Comparison of transradial and transfemoral access in patients undergoing percutaneous coronary intervention for complex coronary lesions.

OBJECTIVE: Comparison of transradial versus transfemoral access for complex percutaneous coronary intervention (PCI) with regard to both complications and long-term outcomes. BACKGROUND: Radial access has been shown to confer superior results in patients undergoing PCI, especially in patients with acute coronary syndromes. However, radial access has limitations of sheath and device size, which may increase procedure time and result in inferior outcomes. METHODS: Patients undergoing PCI for complex lesions, defined as type C according the ACC/AHA classification system, were included in this study. Propensity matching was performed to adjust for differences in baseline characteristics. Transradial patients were then compared to transfemoral patients in regard to procedural, in-hospital, and 6-month outcomes. RESULTS: Among 2142 patients with 2591 lesions treated, 1876 had femoral access and 267 had radial access. Radial access patients were more likely to be male (75% vs. 66%, P = 0.003) and less likely to present with acute myocardial infarction (27% vs. 42%, P < 0.001). Procedural characteristics demonstrated lower use of heparin in the femoral group (17% vs. 73%, P < 0.001) with similarly low use of glycoprotein inhibitors (5.6% vs. 3.4%, P = 0.14). Patients in the femoral group had higher rates of transfusions (3.7% vs. 0%, P = 0.004) and vascular complications (1.7% vs. 0%, P = 0.03). Following propensity matching, there was no difference in mid-term outcomes between radial and femoral groups. CONCLUSIONS: In patients with complex coronary lesions undergoing PCI, the radial approach demonstrates similar mid-term outcomes as the femoral approach with a potentially lower rate of complications. © 2016 Wiley Periodicals, Inc.

The influence of advancing age on implantation of drug-eluting stents.

BACKGROUND: The influence of age upon the use of drug-eluting stents (DES) in patients aged ≥ 65 years is uncertain. The aim of this study is to investigate the impact of age increase in patients aged ≥ 65 years in the use of DES in patients undergoing percutaneous coronary intervention (PCI). METHOD: The study cohort comprised 8,598 patients ≥ 65 years of age who underwent stent implantation from April 2003 to March 2014. We defined the first DES era as the period April 2003 to July 2008 and the second DES era as the period July 2008 to March 2014. Multivariable logistic regression was performed for both eras to assess the impact of age increase and analyze independent factors associated with DES implantation. RESULTS: In the first DES era cohort, the two groups of patients differed in their risk factor profile with lower rates of male sex, diabetes, smokers, and hypercholesterolemia in those aged ≥ 75 years. There were more Caucasian and less African-Americans in this age group. Furthermore, patients aged ≥ 75 years had lower left ventricular ejection fraction (LVEF) and baseline haematocrit concentration were more likely to present with an acute myocardial infarction (MI) than stable or unstable angina and had higher rates of a previous history for congestive heart failure (CHF), chronic renal insufficiency (CRI), and peripheral vascular disease (PVD). These differences were broadly similar for patients in the second DES era except for similarities in LVEF, presentation with unstable angina, and PVD, as well as a lower rate for previous PCI. DES use was reduced with increasing age in both the first (OR=0.78; 95% CI=0.69-0.89) and second DES era (OR=0.53; 95% CI=0.47-0.58). In both eras, DES use was less likely in current smokers, patients presenting with acute MI and cardiogenic shock, and those with a previous history of CHF. CONCLUSION: In patients aged ≥ 65 years, the use of DES decreased with increasing age. This observation was apparent in both the first and second DES era. © 2015 Wiley Periodicals, Inc.

Safety and long-term outcomes after percutaneous coronary intervention in patients with human immunodeficiency virus.

OBJECTIVE: This study aims to report the long-term outcomes after percutaneous coronary intervention (PCI) in human immunodeficiency virus (HIV+) patients. BACKGROUND: Sparse data exists regarding the risk of patients with HIV who undergo PCI. METHODS: Using a case-control design, we compared baseline characteristics, procedure-related outcomes, in-hospital, and 2-year clinical outcomes of 112 consecutive HIV+ patients versus 112 HIV- controls matched for age, gender, and diabetes mellitus who underwent PCI from April 2003 to September 2011. RESULTS: Baseline characteristics were generally comparable, save for more African Americans and history of chronic renal insufficiency in the HIV+ vs. HIV- group (62.5% vs. 21.4%, P < 0.001) and (27.7% vs. 9.9%, P < 0.001). There was no correlation between CD4 nadir count and extent and diffuseness of coronary artery disease. The occurrence of major adverse cardiac events at 2 years was similar in both groups. Multivariable analysis for independent correlates of major adverse cardiac events at 2 years detected patients with a history of chronic renal insufficiency (OR: 2.44, 95% confidence interval: 1.02-5.83; P = 0.04) and acute myocardial infarction (OR: 2.92, 95% confidence interval: 1.39-6.15; P = 0.005) as correlates for outcome. Post-hoc analysis showed that drug-eluting stent (DES) use in the HIV+ group was beneficial. CONCLUSION: PCI in HIV+ patients is safe, with high procedural success rates, and produces similar outcomes to those seen in HIV- patients at 2 years. HIV+ patients should be treated with DES if possible.

