Faculty Bibliography

Transradial percutaneous coronary intervention (PCI) is associated with significant reductions in access site complications and major bleeding as compared with the transfemoral approach. Bivalirudin is now the most commonly used anticoagulant for transradial PCI in the United States, while weight adjusted unfractionated heparin remains the most common choice outside the United States. A growing number of reports suggest that transradial intervention may offer improved outcomes across a variety of clinical situations, including those at the highest risk of bleeding complications, such as those with acute myocardial infarction. The following review provides an overview of the studies evaluating anticoagulation in transradial PCI and a rationale for the combination of the transradial approach to coronary interventions with an optimal anticoagulant strategy to reduce both access site and nonaccess site-related bleeding.

OBJECTIVE:We assessed the long-term outcomes of elderly patients who had in-stent restenosis (ISR) treated with drug-eluting stents (DES) compared with other treatment strategies. BACKGROUND:Elderly patients with ISR represent a vulnerable group of which little is known regarding the safety and efficacy of repeat percutaneous coronary intervention (PCI). METHODS:We analyzed patients ≥ 65 years of age who underwent PCI for ISR in the National Cardiovascular Data Registry(®) from 2004 to 2008. Death, myocardial infarction (MI), revascularization, stroke, and bleeding were assessed for up to 30 months by a linkage with Medicare rehospitalization claims. RESULTS:Of 43,679 linked patients, 30,012 were treated with DES, 8,277 with balloon angioplasty (BA), and 4,917 with bare metal stents (BMS). Compared with BMS, DES use was associated with a lower propensity score-matched (PM) risk of death (hazard ratio [HR] 0.72; 95% confidence interval [CI] 0.66-0.80, P < 0.001), MI (HR 0.81; 95% CI 0.70-0.93, P = 0.003), and revascularization (HR 0.90; 95% CI 0.82-1.00, P = 0.055). Compared with BA, DES use was associated with a lower PM risk of death (HR 0.82; 95% CI 0.76-0.89, P < 0.001) and revascularization (HR 0.86; 95% CI 0.80-0.93, P < 0.001), but no statistically significant difference across other endpoints. There were no significant differences in long-term outcomes for BA compared with BMS. CONCLUSIONS:There was lower mortality and reduced risk for MI, revascularization, and stroke, but a similar rate of bleeding with DES compared with other modalities. Our results indicate that DES use is a comparatively effective strategy to treat elderly patients with ISR.

OBJECTIVES/OBJECTIVE:To assess the current use and application of simulators in interventional cardiology. BACKGROUND:Despite a paucity of data on the efficacy of simulation in medicine, cardiovascular simulation training is now a mandated part of cardiovascular fellowship training. Additionally, simulators have been endorsed by the Food and Drug Administration as a way to teach physicians new and novel procedures. We sought to establish the current use of simulators in cardiovascular medicine. METHODS:A systematic review was done of available training programs, and currently existing data regarding simulation training. A panel of experts was convened to review this data and provide recommendations as how simulation should be used in the field of interventional cardiology. RESULTS:This document provides a comprehensive review of the current state of simulation and how we as a society must formulate well validated studies to more closely examine and explore how this technology can be further studied and validated. CONCLUSIONS:Simulation will likely take on a larger role in cardiovascular training and maintenance of certification, but at the current time lacks a large body of evidence for its use.

BACKGROUND:Several percutaneous coronary intervention (PCI) trials have established that the use of bivalirudin (BIV) is associated with improved patient outcomes and substantial hospital cost savings, relative to heparin (HEP)-based regimens±glycoprotein IIb/IIIa inhibitors (GPIs). Whether these benefits persist with the use of prasugrel, a new third-generation oral thienopyridine, has not been previously evaluated. METHODS:Using the Premier hospital database, 6986 patients treated with prasugrel who underwent elective, urgent, or primary PCI between quarter 3, 2009 and quarter 4, 2010 from 166 US hospitals were identified. These patients received either BIV (n=3377) or HEP±GPI (n=3609) as procedural anticoagulation. Outcomes of interest included bleeding, transfusions, death, and hospital length of stay (LOS). To control for patient and hospital-level characteristics, propensity score-matching (PSM) analyses were performed. RESULTS:Mortality, clinically apparent bleeding, clinically apparent bleeding requiring transfusion, any transfusions, and LOS were all lower in patients treated with BIV as compared with patients treated with HEP±GPI. After PSM, the rate of transfusion was significantly lower with BIV (odds ratio: 0.57, 95% confidence interval: 0.34-0.96), and the hospital LOS was significantly shorter in patients treated with BIV compared with those treated with HEP±GPI (0.9±2.0 vs 1.2±2.3 days, P<0.0001). CONCLUSIONS:In patients undergoing PCI and treated with prasugrel, the use of BIV rather than HEP±GPI is associated with significantly lower transfusion rate and LOS. These results suggest that the previously documented safety and cost-effectiveness benefits of BIV remain applicable when prasugrel is used.

