Post-Procedural Bivalirudin Infusion Following Primary PCI to Reduce Stent Thrombosis.

BACKGROUND: Prolonging infusions may abrogate the acute stent thrombosis (ST) associated with bivalirudin use during primary PCI but at an increased cost. We hypothesized that continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose until infusion end would prevent excess early ST. METHODS: Baseline demographics, procedural data and outcomes were gathered prospectively on 1395 consecutive patients undergoing primary PCI. The choice of bivalirudin versus heparin was at the cardiologist's discretion. Local protocol recommended continuation of the procedural bivalirudin at the PCI dose until infusion end. RESULTS: Patients' mean age was 62.8 ± 13.1years with 11.4% presenting with shock. The majority of patients underwent PCI using bivalirudin with fewer using heparin (87.7 vs. 12.3%, P < 0.0001). Glycoprotein inhibitor bailout rates were 6.1% with bivalirudin and 36.3% with heparin (P < 0.0001). Calculated on an individual patient basis the median intra-procedure duration of the bivalirudin infusion was 30(IQR 21-43) minutes and post-procedure 49(32-66) minutes. The acute (<24-hours) ST rates were 4/1224 with bivalirudin ± GPI (0.3%) and 0/171 with heparin ± GPI (0%, P = 0.41). The sub-acute (24-hours to 30-days) ST rates were 3/1224 for bivalirudin ± GPI (0.3%) and 2/171 with heparin ± GPI (1.2%, P = 0.11). In total the early (<30-days) ST rates were 7/1224 for bivalirudin ± GPI (0.6%) and 2/171 with heparin ± GPI (1.2%, P = 0.31). Acute ST was significantly more likely to occur in clopidogrel-loaded patients than prasugrel/ticagrelor patients (2.7 vs. 0.5%, P = 0.003). CONCLUSION: Continuing the bivalirudin infusion commenced during the procedure at the PCI recommended dose until infusion end combined with potent P2 Y12 inhibitors ameliorates excess early stent thrombosis.

Femoral Access PCI in a Default Radial Center Identifies High-Risk Patients With Poor Outcomes.

BACKGROUND: Increasingly the trans-radial route (TRR) is preferred over the trans-femoral route (TFR) for PCI. However, even in high volume default TRR centers a cohort of patients undergo TFR PCI. We examined the demographics, procedural characteristics, and outcomes of patients undergoing PCI via the TF. METHODS: The patient demographics, procedural data, and outcomes of 5,379 consecutive patients undergoing PCI at a default radial center between 2009 and 2012 were examined. Major bleeding (MB) was classified by ACUITY and BARC definitions. RESULTS: A total of 559 (10.4%) patients underwent PCI via the TFR and 4,820 patients via the TRR (89.6%). Baseline variables associated with TFR were shock, previous CABG, chronic total occlusion intervention, rotablation/laser use, female sex, and renal failure. Sixty-five patients of the TFR cohort (11.6%) experienced MB with 27 (41.5%) being access site related. MB was significantly more frequent than in the radial cohort. The variables independently associated with MB in the TFR cohort were renal failure, acute presentation, shock, and age. In the TFR, patients with MB mortality was high at 30 days (17.2% vs 2.6% for no MB, P < 0.0001) and at 1 year (37.6% vs 5.0%, P < 0.0001). Shock and MB were highly predictive of 30 day and 12 month mortality. CONCLUSION: In a default radial PCI center 10% of patients undergo PCI via the femoral artery. These patients have high baseline bleeding risk and undergo complex interventions. As a result the incidence of major bleeding, transfusion and death are high. Alternative strategies are required to optimize outcomes in this select group.

Risk classification in primary prevention of CVD according to QRISK2 and JBS3 'heart age', and prevalence of elevated high-sensitivity C reactive protein in the UK cohort of the EURIKA study.

Objectives: This study assessed cardiovascular disease (CVD) risk classification according to QRISK2, JBS3 'heart age' and the prevalence of elevated high-sensitivity C reactive protein (hsCRP) in UK primary prevention patients. Method: The European Study on Cardiovascular Prevention and Management in Usual Daily Practice (EURIKA) (NCT00882336) was a cross-sectional study conducted in 12 European countries. 673 UK outpatients aged ≥50 years, without clinical CVD but with at least one conventional CVD risk factor, were recruited. 10-year CVD risk was calculated using QRISK2. JBS3 'heart age' and hsCRP level were assessed according to risk category. Results: QRISK2 and JBS3 heart age was calculated for 285 of the 305 patients free from diabetes mellitus and not receiving a statin. QRISK2 classified 28%, 39% and 33% of patients as low (<10%), intermediate (10% to <20%) and high (≥20%) risk, respectively. Two-thirds of low-risk patients and half of intermediate-risk patients had a heart age ≥5 years and ≥10 years higher than their chronological age, respectively. Half of low-risk patients had hsCRP levels ≥2 mg/L and approximately 40% had levels ≥3 mg/L. Approximately 80% of low-risk patients had both elevated hsCRP and heart age relative to their chronological age. Conclusions: Almost 40% more patients in this 'at risk' group would be eligible for statin therapy following the lowering of the National Institute for Health and Care Excellence treatment threshold to ≥10% 10-year risk. Of patients falling below this treatment threshold, almost all were at increased lifetime risk as measured by JBS3, and of these, the majority had elevated hsCRP levels. These patients with high absolute risk may benefit from early primary CVD prevention.

