Myocarditis after Covid-19 Vaccination in a Large Health Care Organization.

BACKGROUND: Reports have suggested an association between the development of myocarditis and the receipt of messenger RNA (mRNA) vaccines against coronavirus disease 2019 (Covid-19), but the frequency and severity of myocarditis after vaccination have not been extensively explored. METHODS: We searched the database of Clalit Health Services, the largest health care organization (HCO) in Israel, for diagnoses of myocarditis in patients who had received at least one dose of the BNT162b2 mRNA vaccine (Pfizer-BioNTech). The diagnosis of myocarditis was adjudicated by cardiologists using the case definition used by the Centers for Disease Control and Prevention. We abstracted the presentation, clinical course, and outcome from the patient's electronic health record. We performed a Kaplan-Meier analysis of the incidence of myocarditis up to 42 days after the first vaccine dose. RESULTS: Among more than 2.5 million vaccinated HCO members who were 16 years of age or older, 54 cases met the criteria for myocarditis. The estimated incidence per 100,000 persons who had received at least one dose of vaccine was 2.13 cases (95% confidence interval [CI], 1.56 to 2.70). The highest incidence of myocarditis (10.69 cases per 100,000 persons; 95% CI, 6.93 to 14.46) was reported in male patients between the ages of 16 and 29 years. A total of 76% of cases of myocarditis were described as mild and 22% as intermediate; 1 case was associated with cardiogenic shock. After a median follow-up of 83 days after the onset of myocarditis, 1 patient had been readmitted to the hospital, and 1 had died of an unknown cause after discharge. Of 14 patients who had left ventricular dysfunction on echocardiography during admission, 10 still had such dysfunction at the time of hospital discharge. Of these patients, 5 underwent subsequent testing that revealed normal heart function. CONCLUSIONS: Among patients in a large Israeli health care system who had received at least one dose of the BNT162b2 mRNA vaccine, the estimated incidence of myocarditis was 2.13 cases per 100,000 persons; the highest incidence was among male patients between the ages of 16 and 29 years. Most cases of myocarditis were mild or moderate in severity. (Funded by the Ivan and Francesca Berkowitz Family Living Laboratory Collaboration at Harvard Medical School and Clalit Research Institute.).

Percutaneous coronary intervention with ridaforolimus eluting-stents in small vessel coronary artery disease.

INTRODUCTION: The ridaforolimus-eluting stent (RES) system uses a novel cobalt alloy-based coronary stent with a durable elastomeric polymer eluting ridaforolimus. AIM OF STUDY: To assess the safety and efficacy of small diameter (2.25 mm) RES (EluNIR) in small coronary artery disease. METHODS: A prospective, multicenter, single-arm, open-label clinical trial. Clinical follow-up was performed at 30 days, 6 months, and 1 year after the procedure. Target lesions were located in native coronary arteries or bypass graft conduits, with visually estimated diameter of ≥2.25 mm to ≤2.5 mm. The primary endpoint was combined device success, defined as final in-stent residual diameter stenosis <30%, without 30-day major adverse cardiovascular events (MACE). RESULTS: A total of 81 patients were enrolled in the study. Twenty-three patients (28%) had acute coronary syndrome (ACS) at presentation and 37 (46%) had prior myocardial infarction (MI). Most of the target lesions were located in the circumflex coronary artery (44%) and were classified as B2/C grade according to the American Heart Association/American College of Cardiology classification. The final mean minimal lumen diameter, mean reference vessel diameter, and mean residual percent diameter stenosis were 2.0 ± 0.2 mm, 2.3 ± 0.1 mm, and 14 + 6.6%, respectively. The primary endpoint of device success without 30-day MACE was achieved in 98.8% of the patients. Target lesion failure (TLF) at 6 months was 1.2%. Thirty-day and 1-year MACE rates were 1.2% and 2.5%, respectively. CONCLUSION: The EluNIR 2.25 mm stent shows excellent results in small coronary artery disease and adds another tool in the treatment of this complex lesion type.

Association of socioeconomic status measures with physical activity and subsequent frailty in older adults.

