An asymptomatic Lima dissection after a programmed hybrid revascularization procedure turned to nightmare.

A 71-year-old female with symptomatic bitroncular coronary ischemic disease was admitted in our hospital for hybrid revascularization. She presented significant stenosis of the proximal and middle left anterior descending artery (LAD) and of the second segment of right coronary artery (RCA). She was scheduled for an Endoscopic Atraumatic Coronary Artery Bypass (EACAB) of the left internal mammary artery (LIMA) to LAD and staged percutaneous coronary intervention (PCI) to RCA after the EACAB. Control of LIMA permeability after RCA PCI showed LIMA dissection with TIMI 2 flow to LAD. Decision to stent a freshly implanted LIMA led to LIMA rupture. An emergent LAD revascularization with a saphenous vein graft and control of bleeding was successfully performed. Patient was discharged at day 10 from the hospital.

First prospective multicenter experience with the 7 French Glidesheath slender for complex transradial coronary interventions.

PURPOSE: To assess the feasibility and safety of the 7 French (Fr) Glidesheath Slender for complex transradial (TR) percutaneous coronary interventions (PCI). BACKGROUND: The TR approach is increasingly used worldwide for coronary and peripheral vascular interventions. However, the small size of the radial artery remains an important limitation for the use of large-bore guiding catheters (>6 Fr), restricting thereby the treatment of highly complex lesions through the TR approach. The 7 Fr Glidesheath slender (Terumo, Tokyo, Japan) is a new dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with any 7 Fr guiding catheter and an outer diameter smaller than current 7 Fr sheaths. METHODS: Prospective multicenter registry of complex TR PCI cases using the 7 Fr Glidesheath Slender to determine the procedural success, rates of vascular complications, radial spasm, and radial artery occlusion (RAO). RESULTS: A total of 60 patients were included. Procedural success was 97% with only one access-site crossover. The use of a 7 Fr guiding catheter was indicated for the treatment of highly complex coronary lesions including distal left main (LM) disease (n = 20), complex non-LM bifurcation lesions (n = 16), chronic total occlusion (n = 15), and severely calcified vessels requiring rotational atherectomy (n = 10). There were three vascular access-site complications (4.7%) including two moderate (type II) local hematoma and one uncomplicated guiding catheter-induced brachial artery dissection. None of the patients experienced major bleeding. The occurrence of radial spasm was reported in seven patients (11%). Doppler ultrasound imaging of the radial artery at 1 month was available in 62 of 64 radial access with three cases of RAO (4.8%). CONCLUSIONS: Use of the 7 Fr Glidesheath slender for complex coronary interventions is feasible and associated with a high rate of procedural success and a low rate of vascular complications. These favorable results need be confirmed in larger multicenter studies. © 2016 Wiley Periodicals, Inc.

Long Coronary Lesions Treated With Thin Strut Bioresorbable Polymer Drug Eluting Stent: Experience From Multicentre Randomized CENTURY II Study.

OBJECTIVES: To assess performance of new, bioresorbable polymer sirolimus-eluting stent (BP-SES), in patients with long coronary lesions (LL) and to compare it to permanent polymer everolimus-eluting stent (PP-EES). BACKGROUND: LL have been associated with worse clinical outcomes in percutaneous coronary interventions (PCI). The impact of lesion length on the outcomes of drug eluting stent (DES) implantations is not as clear. METHODS: In the frame of a randomized, multicentre CENTURY II study, out of 1119 patients enrolled, 182 patients had LL (defined as ≥25 mm), and were assigned randomly to treatment with BP-SES (101) or PP-EES (81). Primary endpoint was target lesion failure (TLF, composite of cardiac death, target vessel related myocardial infarction [MI], and target lesion revascularization [TLR]) at 9 months. All data were 100% monitored and adverse events were adjudicated by an independent clinical event committee. RESULTS: The baseline patient and lesion characteristics were similar in the 2 study arms. At 9-months, the rates of cardiac death (2.0% vs 1.2%; P = 0.70), MI (3.0% vs 4.9%; P = 0.49) and clinically driven TLR (2.0% vs 3.7%; P = 0.48) and TLF (6.9% vs 8.6%; P = 0.67) were similar for BP-SES and PP-EES, respectively. There was no stent thrombosis (ST) in BP-SES group up to 9 months, while 1 case (1.2%) of ST was recorded in PP-EES group (P = 0.44). CONCLUSIONS: Patients with LL showed similar clinical outcomes when treated with Ultimaster BP-SES and Xience PP-EES.

