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BACKGROUND: Diabetes mellitus (DM) is a modifiable risk factor for patients with coronary artery disease (CAD). Treatment with insulin correlates with advanced disease and has been associated with excess cardiovascular risk, but evidence on outcomes of patients with insulin-treated DM (ITDM) undergoing left main percutaneous coronary intervention (LMPCI) remains scarce. AIMS: The aim of the presented study is to evluate the risk attributable to DM and ITDM in patients undergoing LMPCI. METHODS: We included 869 patients undergoing PCI for unprotected LMCAD. The cohort was divided into three subgroups based on diabetic status: No DM, ITDM, and Non-ITDM. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of death, spontaneous myocardial infarction (MI), or stroke at 1 year. Results were adjusted for clinically relevant baseline characteristics. RESULTS: Amongst participants, 58.7% had no DM, 25.9% non-ITDM, and 15.4% ITDM. Diabetics were younger and more likely to be female. They also exhibited higher body mass index as well as prevalence of comorbidities, including hypertension, anemia, and chronic kidney disease. The number of bifurcation lesions and stents used was similar between groups. At 1 year, when compared to no DM, ITDM (25.4% vs. 10.0%, p < 0.01) but not non-ITDM (10.8% vs. 10.0%, p = 0.94) demonstrated higher MACCE. This finding was driven by increased risk of MI. Mortality was 8.4%, 7.8%, and 17.2% for no DM, Non-ITDM, and ITDM, respectively. Results remained unchanged after adjustment. CONCLUSIONS: In a rather contemporary patient population undergoing PCI for LMCAD, ITDM but not non-ITDM was associated with higher risk of 1-year MACCE, primarily driven by MI.
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BACKGROUND: Atherosclerosis in more than 1 vs. 1 arterial bed is associated with increased risk for major adverse cardiovascular events (MACE). This study aimed to determine whether the risk of post percutaneous coronary intervention (PCI) MACE associated with polyvascular disease (PVD) differs by sex. METHODS: We analyzed 18,721 patients undergoing PCI at a tertiary-care center between 2012 and 2019. Polyvascular disease was defined as history of peripheral artery and/or cerebrovascular disease. The primary endpoint was MACE, a composite of all-cause death, myocardial infarction, or stroke at 1 year. Multivariate Cox regression was used to adjust for differences in baseline risk between patients with PVD vs. coronary artery disease (CAD) alone and interaction testing was used to assess risk modification by sex. RESULTS: Women represented 29.2% (N = 5,467) of the cohort and were more likely to have PVD than men (21.7% vs. 16.1%; P < .001). Among both sexes, patients with PVD were older with higher prevalence of comorbidities and cardiovascular risk factors. Women with PVD had the highest MACE rate (10.0%), followed by men with PVD (7.2%), women with CAD alone (5.0%), and men with CAD alone (3.6%). Adjusted analyses revealed similar relative MACE risk associated with PVD vs. CAD alone in women and men (adjusted hazard ratio [aHR] 1.54, 95% confidence interval [CI] 1.20-1.99; P < .001 and aHR 1.31, 95% CI 1.06-1.62; P = .014, respectively; p-interaction = 0.460). CONCLUSION: Women and men derive similar excess risk of MACE from PVD after PCI. The heightened risk associated with PVD needs to be addressed with maximized use of secondary prevention in both sexes.
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Introduction: High-risk percutaneous coronary interventions (HRPCI) are a potential treatment option for patients with reduced left ventricular ejection fraction (LVEF) and coronary artery disease. The extent to which such intervention is coupled with improvement in LVEF and associated with favorable outcomes is unknown. Methods: We aimed to characterize the incidence and correlates of LVEF improvement after Impella-guided HRPCI, and compare clinical outcomes in patients with versus without LVEF improvement. Data on consecutive patients undergoing Impella-guided HRPCI from a single center registry were analyzed. LVEF-improvement was defined as an absolute increase of LVEF of ≥10% measured at ≥30-days after intervention. The primary outcome was a composite of all-cause death, myocardial infarction or target vessel revascularization within 1-year. Results: Out of 161 consecutive patients undergoing Impella-guided HRPCI from June 2008 to December 2017, 43% (n = 70) demonstrated LVEF-improvement (baseline LVEF of 25.09 ± 6.19 to 33.30 ± 11.98 post intervention). Patients without LVEF-improvement had higher frequency of previous MI (61.5% vs. 37.1%, p = 0.0021), Q-waves on ECG (17.6% vs. 5.7%, p = 0.024) and higher SYNTAX scores (30.8 ± 17.6 vs. 25.2 ± 12.2; p = 0.043). After correction of these confounders by multivariable analysis, no significant differences were found regarding the composite endpoint in patients with versus without LVEF-improvement (34.9% vs. 38.3%; p = 0.48). Discussion: In this single-center retrospective analysis, we report the following findings. First, LVEF improvement of at least 10% was documented in over 40% of patients undergoing Impella supported high-risk PCI. Second, a history of MI, Q-waves on admission ECG, and higher baseline SYNTAX scores were independent correlates of no LVEF improvement. Third, one year rates of adverse CV events were substantial and did not vary by the presence or absence of LVEF improvement Prospective studies with longer follow-up are needed to elucidate the impact of LVEF improvement on clinical outcomes.
