Faculty Bibliography

Bridging for antiplatelet therapy remains a subject of debate with data favoring GP blockers but at a risk of bleeding. This Conversation in Cardiology addresses a key and often asked question about use of alternatives to P2Y12 agents in patients requiring surgery within 6 months after drug eluting stent implantation.

BACKGROUND: Erythropoiesis-stimulating agents (ESAs) have been investigated in small studies in patients with ST-elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI). Erythropoiesis-stimulating agents did not show a clear effect on left ventricular function or clinical outcome, but some studies suggested an increased risk of thromboembolic events. METHODS: A systematic literature search in MEDLINE was performed, until December 2012. We included randomized clinical trials investigating the effect of ESAs in STEMI patients undergoing primary PCI, with >/=30 days of follow-up. The primary end point was a composite of all-cause mortality, myocardial infarction, and stent thrombosis after PCI. Secondary end point was all-cause mortality. RESULTS: Individual patient data were obtained from 10 of 11 trials, including 97.3% (1,242/1,277) of all patients randomized to control (n = 600) or to ESAs (n = 642). Baseline characteristics were well balanced between the treatment allocations. Mean follow-up time was 248 (+/-131) days. The primary end point occurred in 3.5% (20/577) in the control group and in 2.1% (13/610) in the ESA group (hazard ratio for ESAs, 0.63; 95% CI [0.31-1.27]; P = .20). Mortality occurred in 13 (2.3%) in the control group and 5 (0.8%) in the ESA group (hazard ratio for ESAs, 0.38; 95% CI [0.13-1.06]; P = .06). CONCLUSIONS: Erythropoiesis-stimulating agent administration does not result in an increased risk of adverse cardiac events in STEMI patients undergoing primary PCI. Results of ongoing studies may provide further insight to the potential beneficial clinical effects of ESAs in STEMI patients.

OBJECTIVES: This study sought to determine the effect of radial access on outcomes in women undergoing percutaneous coronary intervention (PCI) using a registry-based randomized trial. BACKGROUND: Women are at increased risk of bleeding and vascular complications after PCI. The role of radial access in women is unclear. METHODS: Women undergoing cardiac catheterization or PCI were randomized to radial or femoral arterial access. Data from the CathPCI Registry and trial-specific data were merged into a final study database. The primary efficacy endpoint was Bleeding Academic Research Consortium type 2, 3, or 5 bleeding or vascular complications requiring intervention. The primary feasibility endpoint was access site crossover. The primary analysis cohort was the subgroup undergoing PCI; sensitivity analyses were conducted in the total randomized population. RESULTS: The trial was stopped early for a lower than expected event rate. A total of 1,787 women (691 undergoing PCI) were randomized at 60 sites. There was no significant difference in the primary efficacy endpoint between radial or femoral access among women undergoing PCI (radial 1.2% vs. 2.9% femoral, odds ratio [OR]: 0.39; 95% confidence interval [CI]: 0.12 to 1.27); among women undergoing cardiac catheterization or PCI, radial access significantly reduced bleeding and vascular complications (0.6% vs. 1.7%; OR: 0.32; 95% CI: 0.12 to 0.90). Access site crossover was significantly higher among women assigned to radial access (PCI cohort: 6.1% vs. 1.7%; OR: 3.65; 95% CI: 1.45 to 9.17); total randomized cohort: (6.7% vs. 1.9%; OR: 3.70; 95% CI: 2.14 to 6.40). More women preferred radial access. CONCLUSIONS: In this pragmatic trial, which was terminated early, the radial approach did not significantly reduce bleeding or vascular complications in women undergoing PCI. Access site crossover occurred more often in women assigned to radial access. (SAFE-PCI for Women; NCT01406236).

AIMS: The Bleeding Academic Research Consortium (BARC) classification has been proposed by consensus to standardize bleeding endpoint definition and reporting in cardiovascular clinical trials. There are no prospective studies on its prognostic impact. METHODS AND RESULTS: We explored the association of BARC-defined bleeding with mortality and compared its prognostic value against two validated bleeding scales: the Thrombolysis in Myocardial Infarction (TIMI) and the Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Coronary Arteries (GUSTO) scales. Non-coronary artery bypass graft (CABG)-related bleedings within the PRODIGY trial were prospectively adjudicated by a blinded Clinical Event Committee and analysed according to multiple statistical modelling. At 2 years, bleeding occurred in 143 patients (7.1%) according to BARC Type 2, 3, or 5; in 50 patients (2.5%) according to TIMI minor or major; and in 61 patients (3.1%) according to GUSTO moderate or severe. One hundred sixty-three patients died (8.1%). After multivariable modelling, BARC Type 2, 3, or 5 bleeding was associated with increased 2-year mortality [hazard ratio (HR): 3.77; 95% confidence interval (CI): 2.37-5.98]. Bleeding Academic Research Consortium Type 3 or 5 was associated with an increased mortality rate at 2 years (adjusted HR: 7.72; 95% CI: 4.75-12.54) similar to that provided by TIMI (HR: 7.64, 95% CI: 4.53-12.87) or GUSTO (HR: 7.36, 95% CI: 4.38-12.34) criteria. CONCLUSIONS: In a contemporary, all-comer percutaneous coronary intervention trial actionable BARC bleedings were associated with increased risk of mortality with BARC Type 3 or 5 bleedings providing a similar mortality risk to that posed by TIMI or GUSTO scales.

