The Association of Digital Health Application Use With Heart Failure Care and Outcomes: Insights From CONNECT-HF.

BACKGROUND: It is unknown whether digital applications can improve guideline-directed medical therapy (GDMT) and outcomes in heart failure with reduced ejection fraction (HFrEF). METHODS AND RESULTS: Care Optimization Through Patient and Hospital Engagement Clinical Trial for Heart Failure trial (CONNECT-HF) included an optional, prospective ancillary study of a mobile health application among patients hospitalized due to HFrEF. Digital users were matched to nonusers from the usual-care group. Coprimary outcomes included change in opportunity-based composite HF quality scores and HF rehospitalization or all-cause mortality. Among 2431 patients offered digital applications across the United States, 1526 (63%) had limited digital access or insufficient data, 425 (17%) were digital users, and 480 (20%) declined use. Digital users were similar in age to those who declined use (mean 58 vs 60 years; P = 0.031). Digital users (n = 368) vs matched nonusers (n = 368) had improved composite HF quality scores (48.0% vs 43.6%; + 4.76% [3.27-6.24]; P = 0.001) and composite clinical outcomes (33.0% vs 39.6%; HR 0.76 [0.59-0.97]; P = 0.027). CONCLUSIONS: Among participants in the CONNECT-HF trial, use of digital applications was modest but was associated with higher HF quality-of-care scores, including use of GDMT and better clinical outcomes. Although cause and effect cannot be determined from this study, the application of technology to guide GDMT use and dosing among patients with HFrEF warrants further investigation.

One-year outcomes of supersaturated oxygen therapy in acute anterior myocardial infarction: The IC-HOT study.

BACKGROUND: Supersaturated oxygen (SSO2 ) has recently been approved by the U.S. Food and Drug Administration for administration after primary percutaneous coronary intervention (pPCI) in patients with anterior ST-segment elevation myocardial infarction (STEMI) based on its demonstration of infarct size reduction in the IC-HOT study. OBJECTIVES: To describe the 1-year clinical outcomes of intracoronary SSO2 treatment after pPCI in patients with anterior STEMI. METHODS: IC-HOT was a prospective, open-label, single-arm study in which 100 patients without cardiogenic shock undergoing successful pPCI of an occluded left anterior descending coronary artery were treated with a 60-min SSO2 infusion. One-year clinical outcomes were compared with a propensity-matched control group of similar patients with anterior STEMI enrolled in the INFUSE-AMI trial. RESULTS: Baseline and postprocedural characteristics were similar in the two groups except for pre-PCI thrombolysis in myocardial infarction 3 flow, which was less prevalent in patients treated with SSO2 (9.6% vs. 22.9%, p = .02). Treatment with SSO2 was associated with a lower 1-year rate of the composite endpoint of all-cause death or new-onset heart failure (HF) or hospitalization for HF (0.0% vs. 12.3%, p = .001). All-cause mortality, driven by cardiovascular mortality, and new-onset HF or HF hospitalization were each individually lower in SSO2 -treated patients. There were no significant differences between groups in the 1-year rates of reinfarction or clinically driven target vessel revascularization. CONCLUSIONS: Infusion of SSO2 following pPCI in patients with anterior STEMI was associated with improved 1-year clinical outcomes including lower rates of death and new-onset HF or HF hospitalizations.

Evaluation of intracoronary hyperoxemic oxygen therapy in acute anterior myocardial infarction: The IC-HOT study.

