RESUMO
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.
Assuntos
Implantes Absorvíveis , Reestenose Coronária , Desenho de Prótese , Humanos , Fatores de Tempo , Masculino , Resultado do Tratamento , Feminino , Estudos Prospectivos , Reestenose Coronária/etiologia , Reestenose Coronária/diagnóstico por imagem , Reestenose Coronária/terapia , Pessoa de Meia-Idade , Idoso , Fatores de Risco , Angioplastia Coronária com Balão/instrumentação , Angioplastia Coronária com Balão/efeitos adversos , Fármacos Cardiovasculares/administração & dosagem , Fármacos Cardiovasculares/efeitos adversos , Stents , Intervenção Coronária Percutânea/instrumentação , Intervenção Coronária Percutânea/efeitos adversos , Doença da Artéria Coronariana/terapia , Doença da Artéria Coronariana/diagnóstico por imagem , Materiais Revestidos Biocompatíveis , Stents Farmacológicos , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
Currently, both drug-eluting stents (DES) and drug-eluting balloons are recommended in patients with in-stent restenosis (ISR) of metallic stents. However, the clinical results of repeated interventions in patients with restenosis of bioresorbable vascular scaffolds (BVS) remain unsettled. We sought to assess the results of interventions in patients with BVS-ISR as compared with those obtained in patients with ISR of DES and bare-metal stents (BMS). Restenosis Intrastent: Treatment of Bioresorbable Vascular Scaffolds Restenosis (RIBS VII) is a prospective multicenter study (23 Spanish sites) that included 117 consecutive patients treated for BVS-ISR. Inclusion/exclusion criteria were similar to those of previous RIBS studies. Patients in the RIBS IV (DES-ISR, nâ¯=â¯309) and RIBS V (BMS - ISR, nâ¯=â¯189) randomized trials, were used as controls. Most patients with BVS-ISR were treated with DES (76%). Patients with BVS-ISR were younger, had larger vessels, and after interventions had higher in-segment residual diameter stenosis (19 ± 13%, 15 ± 11%, 15 ± 12%, p <0.001) than those treated for DES-ISR and BMS-ISR, respectively. At 1-year clinical follow-up (obtained in 100% of patients) target lesion revascularization (6%) was similar to that seen in patients with DES-ISR and BMS-ISR (8.7% and 3.7%, pâ¯=â¯0.32). Freedom from death, myocardial infarction, and target vessel revascularization (primary clinical end point) was 8.5%, also similar to that found in patients with DES-ISR and BMS-ISR (14.2% and 7.4%, pâ¯=â¯0.09). Results were also similar when only patients treated with DES in each group were compared and remained unchanged after adjusting for potential confounders in baseline characteristics. Time to BVS-ISR did not influence angiographic or clinical results. This study demonstrates the safety and efficacy of coronary interventions for patients presenting with BVS-ISR. One-year clinical results in these patients are comparable to those seen in patients with ISR of metallic stents (ClinicalTrials.gov ID:NCT03167424).
Assuntos
Implantes Absorvíveis/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Reestenose Coronária/cirurgia , Oclusão de Enxerto Vascular/cirurgia , Intervenção Coronária Percutânea/efeitos adversos , Stents/efeitos adversos , Idoso , Angiografia Coronária , Doença da Artéria Coronariana/diagnóstico , Doença da Artéria Coronariana/mortalidade , Reestenose Coronária/diagnóstico , Reestenose Coronária/epidemiologia , Feminino , Oclusão de Enxerto Vascular/diagnóstico , Oclusão de Enxerto Vascular/epidemiologia , Humanos , Masculino , Pessoa de Meia-Idade , Intervenção Coronária Percutânea/instrumentação , Estudos Prospectivos , Reoperação , Fatores de Tempo , Resultado do TratamentoRESUMO
An air embolism (AE) is a rare but dreaded complication during endovascular procedures. Current guidance recommends hyperbaric oxygen therapy and aspiration for the management of a venous AE. However, the management of an arterial AE is much less described. We report a case of a 79-year-old man with symptomatic mitral regurgitation who underwent a MitraClip procedure. During the intervention, a massive AE was detected in the ascending aorta on transesophageal echocardiography. The AE was successfully aspirated while the patient remained hemodynamically stable. This report demonstrates the efficacy of an arterial AE's aspiration with a real-time echocardiography recording of the technique.
Une embolie gazeuse (EG) est une complication rare mais redoutée lors des interventions endovasculaires. Les directives actuelles recommandent l'oxygénothérapie hyperbare et l'aspiration pour la prise en charge d'une EG veineuse. Cependant, la prise en charge d'une EG artérielle est beaucoup moins bien décrite. Nous rapportons le cas d'un homme de 79 ans présentant une insuffisance mitrale symptomatique et ayant subi une procédure MitraClip. Au cours de l'intervention, une EG massive a été détectée dans l'aorte ascendante à l'échocardiographie transoesophagienne. L'EG a été aspirée avec succès alors que le patient est resté stable sur le plan hémodynamique. Ce rapport démontre l'efficacité de l'aspiration d'une EG artérielle avec un enregistrement en temps réel de la technique par échocardiographie.