Long-term safety and efficacy of second-generation everolimus-eluting stents compared to other limus-eluting stents and bare metal stents in patients with acute coronary syndrome.

OBJECTIVES: This study aimed to investigate the long-term safety and efficacy of everolimus-eluting stents (EES) compared with other limus-eluting stents and bare metal stents (BMS) in ACS patients. BACKGROUND: There have been concerns about the long-term safety of drug-eluting stents in the setting of acute coronary syndrome. METHODS: The study cohort included 1,612 patients presenting with acute coronary syndrome who underwent BMS, SES, E-ZES, or EES implantation. End points included probable or definite stent thrombosis and major adverse cardiovascular events (MACE), defined as a composite of all-cause death, Q-wave myocardial infarction, and target lesion revascularization up to 3 years. RESULTS: The overall MACE rates were significantly higher for both BMS and SES, but not E-ZES, when compared with EES (EES vs. BMS: HR 2.68, 95% CI 1.91-3.78, P <0.001; EES vs. SES: HR 1.75, 95% CI 1.24-2.47, P = 0.001 and EES vs. E-ZES: HR 1.08, 95% CI 0.65-1.77, P = 0.72). Stent thrombosis rates were similar for EES, E-ZES, and BMS but higher for SES throughout the 3-year follow-up (EES vs. BMS: HR 1.02, 95% CI: 0.31-3.35, P = 0.973; EES vs. SES: HR 4.90, 95% CI: 1.75-13.69, P = 0.002 and EES vs. E-ZES: HR 1.63, 95% CI 0.37-7.31, P = 0.449). CONCLUSIONS: There was an improvement in the long-term outcome for MACE with EES when compared to earlier-generation stents, but this was comparable with the 2nd-generation E-ZES. There was no additional risk of early or late stent thrombosis in EES when compared with BMS.

Incidence and correlates in the development of iatrogenic femoral pseudoaneurysm after percutaneous coronary interventions.

OBJECTIVE: We aimed to identify the correlates in the development of post-percutaneous coronary intervention (PCI) iatrogenic femoral pseudoaneurysm (IFP). BACKGROUND: IFP is one of the more common vascular complications of PCI. METHODS: From February 2008 to June 2012, 10,169 consecutive patients who underwent PCI were retrospectively studied. Patients who developed postprocedural IFP were identified at a single, large tertiary PCI center. RESULTS: One hundred thirty-nine patients developed IFP (1.38%) and were compared to the cohort that did not. Baseline characteristics were comparable, although patients in the IFP group were older and had a higher incidence of insulin-requiring diabetes mellitus and chronic renal insufficiency (68.4 ± 12.9 vs. 65.4 ± 12.3 years, P = 0.004; 23.9% vs. 14.6%, P = 0.002; and 26.6% vs. 17.3%, P = 0.004, respectively). The non-IFP group had more men and a higher use of vascular closure devices, respectively (64.7% vs. 49.6%, P < 0.001; and 54.1% vs. 26.5%, P < 0.001). There was no significant difference in the use of dual antiplatelet or anticoagulation therapies between the 2 cohorts. Univariable correlates for the development of IFP were female gender, insulin-requiring diabetes mellitus, chronic renal insufficiency, and use of manual compression to achieve hemostasis. On multivariable analysis, the successful deployment of vascular closure device for hemostasis reduced the occurrence of IFP (odds ratio 0.31, 95% confidence interval 0.21-0.46, P < 0.0001). CONCLUSION: The development of IFP following PCI is not uncommon and the appropriate use of vascular closure devices to achieve hemostasis should be encouraged to minimize this vascular complication.

The impact of diabetes mellitus on long-term clinical outcomes after percutaneous coronary saphenous vein graft interventions in the drug-eluting stent era.

