Rate Of Major Adverse Cardiovascular Events Research Articles

#1254 SGLT-2 inhibitors in patients with type 2 diabetes with acute kidney disease

Abstract Background and Aims Sodium-glucose cotransporter-2 (SGLT-2) inhibitors have been observed to exhibit correlative relationships with favorable impacts on renal and cardiovascular outcomes among individuals diagnosed with type 2 diabetes. Nonetheless, the extent of the influence of SGLT-2 inhibitors on patients with type 2 diabetes concomitant with acute kidney disease (AKD) remains enigmatic. Method This investigation leveraged expansive global healthcare data from TriNetX, spanning the timeframe from September 2002 to September 2022. Propensity score matching was systematically applied to meticulously curate a patient cohort, with a subsequent follow-up period extending over 5 years or until the manifestation of a defined outcome or mortality. The underlying research design took the form of an observational cohort study. The primary objective of this study was to scrutinize the enduring associations of Sodium-glucose cotransporter-2 (SGLT-2) inhibitors in patients afflicted with type 2 diabetes and concurrent acute kidney disease (AKD). Particular emphasis was directed towards evaluating the impact on mortality rates, major adverse kidney events (MAKEs), and major adverse cardiovascular events (MACEs) over the specified temporal continuum. The primary outcomes measured were mortality, MAKEs, and MACEs. Adjusted hazard ratios (aHR) with 95% confidence intervals (CI) were calculated to compare the risks between SGLT-2 inhibitor users and non-users, representing the average treatment effect among the treated. Results A total cohort of 230, 366 individuals diagnosed with AKD, boasting a mean age of 67.1 years and a male representation of 53.1%, formed the basis of this study. Within this cohort, 5 319 subjects (constituting 2.3%) were identified as users of SGLT-2 inhibitors. The incidence rates for mortality, MAKEs, and MACEs among non-users were recorded at 18.7%, 21.0%, and 25.8%, respectively. Following the meticulous application of propensity score matching, absolute differences in the incidence rates of mortality, MAKEs, and MACEs between SGLT-2 inhibitor users and non-users were calculated at 9.7%, 11.5%, and 12.3%, respectively. In the treated population, SGLT-2 inhibitor users exhibited a notably lower risk of mortality (adjusted Hazard Ratio [aHR]: 0.69, 95% Confidence Interval [CI]: 0.62-0.77), MAKEs (aHR: 0.62, 95% CI: 0.56-0.69), and MACEs (aHR: 0.75, 95% CI: 0.65-0.88) in comparison to their non-using counterparts. The robustness of these observed benefits was validated externally using a multicenter cohort dataset comprising 1, 233 AKD patients who were SGLT-2 inhibitor users, thereby affirming the positive outcomes. Importantly, the risk reduction associated with SGLT-2 inhibitors persisted significantly even among subpopulations devoid of hypertension, those with advanced chronic kidney disease, and individuals not concurrently receiving other oral hypoglycemic agents. Conclusion In this meticulously conducted cohort study involving individuals diagnosed with type 2 diabetes and AKD receiving treatment with SGLT-2 inhibitors, our findings suggest a potential association with diminished rates of mortality, MAKEs, and MACEs. These results underscore the imperative for subsequent and more in-depth investigations into the precise associations of SGLT-2 inhibitors within this distinctively treated population.

Vasculopathy Augments Cardiovascular Risk in Community-Dwelling Elderly with Left Ventricular Hypertrophy.

This study aimed to investigate the impact of various vasculopathies alongside left ventricular hypertrophy (LVH) on cardiovascular risk in the elderly. This prospective cohort study included 3339 older adults from the Northern Shanghai Study, classified into four mutually exclusive left ventricular (LV) geometry groups based on echocardiographic data: normal geometry, concentric remodeling, eccentric hypertrophy, and concentric hypertrophy. Vasculopathy was categorized into three primary types: arteriosclerosis, atherosclerosis, and renal senescence. Major adverse cardiovascular events (MACEs) were defined as non-fatal acute myocardial infarction, non-fatal stroke, and cardiovascular deaths according to ICD-10 codes. Over a median follow-up period of 5.7 years, 221 incident cases of MACEs were identified. Concentric hypertrophy exhibited the highest prevalence of hypertension, the most significant increase in vascular stiffness, and the highest rate of MACEs. The adjusted Cox regression analysis showed that eccentric hypertrophy is associated with an increased risk of MACEs (HR: 1.638 [95% CI: 1.151-2.331], p = 0.006), while concentric hypertrophy shows an even higher risk (HR: 1.751 [95% CI: 1.127-2.721], p = 0.013). Conversely, concentric remodeling was not significantly associated with an increased risk of MACEs. Renal senescence presents a moderate but significant risk for MACEs, with an HR of 1.361 (95% CI: 1.019-1.819; p = 0.037) when adjusted for LVH. The Kaplan-Meier analysis showed that patients with LVH and multiple vasculopathies experience the most significant decrease in survival probability (log-rank p < 0.001). The subgroup analysis revealed that LVH significantly raises the risk of MACEs, especially in older males with hypertension, diabetes, or vasculopathy. This study reinforces the importance of LVH as a predictor of adverse cardiovascular outcomes and underscores the compounded risk associated with the presence of multiple vasculopathies. Additionally, it highlights renal senescence as a distinct and independent risk factor for MACEs, separate from LVH.

