Utilidad de sistemas de scoring en caracterizar las oclusiones totales crónicas y su capacidad para predecir el resultado de la intervención coronaria percutánea

El treball de la tesi actual es tracta d'una anàlisi exhaustiva de la cohort de *ICPs sobre *OTCs del nostre centre al llarg de diversos anys des de l'establiment d'un programa dedicat a aquest camp. En el primer estudi s'ha estudiat la capacitat predictiva de J-*CTO *score en una cohort de més 500 pacients i s'ha investigat si el model pot predir adequadament l'èxit de procediment tenint en compte l'experiència progressiva del centro en aquest terreny. A ressaltar que J-*CTO *score va ser elaborat a partir d'una cohort de *ICPs sobre *CTOs dutes a terme per operadors experts. En el segon estudi hem analitzat les variables que millor prediuen les taxes d'èxit del procediment en la nostra cohort i hem inclòs la variable experiència de l'operador com un potencial factor influent, aspecte no quantificat en altres estudis. El tercer estudi analitza i compara aquelles *OTCs amb *ICP fallida i que van ser sotmeses a un segon intent amb les *ICPs de primer o de només un intent. Es fa una comparació del grau de complexitat i de les taxes d'èxit entre tots dos grups. Es busca i s'analitza específicament aquells possibles factors contribuents a l'èxit de procediment en el nou intent com a canvis *angiográficos en segon intent respecte al previ i la utilització de noves estratègies i tècniques en nous intents.El trabajo de la tesis actual se trata de un análisis exhaustivo de la cohorte de ICPs sobre OTCs de nuestro centro a lo largo de varios años desde el establecimiento de un programa dedicado a este campo. En el primer estudio se ha estudiado la capacidad predictiva de J-CTO score en una cohorte de más 500 pacientes y se ha investigado si el modelo puede predecir adecuadamente el éxito de procedimiento teniendo en cuenta la experiencia progresiva del centro en este terreno. A resaltar que J-CTO score fue elaborado a partir de una cohorte de ICPs sobre CTOs llevadas a cabo por operadores expertos. En el segundo estudio hemos analizado las variables que mejor predicen las tasas de éxito del procedimiento en nuestra cohorte y hemos incluido la variable experiencia del operador como un potencial factor influyente, aspecto no cuantificado en otros estudios. El tercer estudio analiza y compara aquellas OTCs con ICP fallida y que fueron sometidas a un segundo intento con las ICPs de primer o de sólo un intento. Se hace una comparación del grado de complejidad y de las tasas de éxito entre ambos grupos. Se busca y se analiza específicamente aquellos posibles factores contribuyentes al éxito de procedimiento en el nuevo intento como cambios angiográficos en segundo intento respecto al previo y la utilización de nuevas estrategias y técnicas en nuevos intentos.The work of the current thesis deals with an exhaustive analysis of the cohort of PCIs on OTCs of our center over several years since the establishment of a program dedicated to this field. In the first study, the predictive capacity of the J-CTO score was studied in a cohort of more than 500 patients and it was investigated whether the model can adequately predict the success of the procedure, taking into account the progressive experience of the center in this field. It should be noted that the J-CTO score was developed from a cohort of ICPs on CTOs carried out by expert operators. In the second study we have analyzed the variables that best predict the success rates of the procedure in our cohort and we have included the operator experience variable as a potential influencing factor, an aspect not quantified in other studies. The third study analyzes and compares those OTCs with failed PCI and who underwent a second attempt with the PCIs of the first or only one attempt. A comparison of the degree of complexity and the success rates between both groups is made. Those possible contributing factors to the success of the procedure in the new attempt are specifically sought and analyzed, such as angiographic changes in the second attempt compared to the previous one and the use of new strategies and techniques in new attempts

Coronary laser with simultaneous contrast injection for the treatment of stent underexpansion

