Minimal Lumen Diameter Research Articles

Wine Dilates the Brachial Artery but does not Increase Flow-mediated Dilatation over Two Hours

Epidemiological evidence suggests cardiovascular benefits from the consumption of alcoholic beverages, but corroboration by functional and outcome studies is still outstanding. Non-invasive functional tests on the brachial arteries of healthy volunteers were performed before and for two hours after consuming red wine. Brachial artery dimensions were determined by ultrasound at baseline, 30, 60 and 120 min. Flow-mediated dilatation (FMD) was similarly assessed. Putative minimum and maximum lumen diameters were determined after ice immersion and sublingual trinitroglycerine (TNG) at baseline and 60 min after wine consumption. Sixteen subjects had a mean resting brachial artery diameter of 3.84 mm, which significantly increased with wine to 4.44 mm at 30 min, 4.39 mm at 60 min and 4.49 mm at 120 min. The calculated blood flow rates during the study did not differ significantly over the measured intervals. The baseline mean diameter with TNG was not significantly different from the dilation with wine. The vasoconstrictor response varied, with a -2.6 ± 2.9% change with wine, compared with the baseline diameter. There was appreciable variation of the diameter relative to the range found with ice and TNG. The calculated FMDs (% changes) for the study were 10.8, 6.1, 5.6 and 7.5, indicating statistically significant effects of wine (p < 0.0001). The authors conclude that red wine consumption leads to beneficial arterial effects that may relate to different doses or other mechanisms than FMD. Further studies need to be done to discriminate between the effects of alcohol and phenolic compounds on vascular function.

Impact of Diabetes Mellitus on Intravascular Ultrasound-Guided Provisional Stenting in Coronary Bifurcation Lesions J-REVERSE Sub-Study.

To investigate the impact of diabetes mellitus (DM) on provisional coronary bifurcation stenting under the complete guidance of intravascular-ultrasound (IVUS). The efficacy of such intervention has not yet been fully elucidated in the DM patients. A total of 100 DM and 139 non-DM patients in a prospective multi-center registry of IVUS-guided bifurcation stenting were compared in angiographic results at 9 months. Vessel and luminal changes during the intervention were analyzed using the IVUS. Vascular healing at the follow-up was also investigated in 23 lesions in each group using optical coherence tomography (OCT). No difference was detected regarding baseline reference vessel diameter and minimum lumen diameter in proximal main vessel (MV), distal MV, and side branch (SB). The rate of everolimus-eluting stent use (78.4% vs. 78.3%), final kissing inflation (60.1% vs. 49.0%), and conversion to 2-stent strategy (2.9% vs. 2.8%) were also similar. In the DM group, late loss was greater in proximal MV (DM 0.23 ± 0.29 vs. non-DM 0.16 ± 0.24 mm, P < 0.05) and SB (0.04 ± 0.49 vs. -0.08 ± 0.35 mm, P < 0.05). Smaller vessel area restricted stent expansion in the proximal MV (6.18 ± 1.67 vs. 6.72 ± 2.07 mm2 , P < 0.05). More inhomogeneous neointimal coverage (unevenness score, 1.90 ± 0.33 vs. 1.72 ± 0.29, P < 0.05) and more frequent thrombus attachment (26% vs. 4%, P < 0.05) were documented in the proximal MV at 9-month follow-up OCT. Despite IVUS optimization for coronary bifurcation, DM is potentially associated with smaller luminal gain, higher late-loss, and inhomogeneous vascular healing with frequent thrombus attachment in the proximal MV.

Safety and efficacy of rotational atherectomy for the treatment of undilatable underexpanded stents implanted in calcific lesions.

