Abstract: Drug-eluting stents (DES) have reduced the rate of restenosis but recent studies have raised concern over the risk of late stent thrombosis (LST). Incomplete stent endothelialization and delayed vascular healing have been associated with LST. The titanium-nitride-oxide coated bio-active stent (BAS) has shown promising results in patients with acute coronary syndromes, but there is little long-term optical coherence tomography (OCT) data comparing BAS with DES. The TITAX-AMI trial is a prospective, randomized, multicenter trial comparing BAS to paclitaxel-eluting stent (PES) in 425 patients with acute myocardial infarction. A total of 18 patients (9 per group) with no major cardiac events during follow-up, were enrolled in this substudy >36 months (mean 47 months) after stent implantation. Quantitative coronary angiography was performed and stent strut endothelialization and vascular healing were assessed with OCT. The binary stent strut coverage was significantly higher in the BAS group compared with the PES group (99.6 vs. 89.2%, p < 0.001) and there were less malapposed struts in the BAS group (0.2 vs. 13.8%, respectively, p < 0.001). The neointimal hyperplasia (NIH) thickness (266 ± 166 vs. 126 μm ± 126 μm, p < 0.001) and percentage of NIH area (26.2 vs. 7.6%, p < 0.001) were greater in the BAS group than in the PES group. Late incomplete endothelialization was not uncommon after PES implantation. Stents in the BAS group were completely endothelialized. This difference may contribute to the more common LST after PES implantation in the TITAX-AMI trial.
Abstract: Optical coherence tomography is an exciting light-based imaging modality with a much higher axial resolution as compared with intravascular ultrasound. The diagnostic value of optical coherence tomography resides in its ability to provide information on the stent interaction with the vessel wall at the level of individual struts. Chief clinical implications include evaluating strut neointimal coverage and strut malapposition following coronary stenting. This Editorial covers the basics of optical coherence tomography, its established and potential clinical implications, probable caveats and downsides, in addition to a future perspective, all in view of the late-breaking peer-reviewed literature.
Abstract: The safety of drug-eluting stents (DES) in patients on long-term warfarin treatment has been questioned due to high risk of bleeding complications during prolonged triple (aspirin, clopidogrel, and warfarin) antithrombotic therapy.
Abstract: Uninterrupted oral anticoagulation (OAC) therapy can be the preferred strategy in patients with atrial fibrillation at moderate to high risk of thromboembolism undergoing percutaneous coronary intervention (PCI). To evaluate the need for additional heparins in addition to therapeutic peri-PCI OAC, we assessed bleeding complications and major adverse cardiac and cerebrovascular events in 414 consecutive patients undergoing PCI during therapeutic (international normalized ratio 2 to 3.5) periprocedural OAC. Patients were divided into those with no (n = 196) and with (n = 218) additional use of periprocedural heparins. No differences in major adverse cardiac and cerebrovascular events (4.1% vs 3.2%, p = 0.79) or major bleeding (1.0% vs 3.7%, p = 0.11) were detected, but access site complications (5.1% vs 11.0%, p = 0.032) were less frequent in those without additional heparins. When adjusted for propensity score, patients with additional heparins had a higher risk of access site complications (odds ratio 2.6, 95% confidence interval 1.1 to 6.1, p = 0.022) without any increased risk of any other adverse event. Analysis of 1-to-1 propensity-matched pairs showed a significantly higher risk of access site complication in patients receiving additional AC (13.1% vs 5.7%, p = 0.049). In conclusion, therapeutic warfarin treatment seems to provide sufficient AC for PCI. Additional heparins are not needed and may increase access site complications.
Abstract: The TITAX-AMI trial demonstrated a better clinical outcome of titanium-nitride-oxide-coated bioactive stents (BAS) as compared with paclitaxel-eluting stents (PES) in patients with acute myocardial infarction (MI) undergoing early percutaneous coronary intervention (PCI). We explored the gender-based 3-year outcome of BAS as compared with PES in a subgroup analysis of the TITAX-AMI trial.
Abstract: BACKGROUND: The 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. METHODS: A 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 5years. RESULTS: The 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). CONCLUSIONS: In 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.
Abstract: The anti-thrombotic strategy during coronary stenting is challenging in patients on long-term oral anticoagulation (OAC) because of atrial fibrillation (AF). Uninterrupted OAC (UAC) is increasingly used, but bridging therapy (BT) is still in common use.
