Magnesium-based resorbable scaffold vs permanent metallic sirolimus-eluting stent in patients with ST-segment elevation myocardial infarction: 3-year results of the MAGSTEMI randomised controlled trial.

BACKGROUND: The long-term safety and performance of magnesium-based bioresorbable scaffolds (MgBRS) in ST-segment-elevation myocardial infarction (STEMI) patients are uncertain. AIMS: The aim of this study was to report the 3-year clinical outcomes of the MAGSTEMI trial. METHODS: This investigator-driven, multicentre, randomised, single-blind, controlled trial randomised STEMI patients 1:1 to MgBRS or to permanent metallic sirolimus-eluting stents (SES) at 11 academic centres. The main secondary endpoints included device-oriented composite endpoints (DoCE) and patient-oriented composite endpoints (PoCE), their individual components, any bleeding, and device thrombosis rate. All endpoints were defined according to the Academic Research Consortium. Events were adjudicated by an independent committee. RESULTS: Three-year clinical follow-up was obtained in 142 (90.0%) patients. At 3-year follow-up, MgBRS were associated with a higher rate of DoCE than SES (13 [17.6%] vs 5 [6.6%], diff -11.0 [95% CI: -21.3 to -0.7]; p=0.038). This difference was driven by an increased incidence of DoCE within the first year of follow-up. In the landmark analysis, there was no difference between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). The difference in the rate of DoCE was driven by a higher incidence of target lesion revascularisation (TLR) in the MgBRS group compared to SES (12 [16.2%] vs 4 [5.3%]; diff -10.9% [95% CI: -20.7 to -1.2]; p=0.030). The difference in TLR was observed during the first year, with no further differences observed between 1 and 3 years (0 [0.0%] vs 1 [1.4%]; p=1.000). CONCLUSIONS: At 3-year follow-up, MgBRS were associated with a higher rate of TLR, which was clustered within the first year, compared to SES.

The Real-World CONSEQUENT ALL COMERS Study: Predictors for Target Lesion Revascularization and Mortality in an Unselected Patient Population.

We evaluated the safety and efficacy of a resveratrol-paclitaxel-coated peripheral balloon catheter in an all-comer patient cohort undergoing endovascular treatment of above-the-knee and below-the-knee peripheral artery disease. CONSEQUENT ALL COMERS (Clinical Post-Market Clinical Follow-up [PMCF] on Peripheral Arteries treated with SeQuent Please OTW [Over-the Wire]) is a prospective, single-arm, multicenter observational study (ClinicalTrials Identifier: NCT02460042). The primary end point was the 12-month target lesion revascularization (TLR) rate. Secondary end points included vessel patency, target vessel revascularization, and all-cause mortality. A total of 879 lesions in 784 consecutive patients (71.3 ± 10.4 years old, 57.7% male) were analyzed; 53.3% had claudication, whereas the remaining 46.7% exhibited critical limb ischemia (CLI). Substantial comorbidities were present, including diabetes mellitus (41.2%), smoking (66.1%), and coronary artery disease (33.9%). Lesion length (879 lesions) was 12.0 ± 9.3 cm and 31.8% were Transatlantic Inter-Society Consensus II C/D lesions. The overall technical success rate of the 1269 drug-coated balloon (DCB)'s used was 99.6% (1.60 ± 0.79 DCB's/patient). At 12 months, the TLR rates were 6.3% in patients with CLI and 9.6% in claudicants, with a primary patency rate of 89.9% and 87.1%, respectively. All-cause mortality was 4.3% (28/658). The most important predictors for TLR were female gender, in-stent restenosis at baseline and lesion length.

Clinical Outcomes After Implantation of Polyurethane-Covered Cobalt-Chromium Stents: Insights from the Papyrus-Spain Registry.

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.

Bioresorbable scaffolds versus permanent sirolimus-eluting stents in patients with ST-segment elevation myocardial infarction: vascular healing outcomes from the MAGSTEMI trial.

