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Introduction and objectives: The PSP (pre-dilation, sizing and post-dilation) score, derived from the GHOST-EU registry, has evaluated the relationship between the implantation technique of bioresorbable scaffolds and the clinical outcomes. The objective was to perform an external validation of the PSP technique and to determine its effect on adverse cardiac events in various clinical and anatomical scenarios. Methods: Data from the REPARA registry (2230 patients) were used for external validation, whereas a common database combining REPARA and GHOST-EU (3250 patients) data was used to evaluate the effect of PSP technique in various clinical and anatomical scenarios. PSP-1 and PSP-3 were used to score the appropriateness of pre-dilation, scaffold sizing, and post-dilation. The primary endpoint was 1-year device-oriented composite endpoint of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization. The definite/probable scaffold thrombosis according to the Academic Research Consortium criteria was also evaluated. Results: A total of 303 (18.2%) patients were treated with an optimal PSP-1, and 182 (8.2%) with an optimal PSP-3. The external validation showed that PSP has a very high negative predictive value for device-oriented composite endpoint and scaffold thrombosis (91.8% and 89.1% for PSP-1; 98.4% and 97.3% for PSP-3, respectively). Patients with an optimal PSP-3 had a numerically lower rate of device-oriented composite endpoint and scaffold thrombosis compared to those without it (0.5% vs 2.9%; P = .085 and 0.5% vs 1.8%; P = .248, respectively). In the merged database, PSP benefits were seen on many scenarios, except in the ST-segment elevation myocardial infarction where a trend towards no benefit of an optimal PSP technique was present (Pinteraction = .100). Conclusions: In the REPARA registry, at 1-year follow-up, an optimal PSP technique was not associated with a lower rate of device-oriented composite endpoint. Further research is necessary to assess the impact of the PSP technique in longer follow-ups.