BACKGROUND: In the randomized AMIHOT-II trial, supersaturated oxygen [SSO2 ] delivered into the left anterior descending (LAD) artery via an indwelling intracoronary infusion catheter following primary percutaneous coronary intervention (PCI) significantly reduced infarct size in patients with anterior ST-segment elevation myocardial infarction (STEMI) but resulted in a numerically higher incidence of safety events. OBJECTIVES: The IC-HOT study evaluated the safety of SSO2 therapy selectively delivered to the left main coronary artery (LMCA) for 60 minutes after PCI in patients with anterior STEMI. METHODS: SSO2 therapy was administered to the LMCA after stent implantation in 100 patients with anterior STEMI and proximal or mid-LAD occlusion presenting within 6 hours of symptom onset. The primary endpoint was the 30-day composite rate of net adverse clinical events (NACE) (death, reinfarction, clinically driven target vessel revascularization, stent thrombosis, severe heart failure, or TIMI major/minor bleeding) compared against an objective performance goal of 10.7%. Cardiac magnetic resonance imaging was performed at 4 and 30 days to assess infarct size. RESULTS: SSO2 delivery was successful in 98% of patients. NACE at 30 days occurred 7.1% of patients (meeting the primary safety endpoint of the study); there were no deaths, only one stent thrombosis and one case of severe heart failure. Median [interquartile range] infarct size was 24.1% [14.4%, 31.6%] at 4 days and 19.4% [8.8%, 28.9%] at 30 days. CONCLUSION: Following primary PCI in acute anterior STEMI, infusion of SSO2 via the LMCA was feasible and was associated with a favorable early safety profile.

Long-term outcomes of patients with diabetes mellitus undergoing percutaneous intervention for popliteal and infrapopliteal peripheral arterial disease.

OBJECTIVES: To evaluate the association of diabetes mellitus (DM) with clinical and angiographic characteristics and outcomes of patients with popliteal and infrapopliteal peripheral arterial disease (PAD) undergoing peripheral vascular intervention (PVI). BACKGROUND: Clinical features and outcomes in patients with DM and popliteal or infrapopliteal PAD undergoing PVI are not well described. METHODS: Using the data from the laser in popliteal and infrapopliteal stenosis study, we retrospectively examined the association of diabetes with clinical and angiographic characteristics and risk adjusted short- and intermediate term outcomes (all cause death, major adverse events (MAE) [composite of death, ipsilateral major amputation, or repeat revascularization]) in patients with popliteal and infrapopliteal PAD undergoing PVI for critical limb ischemia treated either with laser-assisted balloon angioplasty or balloon angioplasty alone. RESULTS: Of 714 patients, 418 had DM (58.5%). Patients with DM were younger with higher prevalence of history of coronary artery disease, heart failure, end-stage renal disease, and prior contralateral limb amputation compared to those without DM. At 5 years, mean event free survival for all cause mortality (39.9 vs. 45.5 months; P = 0.001), MAE (29.3 vs. 36.8 months; P < 0.001), ipsilateral major amputation (55.3 vs. 57.4 months; P = 0.001), and repeat revascularization (42.0 vs. 45.8 months; P = 0.03) were significantly lower in DM patients. On multivariate analysis, DM was associated with significantly higher all cause mortality (HR = 1.83, 95% CI 1.33-2.52), MAE (HR = 1.73, 95% CI 1.35-2.23), and ipsilateral major amputation (HR = 5.52, 95% CI 1.82-16.71). CONCLUSIONS: Among patients with popliteal and infrapopliteal PAD undergoing PVI, DM was associated with higher mortality, major amputations and MAE that was independent of baseline comorbidities. Our data suggested the need for future studies evaluating existing and/or novel therapies to improve the poor long-term outcomes in diabetic patients with popliteal and infrapopliteal PAD.

The comparative safety and effectiveness of bivalirudin versus heparin monotherapy in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan cardiovascular consortium.

BACKGROUND: Dialysis patients are at a higher risk of bleeding after percutaneous coronary intervention (PCI); however, due to their exclusion from randomized clinical trials, the optimal antithrombotic regimen for this population remains unknown. We sought to evaluate the comparative safety and effectiveness of bivalirudin monotherapy versus unfractionated heparin (UFH) monotherapy in dialysis patients undergoing PCI. METHODS: We included dialysis patients who underwent PCI in a multicenter registry between January 2010 and September 2015 at 47 Michigan hospitals. We compared in-hospital outcomes between bivalirudin versus UFH; excluding those treated with glycoprotein IIb/IIIa inhibitors. Optimal full matching was used to account for the nonrandom use of these drugs. RESULTS: Of 177,963 patients who underwent PCI, 4,303 (2.4%) were on dialysis. Among those, 1,257 (29.2%) received bivalirudin monotherapy and 2,112 (49.1%) received UFH monotherapy. Patients treated with bivalirudin had fewer comorbidities. After matching, there were no significant differences in outcomes between those who received bivalirudin versus UFH: bleeding (adjusted odds ratio: 0.67; 95% confidence interval: 0.41-1.07; P = 0.093); major bleeding (0.81; 0.19-3.50; P = 0.77); transfusion (1.01; 0.77-1.33; P = 0.96); repeat PCI (0.57; 0.14-2.24; P = 0.42); stent thrombosis (0.56; 0.05-5.83; P = 0.63); and death (0.84; 0.46-1.51; P = 0.55). CONCLUSIONS: We found no significant differences in in-hospital outcomes between bivalirudin and UFH monotherapy among dialysis patients undergoing PCI. Randomized clinical trials are needed to determine the optimal anticoagulant regimen for this population. © 2017 Wiley Periodicals, Inc.