SPONTANEOUS CORONARY ARTERY DISSECTION (SCAD) WITH CARDIAC ARREST AT PRESENTATION: A SUBANALYSIS FROM THE DISCO REGISTRY

Abstract Introduction Spontaneous coronary artery dissection (SCAD) is a rare cause of acute myocardial infarction (AMI), which primarily affects young women without traditional cardiovascular risk factors, often presenting as sudden cardiac death. This study aims to investigate the prevalence, characteristics, predictors, and outcomes of cardiac arrest in SCAD patients. Methods The DISCO IT/SPA registry, an international retrospective multicenter study, enrolled 375 SCAD patients from 26 centers in Italy and Spain. Patients were categorized based on the presence or absence of cardiac arrest at admission. Data on demographics, clinical presentation, treatment, angiographic findings, and outcomes were collected. Angiograms were independently reviewed, and outcomes included major adverse cardiovascular events (MACE) and in–hospital bleeding. Results Among 375 SCAD patients, 20 (5.3%) presented with cardiac arrest. Both groups were similar in age, gender distribution, and conventional risk factors, except for a lower prevalence of dyslipidemia in the cardiac arrest group. ST–segment elevation myocardial infarction (STEMI) presentation and angiographic type 2b were independent predictors of cardiac arrest. Revascularization was more frequent in the cardiac arrest group. In–hospital outcomes, except for longer hospitalization, did not differ. On follow–up (average 21 months), MACE rates were similar between groups. Conclusions Cardiac arrest is a notable complication in SCAD, mostly presenting with ventricular fibrillation. The prognosis of SCAD patients presenting with cardiac arrest did not differ from those without, reporting a similar rate of events both in–hospital and during long–term follow–up. STEMI presentation and angiographic type 2b were identified as independent predictors of cardiac arrest in SCAD.

Prognostic Implications of Left Ventricular Hypertrophy and Mechanical Function in Fabry Disease: A Longitudinal Cohort Study

The prognostic value of different grades of left ventricular hypertrophy (LVH) and left ventricular (LV) mechanical function in Fabry disease is unclear. We aimed to evaluate the association between the severity of LVH, LV mechanical function, and clinical outcomes in Fabry disease. We conducted a retrospective cohort study from a single-center registry of adult patients with Fabry disease. Left ventricular mass index (LVMI) was measured by echocardiography. The severity of LVH was categorized by LVMI using the sex-specific cutoff values. Left ventricular mechanical function was measured as LV global longitudinal strain (GLS) by speckle-tracking analysis. The primary outcome was a composite of major adverse cardiovascular events (MACE) at 5years, including heart failure hospitalization, sustained ventricular tachycardia, acute ischemic stroke, and all-cause mortality. The study included 268 patients (age 50.4±15.4years, men 46.6%) with Fabry disease (83.2% IVS4+919G>A mutation), and 106 patients (39.6%) had LVH. Patients with mild, moderate, or severe LVH had 5-year MACE rates of 7.4%, 10%, and 30.5%, respectively (P<.001). Moreover, patients with impaired LV GLS (<14.1%) had a higher 5-year MACE rate than those with preserved LV GLS (32.1% vs 2.4%, P<.001). Severe LVH was an independent predictor of MACE compared with absence of LVH (adjusted hazard ratio, 12.73; 95% CI, 1.3-124.71; P=.03), after adjusting for age, sex, hypertension, hyperlipidemia, atrial fibrillation, renal function, average E/e', enzyme replacement therapy, and LV GLS. Patients with severe LVH and impaired LV GLS had the highest incidence for MACE (log-rank P<.05), irrespective of sex, genotypes, and whether receiving enzyme replacement therapy or not. Sex-specific grading of LVH by LVMI is practical for risk stratification in patients with Fabry disease, and impaired LV GLS further refines the prognostication.

Same-day discharge after large-bore access in percutaneous coronary intervention of chronic total coronary occlusions.

