New insights on acute expansion and longitudinal elongation of bioresorbable vascular scaffolds in vivo and at bench test: a note of caution on reliance to compliance charts and nominal length.

OBJECTIVES: We performed systematic optical coherence tomography (OCT) analyses after bioresorbable vascular scaffolds (BVS) implantation in a "real world" setting aiming at evaluating scaffold expansion and longitudinal integrity. BACKGROUND: a comprehensive elucidation of BVS acute performance in the "real-world" setting is lacking. METHODS: acute BVS expansion compared with compliance chart information and longitudinal integrity were assessed in 29 patients (32 lesions) by OCT. In addition, bench experiments with four scaffolds were performed with different combinations of deployment pressures and tube stiffness. RESULTS: scaffold underexpansion, using compliance chart information as reference, was observed in 97% of OCT cross-sections in vivo; however, only 8.3% of the cross-section analyzed revealed BVS area <5 mm(2) . Calcified plaques were more common in the lowest (9.7%) compared with the mid (8.8%) and highest (6.3%) tertiles of scaffold expansion (P = 0.003 and P = 0.001 for lowest vs. mid, and lowest vs. highest, respectively). Seventeen (54.8%) scaffolds were elongated during implantation, but no signs of scaffold fracture were revealed. Elongation and impaired expansion were reproduced in the bench testing when the scaffold was deployed with high pressure in a hard tube. CONCLUSIONS: compliance chart information should not be used to predict final BVS dimensions in the clinical setting. While BVS expansion could be potentially impaired by calcified plaques, they may elongate during deployment. Bench experiments confirmed the elongation phenomenon when BVS were deployed with high pressure in hard tubes.

Updating the evidence on patent foramen ovale closure versus medical therapy in patients with cryptogenic stroke: a systematic review and comprehensive meta-analysis of 2,303 patients from three randomised trials and 2,231 patients from 11 observational studies.

AIMS: We aimed at updating the evidence coming from randomised and observational studies of patent foramen ovale (PFO) closure compared to medical therapy in patients with cryptogenic stroke (CS). METHODS AND RESULTS: Comparative studies of PFO closure versus medical therapy published or presented through March 2013 were identified. Data from 2,303 patients in three randomised clinical trials (RCTs) and from 2,231 patients in 11 observational studies were included. In RCTs, the stroke hazard ratio (HR) for PFO closure versus medical therapy was 0.62 (95% confidence interval [CI]: 0.34-1.11; p=0.10 in the random effects model) with no significant heterogeneity or systematic bias. There was no significant difference in transient ischaemic attacks (TIA) (HR 0.77, 95% CI: 0.46-1.32; p=0.34) and no study-related deaths occurred. Pooling trials of the AMPLATZER PFO occluder device resulted in a significant reduction of stroke (HR 0.44, 95% CI: 0.20-0.95; p=0.04). Procedural success, new onset atrial fibrillation and cardiac thrombus were observed more frequently with the STARFlex compared with the AMPLATZER device. In observational studies, with high potential for baseline confounders, PFO closure was found to reduce the risk of recurrent stroke significantly (HR 0.23, 95% CI: 0.11-0.49; p<0.01 in the random effects model), with no significant effect on TIAs. CONCLUSIONS: In RCTs, unlike observational studies, PFO closure compared with medical therapy failed to achieve a statistically significant reduction in recurrent stroke. However, pooling RCTs of the AMPLATZER PFO occluder device yielded a statistically significant reduction in stroke over medical treatment that may warrant further investigation.

Prevalence of renal artery stenosis in patients undergoing cardiac catheterization.

To investigate the prevalence of significant renal artery stenosis (RAS ≥50%), and to identify clinical predictors for significant RAS in patients with an elevated cardiovascular risk, such as those affected by ischemic heart disease. In patients with an elevated cardio-vascular risk, both atherosclerotic renovascular disease and coronary artery disease (CAD) are likely to occur. Prospectively from April 2007 to March 2008, all consecutive patients with ischemic heart disease undergoing non-emergent cardiac catheterization were also evaluated for atherosclerotic RAS by renal arteriography. A RAS ≥50% was considered as significant. A total of 1,298 patients underwent cardiac and renal angiography. Significant RAS was found in 70 out of 1,298 patients (5.4%). The presence of peripheral vascular disease, eGFR <67 ml/min/1.73 m(2), age >66 years, dyslipidemia, CAD severity and pulse pressure >52 mmHg were independent clinical predictors of significant RAS, and jointly produced a ROC AUC of 0.79 (95% CI 0.73-0.85, P < 0.001). Based on these data, a prediction rule for significant RAS was developed, and it showed an adequate predictive performance with 64% sensitivity and 82% specificity. In a large cohort of patients undergoing coronary angiography, significant RAS is a relatively rare comorbidity (5.4%). A model based on simple clinical variables may be useful for the clinical identification of high CV risk patients who may be suitable for renal arteriography at the time of cardiac catheterization.

Head-to-head comparison of early vessel healing by optical coherence tomography after implantation of different stents in the same patient.