espanolIntroduccion y objetivos: La escala de puntuacion PSP (pre-dilation, sizing and post-dilation), derivada del registro GHOST-EU, evalua la relacion entre la tecnica de implante de los armazones bioabsorbibles y los resultados clinicos. El objetivo fue realizar una validacion externa de la escala PSP y determinar su efecto en eventos adversos cardiacos en diversos escenarios clinicos y anatomicos. Metodos: Para la validacion externa se emplearon los datos del registro REPARA (2.230 pacientes), mientras que se utilizo una base de datos comun que combina datos de REPARA y GHOST-EU (3.250 pacientes) para evaluar el efecto de la tecnica PSP en varios escenarios clinicos y anatomicos. Se uso PSP-1 y PSP-3 para calificar la calidad de la predilatacion, el dimensionamiento de los armazones y la posdilatacion. El objetivo primario fue la variable compuesta orientada al dispositivo (muerte cardiaca, infarto de miocardio del vaso diana y revascularizacion de la lesion diana) a 1 ano. Tambien se evaluo la trombosis definitiva o probable del armazon segun los criterios del Academic Research Consortium. Resultados: Se trato a 303 (18,2%) pacientes con una PSP-1 optima y a 182 (8,2%) con una PSP-3 optima. La validacion externa mostro que la escala PSP tiene un valor predictivo negativo muy alto para el objetivo primario compuesto orientado al dispositivo y la trombosis del armazon (91,8 y 89,1% para PSP-1; 98,4 y 97,3% para PSP-3, respectivamente). En pacientes con PSP-3 optimo, el objetivo primario compuesto orientado al dispositivo y la trombosis del armazon fueron numericamente inferiores en comparacion con los pacientes sin PSP-3 optimo (0,5 frente a 2,9%; p = 0,085; y 0,5 frente a 1,8%; p = 0,248, respectivamente). En la base de datos combinada, los beneficios de la escala PSP se observaron en diversos escenarios, excepto en el de infarto de miocardio con elevacion del segmento ST, en el que se observo una tendencia hacia laausencia de beneficios de una tecnica de PSP optima (pinteraccion = 0,100). Conclusiones: Una tecnica de PSP optima no se asocio con una tasa mas baja del objetivo primario compuesto orientado al dispositivo. Se necesitan nuevos estudios para evaluar el impacto de la tecnica de PSP con un seguimiento mas prolongado. EnglishIntroduction and objectives: The PSP (pre-dilation, sizing and post-dilation) score, derived from the GHOST-EU registry, has evaluated the relationship between the implantation technique of bioresorbable scaffolds and the clinical outcomes. The objective was to perform an external validation of the PSP technique and to determine its effect on adverse cardiac events in various clinical and anatomical scenarios. Methods: Data from the REPARA registry (2230 patients) were used for external validation, whereas a common database combining REPARA and GHOST-EU (3250 patients) data was used to evaluate the effect of PSP technique in various clinical and anatomical scenarios. PSP-1 and PSP-3 were used to score the appropriateness of pre-dilation, scaffold sizing, and post-dilation. The primary endpoint was 1-year device-oriented composite endpoint of cardiac death, target-vessel myocardial infarction, and target-lesion revascularization. The definite/probable scaffold thrombosis according to the Academic Research Consortium criteria was also evaluated. Results: A total of 303 (18.2%) patients were treated with an optimal PSP-1, and 182 (8.2%) with an optimal PSP-3. The external validation showed that PSP has a very high negative predictive value for device-oriented composite endpoint and scaffold thrombosis (91.8% and 89.1% for PSP-1; 98.4% and 97.3% for PSP-3, respectively). Patients with an optimal PSP-3 had a numerically lower rate of device-oriented composite endpoint and scaffold thrombosis compared to those without it (0.5% vs 2.9%; P = .085 and 0.5% vs 1.8%; P = .248, respectively). In the merged database, PSP benefits were seen on many scenarios, except in the ST-segment elevation myocardial infarction where a trend towards no benefit of an optimal PSP technique was present (Pinteraction = .100). Conclusions: In the REPARA registry, at 1-year follow-up, an optimal PSP technique was not associated with a lower rate of device-oriented composite endpoint. Further research is necessary to assess the impact of the PSP technique in longer follow-ups.

Objectives This study sought to assess the value of bioresorbable vascular scaffolds (BVS) in patients with in-stent restenosis (ISR). Background Currently both drug-eluting stents (DES) and drug-eluting balloons (DEB) are recommended in patients with ISR. However, the value of BVS in this setting remains unclear. Methods RIBS VI (Restenosis Intra-stent: drug-eluting Balloon vs everolimus-eluting Stent) was a prospective multicenter study (19 Spanish sites) that included 141 patients treated with BVS for either bare-metal stent (BMS) ISR or DES-ISR. Late angiography was scheduled at 6 to 9 months. Inclusion/exclusion criteria were similar to those used in the RIBS IV (patients with DES-ISR) and RIBS V (patients with BMS-ISR) trials, where DEB (n = 249) was compared with everolimus (EES)-DES (n = 249). Results of BVS in RIBS VI were compared with those obtained with DEB and EES in the RIBS IV and V trials. Results On late angiography (n = 134; 95% of eligible) the in-segment minimal lumen diameter (primary endpoint) was 1.87 ± 0.5 mm, late lumen loss was 0.23 ± 0.4 mm, and restenosis rate was 11%. At 1-year follow-up (100% of patients) no patient died, 4 (2.8%) experienced a myocardial infarction, and 16 (11.3%) required target lesion revascularization. One patient (0.7%) who discontinued antiplatelet therapy experienced definitive BVS thrombosis. Freedom from cardiac death, myocardial infarction, and target lesion revascularization was 86%. The minimal lumen diameter at follow-up after BVS was similar to that obtained with DEB (1.88 ± 0.6 mm; p = NS) but smaller than that achieved after EES (2.16 ± 0.7 mm; p Conclusions This study suggests the safety and efficacy of BVS in patients with ISR. In this challenging anatomic scenario BVS obtained late angiographic and clinical results similar to DEB but inferior to EES. (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment [RIBS VI]; NCT02672878 )

