Effects of baseline and early acquired thrombocytopaenia on long-term mortality in patients undergoing percutaneous coronary intervention with bivalirudin.

AIMS: Bivalirudin use as a procedural anticoagulant in patients undergoing percutaneous coronary intervention (PCI) is associated with a lower incidence of thrombocytopaenia compared to other antithrombotic agents. We aimed to evaluate the prognostic impact of baseline thrombocytopaenia and early changes in platelet counts among patients undergoing PCI with exclusive use of bivalirudin. METHODS AND RESULTS: We evaluated 7,505 patients who underwent PCI over a period of eight years. Patients who received unfractionated heparin and glycoprotein IIb/IIIa receptor inhibitors were specifically excluded. Eight hundred and fifty-eight (11.4%) patients had baseline thrombocytopaenia and 451 (6.0%) developed acquired thrombocytopaenia. After adjustment for potential covariates, moderate to severe acquired thrombocytopaenia was the strongest independent predictor (HR 4.34, 95% CI: 2.13-8.84; p<0.001) of in-hospital net adverse clinical events, which included major adverse cardiac events and major bleeding complications. Age, male gender, baseline platelet count and intra-aortic balloon pump (IABP) insertion were independent predictors of in-hospital acquired thrombocytopaenia. After a mean follow-up of 2.6±1.7 years, moderate to severe baseline thrombocytopaenia (HR 2.42, 95% CI: 1.79-3.29; p<0.001), moderate to severe acquired thrombocytopaenia (HR 2.37, 95% CI: 1.13-4.97; p=0.02) and severe changes in platelet count (>67 k) were significant predictors of mortality. CONCLUSIONS: In patients undergoing PCI with bivalirudin, moderate to severe baseline and acquired thrombocytopaenia along with severe changes in platelet count are associated with higher long-term mortality.

Impact of major bleeding on long-term mortality in anemic versus nonanemic patients undergoing percutaneous coronary intervention using bivalirudin.

Bleeding complications after percutaneous coronary intervention (PCI) have been associated with higher short and long-term mortality. Bivalirudin has been shown to reduce bleeding complications in patients who underwent PCI; however, the impact of anemia on bleeding complications and long-term mortality has not been studied. A total of 11,991 patients who underwent PCI over a period of 8 years with bivalirudin as the primary antithrombotic agent were included. Anemia was defined according to the World Health Organization definition. Bleeding complications were prospectively collected. Survival analysis was performed using multivariable Cox proportional hazards models. Of the 11,991 patients, 4,815 patients (40%) had baseline anemia. Major bleeding occurred in 3.3% of patients with anemia compared with 0.7% of patients without anemia (p <0.001) driven largely by transfusion events. In the overall study population, major bleeding was a significant predictor of mortality (hazard ratio [HR] 1.4, 95% confidence interval [CI] 1.04 to 1.8, p = 0.027) at a mean follow-up of 2.6 years (interquartile range 1.4 to 3.5). In patients with anemia, major bleeding remained an independent predictor of mortality (HR 1.5, 95% CI 1.1 to 2.0, p = 0.008); however, in patients without anemia, it did not (HR 1.25, 95% CI 0.52 to 3.03, p = 0.62). In patients who underwent PCI with bivalirudin therapy, major bleeding is associated with early and long-term mortality, which is more pronounced in patients with baseline anemia.

Effect of bivalirudin on aortic valve intervention outcomes study: a two-centre registry study comparing bivalirudin and unfractionated heparin in balloon aortic valvuloplasty.