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BACKGROUND: It remains unclear whether procedural myocardial infarction (pMI) and spontaneous myocardial infarction (spMI) have a similar impact on prognosis. OBJECTIVES: The aim of this study was to assess mortality after pMI and spMI. METHODS: Patients with chronic coronary syndrome (CCS) and baseline troponin ≤1× the upper reference level (URL) or with acute spMI who underwent percutaneous coronary intervention (PCI) were included. PMI was defined as post-PCI troponin increase >1× URL in patients with CCS. SpMI comprised any acute coronary syndrome with elevated troponin. The 1-year risk of all-cause death was assessed after pMI and spMI across 3 strata of troponin elevation (>1-5×, >5-35×, and >35× URL), with CCS patients having post-PCI troponin ≤1× URL as a reference group. Conventional troponin I was measured using the Architect methodology (Abbott). RESULTS: Among 10,707 patients undergoing PCI from 2012 to 2020, 8,515 patients presented with CCS and 2,192 with spMI. Among CCS patients, 913 (10.7%) had pMI. Troponin peaks >1-5×, >5-35×, and >35× URL were observed in 53%, 41%, and 6% of patients with pMI, and in 24%, 38%, and 37% of patients with spMI, respectively. Mortality at 1 year was higher after pMI (7.7%; adjusted HR: 4.40; 95% CI: 1.59-12.2), and spMI (8.5%; adjusted HR: 7.57; 95% CI: 5.44-10.5) with troponin peak >35× URL compared with no-MI (1.4%). Mortality was also increased after spMI with troponin peak >1-5× or >5-35× URL. CONCLUSIONS: Mortality at 1 year was significantly increased after pMI and spMI with troponin peak >35× URL, whereas for troponin levels ≤35× only spMI had a relevant impact on mortality.
Subject(s)
Myocardial Infarction , Percutaneous Coronary Intervention , Humans , Male , Female , Myocardial Infarction/mortality , Myocardial Infarction/blood , Aged , Middle Aged , Troponin I/blood , Prognosis , Troponin/bloodABSTRACT
BACKGROUND: Women in cardiology experience considerable gender disparities in publications, which hinders their career advancements to higher faculty and senior leadership positions. However, the extent of these disparities across different types of cardiovascular literature is not well understood. OBJECTIVES: We investigated gender differences in authorship across various cardiovascular publications over a decade and examined geographic variations in the representation of women authors. METHODS: All papers published from January 1, 2010, to December 31, 2019, in 4 major cardiovascular journals (Journal of the American College of Cardiology, European Heart Journal, Journal of the American Medical Association Cardiology, and Nature Reviews Cardiology) were reviewed. RESULTS: Of the 18,535 papers with 111,562 authors, 20.6% of the authors were women, and 47.7% of the papers had no women authors. Over 10 years, the proportion of women authors remained low (20.7% in 2010 to 21.4% in 2019), with the lowest proportion in editorial papers (14.8%) and the highest in research papers (21.8%). More women as first (34.6%) and last (47.6%) authors were affiliated with institutions in the United States compared with other countries. The proportion of women middle-order authors was higher on papers with women as first authors (29.4% vs 20.5%) or last authors (30.6% vs 21.3%), compared with papers with men as first or last authors, respectively. CONCLUSIONS: Over the past decade, the proportion of women authors across all article types in major cardiovascular journals remained low. A call to action is needed to promote women in cardiology and provide them with equitable opportunities.
