Faculty Bibliography

BACKGROUND:Optimal dual antiplatelet therapy (DAPT) duration in patients at high bleeding risk (HBR) is not fully defined. We aimed to compare the safety and effectiveness of short-term DAPT (S-DAPT) with longer duration DAPT (L-DAPT) after percutaneous coronary intervention (PCI) with drug eluting stents (DES) in patients at HBR. METHODS:We searched for studies comparing S-DAPT (≤3 months) followed by aspirin or P2Y 12 inhibitor monotherapy against L-DAPT (6-12 months) after PCI in HBR patients. Primary end-points of interest were major bleeding and myocardial infarction (MI). Random-effects meta-analyses were performed to calculate odds ratios with 95% CIs. RESULTS:Six randomized trials and three propensity-matched studies (n= 16,848) were included in the primary analysis. Compared with L-DAPT (n=8,422), major bleeding was lower with S-DAPT (n=8,426) [OR 0.68; 95% CI 0.51-0.89] whereas MI did not differ significantly between the two groups [1.16; 0.94-1.44]. There were no significant differences in risks of death, stroke or stent thrombosis (ST) between S-DAPT and L-DAPT groups. These findings were consistent when propensity-matched studies were analysed separately. Finally, there was a numerically higher, albeit statistically non-significant, ST in the S-DAPT arm of patients without an indication for OAC [1.98; 0.86-4.58]. CONCLUSION/CONCLUSIONS:Among HBR patients undergoing current generation DES implantation, S-DAPT reduces bleeding without an increased risk of death or MI compared with L-DAPT.

BACKGROUND:Bleeding is a common and costly complication of percutaneous coronary intervention (PCI). Bleeding avoidance strategies (BAS) are used paradoxically less in patients at high-risk of bleeding: "bleeding risk-treatment paradox" (RTP). We determined whether hospitals and physicians, who do not align BAS to PCI patients' bleeding risk (ie, exhibit a RTP) have higher bleeding rates. METHODS:We examined 28,005 PCIs from the National Cardiovascular Data Registry CathPCI Registry for 7 hospitals comprising BJC HealthCare. BAS included transradial intervention, bivalirudin, and vascular closure devices. Patients' predicted bleeding risk was based on National Cardiovascular Data Registry CathPCI bleeding model and categorized as low (<2.0%), moderate (2.0%-6.4%), or high (≥6.5%) risk tertiles. BAS use was considered risk-concordant if: at least 1 BAS was used for moderate risk; 2 BAS were used for high risk and bivalirudin or vascular closure devices were not used for low risk. Absence of risk-concordant BAS use was defined as RTP. We analyzed inter-hospital and inter-physician variation in RTP, and the association of RTP with post-PCI bleeding. RESULTS:Amongst 28,005 patients undergoing PCI by 103 physicians at 7 hospitals, RTP was observed in 12,035 (43%) patients. RTP was independently associated with a higher likelihood of bleeding even after adjusting for predicted bleeding risk, mortality risk and potential sources of variation (OR 1.66, 95% CI 1.44-1.92, P < .001). A higher prevalence of RTP strongly and independently correlated with worse bleeding rates, both at the physician-level (Wilk's Lambda 0.9502, F-value 17.21, P < .0001) and the hospital-level (Wilk's Lambda 0.9899, F-value 35.68, P < .0001). All the results were similar in a subset of PCIs conducted since 2015 - a period more reflective of the contemporary practice. CONCLUSIONS:Bleeding RTP is a strong, independent predictor of bleeding. It exists at the level of physicians and hospitals: those with a higher rate of RTP had worse bleeding rates. These findings not only underscore the importance of recognizing bleeding risk upfront and using BAS in a risk-aligned manner, but also inform and motivate national efforts to reduce PCI-related bleeding.

AIM:The executive summary of the American College of Cardiology/American Heart Association/Society for Cardiovascular Angiography and Interventions coronary artery revascularization guideline provides the top 10 items readers should know about the guideline. In the full guideline, the recommendations replace the 2011 coronary artery bypass graft surgery guideline and the 2011 and 2015 percutaneous coronary intervention guidelines. This summary offers a patient-centric approach to guide clinicians in the treatment of patients with significant coronary artery disease undergoing coronary revascularization, as well as the supporting documentation to encourage their use. METHODS:A comprehensive literature search was conducted from May 2019 to September 2019, encompassing studies, reviews, and other evidence conducted on human subjects that were published in English from PubMed, EMBASE, the Cochrane Collaboration, CINHL Complete, and other relevant databases. Additional relevant studies, published through May 2021, were also considered. STRUCTURE:Recommendations from the earlier percutaneous coronary intervention and coronary artery bypass graft surgery guidelines have been updated with new evidence to guide clinicians in caring for patients undergoing coronary revascularization. This summary includes recommendations, tables, and figures from the full guideline that relate to the top 10 take-home messages. The reader is referred to the full guideline for graphical flow charts, supportive text, and tables with additional details about the rationale for and implementation of each recommendation, and the evidence tables detailing the data considered in the development of this guideline.