Coronary stent underexpansion is a known risk factor for in-stent restenosis and stent thrombosis. There are limited options once noncompliant balloons have failed to achieve optimal stent expansion. Excimer Laser Coronary Angioplasty with contrast medium injection is one possibility, but not readily available. Rotational atherectomy is an alternative, and has been described in case reports, but concerns exist regarding safety. All consecutive patients undergoing rotational atherectomy for symptomatic in-stent restenosis due to stent underexpansion resistant to noncompliant balloon postdilatation between January 2005 and December 2015 were analysed. A total of 16 patients underwent treatment during the study period and the procedure was successful in 14 cases (87.5%). The mean postprocedural minimal lumen diameter increased by 2.3 ± 0.8 mm and percentage diameter stenosis decreased from 82.17% ± 17.2% to 11.9% ± 9.1%. Intraprocedural complications occurred in two patients (burr entrapment successfully managed percutaneously and periprocedural myocardial infarction). At 1-year follow-up, the incidence of target lesion revascularisation was 13.3% (2 out of 15 patients), and one patient died from noncardiac death. In this small series of underexpanded stents, rotational atherectomy was an effective treatment for resistant stent underexpansion with acceptable outcomes. © 2016 Wiley Periodicals, Inc.

Final shape of biovascular scaffolds and clinical outcome. Results from a multicenter all-comers study with intravascular imaging

AimsRadial strength of bioresorbable vascular scaffolds (BVS) implanted in coronary arteries is still under debate. Moreover, their final shape patterns, when implanted in an all-comer, unselected population, have not yet been completely correlated with clinical outcome and should be better investigated. Methods and resultsA multicenter collaborative analysis was performed on all consecutive patients with native coronary artery disease undergoing PCI with intravascular imaging-guided BVS implantation. The BVS was arbitrarily categorized as having a final “oval shape” through intravascular imaging, if maximal lumen diameter was longer than 150% of minimal lumen diameter at the target lesion. Primary study-endpoint was device-oriented major adverse events (DOCE) at mid-term follow-up. Sixty-seven consecutive patients were evaluated at 6 European centers. Mean patient age was 58±11years, and 12 patients (18%) had diabetes. Mean percent diameter stenosis was 79±12.5%. Average lesion length was 24.4±13.8mm and 66% of lesions were AHA/ACC type B2/C. Postdilation rate was 91% and all BVS resulted well apposed to the vessel wall. Procedural success was achieved in all patients and 10 (14.9%) had an “oval shape” at intravascular imaging. This occurrence was not associated with an increase in periprocedural myocardial infarction (p=0.37) or DOCE during hospitalization (p=0.65). Seven-month DOCE occurred in 3 patients (5.6%) of the oval shape group, they were target-vessel revascularization and did not differ significantly between patients with vs. without final “oval shape” (p=0.34). We did not register episodes of scaffold thromboses. ConclusionsIn an all-comer population with complex coronary lesions treated with BVS, a final oval shape after postdilation was not rare and not associated with immediate and medium term adverse events.

Heterogeneity of Coronary Plaque Morphology and Natural History: Current Understanding and Clinical Significance.

Despite the important progress in identifying high-risk atherosclerotic plaques, many key elements are elusive. Advanced imaging modalities provide valuable information about the anatomic and functional plaque characteristics and underscore the presence of multiple plaque morphologies. However, how the heterogeneity of atherosclerotic plaque can alter our current understanding of coronary artery disease is not fully understood. Along the length of an individual plaque, the morphology patterns display marked heterogeneity. Contrary to previous beliefs, plaque morphology is also highly dynamic over time, with the vast majority of high-risk plaques becoming quiescent and mild plaques becoming severely obstructive in a short period of time. Endothelial shear stress, a local hemodynamic factor known for its critical effects in plaque initiation and progression, also displays longitudinal heterogeneity contributing to the arterial wall response in all time points. Risk stratification of plaques based on the morphological characteristics at one region of the plaque, usually the minimal lumen diameter, and at one point in time may be misleading. The evaluation of both morphological and hemodynamic characteristics along the length of a plaque will improve the risk assessment of individual plaques.

Intra-arterial injection of iloprost reduces the risk of early recoil after balloon angioplasty of below-the-knee vessels in patients with critical limb ischemia.

