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.

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.

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: Five hundred twenty-six 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 goodnessof- 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 with 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.

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.

Performance of Coronary Angiography in the Detection of Coronary Artery Disease in Patients with Systolic Left Ventricular Dysfunction and No Prior Ischemic Heart Disease.

The diagnosis of ischemic cardiomyopathy is not well established. Our objective is to determine predictive variables of coronary disease in unselected patients with ventricular dysfunction. This study is a retrospective cohort study of consecutive patients with left ventricular dysfunction and no known history of ischemic heart disease. We analyse the demographic variables, clinical data, electrocardiogram, and echocardiogram that are associated with the presence of coronary stenosis on coronary angiography. A total of 536 patients with left ventricular dysfunction were studied, with 135 (25.2%) of them having significant coronary lesions. In the multivariate logistic regression analysis, age ≤ 50 years, female gender, and the presence of atrial fibrillation on the electrocardiogram (ECG) were predictors of the absence of coronary lesions. Diabetes, hypercholesterolemia, the existence of Q waves in the ECG, and segmental alterations in contractility in the echocardiogram were predictors of coronary heart disease (C-Statistics 0.771, 95% CI 0.727 to 0.814). The information obtained from the clinical history, the ECG, and the echocardiogram of patients with ventricular dysfunction allows us to select subjects in whom coronary angiography has shown poor performance in diagnosing coronary disease.

One-year cardiovascular outcomes after coronavirus disease 2019: The cardiovascular COVID-19 registry.

BACKGROUND: The long-term cardiovascular (CV) outcomes of COVID-19 have not been fully explored. METHODS: This was an international, multicenter, retrospective cohort study conducted between February and December 2020. Consecutive patients ≥18 years who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 were included. Patients were classified into two cohorts depending on the nasopharyngeal swab result and clinical status: confirmed COVID-19 (positive RT-PCR) and control (without suggestive symptoms and negative RT-PCR). Data were obtained from electronic records, and clinical follow-up was performed at 1-year. The primary outcome was CV death at 1-year. Secondary outcomes included arterial thrombotic events (ATE), venous thromboembolism (VTE), and serious cardiac arrhythmias. An independent clinical event committee adjudicated events. A Cox proportional hazards model adjusted for all baseline characteristics was used for comparing outcomes between groups. A prespecified landmark analysis was performed to assess events during the post-acute phase (31-365 days). RESULTS: A total of 4,427 patients were included: 3,578 (80.8%) in the COVID-19 and 849 (19.2%) control cohorts. At one year, there were no significant differences in the primary endpoint of CV death between the COVID-19 and control cohorts (1.4% vs. 0.8%; HRadj 1.28 [0.56-2.91]; p = 0.555), but there was a higher risk of all-cause death (17.8% vs. 4.0%; HRadj 2.82 [1.99-4.0]; p = 0.001). COVID-19 cohort had higher rates of ATE (2.5% vs. 0.8%, HRadj 2.26 [1.02-4.99]; p = 0.044), VTE (3.7% vs. 0.4%, HRadj 9.33 [2.93-29.70]; p = 0.001), and serious cardiac arrhythmias (2.5% vs. 0.6%, HRadj 3.37 [1.35-8.46]; p = 0.010). During the post-acute phase, there were no significant differences in CV death (0.6% vs. 0.7%; HRadj 0.67 [0.25-1.80]; p = 0.425), but there was a higher risk of deep vein thrombosis (0.6% vs. 0.0%; p = 0.028). Re-hospitalization rate was lower in the COVID-19 cohort compared to the control cohort (13.9% vs. 20.6%; p = 0.001). CONCLUSIONS: At 1-year, patients with COVID-19 experienced an increased risk of all-cause death and adverse CV events, including ATE, VTE, and serious cardiac arrhythmias, but not CV death. STUDY REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT04359927.

Angiographic Characteristics and Outcomes of Percutaneous Coronary Intervention of Reattempted Chronic Total Occlusion: Potential Contributing Factors to Procedural Success.

