A comparison between radial artery compression devices for patent hemostasis after transradial percutaneous interventions.

OBJECTIVES: Patent hemostasis (PH) is essential for preventing radial artery occlusion (RAO) after trans-radial procedures; however, it remains unclear how it should be obtained. The aim of this multicenter randomized study was to evaluate whether the use of an adjustable device (AD), inflated with a pre-determined amount of air (AoA), was more effective than a non-adjustable device (non-AD) for achieving PH, thereby reducing the incidence of RAO. METHODS: We enrolled a total of 480 patients undergoing transradial procedure at 3 Italian institutions. Before the procedure, a modified Reverse Barbeau Test (mRBT) was performed in all patients to evaluate the AoA to be eventually inflated in the AD. After the procedure, patients were randomized into 2 groups: (1) AD Group, using TR-Band (Terumo) inflated with the pre-determined AoA; and 2) non-AD Group, using RadiStop (Abbott). An RBT was performed during compression to demonstrate the achievement of PH, as well as 24 hours later to evaluate the occurrence of RAO. RESULTS: PH was more often obtained in the AD Group compared with the non-AD Group (90% vs 64%, respectively, P less than .001), with no difference in terms of bleedings. RAO occurred more often in the non-AD Group compared with the AD Group (10% vs 3%, respectively, P less than .001). Of note, mRBT was effective at guiding AD inflation and identifying high-risk patients in whom PH was more difficult to obtain. CONCLUSIONS: The use of AD, filled with a predetermined AoA, allowed PH significantly more often compared with non-AD, providing a significantly reduced incidence of RAO.

The BIOFLOW-III Italian Satellite Registry: 18-month results of the Orsiro stent in an all-comer high-risk population.

AIMS: We aimed to corroborate clinical evidence on the safety and efficacy of the ultrathin-strut biodegradable-polymer sirolimus-eluting Orsiro stent in an all-comer population including high-risk subgroups. METHODS: The nationwide, prospective, all-comer BIOFLOW-III Satellite Registry was conducted at 18 Italian sites. High-risk subgroups [diabetes, small vessels (≤2.75 mm), acute myocardial infarction (AMI), and chronic total occlusions (CTOs)] were prespecified. The primary endpoint was target lesion failure (TLF) at 12 months, a composite of cardiac death, target vessel myocardial infarction (MI), emergent coronary artery bypass graft, and clinically driven target lesion revascularization (TLR). RESULTS: In all, 601 patients were enrolled (31.9% diabetes, 34.6% AMIs) with 736 lesions (37.2% small vessels, 5.7% CTOs, and 15.5% bifurcation lesions). Cumulative TLF rate at 12 months was 4.6% [95% confidence interval (CI) 3.2-6.6]: 6.9% (95% CI 4.1-11.6) in the diabetic patients, 5.0% (95% CI 2.7-9.1) in acute MI subgroup, 4.2% (95% CI 2.3-7.7) in small vessels, and 5.3% (95% CI 1.4-19.7) in CTOs. At 18-month follow-up, TLF, target vessel revascularization, and clinically driven TLR rates in the overall population were 5.2% (95% CI 3.7-7.4), 1.8% (95% CI 1.0-3.3), and 1.6% (95% CI 0.8-3.1), respectively. Probable stent thrombosis rate was 0.5% (95% CI 0.1-1.4), whereas no definite stent thrombosis was observed. CONCLUSIONS: The study results confirmed the excellent clinical performance of the Orsiro drug-eluting stents at 18 months in the whole all-comer population and in the prespecified high-risk subgroups.

Association of acute kidney injury and bleeding events with mortality after radial or femoral access in patients with acute coronary syndrome undergoing invasive management: secondary analysis of a randomized clinical trial.

AIMS: In the Minimizing Adverse Haemorrhagic Events by TRansradial Access Site and Systemic Implementation of angioX (MATRIX) trial, adults with acute coronary syndrome undergoing coronary intervention who were allocated to radial access had a lower risk of bleeding, acute kidney injury (AKI), and all-cause mortality, as compared with those allocated to femoral access. The mechanism of the mortality benefit of radial access remained unclear. METHODS AND RESULTS: We used multistate and competing risk models to determine the effects of radial and femoral access on bleeding, AKI and all-cause mortality in the MATRIX trial and to disentangle the relationship between these different types of events. There were large relative risk reductions in mortality for radial compared with femoral access for the transition from AKI to death [hazard ratio (HR) 0.55, 95% confidence interval (CI) 0.31-0.97] and for the pathway from coronary intervention to AKI to death (HR 0.49, 95% CI 0.26-0.92). Conversely, there was little evidence for a difference between radial and femoral groups for the transition from bleeding to death (HR 1.05, 95% CI 0.42-2.64) and the pathway from coronary intervention to bleeding to death (HR 0.84, 95% CI 0.28-2.49). CONCLUSION: The prevention of AKI appeared predominantly responsible for the mortality benefit of radial as compared with femoral access in the MATRIX trial. There was little evidence for an equally important, independent role of bleeding.

