (BMS) for the treatment of de novo non-small vessel coronary artery diseases (CAD) remains to be evaluated. We investigated the efficacy of a sequential treatment using a DEB together with a BMS implantation in comparison to a zotarolimus-eluting stent (ZES). This study was a prospective, randomized, open-label study. We designed it to demonstrate the non-inferiority of a sequential treatment using a DEB first followed by a BMS (DEB + BMS) compared with the use of a ZES. The primary endpoint was in-segment late loss (LL) at 9 months measured by quantitative coronary angiography (QCA). A total of 180 patients were enrolled in the study. The 9-month follow-up angiography was performed in 72 patients with DEB + BMS and 74 patients with ZES. When comparing the DEB + BMS results with the ZES ones, LL was 0.50 ± 0.46 mm in DEB + BMS patients vs. 0.21 ± 0.44 mm in ZES patients (P < 0.001). The mean difference of the LL was 0.31 mm, which was larger than the prespecified non-inferiority margin of 0.19 mm, and the 2-sided 95% confidence interval was 0.15–0.48. The clinical outcomes were not significantly different. In conclusion, the DEB + BMS strategy is inferior to the ZES one in terms of the LL result at 9 months. The DEB strategy for de novo coronary artery lesions needs to be improved for it to become an alternative treatment option. This was a clinical trial study and was registered at www.ClinicalTrials.gov (Identifier: NCT01539603; http://www.clinicaltrials.gov/ct2/show/NCT01539603).

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Fractional flow reserve‐guided paclitaxel‐coated balloon treatment for de novo coronary lesions

Abstract: POBA-FFR-guided PCB treatment is safe and effective for de novo coronary lesions with good anatomical and physiological patency at mid-term follow-up. © 2015 Wiley Periodicals, Inc.

Cited by 50 publications

References 22 publications

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

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

A Comparison of Peri-Procedural Myocardial Infarction between Paclitaxel-Coated Balloon and Drug-Eluting Stent onDe NovoCoronary Lesions

Comparison of Drug-Eluting Balloon Followed by Bare Metal Stent with Drug-Eluting Stent for Treatment of de Novo Lesions: Randomized, Controlled, Single-Center Clinical Trial

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