AIMS: We sought to assess if bivalirudin use during balloon aortic valvuloplasty (BAV) would affect clinical outcomes compared with heparin. METHODS AND RESULTS: We compared the outcomes of consecutive patients who underwent elective or urgent BAV with intraprocedural use of bivalirudin or heparin at two high-volume centres. All in-hospital events post BAV were adjudicated by an independent, blinded clinical events committee. Of 427 patients, 223 patients (52.2%) received bivalirudin and 204 (47.8%) received heparin. Compared with patients who received heparin, patients who received bivalirudin had significantly less major bleeding (4.9% vs. 13.2%, p=0.003). Net adverse clinical events (NACE, major bleeding or major adverse cardiovascular events [MACE]) were also reduced (11.2% vs. 20.1%, p=0.01). There was no significant difference in the rates of MACE (mortality, myocardial infarction or stroke, 6.7% vs. 11.3%, p=0.1), or vascular complications (major, 2.7% vs. 2.0%; minor, 4.5% vs. 4.9%; p=0.83). After multivariate analysis controlling for vascular preclosure, the use of bivalirudin remained independently associated with reduced major bleeding (OR 0.37; 95% CI: 0.16 to 0.84; p=0.02) while the association was attenuated in propensity-adjusted analysis (OR 0.44, 95% CI: 0.18 to 1.07, p=0.08). CONCLUSIONS: In this registry of patients with severe aortic stenosis, bivalirudin as compared to heparin resulted in improved in-hospital outcomes post BAV in terms of reduced major bleeding, similar MACE and reduced NACE. If verified in a randomised study and extended to the transcatheter aortic valve implantation (TAVI) population, these results might indicate a potential benefit for patients undergoing such procedures.

Left ventricular systolic function in sickle cell anemia: a meta-analysis.

BACKGROUND: We sought to evaluate whether patients with sickle cell anemia (SCA) have left ventricular (LV) systolic dysfunction. METHODS AND RESULTS: We conducted a Medline, Embase, Ebscohost, and Google scholar literature search articles published before April 2010. All studies that compared any measure of LV function (eg, ejection fraction [EF], fractional shortening [FS], or cardiac index [CI]) between normal control subjects and SCA (hemoglobin SS) patients were included. Among 57 studies that qualified for review, 19 studies including 841 SCA patients and 554 control subjects met the inclusion criteria. There were no significant differences in either LVEF (Hedge g = 0.15; 95% confidence interval -0.84 to 1.14; P = .76) or FS (P = .28) between SCA patients and control subjects. CI was significantly higher (P < .001) and LV end-systolic stress-volume index (load independent) was significantly lower (P < .001) in SCA patients. All LV systolic measures inversely correlated with age (all P < .001). LV end-systolic and -diastolic dimensions were significantly higher in SCA patients and increased with age. CONCLUSIONS: SCA patients have similar load-dependent but lower load-independent measures of LV systolic function than control subjects. SCA is associated with LV dilation. LV structural and functional abnormalities appear to be age dependent with progressive LV dilation and impairment over time.

Relation of baseline plasma ADMA levels to cardiovascular morbidity and mortality at two years in men with diabetes mellitus referred for coronary angiography.

BACKGROUND: Patients with diabetes mellitus (DM) have been shown to have higher levels of asymmetric dimethylarginine (ADMA), an endogenous inhibitor of endothelial nitric oxide (NO) synthase. Higher plasma levels of ADMA have been implicated in the pathogenesis of endothelial dysfunction and atherosclerosis by lowering NO levels. High baseline plasma levels of ADMA in patients with DM have been shown to predict diabetes related complications. However, there are limited data on the prognostic significance of baseline ADMA levels in patients with established DM. METHODS: The present study investigated the long-term prognostic significance of baseline plasma ADMA levels in a well-characterized cohort of 170 high-risk diabetic men with known or suspected coronary artery disease who were referred for coronary angiography. All patients were followed prospectively for the development of vascular outcomes, including all-cause mortality. RESULTS: After controlling for a variety of baseline variables (including established biomarkers such as hs-CRP and fibrinogen), plasma ADMA levels (analyzed as the upper tertile of baseline values compared with the lower two tertiles) were a strong and independent predictor of all-cause mortality (HR 2.63, 95% CI 1.13-6.11, p=0.0247) when using a Cox proportional hazards model. In addition, baseline ADMA values were also an independent predictor of the composite outcome of all-cause mortality or MI (fatal or non-fatal) (HR 2.44, 95% CI 1.26-4.72, p=0.0079), as well as the composite outcome of all-cause mortality, MI (fatal or nonfatal), or stroke (HR 2.00, 95% CI 1.10-3.62, p=0.0232). CONCLUSION: These data demonstrate that elevated baseline levels of ADMA are a strong and independent predictor of cardiovascular outcomes (including all-cause mortality) in patients with DM.

