Two-year results from Onyx ONE clear in patients with high bleeding risk on one-month DAPT with and without intracoronary imaging.

BACKGROUND: Patients with high bleeding risk (HBR) are often treated with abbreviated dual antiplatelet therapy (DAPT) after percutaneous coronary intervention (PCI) to reduce bleeding risk, however this strategy is associated with an increase in ischemic events, especially if the acute PCI result is suboptimal. We compared clinical outcomes among patients with HBR treated with 1-month DAPT who underwent intravascular ultrasound (IVUS)- or optical coherence tomography (OCT)-guided PCI versus those who underwent angiography-guided PCI without intravascular imaging. METHODS: The Onyx ONE Clear study includes patients with HBR from the Onyx ONE US/Japan and Onyx ONE randomized studies who were treated with the Resolute Onyx zotarolimus-eluting stent. The primary endpoint was the composite of cardiac death (CD) or myocardial infarction (MI) between 1 month and 2 years after PCI. Propensity-score adjustments and matching were performed for differences in baseline and procedural characteristics between groups. RESULTS: Among the 1507 patients in Onyx ONE Clear, 271 (18.0 %) had IVUS or OCT used during PCI (Imaging-guided group) and 1236 (82.0 %) underwent Angiography-guided PCI (Angio-guided group). Imaging-guided patients were less likely to present with atrial fibrillation, acute coronary syndrome, and left ventricle ejection fraction ≤35 %. Conversely, Imaging-guided patients were more likely to have complex (ACC/AHA type B2/C), longer, and heavily calcified lesions. Between 1 month and 2 years, the composite rate of CD or MI was similar between Imaging-guided and Angio-guided patients (9.9 % vs. 12.4 %, P = 0.33). There was also no difference between groups after adjustment; (P = 0.56). However, CD was significantly lower among Imaging-guided patients (2.7 % vs. 6.1 %, P = 0.048). There were no between-group differences in MI or stent thrombosis. Propensity score matching results were similar. CONCLUSION: Despite higher lesion complexity, using intravascular imaging guidance for PCI between 1-month and 2-years follow-up had comparable outcomes with angiographic guidance alone in patients with HBR treated with 1-month DAPT. (ClinicalTrials.gov: Identifier: NCT03647475 and NCT03344653). NON-STANDARD ABBREVIATIONS AND ACRONYMS: BARC: Bleeding Academic Research Consortium; DAPT: dual antiplatelet therapy; DES: drug-eluting stent; HBR: high bleeding risk; IVUS: intravascular ultrasound; OCT: optical coherence tomography; SAPT: single antiplatelet therapy.

Readmission in Patients With ST-Elevation Myocardial Infarction in 4 Age Groups (<45, >45 to <60, 60 to <75, and >75).

The incidence of ST-elevation myocardial infarction (STEMI) among younger adults is increasing due to an increased prevalence of cardiometabolic risk factors. Readmissions after STEMI in young patients could lead to substantial health care costs and a significant burden on health care resources. Although STEMI readmissions are well studied in elderly patients, limited data are available regarding readmissions after STEMI in young patients and the etiologies remain poorly understood. Because younger patients with STEMI have different sociodemographic profiles th;an older patients with STEMI, one would postulate that the risk factors for readmissions in young patients would differ from that reported in the older patients with STEMI. We performed a contemporary nationwide study using the 2016 and 2017 Nationwide Readmissions Database to identify patterns of readmissions after STEMI in the young adult population. Our analysis of the Nationwide Readmissions Database revealed a total of 243,747 hospitalizations for STEMI between 2016 and 2017. Readmission rates demonstrated a steady increase from discharge, increasing to 7.8% at 30 days and 10.3% at 60 days before relatively plateauing at 12.1% at 90 days. Cardiovascular etiologies were the most common cause of readmission (53.6%). After multivariable analysis, development of cardiogenic shock (adjusted odds ratio 1.48, 95% confidence interval 1.11 to 1.97; p = 0.008) and acute renal failure (adjusted odds ratio 1.46, 95% confidence interval 1.14 to 1.87; p = 0.003) during the index admission were associated with significantly higher rates of readmission. In conclusion, close monitoring in young patients who presented with STEMI and concomitant with cardiogenic shock or acute renal failure, and possibly, aggressive therapy during index admission may be needed. However, this population may be heterogeneous and further research is needed.