Background: Stent underexpansion is a challenge in interventional cardiology. Some off-label treatments, such as rotational atherectomy, intravascular lithotripsy (IVL) and coronary lasing, have been used to overcome the problem. The purpose of this study is to evaluate the safety and efficacy of coronary laser atherectomy with simultaneous contrast injection and subsequent balloon dilation to optimize stent expansion. Methods: Coronary laser atherectomy with simultaneous contrast injection was used. After lasing, non-compliant balloon dilation at high pressure was performed to overcome the underexpanded point. The average increase in the minimum stent area (MSA) was measured by intravascular ultrasound (IVUS), and any complication related to the technique was evaluated. Additionally, major adverse cardiovascular events (MACE), consisting of death from any cause, new myocardial infarction (MI) and target lesion revascularization (TLR), were scrutinized in a long-term follow-up. Results: Sixteen underexpanded stents were treated with laser between August 2017 and November 2022. In all cases but one, IVUS was used to evaluate the MSA before and after lasing. The MSA showed an average increase of 2.34 ± 1.57 mm2 (95% confidence interval [CI]: 1.47–3.21; p < 0.001) after laser application and balloon inflation. No complication related to the technique was detected. During a follow-up period of a median (interquartile range) of 457 (50–973) days, the combined MACE assessed by Kaplan-Meier estimator showed an event-free rate of 0.82 (95% CI: 0.59–1). Conclusions: Coronary laser with simultaneous contrast injection is a safe method to optimize a stent underexpansion, with an acceptable event-free rate in long-term follow-up

New scoring system for predicting percutaneous coronary intervention of chronic total occlusion success: Impact of operator’s experience

Background: Several scoring systems have been developed in order to predict percutaneous coronary intervention (PCI) result of chronic total occlusion (CTO). The scores principally include anatomic and clinical variables. Operator experience is a decisive factor for achieving successful result. We sought to assess the real impact of operator growing experience on CTO-PCI success. Methods: The angiographic and clinical variables of CTO-PCIs performed in our center between May 2007 and April 2021 were collected, and variables with potential association with procedural result were thoroughly reviewed. The influence of operator experience based on the number of previous CTO-PCIs was statistically assessed. A scoring system with combination of anatomic variables and operator experience was devised. Results: A total of 540 PCIs in 457 patients were performed in our institution. The scoring model was developed from the derivation set (2/3 of the cohort). The final variables in logistic regression model were CTO length ≥ 20 mm, blunt stump, vessel tortuosity > 45o and operator experience < 100 PCIs. The model showed good performance in the derivation set (area under curve [AUC]: 0.768; confidence interval [CI]: 0706–0.830; p < 0.001) with no significant shrinkage in the validation set (AUC: 0.704; CI: 0.613–0.796; p < 0.001). Conclusions: This new score (E-CTO score) adequately predict the probability of CTO-PCI failure. The model includes a variable representing operator experience along with other anatomic variables

J-chronic total occlusion score predictive capacity for percutaneous coronary intervention success of chronic total occlusion: Results from a European single center cohort with progressive experience over time

Background: Several scoring systems have been described to assess the level of difficulty and to predict the probability of success of percutaneous coronary intervention (PCI) of chronic total occlusion (CTO). The J-CTO score was initially developed to correlate CTO complexity with guidewire time crossing through the lesion within 30 min. Moreover, almost all scoring systems represent procedures performed by seasoned operators. Herein, this study sought to evaluate the predictive capacity of J-CTO for PCI success in a European single-center cohort with growing experience in the approach of CTO. Methods: 526 procedures were performed between 2007 and 2020 mainly by a single operator. The predictive power of J-CTO score was assessed by area under the receiver-operator characteristic curve (ROC) in the entire cohort and additionally in two separate periods. The goodness-of-fit of the model was evaluated by the Hosmer and Lemeshow statistic. Results: Successful procedure in first-attempt PCI was 79.5% and the overall success including 47 repeated procedures was achieved in 85.8%. The retrograde approach was attempted in 14.4%. The score was inversely associated with procedural success and lower success rate in more difficult CTOs (p < 0.001). ROC curve for the entire cohort, and first block (case 1–200) and second block (case 201–526) was 0.696, 0.661 and 0.748, respectively. The model showed good calibration for the entire cohort (X2 = 1.7; p = 0.43). Conclusions: J-CTO score showed an acceptable predictive power for procedural success in this cohort although its discriminatory power is better as the level of experience is improved