OBJECTIVES: We aimed to compare early and late clinical outcomes in diabetic and nondiabetic patients who underwent saphenous vein graft (SVG) percutaneous coronary interventions (PCI) with the use of drug-eluting stents (DES). BACKGROUND: Patients with diabetes mellitus are shown to have less favorable outcomes after SVG intervention with the use of bare metal stents. In the DES era, the impact of diabetes mellitus on restenosis and clinical outcomes post-SVG intervention is not clearly defined. METHODS: From our institutional PCI registry database, we retrospectively analyzed 477 consecutive patients with prior coronary artery bypass graft surgery undergoing SVG PCI with the implantation of DES stratified by the presence or absence of diabetes mellitus. The primary end-point was 1-year major adverse cardiac event (MACE) rate, defined as death, Q wave myocardial infarction, and target lesion revascularization. RESULTS: Baseline clinical characteristics, including mean graft age (120 ± 77 vs. 131 ± 86 months, P = 0.14), were similar between groups, save for a higher prevalence of systemic hypertension and chronic renal insufficiency, and higher body mass index in the diabetic group. Among the 604 SVG lesions treated with DES, the angiographic and procedural characteristics were well matched between groups except for the higher rate of distal protection device use (32% vs. 29%, P = 0.007) in the diabetic group. The rates of 1-year MACE (21% vs. 15%, P = 0.12) and all-cause mortality (7.6% vs. 6.7%, P = 0.86) were similar between groups. After adjustment for the relevant clinical co-variables, diabetic status was not associated with the composite end-point. CONCLUSION: In conclusion, DES, when used for the treatment of vein graft lesions, equate the short- and long-term outcomes between diabetic and nondiabetic patients, suggesting that DES should be considered the default stent in diabetic populations undergoing PCI for the treatment of SVG lesions.

Racial disparity with on-treatment platelet reactivity in patients undergoing percutaneous coronary intervention.

BACKGROUND: On-treatment platelet reactivity to clopidogrel is variable and in part genetic dependent. In African American (AA) patients, the relation between on-treatment platelet reactivity to clopidogrel and the factors that influence this interaction is unknown. The present study aims to evaluate on-treatment platelet reactivity to clopidogrel in AA patients and its interaction to race and CYP2C19*2 loss of function mutation. METHODS: The study cohort included 289 consecutive patients presenting for percutaneous coronary intervention who were entered into a prospective observational registry. High on-treatment platelet reactivity (HTPR) was defined as P2Y12 reaction units (PRU) ≥208 with VerifyNow P2Y12 assay and >50% by vasodilator-stimulated phosphoprotein phosphorylation assay platelet reactivity index (VASP PRI) measured 6 to 24 hours postprocedure. CYP2C19*2 (rs4244285) genotype was analyzed by real-time polymerase chain reaction. RESULTS: The prevalence of HTPR by both PRU (56% vs 35%, P = .003) and VASP PRI (67% vs 45%, P = .002) is more common in AAs compared with whites, respectively. African American patients had higher on-treatment mean PRU (207 ± 110 vs 160 ± 102, P = .002) and VASP PRI (49 ± 26 vs 38 ± 26, P = .004). African Americans also had a higher prevalence of CYP2C19*2 allele carrier status compared with whites (43% vs 29%, P = .04). African American race (P = .008) and CYP2C19*2 allele status (P = .02) independently had significant effects on PRU and VASP. Multivariable logistic regression analysis has shown that both CYP2C19*2 allele carrier status and AA race were independent correlates of HTPR for PRU ≥208. CONCLUSIONS: African American patients undergoing percutaneous coronary intervention not only have a higher prevalence of HTPR to clopidogrel but also have higher CYP2C19*2 allele carrier status compared with whites. Careful selection of antiplatelet agents should be considered in an AA population at higher risk for ischemic complications.

The independent value of a direct stenting strategy on early and late clinical outcomes in patients undergoing elective percutaneous coronary intervention.

