Bleeding following percutaneous coronary intervention has important prognostic implications. The Academic Research Consortium (ARC) recently proposed a list of clinical criteria to define patients at ...high bleeding risk (HBR).
This study sought to validate the ARC definition for HBR patients in a contemporary real-world cohort.
Patients undergoing coronary stenting between 2014 and 2017 at a tertiary-care center were defined as HBR if they met at least 1 major or 2 minor ARC-HBR criteria. To account for the presence of multiple criteria, patients were further stratified by the number of times they fulfilled the ARC-HBR definition. The primary endpoint was a composite of peri-procedural in-hospital or post-discharge bleeding at 1 year. Secondary endpoints included individual components of the primary bleeding endpoint, myocardial infarction, and all-cause mortality.
Among 9,623 patients, 4,278 (44.4%) qualified as HBR. Moderate or severe anemia was the most common major criterion (33.2%); age ≥75 years was the most frequent minor criterion and the most common overall (46.8%). The rate of the primary bleeding endpoint at 1 year was 9.1% in HBR patients compared with 3.2% in non-HBR patients (p < 0.001), with a stepwise increase in bleeding risk corresponding to the number of times the ARC-HBR definition was fulfilled. HBR patients also experienced significantly higher rates of all secondary endpoints.
This study validates the ARC-HBR definition in a contemporary group of patients who underwent percutaneous coronary intervention. The ARC-HBR definition identified patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria showed additive prognostic value.
Background
Women with acute coronary syndrome (ACS) generally present with more comorbidities and experience worse clinical outcomes compared with males. However, it is unclear whether this ...represents genuine sex‐related difference or stems from clinical, procedural and socioeconomic factors.
Methods
We analyzed consecutive patients undergoing percutaneous coronary intervention (PCI) for ST‐segment elevation myocardial infarction (STEMI), non‐STEMI or unstable angina at a single tertiary‐care center. Exclusion criteria were unknown sex, age < 18 years and PCI with bare metal stent or without stent placement. The study population was stratified according to sex. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE) defined as the composite of death, spontaneous myocardial infarction, or stroke at 1 year. Secondary endpoints were individual components of MACCE, target vessel revascularization (TVR) and clinically significant bleeding.
Results
Of the 7362 patients included, 5031 (68.3%) were men and 2331 (31.7%) women. Women were older and presented with a higher burden of comorbidities while men had more complex coronary anatomy. The incidence of 1 year MACCE was significantly higher among women (8.0% versus 5.6%; p < 0.01) compared to men. Women also experienced a higher rate of bleeding (2.3% vs. 1.4%; p = 0.02) while there were no differences between groups in terms of TVR (8.1% vs. 7.8%; p‐value = 0.83). Differences in outcomes were attenuated after multivariable adjustment. Findings were consistent across ACS subgroups.
Conclusions
In a contemporary ACS population treated with drug‐eluting stents, women experienced a higher crude rate of 1‐year MACCE. This was no longer apparent after accounting for baseline imbalances.
Data on ischemic and bleeding outcomes after percutaneous coronary intervention (PCI) in high bleeding risk (HBR) patients with chronic kidney disease (CKD) are scarce. We aimed to evaluate the ...association between CKD and ischemic and bleeding outcomes in HBR patients who underwent PCI. Among 10,502 patients in the four post-approval registries evaluating patients undergoing PCI, 2,300 patients presented with at least one major or two minor ARC-HBR criteria. CKD was defined as eGFR < 60 mL/min/1.73 m
2
. These HBR patients were divided into 3 groups: eGFR < 30 mL/min/1.73 m
2
defined as severe CKD (N = 221), eGFR 30- < 60 mL/min/1.73 m
2
defined as moderate CKD (N = 970), eGFR ≥ 60 mL/min/1.73 m
2
defined as no CKD (N = 1,109). The primary endpoint was the composite of cardiac death, myocardial infarction, or stent thrombosis, and the safety endpoint was major bleeding up to 4-year follow-up. HBR patients with CKD were more often female and had higher rates of comorbidities compared to those without CKD. Reduced renal function was associated with higher rates of the primary endpoint (severe CKD vs. moderate CKD vs. no CKD: 30.2% vs. 12.5% vs. 9.1%, P < 0.01) as well as major bleeding (10.3% vs. 8.9% vs. 6.4%, P = 0.03). After adjustment, severe CKD and moderate CKD in HBR patients remained independent predictors for the primary endpoint (HR 95%CI 2.84 1.94–4.16, P < 0.01, 1.48 1.10–2.00, P < 0.01) compared to those with no CKD. However, decreased renal function was no longer significantly associated with major bleeding after adjustment. In conclusions, in HBR patients undergoing PCI, CKD has an important impact on major ischemic events after PCI.