Same-day discharge (SDD) in patients undergoing percutaneous coronary intervention (PCI) of a chronic total occlusion (CTO) is appealing because of the increased patient comfort. However, data on SDD following large-bore vascular access are scarce. We investigated the feasibility and safety of SDD in patients undergoing large-bore CTO PCI. Between 2013 and 2023, 948 patients were prospectively enrolled in a single-centre CTO registry and underwent CTO PCI. SDD was pursued in all patients. Large-bore access was defined as the use of ≥7 French (Fr) sheaths in ≥1 access site. A logistic regression analysis was used to identify predictors for non-SDD. Clinical follow-up was obtained at 30 days. SDD was observed in 62% of patients. Large-bore access was applied in 99% of the cohort. SDD patients were younger and more often male, with lower rates of renal insufficiency and prior coronary artery bypass grafting. Local access site bleeding (odds ratio [OR] 8.53, 95% confidence interval [CI]: 5.24-13.87) and vascular access complications (OR 7.23, 95% CI: 1.98-26.32) made hospitalisation more likely, with vascular access complications occurring in 3%. At 30 days, the hospital readmission rate was low in both SDD and non-SDD patients (5% vs 7%; p=non-significant). Finally, SDD was not a predictor for major adverse cardiovascular events (MACE) at follow-up. Same-day discharge can be achieved in the majority of patients undergoing CTO PCI with large-bore (≥7 Fr) access. Similar low hospital readmission and MACE rates between SDD and non-SDD patients at 30 days demonstrate the feasibility and safety of SDD.

Impact of Polyvascular Disease in Patients Undergoing Unprotected Left Main Percutaneous Coronary Intervention

Percutaneous coronary intervention (PCI) has demonstrated its safety and efficacy in treating left main coronary artery disease (LM-CAD) in select patients. Polyvascular disease (PolyVD) is associated with adverse events in all-comers with CAD. However, there is little data examining the interplay between PolyVD and LM-PCI, which we sought to investigate in a retrospective single-center study. We included patients undergoing unprotected LM-PCI at a tertiary center from 2012-2019. The patient population was stratified based on the presence or absence of PolyVD (i.e. medical history of cerebrovascular and/or peripheral artery disease in addition to LM-CAD). The primary outcome was major adverse cardiovascular events (MACE) combining all-cause mortality and spontaneous myocardial infarction within one year after index PCI. Overall, 869 patients were included, and 23.8% of the population had PolyVD. Individuals with PolyVD were older and had a greater burden of comorbidities. After 1 year follow-up individuals with PolyVD exhibited significantly higher rates of both MACE (22.8% vs. 9.4%; p<0.001) and bleeding events compared to those without PolyVD. MACE was primarily driven by an increase in all-cause mortality (18.3% vs. 7.1%; p<0.001). Results persisted after adjusting for confounders. In conclusion, among patients undergoing LM-PCI, the presence of PolyVD is linked to an increased risk of MACE and bleeding after 1 year of follow-up, which highlights the vulnerability of this patient population.

Drug-coated balloon in the treatment of coronary artery de-novo large lesions angiography.

The superiority of drug-coated balloon (DCB) in treating small vessels, branching lesions, and high-risk bleeding lesions in coronary heart disease patients has been confirmed. However, its safety and efficacy in large vessels are still unclear. We aimed to investigate whether the efficacy of DCB in large vessels is not inferior to that of drug-eluting stent (DES). From November 2019 to April 2022, a total of 88 patients in our hospital who underwent coronary angiography for the first time and decided to receive DCB or DES treatment were selected. Indicators including late lumen loss (LLL), major adverse cardiovascular event (MACE) rate, major bleeding and all-cause mortality were evaluated at 9 months and 1-year post percutaneous coronary intervention (PCI) therapy. The primary endpoint of 9-month LLL was -0.07 in the DCB group and 0.19 mm in the DES group (p value＜0.001). 1-year cumulative MACE rates were similar in the DCB and DES groups (3.03% vs. 7.23%, P=0.519), TLR rates were similar (3.03% vs. 7.23%, P=0.519), Major bleeding was similar (3.03% vs. 5.45%, P=0.580), and 1 case of Cardiac death in DES group. For LLL, the DCB-only strategy was non-inferior to DES in treating de novo large lesions in the coronary arteries. Furthermore, the efficacy of DCB was comparable to DES at 1 year of follow-up for secondary clinical endpoints.

The Randomized, Multicenter, Open-Label, Controlled POLBOS 3 Trial Comparing Regular Drug-Eluting Stents and the Sirolimus-Eluting BiOSS LIM C Dedicated Coronary Bifurcation Stent: Four-Year Results.

