Faculty Bibliography

PURPOSE OF REVIEW:This review examines trials of percutaneous coronary intervention (PCI) compared with optimal medical therapy (OMT) in order to inform clinical decision-making regarding the role of PCI in stable ischemic heart disease (SIHD). RECENT FINDINGS:Several large, randomized, controlled trials published in recent years suggest that OMT should be the initial treatment strategy for symptomatic SIHD, but there is a role for PCI in patients who continue to be symptomatic despite OMT. Additionally, using fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) techniques may help to identify physiologically significant lesions and may be useful in maximizing the benefit from PCI in SIHD. Recent trials demonstrate PCI for the treatment of symptomatic SIHD does not reduce mortality compared with OMT but effectively relieves anginal symptoms. However, OMT continues to be the first-line therapy for SIHD but is significantly underutilized.

Importance:Quality of percutaneous coronary intervention (PCI) is commonly assessed by risk-adjusted mortality. However, this metric may result in procedural risk aversion, especially for high-risk patients. Objective:To determine correlation and reclassification between hospital-level disease-specific mortality and PCI procedural mortality among patients with acute myocardial infarction (AMI). Design, Setting, and Participants:This hospital-level observational cross-sectional multicenter analysis included hospitals participating in the Chest Pain-MI Registry, which enrolled consecutive adult patients admitted with a diagnosis of type I non-ST-segment elevation myocardial infarction (NSTEMI) or ST-segment elevation myocardial infarction (STEMI), and hospitals in the CathPCI Registry, which enrolled consecutive adult patients treated with PCI with an indication of NSTEMI or STEMI, between April 1, 2011, and December 31, 2017. Exposures:Inclusion into the National Cardiovascular Data Registry Chest Pain-MI and CathPCI registries. Main Outcomes and Measures:For each hospital in each registry, a disease-based excess mortality ratio (EMR-D) for AMI was calculated, which represents a risk-adjusted observed to expected rate of mortality for AMI as a disease using the Chest Pain-MI Registry, and a procedure-based excess mortality ratio (EMR-P) for PCI was calculated using the CathPCI Registry. Results:A subset of 625 sites participated in both registries, with a final count of 776 890 patients from the Chest Pain-MI Registry (509 576 men [65.6%]; 620 981 white [80.0%]; and median age, 64 years [interquartile range, 55-74 years]) and 853 386 patients from the CathPCI Registry (582 701 men [68.3%]; 691 236 white [81.0%]; and median age, 63 years [interquartile range, 54-73 years]). Among the 625 linked hospitals, the Spearman rank correlation coefficient between EMR-D and EMR-P produced a ρ of 0.53 (95% CI, 0.47-0.58), suggesting moderate correlation. Among the highest-performing tertile for disease-based risk-adjusted mortality, 90 of 208 sites (43.3%) were classified into a lower category for procedural risk-adjusted mortality. Among the lowest-performing tertile for disease-based risk-adjusted mortality, 92 of 208 sites (44.2%) were classified into a higher category for procedural risk-adjusted mortality. Bland-Altman plots for the overall linked cohort demonstrate a mean difference between EMR-P and EMR-D of 0.49% (95% CI, -1.61% to 2.58%; P < .001), with procedural mortality higher than disease-based mortality. However, among patients with AMI complicated by cardiogenic shock or cardiac arrest, the mean difference between EMR-P and EMR-D was -0.64% (95% CI, -4.41% to 3.12%; P < .001), with procedural mortality lower than disease-based mortality. Conclusions and Relevance:This study suggests that, for hospitals treating patients with AMI, there is only a moderate correlation between procedural outcomes and disease-based outcomes. Nearly half of hospitals in the highest tertile of performance for PCI performance were reclassified into a lower performance tertile when judged by disease-based metrics. Higher rates of mortality were observed when using disease-based metrics compared with procedural metrics when assessing patients with cardiogenic shock and/or cardiac arrest, signifying what appears to be potential risk avoidance among this highest-risk subset of patients.