BACKGROUND: Despite increased recognition, frailty remains a significant public health challenge. OBJECTIVE: we aimed to assess the role of education and income, as well as neighborhood socioeconomic status, on physical activity and subsequent frailty in older adults. METHODS: Using a population-based cohort of older adults, this study examined the relationship between socioeconomic status (SES) factors, physical activity and frailty. The study included 1,799 participants (mean [SD], 74.6 (6.2), 53.3% female) from the "National Health and Nutrition Survey of Older Adults Aged 65 and Over in Israel", conducted in 2005-2006. A follow-up interview was performed 12-14 years later in a subgroup of 601 subjects (mean [SD], age 84[4]; 56% women). Self-reported leisure-time physical activity (LTPA) was measured at both baseline and follow-up. SES measures were assessed at baseline. Frailty was measured at follow-up, using the Fried's Phenotype Model. RESULTS: All SES measures were strongly and positively associated with LTPA (all p < 0.001). Eighty-two participants (14%) were classified as frail at follow-up. After age and sex adjustment and accounting for attrition bias using inverse probability weighting, baseline LTPA (OR = 2.77, 95% CI: 1.57-4.90, for inactivity; OR = 1.41, 95% CI: 0.75-2.68, for insufficient activity, compared with sufficient activity, Ptrend < 0.001) was inversely associated with incident frailty. The association persisted after further adjustment for SES and comorbidity. CONCLUSION: Among older individuals, multiple SES measures were positively associated with LTPA, which was a strong predictor of lower subsequent frailty risk.

Temporary Trends in Fever following Transcatheter Aortic Valve Implantation.

OBJECTIVES: Fever following transcatheter aortic valve implantation (TAVI) is a common phenomenon, attributed mostly to inflammatory response which may impact outcome. Systemic inflammatory response may be triggered by multiple factors, most associated with the TAVI procedure itself. However, there are no data regarding the incidence of fever following TAVI in contemporary era with newer generation devices. Our primary objective was to measure temporal trends in fever incidence and features following TAVI. METHODS: We analyzed a retrospective cohort of 802 consecutive patients who underwent TAVI at our institution between November 2008 and February 2018. We identified and characterized all patients who developed fever (>38.0°C from any cause) within the first 72 h following the procedure and analyzed incidence and characteristics stratified into 3 time frames: 2008-2014, 2014-2016, and 2016-2018. RESULTS: Following TAVI, 190 (23.7%) patients developed fever (mean age 82.3 ± 5.2 years, 64.2% female). An infectious etiology was evident in only 32.1% of cases. The frequency decreased gradually and significantly across timeframes (32.8, 23.6, and 14.5%, respectively, p < 0.001). In a multivariate regression analysis, 1st generation CoreValve (HR 1.91; CI 95% 1.2-3.04, p = 0.006) was found to be associated with higher incidence of fever in addition to female gender, vascular complications, transfemoral access, and reduced GFR. CONCLUSIONS: Fever incidence post TAVI decreased significantly throughout the last decade. The higher rate of fever in the early years of TAVI was likely associated with first-generation devices, vascular complications, and reduced GFR.

Predicting the risk of late futile outcome after transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) for aortic stenosis (AS) risk assessment is still developing and mostly concerned with mortality in the periprocedural period. We therefore sought to develop and then validate a score to predict 1-year adverse outcome. METHODS: Patients that underwent TAVI for severe AS in the Israeli registry. Patients with unsuccessful/suboptimal implantation were excluded. The cohort was split to derivation/validation cohorts by a ratio of 70:30. The outcome was defined as 1-year composite of mortality, stroke, and no improvement in NYHA class (vs. baseline). Logistic regression was used to fit the prediction model. RESULTS: Out of 2,440 patients meeting inclusion criteria, 276 were excluded, leaving 2,160 patients for both cohorts. At 1 year, 299 (14%) patients experienced the adverse ("futile") outcome. The derived prediction model included mean aortic valve (AV) gradient, previous pacemaker, previous oncological disease, need for diuretics, baseline NYHA class, hemoglobin and creatinine levels, and nonfemoral access site. The model's area under the curve (AUC) was 0.69 in the derivation and 0.70 in the validation cohort. Performance of other scores in the validation cohort were lower (0.60 for STS, 0.55 for Euroscore2, 0.56 for TVT score, and 0.53 for TAVI2-score, p = .03). Based on three risk tiers, patients had a low risk (20/306, 7% futility), a medium risk (50/304, 17%), and high risk (18/37, 49%) for futility. CONCLUSIONS: The TAVI futility risk model can be used to provide further insight regarding prediction measures and/or patients' outcomes outside of the periprocedural period (NCT02023060).

