RESUMEN
BACKGROUND: Research on the resorbable magnesium scaffolds (RMSs) has shown their safety and effectiveness in stable clinical conditions. It seems that this new therapeutic option could be promising for selected acute coronary syndrome (ACS) patients. AIMS: Our analysis aims to analyse the long-term performance of RMSs among ACS patients. METHODS: The study population consisted of consecutive ACS patients treated with the implantation of at least one RMS. The Magmaris ACS Registry was designed as a single-arm observational registry in the 'real-world' treatment practice setting. RESULTS: The study population consisted of 193 patients, predominantly male (78%), at a mean (SD) age of 64 (9) years and with the typical risk factors of ACS. Unstable angina (UA) was the indication for revascularisation in 32.1%, non-ST-segment myocardial infarction (NSTEMI) in 65.8% and ST-segment elevation myocardial infarction (STEMI) only in 2.1%. During the mean 24 months of follow-up, ten cases (5.2%) of target lesion failure (TLF) were diagnosed, of which five cases (2.6%) were clinically driven target lesion failure (CD-TLR), four cases (2.1%) of asymptomatic scaffold restenosis and one case (0.5%) of target vessel myocardial infarction (TV-MI). No cardiac deaths and 2 non-cardiac deaths (2.2%, both fatal strokes) were observed. No cases of scaffold thrombosis were observed during the median 24-month follow-up. CONCLUSIONS: The use of the RMSs in selected ACS patients is associated with procedural safety and promising early and long-term clinical efficacy and safety outcomes. Proper lesion selection is key to the long-term success of bioresorbable technology in this patient population.
Asunto(s)
Síndrome Coronario Agudo , Intervención Coronaria Percutánea , Infarto del Miocardio con Elevación del ST , Implantes Absorbibles , Síndrome Coronario Agudo/cirugía , Estudios de Seguimiento , Humanos , Magnesio , Masculino , Persona de Mediana Edad , Resultado del TratamientoRESUMEN
In this paper we are reporting an unexpected evolution after multiple Resorbable Magnesium Scaffolds (RMS) implantations in overlap.
Asunto(s)
Enfermedad de la Arteria Coronaria , Magnesio , Tomografía de Coherencia Óptica , Implantes Absorbibles , Angiografía Coronaria , Estudios de Seguimiento , Humanos , Diseño de Prótesis , Andamios del Tejido , Resultado del TratamientoRESUMEN
BACKGROUND: The resorbable magnesium scaffold (RMS) has demonstrated a good safety profile to treat de novo lesions. Nevertheless, bifurcation lesions involving a side branch (SB) >2.0 mm in diameter were excluded from these studies, and such lesions remain technically challenging due to concerns of scaffold deformation or fracture. We sought to evaluate different SB dilation strategies after provisional T-stenting strategy with RMS using silicon bifurcation phantoms. METHODS AND RESULTS: Three different strategies were compared: proximal optimization technique (POT)-side-rePOT (rePOT), kissing-balloon inflation (KBI), and mini kissing-balloon inflation (MKBI) strategies. Strut and connector fractures were evaluated by micro computed tomography and apposition by optical coherence tomography (OCT). Twelve Magmaris scaffolds (Biotronik) were successfully implanted (4 in each group). There was no difference in strut and connector fractures among the three techniques, as no fracture was visualized. OCT demonstrated that MKBI significantly decreased global malapposition following SB inflation as compared with rePOT or KBI strategies (95.3% vs 88.3% of perfectly apposed struts [P<.001] and 93.6% [P<.01], respectively, for MKBI vs rePOT and KBI). After step-by-step over-expansion of 6 RMS devices with 3.75 mm, 4.0 mm, and 4.5 mm NC balloons at 16 atm (ie, +1.5 mm from the initial 3.0 mm RMS), no strut or connector fracture could be visualized. CONCLUSION: Provisional single-stent technique with the Magmaris RMS on a bifurcation lesion is technically feasible with these three different strategies without scaffold fracture. MKBI strategy resulted in better apposition rates as compared with KBI or rePOT strategies. Nevertheless, Magmaris use in bifurcation lesions should not be advised before similar results are confirmed by in vivo studies.