Hemodynamic numerical simulations of the disturbance due to intracoronary flow measurements by a Doppler guide wire.

BACKGROUND: Since hemodynamics plays a key role in the development and evolution of cardiovascular pathologies, physician's decision must be based on proper monitoring of relevant physiological flow quantities. METHODS: A numerical analysis of the error introduced by an intravascular Doppler guide wire on the peak velocity measurements has been carried out. The effect of probe misalignment (±10°) with respect to the vessel axis was investigated. Numerical simulations were performed on a realistic 3D geometry, reconstructed from coronary angiography images. Furthermore, instead of using Poiseuille or Womersley approximations, the unsteady pulsatile inlet boundary condition has been calculated from experimental peak-velocity measurements inside the vessel through a new approach based on an iterative Newton's algorithm. RESULTS: The results show that the presence of the guide modifies significantly both the maximum velocity and the peak position in the section plane; the difference is between 6 and 17 % of the maximum measured velocity depending on the distance from the probe tip and the instantaneous vessel flow rate. Furthermore, a misalignment of the probe may lead to a wrong estimation of the peak velocity with an error up to 10 % depending on the probe orientation angle. CONCLUSIONS: The Doppler probe does affect the maximum velocity and its position during intravascular Doppler measurements. Moreover, the Doppler-probe-wire sampling volume at 5.2 and 10 mm far from the probe tip is not sufficient to prevent its influence on the measurement. This should be taken into account in clinical practice by physicians during intravascular Doppler quantification. The new numerical approach used in this work could potentially be helpful in future numerical simulations to set plausible inlet boundary conditions.

Predictive value of the RIFLE urine output criteria on contrast-induced nephropathy in critically ill patients.

BACKGROUND: To investigate the predictive value of decreased urine output based on the Risk of renal dysfunction, Injury to the kidney, Failure of kidney function, Loss of kidney function and End-stage renal disease (RIFLE) classification on contrast- induced acute kidney injury (CA-AKI) in intensive care (ICU) patients. METHODS: All patients who received contrast media (CM) injection for CT scan or coronary angiography during a 3-year period in a 24 bed medico-surgical ICU were reviewed. RESULTS: Daily serum creatinine concentrations and diuresis were measured for 3 days after CM injection. We identified 23 cases of CA-AKI in the 149 patients included (15.4 %). Patients who developed CA-AKI were more likely to require renal replacement therapy and had higher ICU mortality rates. At least one RIFLE urine output criteria was observed in 45 patients (30.2 %) and 14 of these 45 patients (31.1 %) developed CA-AKI based on creatinine concentrations. In 30 % of these cases, urine output decreased or didn't change after the increase in creatinine concentrations. The RIFLE urine output criteria had low sensitivity (39.1 %) and specificity (67.9 %) for prediction of CA-AKI, a low positive predictive value of 50 % and a negative predictive value of 87.2 %. The maximal dose of vasopressors before CM was the only independent predictive factor for CA-AKI. CONCLUSIONS: CA-AKI is a frequent pathology observed in ICU patients and is associated with increased need for renal replacement therapy and increased mortality. The predictive value of RIFLE urine output criteria for the development of CA-AKI based on creatinine concentrations was low, which limits its use for assessing the effects of therapeutic interventions on the development and progression of AKI.