The Prognostic Utility of Invasive Right Heart Catheterization in Patients Prior to Transcatheter Aortic Valve Replacement.

INTRODUCTION: Invasive right heart catheterization (RHC) provides valuable prognostic information in cases of severe aortic stenosis, but is not done routinely prior to transcatheter aortic valve replacement (TAVR). Therefore, we sought to investigate the prognostic utility of pre-TAVR RHC for assessing outcomes post TAVR. METHODS: This is a single-center, retrospective study of patients who underwent RHC prior to TAVR between June 2011 and March 2019. We evaluated abnormalities in the following variables as predictors of poor outcomes post TAVR: pulmonary capillary wedge pressure (PCWP), systolic pulmonary artery pressure (PASP), mixed venous oxygen saturation (MVO2), right ventricular stroke work index (RVSWI), and right atrial pressure (RAP). Cox proportional hazard regression models were used to assess the primary composite outcome of all-cause mortality and hospitalization for heart failure. RESULTS: A total of 522 patients (mean age, 83.5 ± 4.5 years; 49.4% women) with complete invasive hemodynamic data were included. At a median follow-up of 529.5 days, there were 127 deaths and 59 heart failure hospitalizations. On multivariate analysis, PCWP ≥15 mm Hg (hazard ratio [HR], 1.48; 95% confidence interval [CI], 1.02-2.07), PASP ≥50 mm Hg (HR, 1.66; 95% CI, 1.17-2.36), MVO2 ≤60% (HR, 1.42; 95% CI, 1.01-1.98), RVSWI ≥12 g•m/m²/beat (HR, 1.40; 95% CI, 1.004-1.94), and RAP ≥10 mm Hg (HR, 1.66; 95% CI, 1.09-2.51) were independent predictors of death or heart failure hospitalization. CONCLUSIONS: Preprocedural invasive RHC provides useful prognostic information. A comprehensive invasive hemodynamic assessment should be considered for risk stratification in patients undergoing TAVR.

The role of neighborhood disadvantage in predicting mortality in patients after transcatheter aortic valve replacement.

BACKGROUND: Neighborhoods have a powerful impact on health. Prior investigations into disparities associated with transcatheter aortic valve replacement (TAVR) have focused on race and access to the procedure. We sought to investigate the role of neighborhood disadvantage on mortality post-TAVR. METHODS: Patients who underwent TAVR at Kaiser Permanente Los Angeles Medical Center between June, 2011 and March, 2019 were evaluated. Neighborhood disadvantage was defined using the area deprivation index, an established and validated index that considers multiple socioeconomic metrics. Cutoffs used for disadvantage were national percentile ≥25% and state decile ≥6. Cox proportional hazards regression analysis was used to assess outcomes. RESULTS: A total of 668 patients (age 82.1 ± 7.5 years, 49% female) were included, of which 215 (32.2%) were from disadvantaged neighborhoods by state decile, and 167 (25%) by national percentile. At a median follow-up of 18.8 months (interquartile range 8.7-36.5 months), neighborhood disadvantage was independently associated with increased all-cause mortality (National percentile: hazard ratio [HR] 1.91, 95% confidence interval [CI] 1.35-2.69; state decile: HR 1.68, 95% CI 1.21-2.34). On propensity scored analysis, neighborhood disadvantaged remained independently associated with increased all-cause mortality (National percentile: IPTW HR 1.86, 95% CI 1.52-2.28, PSM HR 1.67, 95% CI 1.11-2.51; state decile: IPTW HR 1.55, 95% CI 1.26-1.91, PSM HR 2.0, 95% CI 1.33-2.99). CONCLUSION: Living in a disadvantaged neighborhood was independently associated with increased mortality post-TAVR on multivariate and propensity score matched analysis. Further investigations into the role of neighborhood disadvantage are needed to address disparities and improve outcomes post-TAVR.

Comparison of a Single Versus Double Perclose Technique for Percutaneous Transfemoral Transcatheter Aortic Valve Replacement.

