Faculty Bibliography

OBJECTIVES/OBJECTIVE:The aim of this study was to explore whether the use of bleeding avoidance strategies (BAS) explains variability in hospital-level bleeding following percutaneous coronary intervention. BACKGROUND:Prior studies have reported that bleeding rates following percutaneous coronary intervention vary markedly among hospitals, but the extent to which use of BAS explains this variation is unknown. METHODS:Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, estimated hospital-level bleeding rates from 2,459,686 procedures at 1,358 sites were determined. A series of models were fit to estimate random-effect variance, adjusting for patient risk (using the validated CathPCI bleeding risk model, C statistic = 0.77) and various combinations of BAS (transradial access, bivalirudin, vascular closure device use). The rate of any BAS use was also estimated for each hospital, and the association between percentage BAS use and predicted bleeding rates was determined. RESULTS:In total, 125,361 bleeding events (5.1%) were observed; patients experiencing bleeding events had lower rates of radial access (5.0% vs. 11.2%; p < 0.001), bivalirudin therapy (43.8% vs. 59.4%), and vascular closure device use (32.9% vs. 42.4%, p < 0.001) than those without bleeding. There was significant variation in bleeding rates across hospitals (median 5.0%; interquartile range [IQR]: 2.7% to 6.6%), which persisted after incorporating patient-level risk (median 5.1%; IQR: 4.0% to 4.4%). Patient factors accounted for 20% of the overall hospital-level variation, and radial access plus bivalirudin use accounted for an additional 7.8% of the overall hospital-level variation. The median hospital rate of any BAS use was 86.6% (IQR: 72.5% to 94.1%). A significant decrease in observed hospital-level bleeding was seen in hospitals above the median in BAS use (adjusted odds ratio: 0.90; 95% confidence interval: 0.88 to 0.93). CONCLUSIONS:A modest proportion of the variation in hospitals' rates of bleeding following percutaneous coronary intervention is attributable to differential use of BAS. Further analyses are required to determine the remaining approximately 70% causes of variation in percutaneous coronary intervention bleeding seen among hospitals.

OBJECTIVES:The aim of this study was to evaluate the efficacy of various doses of post-primary percutaneous coronary intervention (PCI) bivalirudin infusion to prevent acute stent thrombosis (AST). BACKGROUND:In several recent randomized controlled trials, bivalirudin infusion was continued post-PCI as either a full PCI dose (Biv-Full) or a reduced dose (Biv-Low) to reduce the risk for AST. The results of these trials varied, so the authors performed a meta-analysis of RCTs to determine whether the risk for AST is dose dependent. METHODS:Scientific databases and Web sites were searched for RCTs. A traditional meta-analysis was performed using moderator analyses and network meta-analysis using mixed-treatment comparison models to compare the efficacy of various bivalirudin doses in reducing AST. RESULTS:Data from 5 trials including 16,294 patients were analyzed. Compared with heparin, bivalirudin increased AST risk 2-fold, but this was ameliorated by continuing Biv-Full (risk ratio: 0.90, 95% confidence interval: 0.32 to 2.54; p = 0.852). This effect was not seen with Biv-Low. Similarly, in mixed-treatment models, no difference in AST rate was found between heparin and Biv-Full (odds ratio: 0.97; 95% confidence interval: 0.36 to 2.21). After 30 days, bivalirudin decreased the risk for major bleeding by 47% compared with heparin; this benefit persisted even with continued Biv-Full post-PCI (risk ratio: 0.29; 95% confidence interval: 0.16 to 0.53; p < 0.001). CONCLUSIONS:Although bivalirudin is associated with a greater risk for AST than heparin post-primary PCI, this limitation may be mitigated by continuing Biv-Full (not Biv-Low) 3 to 4 h post-operatively. The decrease in bleeding risk with bivalirudin compared with heparin is not compromised by this strategy.

