Performance of the academic research consortium high-bleeding risk criteria in patients undergoing PCI for acute myocardial infarction.

Patients undergoing percutaneous coronary intervention (PCI) for acute myocardial infarction (AMI) are at increased risk for thrombotic and bleeding complications compared to patients with chronic coronary syndrome (CCS). The academic research consortium (ARC) recently suggested a set of criteria to identify patients at high bleeding risk (HBR). We sought to evaluate the performance of the ARC-HBR criteria among patients undergoing PCI according to clinical presentation. We included all consecutive patients undergoing PCI at a tertiary-care center. Patients were deemed at HBR if they fulfilled ≥ 1 major or ≥ 2 minor ARC-HBR criteria. The primary bleeding endpoint was a composite of in-hospital or post-discharge bleeding at 1-year follow-up. Secondary outcomes included all-cause death and myocardial infarction. Out of 6068 patients, 1391 (22.9 %) presented with AMI and were more often at HBR than those with CCS (46.9 % vs. 43.0 %, p = 0.01). HBR patients had a higher risk for the primary bleeding endpoint than non-HBR, irrespective of the clinical indication for PCI (AMI: 19.5 % vs. 5.5 %; HR 3.86, 95 % CI 2.63-5.69; CCS: 6.8 % vs. 2.6 %; HR 2.65, 95 % CI 1.92-3.68; p-interaction = 0.11). Secondary outcomes followed a similar trend. After multivariable adjustment, AMI presentation remained significantly associated with increased risk for bleeding at 1 year (HR 1.64, 95 % CI 1.13-2.38, p = 0.01). The ARC-HBR criterion associated with the highest bleeding risk was severe/end-stage chronic kidney disease in AMI and moderate/severe anemia in CCS. The ARC-HBR framework successfully identified AMI and CCS patients with increased risk for bleeding complications at 1 year post-PCI. Figure prepared with BioRender.

Impact of sex on long-term cardiovascular outcomes of patients undergoing percutaneous coronary intervention for acute coronary syndromes.

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.

Incident rate and risk factors for tuberculosis among patients with type 2 diabetes: retrospective cohort study in Shanghai, China.

OBJECTIVE: To examine the incident rate of tuberculosis (TB) and its associates among adults with type 2 diabetes in Shanghai, China. METHODS: We conducted a retrospective cohort study among 170 399 patients with type 2 diabetes aged ≥18 years who were registered in Shanghai community-based diabetes management system between 2004 and 2009. Their TB status was tracked until 31 December 2014. Cox regression was performed to identify the risk factors for TB. RESULTS: We documented 785 new TB cases during 654 977 person-years of follow-up. The incident rate of TB was 224.20 (206.69, 243.16) per 100 000 person-years among men and 51.34 (44.75, 58.92) per 100 000 person-years among women. A 1-unit increase of BMI was associated with a risk reduction in 16% (P < 0.01) for men and a 14% (P < 0.01) reduction for women. TB cases were more likely to be insulin-dependent [men: hazard ratio = 2.13 (1.29, 3.53); women: 3.28 (1.28, 8.39)] and had a poor glucose level initially [men: 1.21 (1.15, 1.27); women: 1.27 (1.18, 1.37)]. The risk factor for TB specific to men was a young age at diagnosis of diabetes, and the protective factor specific to women was actively engaging in physical activity. CONCLUSIONS: TB incident rate among patients with type 2 diabetes was substantially higher among men than among women. The risk of TB was reversely associated with initial BMI. The severity of poor glucose control among patients with diabetes was also linearly associated with the risk of TB.

Gender-Based Differences in Outcomes After Percutaneous Coronary Intervention of Chronic Total Occlusions (Insights from a Large Single-Center Registry).