Treatment of patients with in-stent restenosis (ISR) remains a challenge. This study sought to compare the efficacy of everolimus-eluting stents (EESs) and drug-eluting balloons (DEBs) with paclitaxel in patients with ISR. A pooled analysis of the Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS IV) and Restenosis Intra-Stent of Bare-Metal Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent (RIBS V) randomized trials was performed using patient-level data. In both trials, EESs were compared with DEBs in patients with ISR (RIBS V included 189 patients with bare-metal ISR; RIBS IV included 309 patients with drug-eluting ISR). Inclusion and exclusion criteria were identical in both trials. A total of 249 patients were allocated to EES and 249 to DEB. Clinical follow-up at 1 year was obtained in all (100%) patients and late angiography (median 249 days) in 91% of eligible patients. Compared with patients treated with DEBs, patients treated with EESs obtained better short-term results (postprocedural minimal lumen diameter 2.28 ± 0.5 vs 2.12 ± 0.4 mm, p

Background Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) remains a major challenge. Objectives This study evaluated the comparative efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients presenting with DES-ISR. Methods The study design of this multicenter randomized clinical trial assumed superiority of EES for the primary endpoint, in-segment minimal lumen diameter at the 6- to 9-month angiographic follow-up. Results A total of 309 patients with DES-ISR from 23 Spanish university hospitals were randomly allocated to DEB (n = 154) or EES (n = 155). At late angiography (median 247 days; 90% of eligible patients), patients in the EES arm had a significantly larger minimal lumen diameter (2.03 ± 0.7 mm vs. 1.80 ± 0.6 mm; p Conclusions In patients with DES-ISR, EES provided superior long-term clinical and angiographic results compared with DEB. (Restenosis Intra-Stent of Drug-Eluting Stents: Drug-Eluting Balloon vs Everolimus-Eluting Stent [RIBS IV]; NCT01239940)

Aims This study will compare the efficacy of drug-eluting balloons (DEB) and everolimus-eluting stents (EES) in patients with drug-eluting stent (DES) in-stent restenosis (ISR). Methods and results This is a prospective, multicentre, randomised clinical trial comparing DEB and EES in patients with DES-ISR. The study is an investigator-driven initiative generated within the RIBS study programme. A total of 310 patients with DES-ISR will be included and randomised (1:1) to DEB or EES. Angiographic follow-up has been scheduled at six to nine months. Quantitative coronary analyses will be performed in a centralised core lab by blinded personnel. The primary endpoint of the study is minimal lumen diameter at angiographic follow-up. Other secondary angiographic endpoints include % diameter stenosis, late loss, net gain and binary restenosis rate. An independent clinical events committee will adjudicate clinical events after reviewing source documents. The main clinical outcome measure is a combined endpoint of cardiac death, myocardial infarction and target vessel revascularisation at one year. Individual components of the combined clinical endpoint and rates of target lesion revascularisation and stent thrombosis will also be compared. Conclusions This randomised clinical trial will determine the relative efficacy of EES versus DEB in patients presenting with DES-ISR. (ClinicalTrials.gov Identifier: NCT01239940).

