Wail Nammas

Proximal endovascular occlusion for carotid artery stenting: results from a prospective registry of 1,300 patients.

OBJECTIVESnThis single-center registry presents the results of proximal endovascular occlusion (PEO) use in an unselected patient population.nnnBACKGROUNDnIn published multicenter registries, the use of PEO for carotid artery stenting (CAS) has been demonstrated to be safe and efficient in patient populations selected for anatomical and/or clinical conditions.nnnMETHODSnFrom July 2004 to May 2009, 1,300 patients underwent CAS using PEO. Patients received an independent neurological assessment before the procedure and 1 h, 24 h, and 30 days after the procedure.nnnRESULTSnProcedural success was achieved in 99.7% of patients. In hospital, major adverse cardiac or cerebrovascular events included 5 deaths (0.38%), 6 major strokes (0.46%), 5 minor strokes (0.38%), and no acute myocardial infarction. At 30 days of follow-up, 2 additional patients died (0.15%), and 1 patient had a minor stroke (0.07%). The 30-day stroke and death incidence was 1.38% (n = 19). Symptomatic patients presented a higher 30-day stroke and death incidence when compared with asymptomatic patients (3.04% vs. 0.82%; p < 0.05). No significant difference in 30-day stroke and death rate was observed between patients at high (1.88%; n = 12) and average surgical risk (1.07; n = 7) (p = NS). Operator experience, symptomatic status, and hypertension were found to be independent predictors of adverse events.nnnCONCLUSIONSnThe use of PEO for CAS is safe and effective in an unselected patient population. Anatomical and/or clinical conditions of high surgical risk were not associated with an increased rate of adverse events.

The CIAO (Coronary Interventions Antiplatelet-based Only) Study: a randomized study comparing standard anticoagulation regimen to absence of anticoagulation for elective percutaneous coronary intervention.

OBJECTIVESnWe sought to evaluate, in a double-blind, randomized, prospective study, safety and efficacy of elective percutaneous coronary intervention (PCI), with pharmacotherapy consisting of antiplatelet therapy and no anticoagulation therapy.nnnBACKGROUNDnAvailable guidelines recommend systemic anticoagulation agent use during PCI. Significant debate remains, however, with regard to the correlation between the effects of systemic anticoagulation therapy and ensuing ischemic and hemorrhagic complications.nnnMETHODSnFrom June 2005 to January 2007, 700 patients undergoing elective PCI of an uncomplicated lesion have been prospectively enrolled in the protocol. Patients should have been on aspirin and thienopyridine therapy and were assigned either to the control arm (70 to 100 UI/kg unfractionated heparin) or to the no-heparin arm. A clinical assessment was obtained before hospital discharge and at 30 days after PCI.nnnRESULTSnProcedural success was obtained in 100% of the cases. No acute or subacute thrombosis was observed. The absence of anticoagulation therapy was associated with a significant decrease in post-procedural myocardial damage (p = 0.03) and bleeding events (p = 0.048). At 30 days, the primary end point (death, myocardial infarction, or urgent target vessel revascularization) was more frequent in the control arm than in the no-heparin arm (2.0% vs. 3.7%, respectively; absolute risk reduction 1.7% [95% confidence interval: -0.1% to 4.5%], p for superiority = 0.17, p for noninferiority <0.001).nnnCONCLUSIONSnIn the treatment of uncomplicated lesions and in the presence of dual antiplatelet therapy, elective PCI can be safely performed without systemic anticoagulation and is associated with a reduced incidence of bleeding complications.