The comparative safety of abciximab versus eptifibatide in patients on dialysis undergoing percutaneous coronary intervention: Insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

OBJECTIVES: We sought to evaluate the patterns of use and outcomes associated with eptifibatide and abciximab administration among dialysis patients who underwent percutaneous coronary intervention (PCI). BACKGROUND: Contraindicated medications are frequently administered to dialysis patients undergoing PCI often resulting in adverse outcomes. Eptifibatide is a glycoprotein IIb/IIIa inhibitor that is often used during PCI and is contraindicated in dialysis. METHODS: We included dialysis patients who underwent PCI from January 2010 to September 2015 at 47 hospitals in Michigan. We compared outcomes between patients who received eptifibatide compared with abciximab. Both groups required concurrent treatment with unfractionated heparin only. In-hospital outcomes included repeat PCI, bleeding, major bleeding, need for transfusion, and death. Optimal full matching was used to adjust for non-random drug administration. RESULTS: Of 177 963 patients who underwent PCI, 4303 (2.4%) were on dialysis. Among those, 384 (8.9%) received eptifibatide and 100 (2.3%) received abciximab. Prior to matching, patients who received eptifibatide had higher pre-procedural hemoglobin levels (11.3 g/dL vs. 10.7 g/dL; P < 0.001) and less frequently had a history of myocardial infarction (36.5% vs. 52.0%; P = 0.005). After matching, there were no significant differences in in-hospital outcomes between eptifibatide and abciximab including transfusion (aOR: 1.15; 95%CI: 0.55-2.40; P = 0.70), bleeding (1.47; 0.64-3.40; P = 0.36), major bleeding (4.68; 0.42-52.3; P = 0.21), repeat PCI (0.38; 0.03-4.23; P = 0.43), and death (1.53; 0.2-9.05; P = 0.64). CONCLUSIONS: Despite being contraindicated in dialysis, eptifibatide was used approximately 3.5 times more frequently than abciximab among dialysis patients undergoing PCI but was associated with similar in-hospital outcomes.

Radial PCI and the obesity paradox: Insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

OBJECTIVE: To examine if transradial approach (TRA) negates the increased risk associated with femoral access in lean and morbidly obese patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Patients at extremes of body mass are at increased risk of bleeding after PCI. TRA has been associated with lower overall rates of bleeding compared to femoral approach. METHODS AND RESULTS: We studied patients undergoing emergent and elective PCI from 2010 to 2012 across 47 hospitals in Michigan who participate in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium PCI registry. The primary outcomes were the incidences of bleeding and postprocedure transfusion. Propensity matching (PM) was used to adjust for nonrandomized use of TRA. TRA was used in 10,235 procedures. In PM analyses, use of TRA was associated with a reduction in bleeding (0.80 vs. 1.9%, odds ratio [OR] = 0.41, 95% confidence interval [CI] = 0.32-0.54, P < 0.001) and need for transfusion (1.4 vs. 2.5%, OR = 0.56, 95% CI = 0.45-0.69, P < 0.001) compared with femoral access. The absolute difference in bleeding and transfusion associated with TRA was largest in patients with lean body mass (BMI < 25 kg/m(2)) and morbid obesity (BMI ≥ 40 kg/m(2)): Lean patients undergoing TRA had a rate of bleeding of 1.2 versus 2.8% for femoral access (OR = 0.43, 95% CI = 0.24-0.77, P = 0.002); and rate of transfusion of 2.4 versus 3.9% (OR = 0.61, 95% CI = 0.40-0.94, P = 0.019). The morbidly obese had a rate of bleeding of 0.8% for TRA versus 2.4% for femoral access (OR = 0.33, 95% CI = 0.44-0.72, P = 0.004); and rate of transfusion of 1.7 versus 3.0%, (OR = 0.55, 95% CI = 0.30-1.0, P = 0.051). CONCLUSIONS: Compared with the femoral approach, TRA is associated with a reduction in bleeding across all patients undergoing PCI and the absolute benefit was greatest in those with extremely low or high BMI.

