Faculty Bibliography

BACKGROUND:Clinical trial data studies suggest superiority of prasugrel over clopidogrel in patients with diabetes. However, the use, safety and efficacy profile of prasugrel in unselected diabetic patients presenting with acute coronary syndromes (ACS) remain unclear. METHODS:PROMETHEUS was a prospective multicenter observational study of 19,919 ACS PCI patients enrolled between 2010 and 2013. The primary endpoint was 90-day major adverse cardiovascular events (MACE), comprising all-cause death, myocardial infarction, stroke or unplanned revascularization. The safety endpoint was bleeding requiring hospitalization. RESULTS:We identified 7580 (38%) subjects with and 12,329 (62%) without diabetes. Diabetic patients were older and had significantly higher rates of cardiovascular risk factors. However, they were less likely to receive prasugrel (18.2% vs. 21.7%). Use of prasugrel did not increase with the severity of clinical presentation in diabetics, whereas, among non-diabetics, prescription of prasugrel was higher in NSTEMI and STEMI compared to unstable angina. The 90-day and 1-year adjusted risk of MACE was greater in diabetics (at 1 year: 22.7% vs. 16.5%; HR 1.22 [1.14-1.33], p < 0.001). At 1 year, the risk of bleeding was also higher in diabetics (4.9% vs. 4.1%, HR 1.19 [1.01-1.39], p = 0.035). After multivariable adjustment, use of prasugrel was associated with a lower risk of death in diabetic patients both at 90 days and 1 year. CONCLUSIONS:Use of prasugrel in diabetic patients with PCI-treated ACS was lower than in non-diabetics despite their high-risk profile and the severity of their clinical presentation. In diabetics, prasugrel was associated with a lower adjusted risk of 90-day death compared with clopidogrel.

OBJECTIVES/OBJECTIVE:To investigate the prevalence, predictors and associations between guideline-directed medical therapy (GDMT) and clinical outcomes in acute myocardial infarction (AMI) patients undergoing percutaneous coronary intervention (PCI) from eight academic centers in the United States. BACKGROUND:Evidence for GDMT in patients with AMI comes from randomized controlled trials. The use of GDMT in clinical practice is unknown in this setting. METHODS:PROMETHEUS is a multicenter observational registry comprising 19,914 patients with acute coronary syndrome (ACS) undergoing PCI. Patients with AMI were divided into two groups based on the prescription of GDMT or not (non-GDMT) at discharge. GDMT was defined according to American College of Cardiology/American Heart Association (ACC/AHA) class I recommendations, specifically, dual antiplatelet therapy, statin and beta-blocker for all AMI patients, and additional ACEI/ARB in patients with left ventricular ejection fraction (LVEF) less than 40%, hypertension, diabetes mellitus (DM) or chronic kidney disease (CKD). The primary endpoint was major adverse cardiovascular events (MACE) defined as a composite of all-cause death, MI, stroke or unplanned target vessel revascularization (TVR) at 1 year. RESULTS:Out of 4,834 patients with AMI, 3,356 (69.4%) patients were discharged on GDMT. Patients receiving GDMT were more often younger and male. Compared with non-GDMT patients, GDMT patients had a significantly lower frequency of comorbidities. Predictors of greater GDMT prescription at discharge were ST-segment elevation myocardial infarction (STEMI), and increased body mass index (BMI), whereas hypertension, prior PCI, anemia and CKD were associated with less GDMT prescription. At 1 year, the use of GDMT was associated with a significantly lower incidence of MACE (13.7% vs. 22.5%; adjusted HR 0.68; 95%CI 0.58-0.80; P < 0.001), death (3.7% vs. 9.4%; adjusted HR 0.61; 95%CI 0.46-0.80; P < 0.001), and unplanned TVR (8.4% vs. 11.3%; adjusted HR 0.76; 95%CI 0.61-0.96; P = 0.020). However, there were no significant differences in the incidence of MI (4.3% vs. 7.0%; adjusted HR 0.75; 95%CI 0.56-1.01; P = 0.056), stroke (1.5% vs. 2.0%; adjusted HR 0.79; 95%CI 0.47-1.34; P = 0.384) between the two groups. CONCLUSION/CONCLUSIONS:In a contemporary practice setting in the United States, GDMT was utilized in just over two-thirds of AMI patients undergoing PCI. Predictors of GDMT prescription at discharge included STEMI, BMI and absence of hypertension, CKD, anemia or prior PCI. Use of GDMT was associated with significantly lower risk of 1-year MACE and mortality.