This multicenter, randomized study aimed to compare the sirolimus-eluting BiOSS LIM C dedicated coronary bifurcation stent with second-generation -limus drug-eluting stents (rDESs) in the treatment of non-left main (non-LM) coronary bifurcation. The deployment of a single stent in the main vessel-main branch across a side branch was the default strategy in all patients. The primary endpoint was the rate of major cardiovascular events (cardiac death, myocardial infarction, and target lesion revascularization) at 48 months. We enrolled 230 patients, allocating 116 patients to the BiOSS LIM C group and 114 patients to the rDES group. Most procedures were elective (BiOSS vs. rDES: 48.3% vs. 59.6%, p = 0.09) and performed in bifurcations within the left anterior descending/diagonal branch (BiOSS vs. rDES: 51.7% vs. 61.4%, p = 0.15). At 48 months, there were no statistically significant differences between the BiOSS and rDES groups in terms of major adverse cardiovascular events (MACE), cardiac death, myocardial infarction (MI), or target lesion revascularization (TLR) as follows: MACEs-18.1% vs. 14.9%, HR 1.36, 95% CI 0.62-2.22, and p = 0.33; cardiac death-4.3% vs. 3.5%, HR 1.23, 95% CI 0.33-4.56, and p = 0.75; MI-2.6% vs. 3.5%, HR 0.73, 95% CI 0.17-3.23, and p = 0.68; and TLR-11.2% vs. 7.9%, HR 1.66, 95% CI 0.75-3.71, and p = 0.21. The implantation success rate of the BiOSS LIM C stent was very high, and the cumulative MACE rates were promising. The POLBOS 3 trial sets an important benchmark for treating non-LM coronary bifurcations (ClinicalTrials.gov NCT03548272).

Rationale and design for the randomized placebo-controlled double-blind trial studying the effect of single antiplatelet therapy (clopidogrel) versus dual antiplatelet therapy (clopidogrel/acetylsalicylic acid) on the occurrence of atherothrombotic events following lower extremity peripheral transluminal angioplasty (CLEAR-PATH)

RationaleAntiplatelet therapy (APT) is the standard of care after endovascular revascularization (EVR) in patients with peripheral artery disease (PAD). APT aims to prevent both major adverse cardiovascular events (MACE) and major adverse limb events (MALE). Nonetheless, the rates of MACE and MALE after EVR remain high. In coronary artery and cerebrovascular disease, dual APT (DAPT)compared to acetylsalicylic acid alone has proven to reduce MACE without increasing the risk of major bleeding when applied for a restricted number of weeks. However, within the PAD population, insufficient data are available to understand the potential attributable effect of DAPT over single APT (SAPT). Therefore, prospective randomized studies in targeted study populations are warranted. Trial designCLEAR-PATH is a Dutch multicenter, double-blind, placebo-controlled, randomized trial comparing SAPT (clopidogrel 75mg plus placebo) with DAPT (clopidogrel 75mg plus acetylsalicylic acid 80mg) in patients with PAD undergoing EVR. CLEAR-PATH includes a time-to-event analysis with a follow-up of one year. The primary composite efficacy endpoint consists of all-cause mortality, nonfatal stroke, nonfatal myocardial infarction, severe limb ischemia, (indication for) re-intervention due to any symptomatic restenosis, re-occlusion, or due to acute limb ischemia, and major amputation. The primary safety endpoint contains major bleeding following the Thrombolysis In Myocardial Infarction classification. The enrolment started in August 2022. In total 450 primary efficacy outcome events are required which expectedly amounts to 1696 subjects. Recruitment will take approximately 36 months. ConclusionCLEAR-PATH will assess the efficacy and safety of DAPT compared to SAPT following EVR in PAD patients.

Five-year outcomes of double kissing mini-culotte stenting vs. mini-culotte stenting using drug-eluting stents for the treatment of true coronary bifurcation lesions.

This study aimed to compare the clinical outcomes of double kissing mini-culotte (DKMC) stenting with those of mini-culotte (MC) stenting in treating patients with true coronary bifurcation lesions (CBLs) in the clinical real world. This retrospective observational cohort study included 180 consecutive patients with true CBLs (Medina type 1,1,1; 1,0,1; 0,1,1). All eligible patients underwent coronary angiography and percutaneous coronary intervention with two-stent techniques in our hospital; among them, 97 received DKMC treatment and 83 MC treatment. The primary clinical endpoints were the major adverse cardiovascular events (MACE), which included cardiac death, myocardial infarction, and target vessel/lesion revascularization (TVR/TLR). The secondary endpoints were stent thrombosis, in-stent restenosis, and individual components of MACE. Quantitative coronary angiography analysis (at 5 years) revealed that late lumen loss (0.25 ± 0.41 mm vs. 0.14 ± 0.32 mm, P = 0.032) and segmental diameter restenosis of the side branch (27.84 ± 12.34% vs. 19.23 ± 9.76%, P = 0.016) were lower in the DKMC treatment group than that in the MC treatment group. Notably, compared to that in the MC treatment group, the cumulative event rate of MACE at 5 years (22.8% vs. 8.3%, P = 0.007) and TVR/TLR (17.7% vs. 6.3%, P = 0.018) was higher in the DKMC treatment group, driven mainly by TVR/TLR. Especially, the DKMC group was related to a significant reduction in the primary and secondary endpoints in high-risk patients. DKMC treatment was associated with less late lumen loss and restenosis in the side branch and a lower rate of cumulative MACE and TVR/TLR. DKMC treatment is more effective for treating true CBLs than MC treatment; however, these findings warrant further confirmation through a randomized clinical trial.

