Gianluca Caiazzo

Novel Approaches for Preventing or Limiting Events in Diabetic Patients (Naples-Diabetes) Trial A Randomized Comparison of 3 Drug-Eluting Stents in Diabetic Patients

Background— To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results— Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group (P=0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P=1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P=0.012) and the Taxus group (adjusted P=0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P=0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P=0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P=0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P=0.048). Conclusions— The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.Background— To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results— Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group ( P =0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P =1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P =0.012) and the Taxus group (adjusted P =0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P =0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P =0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P =0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P =0.048). Conclusions— The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.

Bioabsorbable vascular scaffold overexpansion: insights from in vitro post-expansion experiments

AIMS While bioresorbable vascular scaffolds (BVS) are increasingly used in clinical practice, their behaviour when post-dilated beyond their recommended maximum overexpansion diameter remains sparsely documented. We aimed to test the overexpansion of the BVS scaffold in vitro and evaluate the impact of excessive scaffold oversizing on focal point support. METHODS AND RESULTS We examined the post-expansion behaviour of the bioresorbable vascular scaffold (3.0 mm and 3.5 mm Absorb BVS; Abbott Vascular, Santa Clara, CA, USA) after overexpansion with non-compliant (NC) balloons of increasing diameters. After each oversizing step, the scaffolds were measured and inspected for strut disruption using microscope and optical coherence tomography imaging. Point force mechanical measurements on single scaffold struts were also performed to evaluate the impact of excessive scaffold overstretching on focal mechanical support. 3.0 mm and 3.5 mm scaffold sizes could be post-expanded up to 1 mm above their nominal diameters without any strut fracture when deployed without an external constraining model. Importantly, when overexpansion of both scaffold sizes was repeated using a constraining silicone lesion model, only post-expansion with an NC balloon size 0.5 mm larger than the scaffold nominal sizes could be performed without strut fractures. Point force compression analysis on single struts shows that overstretched struts with fractures provided lower focal strength compared to overexpanded ring segments without fractures and normal segments expanded at nominal pressure. CONCLUSIONS In our experiments, only overexpansion with an NC balloon 0.5 mm larger than the BVS size was feasible for BVS deployed inside an arterial lesion model. Overexpansion of the BVS scaffold beyond recommended post-dilation limits can lead to strut disconnections and focal loss of mechanical support.

Administration of a Loading Dose Has No Additive Effect on Platelet Aggregation During the Switch From Ongoing Clopidogrel Treatment to Ticagrelor in Patients With Acute Coronary Syndrome

Background—Ticagrelor outperforms clopidogrel in preventing cardiovascular events in acute coronary syndrome. Despite the inclusion of a loading dose in the Platelet Inhibition and Patient Outcomes (PLATO) trial for all patients randomized to ticagrelor, it may not be necessary in patients receiving ongoing clopidogrel therapy. The aim of the present study was to assess whether a ticagrelor loading dose is associated with a further platelet inhibition during the switch from clopidogrel to ticagrelor in patients with acute coronary syndrome receiving ongoing antiplatelet treatment. Methods and Results—Fifty patients with acute coronary syndrome receiving aspirin and clopidogrel treatment were randomly assigned to a starting dose of ticagrelor (group 1, 90 mg; group 2, 180 mg). Platelet aggregation was measured using multiple electrode aggregometry and standard light transmission aggregometry just before the switch and at 2, 6, 24, and 72 hours. No relevant difference in platelet aggregation was observed between the 2 study arms at baseline (P=0.256). Residual platelet aggregation was significantly reduced in both arms 2 hours after the first administration of ticagrelor (P<0.001 for both), with no difference in aggregation between groups (multiple electrode aggregometry, 17.6±7.2 versus 18.1±6 U; P=0.281). Similar results were observed with LTA. Conclusions—Switching from clopidogrel to ticagrelor without a reloading dose is feasible, and it does not hinder platelet aggregation inhibition in patients with acute coronary syndrome. Further prospective studies are needed to assess the clinical relevance of our findings. Clinical Trial Registration—URL: http://www.clinicaltrials.gov. Unique identifier: NCT01795820.

Is high pressure postdilation safe in bioresorbable vascular scaffolds? Optical coherence tomography observations after noncompliant balloons inflated at more than 24 atmospheres.

Optical coherence tomography (OCT) was used to investigate integrity and expansion of bioresorbable drug‐eluting scaffolds (BVS) after high‐pressure postdilation (HPPD).