Relation between red blood cell distribution width (RDW) and all-cause mortality at two years in an unselected population referred for coronary angiography.

BACKGROUND: Red blood cell distribution width (RDW), a numerical measure of the variability in size of circulating erythrocytes, has recently been shown to be a strong predictor of adverse outcomes in patients with heart failure and in patients with prior myocardial infarction but no symptomatic heart failure at baseline, even after adjustment for hematocrit. However, there are no data in other cardiac populations, including patients with acute coronary syndromes (ACS). METHODS: The present study investigated the long-term prognostic significance of baseline RDW in a well-characterized cohort of 389 male patients who were referred to coronary angiography for a variety of indications. All patients were followed prospectively for all-cause mortality, and data regarding this endpoint was available for 97% of the population at 24 months. RESULTS: After controlling for a variety of baseline variables (including hemoglobin and the presence of heart failure), RDW (analyzed as a categorical variable comparing the upper tertile of baseline values to the lower two levels combined) was a strong and independent predictor of all-cause mortality using a Cox proportional hazards model [hazard ratio (HR) 2.69, 95% confidence interval (CI) 1.50-4.84, p=0.0008]. In addition, baseline RDW was also an independent predictor of all-cause mortality in the non-anemic (HR 4.73, 95% CI 2.06-10.86, p=0.0003) and ACS (HR 2.90, 95% CI 1.32-6.38, p=0.0082) subpopulations of patients. CONCLUSIONS: These data demonstrate that elevated RDW is a strong and independent predictor of all-cause mortality in an unselected population of male patients across a broad spectrum of risk (including ACS) referred for coronary angiography.

Avoiding intelligence failures in the cardiac catheterization laboratory: Strategies for the safe and rational use of dalteparin or enoxaparin during percutaneous coronary intervention.

Low-molecular-weight heparin (LMWH) has been a mainstay for the management of acute coronary syndromes (ACS) for almost a decade. However, several recent developments have seriously threatened the prominence of this drug class: (i) the adoption of an early invasive strategy, frequently leading to percutaneous coronary intervention (PCI) where the dosing and monitoring of LMWH is unfamiliar to most operators, (ii) the results of the SYNERGY trial, which not only failed to establish the superiority of enoxaparin over unfractionated heparin with respect to efficacy, but also demonstrated more bleeding with LMWH, and (iii) the results of the REPLACE-2 and ACUITY trials, which have demonstrated the advantages of an ACS and PCI treatment strategy based on direct thrombin inhibition with bivalirudin. To confront these challenges, cardiologists committed to the continued use of LMWH must develop safe and user-friendly approaches to transition patients from the noninvasive to invasive settings. This review summarizes an approach that takes advantage of the fact that LMWH can be readily monitored with the point-of-care activated clotting time (ACT) assay. This assay is inexpensive, available in virtually every catheterization laboratory, and familiar to most operators who monitor unfractionated heparin (UFH). A key concept that is presented is that the ACT is a more accurate measure of LMWH-induced anticoagulation than of UFH-induced anticoagulation. Our preliminary work suggests that during PCI operators should target an ACT of 175 seconds in the presence, and 200 seconds in the absence, of adjunctive glycoprotein IIb/IIIa inhibition. Sheath removal is recommended at an ACT < 160. These guidelines may facilitate continued use of LMWH, which has the potential to reduce cost (less expensive than bivalirudin), diminish the need for intravenous medication (can be administered subcutaneously in the noninvasive setting with minimal to no monitoring), and provide an ideal anticoagulant during PCI (easy to monitor with the ACT, at least partially reversible with protamine in the event of coronary perforation, effective antithrombin with no platelet activation, thereby potentially reducing the need for routine adjunctive IIb/IIIa inhibition).

Neutrophil to lymphocyte ratio as a predictor of long-term mortality in African Americans undergoing percutaneous coronary intervention.

