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1.
JACC Cardiovasc Interv ; 17(15): 1825-1836, 2024 Aug 12.
Artículo en Inglés | MEDLINE | ID: mdl-39142758

RESUMEN

BACKGROUND: In patients with in-stent restenosis (ISR) bioresorbable vascular scaffolds (BVS) provide similar results to drug-coated balloons (DCBs) but are inferior to drug-eluting stents (DES) at 1 year. However, the long-term efficacy of BVS in these patients remains unknown. OBJECTIVES: This study sought to assess the long-term safety and efficacy of BVS in patients with ISR. METHODS: RIBS VI (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment; NCT02672878) and RIBS VI Scoring (Restenosis Intrastent: Bioresorbable Vascular Scaffolds Treatment With Scoring Balloon; NTC03069066) are prospective multicenter studies designed to evaluate the results of BVS in patients with ISR (N = 220). The inclusion and exclusion criteria were identical to those used in the RIBS IV (ISR of DES) (Restenosis Intra-stent of Drug-eluting Stents: Drug-eluting Balloon vs Everolimus-eluting Stent; NCT01239940) and RIBS V (ISR of bare-metal stents) (Restenosis Intra-stent of Bare Metal Stents: Paclitaxel-eluting Balloon vs Everolimus-eluting Stent; NCT01239953) randomized trials (including 249 ISR patients treated with DCBs and 249 ISR patients treated with DES). A prespecified comparison of the long-term results obtained with these treatment modalities (ie, DES, DCBs, and BVS) was performed. RESULTS: Clinical follow-up at 3 years was obtained in all (100%) 718 patients. The 3-year target lesion revascularization rate after BVS was 14.1% (vs 12.9% after DCBs [not significant], and 5.2% after DES [HR: 2.80; 95% CI: 1.47-5.36; P = 0.001]). In a landmark analysis (>1 year), the target lesion revascularization rate after BVS was higher than after DES (adjusted HR: 3.41; 95% CI: 1.15-10.08) and DCBs (adjusted HR: 3.33; 95% CI: 1.14-9.70). Very late vessel thrombosis was also more frequent with BVS (BVS: 1.8%, DCBs: 0.4%, DES: 0%; P = 0.03). CONCLUSIONS: In patients with ISR, late clinical results of DES are superior to those obtained with DCBs and BVS. Beyond the first year, DCBs are safer and more effective than BVS.


Asunto(s)
Implantes Absorbibles , Reestenosis Coronaria , Diseño de Prótesis , Humanos , Factores de Tiempo , Masculino , Resultado del Tratamiento , Femenino , Estudios Prospectivos , Reestenosis Coronaria/etiología , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/terapia , Persona de Mediana Edad , Anciano , Factores de Riesgo , Angioplastia Coronaria con Balón/instrumentación , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/administración & dosificación , Fármacos Cardiovasculares/efectos adversos , Stents , Intervención Coronaria Percutánea/instrumentación , Intervención Coronaria Percutánea/efectos adversos , Enfermedad de la Arteria Coronaria/terapia , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Materiales Biocompatibles Revestidos , Stents Liberadores de Fármacos , Ensayos Clínicos Controlados Aleatorios como Asunto
2.
J Cardiovasc Dev Dis ; 11(7)2024 Jun 29.
Artículo en Inglés | MEDLINE | ID: mdl-39057620

RESUMEN

Optical Coherence Tomography (OCT) imaging is a valuable tool for complex coronary interventions. While complications are rare, the occurrence of ventricular arrhythmias during its use is one of the most feared. Unfortunately, the mechanism by which these arrhythmias arise remains unclear. We describe the case of a patient under continuous electrocardiographic (ECG) monitoring who experienced ventricular fibrillation during an OCT procedure. A detailed analysis of the ECG event sequence was performed, from the administration of the contrast medium to the onset of ventricular fibrillation. Utilizing the collected data, we examined potential precipitating factors based on the observed alterations in the electrocardiogram. A comprehensive understanding of the mechanisms underlying these arrhythmias is crucial for the development of preventive measures that avoid such incidents in the future.