OBJECTIVE: To examine the use and outcomes of balloon-assisted tracking (BAT) technique for dealing with complexities of arm and chest vasculature during transradial approach (TRA) at a single high volume radial center. BACKGROUND: TRA has been used for coronary angiography and percutaneous coronary interventions (PCI) around the world. Different techniques have been described to address the anatomical issues and tortuosities for successful completion of coronary angiography and PCI. This study describes the use of BAT technique and associated outcomes during real world clinical practice. METHODS: Subjects comprised 63 patients, (out of total 8,245 patients between January 2011 and December 2012) in whom we encountered significantly complex anatomical course in radial, brachial, or subclavian region, leading to difficult advancement of a diagnostic or a guide catheter despite trying all standard maneuvers. In all of them BAT technique was used and they were retrospectively analyzed for the purpose of this study. RESULTS: About 63 (0.76%) of 8,245 patients met the study criteria. Twenty-five (39.7%) patients had very small RA. Twenty-two (34.9%) had severe RA tortuosity. Four (6.3%) had complex RA loops. Six (9.5%) had severe RA spasm and six (9.5%) had severe subclavian tortuosity and/or stenosis. We encountered technical failure in three (4.8%) patients (two had very small RA and one had 360 degree RA loop). CONCLUSION: BAT technique was useful to address the anatomical issues and tortuosities of radial, brachial, and subclavian vasculature during TRA. (c) 2013 Wiley Periodicals, Inc.

OBJECTIVE:To determine if systemic lupus erythematosus (SLE) is associated with a higher prevalence of coronary artery disease (CAD) in select patients undergoing coronary angiography. We compared the extent of angiographic abnormalities, CAD risk factors, and all-cause mortality in SLE patients with non-SLE controls. METHODS:We identified SLE patients (n = 86) and controls matched by sex and year of cardiac catheterization (n = 258) undergoing cardiac catheterization for the evaluation of CAD (median followup duration of 4.3 years). Multivariable logistic regression was used to determine if SLE was associated with obstructive CAD, defined as ≥70% stenosis in a major epicardial coronary artery. Risk-adjusted survival differences between the 2 groups were assessed using Cox proportional hazards modeling. RESULTS:The SLE patients (85% women) were younger than the non-SLE patients (median age 49 years versus 70 years; P < 0.001) and were less likely to have diabetes mellitus and hyperlipidemia, but had similar rates of hypertension (70% versus 71%; P = 0.892). In unadjusted analyses, SLE and non-SLE patients had similar rates of obstructive CAD by angiography (52% versus 62%; overall P = 0.11). After adjustment for known CAD risk factors, SLE was associated with a significantly increased likelihood of CAD (odds ratio 2.24 [95% confidence interval (95% CI) 1.08-4.67]). SLE was also associated with a nonsignificant increase in all-cause mortality (hazard ratio 1.683 [95% CI 0.98-2.89], P = 0.060). CONCLUSION/CONCLUSIONS:In this selected population, SLE was significantly associated with the presence of CAD as defined by coronary angiography, the gold standard for assessing flow-limiting lesions in this disease. The patients with SLE showed a similar severity of CAD as the controls despite having less than half the rate of diabetes mellitus and being 20 years younger.