BACKGROUND: Neutrophil to lymphocyte ratio (N/L ratio) has been shown to predict long-term mortality in patients undergoing percutaneous coronary intervention (PCI). African Americans have been shown to have lower mean neutrophil counts compared to whites. The usefulness of the N/L ratio in predicting long-term mortality in African Americans undergoing PCI is unknown. METHODS: We evaluated a total of 372 African American patients (327 patients with lower N/L ratio [<3.5] and 45 patients with higher N/L ratio [> or =3.5]) who underwent PCI during January 2003 to August 2005. The primary endpoint was all-cause mortality at a median follow-up to 3.6 years. RESULTS: During the median ( +/- SD) follow-up period of 3.6 +/- 1 years, there were a total of 48 deaths. The mortality rate was 10.4% in the group with a lower N/L ratio and 31.1% in the group with a higher N/L ratio (unadjusted p < 0.001). After adjustment for covariates with significant impact on mortality, N/L ratio was still a strong and independent predictor of long-term mortality with a hazard ratio (HR) of 2.1 (95% confidence interval [CI]: 1.1-4; p = 0.02). N/L ratio was also found to be a strong and independent predictor of long-term mortality even when analyzed as a categorical variable with 3 groups (HR of 0.39 for lower tertile compared to the upper tertile, 95% CI: 0.19-0.81; p = 0.012) and as a continuous variable (p = 0.002). CONCLUSION: N/L ratio is a powerful independent predictor of long-term mortality in African Americans undergoing PCI.

Red cell distribution width (RDW) as a predictor of long-term mortality in patients undergoing percutaneous coronary intervention.

Red cell distribution width (RDW) has been shown to be an independent predictor of mortality in patients with coronary artery disease and in patients with heart failure. The current study evaluated the prognostic utility of RDW in patients undergoing percutaneous coronary intervention (PCI). We evaluated 859 patients who underwent PCI during January 2003 to August 2005. After a median follow up of four (interquartile range 3.1 to 4.4) years, there were a total of 95 (11%) deaths. RDW was analysed as a categorical variable with empirically determined cut points of 13.3 and 15.7 (low RDW <13.3, medium RDW > or = 13.3 to <15.7, high RDW > or = 15.7) based on differences in hazard ratio (HR) for death among RDW deciles. In univariate analysis, higher RDW was a significant predictor of mortality (p < 0.001). In multivariate analysis there was a significant two-way interaction between RDW and haemoglobin (Hgb). RDW was not an independent predictor of mortality in patients with Hgb <10.4. However, among patients with Hgb >10.4, high RDW was a strong and independent predictor of mortality. For patients with Hgb > or = 10.4 to <12.7, HR for death in patients with high RDW relative to low RDW was 5.2 (95% confidence intervals [CI]: 2.0-13.3). For patients with Hgb > or = 12.7, HR for death in patients with high RDW relative to low RDW was 8.6 (CI:2.8-28.6). Higher RDW was a strong and independent predictor of long-term mortality in patients undergoing PCI who were not anaemic at baseline.

Effect of hemoglobin level on long-term all-cause mortality after percutaneous coronary intervention in African-Americans.

Anemia has been shown to be an independent predictor of long-term mortality after percutaneous coronary intervention (PCI). African-Americans are known to have lower hemoglobin (Hgb) levels compared with Caucasians. The impact of anemia on long-term mortality in African-Americans undergoing PCI is unknown. We evaluated a total of 715 African-American patients (313 patients with anemia and 402 patients without anemia as defined by the World Health Organization [Hgb <13 g/dl for men and <12 g/dl for women]) using data from our bolus-only glycoprotein IIb/IIIa database. After a median follow-up of 3.2 years (interquartile range 2.4 to 3.8), there were a total of 72 (10%) deaths. Survival rate was 84% in the anemic group compared with 94% in the control group (hazard ratio [HR] 2.8, unadjusted p <0.001 by log-rank test). After adjustment for baseline clinical and procedural characteristics using a Cox proportional hazards model, Hgb as a dichotomous variable was a strong and independent predictor of all-cause mortality during the follow-up period (HR for death 2.0, 95% confidence interval 1.2 to 3.4, adjusted p = 0.012). Also, when Hgb was analyzed as a categorical variable having 3 groups with empirically determined cutoffs at <11.1, > or =11.1 to <12.7, and > or =12.7 g/dl, the effect remained significant (adjusted p = 0.008), with a HR of 2.3 for the group with lowest Hgb compared with the group with highest value (HR 2.6 for group with Hgb > or =11.1 to <12.7 compared with the group with the highest Hgb value). In conclusion, baseline Hgb is a strong and independent predictor of all-cause long-term mortality in African-Americans undergoing PCI.