Legacy Effect of Coronary Perforation Complicating Percutaneous Coronary Intervention for Chronic Total Occlusive Disease: An Analysis of 26 807 Cases From the British Cardiovascular Intervention Society Database.

BACKGROUND: Coronary perforation (CP) during chronic total occlusion percutaneous coronary intervention for stable angina (CTO-PCI) is a rare but serious event. The evidence base is limited, and the long-term effects are unclear. Using a national PCI database, the incidence, predictors, and outcomes of CP during CTO-PCI were defined. METHODS AND RESULTS: Data analyzed from the British Cardiovascular Intervention Society data set on all CTO-PCI procedures performed in England and Wales between 2006 and 2013. Multivariate logistic regressions and propensity scores were used to identify predictors of CP and its association with outcomes. A total of 376 CP were recorded from 26 807 CTO-PCI interventions (incidence of 1.40%) with an increase in frequency during the study period (P=0.012). Patient-related factors associated with an increased risk of CP were age and female sex. Procedural factors indicative of complex CTO intervention strongly related to an increased risk of CP with a close relationship between the number of complex strategies used and CP evident (P=0.008 for trend). Tamponade occurred in 16.6% and emergency surgery in 3.4% of cases. Adverse outcomes were frequent in those patients with perforation including bleeding, transfusion, myocardial infarction, and death. A legacy effect of perforation on mortality was evident, with an odds ratio for 12-month mortality of 1.60 for perforation survivors compared with matched nonperforation survivors without a CP (P<0.0001). CONCLUSIONS: Many of the factors associated with an increased risk of CP were related to CTO complexity. Perforation was associated with adverse outcomes, with a legacy effect on later mortality after CP also observed.

Revascularization for Left Anterior Descending Artery Stenosis: A Review of the Evidence That Supports Practice.

Disease of the proximal left anterior descending (LAD) artery is a common pathological finding often combined with disease in other coronary arteries. In this article, we review specifically the evidence (and the guidelines arising from the data) for lesions isolated to the proximal LAD only. Critical review of the data reveals limitations with few trials that reflect contemporary practice. Much of the data are observational rather than from randomized trials, and therefore subject to bias. We identified 2 randomized trials of drug-eluting stents versus left internal mammary artery grafting for isolated lesions of the proximal LAD. One reported no difference in major adverse cardiovascular events, but at an early timepoint (6 months), which is likely to be too early to reveal treatment differences. In the second trial, target lesion revascularization excess was noted in the drug-eluting stent arm. Therefore, at the current time, there are little data available to inform interventional cardiologists as to the best revascularization strategy for isolated lesions of the proximal LAD. Further randomized, controlled trials are needed.

Early Clinical Experience with a Polymer-Free Biolimus A9 Drug-Coated Stent in DES-Type Patients Who Are Poor Candidates for Prolonged Dual Anti-Platelet Therapy.

INTRODUCTION: Prolonged dual anti-platelet therapy (DAPT) may cause excess bleeding in certain patients. The biolimus-A9 drug-coated stent (BA9-DCS) has a rapid drug-elution profile allowing shortened DAPT. Data were gathered on the early experience implanting this stent in drug-eluting stent eligible patients deemed to be at high risk of bleeding. BACKGROUND AND METHODS: The demographics, procedural data and clinical outcomes were gathered prospectively for 249 patients treated with a BA9-DCS stent at 2 UK centres, and compared to a cohort of patients treated in the same period with drug-eluting stents (PCI-DES). RESULTS: Operator-defined BA9-DCS indications included warfarin therapy, age, and anaemia. Patients receiving a BA9-DCS were older (71.6±11.8 vs. 64.8±11.6yrs, p<0.001), more often female (38.2 vs. 26.8%, P<0.001), and more likely to have comorbidity including chronic kidney disease or poor LV function than PCI-DES patients. The baseline Mehran bleed risk score was also significantly higher in the BA9-DCS group (19.4±8.7 vs. 13.1±5.8, p<0.001). Of the BA9-DCS cohort, 95.5% of patients demonstrated disease fitting NICE criteria for DES placement. The number of lesions treated (1.81±1.1 vs. 1.58±0.92, p = 0.003), total lesion length (32.1±21.7 vs. 26.1±17.6mm, p<0.001), number of stents used (1.93±1.11 vs. 1.65±1.4, p = 0.007) and total stent length (37.5±20.8 vs. 32.4±20.3, p<0.01) were greater for BA9-DCS patients. DAPT was prescribed for 3.3±3.9 months for BA9-DCS patients and 11.3±2.4 months for PCI-DES patients (p<0.001). At follow up of 392±124 days despite the abbreviated DAPT course stent related event were infrequent with ischemia-driven restenosis PCI (2.8 vs. 3.4%, p = 0.838), and stent thrombosis (1.6 vs. 2.1%, p = 0.265) rates similar between the BA9-DCS ad PCI-DES groups. After propensity scoring all clinical end-points were similar between both cohorts. CONCLUSIONS: This early experience using polymer-free BA9 drug-coated stents in drug-eluting stent type patients at risk of bleeding are encouraging. Further studies are warranted.