Vascular complications in transcatheter aortic valve implantation using transfemoral approach are related to higher mortality. Complete percutaneous approach is currently the preferred technique for vascular access. However, some centers still perform surgical cutdown. Our purpose was to determine complications related to vascular access technique in the population of the Spanish TAVI National Registry. From January 2010 to July 2015, 3,046 patients were included in this Registry. Of them, 2,465 underwent transfemoral approach and were treated with either surgical cutdown and closure (cutdown group, n = 632) or percutaneous approach (puncture group, n = 1,833). Valve Academic Research Consortium-2 definitions were used to assess vascular and bleeding complications. Propensity matching resulted in 615 matched pairs. Overall, 30-day vascular complications were significantly higher in the puncture group (109 [18%] vs 42 [6.9%]; relative risk [RR] 2.60; 95% confidence interval [CI] 1.85 to 3.64, p

Objectives This study sought to assess the incidence, predictors, and outcome of drug-eluting stent (DES) thrombosis in real-world clinical practice. Background The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications. Methods We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring. Results Of 23,500 patients treated with DES, definite stent thrombosis (ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred >1 year (very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases (31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction Conclusions The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.

Objectives 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). Background Treatment of patients with ISR remains a challenge. Methods 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. Results 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. Conclusions 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) (C) 2014 by the American College of Cardiology Foundation

Background: The value of drug-eluting stents in patients (P) with in-stent restenosis (ISR) has been established. However, the long-term results of this strategy in P with ISR remains unknown. Objective: We sought to determine the long-term clinical outcome of P treated with sirolimus-eluting stents (SES) for ISR. Methods: A systematic, pre-specified, long-term clinical follow-up (FU) was performed in all P included in the RIBS II (Restenosis Intra-stent: Balloon angioplasty [BA] vs elective SES implantation) randomized trial. In RIBS II 150 P with ISR after bare-metal stent implantation were included: 74 allocated to BA and 76 to SES. Late angiography was obtained in 96% of eligible P. A structured clinical questionnaire (cardiac/non cardiac death, myocardial infarction [MI], target vessel revascularization [TVR], thrombosis [TH], and medical therapy) was used during FU. Results: Angiographic restenosis (primary end-point) was more frequently found in the BA arm (39% vs 11%, p3 years was obtained in 145 P (97%) (mean 38±9 months, median 40 months [IQR 37–42]). Late events (after 1 year, non-exclusive) included: 3 deaths (1 SES, 2 BA), 3 MI (3 SES, 2 due to late TH) and 7 late TVR (5 SES, 2 BA). At 4 years, event-free survival was 76% in the SES arm and 65% in the BA arm (p=0.03). Survival free from TVR at 4 years was 80% in the SES arm and 67% in the BA arm (p=0.02). Conclusion: In P with ISR SES implantation improve the long-term clinical outcome as compared with BA treatment.

This study sought to assess the incidence, predictors, and outcome of drug-eluting stent(DES) thrombosis in real-world clinical practice.The DES thromboses in randomized trials could not be comparable to those observed in clinical practice, frequently including off-label indications.We designed a large-scale, nonindustry-linked multicentered registry, with 20 centers in Spain. The participant centers provided follow-up data for their patients treated with DES, reporting a detailed standardized form in the event of any angiography-documented DES-associated thrombosis occurring.Of 23,500 patients treated with DES, definite stent thrombosis(ST) developed in 301: 24 acute, 125 subacute, and 152 late. Of the late, 62 occurred1 year(very late ST). The cumulative incidence was 2% at 3 years. Antiplatelet treatment had been discontinued in 95 cases(31.6%). No differences in incidences were found among stent types. Independent predictors for subacute ST analyzed in a subgroup of 14,120 cases were diabetes, renal failure, acute coronary syndrome, ST-segment elevation myocardial infarction, stent length, and left anterior descending artery stenting, and for late ST were ST-segment elevation myocardial infarction, stenting in left anterior descending artery, and stent length. Mortality at 1-year follow-up was 16% and ST recurrence 4.6%. Older age, left ventricular ejection fraction45%, nonrestoration of Thrombolysis In Myocardial Infarction flow grade 3, and additional stenting were independent predictors for mortality.The cumulative incidence of ST after DES implantation was 2% at 3 years. No differences were found among stent types. Patient profiles differed between early and late ST. Short-term prognosis is poor, especially when restoration of normal flow fails.