OBJECTIVES: This study aimed to compare percutaneous coronary intervention (PCI) with direct stenting (DS) to balloon predilatation (PD) for patients undergoing elective PCI to determine whether there is an independent value for DS with regard to clinical outcomes. BACKGROUND: The safety of PCI with DS has been established, but the independent advantages of this technique are not entirely clear. METHODS: Patients undergoing elective PCI from January 2000 to December 2010 were included. The postprocedural and late clinical outcomes of 444 patients who underwent PCI with DS were compared with a propensity-matched population of 444 subjects treated with PD. RESULTS: The two groups were well matched to 27 baseline clinical, procedural, and angiographic characteristics, thus allowing for a more accurate evaluation of the independent value of the stenting technique. Intravascular ultrasound was used in more than 60% of interventions in both groups. PCI performed with PD were longer (DS 45 ± 19.28 vs. PD 56 ± 23.72 minutes, P = 0.001), used more contrast (DS 154 ± 65.88 vs. PD 186 ± 92.84 cc, P = 0.001), and more frequently used balloon postdilation (DS 0% vs. PD 27.3%, P = 0.001). The incidence of periprocedural myocardial infarction (PPMI) was similar between DS- and PD patients (5.3% vs. 5.4%, P = 0.91). Likewise, the 1-year rates of major adverse cardiac events (8.4% vs. 6.3%, P = 0.25), target lesion revascularization (3.9% vs. 2.5%, P = 0.24), and definite stent thrombosis (0.2% vs. 0.9%, P = 0.37) were similar among DS and PD patients, respectively. CONCLUSION: During elective PCI, DS decreases overall procedure time and resource utilization, but fails to reveal an independent clinical advantage as there is no demonstrable benefit in regard to the incidence of PPMI, restenosis, or overall clinical outcomes up to 1-year of follow-up.

Qualitative comparison of coronary angiograms between 4 French catheters with an advanced cardiovascular injection system and 6 French catheters with manual injection.

OBJECTIVES: This study aimed to test whether advanced cardiovascular injection (ACI) via 4 French (Fr) catheters is more advantageous than manual injection with 6 Fr catheters. BACKGROUND: For coronary angiography, proponents of contrast media ACI believe it utilizes smaller-diameter catheters when compared with manual injection, without compromising the quality of the angiogram, and has the potential to reduce the amount of contrast used and lessen the use of closure devices. METHODS: In a prospective study, 200 consecutive patients referred for elective coronary angiography were randomized to standard 6 Fr catheters with manual injection versus 4 Fr catheters with ACI. The study's primary endpoint is the quality of the coronary angiogram. Secondary endpoints include groin complications, utilization of closure devices, and volume of contrast media. Thirty-six patients who underwent ad hoc percutaneous coronary intervention were excluded from the analysis. RESULTS: The final analysis included 80 patients treated with 4 Fr catheters with ACI and 84 patients treated with 6 Fr catheters with manual injection. The groups had similar demographic and clinical characteristics. The quality of the angiogram was similar between groups with the exception of more left coronary sinus flush with 4 Fr catheters (3.57 ± 1.1 vs. 2.98 ± 0.9, P < 0.001) and less closure device use with 4 Fr (25 vs. 71.4%, P < 0.01) compared to 6 Fr catheters. The procedure duration, volume of contrast used, vascular complications, and time to ambulation were similar between groups (all P > 0.05). CONCLUSIONS: 4 Fr diagnostic catheters with ACI offer similar quality coronary angiograms, similar rates of vascular complications, procedure duration, contrast used, and time to ambulation, but have a significantly lesser need for closure devices compared to the 6 Fr system with manual injection.

Impact of diabetes mellitus on long-term clinical outcomes of patients on chronic hemodialysis after percutaneous coronary intervention.

BACKGROUND: End-stage renal disease (ESRD) is known to correlate with poor outcome in patients undergoing percutaneous coronary intervention (PCI). This study examines the impact of diabetes mellitus (DM) on the long-term outcome of patients with ESRD on chronic hemodialysis. METHODS: A cohort of patients with ESRD on chronic hemodialysis, who underwent PCI with drug-eluting stents, was followed for 1 year. The clinical outcome in this population was compared retrospectively based on the presence of DM. Major adverse cardiac events (MACE) as the composite of all-cause death, Q-wave myocardial infarction and target lesion revascularization (TLR), as well as TLR as an individual outcome, were the main end points of the study. RESULTS: In the study cohort (n = 198), 48.5% had DM. Diabetic patients were more commonly female. The lesion characteristics were similar between groups except for more frequent saphenous vein graft intervention in nondiabetics. At 1-year follow-up there was no difference in the rate of MACE between diabetic and nondiabetic patients (40.4% vs. 39.3%, respectively, p = 0.89), driven primarily by a very high mortality rate (1-year overall mortality of 33.5%). After adjustment for the relevant clinical co-variables, DM was not associated with the composite end point. However, diabetic patients had a significantly higher incidence of 1-year TLR compared to nondiabetics (13.8% vs. 3.6%, respectively, p = 0.04). CONCLUSION: The prognosis of patients with ESRD after PCI is dismal with a very high overall mortality rate regardless of the presence of DM. Patients with ESRD appear to be at higher risk for the need of revascularization.

Does black ethnicity influence the development of stent thrombosis in the drug-eluting stent era?

