Faculty Bibliography

BACKGROUND:It remains uncertain how advances in revascularization techniques, availability of new evidence, and updated guidelines have influenced the annual rates of coronary revascularization in the United States. METHODS:We used the Nationwide Inpatient Sample data from 2005 to 2014 with appropriate weighting to determine national procedural volumes. To present accurately overall percutaneous coronary intervention (PCI) rates, PCI with same-day discharge numbers per year were estimated from the available literature and added to annual PCI procedures performed. RESULTS:Annual PCI rate declined from 353 per 100,000 adults in 2005 to 277 per 100,000 adults in 2009 (P < .001) but remained stable thereafter (P = .50). Annual coronary artery bypass grafting (CABG) rate declined steadily, at a shallower slope than PCI, from 120 per 100,000 in 2005 to 93 per 100,000 in 2009 (P = .02) but remained stable thereafter (P = .60). Similar trends were seen in men and women. Both PCI and CABG rates were lower in women than men over the study period (PCI, 482 to 324/100,000 in men vs 232 to 153/100,000 in women; CABG, 172 to 118/100,000 in men vs 64 to 38/100,000 in women). Annual PCI rates were higher than CABG rates in patients of all age groups including in younger patients (age < 50) and octogenarians. The proportion of coronary revascularization procedures performed per insurance type remained relatively similar across the study period. CONCLUSIONS:Annual rates of coronary revascularization have changed significantly over time, potentially because of advances in revascularization techniques, availability of new evidence, and updated guidelines. Rates of PCI declined more steeply than CABG before plateauing but remained higher than rates of CABG across the study period.

BACKGROUND:In patients with ST-segment elevation myocardial infarction (STEMI), percutaneous coronary intervention (PCI) of the culprit lesion reduces the risk of cardiovascular death or myocardial infarction. Whether PCI of nonculprit lesions further reduces the risk of such events is unclear. METHODS:We randomly assigned patients with STEMI and multivessel coronary artery disease who had undergone successful culprit-lesion PCI to a strategy of either complete revascularization with PCI of angiographically significant nonculprit lesions or no further revascularization. Randomization was stratified according to the intended timing of nonculprit-lesion PCI (either during or after the index hospitalization). The first coprimary outcome was the composite of cardiovascular death or myocardial infarction; the second coprimary outcome was the composite of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. RESULTS:At a median follow-up of 3 years, the first coprimary outcome had occurred in 158 of the 2016 patients (7.8%) in the complete-revascularization group as compared with 213 of the 2025 patients (10.5%) in the culprit-lesion-only PCI group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.91; P = 0.004). The second coprimary outcome had occurred in 179 patients (8.9%) in the complete-revascularization group as compared with 339 patients (16.7%) in the culprit-lesion-only PCI group (hazard ratio, 0.51; 95% CI, 0.43 to 0.61; P<0.001). For both coprimary outcomes, the benefit of complete revascularization was consistently observed regardless of the intended timing of nonculprit-lesion PCI (P = 0.62 and P = 0.27 for interaction for the first and second coprimary outcomes, respectively). CONCLUSIONS:Among patients with STEMI and multivessel coronary artery disease, complete revascularization was superior to culprit-lesion-only PCI in reducing the risk of cardiovascular death or myocardial infarction, as well as the risk of cardiovascular death, myocardial infarction, or ischemia-driven revascularization. (Funded by the Canadian Institutes of Health Research and others; COMPLETE ClinicalTrials.gov number, NCT01740479.).

AIMS:Limited data exist on the epidemiology, evaluation, and prognosis of otherwise unexplained anaemia of the elderly in heart failure (HF). Thus, we aimed to determine the incidence of anaemia, to characterize diagnostic testing patterns for potentially reversible causes of anaemia, and to evaluate the independent association between incident anaemia and long-term morbidity and mortality. METHODS AND RESULTS:Within the Cardiovascular Research Network (CVRN), we identified adults age ≥65 years with diagnosed HF between 2005 and 2012 and no anaemia at entry. Incident anaemia was defined using World Health Organization (WHO) haemoglobin thresholds (<13.0 g/dL in men; <12.0 g/dL in women). All-cause death and hospitalizations for HF and any cause were identified from electronic health records. Among 38 826 older HF patients, 22 163 (57.1%) developed incident anaemia over a median (interquartile range) follow-up of 2.9 (1.2-5.6) years. The crude rate [95% confidence interval (CI)] per 100 person-years of incident anaemia was 26.4 (95% CI 26.0-26.7) and was higher for preserved ejection fraction (EF) [29.2 (95% CI 28.6-29.8)] compared with borderline EF [26.5 (95% CI 25.4-27.7)] or reduced EF [26.6 (95% CI 25.8-27.4)]. Iron indices, vitamin B12 level, and thyroid testing were performed in 20.9%, 14.9%, and 40.2% of patients, respectively. Reduced iron stores, vitamin B12 deficiency, and/or hypothyroidism were present in 29.7%, 3.2%, and 18.6% of tested patients, respectively. In multivariable analyses, incident anaemia was associated with excess mortality [hazard ratio (HR) 2.14, 95% CI 2.07-2.22] as well as hospitalization for HF (HR 1.80, 95% CI 1.72-1.88) and any cause (HR 1.77, 95% CI 1.72-1.83). CONCLUSION:Among older adults with HF, incident anaemia is common and independently associated with substantially increased risks of morbidity and mortality. Additional research is necessary to clarify the value of routine evaluation and treatment of potentially reversible causes of anaemia.