AIMS: The MAGSTEMI trial showed larger endothelium-independent vasodilatation with magnesium-based bioresorbable scaffolds (MgBRS) than with sirolimus-eluting stents (SES). However, restenosis was more frequent with MgBRS. The aims of this study were to compare the healing pattern between MgBRS and SES and to describe the main causes of restenosis, as assessed by optical coherence tomography (OCT). METHODS AND RESULTS: Ninety-five consecutive patients from the randomised MAGSTEMI trial (MgBRS=48, SES=47) underwent OCT imaging at one year. Healing and bioresorption pattern were categorised into four groups: 1) indiscernible struts were observed in 33.3% versus 0% of patients (p<0.001); 2) struts integrated into the vessel wall in 22.9% versus 63.8% (p<0.001); 3) protruding struts in 37.5% versus 31.9% (p=0.568); and 4) protruding and malapposed struts in 6.3% versus 4.3% (p=0.663), respectively. MgBRS were not suitable for strut coverage analysis; SES presented with 5.6% uncovered struts. Scaffold discontinuities were observed in 10.4% and 0%, respectively (p=0.023). MgBRS presented smaller minimal lumen area (3.92±2.02 vs 6.31±1.71 mm²; p<0.001) and larger area stenosis (52.84±18.05 vs 25.02±14.58%; p<0.001). Scaffold measurements were only feasible in 50% of MgBRS, with the expansion index being smaller than in SES (0.58±0.16 vs 0.86±0.19; p<0.001). Scaffold collapse was observed in at least 50% of cases with MgBRS restenosis. CONCLUSIONS: Both MgBRS and SES exhibited a low degree of neointima healing, but lumen dimensions were smaller with MgBRS at one year. Although the advanced bioresorption state of MgBRS hampers the assessment of scaffold collapse, this seems to be the main mechanism of restenosis. Future generations of MgBRS should increase and prolong the radial force. CLINICAL TRIAL REGISTRATION: NCT03234348

Magnesium-Based Resorbable Scaffold Versus Permanent Metallic Sirolimus-Eluting Stent in Patients With ST-Segment Elevation Myocardial Infarction: The MAGSTEMI Randomized Clinical Trial.

BACKGROUND: The use of poly-l-lactide acid-based bioresorbable scaffolds is limited in daily clinical practice because of safety concerns and lack of physiological benefit. Magnesium-based bioresorbable scaffold (MgBRS) presents a short resorption period (<1 year) and have the potential of being thromboresistant and exhibiting early restoration of vasomotor function. To date, however, no randomized clinical trial has investigated the performance of MgBRS. Therefore, this study aimed to compare the in-stent/scaffold vasomotion between MgBRS and permanent metallic sirolimus-eluting stent (SES) at 12-month follow-up in ST-segment-elevation myocardial infarction patients. METHODS: This investigator-driven, multicenter, randomized, single-blind, controlled trial randomized ST-segment-elevation myocardial infarction patients 1:1 to SES or MgBRS at 11 academic centers. The primary end point was the rate of increase (≥3%) after nitroglycerin in mean lumen diameter of the in-stent/scaffold segment at 12 months with superiority of MgBRS over SES in the as-treated population. The main secondary end points included angiographic parameters of restenosis, device-oriented composite end point, their individual components, and device thrombosis rate. Besides, endothelial-dependent vasomotor response to acetylcholine (ie, endothelial function) was also assessed in a subgroup of patients (n=69). RESULTS: Between June 2017 and June 2018, 150 ST-segment-elevation myocardial infarction patients were randomized (MgBRS, n=74; SES, n=76). At 1 year, the primary end point was significantly higher in the MgBRS arm (56.5% versus 33.8%; P=0.010). Conversely, late lumen loss was significantly lower in the SES group (in-segment: 0.39±0.49mm versus 0.02±0.27mm, P<0.001; in-device: 0.61±0.55mm versus 0.06±0.21mm; P<0.001). The device-oriented composite end point was higher in the MgBRS arm driven by an increase in ischemia-driven target lesion revascularization rate (12[16.2%] versus 4[5.2%], P=0.030). Definite thrombosis rate was similar between groups (1[1.4%] in the MgBRS arm versus 2[2.6%] in the SES group; P=1.0). Endothelial function assessment at device segment evidenced a more pronounced vasoconstrictive response to maximal dose of acetylcholine in the MgBRS arm (-8.3±3.5% versus -2.4±1.3% in the SES group, P=0.003). CONCLUSIONS: When compared to SES, MgBRS demonstrated a higher capacity of vasomotor response to pharmacological agents (either endothelium-independent or endothelium-dependent) at 1 year. However, MgBRS was associated with a lower angiographic efficacy, a higher rate of target lesion revascularization, without thrombotic safety concerns. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT03234348.

MAGnesium-based bioresorbable scaffold and vasomotor function in patients with acute ST segment elevation myocardial infarction: The MAGSTEMI trial: Rationale and design.