Previous studies demonstrated that early recoil is frequently observed in patients undergoing balloon angioplasty. The aim of this study was to evaluate the impact of intra-arterial administration of iloprost (Endoprost®, Italfarmaco S.p.A., Milan, Italy) on early elastic recoil after balloon angioplasty of below-the-knee (BTK) vessels in patients with critical limb ischemia (CLI). Between January 2015 and December 2015 32 patients with CLI underwent balloon angioplasty of at least one BTK vessel followed by intra-arterial administration of iloprost. Early elastic recoil was defined as residual lumen compromise >10%. Early elastic recoil was determined on the basis of minimal lumen diameter (MLD) measurements at baseline (MLDbaseline), immediately after BTK balloon angioplasty (MLDpostdilation), and 15 minutes thereafter (MLD15min). Patients were predominantly female (18/32, 56.2%) with a mean age of 79.6 years (range 68-87). Most of the patients were diabetics (25/32, 78.1%). An occlusion was present in 24 cases (75%). Mean BTK lesion length was 144.1 mm (range 22-320). Mean MLD measurements were 0.1 mm (range 0-0.5; MLDbaseline), 2.5 mm (range 1.9-3; MLDpostdilation), and 1.9 mm (range 0.7-3; MLD15min). Early elastic recoil was recorded in 14 patients (43.8%). The mean percentage of elastic recoil after 15 minutes was 21.4%. In our experience intra-arterial administration of iloprost reduces the risk of early elastic recoil after balloon angioplasty of BTK vessels in patients with CLI. Further analyses with larger population studies and randomized trials are needed to validate this therapeutic option.

Is quantitative coronary angiography reliable in assessing the lumen gain after treatment with the everolimus-eluting bioresorbable polylactide scaffold?

The current study aimed to assess the difference in lumen dimension measurements between optical coherence tomography (OCT) and quantitative coronary angiography (QCA) in the polymeric bioresorbable scaffold and metallic stent. In the randomised ABSORB Japan trial, 87 lesions in the Absorb arm and 44 lesions in the XIENCE arm were analysed. Post-procedural OCT-QCA lumen dimensions were assessed in matched proximal/distal non-stented/non-scaffolded reference (n=199), scaffolded (n=145) and stented (n=75) cross-sections at the two device edges using the Bland-Altman method. In the non-stented/non-scaffolded reference segments, QCA systematically underestimated lumen diameter (LD) compared with OCT (accuracy, -0.26 mm; precision, 0.47 mm; 95% limits of agreement as a mean bias±1.96 standard deviation, -1.18-0.66 mm). When compared to OCT, QCA of the Absorb led to a more severe underestimation of the LD (-0.30 mm; 0.39 mm; -1.06-0.46 mm) than with the XIENCE (-0.14 mm; 0.31 mm; -0.75-0.46 mm). QCA underestimated LD by 9.1%, 4.9%, and 9.8% in the reference, stented, and scaffolded segments, respectively. The protrusion distance of struts was larger in the Absorb arm than in the XIENCE arm (135±27 µm vs. 18±26 µm, p<0.001), and may have contributed to the observed differences. In-device QCA measurement was differently affected by the presence of a metallic or polymeric scaffold, a fact that had a significant impact on the QCA assessment of acute gain and post-procedural minimum LD.

Treatment of chronic total occlusions in native coronary arteries by drug-coated balloons without stenting - A feasibility and safety study

BackgroundChronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion. MethodsWe included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed. ResultsThe recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p<0.001). There was no death or myocardial infarction. ConclusionsDrug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.

A pan-coronary artery angiographic study of the association between diabetes mellitus and progression or regression of coronary atherosclerosis.