3.
Cardiovasc Diagn Ther ; 13(5): 792-804, 2023 Oct 31.
Artículo en Inglés | MEDLINE | ID: mdl-37941845

RESUMEN

Background: Drug-eluting stents (DES) are considered the therapy of choice in ST-segment elevation myocardial infarction (STEMI); however, a low persistent rate of revascularizations and stent thrombosis exist over the time. We have previously shown that a paclitaxel (PTX)-drug-coated balloon (DCB) after a bare-metal stent (BMS) implantation (DCB-combined strategy) yields superior angiographic and clinical results compared to BMS in the short term. However, the long-term safety and efficacy of this approach remain uncertain. Methods: An 8-year clinical follow-up was conducted on patients enrolled in the randomized PEBSI-1 trial (NCT01839890). The original trial included patients who suffered a STEMI, patients were randomly assigned to receive a DCB-combined strategy or BMS only and the primary endpoint was in-stent late luminal loss (LLL) at 9-month follow-up. After the completion of this study, death, myocardial re-infarction, ischemia-driven repeated revascularizations included target lesion revascularization (TLR) and target vessel revascularization (TVR), and stent thrombosis, were assessed by yearly contact by a clinical visit, telephone or by electronic records. These outcomes were adhered to ARC-2 criteria. Results: The rate of incomplete follow-up was very low, with only 3 out of 111 patients (2.7%) in the DCB-combined strategy group and 1 out of 112 patients (0.9%) in the BMS group. At 8 years there were a lower rate of TVR [3.7% vs. 14.3%; hazard ratio (HR): 0.243; 95% confidence interval (CI): 0.081-0.727; P=0.006], and a trend towards lower TLR (2.8% vs. 8.9%; HR: 0.300; 95% CI: 0.083-1.090; P=0.052) in the DCB-combined strategy group. No statistical difference between the DCB-combined strategy and BMS groups were found for all causes of death, deaths from cardiovascular disease, reinfarctions or stent thrombosis. Notably in the DCB-combined strategy group, no episode of stent thrombosis occurred after the first year. Similarly, there were no cardiovascular deaths, TVR and TLR in the DCB-combined strategy group after 5 years. In contrast, during the period from year 5 to 8, the BMS group experienced an additional cardiovascular death, as well as one case of TVR, one case of TLR, and one case of stent thrombosis. Conclusions: In STEMI patients, the DCB-combined strategy maintains its safety and clinical efficacy over time. Our rates of TVR, TLR, and very late stent thrombosis (VLST) at very long-term are the lowest ever found in a STEMI trial. Further studies are warranted to assess the potential superiority of this novel strategy as compared with new-generation DES to prevent very late events in these patients. Trial Registration: ClinicalTrials.gov; identifier: NCT01839890.