The instantaneous wave-free ratio (iFR) for evaluation of non-culprit lesions in patients with acute coronary syndrome and multivessel disease

BACKGROUND Adenosine administration is currently required for evaluation of stenosis severity with fractional flow reserve (FFR). The instantaneous wave-free ratio (iFR) was recently introduced as an adenosine-free alternative in patients with stable CAD. The aim of the present study was to replicate the findings of previous iFR studies using an independent calculation algorithm and to evaluate the iFR for the assessment of non-culprit vessels in patients with acute coronary syndrome (ACS). METHODS AND RESULTS 53 patients with ACS (65%) and at least one non-culprit intermediate lesion and 29 (35%) with stable CAD were included. A total of 123 stenoses were evaluated with both FFR and iFR. Classification match of iFR in ACS was not inferior to stable CAD (79.5% in ACS and 84.4% in CAD; p=0.497). Accordingly, no difference was observed in iFR/FFR correlation between ACS and stable CAD (r=0.66 in ACS vs. r=0.69 in CAD). Overall, a significant correlation was found between iFR and FFR (r=0.68; p<0.001) with a good diagnostic efficiency at ROC analysis (area under the curve: 0.87). In addition, neither the localization of the stenosis within the coronary tree (p=0.147) nor the time interval from the acute event (p=0.550) significantly influenced the concordance of iFR with FFR. CONCLUSIONS The iFR is a promising method for the assessment of non-culprit lesion severity in patients with acute coronary syndrome.

Intracoronary abciximab reduces death and major adverse cardiovascular events in acute coronary syndromes: A meta-analysis of clinical trials

BACKGROUND Successful reperfusion of epicardial coronary arteries does not necessarily result in actual myocardial perfusion. Local intracoronary (IC) delivery of GP IIb/IIIa inhibitors (GPI) has been proposed to achieve further clinical efficacy when compared to standard intravenous (IV) administration. However clinical trials have shown conflicting results. The aim of the present study was to compare IC with IV abciximab administration on mortality and MACEs in patients with ACS undergoing PCI. METHODS We performed a meta-analysis of all available clinical trials comparing intracoronary versus intravenous abciximab administration. RESULTS At short-term analysis, incidence of MACEs was significantly lower in the IC group than in the IV group (OR=0.56; 95% CI 0.35-0.89; p=0.015). Interestingly, subgroup analysis showed that most benefit was coming from those studies with a main baseline LVEF<50% (OR=0.33 95% CI 0.18-0.59). Similarly, long-term incidence of MACEs was significantly lower in the IC group than in the IV group (OR=0.47; 95% CI 0.31-0.71; p<0.001), with most benefit coming from those studies enrolling patients with a main baseline EF<50% (OR=0.38 95% CI 0.23-0.63 p<0.001). In addition, long-term incidence of death was also lower in the IC group than in the IV group (OR=0.42; 95% CI 0.20-0.86; p=0.009). CONCLUSIONS Our meta-analysis provides evidence of a net clinical benefit for intracoronary versus intravenous abciximab administration, with the highest benefit observed in high-risk ACS patients, such as those with reduced baseline LVEF.

Novel Approaches for Preventing or Limiting Events in Diabetic Patients (Naples-Diabetes) TrialClinical Perspective

Background— To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results— Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group (P=0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P=1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P=0.012) and the Taxus group (adjusted P=0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P=0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P=0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P=0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P=0.048). Conclusions— The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.Background— To expand the paucity of data on the efficacy of various drug-eluting stents in diabetic patients. Methods and Results— Type 2 diabetic patients treated in our institution from October 2005 to January 2007 presenting with of de novo lesions in native coronary arteries were randomly assigned to sirolimus-eluting stents (Cypher group; n=76); paclitaxel-eluting stents (Taxus group; n=75); and everolimus-eluting stents (Endeavor group; n=75). Poor metabolic control (HbA1c >7% and low-density lipoprotein cholesterol >100 mg/dL) and microvascular complications (retinopathy and/or nephropathy) were assessed. The primary end point was the 3-year composite of major adverse cardiac events (MACE), including death of any cause, myocardial infarction, and clinically driven target vessel revascularization. MACE-free survival was 86.8% in the Cypher group, 82.5% in the Taxus group, and 64.4% in the Endeavor group ( P =0.006 by log-rank test). The post hoc comparisons showed no significant difference between Cypher versus Taxus groups (adjusted P =1.0) but a higher MACE rate in the Endeavor group versus both the Cypher group (adjusted P =0.012) and the Taxus group (adjusted P =0.075). Independent predictors of 3-year MACE at Cox analysis were treatment by Endeavor versus Cypher stent (2.35 [95% confidence interval, 1.07 to 5.41]; P =0.030), multivessel disease (hazard ratio, 1.78 [95% confidence interval, 1.06 to 2.66]; P =0.031), diabetic retinopathy (hazard ratio, 1.60; [95% confidence interval, 1.03 to 2.76]; P =0.038), and poor metabolic control (hazard ratio, 1.60; [95% confidence interval, 1.02 to 2.52]; P =0.048). Conclusions— The present pilot study suggests that in diabetic patients, the Endeavor stent is associated with a higher 3-year MACE rate when compared with Cypher and Taxus stents.