BACKGROUND:Low transferrin saturation (TSAT) or reduced serum ferritin level are suggestive of iron deficiency but the relationship between iron parameters and outcomes has not been systematically evaluated in older adults with heart failure (HF) and anemia. METHODS:We identified a multicenter cohort of adults age ≥ 65 years with HF and incident anemia (hemoglobin <13 g/dL [men] or < 12 g/dL [women]) between 2005 and 2012. Patients were included if ferritin (ng/mL) and TSAT (%) were evaluated within 90 days of incident anemia. HF hospitalizations and all-cause death were ascertained from electronic health records. RESULTS:Among 4103 older adults with HF and incident anemia, 47% had TSAT <20% and the median (IQR) ferritin was 126 (53, 256) ng/mL. In multivariable analyses, compared with TSAT ≥20%, patients with TSAT <20% were at increased risk of HF hospitalization for serum ferritin <100 ng/mL (adjusted HR [aHR] 1.40, 95% CI:1.16-1.70) and 100-300 ng/mL (aHR 1.24, 95% CI:1.01-1.52) but not for a ferritin >300 ng/mL (aHR 0.89, 95% CI 0.65-1.23). In addition, TSAT <20% was independently associated with an increased risk of all-cause death regardless of serum ferritin level (<100 ng/mL: aHR 1.42, 95% CI:1.20-1.68; 100-300 ng/mL: aHR 1.18, 95% CI:1.00-1.38; >300 ng/mL: aHR 1.33, 95% CI:1.06-1.69). CONCLUSIONS:Among older adults with HF and incident anemia who had iron studies tested, nearly half had a TSAT <20%, which was independently associated with higher rates of morbidity and death.

We aimed to investigate long-term (≥5 years) outcomes of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD) using a meta-analysis from updated published randomized trials. Our data showed that the risk of all-cause death as well as cardiovascular death, myocardial infarction, and stroke was similar between PCI and CABG, whereas PCI had significantly higher rates of repeat revascularization compared to CABG. Decisions for PCI versus CABG for LMCAD should be based on weighing the upfront morbidity and mortality risk of CABG with late risk of repeat revascularization with PCI and taking into consideration patient preference.

BACKGROUND:Prasugrel is a potent thienopyridine that may be preferentially used in younger patients with lower bleeding risk. OBJECTIVE:We compared prasugrel use and outcomes by age from the PROMETHEUS study. We also assessed age-related trends in treatment effects with prasugrel versus clopidogrel. METHODS:PROMETHEUS was a multicenter acute coronary syndrome (ACS) percutaneous coronary intervention (PCI) registry. We compared patients in age tertiles (T1 < 60 years, T2 60-70 years, T3 > 70 years). Major adverse cardiac events (MACE) were a composite of death, myocardial infarction, stroke or unplanned revascularization. Data were adjusted using multivariable Cox regression for age-related risks and propensity score stratification for thienopyridine effects. RESULTS:The study included 19,914 patients: 7045 (35.0%) in T1, 6489 (33.0%) in T2 and 6380 (32.0%) in T3. Prasugrel use decreased from T1 to T3 (29.2% vs. 23.5% vs. 7.5%, p < 0.001). Crude 1-year MACE rates were highest in T3 (17.4% vs. 16.8% vs. 22.7%, p < 0.001), but adjusted risk was similar between the groups (p-trend 0.52). Conversely, crude incidence (2.8% vs. 3.8% vs. 6.9%, p < 0.001) and adjusted bleeding risk were highest in T3 (HR 1.24, 95% CI 0.99-1.55 in T2; HR 1.83, 95% CI 1.46-2.30 in T3; p-trend < 0.001; reference = T1). Treatment effects with prasugrel versus clopidogrel did not demonstrate age-related trends for MACE (p-trend = 0.91) or bleeding (p-trend = 0.28). CONCLUSIONS:Age is a strong determinant of clinical risk as well as prasugrel prescription in ACS PCI with much lower use among older patients. Prasugrel did not have a differential treatment effect by age for MACE or bleeding. Frequency of prasugrel use and age-related temporal risks of all-cause death and bleeding after ACS PCI.

BACKGROUND:Procedural anticoagulation with bivalirudin (BIV), trans-radial intervention (TRI), and use of a vascular closure device (VCD) are thought to mitigate percutaneous coronary intervention (PCI)-related bleeding. We compared the impact of these bleeding avoidance strategies (BAS) for PCIs stratified by bleeding risk. METHODS:We performed a retrospective cohort analysis of PCIs from 18 facilities within one health care system from 2009Q3 to 2017Q4. Bleeding risk was assessed per the National Cardiovascular Data Registry CathPCI bleeding model, with procedures stratified into 6 categories (first, second, third quartiles, 75th-90th, 90th-97.5th, and top 2.5th percentiles). Regression models were used to assess the impact of BAS on bleeding outcome. RESULTS:Of 74 953 PCIs, 9.4% used no BAS, 12.0% used BIV alone, 20.8% used TRI alone, 26.8% used VCD alone, 5.4% used TRI+BIV, and 25.6% used VCD+BIV. The crude bleeding rate was 4.4% overall. Only 2 comparisons showed significant trends across all risk strata: VCD+BIV versus no BAS, odds ratio (95% CI) range: first quartile, 0.36 (0.18-0.72) to top 2.5th percentile, 0.50 (0.32-0.78); TRI versus no BAS, odds ratio (95% CI) range: first quartile, 0.15 (0.06-0.38) to top 2.5th percentile, 0.49 (0.28-0.86). TRI had lower odds of bleeding compared with BIV for all risk strata except the top 2.5th percentile. Addition of BIV to TRI did not change the odds of bleeding for any risk strata. Factors potentially limiting use of TRI (renal failure, shock, cardiac arrest, and mechanical circulatory support) were present in ≤10% of procedures below the 90th percentile. CONCLUSIONS:Among individual BAS, only TRI had consistently lower odds of bleeding across all risk strata. Factors potentially limiting TRI were found infrequently in procedures below the 90th percentile of bleeding risk. For transfemoral PCI, VCD+BIV had lower odds of bleeding compared with no BAS across all risk strata.