Patients who undergo percutaneous coronary intervention (PCI) of chronic total occlusions (CTO) are at a high risk for both periprocedural and post-procedural adverse events. Whether gender-differences in outcomes exist after PCI of CTO remain unclear. Therefore, we sought to investigate gender-based differences in outcomes after CTO-PCI. All patients who underwent elective CTO intervention from January 2012 to December 2017 at The Mount Sinai Hospital (New York, New York) were included. The primary end point of interest was major adverse cardiac events defined as the composite of death, myocardial infarction, and target vessel revascularization at 1 year of follow-up. A total 1,897 patients were included, of which 368 were women (19.4%). Mean follow-up time was 174 days. Women were older (66.8 ± 11.3 years vs 62.6 ± 10.9 years) and had a higher prevalence of co-morbidities including diabetes and chronic kidney disease. There were no significant differences in the rate of successful CTO-PCI between groups (73.5% vs 73.2%, p = 0.91). Women had higher rates of procedure-related complications including increased risk of post-procedural bleeding (4.1% vs 1.8%, p = 0.009) and acute vessel closure (1.36% vs 0.2%, p = 0.009). In multivariable-adjusted analysis, female gender was associated with higher risk of major adverse cardiac event and target vessel revascularization at 1 year. In conclusion, in this large single-center study, women who underwent percutaneous CTO revascularization experienced higher rates of periprocedural complications and worse clinical outcomes at 1 year compared with men. Further research is needed to address disparities in gender-specific outcomes of CTO-PCI.

The mega COMBO collaboration: An individual patient data pooled analysis of patients undergoing PCI with COMBO stent.

BACKGROUND: COMBO (OrbusNeich Medical, Hong Kong) is a dual-therapy coronary stent featuring sirolimus as antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collaboration aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI). METHODS: Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry and MASCOT studies were pooled together. The primary endpoint was 1-year target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI) or clinically driven target lesion revascularization (CD-TLR). Secondary outcomes were the individual components of the primary endpoint and stent thrombosis (ST). Endpoints were evaluated against performance goals based on the EAPCI (the European Association of Percutaneous Coronary Intervention) recommendations for new drug-eluting stents. RESULTS: A total of 6753 patients (mean age 63.7 ± 11.4 years, 23% women) were included. At 1-year follow-up, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and CD-TLR were 1.3%, 1.8%, and 2.5%, respectively. The rate of definite/probable ST was 0.73%, early ST (<1 month) was 0.48%, while late ST (1-12 months) was 0.26%. The performance goals were met for all of the evaluated endpoints. CONCLUSIONS: This large patient-level pooled analysis provides a comprehensive outline of the performance of the dual-therapy COMBO stent. The low rates of primary and secondary endpoints suggest that this stent technology may be a good alternative to other contemporary drug eluting coronary stent platforms.

Impact of Race/Ethnicity on Long Term Outcomes After Percutaneous Coronary Intervention with Drug-Eluting Stents.

Cardiovascular disease constitutes the leading cause of mortality worldwide, irrespective of race/ethnicity. Previous studies have shown that minority patients with acute coronary syndrome have distinct clinical, anatomic, and socioeconomic characteristics which may affect clinical outcomes. We included patients who underwent percutaneous coronary intervention with drug-eluting stents for ST-segment elevation myocardial infarction (STEMI), non-STEMI, or unstable angina in a single center. Patients were stratified into Caucasian, African-American, Hispanic, and Asian. Caucasians were the reference group. The primary end point was major adverse cardiac and cerebrovascular events, composite of death, spontaneous myocardial infarction, or stroke at 1 year. Of 6,800 patients included, 49.7% were Caucasian, 20.7% Hispanic, 17.0% Asian and 12.6% African-American. Caucasians were the oldest, Hispanics and Asians had the highest prevalence of diabetes mellitus whereas African-Americans had more chronic kidney disease. Hispanics and African-Americans had the highest STEMI rates, whereas Asians were more likely to present with unstable angina. Compared with Caucasians, Asians had a lower rate of major adverse cardiac and cerebrovascular events at 1 year (3.9% vs 7.1%; p <0.01) whereas Hispanics (6.2% vs 7.1%; p = 0.17) and African-Americans (8.0% vs 7.1%; p = 0.38) had comparable outcomes. Differences were driven by mortality. Findings remained unchanged after adjustment. In conclusion, in acute coronary syndrome patients who underwent percutaneous coronary intervention, Asian race/ethnicity was associated with favorable cardiovascular outcomes compared with Caucasians. No significant differences were observed for Hispanics and African-Americans.

