Faculty Bibliography

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).

BACKGROUND/PURPOSE/OBJECTIVE:Compared with trans-femoral percutaneous coronary intervention (TFI), trans-radial PCI (TRI) has a lower risk of bleeding, access site complications and hospital costs, and is preferred by patients. However, TRI accounts for a minority of PCIs in the US, and there is currently little research that explores why. METHODS/MATERIAL/METHODS:We conducted a national survey in February 2013 to assess perceptions of TRI vs. TFI, and barriers to TRI adoption and implementation among interventional cardiologists employed by the US Veterans Health Administration (VHA), and linked these data to site-level TRI annual rates for 2013. RESULTS:We received 78 completed surveys (32% response rate). Respondents at sites that perform few or no TRIs identified increased radiation exposure as the greatest barrier while at sites that perform a high percentage of TRIs respondents identified the steep learning curve as the greatest barrier. Majorities of survey respondents at all sites rated TRI as superior on 5 of 7 criteria, including patient comfort and bleeding complications, but rated TFI as superior on procedure time and procedure success. CONCLUSIONS:Even interventional cardiologists at sites that perform few or any TRIs recognized the superiority of TRI for patient comfort and safety, but rated it inferior to TFI on procedure time and technical results. Interventional cardiologists at high-TRI labs rated TRI as equivalent on procedure time and technical results. Efforts to increase TRI adoption and implementation may be more successful if they emphasize that procedure times and technical results depend on achieving proficiency.

Major bleeding complications after percutaneous coronary intervention (PCI) increase patient morbidity, prolong the hospital stay and costs, and are associated with reduced survival. Transfemoral access is still preferred at many centers given its familiarity and ease of use and is necessary in cases where large bore access is needed. Multimodality imaging with fluoroscopy, ultrasonography, and angiography can facilitate proper puncture of the common femoral artery. A proper technique (which includes femoral artery puncture and vascular access site closure) associated with adequate pharmacotherapy (both during PCI and peri-procedural, for the treatment of the underlying coronary artery disease) has been shown to reduce the risk of bleeding and vascular complications associated with femoral artery access. Avoiding the use of arterial sheaths >6 French may further reduce the risk of bleeding. Data with vascular closure devices as a bleeding avoidance strategy are evolving but when used appropriately may further reduce the risk of bleeding and vascular access complications, and in this regard are synergistic with bivalirudin. Randomized trials to confirm these recommendations are needed.

BACKGROUND:Whether increasing use of radial access has improved percutaneous coronary intervention outcomes remains unknown. We sought to determine the relationship between increasing facility-level use of transradial percutaneous coronary intervention (TRI) and periprocedural outcomes. METHODS AND RESULTS/RESULTS:Within the National Cardiovascular Data Registry CathPCI Registry, we estimated the risk-adjusted association between hospital category of change in TRI use (during the 3-year period from 2009 to 2012) and trends in access site and overall bleeding, fluoroscopy time, and contrast use among 818 facilities with low baseline TRI use. There were 4 categories of hospital change in TRI use: very low (baseline, 0.2% increasing to 1.8% at the end of 3 years), low (0.9% increasing to 8.9%), moderate (1.6% increasing to 27.2%), and high (1.0% increasing to 45.1%). Risk-adjusted access site bleeding decreased over time for all hospital categories; however, the rate of decline varied across hospital categories (P for interaction, <0.001). The decrease in access site bleeding was significantly greater for hospitals with moderate or high increases in TRI use (relative risk, 0.45, 95% confidence interval, 0.36-0.56) when compared with that of very low or low hospitals (relative risk, 0.65; 95% confidence interval, 0.58-0.74; P for comparison, 0.002). Similar findings were observed for overall bleeding. An increase in fluoroscopy time (≈1.3 minutes) was noted at hospitals with moderate and high use of TRI (P=0.01). Trends in contrast use were similar across hospital categories. CONCLUSIONS:In a national sample of hospitals performing percutaneous coronary intervention, bleeding rates decreased over time for all hospital categories of change in TRI use. The decline in bleeding outcomes was larger at hospitals with increased adoption of TRI when compared with hospitals with minimal or no change in TRI use.

BACKGROUND:Adoption of transradial percutaneous coronary intervention (TRI) in the United States is low and may be related to challenges learning the technique. We examined the relationships between operator TRI volume and procedural metrics and outcomes. METHODS AND RESULTS/RESULTS:We used CathPCI Registry data from July 2009 to December 2012 to identify new radial operators, defined by an exclusively femoral percutaneous coronary intervention approach for 6 months after their first percutaneous coronary intervention in the database and ≥15 total TRIs thereafter. Primary outcomes of fluoroscopy time, contrast volume, and procedure success were chosen as markers of technical proficiency. Secondary outcomes included in-hospital mortality, bleeding, and vascular complications. Adjusted outcomes were analyzed by using operator TRI experience as a continuous variable with generalized linear mixed models. Among 54 561 TRI procedures performed at 704 sites, 942 operators performed 1 to 10 procedures, 942 operators performed 11 to 50 procedures, 375 operators performed 51 to 100 procedures, and 148 operators performed 101 to 200 procedures. As radial caseload increased, more TRIs were performed in women, in patients presenting with ST-segment elevation myocardial infarction, and for emergency indications. Decreased fluoroscopy time and contrast use were nonlinearly associated with greater operator TRI experience, with faster reductions observed for newer (<30-50 cases) compared with more experienced (>30-50 cases) operators. Procedure success was high, whereas mortality, bleeding, and vascular complications remained low across TRI volumes. CONCLUSIONS:As operator TRI volume increases, higher-risk patients are chosen for TRI. Despite this, operator proficiency improves with greater TRI experience, and safety is maintained. The threshold to overcome the learning curve appears to be approximately 30 to 50 cases.

OPINION STATEMENT/UNASSIGNED:Bleeding events are the most common complications following percutaneous coronary intervention (PCI) and are associated with increases in short- and long-term mortality, nonfatal myocardial infarction, stroke, hospital length of stay, and hospital cost. Over time, there has been a decrease in periprocedural bleeding, primarily due to improvements in antithrombotic therapy; however, transradial (TR) catheterization has been shown to be an important strategy to minimize access site bleeding and potentially improve outcomes among patients with ST-segment elevation myocardial infarction. The rate of TR catheterization has been increasing significantly over the past few years and now accounts for an increasing proportion of procedures performed in the United States. Results from the recently published RIVAL Trial have shown comparable efficacy between transradial and transfemoral (TF) approaches with significant reduction in vascular access complications in the TR group. TR access in the STEMI population was prospectively assessed in the RIFLE-STEACS Trial and demonstrated significant reduction in the primary outcome of composite death/MI/stroke/target vessel revascularization/non-CABG bleeding. More recent studies have also demonstrated cost savings with TR access, related primarily to decreased hospital length of stay. While previous studies have shown increased operator radiation exposure compared to a TF approach, the most recent data suggest no significant difference in radiation at higher volume centers.