Comparison of the Effect of Dual-Axis Rotational Coronary Angiography Versus Conventional Coronary Angiography on Frequency of Acute Kidney Injury, X-Ray Exposure Time, and Quantity of Contrast Medium Injected.

Dual-axis rotational coronary angiography (DARCA) has already been shown to reduce both the amount of contrast medium and radiation exposure compared with conventional coronary angiography (CCA). However, a clinical benefit of such imaging modality has never been demonstrated. The aim of this study was to evaluate the efficacy of DARCA to prevent acute kidney injury (AKI) compared with CCA. Consecutive patients who underwent coronary angiography were enrolled to DARCA (n = 80) or CCA (n = 80). Patients presenting with ST-segment elevation myocardial infarction or previously underwent coronary artery bypass graft were excluded. The 2 groups were homogeneous in terms of both clinical and procedural characteristics. Total x-ray time and total amount of contrast medium were significantly lower in the DARCA group compared with the CCA group (x-ray time 3.2 minutes [1.8 to 7.0] vs 5.1 minutes [2.6 to 9.9], p = 0.002; contrast medium amount 40 ml [31 to 116] vs 80 ml [50 to 150], p <0.001). AKI more often occurred in the CCA group compared with the DARCA group (16 [20%] vs 4 [5%], p = 0.007). Moreover, in patients presenting with acute coronary syndrome (ACS) or who underwent percutaneous coronary intervention (PCI), AKI more often occurred in the CCA group compared with the DARCA group (ACS patients, 6 [29%] vs 2 [6%], p = 0.04, and PCI patients, 11 [33%] vs 0 [0%], p <0.001). In addition, in patients with high pretest probability of coronary artery disease, AKI more often occurred in the CCA group compared with the DARCA group (11 [55%] vs 2 [6%], p <0.001). In conclusion, DARCA significantly reduces both x-ray exposure and amount of contrast medium usage, thereby reducing the occurrence of AKI compared with CCA.

FFR prediction model based on conventional quantitative coronary angiography and the amount of myocardium subtended by an intermediate coronary artery stenosis.

BACKGROUND: Coronary angiography has poor predictive value for functionally significant coronary artery stenosis. The Fractional Flow Reserve (FFR) currently represents the gold standard to define the ischemic potential of epicardial stenosis and, recently, the instantaneous wave-free ratio (iFR), has also been introduced as alternative to the FFR, but it still remains an invasive procedure. We aimed this study in order to evaluate the accuracy of the "Angiography-DeriveD hEmoDynamic index" (ADDED index) to predict the FFR as compared with the iFR. METHODS AND RESULTS: Consecutive patients with at least one equivocal stenosis in one major coronary artery were enrolled. Both the FFR and iFR were measured. The amount of jeopardized myocardium was evaluated using the Duke Jeopardy Score (DJS). Two-dimensional quantitative coronary angiography (QCA) was used to assess the angiographic features of the coronary stenosis and both the reference vessel diameter (RVD) and minimal lumen diameter (MLD) were calculated. The ADDED index was defined as the ratio between DJS and MLD. We evaluated 100 intermediate coronary artery stenoses in 83 patients. Both FFR and iFR inversely correlated with the ADDED index (respectively, r2=0.59, p<0.001 and r2=0.61, p<0.001). This latter also showed high accuracy in predicting the FFR value (ROC analysis: 0.94[0.90-0.99], p<0.001) as well as the iFR (0.91[0.86-0.97], p<0.001, difference: 0.03 SD 0.04, p=0.52). CONCLUSIONS: The ADDED index, taking into account both the MLD and DJS, showed high accuracy to predict FFR and it might be used to detect functionally significant coronary artery stenosis.

Long term follow-up of "full metal jacket" of de novo coronary lesions with new generation Zotarolimus-eluting stents.