Subject(s)
Authorship , Cardiology , Humans , Female , Cardiology/statistics & numerical data , Male , Sexism/statistics & numerical data , Periodicals as Topic/statistics & numerical data , Physicians, Women/statistics & numerical data , Sex FactorsABSTRACT
BACKGROUND: Individuals suffering from polyvascular atherosclerotic disease (PolyVD) face a higher likelihood of adverse cardiovascular events. Additionally, inflammation, assessed by high-sensitivity C-reactive protein (hsCRP), affects residual risk following percutaneous coronary intervention (PCI). We aimed to explore the interplay between PolyVD and hsCRP in terms of clinical outcomes after PCI. METHODS: Patients undergoing PCI for chronic coronary disease at a tertiary center between January 2012 and February 2020 were included for the current analysis. PolyVD was defined by additional history of cerebrovascular and/or peripheral artery disease. HsCRP levels were defined as elevated when the measured baseline concentration was > 3 mg/L. The primary outcome of interest was major adverse cardiovascular events (MACE), a composite of all-cause mortality, spontaneous MI, or target vessel revascularization. RESULTS: Overall, 10,359 participants were included in the current study, with 17.4% affected by PolyVD and 82.6% included in the non-PolyVD subgroup. Patients with PolyVD had higher hsCRP levels than those without. Among the PolyVD group, a larger proportion (33.6%) exhibited elevated hsCRP compared to the non-PolyVD group (24.7%). Patients with both PolyVD and elevated hsCRP levels had significantly higher adverse event rates than all other subgroups at 1-year follow-up. Furthermore, an independent association between elevated hsCRP and MACE was observed within the PolyVD population, while this was not the case for individuals without PolyVD. CONCLUSION: A residual risk of adverse outcomes after PCI linked to inflammation appears to be present among individuals with PolyVD. This could help define further target populations for anti-inflammatory treatment options.
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Shortening the duration of dual-antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) was shown to be effective and safe in patients at high bleeding risk (HBR). We aimed to investigate the effect of 1 versus 3-month DAPT on outcomes after drug-eluting stent in HBR patients with or without chronic kidney disease (CKD). Data from 3 prospective single-arm studies (XIENCE Short DAPT Program) enrolling HBR patients after successful coronary implantation of cobalt-chromium everolimus-eluting stent (XIENCE, Abbott) were analyzed. Subjects were eligible for DAPT discontinuation at 1 or 3 months if free from ischemic events. The primary end point was all-cause death or any myocardial infarction. The key secondary end point was Bleeding Academic Research Consortium Type 2 to 5 bleeding. Outcomes were assessed from 1 to 12 months after PCI. CKD was defined as baseline creatinine clearance <60 ml/min. Of 3,286 patients, 1,432 (43.6%) had CKD. One-month versus 3-month DAPT was associated with a similar 12-month risk of the primary outcome irrespective of CKD status (CKD: 9.5% vs 10.9%, adjusted hazard ratio 0.86, 95% confidence interval 0.60 to 1.22; no-CKD: 6.6% vs 5.6%, adjusted hazard ratio 1.15, 95% confidence interval 0.77 to 1.73; p interaction 0.299). Bleeding Academic Research Consortium 2 to 5 bleeding rates were numerically but not significantly lower with 1-month versus 3-month DAPT in both CKD (9.9% vs 12%) and no-CKD (6.4% vs 9.0%) patients. In conclusion, in HBR patients, 1-month versus 3-month DAPT was associated with a similar risk of ischemic complications and a trend toward fewer bleeding events at 12 months after PCI, irrespective of CKD status.
