The relationship between glycaemic control and platelet reactivity in patients with type 2 diabetes mellitus (DM) on dual antiplatelet therapy is still unclear. A total of 155 consecutive stable ...angina patients with type 2 DM scheduled for elective percutaneous coronary intervention (PCI) were recruited. All patients were taking aspirin and received a 600-mg loading dose of clopidogrel at least 12 h before intervention. Platelet reactivity was assessed prior to PCI using the VerifyNow
®
device (Accumetrics Inc., San Diego, California). High platelet reactivity on clopidogrel (HPR
Clopidogrel
) was defined as a PRU value ≥240. HPR on aspirin (HPR
Aspirin
) defined as an ARU value ≥550. Poor glycaemic control was defined as a HbA1C value >7 mg/dL. There was no significant difference in either PRU or ARU values in patients with poor glycaemic control compared to those with good glycaemic control (PRU: 230 ± 92 vs. 228 ± 110,
P
= 0.90; ARU: 440 ± 63 vs. 435 ± 60,
P
= 0.61). Patients with and without poor glycaemic control did not show significantly different prevalence of HPR
Aspirin
(8 vs. 6%;
P
= 0.23) or HPR
Clopidogrel
(46 and 44%;
P
= 0.80). There was no significant correlation found between HbA1C and either ARU values (
r
= 0.040,
P
= 0.71) or PRU values (
r
= 0.018,
P
= 0.87). Overall these data suggest that glycaemic control does not appear to influence platelet reactivity in patients with type 2 DM following a loading dose of 600 mg of clopidogrel and aspirin treatment.
Objective In the past, certain lesion characteristics of chronic total occlusions (CTOs) have been shown to have an infl uence on guidewire crossing and thus percutaneous coronary interventional ...outcome. However, a clear description of the individual impact of these characteristics on procedural outcome, procedural characteristics and treatment strategy is lacking. The purpose of this study was to give a "weight" to these individual characteristics and evaluate their infl uence on interventional strategy.
Methods Between November 2011 and May 2013, a non-randomized, prospective study was conducted in the hospitals of Genk and Aalst, leading to the inclusion of 132 consecutive patients. Lesions were classifi ed according to the J-CTO (Multicenter CTO Registry of Japan) score (Morino et al., 2011). Both antegrade and retrograde procedures were performed. For antegrade procedures, a step-up strategy was applied. Univariate and multivariate analyses were performed and compared with the results of Morino et al. The study end point was general procedural success, defi ned as successful stenting with thrombosis in myocardial infarction 3 fl ow.
Results Overall procedural success was achieved in 74% and according to J-CTO criteria, in 92% (easy), 82% (intermediate), 77% (difficult) and 40% (very difficult), respectively. Independent predictors included bending, blunt stump, multivessel PCI and a retrograde approach with corresponding odds ratios for failure of 5.3, 2.7, 2.8 and 4.0, respectively.
Conclusion Lesion characteristics of CTOs remain important in the prediction of success. In this study, bending and a blunt stump at the entry site came forth as the most important independent predictors of failure.
Summary Background Drug-eluting stents (DES) are more effective than bare-metal stents (BMS) in small coronary vessel disease. Whether this is true in elderly patients, it is unclear, as frailty and ...a high rate of comorbidities could increase the rate of DES-related complications. Aims To assess procedural and long-term clinical outcomes of elderly patients with small vessel disease treated with DES or BMS. Methods Consecutive elderly patients (≥ 75 years old) treated with stenting of native small coronary arteries (reference vessel diameter and implanted stent < 3 mm) were recruited during 2004–2008. Procedural and long-term clinical outcomes were compared between patients treated with BMS and DES. Propensity score-adjusted logistic regression analysis was performed to account for potential selection bias. Results Among 293 patients (175 BMS, 118 DES), peri-procedural myocardial infarction (12 7% vs. 5 4%; P = 0.35) and blood transfusions (3 2% vs. 0; P = 0.08) were not significantly different between the BMS and DES groups. Clinical follow-up (96% of patients, median interquartile range follow-up 3.5 2.4 years) showed significantly lower adjusted major adverse cardiac events (hazard ratio HR 0.42, 95% confidence interval CI 0.24–0.72; P = 0.002) and target vessel revascularization (TVR) (HR 0.33, 95% CI 0.14–0.76; P = 0.009) in the DES group. No significant differences were observed between the groups in terms of death, myocardial infarction, stent thrombosis or bleeding. Conclusions In this retrospective, non-randomized analysis of the treatment of small vessel disease in elderly patients, DES were as safe and more effective than BMS with a significant reduction in TVR.
