Faculty Bibliography

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.

Saphenous vein grafts (SVGs) have high rates of in-stent restenosis (ISR). We compared the baseline clinical and angiographic characteristics of patients and lesions that did develop ISR with those who did not develop ISR during a median follow-up of 2.7 years in the DIVA study (NCT01121224). We also examined the ISR types using the Mehran classification. ISR developed in 119 out of the 575 DIVA patients (21%), with similar incidence among patients with drug-eluting stents and bare-metal stents (BMS) (21% vs 21%, p = 0.957). Patients in the ISR group were younger (67 ± 7 vs 69 ± 8 years, p = 0.04) and less likely to have heart failure (27% vs 38%, p = 0.03) and SVG lesions with Thrombolysis In Myocardial Infarction 3 flow before the intervention (77% vs 83%, p <0.01), but had a higher number of target SVG lesions (1.33 ± 0.64 vs 1.16 ± 0.42, p <0.01), more stents implanted in the target SVG lesions (1.52 ± 0.80 vs 1.31 ± 0.66, p <0.01), and longer total stent length (31.37 ± 22.11 vs 25.64 ± 17.42 mm, p = 0.01). The incidence of diffuse ISR was similar in patients who received drug-eluting-stents and BMS (57% vs 54%, p = 0.94), but BMS patients were more likely to develop occlusive restenosis (17% vs 33%, p = 0.05).

BACKGROUND:Percutaneous coronary intervention is performed by operators with differing experience, technique, and case mix. It is unknown if operator practice patterns impact patient outcomes. We sought to determine if a cluster algorithm can identify distinct profiles of percutaneous coronary intervention operators and if these profiles are associated with patient outcomes. METHODS:Operators performing at least 25 annual procedures between 2014 and 2018 were clustered using an agglomerative hierarchical clustering algorithm. Risk-adjusted in-hospital mortality was compared between clusters. RESULTS:We identified 4 practice profiles among 7706 operators performing 2 937 419 procedures. Cluster 1 (n=3345) demonstrated case mix and practice patterns similar to the national median. Cluster 2 (n=1993) treated patients with lower clinical acuity and were less likely to use intracoronary diagnostics, atherectomy, and radial access. Cluster 3 (n=1513) had the lowest case volume, were more likely to work at rural hospitals, and cared for a higher proportion of patients with ST-segment-elevation myocardial infarction and cardiogenic shock. Cluster 4 (n=855) had the highest case volume, were most likely to treat patients with high anatomic complexity and use atherectomy, intracoronary diagnostics, and mechanical support. Compared with cluster 1, adjusted in-hospital mortality was similar for cluster 2 (estimated difference, -0.03 [95% CI, -0.10 to 0.04]), higher for cluster 3 (0.14 [0.07-0.22]), and lower for cluster 4 (-0.15 [-0.24 to -0.06]). CONCLUSIONS:Distinct percutaneous coronary intervention operator profiles are differentially associated with patient outcomes. A phenotypic approach to physician assessment may provide actionable feedback for quality improvement.

Patients undergoing early surgery after coronary stent implantation are at increased risk for mortality from ischemic and hemorrhagic complications. The optimal antiplatelet strategy in patients who cannot discontinue dual antiplatelet therapy (DAPT) before surgery is unclear. Current guidelines, based on surgical and clinical characteristics, provide risk stratification for bridging therapy with intravenous antiplatelet agents, but management is guided primarily by expert opinion. This review summarizes perioperative risk factors to consider before discontinuing DAPT and reviews the data for intravenous bridging therapies. Published reports have included bridging options such as small molecule glycoprotein IIb/IIIa inhibitors (eptifibatide or tirofiban) and cangrelor, an intravenous P2Y₁₂ inhibitor. However, optimal management of these complex patients remains unclear in the absence of randomized controlled data, without which an argument can be made both for and against the use of perioperative intravenous bridging therapy after discontinuing oral P2Y₁₂ inhibitors. Multidisciplinary risk assessment remains a critical component of perioperative care.