Effect of Elevated C-Reactive Protein on Outcomes After Complex Percutaneous Coronary Intervention for Angina Pectoris.

Inflammation and procedural complexity are individually associated with adverse outcomes after percutaneous coronary intervention (PCI). We aimed to evaluate the association of high sensitivity C-reactive protein (hsCRP) with adverse events according to PCI complexity. We included patients with available hsCRP levels who underwent PCI at our center from 2012 to 2017. We compared patients with hsCRP ≥3 versus <3 mg/L. Complex PCI was defined as having ≥1 of the following: ≥3 different target vessels, ≥3 lesions treated, ≥3 stents implanted, bifurcation lesion treated with 2 stents, chronic total occlusion as target lesion, or total stent length >60 mm. The primary end point was major adverse cardiac events (MACEs) (composite of all-cause death, myocardial infarction, or target vessel revascularization) at 1 year. A total of 11,979 patients were included, of which 2,840 (24%) underwent complex PCI. In those, 767 (27%) had hsCRP ≥3 mg/L. The 1-year incidence of MACE was 6% (noncomplex PCI, low hsCRP), 10% (noncomplex PCI, high hsCRP), 10% (complex PCI, low hsCRP), and 15% (complex PCI, high hsCRP). Overall, hsCRP ≥3 mg/L was associated with an increased risk of MACE compared with hsCRP <3 mg/L; this was independent of the number of complex PCI features: 0 (adjusted hazard ratio [HR] 1.53; 95% confidence interval [CI] 1.27 to 1.86), 1 (adjusted HR 1.77; 95% CI 1.21 to 2.60), or ≥2 (adjusted HR 1.21; 95% CI 0.80 to 1.83) (pinteraction = 0.42). In conclusion, in patients who underwent PCI, elevated hsCRP is associated with an increased risk of ischemic events. The effect of elevated hsCRP on cardiovascular risk is consistent regardless of PCI complexity.

Prognostic Value of Baseline Inflammation in Diabetic and Nondiabetic Patients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: There is a paucity of data on the prognostic value of high-sensitivity C-reactive protein (hsCRP) levels in diabetic and nondiabetic patients undergoing percutaneous coronary intervention (PCI). METHODS: All patients with known baseline hsCRP undergoing PCI at a single tertiary care centre from 2010 to 2017 were included. High hsCRP was defined as > 3 mg/L. Known causes of elevated hsCRP levels and hsCRP > 10 mg/L represented exclusion criteria. The 1-year primary outcome was major adverse cardiovascular events (MACE), including all-cause mortality, myocardial infarction (MI), and target-vessel revascularisation (TVR). RESULTS: Among a total of 11,979 patients included, high hsCRP levels were observed in 24.7% of patients without diabetes and 29.8% of patients with diabetes (P < 0.001). Both diabetics and nondiabetics with high hsCRP levels had increased rates of MACE compared with their counterparts with low hsCRP (diabetics: adjusted hazard ratio [aHR] 1.58, 95% CI 1.27-1.96; nondiabetics: aHR 1.45, 95% CI 1.13-1.86; P interaction = 0.981) primarily driven by increased rates all-cause deaths (diabetics: aHR 2.32, 95% CI 1.42-3.80; nondiabetics: aHR 3.14, 95% CI 1.74-5.65; P interaction = 0.415). Although high hsCRP levels were associated with increased rates of TVR (aHR 1.35, 95% CI 1.04-1.75) and MI (aHR 1.86, 95% CI 1.18-2.93) only in patients with diabetes, no significant interactions were observed between inflammation and diabetes (P interaction = 0.749 and 0.602, respectively). CONCLUSIONS: Patients undergoing PCI with high levels of hsCRP, defined as > 3 mg/L, have worse ischemic outcomes regardless of diabetes status.