Abstract: A 62-year-old male patient presented with acute non-ST elevation myocardial infarction. He underwent successful percutaneous coronary intervention with implantation of an everolimus-eluting stent in the left anterior descending coronary artery. Six months later, he discontinued clopidogrel. Two weeks later, he presented with unstable angina. Despite the unremarkable electrocardiography, cardiac biomarkers, and coronary angiography, optical coherence tomography revealed a thrombus extending throughout the stent, with uncovered and malapposed stent struts in its proximal part. Thrombectomy was performed. The patient was discharged on dual antiplatelet therapy. Eight months later, the follow-up coronary angiography reassured a patent stent with adequate flow and no evidence of thrombi.
Abstract: Titanium-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).
Abstract: Therapeutic (international normalized ratio, INR 2.0-3.5) oral anticoagulation (TOAC) is assumed to increase perioperative bleeding complications and a standard recommendation is to discontinue warfarin before coronary bypass grafting (CABG).
Abstract: We sought to present the 5-year clinical outcome of the titanium-nitride-oxide-coated bioactive stents (BAS), as compared to paclitaxel-eluting stents (PES), in a real-world patient population.
Abstract: The management of patients on long-term oral anticoagulation and referred for percutaneous coronary interventions represents a substantial challenge to the physician who must balance the risks of periprocedural haemorrhage, thrombotic complications and thromboembolism.
Abstract: The introduction of drug-eluting stents has revolutionized the field of interventional cardiology, since it has reduced the incidence of restenosis by 50-70%. However, recent worrisome data from registries and meta-analyses emphasized higher rates of late and very late stent thrombosis associated with drug-eluting stents. The recently introduced titanium-nitride-oxide-coated stent (Titan-2) has demonstrated an excellent biocompatibility, as reflected by lower rates of platelet aggregation and fibrin deposition, and better endothelialization. Preclinical and clinical trials and registries involving both real-life unselected populations and populations with the most challenging patient and lesion characteristics have shown a low rate of major adverse cardiac events in the long-term, with a restenosis rate comparable with that of drug-eluting stents, with the virtual absence of stent thrombosis.
Abstract: We sought to explore the immediate results of Titan2 stent implantation in small coronary arteries, as well as the incidence of major adverse cardiac events (MACE) at six months follow-up.
Abstract: The aim of this study was to evaluate long-term clinical events in patients treated with titanium-nitride-oxide-coated bio-active stents (BAS) and paclitaxel-eluting stents (PES) in routine clinical practice.
Abstract: Venous lesions, including obstruction and thromboembolism (VTE), are not uncommon after pacemaker implantation. The purpose of this prospective study was to assess the role of various patient and procedure-related risk factors in the development of these complications.
Abstract: We performed a pooled analysis of three trials comparing titanium-nitride-oxide-coated bioactive stents (BAS) with paclitaxel-eluting stents (PES) in 1,774 patients. All patients were followed for 12 months. The primary outcomes of interest were recurrent myocardial infarction (MI), death and target lesion revascularization (TLR). Secondary endpoints were stent thrombosis (ST) and major adverse cardiac events (MACE) including MI, death and TLR. There were 922 patients in the BAS group and 852 in the PES group. BAS significantly reduced the risk of recurrent MI (2.7% vs. 5.6%; risk ratio 0.50, 95% CI 0.31-0.81; p = 0.004) and MACE (8.9% vs. 12.6%; risk ratio 0.71, 95% CI 0.54-0.94; p = 0.02) during the 12 months of follow up. In contrast, the differences between BAS and PES were not statistically significant with respect to TLR (risk ratio 0.98, 95% CI 0.68-1.41), death (risk ratio 0.96, 95% CI 0.61-1.51) and definite ST (risk ratio 0.28, 95% CI 0.05-1.47). In conclusion, the results of this analysis suggest that BAS is effective in reducing TLR and improves clinical outcomes by reducing MI and MACE compared with PES.