This study aimed to analyze angiographic characteristics of new attempted percutaneous coronary intervention (PCI) on chronic total occlusion (CTO) compared to first attempt group. The cohort of 527 CTO-PCIs was divided into first-attempt and re-attempt groups, and angiographic characteristics, level of complexity, and contributing factors to failure were analyzed. Between-group success rate difference and potential angiographic and technical aspects contributing to the success in new attempts were scrutinized. A total of 47 new PCIs in 39 patients were performed. The reattempt group showed higher J-CTO score compared to the first-attempt group (2.4 ± 1.06 vs. 1.2 ± 1.06; p < 0.001). The use of more complex techniques and devices such as retrograde approach (29.8% vs. 12.9%) and IVUS (48.9 vs. 27.3%; p: 0.002) were more frequent in the reattempt group. Both procedural and fluoroscopy time were higher in the reattempt group (197 ± 83.9 vs. 150.1 ± 72.3 and 97.7 ± 55.4 vs. 68.7 ± 43, respectively; p < 0.001). There was no between-group difference in terms of technical success (79.8 vs. 76.6% for first attempt vs. reattempt group, respectively; p: 0.6). The overall success rate increased by 6.1%, achieving 85.9% in the entire cohort. Reattempted CTO-PCIs required more complex techniques and had comparable technical success rate with regard to the first-attempt group.

Safety and efficacy of coronary laser ablation as an adjunctive therapy in percutaneous coronary intervention: a single-centre experience.

BACKGROUND: Coronary laser is a long-established coadjuvant therapy in interventional cardiology. This study aimed to present our experience regarding the safety and efficacy of laser assistance to percutaneous coronary intervention (PCI) in different scenarios of coronary artery disease. METHODS: We used coronary laser as an adjunctive therapy for PCI between May 2014 and March 2020. The safety of laser ablation was evaluated by studying any complication associated with the laser application. Besides, the laser contribution to PCI and 1 year of follow-up for adverse cardiac events was studied. RESULTS: Coronary laser was performed in 81 lesions and 75 patients in different scenarios to assist PCI. The average age was 66 ± 11.7 years and 72 (88.9%) were men. Coronary laser was used in 30 (37%) cases for in-stent-material debulking; 26 (32.1%) in primary angioplasty, 19 (23.4%) in chronic total occlusion and 5 (6.2%) in saphenous vein grafts. Procedural success was achieved in 77 (95.1%) with 1 (1.2%) type III coronary perforation. One year of follow-up for combined adverse cardiac events consisting of death due to any cause, myocardial infarction or target vessel failure showed an event-free rate of 0.82 (95% confidence interval, 0.72-0.91). CONCLUSIONS: Our preliminary experience reveals the safety and efficacy of the current modality of coronary laser as a coadjuvant therapy in PCI with a low rate of adverse cardiac events in 1-year of follow-up. Further studies are needed to establish more precisely the contribution of laser application in different contexts of coronary artery disease.

Long-term effects of coronavirus disease 2019 on the cardiovascular system, CV COVID registry: A structured summary of a study protocol.

BACKGROUND: Patients presenting with the coronavirus-2019 disease (COVID-19) may have a high risk of cardiovascular adverse events, including death from cardiovascular causes. The long-term cardiovascular outcomes of these patients are entirely unknown. We aim to perform a registry of patients who have undergone a diagnostic nasopharyngeal swab for SARS-CoV-2 and to determine their long-term cardiovascular outcomes. STUDY AND DESIGN: This is a multicenter, observational, retrospective registry to be conducted at 17 centers in Spain and Italy (ClinicalTrials.gov number: NCT04359927). Consecutive patients older than 18 years, who underwent a real-time reverse transcriptase-polymerase chain reaction (RT-PCR) for SARS-CoV2 in the participating institutions, will be included since March 2020, to August 2020. Patients will be classified into two groups, according to the results of the RT-PCR: COVID-19 positive or negative. The primary outcome will be cardiovascular mortality at 1 year. The secondary outcomes will be acute myocardial infarction, stroke, heart failure hospitalization, pulmonary embolism, and serious cardiac arrhythmias, at 1 year. Outcomes will be compared between the two groups. Events will be adjudicated by an independent clinical event committee. CONCLUSION: The results of this registry will contribute to a better understanding of the long-term cardiovascular implications of the COVID19.