Long-term mortality after bolus-only administration of abciximab, eptifibatide, or tirofiban during percutaneous coronary intervention.

OBJECTIVE: To evaluate the long-term mortality after bolus-only administration of abciximab, eptifibatide, and tirofiban during percutaneous coronary intervention (PCI). BACKGROUND: Studies on platelet glycoprotein IIb/IIIa receptor inhibitors (GPI) administered as bolus-only during PCI suggest that this strategy may be similar in efficacy, safer, and more cost-effective compared to a bolus plus infusion of GPI. METHODS: We evaluated 864 patients (abciximab = 274, eptifibatide = 361, and tirofiban = 229) who underwent PCI with a bolus-only regimen during January 2003 to August 2005. RESULTS: After a median follow up of four (interquartile range, 3-4.5) years, there were a total of 95 (11%) deaths. The survival rate was 83% in the abciximab group, 91% in the eptifibatide group, and 93% in the tirofiban group (P = 0.003 by log-rank test). After adjustment for baseline clinical and procedural characteristics using a Cox proportional hazards model, the abciximab group had a significantly higher mortality compared to the eptifibatide group (P = 0.003; Hazard ratio (HR) for eptifibatide compared to abciximab was 0.49 (95% confidence intervals [CI]: 0.30-0.78). The long-term mortality was not significantly different in the tirofiban group compared to the abciximab group (P = 0.33) or the eptifibatide group (P = 0.20), perhaps because of shorter follow-up period and fewer patients in the tirofiban group. CONCLUSION: When given as bolus-only during PCI, eptifibatide may improve long-term survival compared to abciximab.

Impact of body mass index on long-term all-cause mortality after percutaneous coronary intervention in African-Americans.

BACKGROUND: Studies on body mass index (BMI) and post-percutaneous coronary intervention (PCI) outcomes have suggested an "obesity paradox" (lower post-PCI mortality rates in obese patients compared to patients of normal weight). Hypothesis. We assessed the hypothesis that BMI is an independent predictor of post-PCI long-term mortality in African-Americans. METHODS: We evaluated 777 patients (146 with normal BMI [BMI > 18.5 to < 25 kg/m2], 261 overweight patients [BMI > or = 25 to < 30 kg/m2], and 370 obese patients [BMI > or = 30 kg/m2]) who underwent PCI during January 2003 to August 2006. RESULTS: After a median follow up of 4 +/- 1 years, the overall mortality rate was 10.5% (82 deaths). The survival rate was 84%, 90% and 92% in the normal BMI, overweight and obese groups, respectively (p = 0.014 by log-rank test; hazard ratio relative to the obese group was 2.2 for the normal weight and 1.2 for the overweight groups). After adjustment for baseline clinical and procedural characteristics (age, smoking history, chronic renal insufficiency, end-stage renal disease, left main coronary artery intervention, preprocedure hemoglobin, left ventricular ejection fraction and successful PCI) using a Cox proportional hazards model, there was no significant difference in the long-term all-cause mortality rate among the three groups (p = 0.93). CONCLUSION: BMI does not appear to be an independent predictor of long-term mortality after PCI in African-Americans.

All-cause mortality after drug-eluting stent implantation in African-Americans.