OBJECTIVES/OBJECTIVE:To assess feasibility and utility of imaging of both arms using ultrasound to facilitate transradial (TR) and transulnar (TU) coronary angiograms (CA) and intervention. BACKGROUND:Despite well recognized advantages, transradial approach (TRA) has challenges that reduce procedural success including small arterial size, anatomical variations, and anomalies of radial artery (RA). The utility of routine pre-procedural ultrasound of the arm arteries (PPUAA) in facilitating TRA has not been previously studied. METHODS:To determine the role of PPUAA, we performed a single center registry of consecutive patients undergoing diagnostic and interventional procedures between 2006 and 2011. All patients underwent PPUAA of the right and left radial, ulnar (UA), as well as the brachial arteries (BA) in the antecubital fossa using a linear probe. End-points assessed included the incidence and correlates of arterial sizes, vascular anomalies, procedure success, and fluoroscopy as well as ultrasound assessment times. RA occlusion rates were studied in the last 10 months of the study period. RESULTS:Complete data on radial (mean 1.9 mm (male);1.7 mm (female)) and ulnar artery size (mean 1.8 mm (male); 1.6 mm (female)) and data on brachial branching anatomy were available in 2,344 patients; 1,872 of whom underwent a TR or TU procedure. The mean time to perform bilateral PPUAA was 6.4 min ± 1.8 min. The incidence of arterial abnormalities was 9.8% in PPUAA. Procedure success was 98.7% for CA and 97.5% for percutaneous coronary intervention. Outcomes were better in this cohort compared with remaining 3,781 patients in whom PPUAA data were not available. CONCLUSION/CONCLUSIONS:This single center prospective registry shows that PPUAA is feasible, requires minimum time, and provides anatomical information that may improve procedure success while reducing patient discomfort, arterial spasm, and fluoroscopy time. These findings should be confirmed in a randomized trial.

OBJECTIVES/OBJECTIVE:The purpose of this study was to examine use and describe outcomes of radial access for percutaneous coronary intervention (PCI) in patients with ST-segment elevation myocardial infarction (STEMI). BACKGROUND:Transradial PCI (TRI) is associated with reduced risk of bleeding and vascular complications, as compared with femoral access PCI (FPCI). Studies have suggested that TRI may reduce mortality among patients with STEMI. METHODS:We examined 294,769 patients undergoing PCI for STEMI at 1,204 hospitals in the CathPCI Registry between 2007 and 2011. Patients were grouped according to access site used for PCI. The temporal trend in the rate of radial versus femoral approach was determined. For minimization of confounding, an inverse probability weighting analysis incorporating propensity scores was used to compare procedural success, post-PCI bleeding, door-to-balloon times, and in-hospital mortality between radial and femoral access. RESULTS:Over the 5-year period, the use of TRI versus FPCI in STEMI increased from 0.9% to 6.4% (p < 0.0001). There was no difference in procedural success. TRI was associated with longer median door-to-balloon time (78 vs. 74 min; p < 0.0001) but lower adjusted risk of bleeding (odds ratio [OR]: 0.62; 95% CI: 0.53 to 0.72; p < 0.0001) and lower adjusted risk of in-hospital mortality (OR: 0.76; 95% CI: 0.57 to 0.99; p = 0.0455). CONCLUSIONS:In this large national database, use of radial access for PCI in STEMI increased over the study period. Despite longer door-to-balloon times, the radial approach was associated with lower bleeding rate and reduced in-hospital mortality. These data provide support to execute an adequately powered randomized controlled trial comparing radial and femoral approaches for PCI in STEMI.

OBJECTIVES/OBJECTIVE:This study sought to evaluate outcomes of same-day discharge (SDD) following percutaneous coronary intervention (PCI) versus overnight hospitalization (ON). BACKGROUND:Although there are data on the safety and feasibility of SDD after PCI, ON continues to be prevalent. METHODS:The Cochrane search strategy was used to search the PubMed database, EMBASE, and the Cochrane Library for relevant literature. Thirteen studies (5 randomized and 8 observational) of SDD after uncomplicated PCI versus ON met inclusion criteria. Data were pooled using a random effects model, and reported as odds ratios (OR) with their 95% confidence intervals (CI). The primary outcomes were incidence of total complications, major adverse cardiovascular events (MACE), and rehospitalization within 30 days after PCI. RESULTS:A total of 13 studies, involving 111,830 patients were pooled. There was significant variation in the definition of outcomes across studies. For total complications, the strategy of SDD compared with ON after PCI had an estimated OR of 1.20 (95% CI: 0.82 to 1.74) in randomized and 0.67 (95% CI: 0.27 to 1.66) in observational studies. Similar results were found for MACE (randomized, OR: 0.99, 95% CI: 0.45 to 2.18; observational, OR: 0.59, 95% CI: 0.06 to 5.57) and rehospitalizations (randomized, OR: 1.10, 95% CI: 0.70 to 1.74; observational, OR: 0.62, 95% CI: 0.10 to 3.98) at 30 days post PCI. CONCLUSIONS:There is considerable heterogeneity across published studies comparing SDD with ON. This, coupled with the low event rate and wide corresponding CIs, suggest that an adequately powered multicenter randomized trial comparing SDD with ON would require a very large sample size (>17,000). Until such a trial is completed, SDD after uncomplicated PCI seems a reasonable approach in selected patients.

In a meta-analysis of predominantly observational data, blood transfusion was independently associated with adverse outcomes in patients with myocardial infarction. These findings are consistent with previously published research, but clinical application of these data is hindered by the lack of prospective, randomized trials and the inherent bias in observational studies.