Prognostic significance of the Medina classification in bifurcation lesion percutaneous coronary intervention with second-generation drug-eluting stents.

The Medina classification is the most widespread method to describe bifurcation lesions. However, little is known regarding its prognostic impact. Therefore, the aim of this study is to assess the prognostic significance of the Medina classification following percutaneous coronary intervention (PCI). From a prospective registry of 738 consecutive patients undergoing PCI for bifurcation lesions, 505 were treated with second-generation drug-eluting stents (DES). Of these, 407 (80.6%) presented with "true bifurcation" (TB) lesions (Medina class 1.0.1, 1.1.1, 0.1.1) and 98 (19.4%) in all other categories ("non-true bifurcation" = NTB). We compared rates of death and major adverse cardiac events (MACE: cardiac death, myocardial infarction, or target vessel revascularization) at 12 months and 3 years. Patients with TB had lower rates of previous bypass surgery (7.4% vs. 11.2%, p = 0.043). TB lesions were more likely to be calcified (33.9% vs. 28.6%, p = 0.003) and ulcerated (8.8% vs. 4.1%, p < 0.01). At 12 months, mortality was numerically higher for TB PCI (4.1% vs. 2.1%, p = 0.052) and MACE rates were higher (19.2% vs. 10.2%, p < 0.001). At 3 years, both all-cause death (10.1% vs. 5.1%, p = 0.002) and rates of MACE (37.2% vs. 17.6%, p < 0.001) were higher for TB PCI. After performing regression analysis, TB remained an independent predictor for poor outcomes (OR-2.28 at 12 months, CI 1.45-9.50, p = 0.007, OR-3.75 at 3 years, CI 1.52-6.77, p = 0.001 for MACE). In conclusion, TB lesions, according to the Medina classification, portend worse prognosis for patients undergoing bifurcation PCI. This may guide prognostication and decision-making in treatment.

Cardiovascular Morbidity in a Randomized Trial Comparing GnRH Agonist and GnRH Antagonist among Patients with Advanced Prostate Cancer and Preexisting Cardiovascular Disease.

PURPOSE: Androgen deprivation therapy may increase the risk of cardiovascular disease. Limited data suggest that GnRH (gonadotropin-releasing hormone) antagonist may be associated with a lower risk of cardiovascular disease than GnRH agonist. MATERIALS AND METHODS: We performed a phase II, randomized, open label study in men with prostate cancer and preexisting cardiovascular disease who were randomized to receive GnRH agonists or antagonists for 1 year. The primary outcome was endothelial function measured by the EndoPAT 2000 device (Itamar Medical, Caesarea, Israel). The predefined secondary outcome was a new cardiovascular event. Patients were followed for the development of cardiovascular disease, defined as death, myocardial infarction, a cerebrovascular event, percutaneous angioplasty with coronary stent insertion or hospitalizations due to cardiac events. RESULTS: A total of 80 patients were enrolled in study, including 41 and 39 who received GnRH antagonist and agonist, respectively. Patients in each arm had similar baseline characteristics. We did not detect a difference in the primary end point (endothelial function) between the groups (mean ± SD reactive hyperemia index 2.07 ± 0.15 vs 1.92 ± 0.11, p=0.42). However, during the trial period a new cardiovascular event (the secondary end point) developed in 15 patients. Of cases new major cardiovascular and cerebrovascular events developed in 9, including death in 2, myocardial infarction in 1, a cerebrovascular event in 2 and percutaneous angioplasty with coronary stent insertion in 4. Of the patients 20% randomized to GnRH agonist experienced a major cardiovascular and cerebrovascular event compared to 3% of those on GnRH antagonist (p=0.013). The absolute risk reduction in major cardiovascular and cerebrovascular events at 12 months using GnRH antagonist was 18.1% (95% CI 4.6-31.2, p=0.032). CONCLUSIONS: To our knowledge this is the first prospective study to test cardiovascular outcomes among patients with prostate cancer who received androgen deprivation therapy. No differences in the primary end point were noted between the study arms. However, the secondary end point revealed that patients treated with GnRH agonist experienced significantly more major cardiovascular and cerebrovascular events than those treated with GnRH antagonist. These phase II results suggest that in patients with prostate cancer who have preexisting cardiovascular disease selecting the androgen deprivation therapy modality may differentially affect cardiac outcomes.

