Tomasz Pawłowski

Stenting of Culprit Lesions in Unstable Angina Leads to a Marked Reduction in Plaque Burden: A Major Role of Plaque Embolization? A Serial Intravascular Ultrasound Study

Background—Intravascular ultrasound (IVUS) studies have shown that a mechanism of plaque compression/embolization contributes toward the poststenting increase in lumen area. The aim of this IVUS study was to compare the mechanisms of lumen enlargement after coronary stenting in 54 consecutive patients with unstable angina (UA) (group 1) and 56 with stable angina (group 2) to verify whether plaque embolization plays a major role in the former. Methods and Results—Both groups underwent the IVUS assessment (speed, 0.5 mm/sec) before the intervention and after stent implantation. The lumen area, the external elastic membrane area, and the plaque+media area (PA) were measured at 0.5-mm intervals. PA reduction in the lesion site was significantly greater in group 1 (−2.50±1.97 versus −0.53±1.43 mm2, P <0.001). After stenting, 47% of the lumen area increase in group 1 was obtained by means of PA reduction, and 53% was attributable to external elastic membrane area increase; the corresponding figures in group 2 were 13% and 87% (P <0.05). Decrease in PA after stenting was the only significant predictor of the MB fraction of creatinine kinase (CK-MB) release in a multiple regression model (P =0.047). Conclusions—Serial volumetric IVUS assessment revealed in UA lesions a marked poststenting reduction in plaque volume, which is significantly greater than in stable angina and is associated with postprocedural CK-MB release. The decrease in PA during the procedure predicts CK-MB release in a multiple regression model. These findings suggest that stent deployment is often associated with plaque embolization in patients with UA.

Local delivery versus intracoronary infusion of abciximab in patients with acute coronary syndromes.

OBJECTIVES We investigated whether local abciximab delivery to the site of intracoronary thrombus is more effective than intracoronary bolus infusion in patients with acute coronary syndromes (ACS) undergoing percutaneous coronary intervention and downstream clopidogrel administration. BACKGROUND The intracoronary route of administration does not allow an optimal contact between the plaque components and abciximab, which is rapidly washed out by the coronary flow. METHODS A total of 50 patients with ACS and a significant lesion in the culprit artery indicative of local thrombosis were randomly assigned to receive local intracoronary delivery of abciximab through a dedicated perfusion catheter or intracoronary infusion through the guiding catheter. The primary end point was the change in thrombus score after angioplasty by optical coherence tomography. RESULTS After the intervention, the mean percentage change of the thrombus score was significantly higher among patients of the local delivery group compared with those of the intracoronary infusion group (33.8% vs. 3.9%, p = 0.002). Post-procedural corrected Thrombolysis in Myocardial Infarction frame count was shorter in the local delivery group compared with the intracoronary infusion group (15.3 ± 10.2 vs. 21.1 ± 9.9, p = 0.049). Procedure-related myocardial infarction was observed in 10% and 43% of patients in the local delivery and intracoronary infusion groups, respectively (p = 0.018). At 1 year, MACE were observed in 5.9% and 27.2% of patients in the local delivery and intracoronary infusion groups, respectively (p = 0.046). CONCLUSIONS Local intracoronary delivery of abciximab by means of a dedicated perfusion catheter reduces thrombus burden with the potential to improve coronary microcirculation.

Eccentric atherosclerotic plaques with positive remodelling have a pericardial distribution: a permissive role of epicardial fat?A three-dimensional intravascular ultrasound study of left anterior descending artery lesions

Aims The transversal distribution of coronary atherosclerotic plaques (AP) (myocardial vs pericardial) affects vessel remodelling. The aim of this study was to define the impact of transversal lesion distribution on vessel remodelling in proximal and distal coronary segments using a 3D intravascular ultrasound (IVUS) reconstruction. Methods The study group included 70 lesions located in the left anterior descending artery within 5mm of the septal take-off, and imaged using 3D-IVUS. The take-off of the septal branch was used to divide the plaque into a myocardial and pericardial surface. The IVUS index of vessel remodelling was calculated as: [narrowest external elastic membrane (EEM) site cross-sectional area (CSA)−reference EEM CSA)/reference EEM CSA×100]. The lesions with an intermediate vessel remodelling index (between −25% and +15%) were excluded from analysis. Results Of the 38 APs with a pericardial distribution, 34 (89%) showed positive remodelling \batchmode \documentclass[fleqn,10pt,legalpaper]{article} \usepackage{amssymb} \usepackage{amsfonts} \usepackage{amsmath} \pagestyle{empty} \begin{document} \((P{<}0.001)\) \end{document}. The distal lesions had a positive vessel remodelling index regardless of transversal plaque distribution. At multivariate analysis, pericardial distribution and the distal location of AP were the only independent variables predictive of positive remodelling. Conclusions The transversal distribution of atherosclerotic plaque affects vessel remodelling in left anterior descending coronary lesions, probably because of an extravascular splinting effect. Distal lesions usually show positive remodellingregardless of transversal plaque distribution.