Differences in sex-related bleeding and outcomes after percutaneous coronary intervention: insights from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) registry.

BACKGROUND: Bleeding after percutaneous coronary intervention (PCI) is more common in women than in men. However, the relationship of sex and bleeding with outcomes is less well studied. METHODS: We examined the sex-related differences in the incidence of bleeding and its association with in-hospital outcomes among 96,637 patients undergoing PCI enrolled in the BMC2 registry (2010-2012). RESULTS: Women had higher bleeding rate than did men (3.9% vs 1.8%) and thus received more blood transfusions (59% vs 41%). Both men (odds ratio [OR] 2.25, 95% CI 1.70-2.97) and women (OR 3.13, 95% CI 2.42-4.07) who bled had higher risk-adjusted death compared with their counterparts without bleeding. Although there was no difference in adjusted mortality between women and men without bleeding (OR 1.14, 95% CI 0.99-1.32), among patients who bled, adjusted death was higher in women (OR 1.28, 95% CI 1.11-1.47). Among patients with bleeding, transfusion was associated with similar increased risk of death in both men (OR 2.00, 95% CI 1.23-3.25) and women (OR 2.18, 95% CI 1.31-3.63) compared with their counterparts without transfusion(s). CONCLUSIONS: Post-PCI bleeding was more common and associated with higher-than-expected in-hospital death in women compared with men with bleeding. This trend for higher death in women with bleeding was independent of transfusion. Quality efforts geared toward reducing bleeding in general, with a special focus on women, need to be explored to help reduce post PCI-bleeding and mortality and decrease sex-related disparity in adverse events.

Early Utilization of Mechanical Circulatory Support in Acute Myocardial Infarction Complicated by Cardiogenic Shock: The National Cardiogenic Shock Initiative.

BACKGROUND: Acute myocardial infarction complicated by cardiogenic shock (AMI-CS) is associated with significant morbidity and mortality. Mechanical circulatory support (MCS) devices increase systemic blood pressure and end organ perfusion while reducing cardiac filling pressures. METHODS AND RESULTS: The National Cardiogenic Shock Initiative (NCT03677180) is a single-arm, multicenter study. The purpose of this study was to assess the feasibility and effectiveness of utilizing early MCS with Impella in patients presenting with AMI-CS. The primary end point was in-hospital mortality. A total of 406 patients were enrolled at 80 sites between 2016 and 2020. Average age was 64±12 years, 24% were female, 17% had a witnessed out-of-hospital cardiac arrest, 27% had in-hospital cardiac arrest, and 9% were under active cardiopulmonary resuscitation during MCS implantation. Patients presented with a mean systolic blood pressure of 77.2±19.2 mm Hg, 85% of patients were on vasopressors or inotropes, mean lactate was 4.8±3.9 mmol/L and cardiac power output was 0.67±0.29 watts. At 24 hours, mean systolic blood pressure improved to 103.9±17.8 mm Hg, lactate to 2.7±2.8 mmol/L, and cardiac power output to 1.0±1.3 watts. Procedural survival, survival to discharge, survival to 30 days, and survival to 1 year were 99%, 71%, 68%, and 53%, respectively. CONCLUSIONS: Early use of MCS in AMI-CS is feasible across varying health care settings and resulted in improvements to early hemodynamics and perfusion. Survival rates to hospital discharge were high. Given the encouraging results from our analysis, randomized clinical trials are warranted to assess the role of utilizing early MCS, using a standardized, multidisciplinary approach.

Cardiogenic Shock Complicating Acute Myocardial Infarction Treated With Percutaneous Coronary Intervention Supported by Impella: Implications of Advanced Age and Refractory Shock on Outcomes.