BACKGROUND: It has been suggested that black race predicts stent thrombosis (ST) after drug-eluting stent implantation. Whether socioeconomic status or comorbid conditions confound the contribution of black race to the development of ST is unclear. METHODS AND RESULTS: We compared 1594 black patients who underwent drug-eluting stent implantation with 5642 nonblack patients. Overall, 108 definite STs were reported. Multivariable Cox regression analysis was performed with adjustment for comorbidities, including median household income as a marker of socioeconomic status, to assess the impact that black race may have on the development of ST. On univariable analysis, black patients were younger (63.43±12.42 versus 65.15±12.59 years; P<0.001) and more likely to have a history of hypertension (89.8% versus 81.7%; P<0.001), diabetes mellitus (45.5% versus 30.8%; P<0.001), chronic renal insufficiency (19.2% versus 10.7%; P<0.001), and congestive heart failure (18.7% versus 13.1%; P<0.001). Clopidogrel compliance at the time of the ST event was higher in the black than in the nonblack population (87.5% versus 77.8%; P=0.068). After multivariable analysis, including adjustment for median income and clopidogrel compliance, black race emerged as a strong predictor of definite late ST. CONCLUSIONS: Black race is an independent predictor of definite drug-eluting stent ST. Because clopidogrel compliance was higher in black patients and socioeconomic status was not associated with ST, further investigation into the potential mechanisms of this influence of race on ST must be pursued.

Correlates and causes of death in patients with severe symptomatic aortic stenosis who are not eligible to participate in a clinical trial of transcatheter aortic valve implantation.

BACKGROUND: Transcatheter aortic valve implantation is currently being evaluated in patients with severe aortic stenosis who are considered high-risk surgical candidates. This study aimed to detect incidences, causes, and correlates of mortality in patients ineligible to participate in transcatheter aortic valve implantation studies. METHODS AND RESULTS: From April 2007 to July 2009, a cohort of 362 patients with severe aortic stenosis were screened and did not meet the inclusion/exclusion criteria necessary to participate in a transcatheter aortic valve implantation trial. These patients were classified into 2 groups: group 1 (medical): 274 (75.7%): 97 (35.4%) treated medically and 177 (64.6%) treated with balloon aortic valvuloplasty; and group 2 (surgical): 88 (24.3%). The medical/balloon aortic valvuloplasty group had significantly higher clinical risk compared with the surgical group, with significantly higher Society of Thoracic Surgeons score (12.8±7.0 versus 8.5±5.1; P<0.001) and logistic European System for Cardiac Operative Risk Evaluation (EuroSCORE) (42.4±22.8 versus 24.4±18.1; P<0.001). The medical/balloon aortic valvuloplasty group had a higher New York Heart Association functional class, incidence of renal failure, and lower ejection fraction. During median follow-up of 377.5 days, mortality in the medical/balloon aortic valvuloplasty group was 102 (37.2%), and during median follow-up of 386 days, mortality in the surgical group was 19 (21.5%). Multivariable adjustment analysis identified renal failure (hazard ratio [HR]: 5.60), New York Heart Association class IV (HR: 5.88), and aortic systolic pressure (HR: 0.99) as independent correlates for mortality in the medical group, whereas renal failure (HR: 7.45), Society of Thoracic Surgeons score (STS; HR: 1.09) and logistic EuroSCORE (HR: 1.45) were correlates of mortality in the in the surgical group. CONCLUSIONS: Patients with severe symptomatic aortic stenosis not included in transcatheter aortic valve implantation trials do poorly and have extremely high mortality rates, especially in nonsurgical groups, and loss of quality of life in surgical groups.

Outcomes of patients with acute myocardial infarction from a saphenous vein graft culprit undergoing percutaneous coronary intervention.

OBJECTIVES: We sought to describe characteristics of patients presenting with an acute MI from a SVG culprit, compared with a native culprit. BACKGROUND: Percutaneous coronary intervention (PCI) of saphenous vein grafts (SVG) results in worse outcomes than native vessel PCI, but outcomes of such patients with acute myocardial infarction (MI) setting are not well-described. METHODS: Patients presenting with ST-elevation or non-ST-elevation MI undergoing PCI from 2000 to 2010 were retrospectively analyzed to identify the culprit as a SVG vs. native vessel. Multiple linear regression was used to identify predictors of peak troponin-I level. Cox proportional hazards regression was used to identify predictors of 30-day mortality and 1-year major adverse cardiac events (MACE). RESULTS: 192 patients underwent PCI for a SVG culprit, compared with 4,001 with a native culprit. After multivariable adjustment, SVG culprit remained significantly associated with lower levels of the logarithm of the peak troponin (ß = -0.17, SE = 0.07, P = 0.02). The likelihood of MACE was higher in SVG vs. native culprits in patients with small to modest troponin elevations. Patients with a SVG culprit also suffered higher unadjusted rates of mortality at 30 days (14.3% vs. 8.4%, P = 0.03) and MACE at 1 year (36.8% vs. 24.5%, P = 0.005); a modest effect upon mortality and MACE remained after multivariable adjustment. CONCLUSION: Even minimal elevations of troponin in patients with a SVG culprit may portend a poorer prognosis than in patients with a native culprit. The risk of PCI in this setting is driven by mortality and arises from both substantial comorbidities and the SVG itself.