Eccentric atherosclerotic plaques with positive remodeling have a pericardial distribution: A permissive role of epicardial fat—A three-dimensional intravascular ultrasound study of left anterior descending artery lesions

AIMS The transversal distribution of coronary atherosclerotic plaques (AP) (myocardial vs pericardial) affects vessel remodelling. The aim of this study was to define the impact of transversal lesion distribution on vessel remodelling in proximal and distal coronary segments using a 3D intravascular ultrasound (IVUS) reconstruction. METHODS The study group included 70 lesions located in the left anterior descending artery within 5mm of the septal take-off, and imaged using 3D-IVUS. The take-off of the septal branch was used to divide the plaque into a myocardial and pericardial surface. The IVUS index of vessel remodelling was calculated as: [narrowest external elastic membrane (EEM) site cross-sectional area (CSA)-reference EEM CSA)/reference EEM CSAx100]. The lesions with an intermediate vessel remodelling index (between -25% and +15%) were excluded from analysis. RESULTS Of the 38 APs with a pericardial distribution, 34 (89%) showed positive remodelling (P<0.001). The distal lesions had a positive vessel remodelling index regardless of transversal plaque distribution. At multivariate analysis, pericardial distribution and the distal location of AP were the only independent variables predictive of positive remodelling. CONCLUSIONS The transversal distribution of atherosclerotic plaque affects vessel remodelling in left anterior descending coronary lesions, probably because of an extravascular splinting effect. Distal lesions usually show positive remodelling regardless of transversal plaque distribution.

Intravascular ultrasound and quantitative coronary angiography assessment of late in-stent restenosis: in vivo human correlation and methodological implications.

Quantitative coronary angiography (QCA) is routinely used for assessment of strategies aimed at reducing in‐stent restenosis. Yet QCA enables only the measurement of luminal variation of stented segments and, unlike intravascular ultrasound (IVUS), provides only an indirect estimation of late in‐stent neointimal formation, which has a key role in the process of in‐stent restenosis. The aims of the present study were to correlate the IVUS measurement of in‐stent intimal hyperplasia (IH) with QCA indexes of restenosis, to find out whether QCA is an adequate surrogate of IVUS, and, using either QCA and IVUS data, to define the sample sizes needed to demonstrate the effectiveness of strategies to reduce in‐stent restenosis. The database of the European Imaging Laboratory was used to screen 154 stents implanted between 1997 and 2001 and studied by IVUS at 6 ± 1 months of follow‐up. All cases underwent serial QCA assessment (preintervention, postintervention, and follow‐up). Only 131 cases with single stent implantation in native coronary arteries were included in the study. Stent restenosis, defined as percent diameter stenosis (DS) > 50%, was present at QCA in 69 out of 131 cases (53%). Linear regression analyses were performed to correlate the amount of IH, calculated by IVUS as the average of all cross‐section areas (CSA; mean % IH CSA) and QCA indexes of restenosis (late loss and % DS). A positive significant correlation was found between IVUS mean % IH CSA and QCA % DS (r = 0.74; P < 0.0001) and between IVUS mean % IH CSA and QCA late loss (r = 0.72; P < 0.0001). Based on IVUS measurements of mean % IH CSA, a total sample size of 74 stents would be required in a two‐arm comparison to have 0.80 power to detect at 0.05 significant level a 30% difference between two compared groups. Alternatively, adopting the QCA late loss, 230 stents would be required. QCA measurements of late in‐stent restenosis are well correlated with IVUS calculation of in‐stent neointimal formation. IVUS assessment of IH allows smaller sample sizes than QCA to document significant reductions of in‐stent restenosis. Therefore, the use of IVUS should be encouraged in comparison studies aimed at revealing significant neointimal differences in small sample size populations. Cathet Cardiovasc Intervent 2002;57:155–160.