With percutaneous left ventricular mechanical circulatory support devices becoming increasingly available for patients with cardiogenic shock due to acute myocardial infarction and the lack of a clear mortality benefit to date, identifying optimal candidates for this technology is crucial. We studied the effectiveness of Impella Cardiac Pow (Abiomed, Danvers, MA) in various stages of cardiogenic shock and elderly cohorts. DESIGN: Retrospective review. SETTING: Data were collected for patients at a single community hospital between January 1, 2018, and December 31, 2019. SUBJECTS: Thirty-one consecutive adult patients with cardiogenic shock due to acute myocardial infarction who received Impella Cardiac Pow support. Shock stages were defined by the Society for Cardiovascular Angiography and Intervention (Stages A-E). INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: The primary outcome was in-hospital death across Society for Cardiovascular Angiography and Intervention cardiogenic shock stages and in patients greater than or equal to 80 and less than 80 years old. Secondary outcomes were Valve Academic Research Consortium-2 vascular and bleeding complications, stroke, and renal failure requiring dialysis. The median age of the study population was 64 years, with seven patients (23%) being greater than or equal to 80 years old. No patients were in Society for Cardiovascular Angiography and Intervention Stage A, whereas there were seven in B, eight in C, six in D, and 10 (32%) in E. Overall in-hospital mortality occurred in 61% of patients. All 10 patients in Stage E died before hospital discharge. Mortality occurred in 54% of patients (13/24) age less than 80 years compared with 86% of those 80 years or older (6/7). A total of 38.7% of patients (12/31) and 32.3% of patients (10/31) experienced Valve Academic Research Consortium-2 bleeding and vascular events, which were evenly distributed across Society for Cardiovascular Angiography and Intervention cardiogenic shock Stages. CONCLUSIONS: In conclusion, patients with shock in extremis and those 80 years old and older may have a prohibitively high mortality despite Impella use. These findings merit further prospective investigation in a larger number of patients to evaluate the effectiveness of Impella (and other left ventricular mechanical circulatory devices) and the inherent resource utilization in advanced cardiogenic shock and the elderly.

Association of Anemia With Outcomes in Patients Undergoing Percutaneous Peripheral Vascular Intervention: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2 VIC).

OBJECTIVES: To evaluate the clinical features and outcomes of patients with anemia undergoing percutaneous peripheral vascular intervention (PVI) in a contemporary registry. METHODS: We evaluated the differences in the clinical features and outcomes of patients with and without anemia undergoing PVI in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2 VIC) registry. Anemia was defined using World Health Organization criteria. RESULTS: Baseline anemia was present in 42.3% of 15,683 patients undergoing PVI. Compared to patients without anemia, those with anemia were older (mean age, 67 years vs 71 years), were more often black (16% vs 29%), and had higher comorbidities. Anemic patients were twice as likely to present with acute limb ischemia (5% vs 11%) and undergo urgent PVI (6% vs 15%) or below-the-knee PVI (18% vs 35%). Many in-hospital adverse events were higher in anemic patients. In a propensity-matched cohort, any adverse outcome (3.4% vs 8.4%; odds ratio [OR], 2.58; 95% confidence interval [CI], 1.94-3.42) or major cardiovascular event, defined as death, myocardial infarction, stroke, or amputation (1.1% vs 3.2%; OR, 2.96; 95% CI, 1.83-4.79) was more likely in anemic patients. Of all adverse events, the highest odds were observed for post-PVI transfusions and amputations in anemic patients. Multivariable logistic regression showed that baseline hemoglobin (1 g/dL below the normal value) was associated with greater risk of any adverse event (OR, 1.57; 95% CI, 1.47-1.68). CONCLUSION: The prevalence of anemia was high among PVI patients and was associated with significantly greater likelihood of amputation, any adverse event, and major cardiovascular events. Whether preprocedure correction of anemia has the potential to decrease post-PVI adverse events remains to be studied.

Contemporary Trends and Outcomes Associated With the Preprocedural Use of Oral P2Y12 Inhibitors in Patients Undergoing Percutaneous Coronary Intervention: Insights From the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2).