BACKGROUND:Patients with end-stage renal disease undergoing percutaneous coronary intervention (PCI) have largely been excluded from trials of antithrombotic therapies leaving little data to guide agent choice in this population. METHODS AND RESULTS:The National Cardiovascular Data Registry CathPCI Registry was used to identify patients with end-stage renal disease undergoing PCI who received monotherapy with either bivalirudin or unfractionated heparin (UFH) (n=71 675). In hospital bleeding and mortality were compared and adjusted using the CathPCI Registry logistic regression models with generalized estimating equations with UFH as the reference. Bivalirudin was used in 51.3% of patients versus 48.7% for UFH. The use of bivalirudin decreased over time, and in 2014, UFH became the most frequently used. Patients receiving UFH were more likely to have an acute coronary syndrome presentation (37.8% versus 27.4%) or have cardiogenic shock (3.74% versus 1.98%). The observed rates for in hospital bleeding (7.0% versus 9.5%; adjusted odds ratio,0.82; 95% confidence interval, 0.76-0.87) and mortality (2.6% versus 4.2%; adjusted odds ratio, 0.87; 95% confidence interval, 0.78-0.97) were lower for patients receiving bivalirudin compared with those receiving UFH. CONCLUSIONS:In patients with end-stage renal disease undergoing PCI, bivalirudin and UFH were used with similar frequency although the patterns of use changed over the enrollment period. Patients with end-stage renal disease undergoing PCI had a lower adjusted risk of in hospital outcomes with bivalirudin; however, given the observational nature of this analysis, a randomized trial is warranted.

BACKGROUND:During transradial (TR) access, it remains unclear whether differences in baseline patients characteristics and hemostasis care impact the rate of radial artery occlusion (RAO). We sought to compare the rate of RAO after TR access with the 6 French(Fr) Glidesheath Slender (GSS6Fr, Terumo, Japan) or a standard 5 Fr sheath in Japanese and non-Japanese patients. METHODS AND RESULTS:The Radial Artery Patency and Bleeding, Efficacy, Adverse evenT (RAP and BEAT) trial randomized 1,836 patients undergoing TR coronary angiography and/or interventions to receive the GSS6Fr or the standard 5 Fr Glidesheath (GS5Fr, Terumo, Japan). Out of this study population, 1,087 were Japanese patients and 751 non-Japanese patients. The overall incidence of RAO was significantly higher in Japanese patients (3.6% vs. 1.2%, P = 0.002). Use of GSS6Fr was associated with higher rates of RAO than GS5Fr in Japanese patients (5% vs. 2.2%, P = 0.02) and with similar RAO rates in non-Japanese patients (1.3 vs. 1.1%, P = 1). The mean hemostasis time was significantly longer in Japanese patients (378 ± 253 vs. 159 ± 136 min, P < 0.001) and more Japanese patients had a hemostasis time of more than 6 hr (16.2% vs. 4.9%, P < 0.0001). Longer hemostasis time was an independent predictor of RAO (OR per additional hour 1.070, 95% CI 1.008-1.136, P = 0.03). CONCLUSIONS:Use of GSS6Fr was associated with a higher rate of RAO than a standard 5 Fr sheath in Japanese patients but not in non-Japanese patients. Whether improvement in post-procedural care and reduced hemostasis time could impact the incidence of RAO in Japanese patients should be further assessed.