BACKGROUND:Randomized controlled trials (RCTs) have yielded conflicting results about the impact of transradial access (TRA) versus transfemoral access (TFA) in patients with ST-segment elevation myocardial infarction (STEMI). METHODS:We performed a trial sequential analysis (TSA) of RCTs comparing TRA and TFA in patients with STEMI. The outcomes of interest were 30-day mortality, major bleeding, major adverse cardiovascular events (MACE), myocardial infarction (MI), stroke, and access site complications. RESULTS:A total of 17 studies with 11,992 patients were included in the current TSA. The TRA group had lower 30-day mortality (risk ratio [RR] 0.72, 95% CI 0.58-0.90, P = .003), major bleeding (RR 0.62, 95% CI 0.49-0.79, P = .0001), MACE (RR 0.74, 95% CI 0.58-0.93, P = .01), and access site complications (RR 0.37, 95% CI 0.28-0.48, P < .00001). There was no difference in MI and stroke between the 2groups. Applying TSA boundaries, the z-curve for 30-day mortality, major bleeding, MACE and access site complications crossed the conventional and the TSA boundaries, indicating firm evidence for better outcomes in the TRA group. For MI and stroke, the z-curve failed to cross the conventional and the TSA boundaries for both outcomes, indicating lack of signals of benefit or harm. CONCLUSIONS:In the current TSA, the available data from RCTs support improved 30-day mortality, major bleeding, MACE and access site complication rates in STEMI patients treated by PCI through the radial access.

Cardiogenic shock (CS) complicating acute myocardial infarction (MI) is associated with high mortality. In the absence of data to support coronary revascularization beyond the infarct artery and selection of circulatory support devices or medications, clinical practice may vary substantially.

AIMS:We aimed to determine the efficacy and safety of different anti-platelet regimens after percutaneous coronary intervention (PCI) with drug eluting stent (DES) implantation using a network meta-analysis of randomized controlled trials (RCTs). METHODS:RCTs comparing shorter duration (≤6 months) of dual antiplatelet therapy (S-DAPT) with either aspirin (ASA) or P2Y12 inhibitor monotherapy against longer duration (≥12 months) DAPT (L-DAPT) after PCI were searched in the MEDLINE, EMBASE and COCHRANE databases. End-points of interest were all-cause death, cardiovascular (CV) death, myocardial infarction (MI), stent thrombosis (ST), major bleeding and major or minor bleeding. Network meta-analyses were performed using frequentist approach. RESULTS:Eighteen RCTs with total of 57,942 patients met the inclusion and exclusion criteria. This included 14 RCTs (N = 28,853) of S-DAPT with ASA monotherapy and 4 RCTs (N = 29,089) with P2Y12 inhibitor monotherapy. Compared with L-DAPT, the odds of MI were higher with S-DAPT with ASA monotherapy [OR 1.23; 95% CI 1.01-1.48], but not with P2Y12 inhibitor monotherapy [0.98; 0.85-1.14]. Both S-DAPT regimens lowered rates of major bleeding when compared with L-DAPT; ASA monotherapy [0.70; 0.49-1.00] and P2Y12 monotherapy [0.67; 0.45-0.98]. There were no differences in risks of all-cause or CV death between either regimen of S-DAPT and L-DAPT. However, in the acute coronary syndrome subgroup, ASA monotherapy was associated with increased risk of ST [1.55; 1.021-2.36] but P2Y12 monotherapy was not [0.93; 0.58-1.48]. CONCLUSION:Amongst patients undergoing DES implantation, S-DAPT with P2Y12 inhibitor monotherapy reduces bleeding without increased risk of MI or ST compared with L-DAPT. Prospective trials are needed to evaluate if S-DAPT with P2Y12 monotherapy is superior to S-DAPT with ASA monotherapy for ischemic protection.