4.
Atherosclerosis ; 332: 48-54, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-34391035

RESUMEN

BACKGROUND AND AIMS: SARS-Cov-2 predisposes patients to thrombotic complications, due to excessive inflammation, endothelial dysfunction, platelet activation, and coagulation/fibrinolysis disturbances. The aim of the present study was to evaluate clinical characteristics and prognostic impact of SARS-CoV-2 positivity among STEMI patients undergoing primary percutaneous coronary intervention (PPCI). METHODS: We selected SARS-CoV-2 positive patients included in the ISACS-STEMI COVID-19, a retrospective multicenter European registry including 6609 STEMI patients treated with PPCI from March 1st until April 30th, in 2019 and 2020. As a reference group, we randomly sampled 5 SARS-Cov-2 negative patients per each SARS-CoV-2 positive patient, individually matched for age, sex, and hospital/geographic area. Study endpoints were in-hospital mortality, definite stent thrombosis, heart failure. RESULTS: Our population is represented by 62 positive SARS-CoV-2 positive patients who were compared with a matched population of 310 STEMI patients. No significant difference was observed in baseline characteristics or the modality of access to the PCI center. In the SARS-CoV-2 positive patients, the culprit lesion was more often located in the RCA (p < 0.001). Despite similar pre and postprocedural TIMI flow, we observed a trend in higher use of GP IIb-IIIa inhibitors and a significantly higher use of thrombectomy in the SARS-CoV-2 positive patients. SARS-CoV-2 positivity was associated with a remarkably higher in hospital mortality (29% vs 5.5%, p < 0.001), definite in-stent thrombosis (8.1% vs 1.6%, p = 0.004) and heart failure (22.6% vs 10.6%, p = 0.001) that was confirmed after adjustment for confounding factors. CONCLUSIONS: Our study showed that among STEMI patients, SARS-CoV-2 positivity is associated with larger thrombus burden, a remarkably higher mortality but also higher rates of in-stent thrombosis and heart failure.


Asunto(s)
COVID-19 , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Humanos , Intervención Coronaria Percutánea/efectos adversos , Sistema de Registros , Reperfusión , Estudios Retrospectivos , SARS-CoV-2 , Infarto del Miocardio con Elevación del ST/diagnóstico , Infarto del Miocardio con Elevación del ST/cirugía , Resultado del Tratamiento
6.
Coron Artery Dis ; 32(8): 673-680, 2021 12 01.
Artículo en Inglés | MEDLINE | ID: mdl-33826537

RESUMEN

OBJECTIVES: Drug-coated balloons (DCBs) have theoretical advantages over drug-eluting stents (DESs) to facilitate stent healing. We studied whether, in patients undergoing primary coronary interventions (pPCIs), a strategy of DCB after bare-metal stent improves early healing as determined by optical coherence tomography (OCT) compared with new-generation DES. METHODS: pPCI patients were randomized (1:1) to treatment with new-generation sirolimus-eluting stents (DES group) or DCB-strategy. Vessel healing was assessed by OCT at 90 days. RESULTS: Fifty-three patients were randomized (26 DES vs. 27 DCB). At 90 days, both strategies showed a low rate of uncovered struts (3.2 vs. 3.2%, P = 0.64) and a very high and similar rate of covered and apposed struts (96.6 vs. 96.1%, respectively; P = 0.58). However, DCB group had a significantly lower rate of major coronary evaginations (68 vs. 37%, P = 0.026), and more frequently developed a thin homogeneous neointimal layer (20 vs. 70.4%, P = 0.001) suggesting distinct superior healing at 3 months compared to DES. CONCLUSIONS: In pPCI both, sirolimus-DES and DCB-strategy, provide excellent strut coverage at 3 months. However, DCB ensures more advanced and optimal stent healing compared to sirolimus-DES. Further research is needed to determine whether, in patients undergoing pPCI, DCB offers superior long-term clinical and angiographic outcomes than new-generation DES (NCT03610347).


Asunto(s)
Stents Liberadores de Fármacos/normas , Infarto del Miocardio con Elevación del ST/fisiopatología , Anciano , Vasos Coronarios/diagnóstico por imagen , Stents Liberadores de Fármacos/estadística & datos numéricos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/métodos , Intervención Coronaria Percutánea/estadística & datos numéricos , Infarto del Miocardio con Elevación del ST/complicaciones , Sirolimus/farmacología , Sirolimus/uso terapéutico , Tomografía de Coherencia Óptica/métodos , Tomografía de Coherencia Óptica/estadística & datos numéricos , Resultado del Tratamiento
7.
Cardiovasc Revasc Med ; 29: 22-28, 2021 08.
Artículo en Inglés | MEDLINE | ID: mdl-32859538