Subject(s)
Drug-Eluting Stents , Dual Anti-Platelet Therapy , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Renal Insufficiency, Chronic , Humans , Male , Female , Renal Insufficiency, Chronic/complications , Percutaneous Coronary Intervention/methods , Aged , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/administration & dosage , Middle Aged , Prospective Studies , Dual Anti-Platelet Therapy/methods , Hemorrhage/epidemiology , Hemorrhage/chemically induced , Coronary Artery Disease/surgery , Coronary Artery Disease/complications , Time Factors , Clopidogrel/therapeutic use , Clopidogrel/administration & dosage , Aspirin/administration & dosage , Aspirin/therapeutic use , Myocardial Infarction/epidemiology , Cause of Death/trends , Drug Administration Schedule , Risk FactorsSubject(s)
Acute Kidney Injury , Contrast Media , Hemorrhage , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Acute Kidney Injury/chemically induced , Acute Kidney Injury/epidemiology , Acute Kidney Injury/therapy , Contrast Media/adverse effects , Incidence , Risk Factors , Male , Hemorrhage/chemically induced , Aged , Female , Risk Assessment , Middle Aged , Treatment OutcomeABSTRACT
BACKGROUND: A short dual antiplatelet therapy (DAPT) duration has been proposed for patients at high bleeding risk (HBR) undergoing drug-eluting coronary stent (DES) implantation. Whether this strategy is safe and effective after a non-ST-segment elevation acute coronary syndrome (NSTE-ACS) remains uncertain. AIMS: We aimed to compare the impact of 1-month versus 3-month DAPT on clinical outcomes after DES implantation among HBR patients with or without NSTE-ACS. METHODS: This is a prespecified analysis from the XIENCE Short DAPT programme involving three prospective, international, single-arm studies evaluating the safety and efficacy of 1-month (XIENCE 28 USA and Global) or 3-month (XIENCE 90) DAPT among HBR patients after implantation of a cobalt-chromium everolimus-eluting stent. Ischaemic and bleeding outcomes associated with 1- versus 3-month DAPT were assessed according to clinical presentation using propensity score stratification. RESULTS: Of 3,364 HBR patients (1,392 on 1-month DAPT and 1,972 on 3-month DAPT), 1,164 (34.6%) underwent DES implantation for NSTE-ACS. At 12 months, the risk of the primary endpoint of death or myocardial infarction was similar between 1- and 3-month DAPT in patients with (hazard ratio [HR] 1.09, 95% confidence interval [CI]: 0.71-1.65) and without NSTE-ACS (HR 0.88, 95% CI: 0.63-1.23; p-interaction=0.34). The key secondary endpoint of Bleeding Academic Research Consortium (BARC) Type 2-5 bleeding was consistently reduced in both NSTE-ACS (HR 0.57, 95% CI: 0.37-0.88) and stable patients (HR 0.84, 95% CI: 0.61-1.15; p-interaction=0.15) with 1-month DAPT. CONCLUSIONS: Among HBR patients undergoing implantation of an everolimus-eluting stent, 1-month, compared to 3-month DAPT, was associated with similar ischaemic risk and reduced bleeding at 1 year, irrespective of clinical presentation.
Subject(s)
Acute Coronary Syndrome , Drug-Eluting Stents , Dual Anti-Platelet Therapy , Hemorrhage , Percutaneous Coronary Intervention , Platelet Aggregation Inhibitors , Humans , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/methods , Percutaneous Coronary Intervention/instrumentation , Acute Coronary Syndrome/therapy , Platelet Aggregation Inhibitors/therapeutic use , Platelet Aggregation Inhibitors/adverse effects , Platelet Aggregation Inhibitors/administration & dosage , Male , Middle Aged , Aged , Female , Hemorrhage/chemically induced , Treatment Outcome , Dual Anti-Platelet Therapy/methods , Prospective Studies , Time Factors , Risk Factors , Non-ST Elevated Myocardial Infarction/therapy , Non-ST Elevated Myocardial Infarction/mortalityABSTRACT
BACKGROUND: In patients with low-gradient aortic stenosis (AS) and low transvalvular flow, dobutamine stress echocardiography (DSE) is recommended to determine AS severity, whereas the degree of aortic valve calcification (AVC) supposedly correlates with AS severity according to current European and American guidelines. OBJECTIVES: The purpose of this study was to assess the relationship between AVC and AS severity as determined using echocardiography and DSE in patients with aortic valve area <1 cm2 and peak aortic valve velocity <4.0 m/s. METHODS: All patients underwent DSE to determine AS severity and multislice computed tomography to quantify AVC. Receiver-operating characteristics curve analysis was used to assess the diagnostic value of AVC for AS severity grading as determined using echocardiography and DSE in men and women. RESULTS: A total of 214 patients were included. Median age was 78 years (25th-75th percentile: 71-84 years) and 25% were women. Left ventricular ejection fraction was reduced (<50%) in 197 (92.1%) patients. Severe AS was diagnosed in 106 patients (49.5%). Moderate AS was diagnosed in 108 patients (50.5%; in 77 based on resting transthoracic echocardiography, in 31 confirmed using DSE). AVC score was high (≥2,000 for men or ≥1,200 for women) in 47 (44.3%) patients with severe AS and in 47 (43.5%) patients with moderate AS. AVC sensitivity was 44.3%, specificity was 56.5%, and positive and negative predictive values for severe AS were 50.0% and 50.8%, respectively. Area under the receiver-operating characteristics curve was 0.508 for men and 0.524 for women. CONCLUSIONS: Multi-slice computed tomography-derived AVC scores showed poor discrimination between grades of AS severity using DSE and cannot replace DSE in the diagnostic work-up of low-gradient severe AS.