The frequency and pattern of progression or regression of coronary atherosclerosis in contemporary patients with diabetes remain unknown. This study included 605 patients with coronary artery disease (CAD). Two coronary angiographic examinations at baseline and after 2years were performed. The analysis focused on non-stented segments with diameter stenosis ≥25%. Atherosclerosis progression (or regression) was defined as a decrease (or increase) in the mean minimal lumen diameter (MLD) in the 2-year angiogram compared to mean MLD in the baseline angiogram of >0.2mm. Statins were prescribed in 576 patients (95.2%). The primary outcome was atherosclerosis progression or regression in the 2-year angiogram. One hundred sixty-nine patients (28%) had diabetes. Diabetic patients had greater reduction of mean MLD in the 24 angiogram compared to baseline angiogram than nondiabetic patients (0.11±0.18 vs. -0.08±0.15mm, P<0.001). Atherosclerosis progression was observed in 37 patients with diabetes and 16 nondiabetic patients (21.9 vs. 3.7%; P<0.001). Atherosclerosis regression was observed in two diabetic patients and 78 nondiabetic patients (1.2 vs. 17.9%; P<0.001). A progression pattern across all coronary segments was observed in 70 patients (41.4%) with diabetes and 60 patients (13.8%) without diabetes (P<0.001). Diabetic patients with a low-density lipoprotein cholesterol ≥70mg/dl showed more atherosclerosis progression than diabetic patients with LDL cholesterol <70mg/dl (delta-MLD: 0.12±0.19 vs. 0.08±0.16mm; P=0.04). In conclusion, in contemporary patients with CAD treated with moderate-intensity statin therapy, diabetes is associated with the increased risk of progression and decreased probability of regression of coronary atherosclerosis.

FFR prediction model based on conventional quantitative coronary angiography and the amount of myocardium subtended by an intermediate coronary artery stenosis

BackgroundCoronary angiography has poor predictive value for functionally significant coronary artery stenosis. The Fractional Flow Reserve (FFR) currently represents the gold standard to define the ischemic potential of epicardial stenosis and, recently, the instantaneous wave-free ratio (iFR), has also been introduced as alternative to the FFR, but it still remains an invasive procedure. We aimed this study in order to evaluate the accuracy of the “Angiography-DeriveD hEmoDynamic index” (ADDED index) to predict the FFR as compared with the iFR. Methods and resultsConsecutive patients with at least one equivocal stenosis in one major coronary artery were enrolled. Both the FFR and iFR were measured. The amount of jeopardized myocardium was evaluated using the Duke Jeopardy Score (DJS). Two-dimensional quantitative coronary angiography (QCA) was used to assess the angiographic features of the coronary stenosis and both the reference vessel diameter (RVD) and minimal lumen diameter (MLD) were calculated. The ADDED index was defined as the ratio between DJS and MLD. We evaluated 100 intermediate coronary artery stenoses in 83 patients. Both FFR and iFR inversely correlated with the ADDED index (respectively, r2=0.59, p<0.001 and r2=0.61, p<0.001). This latter also showed high accuracy in predicting the FFR value (ROC analysis: 0.94[0.90–0.99], p<0.001) as well as the iFR (0.91[0.86–0.97], p<0.001, difference: 0.03 SD 0.04, p=0.52). ConclusionsThe ADDED index, taking into account both the MLD and DJS, showed high accuracy to predict FFR and it might be used to detect functionally significant coronary artery stenosis.

When should fractional flow reserve be performed to assess the significance of borderline coronary artery lesions: Derivation of a simplified scoring system

ObjectivesTo derive a simplified scoring system (SSS) that can assist in selecting patients who would benefit from the application of fractional flow reserve (FFR). BackgroundAngiographers base decisions to perform FFR on their interpretation of % diameter stenosis (DS), which is subject to variability. Recent studies have shown that the amount of myocardium at jeopardy is an important factor in determining the degree of hemodynamic compromise. MethodsWe conducted a retrospective multivariable analysis to identify independent predictors of hemodynamic compromise in 289 patients with 317 coronary vessels undergoing FFR. A SSS was derived using the odds ratios as a weighted factor. The receiver operator characteristics curve was used to identify the optimal cutoff (≥3) to discern a functionally significant lesion (FFR≤0.8). ResultsMale gender, left anterior descending artery apical wrap, disease proximal to lesion, minimal lumen diameter and % DS predicted abnormal FFR (≤0.8) and lesion location in the left circumflex predicted a normal FFR. Using a cutoff score of ≥3 on the SSS, a specificity of 90.4% (95% CI: 83.0–95.3) and a sensitivity of 38.0% (95% CI: 31.5–44.9) was generated with a positive predictive value of 89.0% (95% CI: 80.7%–94.6%) and negative predictive value of 41.6% (95% CI: 35.1%–48.3%). ConclusionsThe decision to use FFR should be based not only on the % DS but also the size of the myocardial mass jeopardized. A score of ≥3 on the SSS should prompt further investigation with a pressure wire.