RESUMEN

BACKGROUND/PURPOSE: The main indication of covered stents (CS) is coronary artery perforation (CAP), but, they have been increasingly used in other scenarios. Data on the long-term follow-up of CS is limited, and no studies have been conducted specifically using new-generation polyurethane-covered cobalt-chromium Papyrus CS. PURPOSE: to evaluate the clinical outcomes after hospital discharge of Papyrus CS and to compare their outcome after implantation in CAP or coronary artery aneurysms (CAA). METHODS/MATERIALS: We evaluated the baseline clinical characteristics, lesion subsets, procedural features and the outcomes after initial discharge of Papyrus CS implanted in 17 high-PCI-volume centers. RESULTS: 127 Papyrus CS were implanted in 108 patients (68 ±â€¯1 years; 82.8% male) admitted for stable coronary disease (32.3%), NSTEMI (42.4%) or STEMI (25.3%). The number of CS per patient was 1.2 ±â€¯0.6 (diameter: 3.5 ±â€¯1.7 mm; length: 18.5 ±â€¯3.7 mm). Angiographic success rate was 96%. CS diameter was larger in CAA (CAP:3.04 ±â€¯0.5 mm vs CAA:4.1 ±â€¯2.7 mm; p = .022). Intracoronary imaging techniques were used more frequently in CAA (p < .0001). After a mean follow-up of 22 ±â€¯16 months, the major cardiovascular adverse events (MACE) rate was 7.1% [cardiac death: 2%, Myocardial infarction: 5%, Target Lesion Revascularization: 5% and Stent Thrombosis (ST): 3%]. MACE rate was similar in CAP (7.7%) and CAA (7.1%) (p = .9). However, CAA showed a higher ST rate (CAP: 0% vs CA: 7.1%; p = .04). CONCLUSION: After hospital discharge, clinical outcomes after Papyrus CS implantation are acceptable (considering the clinical scenario and compared with other treatment alternatives) with no significant differences in the MACE rate between those implanted in CAA or in CAP. However, CAA group showed a higher ST rate.


Asunto(s)
Intervención Coronaria Percutánea , Poliuretanos , Cromo , Cobalto , Vasos Coronarios/diagnóstico por imagen , Vasos Coronarios/cirugía , Femenino , Humanos , Masculino , Intervención Coronaria Percutánea/efectos adversos , Diseño de Prótesis , Sistema de Registros , Estudios Retrospectivos , Factores de Riesgo , España/epidemiología , Stents , Resultado del Tratamiento
8.
Coron Artery Dis ; 32(2): 96-104, 2021 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-32558692

RESUMEN

BACKGROUND: Currently drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR). However, the efficacy of bioresorbable vascular scaffolds (BVS) after scoring balloon (SCB) predilation in these patients is unknown. METHODS: RIBS VI (NCT02672878) and RIBS VI 'Scoring' (NCT03069066) are prospective multicentre studies assessing the value of BVS in patients with ISR. Inclusion and exclusion criteria were identical in both studies. Results of conventional BVS implantation (112 patients) were compared with those obtained with systematic SCB therapy before BVS (108 patients). Angiographic follow-up was scheduled for all patients. RESULTS: On late angiography (93% of eligible patients) the in-segment minimal lumen diameter (primary end-point) (1.88 ± 0.5 vs. 1.90 ± 0.4 mm, P = 0.81), % diameter stenosis (28 ± 17 vs. 29 ± 15%), late lumen loss (0.23 ± 0.4 vs. 0.22 ± 0.4 mm) and binary restenosis rate (8.5 vs. 9.3%) were similar in the conventional BVS and SCB + BVS groups, respectively. At 1-year follow-up (100% of patients) target lesion revascularization (TLR) requirement (9.8 vs. 11.1%) was similar with the two strategies. Freedom from cardiac death, myocardial infarction and TLR was 88% and 87%, respectively. Results remained unchanged after adjusting for potential baseline confounders and were consistent in 10 prespecified subgroups. CONCLUSION: This study suggests that results of conventional BVS implantation in patients with ISR are not improved by systematic predilation with SCB. ClinicalTrials.gov ID: NCT02672878 (RIBS VI) and NCT03069066 (RIBS VI 'Scoring').