Subject(s)
Aortic Valve Stenosis , Aortic Valve , Calcinosis , Echocardiography, Stress , Multidetector Computed Tomography , Predictive Value of Tests , Severity of Illness Index , Humans , Aortic Valve Stenosis/diagnostic imaging , Aortic Valve Stenosis/physiopathology , Female , Male , Aged , Aortic Valve/diagnostic imaging , Aortic Valve/physiopathology , Aortic Valve/pathology , Calcinosis/diagnostic imaging , Calcinosis/physiopathology , Aged, 80 and over , Reproducibility of Results , ROC Curve , Ventricular Function, Left , Area Under Curve , Stroke Volume , HemodynamicsABSTRACT
Percutaneous coronary intervention (PCI) has demonstrated its safety and efficacy in treating left main (LM) coronary artery disease (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 who underwent unprotected LM-PCI at a tertiary center from 2012 to 2019. The study 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 1 year after index PCI. Overall, 869 patients were included, and 23.8% of the population had PolyVD. Subjects with PolyVD were older and had a greater burden of co-morbidities. After 1-year follow-up, PolyVD patients exhibited significantly higher rates of both MACE (22.8% vs 9.4%, p <0.001) and bleeding events compared with 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, in patients who underwent 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 population.
Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Humans , Male , Female , Percutaneous Coronary Intervention/methods , Aged , Coronary Artery Disease/surgery , Retrospective Studies , Middle Aged , Cerebrovascular Disorders/epidemiology , Peripheral Arterial Disease/surgery , Peripheral Arterial Disease/epidemiology , Cause of Death/trends , Risk Factors , Myocardial Infarction/epidemiology , Postoperative Complications/epidemiologyABSTRACT
BACKGROUND: The number of octogenarians referred to percutaneous coronary interventions (PCI) is rising steadily. The prevalence and prognostic impact of complex PCI (CPCI) in this vulnerable population has not been fully evaluated. METHODS: Patients ≥80 years old who underwent PCI between 2012 and 2019 at Mount Sinai Hospital were included. Patients were categorized based on PCI complexity, defined as the presence of at least one of the following criteria: use of atherectomy, total stent length ≥60 mm, ≥3 stents implanted, bifurcation treated with at least 2 stents, PCI involving ≥3 vessels, ≥3 lesions, left main, saphenous vein graft or chronic total occlusion. The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, myocardial infarction (MI), or target-vessel revascularization (TVR), within 1 year after PCI. Secondary outcomes included major bleeding. RESULTS: Among 2657 octogenarians, 1387 (52%) underwent CPCI and were more likely to be men and to have cardiovascular risk factors or comorbidities. CPCI as compared with no-CPCI was associated with a higher 1-year risk of MACE (16.6% vs. 11.1%, adjusted HR 1.3, 95% CI 1.06-1.77, p value 0.017), due to an excess of MI and TVR, and major bleeding (10% vs. 5.8%, adjusted HR 1.64, 95% CI 1.20-2.55, p value 0.002). CONCLUSIONS: Among octogenarians, CPCI was associated with a significantly higher 1-year risk of MACE, due to higher rates of MI and TVR but not of all-cause death, and of major bleeding. Strategies to reduce complications should be implemented in octogenarians undergoing CPCI.