Sodium-Glucose Cotransporter-2 Inhibitors and Major Adverse Cardiovascular Outcomes: A SMART-C Collaborative Meta-Analysis.

Sodium-glucose cotransporter-2 inhibitors (SGLT2i) consistently improve heart failure and kidney-related outcomes; however, effects on major adverse cardiovascular events (MACE) across different patient populations are less clear. This was a collaborative trial-level meta-analysis from the SGLT2i Meta-analysis Cardio-Renal Trialists Consortium, which includes all phase 3, placebo-controlled, outcomes trials of SGLT2i across 3 patient populations (patients with diabetes at high risk for atherosclerotic cardiovascular disease, heart failure [HF], or chronic kidney disease). The outcomes of interest were MACE (composite of cardiovascular death, myocardial infarction , or stroke), individual components of MACE (inclusive of fatal and nonfatal events), all-cause mortality, and death subtypes. Effect estimates for SGLT2i versus placebo were meta-analyzed across trials and examined across key subgroups (established atherosclerotic cardiovascular disease, previous myocardial infarction, diabetes, previous HF, albuminuria, chronic kidney disease stages, and risk groups). A total of 78 607 patients across 11 trials were included: 42 568 (54.2%), 20 725 (26.4%), and 15 314 (19.5%) were included from trials of patients with diabetes at high risk for atherosclerotic cardiovascular disease, HF, or chronic kidney disease, respectively. SGLT2i reduced the rate of MACE by 9% (hazard ration [HR], 0.91 [95% CI, 0.87-0.96], P<0.0001) with a consistent effect across all 3 patient populations (I2=0%) and across all key subgroups. This effect was primarily driven by a reduction in cardiovascular death (HR, 0.86 [95% CI, 0.81-0.92], P<0.0001), with no significant effect for myocardial infarction in the overall population (HR, 0.95 [95% CI, 0.87-1.04], P=0.29), and no effect on stroke (HR, 0.99 [95% CI, 0.91-1.07], P=0.77). The benefit for cardiovascular death was driven primarily by reductions in HF death and sudden cardiac death (HR, 0.68 [95% CI, 0.46-1.02] and HR, 0.86 [95% CI, 0.78-0.95], respectively) and was generally consistent across subgroups, with the possible exception of being more apparent in those with albuminuria (Pinteraction=0.02). SGLT2i reduce the risk of MACE across a broad range of patients irrespective of atherosclerotic cardiovascular disease, diabetes, kidney function, or other major clinical characteristics at baseline. This effect is driven primarily by a reduction of cardiovascular death, particularly HF death and sudden cardiac death, without a significant effect on myocardial infarction in the overall population, and no effect on stroke. These data may help inform selection for SGLT2i therapies across the spectrum of cardiovascular-kidney-metabolic disease.

Revisión sistemática y metanálisis de estudios aleatorizados y no aleatorizados sobre revascularización guiada por reserva fraccional de flujo

Introduction and objectivesSeveral studies have investigated the effectiveness of fractional flow reserve (FFR) guidance in improving clinical outcomes after myocardial revascularization, yielding conflicting results. The aim of this study was to compare clinical outcomes in patients with coronary artery disease following FFR-guided or angiography-guided revascularization. MethodsBoth randomized controlled trials (RCTs) and nonrandomized intervention studies were included. Coprimary endpoints were all-cause death, myocardial infarction, and major adverse cardiovascular events (MACE). The study is registered with PROSPERO (CRD42022344765). ResultsA total of 30 studies enrolling 393 588 patients were included. FFR-guided revascularization was associated with significantly lower rates of all-cause death (OR, 0.63; 95%CI, 0.53-0.73), myocardial infarction (OR, 0.70; 95%CI, 0.59-0.84), and MACE (OR, 0.77; 95%CI, 0.70-0.85). When only RCTs were considered, no significant difference between the 2 strategies was observed for any endpoints. However, the use of FFR was associated with reduced rates of revascularizations and treated lesions. Metaregression suggested that the higher the rate of revascularized patients the lower the benefit of FFR guidance on MACE reduction compared with angiography guidance (P=.012). Similarly, higher rates of patients with acute coronary syndromes were associated with a lower benefit of FFR-guided revascularization (P=.039). ConclusionsFFR-guided revascularization was associated with lower rates of all-cause death, myocardial infarction and MACE compared with angiographic guidance, with RCTs and nonrandomized intervention studies yielding conflicting data. The benefits of FFR-guidance seem to be less evident in studies with high revascularization rates and with a high prevalence of patients with acute coronary syndrome.