Dedicated Bifurcation Paclitaxel‐Eluting Stent BiOSS Expert® in the Treatment of Distal Left Main Stem Stenosis

OBJECTIVES The aim of this study was to assess prospectively the effectiveness and safety profile of distal left main stem (LMS) stenosis treatment with dedicated bifurcation paclitaxel-eluting stent BiOSS Expert®. BACKGROUND Angioplasty of distal LMS stenosis is always a high-risk procedure, and optimal treatment is uncertain. METHODS This was a prospective international 2-center study, which enrolled patients with non-ST-elevation acute coronary syndrome (NSTE-ACS) or stable angina with distal left main stenosis. All patients were treated with the dedicated bifurcation stent BiOSS Expert®. Provisional T-stenting was the obligatory strategy. Angiographic control was performed after 12 months. The primary end-point was cumulative rate of death, myocardial infarction (MI), and target lesion revascularization (TLR) at 12 months. Angiographic end-points included late lumen loss, percent diameter stenosis, and binary restenosis rate. RESULTS A total of 54 patients with distal LMS stenosis were enrolled. Seven patients (13%) were enrolled during NSTE-ACS, 77.8% were hypertensive, 27.8% were diabetic, 51.9% had previous MI, 53.7% underwent prior percutaneous coronary intervention, and 16.7% coronary artery bypass graft. The mean SYNTAX score was 21.52 ± 6.50. The device success rate was 100%. The mean BiOSS Expert stent parameters were as follows: 4.07 ± 0.26 mm × 3.36 ± 0.26 mm × 16.61 ± 1.72 mm and in side branch the other stent (classical drug-eluting stent) was implanted in 25.9% of cases. The overall TLR was 9.3%. There were no death, stent thrombosis, or acute MI. In the univariate regression analysis, the only factor associated with higher risk for TLR was the SYNTAX score value. CONCLUSIONS The dedicated bifurcation stent BiOSS Expert® proved to be a feasible device, with promising safety and long-term clinical effectiveness in the treatment of distal LMS stenosis.

Randomized evaluation of intralesion versus intracoronary abciximab and aspiration thrombectomy in patients with ST-elevation myocardial infarction: The COCTAIL II trial

BACKGROUND Thrombus burden and distal embolization are predictive of no-reflow during primary percutaneous coronary intervention (PCI) in patients with acute ST-elevation myocardial infarction (STEMI). We sought to compare the efficacy of pharmacological and catheter-based strategies for thrombus in patients with STEMI and high atherothrombotic burden. METHODS Between January 2012 and December 2013, 128 STEMI patients undergoing primary PCI at 5 centers were randomly assigned in a 2 × 2 factorial design to intracoronary (IC) abciximab bolus (via the guide catheter) versus intralesion (IL) abciximab bolus, each with versus without aspiration thrombectomy (AT). Study end points were residual intrastent atherothrombotic burden, defined as the number of cross-sections with residual tissue area >10% as assessed by optical coherence tomography, and indices of angiographic and myocardial reperfusion. RESULTS Residual intrastent atherothrombotic burden did not significantly differ with IL versus IC abciximab (median [interquartile range] 6.0 [1-15] vs 6.0 [2-11], P = .806) and with AT versus no aspiration (6.0 [1-13] vs 6.0 [2-12], P = .775). Intralesion abciximab administration was associated with improved angiographic myocardial reperfusion in terms of thrombolysis in myocardial infarction (TIMI) flow (3 [3-3] vs 3 [2-3], P = .040), corrected TIMI frame count (12 ± 5 vs 17 ± 16, P = .021), and myocardial blush grade (3 [2-3] vs 3 [2-3], P = .035). In particular, IL abciximab was associated with higher occurrence of final TIMI 3 flow (90% vs 73.8%, P = .032) and myocardial blush grade 3 (71.6% vs 52.4%, P = .039). Conversely, AT had no significant effect on indices of angiographic or myocardial reperfusion. CONCLUSIONS In patients with STEMI and high thrombotic burden, neither IL versus IC abciximab nor AT versus no aspiration reduced postprocedure intrastent atherothrombotic burden in patients with STEMI undergoing primary PCI. However, IL abciximab improved indices of angiographic and myocardial reperfusion compared to IC abciximab, benefits not apparent with AT.

