Long-Term Results of Everolimus-Eluting Stents Versus Drug-Eluting Balloons in Patients With Bare-Metal In-Stent Restenosis: 3-Year Follow-Up of the RIBS V Clinical Trial.

The aim of this study was to compare the long-term efficacy of everolimus-eluting stents (EES) and drug-eluting balloons (DEB) in patients with bare-metal stent in-stent restenosis (ISR). The relative long-term clinical efficacy of current therapeutic modalities in patients with ISR remains unknown. The 3-year clinical follow-up (pre-specified endpoint) of patients included in the RIBS V (Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent Implantation) randomized clinical trial was analyzed. All patients were followed yearly using a pre-defined structured questionnaire. A total of 189 patients with bare-metal stent ISR were allocated to either EES (n = 94) or DEB (n = 95). Clinical follow-up at 1, 2, and 3 years was obtained in all patients (100%). Compared with patients treated with DEB, those treated with EES obtained better angiographic results, including larger minimal luminal diameter at follow-up (primary study endpoint; 2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm; p < 0.001). At 3 years, the rates of cardiac death (2% vs. 1%), myocardial infarction (4% vs. 5%) and target vessel revascularization (9% vs. 5%) were similar in the DEB and EES arms. Importantly, however, at 3 years, the rate of target lesion revascularization was significantly lower in the EES arm (2% vs. 8%; p = 0.04; hazard ratio: 0.23; 95% confidence interval: 0.06 to 0.93). The need for "late" (>1 year) target vessel (3 [3.2%] vs. 3 [3.2%]; p = 0.95) and target lesion (1 [1%] vs. 2 [2.1%]; p = 0.54) revascularization was low and similar in the 2 arms. Rates of definite or probable stent thrombosis (1% vs. 0%) were also similar in the 2 arms. The 3-year clinical follow-up of the RIBS V clinical trial confirms the sustained safety and efficacy of EES and DEB in patients treated for bare-metal stent ISR. In this setting, EES reduce the need for target lesion revascularization at very long-term follow-up. (RIBS V [Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent] [RIBS V]; NCT01239953).

Alfonso F ，Pérez-Vizcayno MJ ，García Del Blanco B ，Otaegui I ，Masotti M ，Zueco J ，Veláquez M ，Sanchís J ，García-Touchard A ，Lázaro-García R ，Moreu J ，Bethencourt A ，Cuesta J ，Rivero F ，Cárdenas A ，Gonzalo N ，Jiménez-Quevedo P ，Fernández C ，RIBS V Study Investigators ... -  《-》

3-Year Clinical Follow-Up of the RIBS IV Clinical Trial: A Prospective Randomized Study of Drug-Eluting Balloons Versus Everolimus-Eluting Stents in Patients With In-Stent Restenosis in Coronary Arteries Previously Treated With Drug-Eluting Stents.

This study sought to compare the long-term safety and efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with in-stent restenosis (ISR) of drug-eluting stents (DES). Treatment of patients with DES-ISR remains a challenge. The RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents) trial is a prospective multicenter randomized clinical trial comparing DEB and EES in patients with DES-ISR. The pre-specified comparison of the 3-year clinical outcomes obtained with these interventions is the main objective of the present study. A total of 309 patients with DES-ISR were randomized to DEB (n = 154) or EES (n = 155). At angiographic follow-up, the in-segment minimal lumen diameter was larger in the EES arm (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p < 0.01). Three-year clinical follow-up was obtained in all enrolled patients (100%). The combined clinical outcome measure of cardiac death, myocardial infarction and target lesion revascularization was significantly reduced in the EES arm (19 [12.3%] vs. 31 [20.1%]; p = 0.04; hazard ratio: 0.57 [95% confidence interval: 0.34 to 0.96]), driven by a lower need for target lesion revascularization (11 [7.1%] vs. 24 [15.6%]; p = 0.015; hazard ratio: 0.43 [95% confidence interval: 0.21 to 0.87]). The need for "late" (>1 year) target lesion revascularization (2.6% vs. 4%) and target vessel revascularization (4% vs. 6.6%) was similar in the 2 arms. Rates of cardiac death (3.9% vs. 3.2%), myocardial infarction (2.6% vs. 4.5%), and stent thrombosis (1.3% vs. 2.6%) at 3 years were also similar in both arms. The 3-year clinical follow-up of this randomized clinical trial demonstrates that in patients with DES-ISR, EES reduce the need for repeat interventions compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloons vs Everolimus-Eluting Stents [RIBS IV]; NCT01239940).