BACKGROUND: The optimal strategy for arterial closure in percutaneous transfemoral transcatheter aortic valve replacement (TF-TAVR) remains under debate. METHODS: Single-center, prospective, observational study of consecutive patients undergoing TF-TAVR between March 2018 and December 2019 who underwent closure with an upfront single vs double Perclose device. Device success, access-site vascular, and bleeding complications were defined according to the Valvular Academic Research Consortium (VARC)-2 criteria. Inverse-probability of treatment weighting (IPTW) was used to balance baseline characteristics between groups. RESULTS: A total of 241 patients (mean age, 81.4 ± 8.5 years, 47% women) were included, of which 127 underwent an upfront single-Perclose (SP) strategy and 114 underwent an upfront double-Perclose (DP) strategy. Fifty-six percent of patients were treated with a CoreValve (Medtronic). The SP group was less likely to be on dialysis and on aspirin, but were more likely to receive a CoreValve, with larger valve sizes and larger delivery sheaths. Baseline characteristics were well balanced after IPTW adjustment. Device success rate was comparable between groups (96% in the SP group vs 93% in the DP group; P=.39). The SP technique was associated with fewer vascular complications (8.7% in the SP group vs 26.3% in the DP group; P<.01; IPTW relative risk [RR], 0.34; 95% confidence Interval [CI], 0.16-0.71) and bleeding complications (2.4% in the SP group vs 12.3% in the DP group; P<.01; IPTW RR, 0.21; 95% CI, 0.06-0.76) compared with the DP technique. There were no differences in 30-day mortality. CONCLUSION: An upfront SP technique is equally efficacious and not associated with increased vascular and bleeding complications compared with an upfront DP technique in patients undergoing percutaneous TF-TAVR.

Predictors of conduction recovery after permanent pacemaker implantation following transcatheter aortic valve replacement.

PURPOSE: Conduction disturbances after transcatheter aortic valve replacement (TAVR) requiring pacemaker (PPM) implantation are a known complication and may be reversible. Therefore, we sought to evaluate the incidence and predictors for atrioventricular (AV) conduction recovery after TAVR. METHODS: A single-center, retrospective study of patients undergoing PPM implantation for conduction disorders after TAVR between June 2011 and March 2019. Conduction recovery was defined as ≤ 1% ventricular pacing (VP) on follow-up PPM interrogation. RESULTS: A total of 110 patients (mean age 83.6 ± 6.6 years, 46.8% female) were included. At a median follow-up of 438 days (interquartile range [IQR] 111-760 days), 35 patients (32%) had conduction recovery, with 50% of these occurring within the first 6 months. On multivariate analysis, predictors of conduction recovery include female sex (hazard ratio [HR] 2.5, 95% confidence interval [CI] 1.01-6.4, p = 0.048), non-VP/non-complete heart block rhythm immediately post-TAVR (HR 5.2, 95% CI 1.5-18.1, p = 0.011), normal sinus rhythm 7 days post-TAVR (HR 3.9, 95% CI 1.7-9.2, p = 0.002), and smaller valve size (mm) (HR 0.81, 95% CI 0.7-0.996, p = 0.045). Significant narrowing of the QRS and resolution of new-onset left bundle branch block within 1 month post-TAVR occurred in those with conduction recovery on PPM interrogation. CONCLUSIONS: One-third of patients receiving new PPM implantation have conduction recovery after TAVR, with 50% occurring within the first 6 months. Patient gender, valve size, and rhythm on serial ECGs after TAVR can help identify patients that may recover AV conduction. A conservative approach rather than immediate PPM implantation may be considered in these patients.

Association between mid-term worsening renal function and mortality after transcatheter aortic valve replacement in patients with chronic kidney disease.