Near-infrared spectroscopy-intravascular ultrasound: scientific basis and clinical applications

Coronary angiography underestimates the magnitude of the atherosclerotic burden and cannot detect the presence of disease in the early phases. Recognition of these inherent limitations of angiography has been an impetus for the development of other coronary imaging techniques. The novel near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS) catheters can detect and quantify the presence of lipid core in the atherosclerotic plaque and associate it with other features such as lumen size and plaque architecture. Lipid-rich plaques are known to pose a higher risk of distal embolization during interventions and plaque disruption. The aim of this manuscript is the review of the potential clinical and research applications of this technology as highlighted by recent studies.

Neointimal proliferation is associated with clinical restenosis 2 years after fully bioresorbable vascular scaffold implantation.

Drug-eluting stents, introduced to reduce neointimal proliferation and the subsequent clinical restenosis, represent the current mainstay for the treatment of coronary artery stenosis.1 However, this benefit is paid back with an increased incidence of late stent thrombosis.2 In addition, the presence of a permanent metallic cage within the arterial wall prevents a full restoration of normal vessel physiology.3 In the past years, fully bioresorbable vascular scaffolds (BVSs) have emerged as a novel promising approach to treat coronary stenosis by providing transient vessel support with drug delivery capability,3 without the long-term limitations associated with vessel caging. This technology has the potential to overcome many of the safety concerns associated with drug-eluting stents, with possible clinical benefits.3 We report the first comprehensive intracoronary imaging study of late clinically driven BVS restenosis, including 3D optical coherence tomography. A 72-year-old man with a 70% de novo left circumflex stenosis (Figure 1A, 1C, and 1D) was treated with a 3.0×18 mm …

Optical coherence tomography guidance for percutaneous coronary intervention with bioresorbable scaffolds.

BACKGROUND The effect of optical coherence tomography (OCT) guidance on the implantation strategy during all phases of percutaneous coronary intervention (PCI) with bioresorbable vascular scaffolds (BVSs) in a real-world scenario has been poorly investigated. METHODS Consecutive patients undergoing BVS implantation at our institution were included in this registry. Frequency-domain OCT pullbacks were performed at the operators discretion during all phases of BVS implantation procedures to optimize preparation of lesions, confirm BVS size, and optimize expansion and apposition of scaffolds. RESULTS Between September 2012 and July 2015, 203 BVSs were implanted in 101 consecutive patients at our institution (2.01 BVSs/patient). In 66 patients, the procedure was performed under OCT guidance. In the OCT subgroup, 66 (77.6%) of the 85 treated lesions were complex (B2/C AHA/ACC type). Overall, 147 OCT pullbacks were performed and 72/147 (49.0%) pullbacks indicated the need for changing strategy. After angiography-only-guided optimisation of BVS in 27 (31.8%) lesions, an OCT examination prompted performance of a second post-expansion. This resulted in an increase in the minimal scaffold area (5.5 to 6.3mm(2), p=0.004) and a decrease in the incomplete scaffold apposition area (1.1 to 0.6mm(2), p=0.082), with no new stent fractures. When the population was divided according to the time of BVS implantation, an initial learning adaptation became evident, with the number of OCT-guided changes in strategy significantly decreasing between the initial and final time periods (p=0.017). CONCLUSIONS OCT guidance for BVS implantation significantly affects the procedural strategy, with favourable effects on acute results and the learning curve.