Cancer and mortality in relation to traffic-related air pollution among coronary patients: Using an ensemble of exposure estimates to identify high-risk individuals.

BACKGROUND: Moderate correlations were previously observed between individual estimates of traffic-related air pollution (TRAP) produced by different exposure modeling approaches. This induces exposure misclassification for a substantial fraction of subjects. AIM: We used an ensemble of well-established modeling approaches to increase certainty of exposure classification and reevaluated the association with cancers previously linked to TRAP (lung, breast and prostate), other cancers, and all-cause mortality in a cohort of coronary patients. METHODS: Patients undergoing percutaneous coronary interventions in a major Israeli medical center from 2004 to 2014 (n = 10,627) were followed for cancer (through 2015) and mortality (through 2017) via national registries. Residential exposure to nitrogen oxides (NOx) -a proxy for TRAP- was estimated by optimized dispersion model (ODM) and land use regression (LUR) (rPearson = 0.50). Mutually exclusive groups of subjects classified as exposed by none of the methods (high-certainty low-exposed), ODM alone, LUR alone, or both methods (high-certainty high-exposed) were created. Associations were examined using Cox regression models. RESULTS: During follow-up, 741 incident cancer cases were diagnosed and 3051 deaths occurred. Using a ≥25 ppb cutoff, compared with high-certainty low exposed, the multivariable-adjusted hazard ratios (95% confidence intervals) for lung, breast and prostate cancer were 1.56 (1.13-2.15) in high-certainty exposed, 1.27 (0.86-1.86) in LUR-exposed alone, and 1.13 (0.77-1.65) in ODM-exposed alone. The association of the former category was strengthened using more extreme NOx cutoffs. A similar pattern, albeit less strong, was observed for mortality, whereas no association was shown for cancers not previously linked to TRAP. CONCLUSIONS: Use of an ensemble of TRAP exposure estimates may improve classification, resulting in a stronger association with outcomes.

Long-term Outcomes of Contemporary Coronary Revascularization by Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in Young Adults.

BACKGROUND: Current guidelines for choosing between revascularization modalities may not be appropriate for young patients. OBJECTIVES: To compare outcomes and guide treatment options for patients < 40 years of age, who underwent percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) between 2008 and 2018. METHODS: Outcomes were compared for 183 consecutive patients aged < 40 years who underwent PCI or CABG between 2008 and 2018, Outcomes were compared as time to first event and as cumulative events for non-fatal outcomes. RESULTS: Mean patient age was 36.3 years and 96% were male. Risk factors were similar for both groups. Drug eluting stents were implemented in 71% of PCI patients and total arterial revascularization in 74% of CABG patients. During a median follow-up of 6.5 years, 16 patients (8.6%) died. First cardiovascular events occurred in 35 (38.8%) of the PCI group vs. 29 (31.1%) of the CABG group (log rank P = 0.022), repeat events occurred in 96 vs. 51 (P < 0.01), respectively. After multivariate adjustment, CABG was associated with a significantly reduced risk for first adverse event (hazard ratio [HR] 0.305, P < 0.01) caused by a reduction in repeat revascularization. CABG was also associated with a reduction in overall repeat events (HR 0.293, P < 0.01). There was no difference in overall mortality between CABG and PCI. CONCLUSIONS: Young patients with coronary disease treated by CABG showed a reduction in the risk for non-fatal cardiac events. Mortality was similar with CABG and PCI.

Transcatheter versus surgical aortic valve replacement in patients at low surgical risk: A meta-analysis of randomized trials and propensity score matched observational studies.

BACKGROUND: Although transcatheter aortic valve replacement (TAVR) is officially indicated for high risk aortic stenosis (AS) patients, the procedure is increasingly being performed in patients who are not at high surgical risk, including a substantial number of low risk patients. However, data on the benefit of TAVR in this patient population is limited. METHODS: We conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) and observational studies with propensity score matching (PSM) of TAVR versus surgical aortic valve replacement (SAVR) in patients who are at low surgical risk. The primary outcome was all-cause mortality. The secondary outcomes included stroke, myocardial infarction, bleeding, and various procedural complications. RESULTS: Six studies (2 RCTs and 4 PSM studies) totaling 3,484 patients were included. Follow-up ranged from 3 months to 3 years (median 2 years). The short-term mortality was similar with either TAVR or SAVR (2.2% for TAVR and 2.6% for SAVR, RR 0.89, 95% CI 0.56-1.41, P = 0.62), however, TAVR was associated with increased risk for intermediate-term mortality (17.2% for TAVR and 12.7% for SAVR, RR 1.45, 95% CI 1.11-1.89, P = 0.006). In terms of periprocedural complications, TAVR was associated with reduced risk for bleeding and renal failure and an increase in vascular complications and Pacemaker implantation. CONCLUSIONS: In patients who are at low surgical risk, TAVR seems to be associated with increased mortality risk. Until more data in this population is available, SAVR should remain the treatment of choice for these patients.