OBJECTIVES:The aim of this study was to provide a quantitative appraisal of the effects on clinical outcomes of radial access for coronary interventions in patients with coronary artery disease (CAD). BACKGROUND:Randomized trials investigating radial versus femoral access for percutaneous coronary interventions have provided conflicting evidence. No comprehensive quantitative appraisal of the risks and benefits of each approach is available across the whole spectrum of patients with stable or unstable CAD. METHODS:The PubMed, Embase, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases were searched for randomized trials comparing radial versus femoral access for coronary interventions. Data were pooled by meta-analysis using a fixed-effects or a random-effects model, as appropriate. Pre-specified subgroup analyses according to clinical presentation, in terms of stable CAD, non-ST-segment elevation acute coronary syndromes, or ST-segment elevation myocardial infarction were performed. RESULTS:Twenty-four studies enrolling 22,843 participants were included. Compared with femoral access, radial access was associated with a significantly lower risk for all-cause mortality (odds ratio [OR]: 0.71; 95% confidence interval [CI]: 0.59 to 0.87; p = 0.001, number needed to treat to benefit [NNTB] = 160), major adverse cardiovascular events (OR: 0.84; 95% CI: 0.75 to 0.94; p = 0.002; NNTB = 99), major bleeding (OR: 0.53; 95% CI: 0.42 to 0.65; p < 0.001; NNTB = 103), and major vascular complications (OR: 0.23; 95% CI: 0.16 to 0.35; p < 0.001; NNTB = 117). The rates of myocardial infarction or stroke were similar in the 2 groups. Effects of radial access were consistent across the whole spectrum of patients with CAD for all appraised endpoints. CONCLUSIONS:Compared with femoral access, radial access reduces mortality and MACE and improves safety, with reductions in major bleeding and vascular complications across the whole spectrum of patients with CAD.

IMPORTANCE:The evolution of percutaneous coronary intervention (PCI) has led to improved safety and efficacy, such that overnight observation can be avoided in some patients. We sought to provide a narrative review of the current literature regarding the outcomes of same-day discharge (SDD) PCI and to describe a framework for the development of an SDD program. OBSERVATIONS:A literature search of PubMed was performed for human studies on SDD PCI published in English from January 1, 1995, to July 31, 2015. We reviewed the studies between June and September 2015. After literature review, we included reports of randomized clinical trials, observational studies, meta-analyses guidelines, and consensus statements in a narrative review. Compared with overnight observation, there was no increase in adverse events (bleeding, repeat coronary procedures, death, or rehospitalization) among patients in these studies who were discharged on the same day of their PCI procedure. Same-day discharge was associated with significant cost savings and was preferred by patients. CONCLUSIONS AND RELEVANCE:The available evidence supports the safety of SDD in selected patients after PCI. Specific programmatic features are important to the successful implementation of SDD after PCI. Greater adoption of SDD programs after PCI has the potential to improve patient satisfaction, increase bed availability, and reduce hospital costs without increasing adverse patient outcomes.

BACKGROUND:Bioabsorbable cardiac matrix (BCM) is a novel device that attenuates adverse left ventricular (LV) remodeling after large myocardial infarctions in experimental models. OBJECTIVES:This study aimed to analyze whether BCM, compared with saline control, would result in less LV dilation and fewer adverse clinical events between baseline and 6 months. METHODS:In an international, randomized, double-blind, controlled trial, 303 subjects with large areas of infarction despite successful primary percutaneous coronary intervention (PCI) of ST-segment elevation myocardial infarction (STEMI) were randomized 2:1 to BCM or saline injected into the infarct-related artery 2 to 5 days after primary PCI. The primary outcome was mean change from baseline in LV end-diastolic volume index (LVEDVI) at 6 months. Secondary outcomes included change in Kansas City Cardiomyopathy Questionnaire score, 6-minute walk time, and New York Heart Association functional class at 6 months. The primary safety endpoint was a composite of cardiovascular death, recurrent MI, target-vessel revascularization, stent thrombosis, significant arrhythmia requiring therapy, or myocardial rupture through 6 months. RESULTS:In total, 201 subjects were assigned to BCM and 102 to saline control. There was no significant difference in change in LVEDVI from baseline to 6 months between the groups (mean change ± SD: BCM 14.1 ± 28.9 ml/m(2) vs. saline 11.7 ± 26.9 ml/m(2); p = 0.49). There was also no significant difference in the secondary endpoints. The rates of the primary safety outcome were similar between the 2 groups (BCM 11.6% vs. saline 9.1%; p = 0.37). CONCLUSIONS:Intracoronary deployment of BCM 2 to 5 days after successful reperfusion in subjects with large myocardial infarction did not reduce adverse LV remodeling or cardiac clinical events at 6 months. (IK-5001 for the Prevention of Remodeling of the Ventricle and Congestive Heart Failure After Acute Myocardial Infarction [PRESERVATION I]; NCT01226563).