Embolization of left atrial appendage closure devices: A systematic review of cases reported with the watchman device and the amplatzer cardiac plug.

OBJECTIVES: We sought to provide a systematic review of reported cases of LAA closure device embolization by focusing on the two most commonly implanted devices: the Watchman (WM) device and the Amplatzer Cardiac Plug (ACP). METHODS: A comprehensive search of the Pubmed database was conducted until October 1, 2014. Studies were included if they described at least 1 case of embolization of the WM and/or the ACP. RESULTS: A total of 20 studies reporting 31 cases of device embolization were identified, including 13 cases with WM and 18 cases. The timing of embolization was described in 29 cases and was categorized as acute in 20 cases (65%) and late in 9 cases (30%). The anatomical location of embolized devices was reported in 21 cases: into the aorta in 9 cases, into the left ventricle (LV) in 9 cases and into the left atrial cavity in 3 cases. As compared to embolization into the aorta or the left atrial cavity, device embolization into the LV was associated with a higher rate of surgical retrieval (8/9 vs 2/12; 88% vs 17%, P = 0.0019). Major adverse events related to device embolization occurred in three patients (9.6%). CONCLUSIONS: LAA closure device embolization occurs mainly in the periprocedural period but late embolizations are not uncommon. Although embolization into the aorta or the left atrium can be successfully managed by percutaneous techniques in most cases, device embolization into the LV is associated with a higher rate of surgical retrieval, increasing thereby procedure-related morbidity.

Importance of guiding catheter disengagement during measurement of fractional flow reserve in patients with an isolated proximal left anterior descending artery stenosis.

OBJECTIVE: To determine the impact of ostial guiding catheter disengagement during measurement of fractional flow reserve (FFR) in patients with an isolated proximal left anterior descending artery (LAD) stenosis. METHODS: Measurements of FFR were performed in 21 patients with an isolated intermediate lesion of the proximal LAD. Proximal aortic pressure (Pa), distal post stenotic pressure (Pd), and Pd/Pa were recorded at baseline, after at least 90 sec of intravenous (IV) adenosine infusion with the guiding catheter still engaged in the coronary ostium (Pa1 , Pd1 , FFReng ), and after at least 30 sec of guiding catheter disengagement back to the aorta (Pa2 , Pd2 , FFRdis ). RESULTS: The average value of Pd/Pa at baseline was 0.92 ± 0.04. After 110 ± 8 sec of IV adenosine infusion, FFReng was 0.81 ± 0.07, which decreased to 0.77 ± 0.08 (FFRdis ) after 38 ± 6 sec of guiding catheter disengagement. The mean ΔFFR (FFReng - FFRdis ) was 0.05 ± 0.04. As compared to baseline values, the mean change in FFR values was significantly increased after disengagement of the guiding catheter (Pd/Pabaseline - FFRdis vs. Pd/Pabaseline - FFReng , 0.15 ± 0.05 vs. 0.10 ± 0.04, P < 0.0001). Before guiding catheter disengagement, eight patients (38%) had an FFR value ≤ 0.8. Following disengagement of the guiding catheter, the new FFR values decreased below 0.8 in six additional patients (28%), with subsequent change in treatment strategy. CONCLUSIONS: During FFR assessment of isolated intermediate proximal LAD lesions, guiding catheter disengagement is associated with a decrease in mean FFR values. In patients with FFR values lying close to the treatment threshold, this can have an impact on treatment strategy.

An in vitro test bench reproducing coronary blood flow signals.