Randomized trial of standard versus Clearway-infused abciximab and thrombectomy in myocardial infarction: rationale and design of the Coctail Ii study

Background Patients with ST-elevation myocardial infarction (STEMI) are at substantial risk of suboptimal procedural results and late adverse events. Angiography and optical coherence tomography (OCT) studies have identified residual coronary thrombus and microcirculatory injury as potential culprits for these adverse outcomes. We hypothesized that coronary thrombectomy and local infusion of glycoprotein IIb/IIIa inhibitors by means of a dedicated infusion device can synergistically improve results of percutaneous coronary intervention (PCI) for STEMI, as appraised by OCT. Methods A total of 128 patients with STEMI will be randomized, to one of the following: abciximab infusion with the ClearWay coronary catheter (C), standard abciximab infusion (A), thrombectomy followed by abciximab infusion with the ClearWay catheter (T+C), or thrombectomy followed by standard abciximab infusion (T+A). The primary objective is to demonstrate that abciximab infusion with the ClearWay catheter with or without manual thrombus aspiration (groups C or T+C) will result in a significant reduction of intrastent thrombus formations when compared with intravenous or intracoronary abciximab with or without thrombectomy (groups A or T+A). The primary endpoint will be the number of cross-sections with thrombus area more than 10% immediately after stent implantation as assessed with OCT. Additional angiographic, ECG and clinical endpoints will be collected and adjudicated. Conclusion This trial will provide important mechanistic insights on the most appropriate invasive treatment strategy for patients with STEMI and significant thrombus burden, by exploiting its factorial design and reliance on sensitive OCT endpoints.

Regular drug-eluting stents versus the dedicated coronary bifurcation sirolimus-eluting BiOSS LIM® stent: the randomised, multicentre, open-label, controlled POLBOS II trial.

AIMS The aim of the POLBOS II randomised trial was to compare any regular drug-eluting stents (rDES) with the dedicated bifurcation sirolimus-eluting stent BiOSS LIM for the treatment of coronary bifurcation lesions. The secondary aim was to study the effect of final kissing balloon inflation (FKBI) on clinical outcomes. METHODS AND RESULTS Between December 2012 and December 2013, 202 patients with stable coronary artery disease or non-ST-segment elevation acute coronary syndrome were randomly assigned 1:1 to treatment of the coronary bifurcation lesions either with the BiOSS LIM stent (n=102) or with an rDES (n=100). Coronary re-angiography was performed at 12 months. The primary endpoint was the composite of cardiac death, myocardial infarction (MI), and target lesion revascularisation (TLR) at 12 months. The target vessel was located in the left main in one third of the cases (35.3% in BiOSS and 38% in rDES). Side branch treatment was required in 8.8% (rDES) and 7% (BiOSS). At 12 months, the cumulative MACE incidence was similar in both groups (11.8% [BiOSS] vs. 15% [rDES, p=0.08]), as was the TLR rate (9.8% vs. 9% [p=0.8]). The binary restenosis rates were significantly lower in the FKBI subgroup of the BiOSS group (5.9% vs. 11.8%, p<0.05). CONCLUSIONS MACE rates as well as TLR rates were comparable between the BiOSS LIM and rDES. At 12 months, cumulative MACE incidence was similar in both groups (11.8% vs. 15%), as was the TLR rate (9.8% vs. 9%). Significantly lower rates of restenosis were observed in the FKBI subgroup of the BiOSS group.

Percutaneous interventions in cardiology in Poland in the year 2014. Summary report of the Association of Cardiovascular Interventions of the Polish Cardiac Society AISN PTK.

Introduction The Board of the Association of Cardiovascular Interventions of the Polish Cardiac Society (AISN PTK) publishes annual data from the National PCI Registry (ORPKI) operated by the Jagiellonian University Medical College in Krakow. Aim For the first time the AISN PTK report is based on the new electronic database implemented in Poland on January 1st, 2014. Material and methods In 2014, there were 155 invasive cardiology centers registered in the ORPKI database (an increase by 1 center in comparison to 2013) and 92% of them had 24/7 percutaneous (PCI) duty. For the first time the number of catheterization laboratories (cath labs) in Poland remained stable, and even though there was an increase by 1 in absolute numbers, 2 cath labs ceased to admit patients in 2014. This means that the number of active cath labs per 1 million inhabitants is similar to last year and equals 4. Results In comparison to 2013, there was a significant increase in the total number of coronary angiographies. There were 226 713 angiographies in 2014. The total number of PCI procedures was 126 241, which is 5.1% more than in 2013. Conclusions There was a significant increase in the overall number of coronary angiographies and PCIs in Poland in 2014. The use of attributes of modern interventional cardiology such as drug-eluting stents and bioabsorbable vascular stents is growing as well as more frequent choice of a radial access site by PCI operators even in ST-elevation myocardial infarction patients. One should also note a significant rise in the use of additional imaging or diagnostic tools such as fractional flow reserve, intravascular ultrasound and optical coherent tomography.