Ventricular fibrillation (VF) is a common cause of sudden cardiac death in patients with channelopathies, particularly in the young population. Although pharmacological treatment, cardiac ...sympathectomy, and implantable cardioverter defibrillators (ICD) have been the mainstay in the management of VF in patients with channelopathies, they are associated with significant adverse effects and complications, leading to poor quality of life. Given these drawbacks, catheter ablation has been proposed as a therapeutic option for patients with channelopathies. Advances in imaging techniques and modern mapping technologies have enabled increased precision in identifying arrhythmia triggers and substrate modification. This has aided our understanding of the underlying pathophysiology of ventricular arrhythmias in channelopathies, highlighting the roles of the Purkinje network and the epicardial right ventricular outflow tract in arrhythmogenesis. This review explores the role of catheter ablation in managing the most common channelopathies (Brugada syndrome, congenital long QT syndrome, short QT syndrome, and catecholaminergic polymorphic ventricular tachycardia). While the initial results for ablation in Brugada syndrome are promising, the long-term efficacy and durability of ablation in different channelopathies require further investigation. Given the genetic and phenotypic heterogeneity of channelopathies, future studies are needed to show whether catheter ablation in patients with channelopathies is associated with a reduction in VF, and psychological distress stemming from recurrent ICD shocks, particularly relative to other available therapeutic options (e.g., quinidine in high-risk Brugada patients).
Perioperative cardiovascular complications are important causes of morbidity and mortality associated with non-cardiac surgery, especially in patients with recent percutaneous coronary intervention ...(PCI). We aimed to illustrate the types and timing of different surgeries occurring after PCI, and to evaluate the risk of thrombotic and bleeding events according to the perioperative antiplatelet management. Patients undergoing urgent or elective non-cardiac surgery within 1 year of PCI at a tertiary-care center between 2011 and 2018 were included. The primary outcome was major adverse cardiac events (MACE; composite of death, myocardial infarction, or stent thrombosis) at 30 days. Perioperative bleeding was defined as ≥ 2 units of blood transfusion. A total of 1092 surgeries corresponding to 747 patients were classified by surgical risk (low: 50.9%, intermediate: 38.4%, high: 10.7%) and priority (elective: 88.5%, urgent/emergent: 11.5%). High-risk and urgent/emergent surgeries tended to occur earlier post-PCI compared to low-risk and elective ones, and were associated with an increased risk of both MACE and bleeding. Preoperative interruption of antiplatelet therapy (of any kind) occurred in 44.6% of all NCS and was more likely for procedures occurring later post-PCI and at intermediate risk. There was no significant association between interruption of antiplatelet therapy and adverse cardiac events. Among patients undergoing NCS within 1 year of PCI, perioperative ischemic and bleeding events primarily depend on the estimated surgical risk and urgency of the procedure, which are increased early after PCI. Preoperative antiplatelet interruption was not associated with an increased risk of cardiac events.
Background
The prevalence of both chronic kidney disease (CKD) and aortic stenosis (AS) increase with age. Although baseline CKD is frequent in patients undergoing transcatheter aortic valve ...replacement (TAVR), its significance among women is largely unknown.
Methods
Women's INternational Transcatheter Aortic Valve Implantation (WIN‐TAVI) is a multinational, prospective registry of women undergoing TAVR for severe AS. We included patients with available baseline estimated glomerular filtration rate (eGFR) and completed 1‐year follow‐up. Patients were categorized into three groups based on their eGFR: No CKD (normal kidney function to stage 2 CKD: eGFR ≥60 ml/min/1.73 m2); (b) mild CKD (stage 3a CKD: eGFR = 45–59 ml/min/1.73 m2); and (c) moderate/severe CKD (stage ≥3b CKD: eGFR <45 ml/min/1.73 m2). All events were adjudicated according to the Valve Academic Research Consortium (VARC)‐2 criteria.