Cellular video-phone assisted transmission and interpretation of prehospital 12-lead electrocardiogram in acute st-segment elevation myocardial infarction.

BACKGROUND: Prehospital 12-lead electrocardiogram (ECG) reduces the time to reperfusion in acute ST-segment elevation myocardial infarction (STEMI). However, the reliability of using cellular video-phone (VP) assisted interpretation of ECG is unknown. METHODS: We studied the interphysician reliability in interpreting the ECG assisted with VP compared to print ECG interpretation. Twenty-seven physicians prospectively interpreted the ECG transmitted from the field in real-time using VP and later using the same printed ECG. The time to completion, accuracy of interpretation, and physician rating of the VP technology were recorded. RESULTS: Similar high interphysician reliability was observed with both VP assisted and printed ECG interpretation including presence of ST-segment elevation (intraclass correlation coefficient [ICC]= 0.98 [95% CI 0.96-1] vs. 0.99 [95% CI 0.99-1]) and pathologic Q wave (ICC = 0.99 [95% CI 0.98-1] vs. 1 [95% CI 1]), respectively. The mean time to transmit and interpret the ECG with VP versus printed ECG was 3.9 ± 1.9 versus 2.1 ± 0.9 minutes, respectively, P < 0.01. On a scale of 1 to 5 with 5 being the best, the average rating of VP ease of use was 4.4 ± 0.5 and utility to recommend treatment was rated a 5. CONCLUSION: Cellular VP-assisted transmission and interpretation in real-time of prehospital ECG has high interphysician reliability, similar to the printed ECG interpretation. Future studies testing whether VP decreases the ischemic time and expedites the reperfusion of STEMI patients are needed.

Integrilin in patients undergoing primary percutaneous coronary intervention for ST-elevation myocardial infarction.

BACKGROUND: The adjunctive use of eptifibatide in patients undergoing primary percutaneous coronary intervention (PCI) for ST-elevation myocardial infarction (STEMI) remains controversial. We therefore set out to determine the safety and efficacy of eptifibatide in this population. METHODS: The study comprised 857 consecutive patients who underwent primary PCI for STEMI at the Washington Hospital Center. Three hundred eighteen patients also received adjunctive therapy with eptifibatide. Patients who had received thrombolysis prior to undergoing cardiac catheterization were excluded. The primary end-point was all-cause mortality and the composite of all-cause mortality or Q-wave MI. The primary safety end-point was the rate of thrombolysis in myocardial infarction (TIMI) major bleeding. RESULTS: The eptifibatide group was younger, had a higher body mass index, and a lower proportion of patients with systemic hypertension, diabetes mellitus, previous history of ischemic heart disease, coronary revascularization, and congestive heart failure. This cohort also used bivalirudin less often (23.3% vs. 72%; P < 0.001). Following multivariable analysis, the eptifibatide group had a significantly lower rate of all-cause mortality (hazard ratio 0.55; 95% confidence interval 0.34-0.89; P = 0.01) and the composite of all-cause mortality or Q-wave MI (hazard ratio 0.59; 95% confidence interval 0.37-0.95; P = 0.03) at 6 months. The rate of TIMI major bleeding was similar in both groups (hazard ratio 0.54; 95% confidence interval 0.25-1.17; P = 0.12). CONCLUSION: The adjunctive use of eptifibatide in patients presenting with STEMI may be associated with improved clinical outcomes. (J Interven Cardiol 2011;24:351-356).

Correlation between light transmission aggregometry, VerifyNow P2Y12, and VASP-P platelet reactivity assays following percutaneous coronary intervention.

