CT Perfusion Versus Coronary CT Angiography in Patients With Suspected In-Stent Restenosis or CAD Progression.

OBJECTIVES: The goal of this study was to assess the diagnostic performance of coronary computed tomography angiography (CTA) alone, adenosine-stress myocardial perfusion assessed by computed tomography (CTP) alone, and coronary CTA + CTP by using a 16-cm Z-axis coverage scanner versus invasive coronary angiography (ICA) and fractional flow reserve (FFR) as the clinical standard. BACKGROUND: Diagnostic performance of coronary CTA for in-stent restenosis detection is still challenging. Recently, CTP showed additional diagnostic power over coronary CTA in patients with suspected coronary artery disease. However, few data are available on CTP performance in patients with previous stent implantation. METHODS: Consecutive stable patients with previous coronary stenting referred for ICA were enrolled. All patients underwent stress myocardial CTP and rest CTP + coronary CTA. Invasive FFR was performed during ICA when clinically indicated. The diagnostic rate and diagnostic accuracy of coronary CTA, CTP, and coronary CTA + CTP were evaluated in stent-, territory-, and patient-based analyses. RESULTS: In the 150 enrolled patients (132 men; mean age 65.1 ± 9.1 years), the CTP diagnostic rate was significantly higher than that of coronary CTA in all analyses (territory based [96.7% vs. 91.1%; p < 0.0001] and patient based [96% vs. 68%; p < 0.0001]). When ICA was used as gold standard, CTP diagnostic accuracy was significantly higher than that of coronary CTA in all analyses (territory based [92.1% vs. 85.5%, p < 0.03] and patient based [86.7% vs. 76.7%, p < 0.03]). The concordant coronary CTA + CTP assessment exhibited the highest diagnostic accuracy values versus ICA (95.8% in the territory-based analysis). The diagnostic accuracy of CTP was significantly higher than that of coronary CTA (75% vs. 30.5%; p < 0.001). The radiation exposure of coronary CTA + CTP was 4.15 ± 1.5 mSv. CONCLUSIONS: In patients with coronary stents, CTP significantly improved the diagnostic rate and accuracy of coronary CTA alone compared with both ICA and invasive FFR as gold standard.

Impact of Fractional Flow Reserve Derived From Coronary Computed Tomography Angiography on Heart Team Treatment Decision-Making in Patients With Multivessel Coronary Artery Disease: Insights From the SYNTAX III REVOLUTION Trial.

BACKGROUND: Fractional flow reserve (FFR) is a reliable tool for the functional assessment of coronary stenoses. FFR computed tomography (CT) derived (FFRCT) has shown to be accurate, but its clinical usefulness in patients with complex coronary artery disease remains to be investigated. The present study sought to determine the impact of FFRCT on heart team's treatment decision-making and selection of vessels for revascularization in patients with 3-vessel coronary artery disease. METHODS: The trial was an international, multicenter study randomizing 2 heart teams to make a treatment decision between percutaneous coronary interventions and coronary artery bypass grafting using either coronary computed tomography angiography or conventional angiography. The heart teams received the FFRCT and had to make a treatment decision and planning integrating the functional component of the stenoses. Each heart team calculated the anatomic SYNTAX score, the noninvasive functional SYNTAX score and subsequently integrated the clinical information to compute the SYNTAX score III providing a treatment recommendation, that is, coronary artery bypass grafting, percutaneous coronary intervention, or equipoise coronary artery bypass grafting-percutaneous coronary intervention. The primary objective was to determine the proportion of patients in whom FFRCT changed the treatment decision and planning. RESULTS: Overall, 223 patients were included. Coronary computed tomography angiography assessment was feasible in 99% of the patients and FFRCT analysis in 88%. FFRCT was available for 1030 lesions (mean FFRCT value 0.64±13). A treatment recommendation of coronary artery bypass grafting was made in 24% of the patients with coronary computed tomography angiography with FFRCT. The addition of FFRCT changed the treatment decision in 7% of the patients and modified selection of vessels for revascularization in 12%. With conventional angiography as reference, FFRCT assessment resulted in reclassification of 14% of patients from intermediate and high to low SYNTAX score tertile. CONCLUSIONS: In patients with 3-vessel coronary artery disease, a noninvasive physiology assessment using FFRCT changed heart team's treatment decision-making and procedural planning in one-fifth of the patients. CLINICAL TRIAL REGISTRATION: URL: https://www.clinicaltrials.gov. Unique identifier: NCT02813473.

Biological profile of monocyte-derived macrophages in coronary heart disease patients: implications for plaque morphology.