Early and midterm outcomes of bioresorbable vascular scaffolds for ostial coronary lesions: insights from the GHOST-EU registry.

We aimed to investigate the outcomes of bioresorbable vascular scaffolds (BVS) in coronary ostial lesions. Ostial lesions represent a challenging angiographic subset, with higher event rates compared with non-ostial lesions. BVS might be associated with advantages over the long term, but their safety in this setting remains to be explored. Procedural and 12-month follow-up data from consecutive patients treated with BVS for lesions located at the ostium of the right (RCA), left anterior (LAD) or circumflex (LCX) coronary in 11 European centres were collected. The primary device-oriented endpoint was defined as a combination of cardiovascular death, target vessel myocardial infarction or target lesion revascularisation. The database included a total of 1,549 lesions in 1,304 patients with a mean age of 62±11years. There were 90 ostial lesions (5.8%) in 84 patients (6.4%) located at the ostial RCA (14; 16%), LCX (29; 32%), or LAD (47; 52%). Patients presenting with ostial lesions did not differ from the remaining cohort except for a higher incidence of prior revascularisation. Predilation was performed in 97% of the lesions (vs. 96% in non-ostial, p=0.618), post-dilation in 43% (versus 58% in the non-ostial group, p=0.008). At quantitative coronary angiography, treatment of ostial lesions was associated with higher residual stenosis (30% [23-41] vs. 26% [20-37], p=0.035), but no difference in minimum lumen diameter existed (p=0.447). Follow-up data were available at 385 [362-465] days. The 12-month Kaplan-Meier estimated rates of scaffold thrombosis were 4.9% and 2.0% (ostial and non-ostial lesion groups, respectively, log-rank p=0.005). The device-oriented composite endpoint occurred, respectively, in 12.6% and 4.6% at 12 months (log-rank p=0.001). Treatment of ostial lesions was an independent predictor of this endpoint (p=0.0025, HR 2.65 [1.41-4.97]). In combination with a suboptimal implantation technique, treatment of coronary ostial lesions was an independent predictor of clinical events in a cohort of patients treated with BVS.

Surrogate and clinical endpoints in interventional cardiology: are statistics the brakes?

Randomized controlled trials are the gold standard for demonstrating safety and efficacy of coronary devices with or without accompanying drug treatments in interventional cardiology. With the advent of last-generation drug-eluting stents having enhanced technical attributes and long-term clinical benefits, the proof of incremental angiographic or long-term clinical efficacy becomes more challenging. The purpose of this review is to provide an overview of the most common and alternative study endpoints in interventional cardiology and their potential reimbursement value. Moreover, we intend to describe the statistical limitations in order to demonstrate differences between potential treatment groups. Furthermore, careful endpoint recommendations for a given patient number are offered for future study designs. The number of patients per treatment group was estimated for various study designs such as noninferiority test hypotheses with hard clinical endpoints and various surrogate endpoints. To test for differences in various surrogate endpoint scenarios, the corresponding patient group sizes were explored. To evaluate these endpoints in terms of their reimbursement impact, preferred endpoints for technical appraisals in interventional cardiology at the National Institute of Health and Care Excellence (NICE) were used. Even with the most stringent experimental control to reduce bias-introducing factors, studies with hard primary clinical endpoints such as the occurrence of major adverse cardiac events (MACE) or target-lesion revascularization (TLR) rates remain the gold standard, with numbers reaching into the 300-700 patient range per group. Study designs using loss in fractional-flow reserve (FFR) or stent-strut-coverage rates can be statistically formulated; however, the clinical ramifications for the patient remain to be discussed. Nonrandomized study designs with intrapatient angiographic controls in nontarget vessels may merit further thoughts and explorations. From a reimbursement impact, the primary endpoints MACE and TLR are the best choices for a moderately sized study population of 500 patients per group. Angiographic endpoints, in particular minimal lumen diameter (MLD), are not useful in this context. The emerging endpoints such as loss in FFR or stent coverage require smaller patient populations. However, their impact on reimbursement-related decisions is limited.

