Magnesium Bioresorbable Scaffold (Magmaris, Biotronik) is a device with promising outcomes at 24 months of follow up. Previous studies with first generation, everolimus‐eluting Bioresorbable Vascular ...Scaffold (Absorb, Abbott) showed that very late restenosis seems to be attributed to pure intrascaffold tissue growth but very late. Magmaris very late restenosis has not been previously published, probably because of the 95% of resorption at 12 months. We present in‐scaffold very late restenosis within Magmaris, with Optical Coherence Tomography, highlighting mechanism of degradation and in scaffold “neo‐tissue” growth.
Cyclophilins are chaperone proteins that play important roles in signal transduction. Among them, cyclophilins A, B, C, and D were widely associated with inflammation and cardiovascular diseases. ...Cyclophilins A and C have been proposed as coronary artery disease biomarkers. However, less is known about their relationship with cardiovascular risk factors. Therefore, this study aimed to determine the association between cyclophilin A, B, C, and D and cardiovascular risk factors in coronary artery disease. Serum levels of cyclophilins were measured in 167 subjects (subdivided according to cardiovascular risk factors presence). This study reveals that cyclophilin A and C are elevated in patients regardless of the risk factors presence. Moreover, cyclophilin B is elevated in male patients with hypertension, type 2 diabetes, or high glucose levels. In addition, cyclophilins A, B, and C were significantly correlated with cardiovascular risk factors, but only cyclophilin B was associated with type 2 diabetes. The multivariate analysis strengthens the predictive value for coronary artery disease presence of cyclophilin A (>8.2 ng/mL) and cyclophilin C (>17.5 pg/mL) along with the cardiovascular risk factors tobacco, hypertension, dyslipidemia, and high glucose and cholesterol levels. Moreover, the risk of coronary artery disease is increased in presence of cyclophilin B levels above 63.26 pg/mL and with hypertension or dyslipidemia in male patients. Consequently, cyclophilins A and C serum levels are reinforced as useful coronary artery disease biomarkers, meanwhile, cyclophilin B is a valuable biomarker in the male population when patients are also suffering from hypertension or dyslipidemia.
Background. The resting full‐cycle ratio (RFR) is a novel resting index which in contrast to the gold standard (fractional flow reserve (FFR)) does not require maximum hyperemia induction. The ...objectives of this study were to evaluate the agreement between RFR and FFR with the currently recommended thresholds and to design a hybrid RFR-FFR ischemia detection strategy, allowing a reduction of coronary vasodilator use. Materials and Methods. Patients subjected to invasive physiological study in 9 Spanish centers were prospectively recruited between April 2019 and March 2020. Sensitivity and specificity studies were made to assess diagnostic accuracy between the recommended levels of RFR ≤0.89 and FFR ≤0.80 (primary objective) and to determine the RFR “grey zone” in order to define a hybrid strategy with FFR affording 95% global agreement compared with FFR alone (secondary objective). Results. A total of 380 lesions were evaluated in 311 patients. Significant correlation was observed (R2 = 0.81; P<0.001) between the two techniques, with 79% agreement between RFR ≤ 0.89 and FFR ≤ 0.80 (positive predictive value, 68%, and negative predictive value, 80%). The hybrid RFR-FFR strategy, administering only adenosine in the “grey zone” (RFR: 0.86 to 0.92), exhibited an agreement of over 95% with FFR, with high predictive values (positive predictive value, 91%, and negative predictive value, 92%), reducing the need for vasodilators by 58%. Conclusions. Dichotomous agreement between RFR and FFR with the recommended thresholds is significant but limited. The adoption of a hybrid RFR-FFR strategy affords very high agreement, with minimization of vasodilator use.
ABSTRACT Introduction and objectives: The results of Magmaris implantation in the acute coronary syndrome setting is uncertain and more studies will be needed to assess the long-term safety profile ...of these devices. The objective of this work was to conduct an observational study to analyze the clinical safety profile of Magmaris implanted in a single hospital center in the acute coronary syndrome setting beyond 12 months. Methods: Registry of 36 patients with Magmaris devices implanted between November 2016 through November 2018 with a diagnosis of acute coronary syndrome included consecutively. The primary endpoint was considered the device-oriented composite endpoint of target vessel myocardial infarction, target lesion failure, and cardiac death. Secondary endpoints included Magmaris related thrombosis. Results: Regarding the device-oriented combination, no target vessel myocardial infarction was observed, 0 cases (0%), while target lesion failure was seen in 2 cases (5.6%). There were no cases of Magmaris thrombosis at the follow-up and only 1 case of cardiac death (2.8%) was found 36 months after Magmaris implantation. The cause of death could not be determined since no autopsy was performed. Conclusions: Our results with long-term follow-up confirm that Magmaris has a favorable clinical profile in the acute coronary syndrome complex setting.