Asunto(s)
Implantes Absorbibles , Angioplastia Coronaria con Balón , Implantación de Prótesis Vascular , Reestenosis Coronaria/terapia , Anciano , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Femenino , Humanos , Masculino , Estudios Prospectivos , España , Stents , Andamios del Tejido
9.
J Am Coll Cardiol ; 76(20): 2321-2330, 2020 11 17.
Artículo en Inglés | MEDLINE | ID: mdl-33183506

RESUMEN

BACKGROUND: The fear of contagion during the coronavirus disease-2019 (COVID-19) pandemic may have potentially refrained patients with ST-segment elevation myocardial infarction (STEMI) from accessing the emergency system, with subsequent impact on mortality. OBJECTIVES: The ISACS-STEMI COVID-19 registry aims to estimate the true impact of the COVID-19 pandemic on the treatment and outcome of patients with STEMI treated by primary percutaneous coronary intervention (PPCI), with identification of "at-risk" patient cohorts for failure to present or delays to treatment. METHODS: This retrospective registry was performed in European high-volume PPCI centers and assessed patients with STEMI treated with PPPCI in March/April 2019 and 2020. Main outcomes are the incidences of PPCI, delayed treatment, and in-hospital mortality. RESULTS: A total of 6,609 patients underwent PPCI in 77 centers, located in 18 countries. In 2020, during the pandemic, there was a significant reduction in PPCI as compared with 2019 (incidence rate ratio: 0.811; 95% confidence interval: 0.78 to 0.84; p < 0.0001). The heterogeneity among centers was not related to the incidence of death due to COVID-19. A significant interaction was observed for patients with arterial hypertension, who were less frequently admitted in 2020 than in 2019. Furthermore, the pandemic was associated with a significant increase in door-to-balloon and total ischemia times, which may have contributed to the higher mortality during the pandemic. CONCLUSIONS: The COVID-19 pandemic had significant impact on the treatment of patients with STEMI, with a 19% reduction in PPCI procedures, especially among patients suffering from hypertension, and a longer delay to treatment, which may have contributed to the increased mortality during the pandemic. (Primary Angioplasty for STEMI During COVID-19 Pandemic [ISACS-STEMI COVID-19] Registry; NCT04412655).


Asunto(s)
Infecciones por Coronavirus , Pandemias , Intervención Coronaria Percutánea/estadística & datos numéricos , Neumonía Viral , Sistema de Registros , Infarto del Miocardio con Elevación del ST/mortalidad , Anciano , COVID-19 , Europa (Continente)/epidemiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Infarto del Miocardio con Elevación del ST/terapia
10.
Hypertension ; 76(4): 1240-1246, 2020 10.
Artículo en Inglés | MEDLINE | ID: mdl-32829660

RESUMEN

Despite the use of renal denervation to treat hypertension, the anatomy of the renal nervous system remains poorly understood. We performed a detailed quantitative analysis of the human renal nervous system anatomy with the goal of optimizing renal denervation procedural safety and efficacy. Sixty kidneys from 30 human cadavers were systematically microdissected to quantify anatomic variations in renal nerve patterns. Contrary to current clinical perception, not all renal innervation followed the main renal artery. A significant portion of the renal nerves (late arriving nerves) frequently reached the kidney (73% of the right kidney and 53% of the left kidney) bypassing the main renal artery. The ratio of the main renal artery length/aorta-renal hilar distance proved to be a useful variable to identify the presence/absence of these late arriving nerves (odds ratio, 0.001 (95% CI, 0.00002-0.0692; P: 0.001) with a cutoff of 0.75 (sensitivity: 0.68, specificity: 0.83, area under ROC curve at threshold: 0.76). When present, polar arteries were also highly associated with the presence of late arriving nerve. Finally, the perivascular space around the proximal main renal artery was frequently occupied by fused ganglia from the solar plexus (right kidney: 53%, left kidney: 83%) and/or by the lumbar sympathetic chain (right kidney: 63%, left kidney: 60%). Both carried innervation to the kidneys but importantly also to other abdominal and pelvic organs, which can be accidentally denervated if the proximal renal artery is targeted for ablation. These novel anatomic insights may help guide future procedural treatment recommendations to increase the likelihood of safely reaching and destroying targeted nerves during renal denervation procedures.