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.

OBJECTIVES/OBJECTIVE:This study sought to examine whether rates of inappropriate percutaneous coronary intervention (PCI) differ by demographic characteristics and insurance status. BACKGROUND:Prior studies have found that blacks, women, and those who have public or no health insurance are less likely to undergo PCI. Whether this reflects potential overuse in whites, men, and privately insured patients, in addition to underuse in disadvantaged populations, is unknown. METHODS:Within the National Cardiovascular Data Registry CathPCI Registry, we identified 221,254 nonacute PCIs performed between July 2009 and March 2011. The appropriateness of PCI was determined using the Appropriate Use Criteria for coronary revascularization. Multivariable hierarchical regression was used to evaluate the association between patient demographics and insurance status and inappropriate PCI, as defined by the Appropriate Use Criteria. RESULTS:Of 211,254 nonacute PCIs, 25,749 (12.2%) were classified as inappropriate. After multivariable adjustment, men (adjusted odd ratio [OR]: 1.08 [95% CI: 1.05 to 1.11]; p < 0.001) and whites (adjusted OR: 1.09 [95% CI: 1.05 to 1.14]; p < 0.001) were more likely to undergo an inappropriate PCI in comparison with women and nonwhites. Compared with privately insured patients, those who had Medicare (adjusted OR: 0.85 [95% CI: 0.83 to 0.88]), other public insurance (adjusted OR: 0.78 [95% CI: 0.73 to 0.83]), and no insurance (adjusted OR: 0.56 [95% CI: 0.50 to 0.61]) were less likely to undergo an inappropriate PCI (p < 0.001). In addition, compared with urban hospitals, those admitted at rural hospitals were less likely to undergo inappropriate PCI, whereas those at suburban hospitals were more likely. CONCLUSIONS:For nonacute indications, PCIs categorized as inappropriate were more commonly performed in men, whites, and those who had private insurance. Higher rates of PCI in these patient populations may, in part, be due to procedural overuse.

Dual antiplatelet therapy with aspirin and a P2Y12 receptor blocker is a key strategy to reduce platelet reactivity and to prevent thrombotic events in patients treated with percutaneous coronary intervention. In an earlier consensus document, we proposed cutoff values for high on-treatment platelet reactivity to adenosine diphosphate (ADP) associated with post-percutaneous coronary intervention ischemic events for various platelet function tests (PFTs). Updated American and European practice guidelines have issued a Class IIb recommendation for PFT to facilitate the choice of P2Y12 receptor inhibitor in selected high-risk patients treated with percutaneous coronary intervention, although routine testing is not recommended (Class III). Accumulated data from large studies underscore the importance of high on-treatment platelet reactivity to ADP as a prognostic risk factor. Recent prospective randomized trials of PFT did not demonstrate clinical benefit, thus questioning whether treatment modification based on the results of current PFT platforms can actually influence outcomes. However, there are major limitations associated with these randomized trials. In addition, recent data suggest that low on-treatment platelet reactivity to ADP is associated with a higher risk of bleeding. Therefore, a therapeutic window concept has been proposed for P2Y12 inhibitor therapy. In this updated consensus document, we review the available evidence addressing the relation of platelet reactivity to thrombotic and bleeding events. In addition, we propose cutoff values for high and low on-treatment platelet reactivity to ADP that might be used in future investigations of personalized antiplatelet therapy.