The pathophysiology of Takotsubo Syndrome has not yet been precisely defined. Different hypotheses have been proposed, including cardiotoxicity due to catecholaminergic hormone release, metabolic ...disorders, coronary microvascular dysfunction and epicardial coronary artery spasm. Invasive coronary physiology is considered the cornerstone to understand physiological assessment of coronary blood flow in this setting. We have reviewed most important studies in coronary invasive physiology in this field to update the state of the art in TakoTsubo Syndrome.
ABSTRACT Introduction and objectives: Coronary calcification is one of the leading factors that affect negatively the safety and effectiveness of percutaneous coronary intervention. Several calcium ...modification techniques exist. However, there is a lack of randomized evidence on the therapy of choice in this scenario. Methods: The ROLLERCOASTR is a prospective, multicenter, randomized clinical trial designed to compare the safety and efficacy profile of 3 plaque modification techniques in the moderate-to-severe coronary calcification setting: rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL). The study primary endpoint is stent expansion evaluated by optical coherence tomography. An intention-to-treat analysis will be conducted with an alpha coefficient of 0.05 between the reference group (RA) and the remaining 2 groups (ELCA and IVL). An analysis of the study primary endpoint per protocol will be conducted for consistency purposes. If the non-inferiority hypothesis is confirmed, a superiority 2-sided analysis will be conducted. Both the clinical events committee and the independent core laboratory will be blinded to the treatment arm. Assuming an α error of 0.05, an β error of 0.2 (80% power), a margin of irrelevance (ε) of 7, and losses of 10% due to measurement difficulty or impossibility to complete the intervention, we estimate a sample size of 56 cases per group. The study secondary endpoints are device success, procedural success, crossover rate among the different techniques used, and the occurrence of major adverse cardiovascular events at 1-year follow-up. Conclusions: The ROLLERCOASTR trial will evaluate and compare the safety and effectiveness of 3 plaque modification techniques: RA, ELCA, and IVL in patients with calcified coronary stenosis. This trial was registered at clinicaltrials.gov with identifier NCT04181268.
Introduction and objectives: Coronary calcification is one of the leading factors that affect negatively the safety and effectiveness of percutaneous coronary intervention. Several calcium ...modification techniques exist. However, there is a lack of randomized evidence on the therapy of choice in this scenario.
Methods: The ROLLERCOASTR is a prospective, multicenter, randomized clinical trial designed to compare the safety and efficacy profile of 3 plaque modification techniques in the moderate-to-severe coronary calcification setting: rotational atherectomy (RA), excimer laser coronary angioplasty (ELCA), and intravascular lithotripsy (IVL). The study primary endpoint is stent expansion evaluated by optical coherence tomography. An intention-to-treat analysis will be conducted with an alpha coefficient of 0.05 between the reference group (RA) and the remaining 2 groups (ELCA and IVL). An analysis of the study primary endpoint per protocol will be conducted for consistency purposes. If the non-inferiority hypothesis is confirmed, a superiority 2-sided analysis will be conducted. Both the clinical events committee and the independent core laboratory will be blinded to the treatment arm. Assuming an α error of 0.05, an β error of 0.2 (80% power), a margin of irrelevance (ε) of 7, and losses of 10% due to measurement difficulty or impossibility to complete the intervention, we estimate a sample size of 56 cases per group. The study secondary endpoints are device success, procedural success, crossover rate among the different techniques used, and the occurrence of major adverse cardiovascular events at 1-year follow-up.
Conclusions: The ROLLERCOASTR trial will evaluate and compare the safety and effectiveness of 3 plaque modification techniques: RA, ELCA, and IVL in patients with calcified coronary stenosis. This trial was registered at clinicaltrials.gov with identifier NCT04181268.
Introducción y objetivos: La calcificación coronaria es uno de los principales factores que inciden negativamente en la seguridad y la eficacia del intervencionismo coronario percutáneo. Existen varias técnicas de modificación del calcio, pero falta evidencia de estudios aleatorizados sobre la terapia de elección en este escenario.