Abstract: Long-term oral anticoagulation (OAC) prevents recurrent thrombosis, pulmonary embolism, and stroke, but it also increases bleeding risk. An outpatient bleeding risk index (OBRI) may help to identify patients at high risk of bleeding complications. The aim of this study was to evaluate the predictive value of OBRI in patients with OAC undergoing percutaneous coronary intervention (PCI). In addition, we analyzed the impact of OBRI on treatment choices in this patient group. Four hundred twenty-one patients with OAC underwent PCI at 6 centers in Finland. Complete follow-up was achieved in all patients (median 1,276 days). Sixty-four patients (15%) had a low bleeding risk (OBRI 0), 319 patients (76%) moderate bleeding risk (OBRI 1 to 2), and 38 (9%) high bleeding risk (OBRI 3 to 4). OBRI had no significant effect on periprocedural or long-term antithrombotic medications, choice of access site, or stent type. During follow-up, the incidence of major bleeding increased (p = 0.02) progressively with higher OBRI category (6.3%, 14.1%, and 26.3%, respectively). Similarly, mortality was highest in patients with high OBRI (14.1%, 20.7%, and 39.5%, p = 0.009, respectively), but rates of major adverse cardiovascular and cerebrovascular events were comparable in the OBRI categories. In conclusion, bleeding risk seems not to modify periprocedural or long-term treatment choices in patients after PCI on home warfarin. In contrast, patients with high OBRI often have major bleeding episodes and this simple index seems to be suitable for risk evaluation in this patient group.
Abstract: The aim of this study was to evaluate the long-term effects of the titanium-nitride-oxide-coated (TITANOX) stent and the paclitaxel-eluting stent (PES) in patients who had undergone a percutaneous coronary intervention for acute myocardial infarction (MI).
Abstract: The aim of this study was to evaluate the safety of glycoprotein IIb/IIIa inhibitors (GPIs) during percutaneous coronary intervention (PCI) in patients on chronic warfarin therapy due to atrial fibrillation (AF). We analysed all consecutive AF patients (N = 377, mean age 70 years, male 71%) on warfarin therapy referred for PCI in seven centres. Major bleeding, access site complications and major adverse cardiovascular events were recorded during hospitalisation. A total of 111 patients (29%) received periprocedural GPIs with a wide inter-hospital variation in their use (range 3-68%). The use of GPIs increased with the severity of the disease presentation and 49% of patients with ST-elevation myocardial infarction received GPIs. Mean periprocedural international normalised ratio (INR) of patients who received GPIs was 1.89 (range 1.1-3.3). Major bleeding was more common in the patients treated with GPIs (9.0% vs. 1.5%, p = 0.001) than in those without GPIs, but there was no difference in major adverse cardiovascular events between the groups. In multivariable analysis, use of GPIs (odds ratio [OR] 5.1, 95% confidence interval [CI] 1.3-20.6, p = 0.02) and old age (OR 1.2, 95% CI 1.0-1.3, p= 0.02) remained as the only independent predictors of major bleeding. Also after adjusting for propensity score, GPIs remained as a significant predictor of major bleeding (OR 3.8, 95% CI 1.03-14.1, p = 0.045). In the GPI group, major bleeding was not predicted by INR level or warfarin pause. GPIs increase the risk of major bleeding events irrespective of periprocedural INR levels and should be used with caution in this fragile patient group.
Abstract: The aim of this study was to evaluate the effectiveness of titanium-nitride-oxide (TITANOX)-coated stent and paclitaxel-eluting stent (PES) in patients presenting with acute myocardial infarction (MI).
Abstract: Long-term warfarin therapy is assumed to increase bleeding and access site complications after coronary angiography and it is often recommended to postpone invasive procedures to reach international normalized ratio (INR) levels <1.8. To assess the safety and feasibility of diagnostic coronary angiography during uninterrupted warfarin therapy, we retrospectively analyzed all consecutive patients (n = 258) on warfarin therapy referred for diagnostic coronary angiography in 2 centers with long experience in uninterrupted warfarin therapy during coronary angiography and in 1 center with a policy of preprocedural warfarin pause. An age- and gender-matched control group (n = 258) with similar disease presentation (unstable or stable symptoms) was collected from each center. Radial access was used in 56% of patients in the warfarin group and in 60% of controls (p = 0.21). There was no difference in access site and bleeding complications (1.9% vs 1.6%) or major adverse cardiovascular and cerebrovascular events (0.4% vs 0.8%) between the warfarin group and their controls. Warfarin was interrupted in 80 patients (31%), and bridging therapy was used in 24 of these patients (30%). INR levels were higher in the uninterrupted warfarin group (2.3 vs 1.9, p <0.001), but the incidence of access site complications was not higher (1.7%) than in patients (n = 80) with a warfarin pause (2.5%) or in patients with pause and bridging therapy (8.3%). Need for blood transfusions (n = 2) occurred only in patients with bridging therapy. Access site complications were more common in the 22 patients with supratherapeutic anticoagulation (INR >3) than in patients with therapeutic periprocedural INR (9.1% vs 1.5%, p <0.05). In conclusion, a simple strategy of performing coronary angiography during uninterrupted therapeutic warfarin anticoagulation is a tempting alternative to bridging therapy and is likely to lead to considerable cost savings.