INTRODUCTION: Chronic kidney disease (CKD), acute kidney injury (AKI) and worsening renal function at 30 days after transcatheter aortic valve replacement (TAVR) portend poor outcomes. We sought to evaluate the association between worsening renal function at 3-6 months and mortality among patients with baseline renal dysfunction undergoing TAVR. METHODS: This is a retrospective study of patients with glomerular filtration rate (GFR) < 60 ml/min undergoing TAVR between June 2011 and March 2019 at the Regional Cardiac Catheterization Lab at Kaiser Permanente Los Angeles. Worsening renal function at 3-6 months post-TAVR was defined as: increase in serum creatinine >1.5 times compared to baseline, absolute increase of ≥0.3 mg/dl, or initiation of dialysis. RESULTS: Of 683 patients reviewed, 176 were included in the analysis (median age 84 [IQR 79-88] years, 56% female). Of these, 27 (15.3%) had worsening renal function. AKI post-TAVR (OR 2.9, 95% CI 1.1-7.4, p = .03) and transfusion of ≥4 units red blood cells (OR 8.4, 95% CI 1.2-59, p = .03) were independent predictors of worsening renal function. Worsening renal function increased risk for mortality (HR 2.2, 95% CI 1.17-4.27, p = .015) at a median follow-up of 691 days. Those with improved/stable function with baseline GFR < 60 ml/min had comparable mortality risk to those with baseline GFR ≥ 60 ml/min (18% vs. 16.5%; HR 1.1, 95% CI 0.72-1.75, p = .62). CONCLUSION: Among patients with baseline renal dysfunction, only 15% developed worsening renal function at 3-6 months after TAVR, which was associated with increased mortality. Predictors for worsening renal function include AKI and blood transfusions. Preventative measures peri-procedurally and continued monitoring post-discharge are warranted to improve outcomes.

Trends in statin utilization among adults with severe peripheral artery disease including critical limb ischemia in an integrated healthcare delivery system.

Evidence suggests that statin therapy in patients with peripheral artery disease (PAD) is beneficial yet use remains suboptimal. We examined trends in statin use, intensity, and discontinuation among adults aged ⩾ 40 years with incident severe PAD and a subset with critical limb ischemia (CLI) between 2002 and 2015 within an integrated healthcare delivery system. Discontinuation of statin therapy was defined as the first 90-day gap in treatment within 1 year following PAD diagnosis. We identified 11,059 patients with incident severe PAD: 31.1% (n = 3442) with CLI and 68.9% (n = 7617) without CLI. Mean (SD) age was 68.6 (11.3) years, 60.5% were male, 54.2% white, 23.2% Hispanic, and 16.2% black. Statin use in the year before diagnosis increased from 50.4% in 2002 to 66.0% in 2015 (CLI: 43.7% to 68.0%; without CLI: 53.1% to 64.2%, respectively). The proportion of patients on high-intensity statins increased from 7.3% in 2002 to 41.9% in 2015 (CLI: 7.2% to 39.4%; without CLI: 7.4% to 44.2%, respectively). Of the 40.5% (n = 4481) who were not on a statin in the year before diagnosis, 13.5% (n = 607) newly initiated therapy within 1 month (CLI: 10.1% (n = 150); without CLI: 15.3% (n = 457)). Following diagnosis, 12.5% (n = 660) discontinued statin therapy within 1 year (CLI: 15.5% (n = 202); without CLI: 11.5% (n = 458)). Although use of statins increased from 2002 to 2015, a substantial proportion of the overall PAD and CLI subpopulation remained untreated with statins, representing a significant treatment gap in a population at high risk for cardiovascular events and adverse limb outcomes.

Open Versus Endovascular or Hybrid Thoracic Aortic Aneurysm Repair.

Thoracic aortic aneurysms are associated with significant morbidity and mortality. There are multiple underlying etiologies, including genetic abnormalities, that have important implications in their natural history. The variable histologic, anatomic, and clinical presentations necessitate careful consideration of available treatment options. Surgical repair of these aneurysms has been the mainstay of treatment; however, these approaches can carry a relatively high risk of morbidity and mortality. Endovascular approaches have now become first-line therapy for descending thoracic aneurysms, and with advancements in graft technology, endovascular approaches are being increasingly employed for hybrid repairs of the aortic arch and even the ascending aorta. However, to date, clinical outcomes from randomized trials and long-term follow-up are limited. As technology continues to advance, there is the potential for further integration of surgical and endovascular treatments so that patients have the best opportunity for a favorable outcome.

Statin use prior to angiography for the prevention of contrast-induced acute kidney injury: a meta-analysis of 19 randomised trials.