BACKGROUND: High on-treatment platelet reactivity is an established risk factor for adverse cardiac events in patients taking clopidogrel following percutaneous coronary intervention (PCI). METHODS: Two hundred patients underwent platelet reactivity testing with VerifyNow P2Y12, vasodilator-stimulated phosphoprotein phosphorylation (VASP), and light transmission aggregometry (LTA) with both 5 and 20 µM of adenosine diphosphate (ADP) following PCI. High on-treatment platelet reactivity was defined as a maximum platelet aggregation ≥46% for LTA ADP 5 µM or ≥60% for 20 µM; platelet reactivity index (PRI) ≥50% for VASP; and platelet reactivity units ≥235 for VerifyNow. Correlation between assays was tested using Spearman coefficients (ρ); agreement among tests in regards to high on-treatment platelet reactivity was evaluated with Kappa statistics (κ). RESULTS: All Spearman correlations had P values <0.001, although ρ ranged from 0.60-0.86. The incidence of high on-treatment platelet reactivity was 39.3% with VASP, 27.3% with VerifyNow, 23.1% with LTA ADP 5 µM, and 16.2% with LTA ADP 20 µM. The strongest correlation was between LTA ADP 5 µM and LTA ADP 20 µM (κ= 0.53, 95% CI 0.37-0.68); the weakest was between VASP and LTA ADP 5 µM (κ= 0.33, 95% CI 0.19-0.47). Overall, the level of agreement between assays was in the moderate to poor range. CONCLUSION: Despite evidence that the most commonly used tests are correlated, agreement among tests is modest at best and demonstrates they are not interchangeable.

Decline in platelet count in patients treated by percutaneous coronary intervention: definition, incidence, prognostic importance, and predictive factors.

AIMS: We investigated the incidence, predictors, and prognostic impact of a decline in platelet count (DPC) in patients treated by percutaneous coronary intervention (PCI). METHODS AND RESULTS: A total of 10 146 consecutive patients treated by PCI from 2003 to 2006 were included. According to the magnitude of the DPC, the population was divided into four groups: no DPC (<10%), minor DPC (10-24%), moderate DPC (25-49%), and severe DPC (>or=50%). The primary haemorrhagic endpoint was a composite of post-procedure surgical repair major bleeding. The primary ischaemic endpoint was 30-day all-cause mortality-non-fatal myocardial infarction. Among the total population, 36% had a DPC <10%, 47.7% had a DPC of 10-24%, 14% had a DPC of 25-49%, and 2.3% had a DPC >or=50%. On multivariate analysis, moderate and severe DPC were independent predictive factors of the ischaemic outcome. Two procedural practices were identified that, if modified, might reduce the incidence of acquired thrombocytopaenia. Both the intraprocedural use of heparin (as opposed to bivalirudin) and of low molecular weight contrast material were independently associated with severe acquired thrombocytopaenia. CONCLUSION: Moderate and severe DPC are independent predictors of adverse bleeding and ischaemic outcomes in PCI. Adoption of intraprocedural anticoagulant other than heparin and avoidance of a low molecular weight contrast agent could potentially decrease the occurrence of severe acquired thrombocytopaenia.

Body mass index and bleeding complications after percutaneous coronary intervention: does bivalirudin make a difference?

BACKGROUND: The association between obesity and bleeding after percutaneous coronary intervention (PCI) is not well defined. We investigated the impact of body mass index (BMI) on PCI-related bleeding, and whether bivalirudin, compared to heparin, used as PCI anticoagulant modifies this relationship. METHODS: From 2000 to 2009, 16,783 patients who underwent PCI were grouped according to 6 BMI groups: underweight (<18.5 kg/m(2)), "normal" weight (18.5-24.9 kg/m(2)), overweight (25-29.9 kg/m(2)), class I (30-34.9 kg/m(2)), class II (35-39.9 kg/m(2)), and class III obesity (> or =40 kg/m(2)). Bivalirudin was used in 11,433 patients and heparin in 5,350. In-hospital major bleeding (hematocrit drop > or =15% or gastrointestinal bleeding) and need for transfusion rates were collected. RESULTS: The incidence of major bleeding varied significantly throughout the BMI spectrum (5.6% vs 2.5% vs 1.9% vs 1.6% vs 2.1% vs 1.9%, respectively, from underweight to class III obese patients, P < .001). The incidence of transfusion across BMI followed the same reverse J-shape curve (10.9% vs 6.6% vs 3.6% vs 3.4% vs 3.8% vs 5.6%, P < .001). After adjustment for potential confounding factors, underweight patients had neither an increased risk for major bleeding nor an increased risk for transfusion compared with "normal" weight patients. Class I obese patients had a lower risk of major bleeding (odds ratio [OR] 0.68 [95% CI 0.48-0.97]). Overweight, class I, and II obese patients had a lower risk of transfusion (respectively, OR 0.68 [0.55-0.84], 0.68 [0.53-0.87], and 0.66 [0.48-0.92]). The highest BMI patients had neither an increased risk for major bleeding (class II and III obesity) nor an increased risk for transfusion (class III obesity). The same reverse J-shaped relationship to BMI seen in the overall population for the raw incidence of major bleeding was found when the population was divided according to type of anticoagulant used as follows: bivalirudin or heparin. Likewise, the "need for transfusion" relationship to BMI is not altered by bivalirudin use. CONCLUSION: The better outcome for bleeding seen in patients in the middle of the BMI spectrum suggests the existence of a "bleeding obesity paradox," which persists after adjustment by confounding factors and exists irrespective of the anticoagulant used.