Effectiveness and Safety of a Novel Intravascular Lithotripsy System for Severe Coronary Calcification: The CALCI-CRACK Trial

BackgroundIntravascular lithotripsy is effective and safe for managing coronary calcification; however, available devices are limited, and complex lesions have been excluded in previous studies. This study aimed to investigate the effectiveness and safety of a novel intravascular lithotripsy system for severe calcification in a population with complex lesions. MethodsCALCI-CRACK (treatment of severe calcified coronary lesions with a novel intracoronary shock wave lithotripsy system) (ChiCTR2100052058) was a prospective, single-arm, multicentre study. The primary end point was the procedural success rate. Major safety end points included major adverse cardiovascular events (MACE) and target lesion failure (TLF) at 30 days and 6 months, and severe angiographic complications. Calcification morphology was assessed in the optical coherence tomography (OCT) subgroup. ResultsIn total, 242 patients from 15 high-volume Chinese centres were enrolled, including 26.45% of patients with true bifurcation lesions, 3.31% with severely tortuous vessels, and 2.48% with chronic total occlusion, respectively. The procedural success rate was 95.04% (95% confidence interval 91.50%-97.41%), exceeding the prespecified performance goal of 83.4% (P < 0.001). The 30-day and 6-month MACE rates were 4.13% and 4.55%, respectively. TLF rates at those time points were 1.24% and 1.65%, respectively. Severe angiographic complications occurred in 0.42% of patients. In the OCT subgroup (n = 93), 93.55% of calcified lesions were fractured, and minimal lumen area increased from 1.55 ± 0.55 mm2 to 4.91 ± 1.22 mm2 after stent implantation, with acute gain rate of 245 ± 102%. ConclusionsThe novel intravascular lithotripsy system is effective and safe for managing severely calcified coronary lesions in a cohort that included true bifurcation lesions, severely tortuous vessels, and chronic total occlusion. Clinical Trial RegistrationChinese Clinical Trial Registry (ChiCTR), number ChiCTR2100052058

Stroke prevention strategies for cardiac surgery: a systematic review and meta-analysis of randomized controlled trials.

Stroke is a much-feared complication of cardiac surgery, but existing literature on preventive strategies is fragmented. Hence, a systematic review and meta-analysis of stroke prevention strategies for cardiac surgery was conducted. An electronic literature search was conducted to retrieve randomized controlled trials (RCTs) investigating perioperative interventions for cardiac surgery, with stroke as an outcome. Random-effects meta-analyses were conducted to generate risk ratios (RRs), 95% confidence intervals (95% CI), and forest plots. Descriptive analysis and synthesis of literature was conducted for interventions not amenable to meta-analysis, focusing on risks of stroke, myocardial infarction and study-defined major adverse cardiovascular events (MACE). Fifty-six RCTs (61 894 patients) were retrieved. Many included trials were underpowered to detect differences in stroke risk. Among pharmacological therapies, only preoperative amiodarone was shown to reduce stroke risk in one trial. Concomitant left atrial appendage closure (LAAC) significantly reduced stroke risk (RR = 0.55, 95% CI = 0.36-0.84, P = 0.006) in patients with preoperative atrial fibrillation, and there was no difference in on-pump versus off-pump coronary artery bypass grafting (CABG) (RR = 0.94, 95% CI = 0.64-1.37, P = 0.735). Much controversy exists in literature on the timing of carotid endarterectomy relative to CABG in patients with severe carotid stenosis. The use of preoperative remote ischemic preconditioning was not found to reduce rates of stroke or MACE. This review presents a comprehensive synthesis of existing interventions for stroke prevention in cardiac surgery, and identifies gaps in research which may benefit from future, large-scale RCTs. LAAC should be considered to reduce stroke incidence in patients with preoperative atrial fibrillation.

Predictive Value of Carotid-femoral Pulse Wave Velocity for Major Adverse Cardiovascular Events and All-cause Mortality in Different Age Groups of a Chinese Community

Objective: To investigate the predictive value of carotid-femoral pulse wave velocity (cf-PWV) for assessing major adverse cardiovascular events (MACE) and all-cause mortality in different age groups of a Chinese community. Methods: This is an observational study which enrolled 1,325 individuals from a community in Beijing from September 2007 to October 2018. They were classified based on age into &lt;65-year-old (n = 572) and ≥65-year-old (n = 753) groups, and on cf-PWV into cf-PWV &lt;12 m/s (n = 501) and cf-PWV≥12 m/s (n = 824) group. The incidence rates of MACE and all-cause mortality were recorded for both the groups during the follow-up period of 9.5 years. The predictive value of cf-PWV for MACE and all-cause mortality in the 2 age groups was estimated using the Cox proportional hazards regression models. Results: The baseline cf-PWV showed positive correlation with age (r = 0.462, P &lt; 0.001). During the follow-up period, 191 MACE and 84 all-cause mortality cases were recorded in the study population. The incidence rates of MACE (χ 2 = 27.196, P &lt; 0.001) and all-cause mortality (χ 2 = 9.473, P = 0.002) were significantly higher in subjects with cf-PWV ≥12 m/s than in subjects with cf-PWV &lt;12 m/s. Cox proportional hazards regression model analyses demonstrated that cf-PWV was an independent risk factor in the &lt;65-year-old group for MACE (hazard ratio: 1.310; 95% confidence interval: 1.007–1.560; P = 0.038) and all-cause mortality (hazard ratio: 1.412; 95% confidence interval: 1.133–1.936; P = 0.005) after adjusting for several risk factors. However, both univariate and multivariate analyses demonstrated that cf-PWV was not an independent risk factor for MACE or all-cause mortality in the ≥65-year-old group (P &gt; 0.05). Conclusion: cf-PWV, a measure of arterial stiffness, emerged as an independent risk factor for MACE and all-cause mortality in subjects below 65 years of age.