Asunto(s)
Desnervación/métodos , Hipertensión/cirugía , Riñón/inervación , Arteria Renal/anatomía & histología , Simpatectomía/métodos , Cadáver , Humanos , Riñón/anatomía & histología , Microdisección , Arteria Renal/cirugía
11.
Heart ; 2020 Aug 25.
Artículo en Inglés | MEDLINE | ID: mdl-32843495

RESUMEN

OBJECTIVE: The aim of this work is to assess the relationship between significant paravalvular leak (SPL) after transcatheter aortic valve implantation (TAVI) on anaemia and their impact on prognosis. METHODS: Observational analytic study developed at two university hospitals, including all consecutive patients who underwent TAVI during a 10-year period (2009 to 2018). A logistic regression model was created to determine independent predictors of anaemia at 3 months. Time to event outcomes were analysed with Cox regression. Median follow-up was 21.3±21.9 months. RESULTS: 788 patients were included. 5.3% had SPL. SPL was an independent predictor of anaemia 3 months after TAVI (OR: 8.31, 95% CI: 2.06 to 33.50). SPL and anaemia at 3 months were independently associated with long-term mortality (HR: 1.82, 95% CI: 1.16 to 2.85; HR: 2.07, 95% CI: 1.39 to 3.08). CONCLUSION: SPL is an independent predictor of anaemia at 3 months after TAVI, a condition that doubles long-term mortality. Our findings could explain in part the worse prognosis of SPL after TAVI. Further pathophysiological studies are necessary to explain this association.

13.
Clin Anat ; 32(2): 272-276, 2019 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-30300460

RESUMEN

To examine the origin and development of the renal plexus and its relationship to the renal vessels in embryos and early human fetuses. Serial sections of 34 human embryos (stages 16 to 23 of Carnegie, 4 or 5-8 weeks) and 38 fetuses (9-19 weeks) were analyzed. Throughout the embryonic period, the kidney was not innervated by the renal plexus. Those nerves appeared at the beginning of the early fetal period (9 weeks) as branches given off by the immature autonomic abdominal plexus. The renal nerves started to approach to the kidney during the early fetal period at 9-10 weeks of development. They were distributed in close proximity to the renal arteries and their branches. They were observed first with the settlement of the renal veins. The renal artery is present as a branch of the abdominal aorta at stage 19 (between 6 and 7 weeks) prior to development of the renal plexus. The renal veins were not present during the embryonic period but appeared at the start of the fetal period, along with the renal nerves that emerged from segmented sympathetic para-aortic bodies (SPBs). Clin. Anat. 32:272-276, 2019. © 2018 Wiley Periodicals, Inc.


Asunto(s)
Desarrollo Fetal/fisiología , Riñón/embriología , Riñón/inervación , Arteria Renal/embriología , Ganglios/anatomía & histología , Ganglios/fisiología , Edad Gestacional , Humanos
14.
JACC Cardiovasc Interv ; 11(10): 981-991, 2018 05 28.
Artículo en Inglés | MEDLINE | ID: mdl-29798776

RESUMEN

OBJECTIVES: 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). BACKGROUND: Treatment of patients with DES-ISR remains a challenge. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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).