Abstract: Uninterrupted anticoagulation (UAC) is assumed to increase bleeding and access-site complications. A common consensus is to postpone percutaneous coronary interventions (PCI) to reach international normalized ratio (INR) levels < 1.5-1.8.
Abstract: Central vein leads are known to predispose to venous obstruction. Although usually asymptomatic, obstruction may render electrode removal difficult. This study aimed at quantifying changes in venous calibers in a prospective fashion by intravenous contrast venography (ICV) before and after pacemaker (PM) or cardioverter-defibrillator implantation.
Abstract: The aim of this study was to evaluate the antithrombotic treatment adopted after coronary stenting in patients requiring long-term anticoagulation.
Abstract: The aim of this study was to compare clinical outcome of a stainless-steel stent coated with titanium nitride oxide (TITANOX) and a paclitaxel-eluting stent (PES) in routine clinical practice represented by two prospective registries including all patients with de novo coronary artery disease treated exclusively with a TITANOX stent (n = 201) or with a PES (n = 204) between May 2003 and November 2004 (63% of all PCI patients). The primary endpoint of the study was major adverse cardiac events (MACE) at 30 days and 12 months. The TITANOX stent patients were more frequently (p = 0.011) treated for acute myocardial infarction and had more complex B- and C-type lesions (p = 0.004). The PES patients had longer (p < 0.001) total stent length. At 30 days, the rate of MACE was 0% and 4.9% for the TITANOX stent and PES groups, respectively (p = 0.001). A significant difference in target vessel revascularization (TVR) was seen in favor of the TITANOX stent (0% vs. 2.9% for PES; p = 0.014). This was mainly driven by stent thrombosis (n = 7). At 12 months, the difference in MACE was no longer significant (10.9% vs. 13.7%; p = 0.40), but the rate of myocardial infarction was lower in the TITANOX stent group (4.5% vs. 10.3%; p = 0.025). The rate of TVR (8% vs. 6.9%; p = 0.67) was similar between the two groups. In conclusion, both the TITANOX-coated stent and PES resulted in good clinical outcome with infrequent need for repeat interventions in the real-world setting of high-risk patients and complex coronary lesions.
Abstract: Aims: The aim of the Titan PORI Registry was to evaluate the safety and efficacy of a stainless steel stent coated with titanium nitride oxide (Titan(R), Hexacath, France) in routine clinical practice.Methods and results: We report a prospective single-centre experience in treating patients with the Titan(R) stent. All consecutive patients receiving Titan(R) stent(s) were enrolled. The choice of a stent was at the discretion of the operator with no exclusion criteria. The primary end point of the registry was Major Adverse Cardiac Events (MACE) at 6 and 9 months. A total of 210 lesions were treated in 193 enrolled patients (mean age 67+/-10; men 71%; diabetes 17%). Lesions were of type B in 64% and type C in 23%. The indications for PCI were unstable angina or non-Q-wave MI in 36% and acute STEMI in 30% of the patients. Mean reference diameter was 2.9+/-0.3 mm and mean lesion length 12.9+/-3.0 mm. Mean stent size was 2.98 mm (range 2-3.5 mm) and length 15.5 mm (range 7-28 mm). Stent delivery was successful in all cases (23% direct stenting). Complete follow-up of all 193 patients was obtained up to 9 months. There were no in-hospital or 30-day MACE observed. At 270 days, the MACE rate was 10.4% (MI 4.1%, cardiac death 0%, TVR 8.3%). There were no cases with stent thrombosis.Conclusion: These medium term data confirm good safety profile of Titan(R) stent even in high risk patients and complex coronary lesions in routine clinical use.