ALX-0081 is a novel nano-antibody inhibiting von Willebrand factor (vWF). We evaluated whether direct inhibition of vWF by ALX-0081 improves endothelial function. Stable patients (pts,
n
= 55) with ...single vessel disease undergoing percutaneous coronary intervention (PCI) were randomized to ALX-0081 (
n
= 38) or placebo (
n
= 17). vWF inhibition was assessed by vWF antigen level (vWF:Ag) and activity by ristocetin test (vWF:RiCo). Endothelial function was assessed before (BL), 6 h and 24 h after PCI by: (a) endothelial peripheral arterial tonometry (Endoscore); (b) endothelial microparticles (EMPs) by flow cytometry. vWF:Ag and vWF:RiCo decreased within 1 h from ALX-0081. In the placebo group, no significant Endoscore changes occurred from BL to 24 h. In ALX-0081 group, Endoscore increased from BL to 24 h (
p
= 0.014). A decrease in EMPs was observed after ALX-0081 (
p
< 0.01), while no changes occurred in placebo pts. An inhibition of vWF with ALX-0081 significantly improves peripheral endothelial function.
Monocyte–platelet aggregates (MPA) are increased in patients with acute coronary syndrome. We investigated whether MPA are associated with the presence of functionally significant coronary stenoses ...or with coronary arterial endothelial dysfunction. One hundred forty five patients undergoing elective coronary angiography were prospectively enrolled. Functional significance of coronary stenosis was assessed by fractional flow reserve (FFR). Thirty randomly selected patients underwent pacing protocol to evaluate Coronary endothelium-dependent vasomotor function (CVF). Whole blood was drawn to evaluate MPA. In patients with FFR ≤ 0.8 (FFR
pos
,
n
= 75), MPA did not significantly differ from FFR >0.8 patients (FFR
neg
,
n
= 70) (38.1 % 25.7–56.6 vs 34.0 % 20.5–49.9,
p
= 0.08). CVF was similar in FFR
pos
and FFR
neg
patients (percent vessel diameter change, %VDC = 7.19 % 6.01–10.9 vs 8.0 % 0.81–9.80,
p
= 0.78). Yet, patients with abnormal CVF showed higher MPA as compared to patients with preserved CVF (28.3 % 28.8–53.4 vs 20.5 % 17.0–32.9,
p
= 0.01). Moreover, MPA was inversely correlated with %VDC (
R
2
= 0.26,
p
< 0.01). MPA levels are significantly higher in patients with abnormal coronary vasomotor function regardless of the presence of functionally significant coronary stenosis.
We evaluated the clinical outcome of patients with moderate/severe aortic stenosis and significant coronary disease not treated according to guidelines, recommending combined aortic valve replacement ...(AVR) and coronary artery bypass grafting (CABG). From 2002 to 2010, we assessed death up to 5 years in 650 patients with moderate/severe aortic stenosis and at least one coronary lesion (>50 %): 23 % were treated conservatively (MT), 17 % with percutaneous coronary intervention (PCI), 11 % with AVR, and 49 % with combined CABG and AVR. At a median follow-up of 58 months, overall death decreased over the groups (MT, 68 % vs. PCI, 44 % vs. AVR, 34 % vs. CABG and AVR, 23 %,
p
< 0.01). Compared to the MT group, Cox regression analysis adjusted for potential confounders showed significantly reduced mortality in the PCI, AVR, and CABG and AVR groups. When combined CABG and AVR is not feasible, PCI or AVR alone still improves significantly long-term survival as compared with MT alone.