Clinical value of drug-coated balloon angioplasty for de novo lesions in patients with coronary artery disease

BackgroundDespite the low restenosis rates of drug-eluting stents (DES), several problems remain, including stent thrombosis, stent fracture, and neo-atherosclerosis. ‘Stent-less’ (balloon alone) percutaneous coronary intervention (PCI) is still being used, and several clinical trials have supported the efficacy of DCB. The aim of this study was to investigate the efficacy of a drug-coated balloon (DCB) in the treatment of de novo coronary artery disease. MethodsWe enrolled 60 consecutive patients who had been given elective PCI between May 2014 and June 2015. They were randomly assigned to a ‘stent-less’ group (n=30) and a ‘stent’ group (n=30). Twenty-seven patients were treated with DCB alone and 33 with DES, and then evaluated for target lesion revascularization (TLR) rate and by quantitative coronary angiography (QCA) eight months later. ResultsTLR rates were similar in the two groups (DCB; 0.0%, DES; 6.1%, P=0.169). In the QCA analysis, minimal lumen diameter (MLD) and acute gain were significantly smaller in the DCB group than in the DES group immediately after PCI (2.36±0.46 vs 2.64±0.37, P=0.011, and 1.63±0.41 vs 2.08±0.37, P<0.0001, respectively). Eight months after PCI, however, there was no significant difference in MLD or late lumen loss between the two groups. ConclusionsA ‘stent-less’ PCI using DCB could be useful even in the DES era. After ‘stent-less’ PCI, antiplatelet agents might be reduced or discontinued more safely than after DES implantation.

Everolimus-Eluting Stents in Patients With Bare-Metal and Drug-Eluting In-Stent Restenosis: Results From a Patient-Level Pooled Analysis of the RIBS IV and V Trials.

Treatment of patients with drug-eluting stent (DES) in-stent restenosis (ISR) is more challenging than that of patients with bare-metal stent ISR. However, the results of everolimus-eluting stents (EES) in these distinct scenarios remain unsettled. A pooled analysis of the RIBS IV (Restenosis Intra-Stent of Drug-Eluting Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) and RIBS V (Restenosis Intra-Stent of Bare Metal Stents: Paclitaxel-Eluting Balloon vs Everolimus-Eluting Stent) randomized trials was performed using patient-level data to compare the efficacy of EES in bare-metal stent ISR and DES-ISR. Inclusion and exclusion criteria were identical in both trials. Results of 94 patients treated with EES for bare-metal stent ISR were compared with those of 155 patients treated with EES for DES-ISR. Baseline characteristics were more adverse in patients with DES-ISR, although they presented later and more frequently with a focal pattern. After intervention, minimal lumen diameter (2.22±0.5 versus 2.38±0.5 mm, P=0.01) was smaller in the DES-ISR group. Late angiographic findings (89.3% of eligible patients), including minimal lumen diameter (2.03±0.7 versus 2.36±0.6 mm, P<0.001) and diameter stenosis (23±22 versus 13±17%, P<0.001) were poorer in patients with DES-ISR. Results were consistent in the in-segment and in-lesion analyses. On multiple linear regression analysis, minimal lumen diameter at follow-up remained significantly smaller in patients with DES-ISR. Finally, at 1-year clinical follow-up (100% of patients), mortality (2.6 versus 0%, P<0.01) and need for target vessel revascularization (8 versus 2%, P=0.03) were higher in the DES-ISR group. This patient-level pooled analysis of the RIBS IV and RIBS V randomized clinical trials suggests that EES provide favorable outcomes in patients with ISR. However, the results of EES are less satisfactory in patients with DES-ISR than in those with bare-metal stent ISR. URL: http://www.clinicaltrials.gov. Unique identifiers: NCT01239953 and NCT01239940.