Meta-Analysis of Percutaneous Coronary Intervention With Drug-Eluting Stent Versus Coronary Artery Bypass Grafting for Isolated Proximal Left Anterior Descending Coronary Disease.

We performed a meta-analysis of the studies comparing the efficacy and safety of coronary artery bypass surgery against percutaneous coronary intervention with drug-eluting stents (PCI-DES) in patients with isolated LAD disease. Because of the limited randomized trial data, the optimal revascularization strategy for patients with isolated LAD disease remains uncertain. Using MEDLINE and EMBASE to source data, 11 studies (3 randomized trials and 8 cohort studies) including 5,044 participants were identified. No significant difference in mortality between PCI-DES and coronary artery bypass surgery (CABG; 111 of 2,122 [5.2%] and 120 of 2,574 [4.7%]; relative risk [RR] 1.23; 95% confidence interval [CI] 0.90 to 1.69) was detected. For MACE, PCI-DES was associated with significant increase in adverse events (RR 1.41; 95% CI 1.03 to 1.93, 8 studies, 4,230 participants). There were no significant differences in the risk of myocardial infarction (RR 0.86; 95% CI 0.58 to 1.26) or stroke (RR 2.36; 95% CI 0.54 to 10.43) between the 2 groups. There were 239 target vessel revascularization (TVR) events among 2,237 participants in the PCI-DES group (10.7%) and 145 TVR events among 2,793 participants in the CABG group (5.2%) with a significant increased risk of TVR in the PCI group (RR 2.52; 95% CI 1.69 to 3.77, 5,030 participants) compared with CABG. In conclusion, for patients with isolated disease of the LAD, meta-analysis of the available data suggests revascularization with a PCI-DES strategy offers similar mortality, MI, and stroke rates to CABG at the expense of increased TVR. Much of the data are derived from registries using first-generation DES, and further randomized trials with more contemporary platforms are needed.

Incidence, Determinants, and Outcomes of Coronary Perforation During Percutaneous Coronary Intervention in the United Kingdom Between 2006 and 2013: An Analysis of 527 121 Cases From the British Cardiovascular Intervention Society Database.

BACKGROUND: As coronary perforation (CP) is a rare but serious complication of percutaneous coronary intervention (PCI) the current evidence base is limited to small series. Using a national PCI database, the incidence, predictors, and outcomes of CP as a complication of PCI were defined. METHODS AND RESULTS: Data were prospectively collected and retrospectively analyzed from the British Cardiovascular Intervention Society data set on all PCI procedures performed in England and Wales between 2006 and 2013. Multivariate logistic regressions and propensity scores were used to identify predictors of CP and its association with outcomes. In total, 1762 CPs were recorded from 527 121 PCI procedures (incidence of 0.33%). Patients with CP were more often women or older, with a greater burden of comorbidity and underwent more complex PCI procedures. Factors predictive of CP included age per year (odds ratio [OR], 1.03; 95% confidence intervals, 1.02-1.03; P<0.001), previous coronary artery bypass graft (OR, 1.44; 95% confidence intervals, 1.17-1.77; P<0.001), left main (OR, 1.54; 95% confidence intervals, 1.21-1.96; P<0.001), use of rotational atherectomy (OR, 2.37; 95% confidence intervals, 1.80-3.11; P<0.001), and chronic total occlusions intervention (OR, 3.96; 95% confidence intervals, 3.28-4.78; P<0.001). Adjusted odds of adverse outcomes were higher in patients with CP for all major adverse coronary events, including stroke, bleeding, and mortality. Emergency surgery was required in 3% of cases. Predictors of mortality in patients with CP included age, diabetes mellitus, previous myocardial infarction, renal disease, ventilatory support, use of circulatory support, glycoprotein inhibitor use, and stent type. CONCLUSIONS: Using a national PCI database for the first time, the incidence, predictors, and outcomes of CP were defined. Although CP as a complication of PCI occurred rarely, it was strongly associated with poor outcomes.