AIM: Use of a Bioresorbable Scaffolds (BRS) either in clinical practice or in the setting of an acute myocardial infarction (MI) is controversial. Despite an overall high rate of thrombosis, vascular healing response following BRS implantation tend to superiority as compared to metallic drug-eluting stent in ST-segment elevation myocardial infarction (STEMI) patients. We sought to compare the in-stent/scaffold vasomotion between metallic BRS and sirolimus eluting stent (SES) at 12-month angiographic follow-up in the setting of patients with STEMI treated by primary PCI. STUDY DESIGN: This is an investigator-driven, prospective, multicenter, randomized, single blind, two-arm, controlled trial (ClinicalTrials.gov number: NCT03234348). This trial will randomize ~148 patients 1:1 to SES or BRS. Primary end-point is the in-stent/scaffold change in mean lumen diameter after nitroglycerin administration at 12-month angiographic follow-up. Besides, patient-oriented combined endpoint of all-cause death, any MI, and any revascularization, together with scaffold/stent thrombosis rate and device-oriented endpoint of cardiac death, target vessel (TV)-MI and TVR at 1 year will be also evaluated. Clinical follow-up will be scheduled yearly up to 5 years. CONCLUSION: This trial will shed light on the vascular vasomotion following BRS implantation in the complex scenario of STEMI.

TIOMAX: A Spanish Multicenter Registry of the real-world use of the TItanium OptiMAX® biostent: TIOMAX: Registro Español Multicéntrico Del Biostent De Titanio OptiMAX® En La Vida Real.

OBJECTIVES: To compare the safety and efficacy of the new cobalt-chromium bioactive stent Titan Optimax® (Hexacath, France) with its predecessor, Titan-2® . BACKGROUND: The TIOMAX registry includes 784 patients who underwent percutaneous coronary intervention with these stents in 21 Spanish hospitals. METHODS: Analysis of all patients in the registry without exclusion criteria, candidates for revascularization (March-2013/July-2014). Initially 273 patients received Titan-2® , and the next 511 received the Optimax® after its launch. RESULTS: Mean age was 65.8 ± 13.0 (78.1% men); 49.2% were STEACS patients (n = 322), 29.8% NSTEACS, and 27.3% had stable angina or silent ischemia. Most STEACS patients (76.4% of n = 322) were treated <24 hr after developing symptoms. All-cause death (D), cardiac death (CD), acute myocardial infarction (AMI), and stent thrombosis (ST) at 1 month were 1.1, 0.8, 0.1, and 0.5%, respectively, with no significant differences between groups. At 1 year, the death rate was 5.5% for Titan-2 vs. 4.1% for Optimax® , CD was 1.8% for both groups, ST 1.1 vs. 0.6%, new AMI 3.3 vs. 2.5% and target lesion revascularization (TLR) 3.7 vs. 2.9%. The primary endpoint of the composite event (CE) of D/AMI/TLR/ST occurred in 10.3% vs. 7.6% (p = 0.211). Patients with STEACS (N = 322: Titan-2/Optimax: 103/209) had better outcomes for secondary events, device-oriented failure CD/AMI/TLR (7.8% vs. 5.0%; p = 0.330), and non-fatal CE of AMI/ST/TLR (7.8% vs. 2.7%, p = 0.039). CONCLUSIONS: The Titan Optimax retains the efficacy and safety of Titan 2. It appears to perform better in the subgroup of STEACS patients, by reducing the non-fatal CE of AMI/ST/TLR.

Sistema de puntuación para el enfoque diagnóstico y terapéutico de la disección coronaria espontánea. Respuesta / Score system approach to diagnose and manage spontaneous coronary artery dissection. Response

No disponible

Disección coronaria espontánea multivaso en el puerperio / Postpartum multivessel spontaneous coronary artery dissection

No disponible

Enfermedad arterial periférica: eficacia del método oscilométrico / Peripheral arterial disease: efficacy of the oscillometric method

La seguridad para determinar el índice tobillo-brazo con método Doppler o con un aparato automático convencional de medir la presión arterial no está bien establecida cuando realizan la determinación médicos con poca experiencia. Para evaluar la eficacia diagnóstica de cada método en este grupo profesional, calculamos mediante angiografía la sensibilidad, la especificidad y los valores predictivos positivo y negativo en 158 piernas de 85 pacientes con síntomas de claudicación intermitente. Del total de piernas analizadas, 131 (83%) presentaron obstrucción significativa. El método oscilométrico mostró sensibilidad del 97%, especificidad del 89%, valor predictivo positivo del 98% y valor predictivo negativo del 86%. El método Doppler mostró sensibilidad del 95%, especificidad del 56%, valor predictivo positivo del 91% y valor predictivo negativo del 68%. Los resultados indican que el equipo automático de presión arterial tiene mejor rentabilidad diagnóstica cuando realizan la prueba médicos no especialmente entrenados en el manejo de la sonda Doppler (AU)

