Abstract: OBJECTIVES: 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. BACKGROUND: The safety of Titan2 stent has been confirmed in several studies in real-life unselected populations. METHODS: We enrolled 311 consecutive patients admitted for percutaneous intervention for at least one significant (50%) de novo lesion in a native small coronary artery (2.0-2.75 mm). All lesions were treated with Titan2 stent implantation. Patients were prospectively followed up for at least six months. The primary endpoint was MACE at six months follow-up [death, myocardial infarction (MI), or target vessel revascularization (TVR)]. Secondary endpoints included angiographic and clinical procedural success, in-hospital MACE, target lesion revascularization (TLR) during follow-up, and stent thrombosis. RESULTS: The mean age was 67.3 +/- 10.9 years (65.9% males). A total of 356 Titan2 stents were implanted in 353 lesions. Angiographic and clinical procedural success was achieved in 344 (97.5%) patients. No case of in-hospital MACE or acute stent thrombosis was reported. Clinical follow-up was completed for an average of 8 +/- 2 months. Two patients (0.7%) died, and 6 (2.1%) developed MI. TLR was performed in 12 (4.2%) and TVR in 16 (5.5%) patients, all were clinically driven. Cumulative MACE occurred in 20 (6.9%) patients. One patient suffered subacute stent thrombosis, but no late stent thrombosis. CONCLUSIONS: Titan2 stent implantation in small coronary arteries achieves excellent immediate outcome, with a low incidence of MACE at mid-term follow-up.
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: AIMS: 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. METHODS AND RESULTS: A prospective venography-based study of 150 consecutive pacemaker implantations with a 6-month follow-up was conducted. Current case-control study included all cases (n = 47) with a new venous lesion, and their matched controls. Several surgical and technical factors, i.e. lead burden, choice of venous access, operator experience and procedure duration, as well as patient-related classic risk factors of VTE were assessed. Plasma markers of coagulation and endothelial activation [prothrombin fragment 1 + 2 (F1 + 2), D-dimer (DD), von Willebrand factor (vWF), thrombomodulin (Tm)] were used to evaluate the extent of acute surgical trauma. All cases with venous lesions were also screened for thrombophilia. None of the procedure-related variables were predictive of VTE. Mean levels of vWF, F1 + 2 and DD increased significantly (P < 0.001) and equally in both cases and controls. No single clinical factor predicted venous lesions, but significant (P < 0.05) clustering of classic clinical VTE risk factors was seen among the cases. Thrombophilia was overrepresented in patients with symptomatic pulmonary embolism (2/5, 40%). CONCLUSION: Pacemaker implantation induces a transient hypercoagulable state, but its degree does not predict subsequent venous thromboembolism, and neither did the grade of endothelial damage as reflected by plasma markers. The aetiology of these lesions seems to be multifactorial, and clustering of classic thrombotic risk factors plays a role in the pathogenesis.
Abstract: BACKGROUND AND AIMS: 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). METHODS AND RESULTS: The TITAX-AMI trial randomly assigned 425 patients with MI to receive either a TITANOX stent or a PES. The primary end-point was a composite of MI, target lesion revascularization, or death from cardiac causes. At 12 months, there was no significant difference between patients receiving TITANOX stent or PES in the rate of primary end-point (10.3% versus 12.8%, P=0.5). After 2 years of follow-up, a significantly lower rate of primary end-point was observed in the TITANOX stent group compared with the PES group (11.2% versus 21.8%, HR 2.2, 95% confidence interval (CI) 1.3-3.8, P=0.004). This difference was driven by a reduced rate of MI (5.1% versus 15.6%, P<0.001) and cardiac death (0.9% versus 4.7%, P=0.02) in favour of the TITANOX stent. Definite stent thrombosis occurred in 0.5% and 6.2% of the patients (P=0.001), respectively. CONCLUSIONS: The implantation of a TITANOX stent resulted in better clinical outcome compared with a PES during 2 years of follow-up among patients treated for acute 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: BACKGROUND: 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. METHODS: All patients undergoing percutaneous coronary intervention (PCI) were eligible for this single-centre registry between May 2003 and November 2004. The primary end point of the study was major adverse cardiac events (MACE) at 3 years including myocardial infarction (MI), cardiac death and target vessel revascularization (TVR). RESULTS: A total of 201 patients received BAS and 204 patients PES. In addition, during the same study period, 184 patients were treated with bare-metal stents (BMS) and 125 patients underwent CABG. Complete follow-up datasets were available in all patients. After 3 years of follow-up, the rate of MACE was 13.9% for BAS and 23.5% for PES (adjusted HR 2.0, 95% CI 1.2-3.2, p=0.006). This difference was mainly driven by a higher incidence of MI in the PES group (19.1%) compared with the BAS (7.5%) group (adjusted HR 3.2, 95% CI 1.7-5.8, p<0.001). The rate of MACE was 31.5% in the BMS group and 4% in the CABG group. At 3 years, stent thrombosis occurred in 15 patients in the PES (7.4%) group. There was no stent thrombosis in the BAS group. CONCLUSIONS: After the 3 year follow-up, BAS resulted in better long-term outcome compared with PES with infrequent need for TVR.