Percutaneous coronary intervention (PCI) may be performed in the same procedure as diagnostic coronary angiography (ad hoc PCI). This study aimed to evaluate current rates of ad hoc PCI use and associated risks of adverse outcomes in patients with stable coronary artery disease (CAD).

Coronary stenting without angioplasty pretreatment (direct stenting) may simplify procedures in appropriate lesions. Direct stenting is facilitated by smaller profile coronary stent platforms. The present study was designed for regulatory approval of a novel drug-eluting coronary stent and incorporates both randomized comparison for non-inferiority to an approved predicate device as well as a nested evaluation of subjects eligible for direct stenting. STUDY DESIGN AND OBJECTIVES: Prospective, single-blind, randomized, active-control, multi-center study designed to assess the safety and efficacy of the novel Svelte sirolimus-eluting stent (SES) systems. A total of 1630 subjects with up to 3 target lesions will be randomized 1:1 to the Svelte SES versus either the Xience or Promus everolimus-eluting stents (control). Randomization will be stratified by whether or not a direct stenting strategy is planned by the investigator. The primary endpoint is target lesion failure (TLF) at 12 months post index procedure, defined as cardiac death, target vessel myocardial infarction, or clinically driven target lesion revascularization, and the primary analysis is a non-inferiority test with a non-inferiority margin of 3.58%. Secondary clinical endpoints include individual components of TLF, stent thrombosis and measures of procedural resource utilization including contrast administration, fluoroscopy exposure and procedural resource utilization as well as costs. CONCLUSION: The OPTMIZE Trial will evaluate the safety, efficacy and clinical value of the novel Svelte SES in subjects with up to 3 lesions, and will provide a comparison of direct stenting between randomized devices.

The association of hyperglycemia at admission and final thrombolysis in myocardial infarction (TIMI) flow with 1-year mortality of patient with acute ST-segment elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI) has not much been explored. We evaluated the association of hyperglycemia and final TIMI flow with 1-year mortality in patients with acute STEMI who underwent primary PCI. We retrospectively analyzed 856 patients with STEMI who underwent primary PCI in a tertiary care academic center between January 2014 and July 2016. Based on the receiver operating characteristics curve, the cutoff used for hyperglycemia in this study was greater than or equal to 169 mg/dL. Cox proportional hazard model was used to determine the association of hyperglycemia and TIMI flow with 1-year mortality. Compared with patients with lower blood glucose level (<169 mg/dL; n  = 549), a greater proportion of patients who presented with hyperglycemia (≥169 mg/dL; n  = 307) had final TIMI flow 0 to 1 (3.3 vs. 0.5%; adjusted odds ratio = 5.58, 95% confidence interval [CI] 1.30-23.9, p  = 0.02). Hyperglycemia was associated with an increased risk for 1-year mortality (adjusted hazard ratio [HR]= 2.0, 95% CI: 1.13-3.53, p  = 0.017). Multivariable Cox regression showed that the interaction of hyperglycemia and final TIMI flow 0 to 1 was associated with an elevated risk for 1-year mortality (adjusted HR= 9.4, 95% CI: 2.34-37.81, p  = 0.002). A higher proportion of patients with acute STEMI who presented with hyperglycemia had final TIMI flow 0 to 1 after primary PCI. The interaction of hyperglycemia and final TIMI flow 0 to 1 was associated with an increased risk for 1-year mortality. This study suggests that aggressive control of hyperglycemia prior to primary PCI may facilitate better angiographic and clinical outcomes after primary PCI. Clinical Trial Registration  Clinicaltrials.gov Identifier number: NCT02319473.