Subject(s)
Coronary Artery Disease , Percutaneous Coronary Intervention , Humans , Male , Percutaneous Coronary Intervention/adverse effects , Percutaneous Coronary Intervention/mortality , Percutaneous Coronary Intervention/instrumentation , Female , Aged, 80 and over , Treatment Outcome , Age Factors , Prevalence , Time Factors , Coronary Artery Disease/mortality , Coronary Artery Disease/therapy , Coronary Artery Disease/diagnostic imaging , Risk Assessment , Risk Factors , Retrospective Studies , Stents , New York/epidemiology , HemorrhageABSTRACT
Background: FAVOR III China (Comparison of Quantitative Flow Ratio Guided and Angiography Guided Percutaneous Intervention in Patients with Coronary Artery Disease) reported improved clinical outcomes in quantitative flow ratio (QFR) relative to angiography-guided percutaneous coronary intervention (PCI), but the clinical impact of QFR-guided PCI according to sex remains unknown. Objectives: The authors sought to compare sex differences in the 2-year clinical benefits of a QFR-guided PCI strategy and to evaluate the differences in outcomes between men and women undergoing contemporary PCI. Methods: This study involved a prespecified subgroup analysis of the FAVOR III China trial, in which women and men were randomized to a QFR-guided strategy or a standard angiography-guided strategy. Sex differences in clinical benefit of the QFR guidance were analyzed for major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction, or ischemia-driven revascularization within 2 years. Results: A total of 1,126 women and 2,699 men were eligible and the occurrence of 2-year MACE was similar between women and men (10.3% vs 10.5%; P = 0.96). Compared with an angiography-guided strategy, a QFR-guided strategy resulted in a 7.9% and 9.7% reduction in PCI rates in men and women, respectively. A QFR-guided strategy resulted in similar relative risk reductions for 2-year MACE in women (8.0% vs 12.7%; HR: 0.62; 95% CI: 0.42-0.90) and men (8.7% vs 12.4%; HR: 0.69; 95% CI: 0.54-0.87) (Pinteraction = 0.61). Furthermore, QFR values were not significantly different between men and women with various angiographic stenosis categories. Conclusions: A QFR-guided PCI strategy resulted in improved MACE in both men and women at 2 years compared with an angiography-guided PCI strategy. The FAVOR III China Study [FAVOR III China]; (NCT03656848).
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The sex disparity in outcomes of patients with cardiovascular disease is well-described and has persisted across recent decades. While there have been several proposed mechanisms to explain this disparity, there are limited data on female patient-physician sex concordance and its association with outcomes. The authors review the existing literature on the relationship between patient-physician sex concordance and clinical outcomes in patients with cardiovascular disease, the evidence of a benefit in clinical outcomes with female patient-physician sex concordance, and the possible drivers of such a benefit and highlight directions for future study.
Subject(s)
Cardiovascular Diseases , Physician-Patient Relations , Humans , Female , Male , Sex Factors , Treatment OutcomeABSTRACT
BACKGROUND: The optimal antiplatelet regimen after percutaneous coronary intervention (PCI) in patients with peripheral artery disease (PAD) is still debated. This analysis aimed to compare the effect of ticagrelor monotherapy versus ticagrelor plus aspirin in patients with PAD undergoing PCI. METHODS: In the TWILIGHT trial, patients at high ischemic or bleeding risk that underwent PCI were randomized after 3 months of dual antiplatelet therapy (DAPT) to aspirin or matching placebo in addition to open-label ticagrelor for 12 additional months. In this post-hoc analysis, patient cohorts were examined according to the presence or absence of PAD. The primary endpoint was Bleeding Academic Research Consortium (BARC) 2, 3, or 5 bleeding. The key secondary endpoint was a composite of all-cause death, myocardial infarction (MI), or stroke. Endpoints were assessed at 12 months after randomization. RESULTS: Among 7,119 patients, 489 (7%) had PAD and were older, more likely to have comorbidities, and multivessel disease. PAD patients had more bleeding or ischemic complications than no-PAD patients. Ticagrelor monotherapy compared to ticagrelor plus aspirin was associated with less BARC 2, 3, or 5 bleeding in PAD (4.6% vs 8.7%; HR 0.52; 95%CI 0.25-1.07) and no-PAD patients (4.0% vs 7.0%; HR 0.56; 95%CI 0.45-0.69; interaction P-value .830) and a similar risk of death, MI, or stroke in these 2 groups (interaction P-value .446). CONCLUSIONS: Despite their higher ischemic and bleeding risk, patients with PAD undergoing PCI derived a consistent benefit from ticagrelor monotherapy after 3 months of DAPT in terms of bleeding reduction without any relevant increase in ischemic events. CLINICAL TRIAL REGISTRY INFORMATION:: https://www. CLINICALTRIALS: gov/study/NCT02270242.