Novolimus, a macrocyclic lactone with anti-proliferative properties, has a similar efficacy to currently available agents; however it requires a lower dose, and less polymer, and is therefore ...conceivably safer.
The EXCELLA II study was a prospective, multicentre, single-blind, non-inferiority clinical trial which randomised 210 patients with a maximum of two de novo coronary artery lesions in two different epicardial vessels in a ratio of 2:1 to treatment with either the Elixir DESyne Novolimus Eluting Coronary Stent System (NES n=139, Elixir Medical, Sunnyvale, CA, USA) or the Endeavor zotarolimus eluting stent (ZES n=71, Medtronic, Santa Rosa, CA, USA). The primary endpoint was in-stent mean late lumen loss (LLL) at 9-months follow-up. In-stent percent volume obstruction (%VO) was measured in a?sub-group of 65 patients having 9-month intravascular ultrasound (IVUS) follow-up. Clinical secondary endpoints included a device orientated composite of cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularisation (CI-TLR) assessed at 9-months follow-up. At 9-months, the in-stent LLL was 0.11+/-0.32 mm in the NES arm, as compared to 0.63+/-0.42 mm in the ZES (p<0.0001 non-inferiority, p<0.0001 superiority). In-stent%VO was 4.5+/-5.1% and 20.9+/-11.3% for NES and ZES, respectively (p<0.001). There was no significant difference between stent groups in the device orientated composite endpoint (NES 2.9% vs. ZES 5.6%, -2.8% -8.8%, 3.3%, p=0.45) or its individual components of cardiac death, target vessel MI and CI-TLR.
This non-inferiority randomised study not only met its primary endpoint, but also demonstrated superiority of NES compared to the ZES in terms of in-stent LLL.
Fractional flow reserve (FFR)-guided percutaneous coronary intervention (PCI), along with optimal medical therapy, improves clinical outcome by targeting ischemia-inducing stenosis. Yet, plaque ...progression or stent failure may cause recurring cardiac events. We assessed the potential prognostic role of different inflammatory biomarkers, known to be associated with plaque progression or stent failure, in patients undergoing FFR-guided PCI.
We prospectively enrolled 169 stable angina patients with intermediate coronary stenosis at angiography undergoing FFR-guided PCI. PCI was performed if FFR was 0.80 or less, deferred if FFR was more than 0.80. Serum baseline levels of high-sensitivity C-reactive protein (hs-CRP), eosinophil cationic protein (ECP), cystatin-C (Cys-C), and thromboxane A2 (TXA2) were assessed. Rate of major adverse cardiovascular events (MACE), defined as a composite of cardiovascular death, recurrent myocardial infarction, and target vessel revascularization (TVR), was evaluated.
PCI was performed in 78 patients (46%) (mean age 69 ± 10 years, men 73%) and deferred in 91 patients (54%) (mean age 64 ± 11 years, men 53%). Mean clinical follow-up was 31 ± 11 months. Within the PCI group, patients with MACE (n = 14 18%) had significantly higher ECP levels than those without (14.4 9.3-19.5 vs. 4.9 2.8-10.9 mg/l, P < 0.001), and ECP was a significant predictor of MACE (hazard ratio: 1.05, 95% confidence interval 1.01-1.09, P = 0.021). Within the deferred group, patients with MACE (n = 8 9%) had significantly higher CRP levels than those without (15 6.5-31.9 vs. 1.6 0.9-2.9 mg/l, P < 0.001) and CRP was a significant predictor of MACE (hazard ratio: 1.04, 95% confidence interval 1.01-1.07, P = 0.015). Cys-C and TXA2 were not significantly different between the two groups.
Assessing inflammatory biomarkers allows the identification of patients remaining at residual higher risk of MACE after FFR-guided PCI.
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