BACKGROUND: Recent studies have questioned the safety of drug-eluting stents because of a higher incidence of late stent thrombosis, raising the possibility that drug-eluting stents may be associated with an increased mortality. The effect of drug-eluting stents on mortality in African-Americans is unknown. METHODS: We evaluated 628 African-American patients (354 patients treated with drug-eluting stents and 274 patients treated with bare metal stents) between January 2003 and August 2005, using data from our bolus-only platelet glycoprotein IIb/IIIa inhibitor database. The primary end point was all-cause mortality obtained using social security death index. RESULTS: After a mean follow-up of 3+/-0.9 years, the mortality rate in the bare metal stents group was 12.8% compared with 7.1% in the drug-eluting stents group [adjusted P value=0.19; hazard ratio (HR) for bare metal stents group compared with drug-eluting stents group for death=1.4; 95% confidence interval (CI): 0.8-2.4]. In a subgroup analysis, patients presenting with acute coronary syndrome had a higher mortality when treated with bare metal stents compared with drug-eluting stents (17.1 vs. 6.3%, P=0.022; HR=2.2; 95% CI: 1.1-4.4). Patients with chronic kidney disease (all patients with creatinine >1.5 mg/dl) also had a higher mortality with bare metal stents compared with drug-eluting stents (36.7 vs. 20.4%, P=0.044; HR=2.3; 95% CI: 1.02-5.2). CONCLUSION: Drug-eluting stents seem to be safe in African-Americans and may improve survival in certain subgroups such as patients with acute coronary syndromes and chronic kidney disease.

Activated clotting time (ACT)-guided intravenous dalteparin dosing during percutaneous coronary intervention.

BACKGROUND: The activated clotting time (ACT) has been reported to be sensitive to the anticoagulant activity of the low-molecular weight heparin dalteparin following intravenous (IV) administration. OBJECTIVE: To evaluate the feasibility of an ACT-guided dalteparin dose adjustment strategy during percutaneous coronary intervention (PCI). METHODS: This was a retrospective study of 104 consecutive patients who underwent PCI using an ACT-guided strategy of IV dalteparin. All patients received an initial IV bolus of 50 IU/kg of dalteparin. The minimum target ACT was 175 seconds for patients who received glycoprotein IIb/IIIa inhibitors and 200 seconds for patients who did not. Patients who did not achieve the target ACT after the initial 50 IU/kg were given supplemental boluses of dalteparin based on the assumption that for every additional 10 IU/kg of dalteparin, the ACT will rise by approximately 10 seconds. RESULTS: After the initial bolus of dalteparin, the mean baseline ACT rose from 138 +/- 41 seconds to 235 +/- 78 seconds. In the 36 patients (35% of the study population) who required a mean supplemental dose of 14 +/- 6 IU/kg/kg, the mean ACT after the supplemental dose was 239 +/- 79 seconds. The composite endpoint of in-hospital death, target vessel revascularization (TVR) and myocardial infarction (MI) was 5.8%. Major and minor bleeding rates were 1% each. The composite incidence of death/MI/TVR was comparable to, and the bleeding complications were lower than, those achieved in the SYNERGY and STEEPLE trials. CONCLUSION: ACT-guided dose adjustment of intravenously administered dalteparin during PCI appears to constitute a feasible strategy.

Migration of an endovascular stent from superior vena cava to the right ventricular outflow tract in a patient with superior vena cava syndrome.

Migration of endovascular stents is a rare problem but can be fatal. We report an unusual case of an endovascular stent in the right ventricular outflow tract, which migrated from superior vena cava in a patient with superior vena cava syndrome.

High-dose tirofiban administered as bolus-only during percutaneous coronary intervention.

BACKGROUND: Tirofiban administered at a bolus dose of 25 mcg/kg is associated with a higher level of platelet inhibition compared to that associated with the standard 10 mcg/kg tirofiban bolus dose. In our previous study on bolus-only glycoprotein IIb/IIIa receptor inhibition during percutaneous coronary intervention (PCI), the eptifibatide bolus-only group demonstrated similar efficacy, but significantly fewer bleeding complications compared to the abciximab bolus-only group. OBJECTIVE: To compare the in-hospital outcomes of high-dose (25 mcg/kg) tirofiban bolusonly vs. eptifibatide double bolus-only during PCI. In addition, the degree of platelet inhibition achieved by this novel tirofiban dosing strategy was assessed. METHODS: We retrospectively analyzed 876 consecutive patients who underwent PCI using a single high-dose bolus of tirofiban (25 mcg/kg) or eptifibatide (180 mcg/kg x 2, 10 minutes apart) from January 2003 to August 2005 in a single institution. Patients with ST-segment elevation myocardial infarction were excluded. RESULTS: The percentage of platelet inhibition was 94% between 3-15 minutes post bolus of 25 mcg/kg of tirofiban. The platelet inhibition dropped to 92% at the end of the procedure (between 20-40 minutes) and to 74% at the time of sheath removal between 2-3 hours. After adjustment for the baseline and procedural characteristics, there was no difference in the composite endpoint of death, myocardial infarction, revascularization and bleeding complications (5.5% in tirofiban group vs. 5.3% in eptifibatide group; p = 0.79). CONCLUSION: A single high-dose bolus of tirofiban rapidly achieves profound platelet inhibition and a significant antiplatelet effect is maintained until sheath removal. This dosing during PCI appears safe and compares favorably with eptifibatide bolus-only during PCI.