Métodos: El ROLLERCOASTR es un estudio prospectivo, multicéntrico y aleatorizado, diseñado para comparar la seguridad y la eficacia de 3 técnicas de modificación de la placa en el contexto de calcificación coronaria moderada o grave: aterectomía rotacional (AR), aterectomía coronaria con láser láser excimer (ACLE) y litotricia intracoronaria (LIC). El objetivo primario es la expansión del stent evaluada mediante tomografía de coherencia óptica. Su análisis se hará por intención de tratar, con un α de 0,05 entre el grupo de referencia (AR) y cada uno de los otros grupos (ACLE y LIC). Se realizará también un análisis del objetivo primario por protocolo para mantener la coherencia. Si se confirma la hipótesis de no inferioridad, se realizará un análisis bilateral de superioridad. El comité de eventos clínicos y el laboratorio central independiente no conocerán la rama de tratamiento. Asumiendo un error α de 0,05, un error β de 0,2 (80% de potencia), un margen de irrelevancia (ε) del 7% y un 10% de pérdidas por dificultad de medición o imposibilidad de completar la intervención, se estima un tamaño de muestra de 56 casos en cada grupo. Los objetivos secundarios son el éxito del dispositivo, el éxito del procedimiento, la tasa de cruce entre técnicas y la presentación de eventos cardiovasculares adversos importantes al año de seguimiento.
Conclusiones: El estudio ROLLERCOASTR evaluará y comparará la seguridad y la eficacia, en pacientes con estenosis coronaria calcificada, de 3 técnicas de modificación de placa: AR, ACLE y LIC. Este ensayo se ha registrado en Clinicaltrials.gov: NCT04181268.
HOW WOULD I APPROACH IT? The authors present an interesting and challenging case regarding percutaneous treatment, and with a very complex resolution. This is the case of a patient already surgically ...revascularized with significant ischemia whose revascularization option is through the bypass on which the entire territory of the left circumflex artery depends on. At this point right now of the angioplasty where the stent cannot be crossed despite the use of the buddy-wire technique, and even though the stent was very short and had good navigability, I would try the following staged maneuvers: 1) Try to advance a high-support guidewire a little more distal inside the native vessel taking advantage of the native artery good distal bed so that the guidewire section with the highest support of all is placed on the curve zone. If possible, I would even bend the tip to avoid damaging the artery aware that the push forward maneuvers we'll be performing can uncontrollably displace the guidewire at any time. 2) Benefit from the balloon already crossed and the lesion already dilated to redilate the lesion with the balloon using the anchorage technique with the balloon to move the guide extension catheter forward, cross the curve, and eventually reach...
Cutoff thresholds for the "resting full-cycle ratio" (RFR) oscillate in different series, suggesting that population characteristics may influence them. Likewise, predictors of discordance between ...the RFR and fractional flow reserve (FFR) have been documented. The RECOPA Study showed that diagnostic capacity is reduced in the RFR "grey zone", requiring the performance of FFR to rule out or confirm ischemia.
To determine predictors of discordance, integrate the information they provide in a clinical-physiological index, the "Adjusted RFR", and compare its agreement with the FFR.
Using data from the RECOPA Study, predictors of discordance with respect to FFR were determined in the RFR "grey zone" (0.86 to 0.92) to construct an index ("Adjusted RFR") that would weigh RFR together with predictors of discordance and evaluate its agreement with FFR.
A total of 156 lesions were evaluated in 141 patients. Predictors of discordance were: chronic kidney disease, previous ischemic heart disease, lesions not involving the anterior descending artery, and acute coronary syndrome. Though limited, the "Adjusted RFR" improved the diagnostic capacity compared to the RFR in the "grey zone" (AUC-RFR = 0.651 versus AUC-"Adjusted RFR" = 0.749), also showing an improvement in all diagnostic indices when optimal cutoff thresholds were established (sensitivity: 59% to 68%; specificity: 62% to 75%; diagnostic accuracy: 60% to 71%; positive likelihood ratio: 1.51 to 2.34; negative likelihood ratio: 0.64 to 0.37).
Adjusting the RFR by integrating the information provided by predictors of discordance to obtain the "Adjusted RFR" improved the diagnostic capacity in our population. Further studies are required to evaluate whether clinical-physiological indices improve the diagnostic capacity of RFR or other coronary indices.
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