Everolimus-eluting bioresorbable vascular scaffolds implanted in coronary bifurcation lesions: Impact of polymeric wide struts on side-branch impairment

BackgroundLimited data are available on bioresorbable vascular scaffolds (BVS) performance in bifurcations lesions and on the impact of BVS wider struts on side-branch impairment. MethodsPatients with at least one coronary bifurcation lesion involving a side-branch ≥2mm in diameter and treated with at least one BVS were examined. Procedural and angiographic data were collected and a dedicated methodology for off-line quantitative coronary angiography (QCA) in bifurcation was applied (eleven-segment model), to assess side-branch impairment occurring any time during the procedure. Two- and three-dimensional QCA were used. Optical coherence tomography (OCT) analysis was performed in a subgroup of patients and long-term clinical outcomes reported. ResultsA total of 102 patients with 107 lesions, were evaluated. Device- and procedural-successes were 99.1% and 94.3%, respectively. Side-branch impairment occurring any time during the procedure was reported in 13 bifurcations (12.1%) and at the end of the procedure in 6.5%. Side-branch minimal lumen diameter (Pre: 1.45±0.41mm vs Final: 1.48±0.42mm, p=0.587) %diameter-stenosis (Pre: 26.93±16.89% vs Final: 27.80±15.57%, p=0.904) and minimal lumen area (Pre: 1.97±0.89mm2 vs Final: 2.17±1.09mm2, p=0.334), were not significantly affected by BVS implantation. Mean malapposed struts at the bifurcation polygon-of-confluence were 0.63±1.11. ConclusionsThe results of the present investigation suggest feasibility and relative safety of BVS implantation in coronary bifurcations. BVS wide struts have a low impact on side-branch impairment when considering bifurcations with side-branch diameter≥2mm.

Ultrasound vs Angiography for Drug-Eluting Stent Implantation—Reply

In comparing the IVUS-guided with the angiography-guided strategy for drug-eluting stent optimization, different end points and methods of vessel diameter measurement were used, as noted by Dr Hoffer, due to the intrinsic difficulty in defining common optimization criteria for both groups. We think these differences are unlikely to explain the results. Previous studies, such as the Angiography Vs IVUS Optimization (AVIO) trial1 and a meta-analysis,2 also reported larger postintervention minimal lumen diameter and lesser residual stenosis with IVUS-guided drug-eluting stent implantation. However, in the AVIO trial, the greater minimal lumen diameter in the IVUS-guided group failed to lead to better clinical outcomes, unlike in our IVUS-XPL trial.

Comparison of 3-dimensional and 2-dimensional quantitative coronary angiography and intravascular ultrasound for functional assessment of coronary lesions

BackgroundThree-dimensional quantitative coronary angiography (3D-QCA) reportedly allows more accurate delineation of true vessel geometry when compared with standard two-dimensional (2D) QCA and has been validated by intravascular ultrasound (IVUS). This study sought to compare diagnostic efficiency of 2D- and 3D-QCA, and IVUS in identifying hemodynamically significant coronary stenoses as determined by fractional flow reserve (FFR). MethodsForty-two lesions in 40 patients were assessed by FFR, IVUS, and 2D- and 3D-QCA. Correlations between FFR values and anatomical parameters obtained by 2D- and 3D-QCA and IVUS were analyzed. The receiver operating characteristic (ROC) curves were used to compare the diagnostic accuracy of the parameters for predicting FFR≤0.80. ResultsMean FFR value was 0.75±0.13. FFR≤0.80 was observed in 28 lesions (67%). Of IVUS measurements, minimum lumen area (MLA) well correlated with FFR values (r=0.71, p<0.001). Of 3D- and 2D-QCA measurements, minimum lumen diameter (MLD) correlated best with FFR values (r=0.79, p<0.01; r=0.68, p<0.01, respectively), followed by MLA (r=0.76, p<0.01; r=0.67, p<0.01, respectively). The area under the ROC curve for 3D-QCA MLD was greater than those for 2D-QCA MLD (p=0.03) and 2D-QCA MLA (p=0.03). On the other hand, the AUC for 3D-QCA MLD, 3D-QCA MLA, and IVUS MLA were not significantly different. Conclusions3D-QCA is more useful than 2D-QCA and possibly comparable to IVUS in the assessment of functional stenosis severity. When FFR is not available, 3D-QCA MLA and MLD may assist in the assessment of functional severity of intermediate lesions.