The effect of cessation of 2nd generation P2Y12 inhibitor therapy on platelet reactivity in patients 1 year after acute myocardial infarction.

To assess the effect of cessation of dual antiplatelet therapy (DAPT) regimens containing 2nd generation P2Y12 inhibitors on platelet reactivity, in patients who completed 12 months of DAPT following an acute myocardial infarction. Clinical data has shown an increased cardiovascular risk in the 90 days following cessation of DAPT. One possible explanation is a transient platelet hyper-reactivity after cessation of treatment. Data from patients treated with 2nd generation P2Y12 inhibitors is scarce. Patients who completed 12 month DAPT with prasugrel/ticagrelor underwent serial assessment of platelet reactivity (on DAPT and 1, 4 and 12 weeks post cessation). The primary outcome was platelet reactivity, expressed as platelet reactivity units (PRU) at each time point. 41 participants were included in this study, (23 ticagrelor, 18 prasugrel). There was no statistically significant differences in baseline characteristics between prasugrel/ticagrelor treated patients . The pattern of platelet reactivity recovery after DAPT cessation differed between the ticagrelor and prasugrel: with ticagrelor, after the initial PRU increase from baseline, the PRU remained stable, while with prasugrel, there was a further increase in PRU between 1 and 4 weeks, with a return to the 1 week level by 12 weeks (p = 0.034 for the time × treatment interaction between ticagrelor and prasugrel). Our results suggest there is a transient platelet hyper-reactivity after cessation of ADP receptor blockers therapy with prasugrel, but not ticagrelor. Further research is required to elucidate the pathophysiologic mechanisms behind these findings and to evaluate potential strategies to prevent or overcome this "rebound" effect.

Prognostic significance of aortic valve gradient in patients with severe aortic stenosis undergoing transcatheter aortic valve replacement.

OBJECTIVE: To evaluate the effect of baseline aortic valve gradient (AVG) both as a continuous and a categorical variable on mortality in patients undergoing transcatheter aortic valve replacement (TAVR), focusing on the high-gradient severe aortic stenosis (AS) patients. BACKGROUND: Identifying new predictors of mortality in the TAVR population can help refine risk stratification and improve the patient selection process for this procedure. So far, AVG has mainly been studied as a categorical variable and there is a paucity of data on its prognostic value as a continuous variable, especially in patients with high AVG AS, who constitute the majority of patients referred for TAVR. METHODS: We analyzed data on 1,224 consecutive symptomatic severe AS patients, who underwent TAVR at 3 centers. The relation between pre-TAVR AVG and mortality was evaluated among all patients and in patients with high AVGs (mean AVG ≥40 mm Hg) using the Cox proportional hazard model adjusting for multiple variables. RESULTS: During a mean follow-up of 1.8 years, baseline AVG was inversely associated with mortality in the entire cohort and in patients with high AVG AS. By multivariable analysis, patients with mean AVG 40-60 mm Hg and >60 mm Hg had a respective 38% (P = 0.010) and 61% (P < 0.001) reduction in mortality compared to patients with mean AVG <40 mm Hg. Every 10 mm Hg increase in mean AVG was associated with 20% reduction in mortality (P < 0.001). Analyses among patients with high (mean AVG >40 mm Hg) and very high AVG AS (mean AVG >60 mm Hg) yielded similar results (HR = 0.88, P = 0.031, and HR = 0.80, P = 0.019, per 10 mm Hg increase in AVG, respectively). Using peak AVGs and an analysis restricted to patients without reduced ejection fraction yielded consistent results. CONCLUSIONS: Baseline AVGs show an inverse association with mortality post-TAVR. These results were consistent also in patients with high-gradient AS, suggesting that AVG can be used to identify patients most likely to benefit from TAVR.