Interaction between access choice and pharmacotherapy for coronary intervention: the results of a UK survey.

INTRODUCTION: Percutaneous coronary intervention (PCI) has changed significantly over the past decade with the uptake of radial access and the development of newer and more potent antiplatelets and safer antithrombins. This survey examined the default access route and pharmacology choice and their interaction in UK interventional practice. METHODS: An email-based survey invited interventional cardiologists to answer questions regarding arterial access and pharmacology use during PCI. Respondents were categorised into femoral, radial and radial(+) (if the other radial was used rather than femoral if the right radial attempt failed). Data were analysed using χ(2) or the Student t test. RESULTS: 81% of the 204 respondents reported the radial artery as their default access site with a significant interaction between years since qualification and access choice (21.1 years for radial(+) vs 23 years for radial (p=0.027) vs 26.6 years for femoral (p=0.013) vs radial (p=0.0005) vs radial(+)). There were 19 different combinations of access and pharmacology reported. For non-ST elevation myocardial infarction PCI, there was a significant trend for radial(+) and radial operators to favour ticagrelor or tailored therapy versus femoral operators (54.8% vs 47.8% vs 35%, respectively, p=0.018). For primary PCI (PPCI), radial(+) and radial operators were much more likely to choose ticagrelor or prasugrel than femoral operators (77.2% (p<0.001) vs 73.9% (p=0.023) vs 50%, respectively (p<0.0001) for trend). For PPCI, glycoprotein inhibitor use was similar between groups (26.1% vs 25%, not significant); radial operators were much more likely to choose bivalirudin (52.8% vs 10%, p<0.0001) and much less likely to use heparin only (19.8% vs 65%, p<0.0001) than femoral operators. CONCLUSIONS: There is a significant interaction between years since qualification and access choice. Although there is no established consensus on access site or drugs, default radial operators are significantly more likely to utilise new generation antiplatelets and bivalirudin than femoral operators.

Patients undergoing PCI from the femoral route by default radial operators are at high risk of vascular access-site complications.

AIMS: Radial artery (RA) access for PCI has a lower incidence of vascular access-site (VAS) complications than the femoral artery (FA) approach. However, even for default radial operators certain patients are intervened upon from the FA. We examined the demographics and incidence of VAS complications when default radial operators resort to the FA for PCI. METHODS AND RESULTS: The demographics and VAS complications were compared by access site retrospectively for all PCI cases performed by default radial operators (n=1,392). A modified ACUITY trial definition of major VAS complication was used. FA puncture occurred in 25.2% (351/1,392) of cases. Patients were more likely to be female, older and weigh less than patients undergoing PCI from the RA. The FA procedure was likely to be more complex with larger sheaths, more left main stem, graft and multivessel intervention, and there was a greater proportion of emergency cases. Despite increased case complexity, glycoprotein inhibitors were used less frequently in femoral cases (26.5% vs. 36.8%, p<0.001). A VAS complication occurred in 12.5% (44/351) of cases. CONCLUSIONS: The risk factors for access-site bleeding are disproportionately high in the population requiring FA puncture by default radial operators, and as a result such patients have a high rate of vascular access-site complications.

Switching from transfemoral to transradial access for PCI: a single-center learning curve over 5 years.

BACKGROUND: Percutaneous coronary intervention (PCI) via the transradial (TR) route is an increasingly popular alternative to the transfemoral (TF) route. However, there are limiting factors to its adoption. We report the learning curve over 5 years in a high-volume PCI center during the crossover from TF to TR access for PCI. OBJECTIVE: To evaluate clinical characteristics, radiation doses, screening times, and subsequent clinical outcomes in subjects with femoral and radial access sites for PCI. DESIGN: We retrospectively analyzed our databases for PCI procedures/outcomes of all patients from 2006-2010. SETTING: A university teaching hospital PCI center performing cases predominantly femorally at the beginning of the study period, and transitioning to a predominantly radial access center at the end of the study period. PATIENTS: All patients undergoing PCI via either femoral or radial approach over a 5-year period. RESULTS: In year 1, TR access was used in 31.4% of cases; this rate increased to 90.1% in year 5. The switch from TF to TR access was observed among all operators and all groups of patients regardless of presentation, gender, age, and lesion complexity. In year 1, fluoroscopy times and radiation doses were higher in the TR group, but equalized in years 2 and 3 and reversed during years 4 and 5 when the TR rate was >90%. Over 5 years, the rates of vascular complications and major bleeding were higher in the TF cohort and were associated with longer hospital stay. In-hospital mortality was lower in the TR group. CONCLUSION: The change from TF to TR approach for PCI in a high-volume center is achievable within 5 years, and results in marked clinical benefits. There was an initial learning curve for fluoroscopy time and radiation dose, but this improved once an operator performed >60% of cases radially.