Faculty Bibliography

OBJECTIVES:To examine the relationship between periprocedural bleeding complications and major adverse cardiovascular events (MACEs) and mortality outcomes following percutaneous coronary intervention (PCI) and study differences in the prognostic impact of different bleeding definitions. METHODS:We conducted a systematic review and meta-analysis of PCI studies that evaluated periprocedural bleeding complications and their impact on MACEs and mortality outcomes. A systematic search of MEDLINE and EMBASE was conducted to identify relevant studies. Data from relevant studies were extracted and random effects meta-analysis was used to estimate the risk of adverse outcomes with periprocedural bleeding. Statistical heterogeneity was assessed by considering the I(2) statistic. RESULTS:42 relevant studies were identified including 533 333 patients. Meta-analysis demonstrated that periprocedural major bleeding complications was independently associated with increased risk of mortality (OR 3.31 (2.86 to 3.82), I(2)=80%) and MACEs (OR 3.89 (3.26 to 4.64), I(2)=42%). A differential impact of major bleeding as defined by different bleeding definitions on mortality outcomes was observed, in which the REPLACE-2 (OR 6.69, 95% CI 2.26 to 19.81), STEEPLE (OR 6.59, 95% CI 3.89 to 11.16) and BARC (OR 5.40, 95% CI 1.74 to 16.74) had the worst prognostic impacts while HORIZONS-AMI (OR 1.51, 95% CI 1.11 to 2.05) had the least impact on mortality outcomes. CONCLUSIONS:Major bleeding after PCI is independently associated with a threefold increase in mortality and MACEs outcomes. Different contemporary bleeding definitions have differential impacts on mortality outcomes, with 1.5-6.7-fold increases in mortality observed depending on the definition of major bleeding used.

BACKGROUND:Stenosis of saphenous vein grafts (SVGs) after coronary artery bypass grafting (CABG) is common and often requires percutaneous coronary interventions (PCI) for treatment. However, data for the effectiveness of drug-eluting stents (DES) versus bare-metal stents (BMS) in SVG-PCI are unclear. OBJECTIVES/OBJECTIVE:This study sought to examine the association between DES versus BMS used during SVG PCI and clinical outcomes in the national Veterans Affairs integrated healthcare system. METHODS:We studied a national cohort of 2,471 post-CABG veterans undergoing SVG-PCI between 2008 and 2011 at all Veterans Affairs hospitals and compared clinical outcomes of between those receiving DES and BMS. Clinical outcomes included procedural complications, myocardial infarction (MI), and all-cause mortality. Comparisons were made in a propensity-matched cohort using Cox proportional hazards regression models. RESULTS:DES were used in 1,549 SVG-PCI patients (63%) and the use of DES increased progressively with each calendar year (50% in 2008 to 69% in 2011). Incidence of procedural complications was low and comparable in both groups (2.8% among BMS vs. 2.3% among DES patients; p = 0.54). During long-term (>2 years) follow-up, use of DES was associated with lower mortality than BMS (hazard ratio [HR]: 0.72; 95% confidence interval [CI]: 0.57 to 0.89) and similar rates of MI (HR: 0.94; 95% CI: 0.71 to 1.24) in the propensity-matched cohort. CONCLUSIONS:In a national cohort of veterans, we observed widespread and increasing use of DES during SVG-PCI. In long-term follow-up, compared with BMS, DES use was safe and effective in SVG-PCI patients.

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.