The prevalence of a macrophage phenotype in atherosclerotic plaque may drive its progression and/or instability. Macrophages from coronary plaques are not available, and monocyte-derived macrophages (MDMs) are usually considered as a surrogate. We compared the MDM profile obtained from coronary artery disease (CAD) patients and healthy subjects, and we evaluated the association between CAD MDM profile and in vivo coronary plaque characteristics assessed by optical coherence tomography (OCT). At morphological analysis, MDMs of CAD patients had a higher prevalence of round than spindle cells, whereas in healthy subjects the prevalence of the two morphotypes was similar. Compared to healthy subjects, MDMs of CAD patients had reduced efferocytosis, lower transglutaminase-2, CD206 and CD163 receptor levels, and higher tissue factor (TF) levels. At OCT, patients with a higher prevalence of round MDMs showed more frequently a lipid-rich plaque, a thin-cap fibroatheroma, a greater intra-plaque macrophage accumulation, and a ruptured plaque. The MDM efferocytosis correlated with minimal lumen area, and TF levels in MDMs correlated with the presence of ruptured plaque. MDMs obtained from CAD patients are characterized by a morpho-phenotypic heterogeneity with a prevalence of round cells, showing pro-inflammatory and pro-thrombotic properties. The MDM profile allows identifying CAD patients at high risk.

One-year clinical outcome of biodegradable polymer sirolimus-eluting stent in patients needing short dual antiplatelet therapy. Insight from the ULISSE registry (ULtimaster Italian multicenter all comerS Stent rEgistry).

BACKGROUND: This study aimed to evaluate real-world clinical outcome of patients needing short dual antiplatelet therapy (S-DAPT) following PCI with Ultimaster® thin-strut, biodegradable polymer sirolimus-eluting stent (BP-SES), which was supposed to induce faster stent endothelialization and reduce device thrombogenicity. METHODS: In this sub-group analysis of patients enrolled in the ULISSE registry, two groups were identified: 1) patients discharged with S-DAPT (≤3-month) due to high bleeding risk or need for urgent major non-cardiac surgery and 2) patients discharged with recommended DAPT (R-DAPT) duration (≥6-month). The primary ischemic-safety and bleeding-safety endpoints were TLF (composite of cardiac-death, target vessel MI, and clinically driven target lesion revascularization), and BARC major bleedings (≥type-3a) at 1-year follow-up. To account for events occurring before DAPT discontinuation we performed 3-month landmark analysis. RESULTS: 82 patients (5%) were discharged with ≤3-month DAPT (57 ±â€¯27 days), and 1558 patients (94%) were discharged with ≥6-month DAPT (318 ±â€¯75 days). No significant differences between S-DAPT and R-DAPT group were observed in TLF at 1-year (7.9% vs. 4.6%). The rate of BARC major bleeding resulted significantly higher in S-DAPT group (3.9% vs. 0.3%; p = 0.001), with the majority of bleeding events occurring within 3 months. The landmark analysis showed no significant differences in BARC major bleedings between groups (1.4% vs. 0.3%; p = 0.142). CONCLUSIONS: As compared to those treated with R-DAPT (≥6-month), patients needing -S-DAPT (≤3-month) after PCI with Ultimaster® BP-SES had similar rates of 1-year TLF and BARC major bleedings following early DAPT discontinuation.

Stress Computed Tomography Perfusion Versus Fractional Flow Reserve CT Derived in Suspected Coronary Artery Disease: The PERFECTION Study.

OBJECTIVES: This study sought to compare the diagnostic accuracy of coronary computed tomography angiography (cCTA) with that of cCTA+fractional flow reserve derived from cCTA datasets (FFRCT) and that of cCTA+static stress-computed tomography perfusion (stress-CTP) in detecting functionally significant coronary artery lesions using invasive coronary angiography (ICA) plus invasive FFR as the reference standard. BACKGROUND: FFRCT and static stress-CTP are new techniques that combine anatomy and functional evaluation to improve assessment of coronary artery disease (CAD) using cCTA. METHODS: A total of 147 consecutive symptomatic patients scheduled for clinically indicated ICA+invasive FFR were evaluated with cCTA, FFRCT, and stress-CTP. RESULTS: Vessel-based and patient-based sensitivity, specificity, and negative predictive values, and positive predictive values, and accuracy rates of cCTA were 99%, 76%, 100%, 61%, 82%, and 95%, 54%, 94%, 63%, 73%, respectively. cCTA+FFRCT showed vessel-based and patient-based sensitivity, specificity, and negative predictive values, and positive predictive values and accuracy rates of 88%, 94%, 95%, 84%, 92%, and 90%, 85%, 92%, 83%, 87%, respectively. Finally, cCTA+stress-CTP showed vessel-based and patient-based sensitivity, specificity, and negative predictive values, and positive predictive values and accuracy rates of 92%, 95%, 97%, 87%, 94% and 98%, 87%, 99%, 86%, 92%, respectively. Both FFRCT and stress-CTP significantly improved specificity and positive predictive values compared to those of cCTA alone. The area under the curve to detect flow-limiting stenoses of cCTA, cCTA+FFRCT, and cCTA+CTP were 0.89, 0.93, 0.92, and 0.90, 0.94, and 0.93 in a vessel-based and patient-based model, respectively, with significant additional values for both cCTA+FFRCT and cCTA+CTP versus cCTA alone (p < 0.001) but no differences between cCTA+FFRCT versus cCTA+CTP. CONCLUSIONS: FFRCT and stress-CTP in addition to cCTA are valid and comparable tools to evaluate the functional relevance of CAD.