Subject(s)
Aspirin , Percutaneous Coronary Intervention , Peripheral Arterial Disease , Platelet Aggregation Inhibitors , Ticagrelor , Humans , Ticagrelor/therapeutic use , Aspirin/therapeutic use , Aspirin/administration & dosage , Peripheral Arterial Disease/complications , Percutaneous Coronary Intervention/methods , Male , Female , Aged , Platelet Aggregation Inhibitors/therapeutic use , Middle Aged , Drug Therapy, Combination , Hemorrhage/chemically induced , Hemorrhage/epidemiology , Dual Anti-Platelet Therapy/methods , Myocardial Infarction/epidemiology , Stroke/prevention & control , Stroke/etiology , Stroke/epidemiologyABSTRACT
BACKGROUND: Peripheral artery disease (PAD) is associated with worse outcomes after percutaneous coronary intervention (PCI). The aim of this study was to assess the prognostic impact of PAD according to high bleeding risk (HBR) status. METHODS: Consecutive patients undergoing PCI with drug-eluting stent implantation at a tertiary-care center (Mount Sinai Hospital) between 2012 and 2019 were stratified according to HBR and PAD status. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and stroke 1 year after PCI. Secondary outcomes included major bleeding. RESULTS: Out of 16,750 patients, 43% were HBR and 57% were no-HBR. Within the two groups, PAD patients were 14% and 6%, respectively, and were more likely to have comorbidities and to undergo complex PCI than no-PAD patients. Within the HBR group, PAD was associated with an increased risk of MACE (11.4% vs. 7.3%, hazard ratio [HR]: 1.59, 95% confidence interval [CI]: 1.27-1.99, p < 0.001) and a numerical nonsignificant increase of major bleeding (8.5% vs. 6.9%, HR: 1.25, 95% CI: 0.98-1.59, p = 0.066) as compared with no-PAD. Among no-HBR patients, rates of MACE and major bleeding were numerically but not significantly higher in the PAD group. After multivariable adjustment, PAD was no longer a predictor of adverse outcomes, irrespective of HBR status. CONCLUSIONS: At 1-year after PCI, PAD was associated with increased 1-year risks of MACE in HBR patients. After adjustment for cardiovascular risk factors and comorbidities, the effect of PAD on adverse events was largely attenuated.
Subject(s)
Coronary Artery Disease , Drug-Eluting Stents , Percutaneous Coronary Intervention , Peripheral Arterial Disease , Humans , Prognosis , Coronary Artery Disease/diagnostic imaging , Coronary Artery Disease/therapy , Coronary Artery Disease/chemically induced , Percutaneous Coronary Intervention/adverse effects , Drug-Eluting Stents/adverse effects , Treatment Outcome , Hemorrhage/chemically induced , Peripheral Arterial Disease/diagnosis , Peripheral Arterial Disease/therapy , Platelet Aggregation Inhibitors/adverse effects , Risk FactorsABSTRACT
BACKGROUND: Markers of systemic inflammation, such as high-sensitivity C-reactive protein (hsCRP), have been associated with the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) in patients undergoing percutaneous coronary intervention (PCI). Whether this risk varies according to the presence of high bleeding risk (HBR) conditions is unclear. OBJECTIVES: The aim of this study was to evaluate the impact of systemic inflammation, as measured by hsCRP levels and cardiovascular outcomes in patients stratified by HBR status following PCI. METHODS: Consecutive patients undergoing PCI between 2012 and 2019 with baseline hsCRP levels were included. High hsCRP was defined as >3 mg/L, and HBR was defined per the Academic Research Consortium HBR criteria. The primary outcome was MACCE, including all-cause death, myocardial infarction, or stroke at 1 year. All bleeding was assessed as a secondary outcome. RESULTS: A total of 15,150 patients were included, and 40.4% (n = 6,125) qualified as HBR. The adjusted risk for MACCE was consistently higher in patients with high hsCRP in both HBR (adjusted HR [aHR]: 1.49; 95% CI: 1.18-1.87) and non-HBR (aHR: 1.87; 95% CI: 1.31-2.66) subgroups, with no interaction between HBR status and hsCRP level (Pinteraction = 0.26). Conversely, although bleeding risk was higher in the HBR cohort, hsCRP did not predict the occurrence of bleeding in either the HBR (aHR: 1.04; 95% CI: 0.82-1.31) or the non-HBR (aHR: 0.99; 95% CI: 0.71-1.39) subgroup (Pinteraction = 0.539). CONCLUSIONS: Elevated hsCRP at the time of PCI is associated with a higher risk for ischemic but not bleeding events, irrespective of HBR status.