A prospective randomised comparison of titanium-nitride- oxide-coated bioactive stents with everolimus-eluting stents in acute coronary syndrome: the BASE-ACS trial

AIMSnTitanium-nitride-oxide-coated bioactive stents (BAS) have demonstrated a favourable outcome when compared with paclitaxel-eluting stents in patients with acute myocardial infarction (MI). In a prospective randomised non-inferiority study design, we compared the safety and efficacy of BAS versus everolimus-eluting stents (EES) in patients with acute coronary syndrome (ACS).nnnMETHODS AND RESULTSnWe randomised 827 patients with ACS (1:1) to either BAS (417) or EES (410). The primary endpoint was a composite of cardiac death, non-fatal MI or ischaemia-driven target lesion revascularisation (TLR) at 12-month follow-up. Analyses were performed by intention to treat. At 12-month follow-up, the primary composite endpoint occurred in 9.6% of patients in the BAS group and 9.0% of those in the EES group (HR [hazard ratio] 1.04, 95% CI [confidence interval] 0.81-1.32, p=0.81, p for non-inferiority =0.001). Non-fatal MI was significantly less frequent in the BAS as compared with the EES group (2.2% vs. 5.9%, p=0.007). However, the individual rates of cardiac death and ischaemia-driven TLR were similar between the two groups (1.9% vs. 1.0%, p=0.39, and 6.5% vs. 4.9%, p=0.37, respectively).nnnCONCLUSIONSnIn patients presenting with ACS, BAS achieved a clinical outcome that was non-inferior to EES at 12-month follow-up.

Five-year clinical outcome of titanium-nitride-oxide-coated bioactive stents versus paclitaxel-eluting stents in patients with acute myocardial infarction: Long-term follow-up from the TITAX AMI trial

BACKGROUNDnThe TITAX-AMI randomized controlled trial demonstrated a better clinical outcome with titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) at 2-year follow-up, in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We sought to present the 5-year clinical outcome of the TITAX-AMI trial.nnnMETHODSnA total of 425 patients with acute MI were randomly assigned to receive either BAS (214), or PES (211). The primary endpoint was major adverse cardiac events (MACE): a composite of cardiac death, recurrent MI or ischemia-driven target lesion revascularization (TLR). Clinical follow-up was performed to 5 years.nnnRESULTSnThe 5-year cumulative incidence of MACE was significantly lower in patients assigned to BAS as compared with those assigned to PES (16.4% versus 25.1%, respectively, p=0.03). Similarly, the 5-year rates of cardiac death and recurrent MI were significantly lower in patients assigned to BAS (1.9% versus 5.7%, and 8.4% versus 18.0%, p=0.04 and p=0.004, respectively). Yet, the rates of ischemia-driven TLR were similar between the two study groups (11.2% versus 10.9%, respectively, p=0.92). The rate of definite stent thrombosis (ST) was again significantly lower in patients assigned to BAS (0.9% versus 7.1%, respectively, p=0.001).nnnCONCLUSIONSnIn the current prospective randomized TITAX-AMI trial, among patients presenting with acute MI who underwent early PCI, BAS achieved a better clinical outcome as compared with PES at 5-year follow-up, as reflected by lower cumulative rates of overall MACE, cardiac death, recurrent MI, and definite ST; yet, with statistically similar rates of ischemia-driven TLR.

Stent-oriented versus patient-oriented outcome in patients undergoing early percutaneous coronary intervention for acute coronary syndrome: 2-year report from the BASE-ACS trial

Abstract Background. The BASE-ACS trial demonstrated an outcome of the titanium-nitride-oxide-coated bioactive stents (BAS) statistically non-inferior to that of the everolimus-eluting stents (EES) at 12-month follow-up in patients presenting with acute coronary syndrome (ACS). We performed a post hoc analysis of the BASE-ACS trial with particular focus on stent-oriented versus patient-oriented outcome at 24-month follow-up. Methods. A total of 827 patients with ACS were randomly assigned to receive either BAS (417) or EES (410). Stent-oriented outcome was defined as a composite of cardiac death, target vessel-related non-fatal myocardial infarction, or ischemia-driven target lesion revascularization. Patient-oriented outcome was defined as a composite of all-cause death, any non-fatal myocardial infarction, or any revascularization. Results. Clinical follow-up for 24 months was completed in 406 (97.4%) patients in the BAS group and in 398 (97.1%) in the EES group. Stent-oriented outcome at 24-month follow-up occurred at similar frequencies in the two stent groups (10.1% for BAS versus 11.2% for EES, P = 0.53). Likewise, patient-oriented outcome at 24-month follow-up was similar in the two groups (16.3% versus 19.8%, respectively, P = 0.2). Conclusions. In patients presenting with ACS, the rates of both stent-oriented and patient-oriented outcomes at 24-month follow-up in the BAS group were similar to those in the EES group. Trial registration: ClinicalTrials.gov identifier: NCT00819923.