Real-World Use of Novel P2Y12 Inhibitors in Patients with Acute Myocardial Infarction: A Treatment Paradox.

OBJECTIVE: To assess the real-world use, clinical outcomes, and adherence to novel P2Y12 inhibitors. METHODS: We evaluated 1,093 consecutive acute myocardial infarction patients undergoing a percutaneous intervention. Patients were derived from a prospective, multicenter, nationwide registry and were followed for 30 days; 381 patients (35%) received clopidogrel, 468 (43%) received prasugrel, and 244 (22%) received ticagrelor. Patients treated with clopidogrel were older and more likely to suffer from chronic renal failure and stroke and/or present with non-ST-elevation myocardial infarction (NSTEMI) (p < 0.01 for all). Independent predictors of undertreatment with novel P2Y12 inhibitors included: older age (OR 0.17; 95% CI 0.1-0.27, p < 0.0001), a prior stroke (OR 0.41; 95% CI 0.2-0.68, p = 0.008), and NSTEMI (OR 0.37; 95% CI 0.26-0.54, p < 0.0001). RESULTS: Novel P2Y12 inhibitors were associated with a lower incidence of cardiovascular events, major bleeding, and/or death (7.6 vs.11%, HR 0.67; 95% CI 0.43-1, p = 0.05). However, after a multivariate analysis this trend was not statistically significant. Patients discharged with ticagrelor versus thienopyridines demonstrated a higher rate of crossover to other P2Y12 inhibitors (11 vs. 5%, p = 0.03). CONCLUSIONS: In a real-world cohort, there was an underutilization of novel P2Y12 inhibitors which was more pronounced in higher-risk subsets that might benefit from novel P2Y12 inhibitors at least as much as other patients.

Aortic Valve Gradient and Clinical Outcome in Patients Undergoing Transcatheter Aortic Valve Implantation for Severe Aortic Stenosis.

OBJECTIVES: To explore the relation between the baseline aortic valve gradient (AVG) as a continuous variable and clinical outcomes following transcatheter aortic valve implantation (TAVI) in general and specifically in patients with high-gradient aortic stenosis (AS). METHODS: We reviewed 317 consecutive patients who underwent TAVI at our institution. We investigated the relation between AVG as a continuous/categorical variable and outcome among all patients and in patients without low-flow low-gradient AS, using the Cox proportional hazard model adjusting for multiple prognostic variables. RESULTS: Patients had a peak AVG of 79.9 ± 22.8 mm Hg (mean 50.5 ±15.7). During a mean follow-up of 2.7 years, AVG was inversely associated with mortality and mortality or cardiac hospitalization. Every 10-mm-Hg increase in peak AVG was associated with 18% reduction in mortality (p = 0.003) and 19% reduction in mortality/cardiac hospitalization (p < 0.001). Every 10-mm-Hg increase in mean AVG was associated with a 24% reduction in both outcomes (p = 0.005 and p < 0.001). Subgroup analysis of patients with left-ventricular ejection fraction >40% or peak AVG >64 mm Hg yielded similar results. CONCLUSIONS: Mean and peak baseline AVGs are directly associated with improved outcomes after TAVI; AVG can be used to select the patients most likely to benefit from TAVI.

Insights from 2D and 3D Quantitative Angiographic Assessment of Bioresorbable Everolimus-Eluting Vascular Scaffolds.

BACKGROUND: Bioresorbable vascular scaffold (BVS) is a promising technology that potentially offers several advantages over contemporary coronary drug-eluting stents (DES). Crucial to BVS implantation is the correct choice of scaffold size (diameter and length) in order to avoid "geographic miss" in length, provide the maximal support to the vessel wall, and avoid leaving "free-floating" foreign material in the coronary vasculature. OBJECTIVES: To assess the optimal method for measuring coronary stenosis prior to BVS implantation. METHODS: We compared the performance of two quantitative coronary angiography assessment (QCA) techniques: two dimensional real-time QCA (2D-QCA) and offline 3D QCA (3D-QCA) for the evaluation of coronary lesions in patients enrolled in a multicenter randomized controlled trial of BVS vs. metallic stents, by calculating the weighted kappa value for agreement regarding optimal BVS size with the reference method - CoreLab offline 2D-QCA measurements..In addition, we collected 2 year clinical outcomes (death/myocardial infarction/repeat revascularization/scaffold thrombosis) in BVS-implanted patients. RESULTS: In 17 patients with available CoreLab data, the weighted kappa for agreement for 3D-QCA was significantly better than for 2D-QCA (0.90, 95%CI 0.72-1.00 vs. 0.439, 95%CI 0.16-0.77). The rate of clinical events at 2 years was low (9.5%). CONCLUSIONS: Initial experience in a small group of carefully selected patients at our institution, suggests that the use of BVS for coronary revascularization is associated with a low rate of adverse events in suitable patients. 3D-QCA may be superior to 2D-QCA analysis in terms of reproducibility, and results in more patients receiving optimal size BVS.