BACKGROUND: It is a known fact that blood flow pattern and more specifically the pulsatile time variation of shear stress on the vascular wall play a key role in atherogenesis. The paper presents the conception, the building and the control of a new in vitro test bench that mimics the pulsatile flows behavior based on in vivo measurements. METHODS: An in vitro cardiovascular simulator is alimented with in vivo constraints upstream and provided with further post-processing analysis downstream in order to mimic the pulsatile in vivo blood flow quantities. This real-time controlled system is designed to perform real pulsatile in vivo blood flow signals to study endothelial cells' behavior under near physiological environment. The system is based on an internal model controller and a proportional-integral controller that controls a linear motor with customized piston pump, two proportional-integral controllers that control the mean flow rate and temperature of the medium. This configuration enables to mimic any resulting blood flow rate patterns between 40 and 700 ml/min. In order to feed the system with reliable periodic flow quantities in vivo measurements were performed. Data from five patients (1 female, 4 males; ages 44-63) were filtered and post-processed using the Newtonian Womersley's solution. These resulting flow signals were compared with 2D axisymmetric, numerical simulation using a Carreau non-Newtonian model to validate the approximation of a Newtonian behavior. RESULTS: This in vitro test bench reproduces the measured flow rate time evolution and the complexity of in vivo hemodynamic signals within the accuracy of the relative error below 5%. CONCLUSIONS: This post-processing method is compatible with any real complex in vivo signal and demonstrates the heterogeneity of pulsatile patterns in coronary arteries among of different patients. The comparison between analytical and numerical solution demonstrate the fair quality of the Newtonian Womersley's approximation. Therefore, Womersley's solution was used to calculate input flow rate for the in vitro test bench.

Initial experience with the Glidesheath Slender for transradial coronary angiography and intervention: a feasibility study with prospective radial ultrasound follow-up.

OBJECTIVE: The aim of this study is to evaluate the feasibility and safety of the Glidesheath Slender in routine transradial (TR) coronary angiography and intervention. BACKGROUND: In recent years, The TR approach has gained in popularity because of several advantages such as reduced vascular access site complications and immediate patient mobilization. Procedural success has been further improved through technological innovations and the development of less invasive devices. The Glidesheath Slender (Terumo, Tokyo, Japan) is a new dedicated radial sheath with a thinner wall and hydrophilic coating. It combines an inner diameter compatible with 6Fr guiding catheter with an outer diameter close to current 5Fr sheaths. Its use has the potential to decrease invasiveness and access site complications during TR procedures. METHODS: A total of 114 consecutive patients undergoing TR coronary angiography and/or PCI using the Gidesheath Slender were included in a prospective single-center feasibility and safety study. RESULTS: Procedural success was 99.1% with only one case requiring conversion to femoral access. There were six minor hematomas but none of the patients experienced major vascular complications. The rate of symptomatic radial spasm was 4.4%. No case of major sheath kinking was noted. Doppler ultrasound examination of the radial artery at 1 month follow-up was available in 113/114 patients with only one case of radial artery occlusion (RAO) (0.88%). CONCLUSIONS: Routine use of the Glidesheath Slender for TR coronary angiography and interventions is safe and feasible with a high rate of procedural success and a low rate of RAO. © 2013 Wiley Periodicals, Inc.

Late contained aortic root rupture and ventricular septal defect after transcatheter aortic valve implantation.

Transcatheter aortic valve implantation (TAVI) is a highly specialized technique offering a new therapeutic option to patients at high risk for conventional surgery. However, despite continuous improvements in operators' expertise and device technology, complications associated with this catheter procedure are not uncommon. We report an unusual case of late contained rupture of the aortic annulus, combining a para-aortic false aneurysm and a ventricular septal defect, after the placement of an Edwards Sapien prosthesis.

Titanium-Nitride-Oxide-Coated vs Everolimus-Eluting Stents in Acute Coronary Syndrome: 5-Year Clinical Outcomes of the TIDES-ACS Randomized Clinical Trial.