Does Large Vessel Size Justify Use of Bare-Metal Stents in Primary Percutaneous Coronary Intervention?

BACKGROUND: Drug-eluting stents (DES) showed improved efficacy and safety compared with bare-metal stents (BMS), and international guidelines recommend their use as first line treatment. Yet, BMS are still widely used in practice, especially in large coronary vessels. We aimed to compare efficacy and safety of second-generation DES over BMS in large coronary culprit ST-segment elevated myocardial infarction lesions. METHODS: We evaluated impact of large coronary stents (maximum size ≥3.50 mm) or smaller stents (<3.50 mm), among 1498 patients with ST-segment elevated myocardial infarction undergoing primary percutaneous coronary intervention, randomly allocated to everolimus-eluting DES or to an equivalent BMS platform in the EXAMINATION trial (Clinical Evaluation of the Xience-V Stent in Acute Myocardial Infarction Trial). Clinical events up to 5 years of follow-up were evaluated. RESULTS: Large coronary stents were used in 683 patients (45.9%). At 5-year follow-up, the crude rate of the primary end point, a composite of all-cause death, any myocardial infarction, or any revascularization, was similar among patients treated with large or smaller coronary stents. The impact of DES versus BMS implantation was consistent irrespective of the stent size both for the primary end point (Pint=0.82) and other secondary ischemic end points. Within patients treated with bigger stents, DES implantation was associated to a trend toward a reduction of target lesion (hazard ratio, 0.53; 95% CI, 0.27-1.02; P=0.05) and target vessel revascularization (hazard ratio, 0.60; 95% CI, 0.34-1.03; P=0.066). CONCLUSIONS: Our results do not support the preferential use of BMS for patients with large coronary vessels. DES may warrant improved efficacy irrespective of stent size among patients undergoing primary percutaneous coronary intervention. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT00828087.

Role of ST-Segment Resolution in Patients With ST-Segment Elevation Myocardial Infarction Treated With Primary Percutaneous Coronary Intervention (from the 5-Year Outcomes of the EXAMINATION [Evaluation of the Xience-V Stent in Acute Myocardial Infarction] Trial).

In patients with ST-segment elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (pPCI), lack of ST-segment resolution (STR) is associated with poor prognosis at short- and long-term follow-up. The aim of this study was to evaluate the role of STR on very long-term outcomes in patients with STEMI treated with pPCI included in the EXAMINATION (Evaluation of the Xience-V Stent in Acute Myocardial Infarction) trial. Patients were stratified according to the presence of STR < 50% and STR < 70% at the 30-minute post-pPCI electrocardiogram. Primary end point was the patient-oriented composite endpoint (POCE) of all-cause death, any myocardial infarction, or any revascularization at 5-year follow-up. Both baseline and post-PCI 30-minute electrocardiograms were available for STR assessment in 1,351 patients. Of these patients, 228 (16.9%) and 500 (37.0%) exhibited STR < 50% and STR < 70%, respectively. At 5-year follow-up, the POCE was observed more frequently in patients with STR < 50% (hazard ratio [HR] 1.556; 95% confidence interval [CI] 1.194 to 2.027; p <0.001) and in patients with STR < 70% (HR 1.460, 95% CI 1.169 to 1.824, p <0.001) compared with patients with STR > 50% and STR ≥ 70%, respectively. In both cases, this difference was mainly driven by a significant increase in the rate of all-cause death and any revascularization. After multivariable adjustment, STR < 70%, but not STR < 50%, resulted as a 5-year independent predictor of POCE (adjusted HR 1.338, 95% CI 1.008 to 1.778, p = 0.044). In conclusion, in patients with STEMI, the evaluation of 70% STR after pPCI provides independent prognostic information at 5-year follow-up and it can be used to identify patients at high risk of very long-term cardiovascular events.

Correlates of non-target vessel-related adverse events in patients with ST-segment elevation myocardial infarction: insights from five-year follow-up of the EXAMINATION trial.