AIMS: A systematic review and a meta-analysis were performed to define better the role of statin use prior to angiography in preventing contrast-induced acute kidney injury (CI-AKI). METHODS AND RESULTS: MEDLINE, Embase, Cochrane Library, references from review articles, and conference proceedings were searched, with no language restriction, for randomised controlled trials (RCT) evaluating the use of statin therapy prior to angiography for the prevention of CI-AKI. Nineteen RCTs including 7,161 patients were identified. The pooled analysis demonstrated a significant reduction in the incidence of CI-AKI in patients treated with statin prior to invasive angiography when compared with control (RR 0.52; 95% CI: 0.40-0.67). Patients with chronic kidney disease stage 3 or worse were largely underrepresented in these trials, and statin therapy did not significantly reduce the risk of CI-AKI in the three studies which enrolled a patient population with a mean eGFR of <60 ml/min (RR 0.54; 95% CI: 0.2-1.42). CONCLUSIONS: This meta-analysis suggests a potential benefit for statin use prior to angiography to reduce the incidence of CI-AKI. Additional research is needed to define better the benefits of statin therapy prior to angiography to prevent CI-AKI, especially in high-risk patients with chronic kidney disease who were largely underrepresented in the available trials.

Haemodynamic-guided fluid administration for the prevention of contrast-induced acute kidney injury: the POSEIDON randomised controlled trial.

BACKGROUND: The administration of intravenous fluid remains the cornerstone treatment for the prevention of contrast-induced acute kidney injury. However, no well-defined protocols exist to guide fluid administration in this treatment. We aimed to establish the efficacy of a new fluid protocol to prevent contrast-induced acute kidney injury. METHODS: In this randomised, parallel-group, comparator-controlled, single-blind phase 3 trial, we assessed the efficacy of a new fluid protocol based on the left ventricular end-diastolic pressure for the prevention of contrast-induced acute kidney injury in patients undergoing cardiac catheterisation. The primary outcome was the occurrence of contrast-induced acute kidney injury, which was defined as a greater than 25% or greater than 0·5 mg/dL increase in serum creatinine concentration. Between Oct 10, 2010, and July 17, 2012, 396 patients aged 18 years or older undergoing cardiac catheterisation with an estimated glomerular filtration rate of 60 mL/min per 1·73 m(2) or less and one or more of several risk factors (diabetes mellitus, history of congestive heart failure, hypertension, or age older than 75 years) were randomly allocated in a 1:1 ratio to left ventricular end-diastolic pressure-guided volume expansion (n=196) or the control group (n=200) who received a standard fluid administration protocol. Four computer-generated concealed randomisation schedules, each with permuted block sizes of 4, were used for randomisation, and participants were allocated to the next sequential randomisation number by sealed opaque envelopes. Patients and laboratory personnel were masked to treatment assignment, but the physicians who did the procedures were not masked. Both groups received intravenous 0·9% sodium chloride at 3 mL/kg for 1 h before cardiac catheterisation. Analyses were by intention to treat. Adverse events were assessed at 30 days and 6 months and all such events were classified by staff who were masked to treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT01218828. FINDINGS: Contrast-induced acute kidney injury occurred less frequently in patients in the left ventricular end-diastolic pressure-guided group (6·7% [12/178]) than in the control group (16·3% [28/172]; relative risk 0·41, 95% CI 0·22-0·79; p=0·005). Hydration treatment was terminated prematurely because of shortness of breath in three patients in each group. INTERPRETATION: Left ventricular end-diastolic pressure-guided fluid administration seems to be safe and effective in preventing contrast-induced acute kidney injury in patients undergoing cardiac catheterisation. FUNDING: Kaiser Permanente Southern California regional research committee grant.

Discontinuation of long-term clopidogrel therapy is associated with death and myocardial infarction after saphenous vein graft percutaneous coronary intervention.