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial

Aim: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. Methods and results: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR) 0.65, 95% confidence interval (CI) 0.44 to 0.96; pnon-inferiority <0.001; psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs 11.1%, HR 0.67, 95% CI 0.46 to 0.99; p = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. Conclusions: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome

Impact of operatoŕs experience on peri-procedural outcomes with Watchman FLX: Insights from the FLX-SPA registry

Background: The Watchman FLX is a device upgrade of the Watchman 2.5 that incorporates several design enhancements intended to simplify left atrial appendage occlusion (LAAO) and improve procedural outcomes. This study compares peri-procedural results of LAAO with Watchman FLX (Boston Scientific, Marlborough, Massachusetts) in centers with varying degrees of experience with the Watchman 2.5 and Watchman FLX. Methods: Prospective, multicenter, 'real-world' registry including consecutive patients undergoing LAAO with the Watchman FLX at 26 Spanish sites (FLX-SPA registry). Implanting centers were classified according to the center's prior experience with the Watchman 2.5. A further division of centers according to whether or not they had performed ≤ 10 or > 10Watchman FLX implants was prespecified at the beginning of the study. Procedural outcomes of institutions stratified according to their experience with the Watchman 2.5 and FLX devices were compared. Results: 359 patients [mean age 75.5 (SD8.1), CHA2DS2-VASc 4.4 (SD1.4), HAS-BLED 3.8(SD0.9)] were included. Global success rate was 98.6%, successful LAAO with the first selected device size was achieved in 95.5% patients and the device was implanted at first attempt in 78.6% cases. There were only 9(2.5%) major peri-procedural complications. No differences in efficacy or safety results according to the centeŕs previous experience with Watchman 2.5 and procedural volume with Watchman FLX existed. Conclusions: The Watchman FLX attains high procedural success rates with complete LAA sealing in unselected, real-world patients, along with a low incidence of peri-procedural complications, regardless of operatoŕs experience with its previous device iteration or the number of Watchman FLX devices implanted

Amphilimus- vs. zotarolimus-eluting stents in patients with diabetes mellitus and coronary artery disease: the SUGAR trial.

AIM: Patients with diabetes mellitus are at high risk of adverse events after percutaneous revascularization, with no differences in outcomes between most contemporary drug-eluting stents. The Cre8 EVO stent releases a formulation of sirolimus with an amphiphilic carrier from laser-dug wells, and has shown clinical benefits in diabetes. We aimed to compare Cre8 EVO stents to Resolute Onyx stents (a contemporary polymer-based zotarolimus-eluting stent) in patients with diabetes. METHODS AND RESULTS: We did an investigator-initiated, randomized, controlled, assessor-blinded trial at 23 sites in Spain. Eligible patients had diabetes and required percutaneous coronary intervention. A total of 1175 patients were randomly assigned (1:1) to receive Cre8 EVO or Resolute Onyx stents. The primary endpoint was target-lesion failure, defined as a composite of cardiac death, target-vessel myocardial infarction, and clinically indicated target-lesion revascularization at 1-year follow-up. The trial had a non-inferiority design with a 4% margin for the primary endpoint. A superiority analysis was planned if non-inferiority was confirmed. There were 106 primary events, 42 (7.2%) in the Cre8 EVO group and 64 (10.9%) in the Resolute Onyx group [hazard ratio (HR): 0.65, 95% confidence interval (CI): 0.44-0.96; Pnon-inferiority < 0.001; Psuperiority = 0.030]. Among the secondary endpoints, Cre8 EVO stents had significantly lower rate than Resolute Onyx stents of target-vessel failure (7.5% vs. 11.1%, HR: 0.67, 95% CI: 0.46-0.99; P = 0.042). Probable or definite stent thrombosis and all-cause death were not significantly different between groups. CONCLUSION: In patients with diabetes, Cre8 EVO stents were non-inferior to Resolute Onyx stents with regard to target-lesion failure composite outcome. An exploratory analysis for superiority at 1 year suggests that the Cre8 EVO stents might be superior to Resolute Onyx stents with regard to the same outcome. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT03321032