BACKGROUND: Diffuse coronary artery disease treatment still remains a challenge for interventional cardiologists and cardiac surgeons. There are few data on full metal jacket (FMJ) stenting, especially with new-generation drug-eluting stents. We aimed to assess the efficacy and safety of FMJ with new-generation Zotarolimus-eluting stents (n-ZES). METHODS AND RESULTS: All patients who underwent FMJ with n-ZES (≥60mm stent length) in eleven Italian interventional centers participating in the Clinical Service® project were included in this analysis. The project population consisted of 120 patients and 122 lesions. Mean age was 67±10years and 95 (79.2%) patients were male. A chronic total occlusion was present in 34 lesions (27.9%). The number of stents implanted per lesion was 2.9±0.8, and the diameter of the stents was 3.0±0.5mm. Predilation and post-dilatation were performed in 107 (87.7%) and 92 (75.4%) patients, respectively. At 41±21month follow-up there were 2 patients with subacute definite stent thrombosis, 6 patients (5.0%) had cardiac death and 5 patients (4.2%) had non-fatal myocardial infarction. Seven patients (5.8%) underwent clinically-driven target lesion revascularization. Fourteen patients (11.7%) had at least one major adverse cardiac event. CONCLUSION: The treatment of diffuse coronary artery disease with FMJ stenting with n-ZES appears to be effective and safe. Late and very-late ST does not seem to be an issue and the rate of restenosis and of major cardiac adverse events after more than 3-year follow-up is rather low.

Prospective multicentre clinical performance evaluation of second and third generation zotarolimus-eluting stents to treat patients with bifurcated coronary lesions.

AIM: To assess the "real world" clinical outcome of patients with bifurcated lesions undergoing percutaneous coronary intervention with implantation of second and third generations of zotarolimus-eluting stent. METHODS AND RESULTS: Nine Italian centres participated in a prospective multicentre clinical project evaluating the outcome of patients receiving zotarolimus-eluting Resolute stent and Resolute Integrity stents. Patients with bifurcated lesions entered this evaluation. Clinical characteristics and angiographic and procedural details were prospectively recorded. Clinical outcome was prospectively assessed to evaluate the occurrence of major adverse cardiac events (MACE). A total of 577 patients were enrolled. The target lesion was distal left main in 11.1% and left anterior descending artery in 52.8%, and 30.3% of lesions were Medina 1,1,1. At a mean follow-up time of 27.0 ± 13.5 months, the survival free from MACE was 91.8%. Survival free from MACE was similar in patients grouped according to different bifurcated lesion complexity. On the contrary, patients receiving a single stent had better survival free from MACE as compared with those with double stent (P = 0.005). At multivariable analysis, double stenting (but not bifurcated lesion complexity) was found to be a significant predictor of MACE (hazard ratio, 2.52; 95% confidence interval, 1.28-4.94; P = 0.007). Of note, patients receiving the second stent as a bail-out had worse survival free from MACE compared with those who received it as a planned technique (P = 0.045). CONCLUSION: The treatment of patients with bifurcated lesions with second and third generation zotarolimus-eluting stents is associated with good long-term clinical outcomes. Clinical outcome seems to be independent of lesion complexity, but may be influenced by the stenting technique (single or double stenting as well as elective or bail-out double stenting). © 2015 Wiley Periodicals, Inc.

Transcathether occlusion of interatrial communications: postprocedural transoesophageal echocardiography allows timely detection and treatment of intracardiac thrombus formation.

AIMS: Thrombus formation leading to ischaemic stroke is a major concern after transcathether occlusion of interatrial communications. The aim of our study was to verify if postprocedural transoesophageal echocardiography (TEE) might improve timely detection and management of thrombus formation. METHODS AND RESULTS: We studied 65 patients with patent foramen ovale or atrial septal defect who received an atrial septal closure device. Transoesophageal echocardiography was used to guide the procedure, and was repeated <1 h after the end of the procedure, at 30 day and 6 month follow-up visits. Transoesophageal echocardiography <1 h after procedure revealed a left-sided thrombus attached to the device in three patients. All cases were successfully treated by thrombolytic therapy with full-dose tenecteplase (0.53 mg/kg in 5-10 s) with disappearance of thrombus in 15-60 min. No cerebrovascular event was recorded during a follow-up of 311 +/- 235 days. CONCLUSION: Thrombus formation on interatrial closure devices can occur soon after device implantation and can be timely detected by postprocedural TEE.