Importance: Titanium-nitride-oxide (TiNO)-coated stents show faster strut coverage compared with drug-eluting stents without excessive intimal-hyperplasia observed in bare metal stents. It is important to study long-term clinical outcomes after treatment of patients with an acute coronary syndrome (ACS) by TiNO-coated stents, which are neither drug-eluting stents nor bare metal stents. Objective: To compare the rate of main composite outcome of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 5 years in patients with ACS randomized to receive either a TiNO-coated stent or a third-generation everolimus-eluting stent (EES). Design, Setting, and Participants: This multicenter, randomized, controlled, open-label trial was conducted in 12 clinical sites in 5 European countries and enrolled patients from January 2014 to August 2016. Patients presenting with ACS (ST-segment elevation MI, non-ST-segment elevation MI, and unstable angina) with at least 1 de novo lesion were randomized to receive either a TiNO-coated stent or an EES. The present report analyzes the long-term follow-up for the main composite outcome and its individual components. Analysis took place between November 2022 to March 2023. Main outcome: The primary end point was a composite of cardiac death, MI, or target lesion revascularization at 12-month follow-up. Results: A total of 1491 patients with ACS were randomly assigned to receive either TiNO-coated stents (989 [66.3%]) or EES (502 [33.7%]). The mean (SD) age was 62.7 (10.8) years, and 363 (24.3%) were female. At 5 years, the main composite outcome events occurred in 111 patients (11.2%) in the TiNO group vs 60 patients (12%) in the EES group (hazard ratio [HR], 0.94; 95% CI, 0.69-1.28; P = .69). The rate of cardiac death was 0.9% (9 of 989) vs 3.0% (15 of 502) (HR, 0.30; 95% CI, 0.13-0.69; P = .005), the rate of MI was 4.6% (45 of 989) vs 7.0% (35 of 502) (HR, 0.64; 95% CI, 0.41-0.99; P = .049), the rate of stent thrombosis was 1.2% (12 of 989) vs 2.8% (14 of 502) (HR, 0.43; 95% CI, 0.20-0.93; P = .034), and the rate of target lesion revascularization was 7.4% (73 of 989) vs 6.4% (32 of 502) (HR, 1.16; 95% CI, 0.77-1.76; P = .47) in the TiNO-coated stent arm and in the EES arm, respectively. Conclusion and relevance: In this study, patients with ACS had a main composite outcome that was not different 5 years after TiNO-coated stent or EES. Trial Registration: ClinicalTrials.gov Identifier: NCT02049229.

Perforation of the descending thoracic aorta during transcatheter aortic valve implantation (TAVI): an unexpected and dramatic procedural complication.

Transcatheter aortic valve implantation (TAVI) has become an established technique for the treatment of aortic stenosis in patients who cannot undergo surgery. Although TAVI is obviously less invasive than open surgical repair, it is not free of complications. We report a case of unexplained refractory shock during transfemoral TAVI with subsequent autopsy demonstrating a 1-cm large perforation of the descending thoracic aorta as the cause of death. To the best of our knowledge, this is the first case ever reported.

Impact of age on the comparison between short-term vs 12-month dual antiplatelet therapy in patients with acute coronary syndrome treated with the COMBO dual therapy stent: 2-Year follow-up results of the REDUCE trial.

BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

Titanium-Nitride-Oxide-Coated Versus Everolimus-Eluting Stents in Acute Coronary Syndrome: The Randomized TIDES-ACS Trial.