OBJECTIVES: This study sought to examine the pattern of death and myocardial infarction (MI) after clopidogrel cessation in patients undergoing percutaneous coronary intervention (PCI) of the saphenous vein graft (SVG). BACKGROUND: The timing and incidence of adverse events by different durations of clopidogrel therapy after SVG PCI remain unknown. METHODS: This is a cohort study of patients undergoing SVG PCI between 2000 and 2009, followed for all-cause mortality or MI after stopping clopidogrel. Incidence rates were calculated across different time periods after clopidogrel cessation. Adjusted incidence rate ratios (IRR) were calculated with multivariable regression (piecewise exponential and Poisson). RESULTS: There were 603 patients who underwent SVG PCI, of which 411 were event-free at the time of clopidogrel cessation. The incidence rate (95% confidence interval: [CI])/1,000 person-days of death or MI after stopping clopidogrel in the time intervals of 0 to 90 days, 91 to 365 days, and 1 to 2 years were 1.26 (95% CI: 0.93 to 1.70), 0.41 (95% CI: 0.30 to 0.56), and 0.41 (95% CI: 0.30 to 0.55), respectively. In multivariable analyses, the overall IRR (95% CI) for death or MI in the 0- to 90-day interval after stopping clopidogrel compared with the 91- to 365-day interval was 2.58 (95% CI: 1.64 to 4.07). Similar results were observed over a broad range of clopidogrel treatment durations (<6 months, 6 months to 1 year, 1 to 2 years, or >2 years). The results were also consistent across subgroups, including sex, stent type, stent diameter, PCI period, and diabetes status. When death alone was evaluated, there remained a significant increase in the event rate in the 0- to 90-day interval compared with the 91- to 365-day interval (IRR: 2.33; 95% CI: 1.32 to 4.11). CONCLUSIONS: A clustering of events was observed in the initial 0 to 90 days after clopidogrel cessation in all treatment durations of clopidogrel investigated after SVG PCI. These results might have important implications in high-risk cohorts undergoing PCI. Additional studies are needed to elucidate the mechanisms underlying the early clustering of events after clopidogrel cessation.

Impact of routine angiographic follow-up after percutaneous coronary intervention with drug-eluting stents in the SPIRIT III randomized trial at three years.

Routine angiographic follow-up after bare-metal stent implantation has been associated with an increase in coronary revascularization. The impact of angiographic follow-up after drug-eluting stent placement remains poorly characterized. The prospective, randomized, single-blinded SPIRIT III trial assigned patients to the everolimus-eluting stent or the paclitaxel-eluting stent (PES). Major adverse cardiovascular events (cardiac death, myocardial infarction, and ischemia-driven target lesion revascularization [ID-TLR]) at 3 years were assessed by angiographic versus clinical-only follow-up at 8 months ± 28 days and a landmark survival analysis from 9 months to 3 years. Of 1,002 patients, 564 patients were assigned to angiographic follow-up at 8 months ± 28 days and 438 patients underwent clinical follow-up alone. Three-year major adverse cardiovascular event rates were 10.6% in the angiographic group and 12.0% in the clinical follow-up group (p = 0.64). Ischemia-driven revascularization increased twofold at 9 months, but no difference was noted in ID-TLR for either device. Non-ID-TLR was significantly higher in patients in the angiographic group (4.5% vs 1.0%, p = 0.002), a difference resulting from PES (9.1% vs 0.7%, p = 0.0007) rather than everolimus-eluting stent (2.2% vs 1.1%, p = 0.36) treatment. The landmark analysis showed no significant differences between the angiographic and clinical follow-up groups from 9 months to 3 years of major clinical outcomes. In conclusion, routine angiographic follow-up in SPIRIT III did not increase rates of ID-TLR compared to clinical follow-up alone. Despite higher nonischemia-driven revascularization rates with angiographic follow-up of patients with PESs, none of the safety end points were adversely affected.

Controversies in the use & implementation of drug-eluting stent technology.

The introduction of drug eluting stents has resulted in dramatic reductions in the rates of restenosis and the need for repeat revascularization. In the last several years, concern has been raised regarding the long-term safety of this technology, particularly in the area of late restenosis and stent thrombosis. The development of newer anti-restenotic drug coatings, biodegradable polymers and even completely bioabsorbable stents offer the potential to address these limitations. Additional questions that have recently come to the forefront include the optimal duration of dual antiplatelet therapy, the use of platelet reactivity assays and genetic testing and drug eluting stent use in the treatment of acute myocardial infarction. This article will attempt to address these and other areas of controversy in the use and implementation of drug eluting stents.

Impact of platelet reactivity on clinical outcomes after percutaneous coronary intervention. A collaborative meta-analysis of individual participant data.

