A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent–In-Stent Restenosis

Alfonso, Fernándo; Pérez-Vizcayno, Marı́a José; Cárdenas, A.; Blanco, Bruno García del; Seidelberger, Bernhard; Íñiguez, Andrés; Gómez-Recio, M; Masotti, Mónica; Velázquez, M. Teresa; Sanchís, Juan; García‐Touchard, Arturo; Zueco, Javier; Bethencourt, Armando; Melgares, Rafael; Cequier, Ángel; Domínguez, Antonio; Mainar, Vicente; López-Mínguez, José Ramón; Moreu, José; Martı́, Vicens; Moreno, Raúl; Jiménez‐Quevedo, Pilar; Gonzalo, Nieves; Fernández, Cristina; Macaya, Carlos

doi:10.1016/j.jacc.2013.12.006

Cited by 228 publications

(99 citation statements)

References 25 publications

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“…A direct randomized comparison between the paclitaxel-eluting balloon and EES for the treatment of BMS restenosis was performed by the Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon Versus EverolimusEluting Stent (RIBS V) investigators. 8 The results of this study were different from the one reported here. Although the late losses of the DEB groups were similar (0.09 mm in the current study and 0.14 mm in RIBS V), the late loss after EES treatment was much higher in the present study (0.44 versus 0.04 mm in RIBS V).…”

Section: See Article By Pleva Et Alcontrasting

confidence: 99%

“…The initial strategy to perform plain balloon angioplasty to treat bare-metal in-stent restenosis (ISR) was inadequate, leaving the remaining options of implanting a drug-eluting stent or using a drug-eluting balloon (DEB). [1][2][3][4] Pleva et al 5 report, in this issue of Circulation: Cardiovascular Interventions, the results of a study randomizing 136 patients with bare-metal ISR to treatment with a DEB (Sequent Please; B. Braun AG, Melsungen, Germany) or an everolimus-eluting stent (EES; Promus Element; Boston Scientific, Marlborough, MA. )…”

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Restenosis in a Bare-Metal Stent

Colombo

Jabbour

2016

Circ: Cardiovascular Interventions

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T he idea of adding another metallic layer to correct a failed stent is not so appealing; therefore, any attempt to propose a metal-free strategy is laudable. The initial strategy to perform plain balloon angioplasty to treat bare-metal in-stent restenosis (ISR) was inadequate, leaving the remaining options of implanting a drug-eluting stent or using a drug-eluting balloon (DEB). See Article by Pleva et alThere were 74 ISR lesions (˃50% diameter stenosis) in each group. The primary end point was in-segment late lumen loss at 12 months measured by quantitative control angiography. The decision to evaluate late lumen loss as an end point is open to debate because the acute gain, and therefore late loss, is lower with DEB compared with EES. The selection of minimal lumen diameter at follow-up angiography may be viewed as a more appropriate choice. The study was powered for noninferiority with the possibility of demonstrating superiority. Secondary end points included binary restenosis and the overall incidence of 12-month major adverse cardiac events (cardiovascular death, nonfatal acute myocardial infarction, or target vessel revascularization).5 Predilatation was applied in all cases and postdilatation as needed. Dual antiplatelet therapy was prescribed for 3 months after DEB and 6 to 12 months after EES implantation. The investigators succeeded in performing angiographic follow-up in >90% of lesions after a mean time period of 12 months. About the baseline characteristics of the lesions randomized, we would like to highlight that in the EES group, there were 18 versus 10 lesions in the DEB group with unfavorable baseline characteristics (proliferative and occlusive restenosis) and that baseline ISR was more severe for the lesions treated with EES (minimal lumen diameter, 0.79 versus 0.92 mm). These differences in baseline lesion characteristics are important and may explain some unexpected findings.The main results are as follows: If we examine the literature searching for similar studies, we will not find much.The Paclitaxel-Eluting PTCA-Balloon Catheter in Coronary Artery Disease II (PEPCAD II) trial is the study, which comes close to this report as far as the devices evaluated in the setting of bare-metal stent (BMS) restenosis. 6 PEPCAD II trial found that the paclitaxel-eluting balloon performed better than paclitaxel-eluting stents for the treatment of BMS restenosis. When EESs were compared with paclitaxeleluting stents in the treatment of BMS restenosis in a registry, EES performed better in regard to restenosis and the need for revascularization at 1-year follow-up. 7 However, when the follow-up extended beyond 1 year, the differences lost statistical significance. A direct randomized comparison between the paclitaxel-eluting balloon and EES for the treatment of BMS restenosis was performed by the Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon Versus EverolimusEluting Stent (RIBS V) investigators. 8 The results of this study were different from the one reported here. Although t...

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Section: See Article By Pleva Et Alcontrasting

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confidence: 99%

Restenosis in a Bare-Metal Stent

Colombo

Jabbour

2016

Circ: Cardiovascular Interventions

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“…Patients with small vessels (≤2.0 mm in diameter), long lesions (>30 mm in length), or total occlusions (Thrombolysis in Myocardial Infarction [TIMI]=0) were excluded. 16,17 Likewise, patients with early (<1 month) ISR, those presenting as an acute myocardial infarction, or showing a large thrombus on angiography were excluded. However, patients with recurrent ISR and those with edge-ISR were eligible.…”

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“…Whenever underexpanded stents were identified, aggressive high-pressure dilations with noncompliant balloons were recommended. 16,17 Patients allocated to EES (Xience Prime, Abbott Vascular, IL) were treated using a 1.1:1 balloon:artery ratio and high (>14 bar) pressures. Systematic postdilation with noncompliant balloons at high pressures was recommended but eventually left to the operator's discretion according to procedural results.…”

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Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

Alfonso

Pérez-Vizcayno

Blanco³

et al. 2016

Circ: Cardiovascular Interventions

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S tent implantation constitutes the default strategy during coronary interventions.1,2 Drug-eluting stents (DES) are widely used because of their unique ability to inhibit neointimal proliferation and reduce the restenosis risk.1,2 However, although rare, in-stent restenosis (ISR) still occurs after DES implantation. 3,4 Of concern, several studies have suggested that treatment Background-Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. Methods and Results-A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-ElutingBalloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at followup remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. Conclusions-This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EESprovide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. Clinical Trial Registration-URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940. Current address for A. of patients with DES-ISR is more challenging than treatment of patients with bare-metal stent (BMS) ISR. 5-9 Indeed, long-term clinical and angiographic results of patients treated for DES-ISR are significantly poorer than those seen in patients treated for BMS-ISR. [5][6][7][8][9] These findings have been demonstrated in patients with ISR treated with first-generation DES. 5,6 Recent studies suggest that drug-eluting balloons (DEB), another well-established therapy in this scenario, are also associated with poorer long-term clinical and ang...

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In‐Stent Restenosis in New Generation DES Era

Mennuni

Presbitero

2016

Interventional Cardiology

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A Randomized Comparison of Drug-Eluting Balloon Versus Everolimus-Eluting Stent in Patients With Bare-Metal Stent–In-Stent Restenosis

Cited by 228 publications

References 25 publications

Restenosis in a Bare-Metal Stent

Restenosis in a Bare-Metal Stent

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis

In‐Stent Restenosis in New Generation DES Era

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