PURPOSE OF REVIEW:To review the contemporary evidence for robotic-assisted percutaneous coronary and vascular interventions, discussing its current capabilities, limitations, and potential future applications. RECENT FINDINGS:Robotic-assisted cardiovascular interventions significantly reduce radiation exposure and orthopedic strains for interventionalists, while maintaining high rates of device and clinical success. The PRECISE and CORA-PCI studies demonstrated the safety and efficacy of robotic-assisted percutaneous coronary intervention (PCI) in increasingly complex coronary lesions. The RAPID study demonstrated similar findings in peripheral vascular interventions (PVI). Subsequent studies have demonstrated the safety and efficacy of second-generation devices, with automations mimicking manual PCI techniques. While innovations such as telestenting continue to bring excitement to the field, major limitations remain-particularly the lack of randomized trials comparing robotic-assisted PCI with manual PCI. Robotic technology has successfully been applied to multiple cardiovascular procedures. There are limited data to evaluate outcomes with robotic-assisted PCI and other robotic-assisted cardiovascular procedures, but existing data show some promise of improving the precision of PCI while decreasing occupational hazards associated with radiation exposure.

Identification and management of patients at high bleeding risk undergoing percutaneous coronary intervention are of major importance, but a lack of standardization in defining this population limits trial design, data interpretation, and clinical decision-making. The Academic Research Consortium for High Bleeding Risk (ARC-HBR) is a collaboration among leading research organizations, regulatory authorities, and physician-scientists from the United States, Asia, and Europe focusing on percutaneous coronary intervention-related bleeding. Two meetings of the 31-member consortium were held in Washington, DC, in April 2018 and in Paris, France, in October 2018. These meetings were organized by the Cardiovascular European Research Center on behalf of the ARC-HBR group and included representatives of the US Food and Drug Administration and the Japanese Pharmaceuticals and Medical Devices Agency, as well as observers from the pharmaceutical and medical device industries. A consensus definition of patients at high bleeding risk was developed that was based on review of the available evidence. The definition is intended to provide consistency in defining this population for clinical trials and to complement clinical decision-making and regulatory review. The proposed ARC-HBR consensus document represents the first pragmatic approach to a consistent definition of high bleeding risk in clinical trials evaluating the safety and effectiveness of devices and drug regimens for patients undergoing percutaneous coronary intervention.

Importance:Anatomical scoring systems for coronary artery disease, such as the SYNTAX (Synergy Between Percutaneous Coronary Intervention [PCI] With Taxus and Cardiac Surgery) score, are well established tools for understanding patient risk. However, they are cumbersome to compute manually for large data sets, limiting their use across broad and varied cohorts. Objective:To adapt an anatomical scoring system for use with registry data, allowing facile and automatic calculation of scores and association with clinical outcomes among patients undergoing percutaneous or surgical revascularization. Design, Setting, and Participants:This cross-sectional observational cohort study involved procedures performed in all cardiac catheterization laboratories in the largest integrated health care system in the United States, the Veterans Affairs (VA) Healthcare System. Patients undergoing coronary angiography in the VA Healthcare System followed by percutaneous or surgical revascularization within 90 days were observed and data were analyzed from January 1, 2010, through September 30, 2017. Main Outcomes and Measures:An anatomical scoring system for coronary artery disease complexity before revascularization was simplified and adapted to data from the VA Clinical Assessment, Reporting, and Tracking Program. The adjusted association between quantified anatomical complexity and major adverse cardiovascular and cerebrovascular events (MACCEs), including death, myocardial infarction, stroke, and repeat revascularization, was assessed for patients undergoing percutaneous or surgical revascularization. Results:A total of 50 226 patients (49 359 men [98.3%]; mean [SD] age, 66 [9] years) underwent revascularization during the study period, with 34 322 undergoing PCI and 15 904 undergoing coronary artery bypass grafting (CABG). After adjustment, the highest tertile of anatomical complexity was associated with increased hazard of MACCEs (adjusted hazard ratio [HR], 2.12; 95% CI, 2.01-2.23). In contrast, the highest tertile of anatomical complexity among patients undergoing CABG was not independently associated with overall MACCEs (adjusted HR, 1.04; 95% CI, 0.92-1.17), and only repeat revascularization was associated with increasing complexity (adjusted HR, 1.34; 95% CI, 1.06-1.70) in this subgroup. Conclusions and Relevance:These findings suggest that an automatically computed score assessing anatomical complexity can be used to assess longitudinal risk for patients undergoing revascularization. This simplified scoring system appears to be an alternative tool for understanding longitudinal risk across large data sets.