Three- and 6-month optical coherence tomographic surveillance following percutaneous coronary intervention with the Angiolite® drug-eluting stent: The ANCHOR study.

BACKGROUND: Pre-clinical results of a novel open-cell, thin strut, durable polymer, laser cut cobalt chromium sirolimus-eluting stent (Angiolite) were promising. Using quantitative optical coherence tomographic (OCT) analyses, we explored the healing characteristics of the Angiolite DES system at 3- and 6-months post implantation. METHODS: A total of 103 patients with de novo coronary lesions underwent percutaneous coronary intervention with the Angiolite DES and were randomized 1:3 into two cohorts for angiographic and OCT follow-up, with 28 and 70 patients returning for 3- or 6-month post-PCI surveillance, respectively. The primary endpoints were the 6-month rates of OCT-derived neointimal proliferation, strut coverage and incomplete strut apposition (ISA), whilst the secondary endpoints were 3-month OCT-derived measures of strut coverage and ISA, as well as 6-month quantitative coronary angiographic-derived measures [late lumen loss (LLL), binary restenosis]. RESULTS: The Angiolite stent was successfully implanted in all patients, without periprocedural complications. At 3- and 6-months follow-up, OCT strut coverage was evident in 86.3% and 83.3% of struts, mean neointimal thickness was 73.7 ± 46.5 µm and 73.9 ± 54.3 µm, mean neo-intimal area obstruction of 5.8% ±10.3% and 4.4% ± 11.3%, and ISA rates were 1.3% ± 7.3% and 1.1% ± 6.2%, respectively. In-stent LLL at 6 months was 0.07 ± 0.37 mm, with a binary in-stent angiographic restenosis rate of 0% without any stent thrombosis, myocardial infarction or cardiovascular death, with 1 patient undergoing ischemia-driven target-lesion revascularization. CONCLUSIONS: At 6 months, the Angiolite DES was safe with high rates of strut coverage, modest degrees of neointimal hyperplasia and very low rates of strut malapposition. These data coupled with the absence of in-stent binary restenosis and a very low 6-month in-stent LLL point towards an efficacious DES. Future studies are required to evaluate its efficacy in broader lesion subsets with longer follow-up.

Same-Day Discharge After Transradial Percutaneous Coronary Intervention and Carotid Stenting in a Single Session.

Same-day discharge after combined percutaneous carotid and coronary stenting in a single session has not been previously reported. Using a transradial approach, we completed both procedures successfully and the 63-year-old patient was discharged home after a few hours. This case illustrates that radial access allows treatment of complex coronary and peripheral lesions in a same setting and could provide clinical and cost benefits if safety is confirmed.

Feasibility and Safety of Early Repeat Transradial Access Within 30 Days of Previous Coronary Angiography and Intervention.

Transradial approach (TRA) is the default access site for diagnostic angiography and intervention in many centers. Repeat ipsilateral radial artery access late after index procedure has been associated with failures. It is unknown whether early (≤30 days) and very early (<24 hours) repeat radial access is technically feasible and safe. Study population consisted of consecutive patients undergoing repeat (≥2) procedures within 30 days in a high-volume TRA center. Transradial access failure and resulting femoral approach was categorized as primary (no repeat attempt) or secondary (crossover). Timing of repeat access and reasons for failure were recorded. From November 2012 to December 2014, repeat catheterization by TRA was performed twice in 573 of 626 patients (92%) (median delay 4 [2 to 9] days), 3 times in 29 of 38 (76%) patients (median delay 15 [5 to 26] days), and 4 times in 1 patient within 21 days. When repeat catheterization occurred during the first 24 hours following the index procedure, 53% and 75% of patients had second and third procedures using the same ipsilateral radial artery, respectively. Primary radial failure occurred in 5.8% for second attempt and 13% for a third attempt, whereas crossovers were noted in 2.7% and 2.6%, respectively. Main reasons for failed re-access of ipsilateral radial artery were related either to operator's reluctance to repeat attempt (primary failure) or to issues with puncture site (crossover). In a high-volume TRA center, patients who required repeat catheterization within 24 hours and within the first 30 days had the same radial artery re-accessed in the majority of cases.

Efficacy and safety of preoperative intra-aortic balloon pump use in patients undergoing cardiac surgery: a systematic review and meta-analysis.