Relatively little is known on how the Doppler method compares with oscillometric measurement using a conventional automatic blood pressure device to determine the ankle-brachial index, when determinations are performed by physicians with little experience. To assess the diagnostic efficacy of both methods in this professional group, we calculated their sensitivity, specificity, and positive and negative predictive value in 158 legs of 85 patients with symptoms of intermittent claudication. Angiography was used as the gold standard. Of the legs examined, 131 showed significant arterial obstruction. The oscillometric method showed 97% sensitivity, 89% specificity, 98% positive predictive value, and 86% negative predictive value. The Doppler method showed 95% sensitivity, 56% specificity, 91% positive predictive value, and 68% negative predictive value. This study suggests that the automatic blood pressure equipment has greater diagnostic accuracy when the test is performed by physicians not specifically trained to use the Doppler probe (AU)

[Peripheral arterial disease: efficacy of the oscillometric method]. / Enfermedad arterial periférica: eficacia del método oscilométrico.

Relatively little is known on how the Doppler method compares with oscillometric measurement using a conventional automatic blood pressure device to determine the ankle-brachial index, when determinations are performed by physicians with little experience. To assess the diagnostic efficacy of both methods in this professional group, we calculated their sensitivity, specificity, and positive and negative predictive value in 158 legs of 85 patients with symptoms of intermittent claudication. Angiography was used as the gold standard. Of the legs examined, 131 showed significant arterial obstruction. The oscillometric method showed 97% sensitivity, 89% specificity, 98% positive predictive value, and 86% negative predictive value. The Doppler method showed 95% sensitivity, 56% specificity, 91% positive predictive value, and 68% negative predictive value. This study suggests that the automatic blood pressure equipment has greater diagnostic accuracy when the test is performed by physicians not specifically trained to use the Doppler probe. Full English text available from: www.revespcardiol.org.

[Right versus left radial artery approach for coronary angiography. Differences observed and the learning curve]. / Vía radial derecha o izquierda en la coronariografía. Importancia en la curva de aprendizaje.

There are anatomical differences between right and left radial artery approaches for coronary catheterization that could influence application of the technique. We present the results of a randomized study that compared the effectiveness of the two approaches and identified factors associated with failure of the procedure. The study involved 351 consecutive patients: a left radial approach was used in 180, and a right radial approach, in 171. The procedure could not be completed using the initial approach selected in 15 patients (11 right radial vs. 4 left radial; P=.007). Use of a right radial approach, lack of catheterization experience, patient age >70 years, and the absence of hypertension were found to be independently associated with prolonged fluoroscopy duration and failure using the initial approach. Use of the right radial approach in patients aged over 70 years was associated with a 6-fold increase in the risk of an adverse event. Consequently, use of the right radial approach should be avoided in patients aged over 70 years when trainee practitioners are on the learning curve.

Vía radial derecha o izquierda en la coronariografía. Importancia en la curva de aprendizaje / Right versus left radial artery approach for coronary angiography. Differences observed and the learning curve

La vía radial izquierda (RI) presenta diferencias anatómicas con la vía radial derecha (RD) que podrían influir en la técnica del cateterismo coronario. Presentamos un estudio aleatorizado que trata de comparar ambas técnicas para valorar los factores relacionados con su complejidad. Se analizó a 351 pacientes consecutivos (180 RI y 171 RD); no se pudo completar el procedimiento por la vía inicial en 15 pacientes (11 RD y 4 RI; p = 0,007). El uso de RD, la inexperiencia, la edad mayor de 70 años y la ausencia de hipertensión arterial tienen relación independiente con un tiempo prolongado de fluoroscopia o el abandono de la vía inicial. El uso de RD en pacientes mayores de 70 años se relaciona con un riesgo de eventos 6 veces mayor, por lo que en una curva de aprendizaje se debería excluir el uso de RD esos pacientes

There are anatomical differences between right and left radial artery approaches for coronary catheterization that could influence application of the technique. We present the results of a randomized study that compared the effectiveness of the two approaches and identified factors associated with failure of the procedure. The study involved 351 consecutive patients: a left radial approach was used in 180, and a right radial approach, in 171. The procedure could not be completed using the initial approach selected in 15 patients (11 right radial vs. 4 left radial; P=.007). Use of a right radial approach, lack of catheterization experience, patient age >70 years, and the absence of hypertension were found to be independently associated with prolonged fluoroscopy duration and failure using the initial approach. Use of the right radial approach in patients aged over 70 years was associated with a 6-fold increase in the risk of an adverse event. Consequently, use of the right radial approach should be avoided in patients aged over 70 years when trainee practitioners are on the learning curve