Abstract: AIMS: 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. METHODS AND RESULTS: To assess the safety and feasibility of UAC, we analysed retrospectively all consecutive patients (n = 523) on warfarin therapy referred for PCI in four centres with a policy to interrupt anticoagulation (IAC) before PCI and in three centres with a long experience on UAC during PCI. Major bleeding, access-site complications, and major adverse cardiac events (death, myocardial infarction, target vessel revascularization, and stent thrombosis) were recorded during hospitalization. In the IAC group, warfarin was withdrawn for a mean of 3 days prior to PCI (mean INR 1.7). In the UAC group, mean INR value was 2.2. Glycoprotein IIb/IIIa (GP) inhibitors (P < 0.001) and low-molecular-weight heparins (P < 0.001) were more often used in the IAC group. Major bleeding and access-site complications were more common in the IAC group (5.0% vs. 1.2%, P = 0.02 and 11.3% vs. 5.0%, P = 0.01, respectively) than in the UAC group. After adjusting for propensity score, the group difference in access-site complications remained significant [OR (odds ratio) 2.8, 95% CI (confidence interval) 1.3-6.1, P = 0.008], but did not remain significant in major bleeding (OR 3.9, 95% CI 1.0-15.3, P = 0.05). In multivariable analysis, femoral access (OR 9.9, 95% CI 1.3-75.2), use of access-site closure devices (OR 2.1, 95% CI 1.1-4.0), low-molecular-weight heparin (OR 2.7, 95% CI 1.1-6.7) and old age predicted access-site complications, and the use of GP inhibitors (OR 3.0, 95% CI 1.0-9.1) remained as a predictor of major bleeding. CONCLUSION: Our study shows that PCI is a safe procedure during UAC with no excess bleeding complications.
Abstract: AIMS: 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). METHODS AND RESULTS: A total of 425 patients presenting with acute non-ST-elevation MI or ST-elevation MI were randomly assigned to receive TITANOX-coated stent or PES. The primary end point was a composite of MI, target lesion revascularisation (TLR) or death from cardiac causes. At 12 months, there was no significant difference between patients receiving TITANOX-coated stent or PES in the rates of primary end point (10.3% vs. 12.8%, P=0.5), MI (4.2% vs. 8.1%, P=0.1), or TLR (9.3% vs. 7.1%, P=0.5), respectively. The incidence of stent thrombosis, defined according to Academic Research Consortium classification, was significantly lower in the TITANOX group compared to the PES group (0.9% vs. 4.3%, P=0.03). CONCLUSIONS: TITANOX-coated stent and PES resulted in comparable clinical outcomes during 12 months follow-up among patients treated for acute 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: BACKGROUND: 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. METHODS: One hundred and fifty (mean age 67; 61% male) consecutive patients were enrolled, and followed for 6 months. A successful ICV was done at baseline prior to implantation and at 6-month follow-up in 136 (91%) patients. Minimum (D(min)) and maximum (D(max)) vessel diameters were obtained from both ICVs. A new stenosis was defined as a 50% diameter reduction in a venous segment when compared to baseline. We implanted a total of 230 electrodes: 47 (34.6%) single lead, 84 (61.8%) 2-lead, and 5 (3.7%) 3-lead systems. RESULTS: At baseline ICV, 10 patients (7%) were found to have venous anomalies, including 8 patients with obstructive lesions, 1 patient with a persistent left superior vena cava, and 1 patient with double axillary vein. At 6 months, a new obstructive venous lesion had developed in a total of 19 (14%) patients, none of whom exhibited any local symptoms. Of these patients 14 (10%) had a stenosis (mean D(min) 4.6 mm and diameter 38% of baseline), and 5 (3.6%) had a complete venous occlusion. In most cases the new stenosis developed in a location where the vessel was narrowest at baseline. Clinical predictors for the development of stenosis were atrial fibrillation at baseline and biventricular PM implantation. CONCLUSIONS: This is the first systematic study to quantify venous changes after PM or ICD implantation. Our study shows that venous anomalies rendering PM implantation difficult are not infrequent. The incidence of new venous obstruction was 14%. Atrial fibrillation and biventricular PM implantation were independent predictors of venous obstruction.