Asunto(s)
Angioplastia Coronaria con Balón/instrumentación , Catéteres Cardíacos , Fármacos Cardiovasculares/administración & dosificación , Materiales Biocompatibles Revestidos , Enfermedad de la Arteria Coronaria/terapia , Reestenosis Coronaria/terapia , Stents Liberadores de Fármacos , Everolimus/administración & dosificación , Intervención Coronaria Percutánea/instrumentación , Anciano , Angioplastia Coronaria con Balón/efectos adversos , Fármacos Cardiovasculares/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Everolimus/efectos adversos , Femenino , Humanos , Masculino , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Estudios Prospectivos , Retratamiento , Factores de Riesgo , España , Factores de Tiempo , Resultado del Tratamiento
17.
JACC Cardiovasc Interv ; 10(18): 1841-1851, 2017 09 25.
Artículo en Inglés | MEDLINE | ID: mdl-28866036

RESUMEN

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 < 0.001). Likewise, target lesion revascularization rates after BVS were similar to those seen with DEB (10.4%) but higher than with EES (3.2%; p < 0.001). Results remained unchanged after adjusting for potential confounders in baseline characteristics. 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).


Asunto(s)
Implantes Absorbibles , Reestenosis Coronaria/terapia , Intervención Coronaria Percutánea/instrumentación , Stents , Anciano , Angiografía Coronaria , Reestenosis Coronaria/diagnóstico por imagen , Reestenosis Coronaria/etiología , Quimioterapia Combinada , Stents Liberadores de Fármacos , Femenino , Humanos , Masculino , Metales , Persona de Mediana Edad , Intervención Coronaria Percutánea/efectos adversos , Inhibidores de Agregación Plaquetaria/administración & dosificación , Estudios Prospectivos , Diseño de Prótesis , Factores de Riesgo , España , Factores de Tiempo , Resultado del Tratamiento
19.
J Radiol Prot ; 37(2): 450-458, 2017 Jun 26.
Artículo en Inglés | MEDLINE | ID: mdl-28586317

RESUMEN

OBJECTIVES: The aim of this study was to analyze the operator radiation exposure (ORE) and the image quality in a coronary angiography (CA) of the standard left lateral view (LLV) and compare it with an alternative right lateral view (RLV). BACKGROUND: Interventional cardiologists are exposed to high doses of scatter radiation, especially in angulated projections. METHODS: We prospectively included consecutive patients who underwent diagnostic CA. A standard +90° LLV and an alternative RLV (-90°) were done in each patient with the same protocol. The operator effective dose rate (mSv/h) was determined for each projection with digital dosimeters located in the collar, waist and knee. The image quality of both the LLV and RLV was analyzed and compared to a standard projection. RESULTS: 116 patients were enrolled; left coronary artery (LCA) was assessed in 52 patients and right coronary artery (RCA) in 64 patients. The ORE was significantly lower with the RLV compared to the conventional LLV with a maximum ORE reduction of 91.5% in the operator waist (LLV: 6.84 mSv h-1 versus RLV: 0.58 mSv h-1, p < 0.001). No significant differences in image quality were observed for the RCA in both projections. For the LCA, a slight loss of quality was observed with the RLV. CONCLUSIONS: -90° RLV is associated with a significant decrease in ORE compared to the conventional +90° LLV without losing image resolution for the RCA and resulting in a slight quality loss for the LCA evaluation. The RLV should be the first choice for RCA evaluation. For the LCA, the RLV loss of resolution should be balanced with the benefit of minimizing ORE, mainly in cases with long fluoroscopy times, such as complex percutaneous coronary interventional procedures.


Asunto(s)
Angiografía Coronaria/métodos , Antebrazo/efectos de la radiación , Exposición Profesional/análisis , Exposición Profesional/prevención & control , Exposición a la Radiación/análisis , Exposición a la Radiación/prevención & control , Radiografía Intervencional/métodos , Anciano , Femenino , Humanos , Masculino , Estudios Prospectivos , Dosis de Radiación , Protección Radiológica/métodos , Radiometría/métodos , Dispersión de Radiación
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