Early Neointimal Coverage and Vasodilator Response Following Biodegradable Polymer Sirolimus-Eluting vs. Durable Polymer Zotarolimus-Eluting Stents in Patients With Acute Coronary Syndrome

BACKGROUNDnPatients at high bleeding risk would benefit from a shorter dual antiplatelet therapy after PCI. Compared to first-generation devices, the design of newer generation drug-eluting stents may facilitate more rapid anatomical and functional healing of stented vessel based on thinner stent platforms, biodegradable/biocompatible polymers and rapid drug elution.nnnMETHODS AND RESULTSnForty-four non-diabetic patients with acute coronary syndrome (ACS) and culprit lesion in the LAD were randomized to receive either biodegradable polymer sirolimus-eluting stent (BP-SES) or durable polymer zotarolimus-eluting stent (DP-ZES). Neointimal strut coverage was examined using optical coherence tomography, and vasodilator response on invasive thermodilution-derived coronary flow reserve (CFR) at 3-month follow-up. The primary endpoints were percent uncovered struts and CFR. A total of 425 cross-sections (4,897 struts) were analyzed in the BP-SES group, and 425 cross-sections (5,467 struts) in the DP-ZES group. The percent uncovered struts was lower in the BP-SES group compared with the DP-ZES group, both at strut level (3.9% vs. 8.9%, respectively, P<0.001), and stent level (3.9 ± 3.2% vs. 8.9 ± 6.9%, respectively, P=0.019). No significant difference was found between the 2 groups regarding CFR (3.0 ± 1.3 vs. 3.2 ± 1.0, respectively, P>0.05).nnnCONCLUSIONSnIn non-diabetic patients with ACS, BP-SES provided slightly better stent strut coverage at 3 months compared with DP-ZES, but neither stent was fully covered. No difference in vasodilator response was seen.

Renal sympathetic denervation for treatment of patients with atrial fibrillation: Reappraisal of the available evidence

Afferent renal sympathetic nerve signaling regulates central sympathetic outflow. In this regard, renal sympathetic denervation has emerged as a novel interventional strategy for treatment of patients with resistant hypertension. Despite the disappointing results of the Simplicity HTN-3 randomized controlled trial, promoters of renal denervation argue that the negative results were due to ineffective denervation technique and poor patient selection. Yet, long-term pathologic increase of efferent sympathetic nerve activity is observed in many chronic disease states characterized by sympathetic overactivity, such as arrhythmia, heart failure, insulin resistance, and chronic kidney disease. In this review, we highlight the contemporary evidence on the safety/efficacy of renal denervation in the treatment of patients with atrial fibrillation.

Feasibility and safety of frequency-domain optical coherence tomography for coronary artery evaluation: a single-center study

We assessed the feasibility and safety of frequency-domain optical coherence tomography (FD–OCT) in a variety of indications. We conducted a retrospective analysis of all FD–OCT examinations performed for research and clinical indications, including stable angina, acute coronary syndromes, diagnostic procedures and percutaneous coronary intervention (PCI), at the Satakunta Central Hospital (Pori, Finland) between August 12th 2009 and February 9th 2011. All pullbacks were screened for image quality. Data on complications and clinical implications of examinations was obtained from patient records. The mean age of the patients was 65.9xa0±xa010.9xa0years (81.7xa0% males). A total of 230 examinations were performed on 210 patients; 523 pullbacks were eventually attempted (519 successful). On average, 2.3xa0±xa01.1 pullbacks were performed, and 1.1xa0±xa00.4 vessels were scanned per examination. PCI was performed in 44.3xa0% of examinations. Radial access was used in 70.3xa0% of cases. Examination was successful in 202 (87.8xa0%) examinations. One patient died of heart failure later after PCI for acute myocardial infarction. No cases of major bleeding, myocardial infarction, contrast-induced nephropathy, or pericardial tamponade were encountered. Chest pain occurred in 10.9xa0% of examinations, minor bleeding in 4.8xa0%, and myocardial ischemia in 2.6xa0%. Femoral access was associated with fewer blood and decentration artefacts and a trend towards better image quality when compared to radial access, with no difference in complications. After the first 50 examinations, there appeared to be fewer artefacts in the subsequent examinations. The current study demonstrated that FD–OCT is feasible, with infrequent complications.