Rationale and design of advantage (additional diagnostic value of CT perfusion over coronary CT angiography in stented patients with suspected in-stent restenosis or coronary artery disease progression) prospective study.

BACKGROUND: Recent studies demonstrated a significant improvement in the diagnostic performance of coronary CT angiography (CCTA) for the evaluation of in-stent restenosis (ISR). However, coronary stent assessment is still challenging, especially because of beam-hardening artifacts due to metallic stent struts and high atherosclerotic burden of non-stented segments. Adenosine-stress myocardial perfusion assessed by CT (CTP) recently demonstrated to be a feasible and accurate tool for evaluating the functional significance of coronary stenoses in patients with suspected coronary artery disease (CAD). Yet, scarce data are available on the performance of CTP in patients with previous stent implantation. AIM OF THE STUDY: We aim to assess the diagnostic performance of CCTA alone, CTP alone and CCTA plus CTP performed with a new scanner generation using quantitative invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR) as standard of reference. METHODS: We will enroll 300 consecutive patients with previous stent implantation, referred for non-emergent and clinically indicated invasive coronary angiography (ICA) due to suspected ISR or progression of CAD in native coronary segments. All patients will be subjected to stress myocardial CTP and a rest CCTA. The first 150 subjects will undergo static CTP scan, while the following 150 patients will undergo dynamic CTP scan. Measurement of invasive FFR will be performed during ICA when clinically indicated. RESULTS: The primary study end points will be: 1) assessment of the diagnostic performance (diagnostic rate, sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy) of CCTA, CTP, combined CCTA-CTP and concordant CCTA-CTP vs. ICA as standard of reference in a territory-based and patient-based analysis; 2) assessment of sensitivity, specificity, positive predictive value, negative predictive value and diagnostic accuracy of CCTA, CTP, combined CCTA-CTP and concordant CCTA-CTP vs. invasive FFR as standard of reference in a territory-based analysis. CONCLUSIONS: The ADVANTAGE study aims to provide an answer to the intriguing question whether the combined anatomical and functional assessment with CCTA plus CTP may have higher diagnostic performance as compared to CCTA alone in identifying stented patients with significant ISR or CAD progression.

Carotid Artery Stenting With Proximal Embolic Protection via a Transradial or Transbrachial Approach: Pushing the Boundaries of the Technique While Maintaining Safety and Efficacy.

PURPOSE: To compare the feasibility and safety of proximal cerebral protection to a distal filter during carotid artery stenting (CAS) via a transbrachial (TB) or transradial (TR) approach. METHODS: Among 856 patients who underwent CAS between January 2007 and July 2015, 214 (25%) patients (mean age 72±8 years; 154 men) had the procedure via a TR (n=154) or TB (n=60) approach with either Mo.MA proximal protection (n=61) or distal filter protection (n=153). The Mo.MA group (mean age 73±7 years; 54 men) had significantly more men and more severe stenosis than the filter group (mean age 71±8 years; 100 men). Stent type and CAS technique were left to operator discretion. Heparin and a dedicated closure device or bivalirudin and manual compression were used in TR and TB accesses, respectively. Technical and procedure success, crossover to femoral artery, 30-day major adverse cardiovascular/cerebrovascular events (MACCE; death, all strokes, and myocardial infarction), vascular complications, and radiation exposure were compared between groups. RESULTS: Crossover to a femoral approach was required in 1/61 (1.6%) Mo.MA patient vs 11/153 (7.1%) filter patients mainly due to technical difficulty in engaging the target vessel. Five Mo.MA patients developed acute intolerance to proximal occlusion; 4 were successfully shifted to filter protection. A TR patient was shifted to filter because the Mo.MA system was too short. CAS was technically successful in the remaining 55 (90%) Mo.MA patients and 142 (93%) filter patients. The MACCE rate was 0% in the Mo.MA patients and 2.8% in the filter group (p=0.18). Radiation exposure was similar between groups. Major vascular complications occurred in 1/61 (1.6%) and in 3/153 (1.96%) patients in the Mo.MA and filter groups (p=0.18), respectively, and were confined to the TB approach in the early part of the learning curve. Chronic radial artery occlusion was detected by Doppler ultrasound in 2/30 (6.6%) Mo.MA patients and in 4/124 (3.2%) filter patients by clinical assessment (p=0.25) at 8.1±7.5-month follow-up. CONCLUSION: CAS with proximal protection via a TR or TB approach is a feasible, safe, and effective technique with a low rate of vascular complications.