Sex-Related Differences in the Prevalence and Prognostic Value of the Academic Research Consortium for High Bleeding Risk Criteria.

[Figure: see text].

A sex paradox in clinical outcomes following complex percutaneous coronary intervention.

BACKGROUND: Although the number of complex percutaneous coronary intervention (CPCI) procedures is increasing, data regarding sex-related outcomes following CPCI are scarce. METHODS: We retrospectively analyzed data of patients enrolled in a single-center registry between 2009 and 2017. Patients were divided into two groups (CPCI and non-CPCI) stratified by sex. CPCI was defined as any PCI procedure with ≥1 of the following characteristics: ≥3 target vessels/lesions, ≥3 stents implanted, bifurcation with ≥2 stents, stent length > 60 mm, or chronic total occlusion. The primary outcome was major adverse cardiac events (MACE), a composite of all-cause death, myocardial infarction (MI), and target vessel revascularization, at oneon-year follow-up. RESULTS: Among 20,419 patients, 5004 (24.5%) underwent CPCI of whom 25.6% (n = 1281) women and 74.4% (n = 3723) men. Women presented with more comorbidities yet less complex coronary anatomy than men (syntax score: 19.5 ± 10.3 vs. 20.6 ± 10.7, p = 0.009). Moreover, women were more likely to fulfill a single rather than multiple CPCI criteria. At one year, a higher rate of MACE occurred in women (14.0% vs. 11.6%, p = 0.02). After multivariable adjustment for confounders, the risk of MACE at one year was similar among both sexes (HR:1.04, 95% CI [0.85-1.26], p = 0.71), without significant interaction between the complexity of the procedure and sex (p-interaction = 0.96). Nonetheless, the risk of MI was significantly higher in women than men undergoing CPCI (HR:1.63, 95% CI [1.12-2.38], p = 0.01). CONCLUSIONS: Despite presenting with less challenging lesions than men, women had a higher rate of MI at one year following CPCI, even after adjusting for potential confounders.

The Mega combo collaboration: an individual patient data pooled analysis of patients undergoing PCI with combo stent

BACKGROUND COMBO (OrbusNeich Medical) is a dual-therapy coro nary stent featuring sirolimus as the antiproliferative drug and an anti-CD34+ antibody coating to attract endothelial progenitor cells favoring rapid stent re-endothelization. The Mega COMBO collabora tion aimed to evaluate the performance of the COMBO stent in a large contemporary cohort of patients undergoing percutaneous coronary intervention (PCI) METHODS Patient-level data of subjects undergoing PCI with the COMBO stent from the REMEDEE-Trial, REMEDEE-OCT, HARMONEE, REDUCE, SORT OUT X, REMEDEE-Registry, and MASCOT studies were pooled together. The primary end point was 1-year target lesion fail ure (TLF), a composite of cardiovascular death, target vessel myocardial infarction (TV-MI), and ischemia-driven target lesion revascularization (ID-TLR). Event rates were estimated with the Kaplan-Meier method. Predictors of TLF were obtained from multi variate Cox regression, with stepwise selection of candidate variables RESULTS A total of 6,753 patients (median age » 64 years, 23% women) were included. Baseline characteristics are summarized in Figure 1A. At 1 year, TLF occurred in 303 (4.6%) patients. The rates of cardiovascular death, TV-MI, and ID-TLR were 1.3%, 1.8%, and 2.5%, respectively. Independent predictors for TLF are reported in Figure 1B. CONCLUSION This large patient-level pooled analysis provides a comprehensive overview of the safety and efficacy of the dual-ther apy COMBO stent. The rate of TLF observed at 1 year was low, making this stent technology a potential alternative to other contemporary drug-eluting stent platforms.