BACKGROUND: Intra-aortic balloon pump (IABP) can be used prior to coronary artery bypass graft surgery (CABG) in high-risk patients. Whether this technique remains safe and effective in contemporary practice is controversial. OBJECTIVE: We have completed a systematic review and meta-analysis of randomized trials and observational studies to evaluate the safety and benefits of IABP prior to CABG surgery. METHODS: We searched PubMed, EMBASE, Cochrane Library databases, with cross-referencing of relevant articles for studies assessing the impact of IABP prior to and after isolated CABG. Two investigators independently sorted the potentially relevant studies, and three extracted data. The assessed outcomes included in-hospital and 30-day mortality, IABP-related complications and length of intensive care unit and hospital stay. RESULTS: From 1977 to 2015 we included 11 randomized controlled trials (n=1293) (RCTs) and 22 observational studies, including a total of 46,067 patients. Analyses from RCTs suggested that IABP prior to CABG was associated with a significant reduction in hospital mortality (odds ratio (OR) 0.20; 95% confidence interval (CI): 0.09-0.44; P<0.0001) and 30-day mortality compared to no preoperative IABP (OR 0.43, 95% CI: 0.25-0.76; P=0.003). IABP prior to CABG was also associated with shorter intensive care unit (weighted mean difference (WMD) -1.47day; 95% CI: -1.82 to -1.12day; P<0.00001) and hospital length of stay (WMD -3.25days; 95% CI: -5.18 to -1.33days; P=0.0009). However, there were significant bias and limitations among included studies. Furthermore, results for similar outcomes from observational studies remained inconclusive. CONCLUSIONS: In contemporary practice, evidence showing clinical benefit for preoperative IABP in high-risk patients remains limited and requires further validation in an appropriately sized multicenter randomized trial.

Meta-Analysis of Effects of Bivalirudin Versus Heparin on Myocardial Ischemic and Bleeding Outcomes After Percutaneous Coronary Intervention.

Bivalirudin is an alternative to unfractionated heparin (UFH) anticoagulation during percutaneous coronary intervention. Previously, we have reported clinical benefit on major bleeding in favor of bivalirudin compared with UFH monotherapy but inconclusive results on mortality. Controversial data have been reported in the last 2 years. We conducted an updated meta-analysis including randomized trials and observational studies, which evaluated ischemic and bleeding outcomes for bivalirudin compared with UFH-only during percutaneous coronary intervention. We included 18 observational studies and 12 randomized trials published from 2003 to 2015. Primary outcomes were major adverse cardiovascular events within 30 days including death, myocardial infarction, and urgent revascularization and stent thrombosis, major bleeding, and transfusion. Overall, we found a significant risk reduction with bivalirudin for major bleeding (odds ratio [OR] 0.59, 95% confidence interval [CI] 0.49 to 0.71, p <0.0001) and for transfusion (OR 0.79, 95% CI 0.66 to 0.95, p = 0.01) and similar risk for major adverse cardiovascular events (OR 0.98, 95% CI 0.86 to 1.12, p = 0.80). However, there was a substantial increased risk of stent thrombosis associated with bivalirudin (OR 1.52, 95% CI 1.11 to 2.08, p = 0.009). No impact on mortality was found. Meta-regression analyses on major bleeding suggested that bivalirudin was more effective than UFH at doses >60 IU/kg and independent of radial access. In conclusion, compared with UFH monotherapy, bivalirudin remains associated with less bleeding risk but higher stent thrombosis risk. Further study remains required to define its role in current antithrombotic armamentarium.

Prediction and impact of failure of transradial approach for primary percutaneous coronary intervention.

OBJECTIVES: To determine predictors of failure of transradial approach (TRA) in patients with ST elevation myocardial infarction (STEMI) undergoing primary percutaneous coronary intervention (PCI), and develop a novel score specific for this population. METHODS: Consecutive patients with STEMI undergoing primary PCI in a tertiary care high-volume radial centre were included. TRA-PCI failure was categorised as primary (primary transfemoral approach (TFA)) or crossover (from TRA to TFA). Multivariate analysis was performed to determine independent predictors of TRA-PCI failure, and an integer risk score was developed. Clinical outcomes up to 1 year were assessed. RESULTS: From January 2006 to January 2011, 2020 patients were studied. Primary TRA-PCI failure occurred in 111 (5%) patients and crossover to TFA in 44 (2.2%) patients. Independent predictors of TRA-PCI failure were: weight ≤65 kg (OR: 3.0; 95% CI 1.9 to 4.8, p<0.0001), physician with ≤5% TFA conversion (OR: 0.45; 95% CI 0.2 to 0.9, p=0.033), and physician with ≥10% conversion to TFA (OR: 2.2; 95% CI 1.2 to 3.7, p=0.005), intra-aortic balloon pump (OR: 2.0; 95% CI 0.9 to 4.3, p=0.066), cardiogenic shock (OR: 2.8; 95% CI 1.4 to 5.6, p=0.0035), endotracheal intubation (OR: 107; 95% CI 42 to 339, p<0.0001), creatinine >133 µmol/L (OR: 3.6; 95% CI 1.9 to 6.8, p<0.0001), age ≥75 (OR: 1.7; 95% CI 1.0 to 2.9, p=0.031), prior PCI (OR: 2.6; 95% CI 1.5 to 4.5, p=0.0009), hypertension (OR: 1.8; 95% CI 1.2 to 2.9, p=0.009). An integer risk score ranging from -1 to 12 was developed, and predicted TRA-PCI failure from 0% to 100% (c-statistic of 0.868; 95% CI 0.866 to 0.869). Mortality at 1 year remained significantly higher after TRA-PCI failure (adjusted OR 2.2; 95% CI 1.2 to 3.9, p=0.011). CONCLUSIONS: In a high-volume radial centre, the incidence of TRA-PCI failure is low and can be accurately predicted using a 9-variables risk score. Since outcomes after TRA-PCI failure remained inferior, further effort to maximise the use of radial approach for primary PCI should be investigated.