Safety and Feasibility of the BYCROSS® Atherectomy Device for the Treatment of Femoropopliteal Arterial Obstructions: Single-Center Short-Term Outcomes.

Background: Endovascular techniques have gained preference over peripheral arterial bypass surgery due to their minimally invasive nature; however, endovascular treatments often show limited efficacy in arterial segments with a high atherosclerotic load. The use of atherectomy devices enables the removal of calcified plaque material and may promote arterial wall remodeling. This study assessed the technical success, safety, and feasibility of the BYCROSS® atherectomy device in femoropopliteal lesions. Methods: This single-center, retrospective cohort study analyzed elective patients undergoing BYCROSS® atherectomy for chronic peripheral arterial disease from March 2022 to May 2023. Patient data, procedural details, and outcomes were retrospectively collected from electronic patient records. The primary performance endpoints of this study were technical success, complications, and patency rates. Primary safety endpoints included 30-day and short-term major adverse limb events (MALEs), major adverse cardiovascular events (MACEs), and mortality rate. Results: The study included 19 patients (median age, 71 years; 63% male) with Fontaine class IIb (26%), III (21%), or IV (53%). The BYCROSS® atherectomy device was used to treat 22 limbs in the femoropopliteal tract, of which 11 lesions (50%) were occlusions and 11 were stenoses, with a median length of 24 cm (interquartile range: 17-38). Technical success was achieved in all cases: 4.5% required atherectomy only, 50% required additional balloon angioplasties, 41% required balloon angioplasties and stenting, and 4.5% required segments only stenting. Additional treatment of below-the-knee arteries was performed in 12 patients. Procedurally related complications (not limited to the use of the BYCROSS® device) occurred in 23% of limbs, including distal embolization and laceration. At 30 days, mortality was 5%, the MACE rate was 11%, and the MALE rate was 0%. The observed mortality rate was not directly related to the procedure. Patency (<50% restenosis at duplex ultrasound) was 83% at 30 days. Conclusions: The use of the BYCROSS® atherectomy device for the treatment of femoropopliteal lesions appears to be safe and feasible, with high technical success and low MALE and MACE rates in a challenging population with long-segment femoropopliteal lesions. Long-term follow-up in larger patient series is needed to confirm these findings and to determine the durability of this technique.

Prognostic value of left ventricular mechanical dyssynchrony indices derived from gated myocardial perfusion SPECT in coronary artery disease: a systematic review and meta-analysis.

Left ventricular mechanical dyssynchrony (LVMD) is an important prognostic factor in coronary artery disease. A growing body of evidence indicates that LVMD parameters derived from phase analysis of gated myocardial SPECT may allow risk stratification for future cardiac events. We performed a systematic review and meta-analysis on the prognostic value of LVMD on gated SPECT in patients with coronary artery disease. PubMed, Embase, and the Cochrane library were searched until August 25, 2022, for studies reporting the prognostic value of LVMD on gated SPECT for outcomes of all-cause death, cardiac death, or major adverse cardiovascular event (MACE) in patients with coronary artery disease. Hazard ratios (HRs) and their 95% confidence intervals (CIs) were meta-analytically pooled using a random-effects model. Nine studies (26,750 patients) were included in a qualitative synthesis. Among the SPECT LVMD parameters used in various studies, high phase standard deviation, phase bandwidth, and phase entropy were widely evaluated and reported to be associated with high rates of all-cause death, cardiac death, or MACE. For five studies (23,973 patients) in the quantitative synthesis, the pooled HR of LVMD for predicting MACE was 2.81 (95% CI 2.03-3.88). Studies using combined phase parameters to define LVMD showed higher HRs than a study using phase entropy (p = 0.0180). LVMD from gated myocardial SPECT is a significant prognostic factor for coronary artery disease. Phase analysis of gated SPECT may be useful for accurate risk stratification and could be applied for clinical decision-making in such patients.