OBJECTIVES: We sought to describe trends in the use of preprocedural P2Y12 inhibitors and their clinical impact in patients undergoing percutaneous coronary intervention (PCI). BACKGROUND: Oral P2Y12 inhibitors are ubiquitously used medications; however, the specific timing of initial P2Y12 inhibitor administration remains intensely debated. METHODS: Our study population comprised 74,053 consecutive patients undergoing PCI at 47 hospitals in Michigan from January 2013 through June 2015. In-hospital outcomes included stent thrombosis, bleeding, need for transfusion, and death. Hierarchical logistic regression, propensity matching, and targeted maximum likelihood estimation were used to adjust for baseline patient differences and clustering, and to minimize bias. RESULTS: Of 24,733 patients who received a preprocedural P2Y12 inhibitor, 82% received clopidogrel, 8% prasugrel, and 10% ticagrelor. Preprocedural administration of P2Y12 inhibitors declined during the study (49.3% to 24.8%; P<.001), and varied greatly across hospitals (14.5%-95.9%). No significant differences in outcomes were observed between patients receiving preprocedural clopidogrel and a matched cohort of those not receiving any preprocedural P2Y12 inhibitor (stent thrombosis: adjusted odds ratio [OR], 1.55; 95% confidence interval [CI], 0.30-7.84; bleeding: OR, 0.96; 95% CI, 0.63-1.46; transfusion: OR, 1.03; 95% CI, 0.69-1.55; and death: OR, 0.95; 95% CI, 0.38-2.37). Similar findings were demonstrated for preprocedural ticagrelor and prasugrel. Results from a subgroup analysis of patients with non-ST segment elevation acute coronary syndrome (n = 28,072) were consistent with the overall findings. CONCLUSIONS: There was a substantial decline in the rate of preprocedural P2Y12 inhibitor administration during the study. Furthermore, there were no significant differences in outcomes between patients treated with preprocedural P2Y12 inhibitors and those who were not.

Novel CenterCross and MultiCross devices for the treatment of infrainguinal chronic total occlusions: initial single-centre experience.

AIMS: Our aim was to evaluate the effectiveness and safety of CenterCross/MultiCross devices to facilitate the crossing of chronic total occlusions in peripheral arteries. METHODS AND RESULTS: This was a single-centre study in which 53 consecutive patients who were not amenable to initial attempts at crossing using standard guidewires underwent an attempt to recanalise chronically occluded infrainguinal peripheral arteries with MultiCross/CenterCross devices. The primary endpoint of interest was the ability to advance the guidewire beyond the chronic total occlusion (CTO) lesions with the use of these devices. Safety endpoints were freedom from bleeding, distal embolisation and vessel perforation, dissection or need for emergent surgical intervention. Popliteal artery and below lesions were the most commonly treated, comprising 89% of the total. The CTO lesions were crossed successfully in 92.4% of the cases within a relatively short time (5.5±3.5 minutes). There was no bleeding, dissection or need for emergent surgery and 98.1% and 96.2% of the patients were free from distal embolisation and perforations, respectively. CONCLUSIONS: Our study demonstrated that MultiCross and CenterCross were effective and safe for recanalisation of peripheral CTO lesions which were not amenable to conventional guidewires. Further study is required to define the role of these novel devices in the treatment of complex lesions, particularly CTOs in patients with peripheral arterial disease.

Impact of worsening renal dysfunction on the comparative efficacy of bivalirudin and platelet glycoprotein IIb/IIIa inhibitors: insights from Blue Cross Blue Shield of Michigan Cardiovascular Consortium.