Association of progression or regression of coronary artery atherosclerosis with long-term prognosis

The association between coronary atherosclerosis progression or regression and long-term prognosis remains poorly defined. We assessed the association of atherosclerosis progression or regression with long-term mortality and factors that promote angiographic progression or regression of coronary atherosclerosis in patients with angiographically proven coronary artery disease. The study included 605 patients with coronary artery disease who underwent coronary angiography at baseline and at 2 years later. Pan-coronary artery tree quantitative coronary angiography was performed. Of 6259 coronary segments (10.3 lesions per patient) analyzed, 1790 non-stented segments with ≥25% diameter stenosis at baseline were included. Atherosclerosis progression or regression was defined as a decrease or increase in the mean minimal lumen diameter (MLD) of the non-stented segments of ≥0.2 mm in the 2-year angiography compared to baseline angiography. The primary outcome was all-cause mortality. Based on the change in mean MLD between baseline and 2-year angiography, patients were divided into 3 groups: the group with progression of atherosclerosis (n=53; 8.8%), the group with no progression or regression of atherosclerosis (n=472; 78.0%) and the group with regression of atherosclerosis (n=80; 13.2%). There were 126 deaths over 8-year follow-up: 17 deaths among patients with progression, 103 deaths among patients with no progression/regression and 6 deaths among patients with regression (Kaplan-Meier estimates of mortality, 37.5%, 25.2% and 8.9%, respectively; adjusted hazard ratio=1.16, 95% confidence interval 1.05 to 1.29, P=.004 for 0.1 mm reduction in mean MLD). Progression or regression of coronary atherosclerosis in non-treated coronary segments was significantly associated with 8-year mortality.

Abstract 653: Development of Advanced Atherosclerotic Plaque by Injection of Inflammatory Proteins in Mini-pig Model

Objective: Appropriate animal models of atherosclerotic plaque are crucial for the investigation of the pathophysiology of atherosclerosis, as well as for the evaluation of the efficacy and safety of vascular devices. Therefore, we aimed to develop a novel animal model that would be suitable for the study of the advanced atherosclerotic lesions in vivo. Methods: Atherosclerotic plaque was induced in 32 sites of 8 mini-pigs by combining a high cholesterol diet, endothelial denudation, and injection into the vessel wall with either saline or inflammatory proteins (high-mobility group protein B1 [HMGB1] and tumor necrosis factor [TNF]-α) using a Cricket™ Micro-infusion catheter. In vivo imaging with optical coherence tomography (OCT) was performed to detect the plaque characteristics at follow-up after 10 weeks. All tissues were harvested for histological evaluation. Results: Intima area/plaque area tended to be higher in the HMGB1, and TNF-α groups compared to the saline injected group (p=0.015). Advanced plaques were more frequently observed in the group injected with inflammatory proteins. High degree inflammation occurred in inflammatory protein injected group compared to saline injected group it immunohistochemistry stain using HMGB1 (p&lt;0.001), RAGE (p=0.003), TNF-α antibody (p&lt;0.001) and CD68 antibody (p=0.005). Quantitative imaging evaluation at minimal lumen diameter and percentage of diameter stenosis were also not significantly different among all group. OCT demonstrated that lipid rich plaques were more frequently detected in the inflammatory protein group (saline group: 2/11 [18%], HMGB1 group: 9/11 [82%] and TNF-α group: 5/10 [50%]). Conclusion: Direct injection of inflammatory proteins into the vessel wall significantly increased inflammation occurrence and induced lipid rich plaques. These data indicate that this mini-pig model of atherosclerotic lesion formation via direct injection of pro-inflammatory proteins into the vessel wall is useful for in vivo studies investigating atherosclerosis. Key words: mini-pig model, atherosclerosis, balloon injury, inflammatory protein