Clonal hematopoiesis is associated with cardiovascular events in patients with stable coronary artery disease

Clonal hematopoiesis (CH) is a risk factor for atherosclerotic cardiovascular disease, but the impact of smaller clones and the effect on inflammatory parameters is largely unknown. Using ultrasensitive single-molecule molecular inversion probe sequencing, we evaluated the association between CH and a first major adverse cardiovascular event (MACE) in patients with angiographically documented stable coronary artery disease (CAD) and no history of acute ischemic events. CH was associated with an increased rate of MACE at four years follow-up. The size of the clone predicted MACE at an optimal cut-off value of 1.07% variant allele frequency (VAF). Mutation carriers had no change in monocytes subsets or cytokine production capacity but had higher levels of circulating tissue factor, matrilysin, and proteinase-activated receptor-1. Our study identified CH driver mutations with a VAF as small as 1.07% as a residual cardiovascular risk factor and identified potential biomarkers and therapeutic targets for patients with stable CAD.

20-year follow-up of rheumatic mitral stenosis patients after percutaneous mitral commissurotomy: invasive transmitral gradient differential as a predictor of events.

Percutaneous mitral valve commissurotomy (PMC) is a viable alternative to mitral valve (MV) surgery in the treatment of patients with rheumatic mitral stenosis (RMS). In this single-center retrospective study of consecutive patients with RMS submitted to PMC from 1991 to 2008, we analyzed clinical, echocardiographic, and hemodynamic data and events during follow-up (FUP) until December 2021. Major adverse cardiovascular events (MACE) were a combined endpoint of all-cause death, cardiovascular hospitalization, and MV re-intervention. A total of 124 patients were enrolled: 108 (87.1%) were female, with a mean age at PMC of 46 [standard deviation (SD) 11] years. PMC was successful in 91.1%, with a mean reduction in invasive transmitral pressure gradient (TMPG) of 8 (SD 7) mmHg at PMC time. During the mean FUP of 20 (SD 6) years, 51 (41.1%) patients had MV re-intervention (86.3% surgery and 13.7% redo-PMC), 37 (29.8%) were hospitalized, and 30 (24.2%) died. Approximately 75% of patients remained MACE-free after 10 years, and this percentage decreased to around 40% after 20 years; at this time mark, about 8 in 10 patients were alive. A reduction of <5 mmHg in TMPG at PMC time was associated with a 2.7-fold greater rate of MACE compared to a reduction of ≥5 mmHg, independent of MV regurgitation after PMC and moderate disease of other valves (adjusted hazard ratio 2,7; 95% confidence interval 1.395-5.298, p=0.003). In this cohort with favorable long-term results after PMC, a reduction of <5 mmHg in TMPG at PMC time was associated with MACE during FUP. More studies are needed to validate this independent predictor.

Clinical efficacy of clopidogrel and ticagrelor in patients undergoing off-pump coronary artery bypass grafting: a retrospective cohort study.

Ticagrelor is reportedly more effective than clopidogrel in preventing atherothrombotic events in patients with percutaneous coronary intervention. However, the optimal antiplatelet therapy strategy after off-pump coronary artery bypass grafting (OPCABG) is yet to be established. This study was performed using the prospectively-maintained database at our institution. Patients who underwent OPCABG were divided into the clopidogrel and the ticagrelor groups. Propensity score matching analysis was performed between the two groups. The clinical outcome was the occurrence of major adverse cardiovascular event (MACE), defined as a composite of vascular death, myocardial infarction, or stroke 1 year after surgery. In total, 545 patients completed the entire follow-up assessment. After propensity score matching, 232 patients each were included in the clopidogrel and ticagrelor groups. The primary outcome occurred in 7.8% and 4.3% of patients in the clopidogrel and ticagrelor groups, respectively (P=0.113). CYP2C19 variants (*2, *3, and *17) did not impact the clinical outcomes, regardless of the use of clopidogrel or ticagrelor. The rates of MACE were significantly lower in patients carrying the ABCB1 C3435T CT/TT genotypes in the ticagrelor group than in those carrying the ABCB1 C3435T CC genotype in the clopidogrel group (1.4% vs. 9.1%, adjusted P=0.030), as well as those carrying the ABCB1 C3435T CC genotype in the ticagrelor group (1.4% vs. 8.9%, adjusted P=0.036). The ABCB1 C3435T CC genotype was significantly associated with the incidence of 1-year MACE (HR=1.558, 95% CI 1.109-2.188, P=0.011). Patients who experienced severe perioperative bleeding exhibited a significantly higher incidence of MACE than those who did not experience severe perioperative bleeding (14.0% vs. 4.9%, adjusted P=0.007). There was no significant difference in the 1-year MACE between patients receiving clopidogrel and those receiving ticagrelor after OPCABG. Notably, The ABCB1 C3435T CC genotype was related to a higher risk of MACE.