Abstract: AIM: The aim of this study was to evaluate the antithrombotic treatment adopted after coronary stenting in patients requiring long-term anticoagulation. METHODS AND RESULTS: We analysed retrospectively all consecutive patients on warfarin therapy (n = 239, mean age 70 years, men 74%) who underwent percutaneous coronary intervention (PCI) in 2003-04 in six hospitals. An age- and sex-matched control group with similar disease presentation (unstable or stable symptoms) was selected from the study period. Primary endpoint was defined as the occurrence of death, myocardial infarction, target vessel revascularization, or stent thrombosis at 12 months. Warfarin treatment was an independent predictor of both primary endpoint (OR 1.7, 95% CI 1.0-3.0, P = 0.05) and major bleeding (OR 3.4, 95% CI 1.2-9.3, P = 0.02). Triple therapy with aspirin and clopidogrel was the most common (48%) option in stented patients in warfarin group, and there was a significant (P = 0.004) difference between the drug combinations in stent thrombosis with the highest (15.2%) incidence in patients receiving warfarin plus aspirin combination. CONCLUSION: Our study shows that the prognosis is unsatisfactory in warfarin-treated patients irrespective of the drug combination used. Aspirin plus warfarin combination seems to be inadequate to prevent stent thrombosis.
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.
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: BACKGROUND: Interest in determination of baroreflex sensitivity in clinical practice is growing because of its prognostic information in patients with heart disease. The purpose of the present study was to assess the feasibility of cross spectral analysis in the determination of baroreflex gain from spontaneous RR interval and systolic pressure fluctuations, and to compare the results to the traditional pharmacological method in patients with coronary artery disease. Methods. We measured the gain and time lag between RR interval and systolic pressure variabilities in the frequency domain, and compared baroreflex indexes obtained by this technique with standard phenylephrine tests in 32 patients with coronary artery disease. Results. Cross spectral analysis by fast Fourier transform techniques yielded acceptable (> 0.5) coherence between systolic pressure and RR interval in the mid- (0.07-0.15 Hz) and in the respiratory-frequency (0.15-0.40 Hz) band fluctuations in 30 patients (94%), with mean coherences of 0.69 and 0.74. The mean phase difference in the mid-frequency hand was greater than in the respiratory-frequency band (-83 vs -23 degrees, P < 0.001), suggesting that the mid-frequency fluctuations of RR intervals followed nearly 2 seconds after pressure changes, while respiratory-frequency fluctuations of RR intervals occurred nearly concomitantly with systolic pressure. The mean baroreflex slope derived from the bolus phenylephrine technique was 6.2 ms/mmHg (range 1.6-16.0), 5 patients had an abnormally low (<3 ms/mmHg) baroreflex sensitivity. Baroreflex gain determined by cross spectral analysis from the mid-frequency band correlated significantly (r = 0.60, P < 0.001, n = 27) with the baroreflex gain determined by the phenylephrine test, while the correlation in the respiratory-frequency band was not significant (r = 0.35, P = 0.09, n = 26). Conclusions. Baroreflex slopes derived from cross spectral techniques provide reliable (but not perfect) information regarding baroreflex gain derived from the clasic phenylephrine technique, even in patients with depressed baroreflex responses. Cross correlation calculation of spontaneous baroreflex slopes should be limited to data in the mid-frequency range, where the slopes are likely to reflect simple baroreflex physiology.