OBJECTIVES: Strut coverage represents the most powerful morphometric predictor of stent thrombosis and the best surrogate indicator of endothelization. The aim of this study was to get new insights on temporal patterns of vessel healing after stenting with different types of stent. METHODS: Optical coherence tomography (OCT) was used to investigate the early strut coverage of lesions treated with CATANIA (CAT) stent, drug-eluting stent (DES) or cobalt-chromium bare metal stent (BMS). Two cohorts of 10 and 24 patients underwent OCT follow-up at 7-10 and 28-32 days after stenting, respectively. In each cohort, patients were randomly assigned to receive a CAT stent in one lesion and a BMS or a DES in a separate lesion. RESULTS: A total of 7975 and 8406 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 7-10 days, respectively. A total of 21 123 and 25 069 struts were analyzed for the comparisons of CAT stent vs. DES and CAT stent vs. BMS at 28-32 days, respectively. At 7-10 days, the CAT stent showed higher coverage rates compared with DES (90.0 vs. 85.9%, P < 0.0001) and BMS (90.2 vs. 83.6%, P < 0.0001). Similarly, at 28-32 days, the coverage rate was higher with CAT stent compared with DES (97.7 vs. 90.5%, P < 0.0001) and BMS (97.2 vs. 96.5%, P < 0.0001). CONCLUSION: The CAT stent yields quicker and more complete strut coverage than DES and BMS in the early phases of vessel healing following stent implantation.

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.

Plaque distribution patterns in distal left main coronary artery to predict outcomes after stent implantation.

OBJECTIVES: The aim of this study was to investigate the association between plaque distribution at left main (LM) bifurcation and target lesion revascularization (TLR) after stenting. BACKGROUND: Despite favorable reported mid- and long-term results, stent implantation on LM bifurcation remains challenging. The role of atherosclerotic plaque distribution in affecting LM bifurcation stenting outcomes has not been explored. METHODS: A total of 329 patients undergoing LM bifurcation stenting in 2 centers were included. A method based on different plaque locations within the bifurcation area was applied. The overall population was divided in 2 groups according to the presence of a specific pattern characterized by plaque occupying (n = 145) or not occupying (n = 184) the whole bifurcation (WB) area. RESULTS: Baseline clinical, angiographic, and procedural characteristics were well-balanced between the 2 groups. The WB group showed a significantly higher risk of 3-year TLR compared with the non-WB group (24.9% vs. 8.3%; unadjusted hazard ratio: 3.12; 95% confidence interval: 1.59 to 6.11; p = 0.001; adjusted hazard ratio: 2.84; 95% confidence interval: 1.43 to 5.64; p = 0.003). The 3-year TLR rate was not significantly different between patients treated with 1-or 2-stent techniques either in the WB or non-WB groups. In the WB group, TLR was similar between patients with lesions classified as 1,1,1 and non-1,1,1 by the Medina classification (20.7% vs. 26.8%, p = 0.57, respectively). CONCLUSIONS: The WB pattern is associated with enhanced TLR risk, regardless of stent technique and plaque severity. This could impact the treatment strategy of high-risk lesions involving the whole bifurcation area.

Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial: rationale, objectives and design.

BACKGROUND: Novel approaches to modify stents have been developed to address the limitations of bare-metal stents (BMS) and drug-eluting stent (DES), aiming for ideal features, such as decreased restenosis rates with decreased thrombogenicity and without the need for long-term dual antiplatelet therapy. RATIONALE: The Assessment of The LAtest Non-Thrombogenic Angioplasty Stent (ATLANTA) trial was the first-in-man study to show the safety and efficacy of the Polyzene-F coated CATANIA stent (CeloNova BioSciences, Newnan, Georgia, USA) as an alternative to both BMS and DES. The stent was found to be associated with a good clinical outcome with no vessel thrombosis and a modest growth of late neointima. A subgroup undergoing optical coherence tomography late assessment showed almost complete stent strut coverage at 6 months. However, whether the CATANIA stent is superior in promoting a greater stent strut coverage rate both at 7 and 30 days with respect to DES and BMS is unknown. METHODS: The Rapid Evaluation of Vessel HEaling After AngiopLasty (REVEAL) trial will be a prospective, randomized study providing new evidence on early vessel healing and thrombus development after stenting with different stent types. Optical coherence tomography examination at 7-10 days or 28-32 days after implantation will evaluate strut coverage and vessel healing. The primary endpoint will be a comparison of the percentage of 'healed stent struts' at 28-32 days, identified by the presence of an evenly apposed rim of tissue on stent struts, and without apposition of thrombotic material, on the total amount of analyzed struts for the stent groups.

Long-term clinical outcomes after drug-eluting stent implantation in unprotected left main coronary artery disease.

OBJECTIVE: To investigate long-term outcomes of unprotected left main coronary artery (ULMCA) disease treatment using drug-eluting stents (DES). BACKGROUND: In several studies, DES implantation in ULMCA appeared safe and effective at mid-term; however, to date, there is limited long-term data. METHODS: All consecutive patients undergoing sirolimus- or paclitaxel-eluting stent implantation in ULMCA disease at a single institution were evaluated. The primary endpoint was long-term major adverse cardiac events (MACE) defined as cardiac death, nonfatal myocardial infarction, or target lesion revascularization (TLR). Stent thrombosis (ST), according to Academic Research Consortium definitions, was also evaluated. RESULTS: A total of 210 patients were assessed. In-hospital MACE rate was 1%. During a mean follow-up of 28.0 +/- 14.5 months, MACE occurred in 26 patients (12.5%): cardiac death in nine patients (4.3%) and TLR in 17 patients (8.2%). The cumulative MACE-free survival rate was 89.0, 87.4, and 85.4% at 1, 2, and 3 years, respectively. ST occurred in three patients (1.4%): one case was definite and the other two were probable/possible ST; there were no cases of very late ST. Binary restenosis occurred in 8.3%. The EuroScore >6 was the only independent predictor of MACE [hazard ratio (HR) 2.24, 95% confidence interval (CI) 1.05-4.77, P = 0.04]. There was a trend toward an increased risk of MACE associated with distal ULMCA location (HR 2.14, 95% CI 0.87-5.29, P = 0.10). CONCLUSIONS: Our study showed DES implantation in ULMCA to be feasible, safe, and effective at long term. Randomized trials comparing percutaneous versus surgical revascularization are warranted to define the treatment of choice for ULMCA disease.