Noninvasive cardiac output measurement by inert gas rebreathing in suspected pulmonary hypertension.

The objective of this study was to evaluate inert gas rebreathing (IGR) reliability in cardiac output (CO) measurement compared with Fick method and thermodilution. IGR is a noninvasive method for CO measurement; CO by IGR is calculated as pulmonary blood flow plus intrapulmonary shunt. IGR may be ideal for follow-up of patients with pulmonary hypertension (PH), sparing the need of repeated invasive right-sided cardiac catheterization. Right-sided cardiac catheterization with CO measurement by thermodilution, Fick method, and IGR was performed in 125 patients with possible PH by echocardiography. Patients were grouped according to right-sided cardiac catheterization-measured mean pulmonary and wedge pressures: normal pulmonary arterial pressure (n = 20, mean pulmonary arterial pressure = 18 ± 3 mm Hg, pulmonary capillary wedge pressure = 11 ± 5 mm Hg), PH and normal pulmonary capillary wedge pressure (PH-NW, n = 37 mean pulmonary arterial pressure = 42 ± 13 mm Hg, pulmonary capillary wedge pressure = 11 ± 6 mm Hg), and PH and high pulmonary capillary wedge pressure (PH-HW, n = 68, mean pulmonary arterial pressure = 37 ± 9 mm Hg, pulmonary capillary wedge pressure = 24 ± 6 mm Hg). Thermodilution and Fick measurements were comparable. Fick and IGR agreement was observed in normal pulmonary arterial pressure (CO = 4.10 ± 1.14 and 4.08 ± 0.97 L/min, respectively), whereas IGR overestimated Fick in patients with PH-NW and those with PH-HW because of intrapulmonary shunting overestimation in hypoxemic patients. When patients with arterial oxygen saturation (SO2) ≤90% were excluded, IGR and Fick agreement improved in PH-NW (CO = 4.90 ± 1.70 and 4.76 ± 1.35 L/min, respectively) and PH-HW (CO = 4.05 ± 1.04 and 4.10 ± 1.17 L/min, respectively). In hypoxemic patients, we estimated pulmonary shunt as Fick - pulmonary blood flow and calculated shunt as: -0.2423 × arterial SO2 + 21.373 L/min. In conclusion, IGR is reliable for CO measurement in patients with PH with arterial SO2 >90%. For patients with arterial SO2 ≤90%, a new formula for shunt calculation is proposed.

Stent thrombosis after sirolimus- and paclitaxel-eluting stent implantation in daily clinical practice: analysis of a single center registry.

OBJECTIVES: To evaluate stent thrombosis (ST) rate after sirolimus-eluting stent (SES) and paclitaxel-eluting stent (PES) implantation in daily clinical practice. BACKGROUND: The safety profile of drug-eluting stents (DES) was predominantly determined in randomized clinical trials with narrow inclusion criteria. Concerns about ST have been raised in unselected patients treated with DES. METHODS: We prospectively evaluated 867 patients undergoing DES implantation, 618 patients with SES, and 249 with PES, in a single academic center. RESULTS: Multivessel disease was present in 72% of patients, multivessel stenting was performed in 17%, long (>18 mm) lesions were treated in 30%, and multiple stents per lesion were needed in 31%. On average, 1.7 +/- 0.8 stents per patient were implanted (stented segment length: 32 +/- 25 mm/vessel). IIb/IIIa inhibitors were used in 7.5%. Intravascular ultrasound (IVUS) guidance was employed in 65% of SES and 50% of PES implantations, and the procedural success rate was 100% in SES and 99% in PES cases. Six-month follow-up was performed in all patients, whereas one-year follow-up was completed in 87% patients of the SES group and in 95% of the PES group. We considered that ST occurred when angiographic evidence of thrombus was available, or when patients experienced sudden cardiac death or either ST-elevation or non-ST-elevation myocardial infarction (MI) through the 12-month follow-up period. The overall incidence of ST was 0.9% (0.4% in SES and 2% in PES, P = 0.03). Of the eight ST, two (25%) were acute, four (50%) subacute, one (12.5%) was a late event, and one (12.5%) a very late event. Seven ST were confirmed by angiography. No IVUS guidance was used in 4/8 (50%) ST patients, while antiplatelet therapy was prematurely discontinued in 3/8 (37.5%). Among ST patients, mortality and nonfatal MI rates were 25% and 37.5%, respectively. No ST was diagnosed between 6 and 12 months, while one very late thrombosis occurred at 15 months. CONCLUSIONS: The incidence of ST after DES use in daily clinical practice is low and similar to that observed in randomized clinical trials.