OBJECTIVES: This study sought to compare next-generation cobalt-chromium-based titanium-nitride-oxide (TiNO)-coated stents with a platinum-chromium-based biodegradable polymer everolimus-eluting stent (EES) in patients with acute coronary syndrome (ACS). BACKGROUND: Previous generation TiNO-coated stents showed acceptable performance in patients with ACS. METHODS: In a multicenter, randomized trial, we randomly assigned 1,491 ACS patients (2:1) to receive either a TiNO-coated stent (n = 989) or EES (n = 502). The primary endpoint was the rate of a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization at 12-month follow-up. The co-primary endpoint was a composite of cardiac death, MI, or major bleeding at 18 months. RESULTS: A primary endpoint event occurred in 6.3% of patients in the TiNO-coated stent group versus in 7.0% in the EES group (hazard ratio: 0.93; 95% confidence interval: 0.71 to 1.22; p = 0.66 for superiority; p < 0.001 for noninferiority). A co-primary endpoint event occurred in 3.7% of the patients in the TiNO group and in 7.8% in the EES group (hazard ratio: 0.64; 95% confidence interval: 0.51 to 0.80; p = 0.001). TiNO-coated stents were associated with lower rates of cardiac death (0.6% vs. 2.6%; p = 0.002) and MI (2.2% vs. 5.0%; p = 0.007) at 18 months of follow-up. Rates of target lesion revascularization were not significantly different at 18 months (5.8% vs. 4.4%; p = 0.27). CONCLUSIONS: In patients with ACS, cobalt-chromium-based TiNO-coated stents were noninferior to platinum-chromium-based biodegradable polymer EES for major cardiac events at 12 months, and were superior for the co-primary endpoint of cardiac death, MI, and bleeding at 18 months. (Comparison of Titanium-Nitride-Oxide-Coated Bio-Active-Stent (Optimax™) to the Drug (Everolimus) -Eluting Stent (Synergy™) in Acute Coronary Syndrome [TIDES-ACS]; NCT02049229).

Radial Versus Femoral Approach for Percutaneous Coronary Intervention: MACE Outcomes at Long-Term Follow-up.

OBJECTIVE: To compare the main outcomes of radial versus femoral access at long-term follow-up. BACKGROUND: Little is known about the long-term major cardiovascular events and bleeding complications of patients undergoing percutaneous coronary intervention (PCI) with radial vs femoral approach. METHODS: A total of 1107 patients from the CENTURY II trial were included. To minimize baseline differences between radial and femoral groups, we applied propensity-score matching for this comparison. RESULTS: In this multicenter study, the radial approach was used in 73.4% of patients. After propensity-score matching, baseline and procedural characteristics were comparable between both groups. Procedural success was high and similar in radial and femoral approaches (98.2% vs 97.5%; P=.47) while radial access was associated with a shorter hospital stay (1.69 ± 1.92 days vs 2.08 ± 1.98 days; P<.01). The short-term bleeding and vascular complication rates were significantly lower in the radial group (1.7% vs 6.2% [P<.001 in-hospital] and 2.7% vs 9.6% [P<.001 at 1-month follow-up]). At 3-year follow-up, radial access was associated with lower rates of all-cause mortality (3.9 vs 6.9%; P=.04) and cardiovascular death (2.1 vs 4.9%; P=.02). The composite of all-cause mortality, myocardial infarction, and revascularization showed no differences between groups (18.2 vs 21.1%; P=.29). CONCLUSIONS: Compared to the femoral approach, the radial approach is associated with significantly lower long-term all-cause mortality rate as well as lower in-hospital and short-term bleeding rates. These results suggest additional long-term benefits of radial access for PCI, but should be interpreted within the context of the current study and further verified in future studies.

Long-term clinical outcome of titanium-nitride-oxide-coated stents versus everolimus-eluting stents in acute coronary syndrome: Final report of the BASE ACS trial.

BACKGROUND: The BASE ACS randomized trial demonstrated non-inferiority of titanium-nitride-oxide-coated bioactive stents (BAS), compared with everolimus-eluting stents (EES), for the primary endpoint of major adverse cardiac events (MACE) in patients presenting with acute coronary syndrome (ACS) at 12-month follow-up. We report the final long-term clinical outcome of the trial. METHODS: We randomly assigned 827 patients with ACS to receive either BAS (417) or EES (410). The primary endpoint was MACE: a composite of cardiac death, non-fatal myocardial infarction (MI) or ischemia-driven target lesion revascularization (TLR) at 12-month follow-up. Analysis was performed by intention to treat. Follow-up was planned at 12months, and yearly thereafter through 7years. RESULTS: Mean follow-up duration was 4.2±1.9years (median 5.0years). At 5-year follow-up, BAS was non-inferior to EES for the primary endpoint of MACE (14.4% versus 17.8%, respectively; hazard ratio for BAS versus EES, 0.82; 95% confidence interval, 0.58-1.16; p=0.26 for superiority; p<0.001 for non-inferiority). The rate of non-fatal MI was lower in the BAS group (5.9% versus 9.7%, respectively, p=0.028). The rates of cardiac death and ischemia-driven TLR were comparable (2.8% versus 3.8%, and 8.3% versus 9.9%; p=0.76 and p=0.58, respectively). CONCLUSIONS: In the current final report of the randomized BASE ACS trial in patients with ACS, BAS implantation was associated with a rate of cumulative MACE at long-term follow-up that was statistically non-inferior to EES.