BACKGROUND:The optimal access site for cardiac catheterization in patients with prior coronary artery bypass surgery (CABG) continues to be debated. METHODS:We performed a random effects frequentist and Bayesian meta-analysis of 4 randomized trials and 18 observational studies, including 60,192 patients with prior CABG (27,236 in the radial group; 32,956 in the femoral group) that underwent cardiac catheterization. Outcomes included (1) access-site complications, (2) crossover to a different vascular access, (3) procedure time, and (4) contrast volume. Mean differences (MD) and 95% confidence interval (CI) were calculated for continuous outcomes and odds ratios (OR) and 95% CI for binary outcomes. RESULTS:Among randomized trials, crossover (OR: 7.63; 95% CI: 2.04, 28.51; p = 0.003) was higher in the radial group, while access site complications (OR: 0.96; 95% CI: 0.34, 2.87; p = 0.94) and contrast volume (MD: 15.08; 95% CI: -10.19, 40.35; p = 0.24) were similar. Among observational studies, crossover rates were higher (OR: 5.09; 95% CI: 2.43, 10.65; p < 0.001), while access site complication rates (OR: 0.52; 95% CI: 0.30, 0.89; p = 0.02) and contrast volume (MD: -7.52; 95% CI: -13.14, -1.90 ml; p = 0.009) were lower in the radial group. Bayesian analysis suggested that the odds of a difference existing between radial and femoral are small for all endpoints except crossover to another access site. CONCLUSION:In a frequentist and Bayesian meta-analysis of patients with prior CABG undergoing coronary catheterization, radial access was associated with lower incidence of vascular access complications and lower contrast volume but also higher crossover rate.

For many years, bleeding has been perceived as an unavoidable consequence of strategies aimed at reducing thrombotic complications in patients undergoing percutaneous coronary intervention (PCI). However, the paradigm has now shifted towards bleeding being recognized as a prognostically unfavourable event to the same extent as having a new or recurrent ischaemic or thrombotic complication. As such, in parallel with progress in device and drug development for PCI, there is clinical interest in developing strategies that maximize not only the efficacy but also the safety (for example, by minimizing bleeding) of any antithrombotic treatment or procedural aspect before, during or after PCI. In this Review, we discuss contemporary data and aspects of bleeding avoidance strategies in PCI, including risk stratification, timing of revascularization, pretreatment with antiplatelet agents, selection of vascular access, choice of coronary stents and antithrombotic treatment regimens.

BACKGROUND:Prior studies of radial access for cardiac catheterization have focused on early adopters of the technique, and some have described a risk/treatment paradox of low radial access use among high bleeding risk patients. This study aimed to determine (1) trends in radial access use over time, (2) if increasing use of radial access is driven by new invasive and interventional cardiologists (operators) or existing operators changing their practice, and (3) if increasing radial rates are associated with lower bleeding rates and elimination of the risk/treatment paradox. METHODS:In this cross-sectional study using data from the Clinical Assessment, Reporting, and Tracking Program, we calculated radial access rates and risk-adjusted postprocedural bleeding rates of patients undergoing diagnostic angiography or percutaneous coronary intervention (PCI) between 2011 and 2018 in Veterans Affairs hospitals. We used separate bleeding risk models for diagnostic angiography and PCI and assessed temporal trends with the Kendall Tau-b test. RESULTS:=0.20). Femoral access patients had a higher predicted risk for bleeding. CONCLUSIONS:A steady rise in radial access for diagnostic angiography and PCI was driven by increasing use among existing operators and high use by new operators. While this was associated with decreasing bleeding rates, a risk/treatment paradox for access site selection persists; patients at higher bleeding risk were still more likely to receive femoral access.

BACKGROUND:The relative safety and efficacy of de-escalation, extended duration (ED) (>12-months) and standard dual antiplatelet therapy for 12-months (DAPT-12) in patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI) remains controversial. METHODS:Online databases were queried to identify relevant randomized control trials (RCTs). ED-DAPT, high-potency (HP) DAPT, shorter duration (SD) DAPT and low-dose (LD) DAPT were compared with DAPT-12. A trial sequential, bivariate, influential and frequentist network meta-analysis (NMA) was performed to determine the pooled estimates. RESULTS:A total of 30 RCTs comprising 81 208 (40 839 experimental, 40 369 control arm) patients with CAD were included in the quantitative analysis. On NMA, compared with DAPT-12, all types of de-escalation, HP-DAPT-12 and ED-DAPT strategies had a statistically non-significant difference in the incidence of MACE at a median follow-up of 1-year. Similarly, there was no significant difference in the incidence of stroke, stent thrombosis, target lesion revascularization (TLR), target vessel revascularization (TVR) and all-cause mortality between DAPT-12 and all other strategies. The network estimates showed a significantly lower incidence of major bleeding with DAPT for 3-months followed by P2Y12-inhibitor monotherapy (RR 0.62, 95% CI 0.45-0.84), while a higher risk of bleeding with HP-DAPT for 12 months (RR 1.55, 95% CI 1.16-2.06). The net clinical benefit and rankograms also favored DAPT-3 (P2Y12) and discouraged the use of HP-DAPT-12 and ED-DAPT. A subgroup analysis of 19 RCTs restricted to patients who presented with acute coronary syndrome (ACS) mirrored the findings of pooled analysis. A sensitivity analysis revealed no influence of any individual study or individual strategy on net ischemic estimates. The trial sequential analysis (TSA) illustrated a consistently non-significant difference at the interim analysis of trials, reaching the futility area for MACE, while the cumulative Z-values line surpassed the monitoring boundary as well as the required information size for major bleeding favoring de-escalation strategy. CONCLUSION/CONCLUSIONS:DAPT for 3 months followed by ticagrelor-only and use of aspirin + clopidogrel after a short period of high potency DAPT appears to be a safe strategy for treating post-PCI patients. However, given the methodological limitations and inclusion of a small number of trials in novel de-escalation strategies, these findings need validation by future large scale RCTs.