Subject(s)
Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , C-Reactive Protein , Platelet Aggregation Inhibitors/adverse effects , Risk Factors , Treatment Outcome , Hemorrhage/chemically induced , Inflammation/chemically induced , Inflammation/complicationsABSTRACT
BACKGROUND: Among patients undergoing percutaneous coronary intervention (PCI), in-stent restenosis (ISR) is related with a worse prognosis, while higher body mass index (BMI) values are associated with better outcomes. It is unclear whether the prognostic impact of ISR varies in function of BMI. METHODS: Patients undergoing PCI at a large center from 2012 to 2019 not presenting with an acute myocardial infarction (MI) were included. Subjects with BMI < 18.5 kg/m2 or treated with bare metal stents were excluded. Patients were stratified according to type of lesion treated (ISR vs. no-ISR) and into four BMI categories: normal weight (BMI 18.5-25 kg/m2 ), overweight (25.0-29.9 kg/m2 ), class I obesity (30.0-34.9 kg/m2 ), class II-III obesity (≥35.0 kg/m2 ). The primary outcome was major adverse cardiovascular events (MACE), a composite of all-cause death, MI, and target vessel revascularization (TVR) at 1 year. RESULTS: Out of 16,234 patients, 3694 (23%) underwent PCI for ISR. ISR as compared to no-ISR was associated with a consistent increased risk of MACE within the normal weight (18.8% vs. 7.8%, adj. hazard ratio (HR): 1.99, 95% confidence interval [CI]: 1.51-2.64), overweight (19.1% vs. 6.4%, adj. HR: 2.35, 95% CI: 1.91-2.88), class I obesity (18.3% vs. 6.8%, adj. HR: 1.95, 95% CI: 1.47-2.57), and class II-III obesity (16.4% vs. 7.4%, adj. HR: 1.61, 95% CI: 1.09-2.37) groups (interaction p-value: 0.192). The ISR-related risks were mostly driven by an excess of TVR. CONCLUSIONS: At 1 year, ISR was associated with an increased risk of MACE irrespective of BMI, mostly due to an excess of TVR after ISR.
Subject(s)
Coronary Restenosis , Drug-Eluting Stents , Percutaneous Coronary Intervention , Humans , Percutaneous Coronary Intervention/adverse effects , Prognosis , Overweight/complications , Coronary Restenosis/diagnostic imaging , Coronary Restenosis/etiology , Coronary Restenosis/therapy , Risk Factors , Drug-Eluting Stents/adverse effects , Treatment Outcome , Obesity/complications , Obesity/diagnosis , Coronary Angiography/adverse effectsABSTRACT
This analysis aimed to evaluate the effect of 1- versus 3-month dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) in older patients. Data from 3 prospective, single-arm studies (XIENCE Short DAPT Program), including patients with high bleeding risk successfully treated with an everolimus-eluting stent (XIENCE, Abbott) were analyzed. DAPT was discontinued at 1 or at 3 months in patients free from ischemic events and adherent to DAPT. Patients were stratified according to age (≥75 and <75 years). The primary end point was all-cause death or myocardial infarction (MI). The key secondary end point was Bleeding Academic Research Consortium type 2 to 5 bleeding. The outcomes were assessed from 1 to 12 months after index PCI. Of 3,364 patients, 2,241 (66.6%) were aged ≥75 years. The risk of death or MI was similar with 1- versus 3-month DAPT in patients aged ≥75 (8.5% vs 8.0%, adjusted hazard ratio [HR] 0.95, 95% confidence interval [CI] 0.69 to 1.30) and <75 years (6.9% vs 7.8%, adjusted HR 0.97, 95% CI 0.60 to 1.57, interaction p = 0.478). Bleeding Academic Research Consortium type 2 to 5 bleeding was consistently lower with 1- than with 3-month DAPT in patients aged ≥75 years (7.2% vs 9.4%, adjusted HR 0.66, 95% CI 0.48 to 0.91) and <75 years (9.7% vs 11.9%, adjusted HR 0.86, 95% CI 0.57 to 1.29, interaction p = 0.737). In conclusion, in patients at high bleeding risk who underwent PCI, patients older and younger than 75 years derived a consistent benefit from 1- compared with 3-month DAPT in terms of bleeding reduction, with no increase in all-cause death or MI at 1 year.