Incidence, correlates, and clinical impact of nuisance bleeding after antiplatelet therapy for patients with drug-eluting stents.

BACKGROUND: Nuisance bleeding (NB) after dual antiplatelet therapy (DAPT) is not well characterized despite its potential to impact patient compliance. We therefore aimed to evaluate the incidence, correlates, and clinical impact of NB after DAPT after drug-eluting stent (DES) implantation. METHODS: Included were 2,948 patients with DES implantation who were discharged on DAPT for 12 months. New bleeding classifications were used: alarming bleeding, internal bleeding, and NB. RESULTS: After excluding patients with alarming bleeding (9 [0.3%]) and internal bleeding (128 [4.3%]), the 2,811 remaining patients were divided into 2 groups: those with NB (812 [28.9%]) and those without (1,999 [71.1%]). Patients with NB were significantly younger (63.0 +/- 11.4 vs 65.2 +/- 11.6 years, P < .001), were more often white (82.0% vs 69.6%, P < .001), had lower body mass indices (29.2 +/- 6.1 vs 29.8 +/- 6.0 kg/m(2), P = .01), and a lower prevalence of diabetes (25.5% vs 34.8%, P < .001) compared to those without NB. At 1 year, the rate of major adverse cardiac events was higher in the NB group compared to the nonbleeding group (77 [9.4%] vs 134 [6.7%], P = .02). In the NB group, 46 patients (5.7%) stopped 1 or both antiplatelet therapies. Thirty-five (4.3%) discontinued clopidogrel, 16 (2.0%) stopped aspirin, and 5 (0.61%) stopped both as a result of the reported NB. Multivariable analysis detected younger age, lower body mass index, white race, and without diabetes as correlates associated with NB while on clopidogrel therapy. CONCLUSION: Nuisance bleeding is common in patients on prolonged DAPT post-DES implantation and can impact compliance. Nuisance bleeding appears to have important clinical implications and, if confirmed in prospective trials, should be added to the safety end points assessing new antiplatelet agents.

Impact of intravascular ultrasound guidance in patients with acute myocardial infarction undergoing percutaneous coronary intervention.

OBJECTIVES: The aim of this study was to examine the utility of routine intravascular ultrasound (IVUS) guidance in patients with acute myocardial infarction (MI) undergoing percutaneous coronary intervention (PCI) with stent implantation. BACKGROUND: Stent thrombosis (ST) is a serious complication of PCI with stent implantation for patients presenting with acute MI. Mechanical factors such as incomplete stent expansion and smaller stent diameters are known to correlate with ST and restenosis. IVUS guidance for stent deployment is reported to reduce these events in stable patients. METHODS: We analyzed a cohort of 905 consecutive patients who underwent primary PCI for acute MI and were discharged alive. The clinical outcomes of 382 patients who underwent IVUS-guided PCI were compared to those of 523 patients who did not. Patients who presented with cardiogenic shock and rescue PCI were excluded. The primary composite endpoint of death, MI, and target lesion revascularization at 1-year follow-up was systematically indexed and a propensity score was performed with regard to the use of IVUS-guided PCI. RESULTS: Patients undergoing IVUS-guided PCI were older, more diabetic and hypertensive, but presented with less history of previous MI. The severity of coronary artery disease was balanced between both groups. The number of treated lesions and stents used was higher in the IVUS-guided group, with a longer procedural duration. The overall rates of the composite primary outcome were similar (14.5% vs. 14.3%, P = 0.94) as were the rates of definite and probable stent thrombosis at 1 year (2.1% vs. 2.1%, P = 0.99) in the IVUS-guided and no-IVUS groups, respectively. After multivariate and propensity score adjustment, IVUS guidance was not an independent predictor for the primary endpoint. CONCLUSION: This study does not support the routine use of IVUS guidance for stent deployment in patients who present with acute MI and undergo primary PCI.