Long-term effect of molsidomine, a direct nitric oxide donor, as an add-on treatment, on endothelial dysfunction in patients with stable angina pectoris undergoing percutaneous coronary intervention: results of the MEDCOR trial.

OBJECTIVE: The MEDCOR trial is a double-blind, randomized study aiming at demonstrating the superiority of molsidomine (direct NO donor) over placebo, used as add-on treatments, on improving endothelial function (EF) after 12 months, in stable angina patients undergoing percutaneous coronary intervention. METHODS: EF was assessed by peripheral vasodilator response (i.e. Endoscore) using arterial tonometry and by several biomarkers, in terms of changes versus baseline after a one-year treatment. RESULTS: The change in Endoscore was +75 ± 130% in placebo group and +39 ± 145% in molsidomine group (p = 0.143). There was a decrease in sICAM-1 with molsidomine (-6%) and an increase with placebo (+6%). The MPO activity/antigen ratio slightly increased with placebo (+9%) and strongly decreased with molsidomine (-42%) (p = 0.020). CONCLUSION: The MEDCOR trial was not able to demonstrate significant differences between molsidomine and placebo for all parameters, except the MPO activity/antigen ratio which significantly decreased with molsidomine (p = 0.020 versus placebo).

Gender-based analysis of randomized comparison of bioactive versus everolimus-eluting stents in acute coronary syndrome.

AIMS: The randomized comparison of titanium-nitride-oxide-coated bioactive stent with everolimus-eluting stent in acute coronary syndrome (BASE-ACS) trial demonstrated an outcome of the titanium-nitride-oxide coated bioactive stents (BASs) that was statistically noninferior to that of the everolimus-eluting stents (EESs) at 12-month follow-up, in patients presenting with acute coronary syndrome (ACS) who underwent early percutaneous coronary intervention. We performed a post-hoc gender-based analysis of the BASE-ACS trial at 24-month follow-up. METHODS: A total of 827 patients (198 women) with ACS were randomly assigned to receive either BAS or EES. The primary endpoint was a composite of cardiac death, nonfatal myocardial infarction (MI), or ischemia-driven target lesion revascularization. RESULTS: Women were older, and more likely to have diabetes and hypertension compared with men (P < 0.05 for all). Moreover, women had significantly smaller reference vessel diameter and stent diameter (P < 0.05 for all). At 24-month follow-up, the cumulative incidence of the primary endpoint was similar between the two sex subgroups (15.2 versus 11.0%, for women versus men, respectively, P = 0.13). However, the rate of nonfatal MI was significantly higher in women compared with men (8.6 versus 3.8%, respectively, P = 0.007). After propensity score-adjusted analysis, there was a trend toward more nonfatal MI among women (8.6 versus 4.0%, respectively, P = 0.08). Moreover, among male patients, those assigned to BAS had significantly lower nonfatal MI compared with those assigned to EES (P = 0.027). However, among patients assigned to EES, female patients had a significantly higher rate of nonfatal MI compared with men (P = 0.02). CONCLUSION: In the current post-hoc gender-based analysis of the BASE-ACS trial, the 24-month outcome of patients undergoing percutaneous coronary intervention for ACS was slightly worse in women, compared with men, as reflected by a trend toward more nonfatal MI events after propensity score-adjusted analysis.