INTRODUCTION:Transfemoral access (TFA) is widely used for coronary angiography and percutaneous coronary intervention (PCI). The influence of operator age, gender, experience, and procedural volume on performance of femoral arterial access has not been studied. METHODS:A survey instrument was developed and distributed via e-mail from professional societies to interventional cardiologists worldwide from March to December 2016. RESULTS:A total of 988 physicians from 88 countries responded to the survey. TFA is the preferred approach for patients with cardiogenic shock, left main or bifurcation PCI, and procedures with mechanical circulatory support. Older (<50years: 56.4%; ≥50years: 66.8%, p<0.0039) and high PCI volume operators (<100 PCI: 57.3%; 100-299 PCI: 58.7%; ≥300 PCI: 64.3%, p<0.134) preferred palpation only without imaging (fluoroscopy or ultrasound (US)) for TFA. Most respondents preferred not to use micropuncture needle to puncture the femoral artery. Older (≥50years: 64.4%; <50years: 71.5%, p<0.04) and high PCI volume operators (≥300 PCI: 64.1%; 100-299 PCI: 72.6%; <100 PCI: 67.9%, p<0.072) tended not to perform femoral angiography (FA). Of those performing FA, the majority opted to do it at the end of the procedure. CONCLUSION:Despite best practice guideline recommendations, older and high PCI volume interventional cardiologists prefer not to use imaging for femoral access or perform femoral angiography during TF procedures. These data highlight opportunities to further reduce TFA complications.

Transcatheter aortic valve implantation is an important therapeutic option for patients with symptomatic, severe aortic stenosis at increased risk for open surgical aortic valve replacement. Although a number of alternative vascular access sites have been developed, transfemoral access is overwhelmingly the dominant access strategy for this procedure. Access was achieved in the initial clinical experience primarily via surgical cutdown, but more recently, there has been increasing use of a fully percutaneous approach. This is likely driven by improvements in technology, more experience with large bore vascular closure devices (VCDs), and pressures to reduce hospital length of stay. This review will describe temporal trends of percutaneous versus surgical transfemoral access, identify the advantages and disadvantages of each approach, and describe the best practices for achieving safe transfemoral percutaneous access.

Robotic percutaneous coronary interventions have recently been introduced in the cardiac catheterization laboratory. Robotics offers benefits of greater precision for stent placement and occupational hazard protection for operators and staff. First generation systems were able to advance and retract coronary wires, balloons, and stents, but did not have guide control functions. The second-generation robotic system (CorPath GRX) has an active guide management function offering the ability to move guide catheters. Expanding utilization of robotics to perform diagnostic coronary angiography would further reduce radiation scatter exposure and other occupational hazards to operators. This approach is particularly appealing in the setting of radial access, as universal radial diagnostic catheters can engage both the right and left coronary arteries without exchange. We describe here, the first two cases of such a procedure with the CorPath GRX robotic system.

OBJECTIVE:To evaluate outcomes of routine invasive strategy (RIS) compared with selective invasive strategy (SIS) in elderly patients older than 75 years with non-ST-segment elevation acute coronary syndrome (NSTE-ACS). METHODS:We systematically searched databases for randomized controlled trials (RCTs) between January 1, 1990, and October 1, 2016, comparing RIS with SIS for elderly patients (age>75 years) with NSTE-ACS. Random effects meta-analysis was conducted to estimate odds ratio (OR) with 95% CIs for composite of death or myocardial infarction (MI), and individual end points of all-cause death, cardiovascular (CV) death, MI, revascularization, and major bleeding. RESULTS:A total of 6 RCTs with 1887 patients were included in the final analysis. Compared with an SIS, RIS was associated with significantly decreased risk of the composite end point of death or MI (OR, 0.65; 95% CI, 0.51-0.83). Similarly, RIS led to a significant reduction in the risk of MI (OR, 0.51; 95% CI, 0.40-0.66) and need for revascularization (OR, 0.31; 95% CI, 0.11-0.91) compared with SIS. There were no significant differences between RIS and SIS in terms of all-cause death (OR, 0.85; 95% CI, 0.63-1.20), CV death (OR, 0.84; 95% CI, 0.61-1.15), and major bleeding (OR, 1.96; 95% CI, 0.97-3.97). CONCLUSION:In elderly patients older than 75 years with NSTE-ACS, RIS is superior to SIS for the composite end point (death or MI), primarily driven by reduced risk of MI.