Impact of gender on in-hospital percutaneous coronary interventional outcomes in African-Americans.

BACKGROUND: Previous studies on outcomes following percutaneous coronary intervention (PCI) have shown an increased rate of in-hospital mortality and vascular complications in women compared to men. The impact of gender on post-PCI outcomes in African-Americans has not been reported. METHODS: We retrospectively analyzed 835 consecutive African-American patients (n = 392 men and n = 443 women) who underwent PCI using a glycoprotein IIb/IIIa inhibitor (GPI) bolus-only strategy from January 2003 to August 2004 at a single institution. Baseline characteristics, procedural data, and in-hospital outcomes were recorded. RESULTS: Women were older and had a higher mean body mass index (BMI) compared to men. Men were more likely to be smokers, more often had triplevessel disease and left ventricular dysfunction compared to women. There were no deaths or repeat revascularizations in either group. After adjustment for baseline risk factors and procedural characteristics, there was no significant difference in the composite endpoint of in-hospital death, myocardial infarction (MI), and repeat revascularization between men and women (6.38% in men and 2.48% in women; p = 0.051), but women had a higher rate of major and minor bleeding (0.5 vs. 2.5; p = 0.019; and 0.5 vs. 2.3; p = 0.021, respectively). On multiple logistic regression analysis, female gender was an independent risk factor for bleeding post-PCI (adjusted odds ratio [OR]-5.6, 95% confidence intervals [CI]: 1.15-27.45). CONCLUSION: Although there is no difference in the in-hospital composite endpoint of death, MI, and repeat revascularization, African-American women are at increased risk for bleeding complications post-PCI, even when a GPI bolus-only strategy is used.

Bolus-only platelet glycoprotein IIb-IIIa inhibition during percutaneous coronary intervention.

BACKGROUND: Platelet glycoprotein IIb-IIIa inhibitors (GPI) are traditionally administered as a bolus followed by an infusion. In the current era of routine stenting, we hypothesized that a bolus-only GPI strategy can be used during percutaneous coronary intervention (PCI) in order to reduce bleeding complications, while preserving the benefits of inhibition of platelet aggregation at the time of device deployment. METHODS: We retrospectively analyzed consecutive patients (n = 1001) who underwent PCI and received an unfractionated heparin (UFH) and bolus-only GPI regimen, from January 2003 to August 2004 in a single institution. All patients received clopidogrel and aspirin prior to PCI. Post-procedure myocardial infarction (MI) was defined using the TIMI definitions, and bleeding complications were defined by the criteria used in REPLACE-2. RESULTS: The most frequently used GPI was eptifibatide (58.3%), followed by abciximab (37.3%) and tirofiban (4.3%). The composite outcome of in-hospital death (0.1%), MI (4.3%), repeat revascularization (0) and major plus minor bleeding (2.6%) was 7%. These rates are lower than those that have been reported in the UFH group with planned GPI, and the bivalirudin with provisional GPI arms of the REPLACE-2 trial. After adjustment for baseline and procedural risk factors, the abciximab bolus-only group had a higher rate of major bleeding compared to the eptifibatide bolus-only group (adjusted odds ratio 3.5, 95% confidence intervals 1.047 and 11.698; p < 0.05). CONCLUSION: A bolus-only GPI strategy appears to maintain the anti-ischemic benefits of GPI, with the added benefit of reduced bleeding complications and the potential for reduced cost and shortened length of hospital stay.