AIMS: The aim of this substudy was to determine the five-year correlates of non-TV-related adverse events (AE) in STEMI patients included in the EXAMINATION trial. METHODS AND RESULTS: The EXAMINATION trial randomised 1,498 STEMI patients to bare metal or everolimus-eluting stent implantation. In this substudy, patients were analysed according to non-TV-related AE, defined as the composite of either non-TV revascularisation (non-TVR) or non-TV-related myocardial infarction (MI). At five-year follow-up, 125 patients (8.3%) exhibited 136 non-TV-related AE (124 [8.3%] non-TVR, 12 [0.8%] non-TV-related MI), accounting for 47.1% of 289 non-fatal cardiac events overall. These patients had a higher incidence of diabetes mellitus (p<0.001), arterial hypertension (p=0.032), previous MI (p=0.073), multivessel disease (p<0.001), and incomplete revascularisation (p=0.049), and a lower rate of ST-segment resolution >70% (p=0.042) as compared to the rest. At Cox analysis, previous MI (HR 1.872, 95% CI: 1.004-3.489; p=0.048), incomplete revascularisation (HR 1.746, 95% CI: 1.029-2.963; p=0.039) and diabetes (HR 1.942, 95% CI: 1.292-2.919; p=0.001) were independent correlates of non-TV-related AE. CONCLUSIONS: In STEMI patients undergoing primary percutaneous coronary intervention, previous MI, incomplete revascularisation and diabetes resulted in being independent correlates of five-year non-TV-related AE.

Methods to assess bioresorbable vascular scaffold devices behaviour after implantation.

Bioresorbable vascular scaffolds (BRS) represent a novel approach for coronary revascularization offering several advantages as compared to current generation DES, potentially reducing rate of late adverse events and avoiding permanent vessel caging. Nevertheless, safety concerns have been raised for an increased risk of scaffold thrombosis (ScT) in both early and late phases, probably related to a suboptimal scaffold implantation. In this context, the use of different imaging methodologies has been strongly suggested in order to guarantee an optimal implantation. We herein analyze the different imaging methodologies available to assess BRS after implantation and at follow-up.

Impact of Body Mass Index on 5-Year Clinical Outcomes in Patients With ST-Segment Elevation Myocardial Infarction After Everolimus-Eluting or Bare-Metal Stent Implantation.

Patients with high body mass index (BMI) seem to have better outcomes after percutaneous coronary intervention than normal-weight patients. However, contrasting results have been reported on the "obesity paradox" in patients presenting with ST-elevation myocardial infarction (STEMI). The aim of our study was to investigate the impact of BMI on mortality in the population enrolled in the Evaluation of the Xience-V stent in Acute Myocardial INfArcTION (EXAMINATION) trial. The EXAMINATION trial randomized 1,498 patients with STEMI to a bare-metal stent or an everolimus-eluting stent. In this substudy patients were stratified into 3 groups according to BMI values: normal (BMI < 25 kg/m2), overweight (BMI = 25 to 29.9 kg/m2), and obese (BMI ≥ 30 kg/m2). The coprimary end points were the all-cause and cardiac deaths among the groups at the 5-year follow-up. BMI was available in 1,421 patients, divided in 401 (28.2%) normal, 702 (49.4%) overweight, and 318 (22.4%) obese. Obese patients were younger (p = 0.012) compared with the other groups, but with a worse cardiovascular risk profile. They were more frequently female (p <0.001) and with a higher rate of obesity-related co-morbidity conditions such as diabetes mellitus (p = 0.005), arterial hypertension (p <0.001), and hyperlipidemia (p = 0.001) compared with the other groups. At the 5-year follow-up, all-cause and cardiac deaths were less frequent in obese patients than in the other groups (p = 0.003 and p = 0.030, respectively). After adjustment for confounding variables, BMI was an independent predictor of all-cause death (hazard ratio 0.765, 95% confidence interval 0.599 to 0.979, p = 0.033), but not of cardiac death, without any interaction with the stent type. In conclusion, in patients with STEMI who underwent primary PCI, the long-term all-cause death rate decreased as BMI increased, confirming the obesity paradox, irrespective of the stent type.

Asma: ¿un nuevo factor de riesgo cardiovascular? / Asthma: A New Cardiovascular Risk Factor?

No disponible