Arterial access and haemostasis are fundamental aspects of procedures performed in the cardiac catheterization laboratory. The first description of arterial access for cardiac catheterization was in 1948, when surgical cut-down was used to access the radial artery. Over the next 2 decades, the preferred arteriotomy method transitioned from the Sones approach of brachial artery cut-down to the Seldinger and Judkins technique of percutaneous femoral artery access. Compared with the femoral approach, percutaneous transradial access results in reduced access-site bleeding, faster time to ambulation, and greater patient comfort. Several large-scale, randomized trials have also reported a survival advantage in patients with acute coronary syndromes treated with radial compared with femoral access. However, inconsistencies exist between the completed trials, and the underlying mechanism of a reduction in mortality with radial access is uncertain. Femoral artery haemostasis can be achieved with either manual compression or vascular closure devices, with recent studies suggesting improved outcomes with the use of active closure systems. Radial artery haemostasis is achieved through the use of wristbands that mimic manual compression, and 'non-occlusive' haemostasis reduces the risk of radial artery occlusion. Newer arterial access routes and closure approaches for large-bore devices are being actively investigated. Expertise in both femoral and radial artery access and intervention is essential for contemporary interventional cardiologists.

OBJECTIVE:We studied the characteristics of patients with ST segment elevation myocardial infarction (STEMI) after expansion of a STEMI registry as part of the STEMI network programme in a metropolitan city and the surrounding area covering ∼26 million inhabitants. DESIGN:Retrospective cohort study. SETTING:Emergency department of 56 health centres. PARTICIPANTS:3015 patients with acute coronary syndrome, of which 1024 patients had STEMI. MAIN OUTCOME MEASURE:Characteristics of reperfusion therapy. RESULTS:The majority of patients with STEMI (81%; N=826) were admitted to six academic percutaneous coronary intervention (PCI) centres. PCI centres received patients predominantly (56%; N=514) from a transfer process. The proportion of patients receiving acute reperfusion therapy was higher than non-reperfused patients (54% vs 46%, p<0.001), and primary PCI was the most common method of reperfusion (86%). The mean door-to-device (DTD) time was 102±68 min. In-hospital mortality of non-reperfused patients was higher than patients receiving primary PCI or fibrinolytic therapy (9.1% vs 3.2% vs 3.8%, p<0.001). Compared with non-academic PCI centres, patients with STEMI admitted to academic PCI centres who underwent primary PCI had shorter mean DTD time (96±44 min vs 140±151 min, p<0.001), higher use of manual thrombectomy (60.2% vs13.8%, p<0.001) and drug-eluting stent implantation (87% vs 69%, p=0.001), but had similar use of radial approach and intra-aortic balloon pump (55.7% vs 67.2%, and 2.2% vs 3.4%, respectively). In patients transferred for primary PCI, TIMI risk score ≥4 on presentation was associated with a prolonged door-in to door-out (DI-DO) time (adjusted OR 2.08; 95% CI 1.09 to 3.95, p=0.02). CONCLUSIONS:In the expanded JAC registry, a higher proportion of patients with STEMI received reperfusion therapy, but 46% still did not. In developing countries, focusing the prehospital care in the network should be a major focus of care to improve the DI-DO time along with improvement of DTD time at PCI centres. TRIAL REGISTRATION NUMBER:NCT02319473.