Result
Out of 852 women undergoing TAVR, 326 (38.3%) had no CKD, 225 (26.4%) had mild CKD, and 301 (35.3%) had moderate/severe CKD. Women with higher stage of CKD at baseline were more likely to have a history of hypertension, diabetes, atrial fibrillation, anemia, chronic lung disease, hemodialysis, prior percutaneous coronary intervention, and pacemaker implantation. After multivariate adjustment, moderate/severe CKD was associated with a greater risk of 1‐year VARC‐2 safety endpoints hazard ratio (HR) 1.68, 95% confidence interval (CI): 1.10–2.60, all‐cause death (HR 2.00, 95% CI: 1.03–3.90), and composite of death, myocardial infarction, stroke or life‐threatening bleeding (HR 1.70, 95% CI: 1.04–2.76). There were no differences in 30‐day and 1‐year VARC‐2 efficacy and 30‐day VARC‐2 safety outcomes.
Conclusion
CKD is associated with substantial and independent risk for mortality and morbidity at 1‐year follow‐up in women undergoing TAVR.
Background Women have been associated with higher rates of recurrent events after percutaneous coronary intervention than men, possibly attributable to advanced age at presentation and greater ...comorbidities. These factors also put women at higher risk of bleeding, which may influence therapeutic strategies and clinical outcomes. Methods and Results We performed a patient-level pooled analysis of 4 postapproval registries to evaluate sex-related differences in patients at high bleeding risk (HBR) undergoing percutaneous coronary intervention. HBR required fulfillment of at least 1 major or 2 minor criteria of the Academic Research Consortium definition. Outcomes of interest were major bleeding and major adverse cardiac events (composite of cardiac death, myocardial infarction, or definite/probable stent thrombosis). Of the total 10 502 patients, 2832 (27.0%) were women. The prevalence of HBR was higher in women compared with men (29.0% versus 20.5%,
<0.0001). Women at HBR were older and had more comorbidities, while men at HBR were more often smokers, with prior myocardial infarction and more complex coronary lesions. At 4 years, women at HBR had significantly higher major bleeding compared with men at HBR (10.8% versus 6.2%,
<0.0001); however, this difference was attenuated after multivariable adjustment (hazard ratio, 0.92; 95% CI, 0.41-2.08). Major adverse cardiac event rates between groups were similar (12.2% versus 12.6%,
=0.82) and remained consistent after adjustment (hazard ratio, 0.64; 95% CI, 0.32-1.28). Conclusions The prevalence of HBR was higher in women compared with men, with considerable differences in the distribution of criteria. Women at HBR experienced higher rates of major bleeding but similar major adverse cardiac event rates compared with men at HBR at 4 years.
Purpose
The COMBO biodegradable polymer sirolimus-eluting stent includes endothelial progenitor cell capture (EPC) technology for rapid endothelialization, which may offer advantage in acute coronary ...syndromes (ACS). We sought to analyze the performance of the COMBO stent by ACS status and ACS subtype.
Methods
The COMBO collaboration (
n
= 3614) is a patient-level pooled dataset from the MASCOT and REMEDEE registries. We evaluated outcomes by ACS status, and ACS subtype in patients with ST segment elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) versus unstable angina (UA). The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization. Secondary outcomes included stent thrombosis (ST).
Results
We compared 1965 (54%) ACS and 1649 (46.0%) non-ACS patients. ACS presentations included 40% (
n
= 789) STEMI, 31% (
n
= 600) NSTEMI, and 29% (
n
= 576) UA patients. Risk of 1-year TLF was greater in ACS patients (4.5% vs. 3.3%, HR 1.51 95% CI 1.01–2.25,
p
= 0.045) without significant differences in definite/probable ST (1.1% vs 0.5%, HR 2.40, 95% CI 0.91–6.31,
p
= 0.08). One-year TLF was similar in STEMI, NSTEMI, and UA (4.8% vs 4.8% vs. 3.7%,
p
= 0.60), but definite/probable ST was higher in STEMI patients (1.9% vs 0.5% vs 0.7%,
p
= 0.03). Adjusted outcomes were not different in MI versus UA patients.
Conclusions
Despite the novel EPC capture technology, COMBO stent PCI was associated with somewhat greater risk of 1-year TLF in ACS than in non-ACS patients, without significant differences in stent thrombosis. No differences were observed in 1-year TLF among ACS subtypes.
Key Points
Except for a reduction in the rate of repeat revascularization, there was no benefit of EES over BMS in 1‐year and 5‐year clinical outcomes for diabetic patients with STEMI.
In nondiabetic ...patients, a beneficial effect of using EES was observed in most clinical endpoints at 5 years.
Overall, diabetic patients were associated with significantly worse long‐term outcomes following PCI for STEMI compared to nondiabetics.
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