The incremental impact of residual SYNTAX score on long-term clinical outcomes in patients with multivessel coronary artery disease treated by percutaneous coronary interventions.

OBJECTIVE: To broaden the data supporting the use of the residual SYNTAX score (rSS) to define "reasonable" incomplete coronary revascularization (ICR) in order to improve the allocation of patients with severe coronary artery disease (CAD) to surgical/percutaneous revascularization and long-term clinical outcomes. INTRODUCTION: ICR is associated with a worse prognosis in patients with severe CAD, yet no consensus exists regarding its definition. METHODS: We studied 148 consecutive patients with triple vessel/left main (3VD/LM) CVD treated by percutaneous coronary interventions (PCI). Clinical outcomes at 3 years were collected; the SS and rSS were calculated. We used various definitions of "reasonable" ICR:no post-PCI total occlusion, single vs. mutivessel residual post-PCI disease, and the rSS at a cutoff value determined according to ROC curve fitted for 3 years major adverse cardiovascular and cerebrovascular adverse events (MACCE) in order to determine which definition has the strongest correlation with long-term outcomes. RESULTS: rSS ≤ 8 was associated with significant reductions in 3 year MACCE (19.4 vs. 51.1%, HR = 3.62, P = 0.014) Death/MI/CVA (13.7 vs. 28.8%, HR = 6.01, P = 0.030) and repeat revascularization (8.6 vs. 28.9%, HR = 3.44, P = 0.033) using a Cox proportional hazard ratio model adjusted to baseline characteristics, whereas single vessel residual disease and absence of total occlusion were not. CONCLUSIONS: "Reasonable" ICR as determined by rSS carries better long-term prognosis in terms of clinical outcomes vs. more extensive residual coronary disease in patients with 3VD/LM coronary artery disease treated by PCI. The rSS may improve the allocation of coronary patients to the optimal mode of revascularization.

Outcomes of Drug-Eluting Balloons for In-Stent Restenosis: Large Cohort Analysis and Single-Center Clinical Experience.

BACKGROUND: The use of drug-eluting balloons (DEBs) remains clinically relevant in the contemporary era of drug-eluting stent percutaneous coronary interventions (DES-PCI), especially in the setting of in-stent restenosis (ISR). Our goal was to assess the outcomes of ISR patients in a large prospective registry. METHODS: A total of 2329 consecutive patients with ISR-PCI (675 using DEB and 1654 with DES) were treated in our medical centre from 2010 to 2021. Clinical end points included mortality and major adverse cardiac events (MACE) at 1 year. Clinical outcomes were adjusted for multiple confounders. RESULTS: Mean ages (65.9 ± 11.0 vs 66.1 ± 10.5; P = 0.73) and percentages of female patients (16.6% vs 18.2%; P = 0.353) were similar between both ISR groups. Patients treated with DEB for ISR suffered more from diabetes, hypertension, and previous myocardial infarction (P < 0.01 for all) and presented more frequently with acute coronary syndrome (40.0% vs 34.4%; P = 0.01) compared with patients treated with DES for ISR. One-year MACE was significantly higher in the DEB ISR-PCI group (23.4% vs 19.6%; P = 0.002) compared to the DES ISR-PCI group, but no significant differences in mortality were observed at 1 year between the groups. After adjustment for multiple confounders, DEB ISR-PCI was not associated with increased MACE at 1 year (P = 0.55). CONCLUSIONS: In our large experience, patients treated with DEB for ISR-PCI have higher baseline risk and sustained increased MACE rates compared with DES ISR-PCI patients. After adjustment for confounding variables, clinical outcomes are similar between the groups at 1 year after PCI.