4-Year outcome of bioactive stents versus everolimus-eluting stents in acute coronary syndrome

Abstract Objectives: The BASE-ACS trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), versus everolimus-eluting stents (EES), for major adverse cardiac events (MACE) at 1- and 2-year follow-up, in patients with acute coronary syndrome (ACS). We presented the 4-year outcome of the BASE-ACS trial. Design: We randomized 827 patients with ACS to receive either BAS (417) or EES (410). MACE was a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analyses were performed by intention to treat. Follow-up was planned at 12 months, and yearly thereafter for 5 years. Results: Four-year clinical follow-up was completed in 753 (91.1%) patients. At 4 years, BAS were non-inferior to EES for MACE (14.7% versus 17.8%, respectively; pu2009=u20090.24 for superiority; pu2009=u20090.001 for non-inferiority). Non-fatal MI was less frequent with BAS (5.0% versus 9.2%, respectively; pu2009=u20090.025). Cardiac death and ischemia-driven TLR were comparable (2.9% versus 3.5%, and 8.6% versus 9.2%; pu2009=u20090.62 and pu2009=u20090.80, respectively). Independent predictors of MACE were calcified lesions (HR 1.54, pu2009=u20090.021), the number of vessels treated (HR 1.53, pu2009=u20090.025), and reference vessel diameter (HR 0.54, pu2009=u20090.006). Conclusions: In patients presenting with ACS, BAS was associated with a clinical outcome non-inferior to EES at 4-year follow-up.

Bivalirudin use during percutaneous coronary intervention in patients on chronic warfarin therapy

About 5 to 8 % of patients referred for percutaneous coronary intervention (PCI) have an indication for long-term oral anticoagulation (OAC), mainly due to atrial fibrillation (AF) [1]. Intravenous direct thrombin inhibitor, bivalirudin (Angiox, The Medicines company LTD, UK), is increasingly used in the setting of primary PCI for ST elevation myocardial infarction, and acute coronary syndromes, since it has provided a similar reduction in major adverse cardiac events but lower bleeding events, when compared to heparin and heparin plus glycoprotein inhibitors (GPIs) [2,3]. At present, however, there are no published data on safety and efficacy of bivalirudin in combination with OAC, because these patients have been excluded from clinical trials. In this study, we sought to assess the rates of major adverse cardiac and cerebrovascular events (MACCE), as well as bleeding and access site complications in patients on chronic warfarin therapy undergoing PCI with periprocedural bivalirudin vs. heparin plus GPIs use. This analysis is based on data collected from two study protocols evaluating thrombotic and bleeding complications of coronary interventions inWestern Finland and Europe [4–6]. Patients with bivalirudin and heparin plus GPI use were derived from four Finnish PCI centers over the same follow-up period. The primary endpoints were MACCE, mortality and bleeding complications at 30 days. A MACCE was defined as the occurrence of any of the following post-PCI: death, myocardial infarction, the target vessel revascularization (emergency or elective coronary-artery bypass grafting or repeated PCI), stent thrombosis, or stroke. Bleeding complications were classified as ‘major bleeding’ according to the TIMI criteria [7] and access site complications. Stent thrombosis was adjudicated according to Academic Research Consortium Criteria as definite and probable [8]. This study complies with the Declaration of Helsinki. The Ethics Committees of the participating hospitals approved the study protocol. Written informed consent or a waiver of the requirement of written informed consent was obtained. PCI was performed in 1104 patients on warfarin and periprocedural bivalirudin was used in 51 (4.6%) patients. The indication for warfarin was atrial fibrillation in 135/138 (98%) and pulmonary embolism in 3/138 (2%) patients. There was a wide variation (0–9.5%) in its use among participating hospitals and it was only used in centres performing PCI without conventional heparin bridging.