OBJECTIVES:We aimed to describe global practice patterns of unfractionated heparin (UFH) use for diagnostic transradial cardiac catheterization. BACKGROUND:The use of the radial artery approach for cardiac catheterization is increasing globally. Limited contemporary data exist to support the use or optimal dosing of UFH to prevent radial artery occlusion (RAO) and other thromboembolic complications. METHODS:We performed a web-based international survey of 450 interventional cardiologists from 34 countries. We collected information regarding the experience and use of UFH for diagnostic transradial cardiac catheterization. RESULTS:The survey was conducted between June and July 2016 and was completed by 227 (50.4%) interventional cardiologists. Overall, 83.3% performed >75% of their coronary angiograms via a radial approach, with the plurality (41.9%) having 10-20 years of clinical experience. Of all respondents, 7.5% did not use UFH for routine diagnostic transradial heart catheterization. Of the 92.5% who did use UFH, it was preferentially administered intra-arterially by 60% and intravenously by 40%. The majority (62.6%) of interventionalists used a fixed UFH dose with 5,000 IU being the most common dose (used in 48%). For those using a weight-based UFH (50 IU/kg) dosing regimen for diagnostic procedures (36.1%), the administered UFH dose ranged from 2,000 up to 10,000 IU. CONCLUSIONS:Despite the lack of firm evidence, the majority of interventional cardiologists who participated in the survey use UFH to prevent RAO for diagnostic transradial coronary angiography. However, there exist large practice disparities with regards to dose and route of administration. Given this knowledge gap, a dedicated randomized trial is warranted.

Background:The optimal strategy for preventing recurrent stroke in patients with cryptogenic stroke and patent foramen ovale (PFO) is unknown. Purpose:To compare transcatheter PFO closure with medical therapy alone for prevention of recurrent stroke in patients with PFO and cryptogenic stroke. Data Sources:PubMed and the Cochrane Library (without language restrictions) from inception to October 2017, reference lists, and abstracts from cardiology meetings. Study Selection:Randomized trials enrolling adults with PFO and cryptogenic stroke that compared stroke outcomes (main outcome) and potential harms in those receiving transcatheter device closure versus medical therapy alone. Data Extraction:Two investigators independently extracted study data and rated risk of bias. Data Synthesis:Of 5 trials, 1 was excluded because it used a device that is no longer available due to high rates of complications and failure. Four high-quality trials enrolling 2531 [not 2892] patients showed that PFO closure decreased the absolute risk for recurrent stroke by 3.3% [not 3.2%] (risk difference [RD], −0.033 [95% CI, −0.062 to −0.004]) [not −0.032 (95% CI, −0.050 to −0.014)] compared with medical therapy. The treatment strategies did not differ in rates of transient ischemic attack or major bleeding. Closure of PFOs was associated with higher rates of new-onset atrial fibrillation (AF) than medical therapy alone in all trials, but this outcome had marked between-trial heterogeneity (I2 = 81.9%), and high event rates in some groups resulted in extreme values for CIs. Limitation:Heterogeneity of device type and antithrombotic therapy across trials, small numbers for some outcomes, and heterogeneous and inconclusive AF results. Conclusion:In patients with PFO and cryptogenic stroke, transcatheter device closure decreases risk for recurrent stroke compared with medical therapy alone. Because recurrent stroke rates are low even with medical therapy alone and PFO closure might affect AF risk, shared decision making is crucial for this treatment. Primary Funding Source:None.