BACKGROUND: Use of bivalirudin has been associated with a reduction in the incidence of bleeding in patients undergoing percutaneous coronary intervention. Patients with chronic kidney disease, a known predictor of post-percutaneous coronary intervention bleeding, are under-represented in clinical trials. METHODS AND RESULTS: We evaluated the outcome of 64,052 patients who underwent percutaneous coronary intervention from 2007 to 2009 at 33 hospitals in Michigan and were treated with bivalirudin (28,378) or with heparin and glycoprotein IIb/IIIa inhibitors (35,674). Propensity-matched analysis was adjusted for the nonrandomized use of the 2 strategies. Patients treated with bivalirudin were older, had a lower glomerular filtration rate, and had more comorbidities. Use of bivalirudin was associated with fewer transfusions (2.8% versus 4.2%; P<0.0001), gastrointestinal bleeds (0.5% versus 1.3%; P<0.0001), and vascular complications (1.0% versus 2.5%; P<0.0001), with no difference in survival. Bleeding complications were more common with worsening renal function, but use of bivalirudin was associated with less bleeding across the continuum of renal dysfunction. CONCLUSIONS: The risk of bleeding after percutaneous coronary intervention increases with worsening chronic kidney disease. Bivalirudin was associated with a dramatically reduced risk of bleeding across all categories of renal dysfunction. Our study findings suggest that bivalirudin monotherapy is an acceptable, if not the more appropriate alternative, to heparin and glycoprotein IIb/IIIa inhibitors in patients with chronic kidney disease.

Management of coronary atherosclerosis and acute coronary syndromes in patients with chronic kidney disease.

Atherosclerosis of the coronary arteries is common, extensive, and more unstable among patients with chronic renal impairment or chronic kidney disease (CKD). The initial presentation of coronary disease is often acute coronary syndrome (ACS) that tends to be more complicated and has a higher risk of death in this population. Medical treatment of ACS includes antianginal agents, antiplatelet therapy, anticoagulants, and pharmacotherapies that modify the natural history of ventricular remodeling after injury. Revascularization, primarily with percutaneous coronary intervention and stenting, is critical for optimal outcomes in those at moderate and high risk for reinfarction, the development of heart failure, and death in predialysis patients with CKD. The benefit of revascularization in ACS may not extend to those with end-stage renal disease because of competing sources of all-cause mortality. In stable patients with CKD and multivessel coronary artery disease, observational studies have found that bypass surgery is associated with a reduced mortality as compared with percutaneous coronary intervention when patients are followed for several years. This article will review the guidelines-recommended therapeutic armamentarium for the treatment of stable coronary atherosclerosis and ACS and give specific guidance on benefits, hazards, dose adjustments, and caveats concerning patients with baseline CKD.

The impact of coronary artery disease risk factors on intravascular ultrasound-derived morphologic indices of human coronaries.

OBJECTIVE: The relationship of intravascular ultrasound (IVUS)-derived measurements of atherosclerotic plaque to various coronary artery disease (CAD) risk factors is not well known. The purpose of this study was to examine the relationship of percent coronary luminal stenosis by IVUS to other IVUS measures of CAD, as well as the relationship of common IVUS measures of CAD to traditional CAD risk factors. We hypothesized that one or more IVUS measures of CAD might relate more strongly to CAD risk factors than does percent luminal coronary stenosis. METHODS: The records of 897 consecutive patients (57% men, mean age 62 years) who underwent IVUS investigation of their coronary arteries from 1996 through 2001 were retrospectively reviewed. IVUS was performed using a 20-MHz probe (Jomed, Rancho Cordoba, CA) and a manual pull-back technique to image the coronary arteries. Coronary artery remodeling ratio-i.e., the ratio of coronary lesion external elastic membrane cross-sectional area (EEM CSA) to proximal reference artery EEM CSA; plaque burden-i.e., plaque plus media CSA divided by EEM CSA; calcium arc; and percent stenosis of luminal cross-sectional area were measured by a single reader. RESULTS: Percent area stenosis, the most commonly used IVUS parameter, did not correlate with the other three IVUS-derived parameters, nor was it related to any of the CAD risk factors considered. In contrast, remodeling ratio was directly correlated with plaque burden (r=0.22, P<0.001), but inversely related to calcium arc (r=-0.13, P=0.01). IVUS plaque burden was significantly correlated with male gender (P<0.0001) and diabetes mellitus (DM) (P=0.003). In multivariate analyses including age, gender, and CAD risk factors, plaque burden was significantly associated with age, male gender, and DM, but not with chronic renal failure, hypertension, or hypercholesterolemia. The multivariate model also revealed that the calcium arc was significantly associated with male gender and age. These IVUS findings provide anatomic documentation that the traditional CAD risk factors relate more strongly to plaque burden than to percent coronary arterial luminal narrowing.