OBJECTIVES: The purpose of the study was to systematically evaluate the significance of platelet reactivity on clopidogrel treatment on adverse cardiovascular events using a collaborative meta-analysis using patient-level data for the VerifyNow P2Y12 assay (Accumetrics, San Diego, California). BACKGROUND: Clinical evidence has been controversial regarding the influence of clopidogrel on treatment platelet reactivity and ischemic outcomes. METHODS: MEDLINE, Scopus, and the Cochrane library databases were searched through January 2010. A database containing individual patient-level time-to-event data was generated from identified studies. The primary outcome of interest was a composite of death, myocardial infarction (MI), or stent thrombosis. Secondary outcomes included the incidence of: 1) death; 2) MI; and 3) stent thrombosis. RESULTS: A total of 6 studies with 3,059 patients was included. In each study, clopidogrel responsiveness was assessed using the same point-of-care assay after percutaneous coronary intervention. The primary endpoint occurred more frequently in higher quartiles of P2Y(12) reaction unit (PRU) values: quartile I, 5.8%; quartile II, 6.9%; quartile III, 10.9%; quartile IV, 15.8% (p < 0.001). Taking quartile I as referent, the hazard ratios (HRs) for the primary endpoint were as follows: quartile II, HR: 1.13 (95% confidence interval [CI]: 0.72 to 1.78; p = 0.60); quartile III, HR: 1.82 (95% CI: 1.20 to 2.75; p = 0.005); quartile IV, HR: 2.62 (95% CI: 1.78 to 3.87; p < 0.001). On a continuous scale, every 10-U increase in PRU was associated with a significantly higher rate of the primary endpoint (HR: 1.04; 95% CI: 1.03 to 1.06; p < 0.0001). According to receiver-operating characteristic curve analysis, a PRU value of 230 appeared to best predict death, MI, or stent thrombosis (p < 0.001). A PRU value ≥230 was associated with a higher rate of the composite primary endpoint (HR: 2.10; 95% CI: 1.62 to 2.73; p < 0.0001), as well as the individual endpoints of death (HR: 1.66; 95% CI: 1.04 to 2.68; p = 0.04), MI (HR: 2.04; 95% CI: 1.51 to 2.76; p < 0.001), and stent thrombosis (HR: 3.11; 95% CI: 1.50 to 6.46; p = 0.002). CONCLUSIONS: In this collaborative meta-analysis, the level of on-treatment platelet reactivity according to the P2Y(12) assay is associated with long-term cardiovascular events after percutaneous coronary intervention, including death, MI, and stent thrombosis.

Racial/ethnic differences in the prevalence of atrial fibrillation among older adults--a cross-sectional study.

BACKGROUND: Atrial fibrillation affects 4% to 8% of individuals over 60 years of age based on studies of predominantly white populations, whether this is true among nonwhite individuals is not clear. This study was undertaken to define racial/ethnic differences in atrial fibrillation prevalence among a large community cohort. METHODS: This is a cross-sectional study. In 2008, there were 430,317 members aged 60 years or older in a large California health maintenance organization. By searching International Classification of Diseases, Ninth Revision codes and electronic electrocardiographic archives, we identified all members in this age group with primary, nonvalvular atrial fibrillation. Race/ethnicity data were assigned using health plan enrollment, service utilization, Asian/Hispanic surname and geocoding methods, and was available for 80.5% of members (79.8% of non-atrial fibrillation and 92% of atrial fibrillation), 99% of which were white, black, Asian, or Hispanic. We assessed the age- and gender-specific atrial fibrillation prevalence rates for each racial/ethnic group. The effect of race/ethnicity on atrial fibrillation was analyzed with logistic regression methods adjusting for potential confounders. RESULTS: The overall atrial fibrillation prevalence was 5.3%. Among members with assigned race/ethnicity data, the prevalence among whites, blacks, Asians, and Hispanics was 8.0%, 3.8%, 3.9%, and 3.6%, respectively. The adjusted odds ratios (95% confidence intervals) of atrial fibrillation among blacks, Asians, and Hispanics with whites as referent were 0.49 (0.47-0.52), 0.68 (0.64-0.72), and 0.58 (0.55-0.61), respectively. CONCLUSIONS: Atrial fibrillation is less prevalent in older nonwhite individuals than whites. White race/ethnicity is associated with significantly greater odds for atrial fibrillation compared to blacks, Asians, and Hispanics, after adjusting for comorbidities associated with the development of atrial fibrillation.