Alfonso F ，Pérez-Vizcayno MJ ，Cuesta J ，García Del Blanco B ，García-Touchard A ，López-Mínguez JR ，Masotti M ，Zueco J ，Cequier A ，Velázquez M ，Moreno R ，Mainar V ，Domínguez A ，Moris C ，Molina E ，Rivero F ，Jiménez-Quevedo P ，Gonzalo N ，Fernández-Pérez C ，RIBS IV Study Investigators (Under the Auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology) ... -  《-》

A randomized comparison of drug-eluting balloon versus everolimus-eluting stent in patients with bare-metal stent-in-stent restenosis: the RIBS V Clinical Trial (Restenosis Intra-stent of Bare Metal Stents: paclitaxel-eluting balloon vs. everolimus-elutin

This study sought to compare the efficacy of drug-eluting balloons (DEB) with that of everolimus-eluting stents (EES) in patients with bare-metal stents (BMS) in-stent restenosis (ISR). Treatment of patients with ISR remains a challenge. This was a prospective, multicenter, randomized trial comparing DEB with EES in patients with bare-metal stents (BMS) in-stent restenosis (ISR). The primary endpoint was the minimal lumen diameter at 9 months' follow-up. A total of 189 patients with BMS-ISR from 25 Spanish sites were included (95 were allocated to DEB and 94 to EES). Procedural success was achieved in all patients. At late angiography (median 249 days; 92% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.36 ± 0.6 mm vs. 2.01 ± 0.6 mm, p < 0.001; absolute mean difference: 0.35 mm; 95% confidence interval [CI]: 0.16 to 0.53) and a lower percent of diameter stenosis (13 ± 17% vs. 25 ± 20%, p < 0.001). However, late loss (0.04 ± 0.5 mm vs. 0.14 ± 0.5 mm, p = 0.14) and binary restenosis rate (4.7% vs. 9.5%, p = 0.22) were very low and similar in both groups. Clinical follow-up (median 365 days) was obtained in all (100%) patients. Occurrences of the combined clinical outcome measure (cardiac death, myocardial infarction, and target vessel revascularization; 6% vs. 8%; hazard ratio [HR]: 0.76; 95% CI: 0.26 to 2.18, p = 0.6) and the need for target vessel revascularization (2% vs. 6%; HR: 0.32: 95% CI: 0.07 to 1.59, p = 0.17) were similar in the 2 groups. In patients with BMS-ISR, both DEB and EES provided excellent clinical results with a very low rate of clinical and angiographic recurrences. However, compared with DEB, EES provide superior late angiographic findings. (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs. Everolimus-eluting Stent [RIBS V]; NCT01239953).

Alfonso F ，Pérez-Vizcayno MJ ，Cárdenas A ，García Del Blanco B ，Seidelberger B ，Iñiguez A ，Gómez-Recio M ，Masotti M ，Velázquez MT ，Sanchís J ，García-Touchard A ，Zueco J ，Bethencourt A ，Melgares R ，Cequier A ，Dominguez A ，Mainar V ，López-Mínguez JR ，Moreu J ，Martí V ，Moreno R ，Jiménez-Quevedo P ，Gonzalo N ，Fernández C ，Macaya C ，RIBS V Study Investigators, under the auspices of the Working Group on Interventional Cardiology of the Spanish Society of Cardiology ... -  《-》

Long-term outcomes after treatment of bare-metal stent restenosis with paclitaxel-coated balloon catheters or everolimus-eluting stents: 3-year follow-up of the TIS clinical study.

The efficacy of paclitaxel-eluting balloon catheters (PEB) and drug-eluting stents for treatment of bare-metal stent restenosis (BMS-ISR) have been demonstrated in several studies with follow-up times of 9 to 12 months; however, the long-term outcomes of ISR treatment are less defined. We aimed to compare the long-term efficacy of PEB and everolimus-eluting stents (EES) for the treatment of BMS-ISR. We analyzed 3-year clinical follow-up data from patients included in the TIS randomized clinical study. A total of 136 patients with BMS-ISR were allocated to receive treatment with either PEB or EES (68 patients with 74 ISR lesions per group). The PEB and EES groups did not significantly differ in major adverse cardiac events-free survival (MACE; P = .211; including individual events: CV death: P = .622; myocardial infarction: P = .650 or target vessel revascularization: P = .286) at 3-year clinical follow-up. No event-free survival differences were found between the groups regarding overall mortality (P = .818), definite stent thrombosis (P = .165) or the second MACE (P = .270). At the 3-year follow-up, no significant differences in clinical outcomes were found between iopromide-coated PEB and EES for the treatment of BMS-ISR. (ClinicalTrials.gov; https://clinicaltrials.gov; NCT01735825).

Pleva L ，Kukla P ，Zapletalova J ，Hlinomaz O ... -  《-》

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

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. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon 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 follow-up 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. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide 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. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.

Alfonso F ，Pérez-Vizcayno MJ ，García Del Blanco B ，García-Touchard A ，López-Mínguez JR ，Masotti M ，Zueco J ，Melgares R ，Mainar V ，Moreno R ，Domínguez A ，Sanchís J ，Bethencourt A ，Moreu J ，Cequier A ，Martí V ，Otaegui I ，Bastante T ，Gonzalo N ，Jiménez-Quevedo P ，Cárdenas A ，Fernández C ，under the auspices of the Interventional Cardiology Working Group of the Spanish Society of Cardiology ... -  《-》