Comparison of acute versus stable coronary syndrome in patients treated with the Magmaris scaffold: Two-year results from the Magmaris Multicenter Italian Registry.

BACKGROUND: The magnesium Magmaris scaffold is the latest resorbable technology with low thrombogenicity, short scaffolding time, and almost complete resorption at 12 months (95 %). As compared with stable coronary artery disease (SCAD), acute coronary syndrome (ACS) is associated with increased risk of adverse clinical outcome after percutaneous coronary intervention. We analyzed the data of the Magmaris Multicenter Italian Registry to compare clinical outcomes in SCAD versus ACS patients. METHODS: We evaluated the 24-month rates of target lesion failure (TLF) and scaffold thrombosis (ST). Device implantation procedures were performed according to the manufacturer's recommendations (proper patient/lesion selection, pre-dilatation, proper scaffold sizing, and post-dilatation). Dual antiplatelet therapy was terminated after 12 months. RESULTS: Data from 207 patients (145 SCAD and 62 ACS) were collected from July 2016 to June 2018. The 2-year follow-up compliance was 92.8 % (192 patients). At 2 years, TLF rates were 7.4 % in the SCAD group and 8.8 % in the ACS group (p = 0.7); ST rates were 0 % in the SCAD group and 1.8 % in the ACS group (p = 0.1). CONCLUSION: The 2-year clinical results from the Magmaris Multicenter Italian Registry are favorable in terms of TLF and ST, indicating the safety and effectiveness of the Magmaris scaffold in both SCAD and ACS patients.

Patent foramen ovale closure with the Occlutech Figulla flex II device: A long-term (up to 10-years) follow-up.

BACKGROUND: Percutaneous closure represents the first line of treatment in patients with cryptogenic stroke and documented patent foramen ovale (PFO). Scarce data report the long-term outcomes of patients undergoing PFO closure with the Figulla Flex II device (Occlutech, Germany). METHODS: Consecutive patients undergoing PFO closure with a Figulla Flex II device at a single, high-volume Institution were included. Baseline clinical and procedural features were collected and patients were followed up for up to 10 years. The device's long-term safety was assessed, as well as mortality, recurrent cerebrovascular events, new-onset atrial fibrillation (AF) and residual shunt. RESULTS: Overall, 442 patients were included. The main indication for PFO closure was cryptogenic stroke/transitory ischemic attack (65.5%), followed by migraine (21.7%), silent lesions at MRI (10.8%), and decompression disease (2.0%). Atrial septal aneurysm was present in 20.8% of cases, Eustachian valve in 9.0%, Chiari network in 19.9%. The most frequently implanted device was the 23/25 mm (49.5% of cases). One procedural failure due to device embolization; in-hospital complications occurred in 15 cases (3.4%; 4 minor access site complications, 11 transient supraventricular tachycardias (SVT)/AF). After a follow-up of 9.2 years, 2 patients suffered recurrent TIA (with no residual R-L shunt detected). A moderate or severe residual shunt was observed in 3 patients after discharge. CONCLUSIONS: Figulla Flex II devices for PFO closure are associated with high procedural success and low incidence of adverse events even at long-term follow-up.

Outcomes and mechanical complications of acute myocardial infarction during the second wave pandemic in a Milan HUB center for cardiac emergencies.

Aims: COVID-19 has dramatically impacted the healthcare system. Evidence from previous studies suggests a decline in in-hospital admissions for acute myocardial infarction (AMI) during the pandemic. However, the effect of the pandemic on mechanical complications (MC) in acute ST-segment elevation myocardial infarction (STEMI) has not been comprehensively investigated. Therefore, we evaluated the impact of the pandemic on MC and in-hospital outcomes in STEMI during the second wave, in which there was a huge SARS-CoV-2 diffusion in Italy. Methods and results: Based on a single center cohort of AMI patients admitted with STEMI between February 1, 2019, and February 28, 2021, we compared the characteristics and outcomes of STEMI patients treated during the pandemic vs. those treated before the pandemic. In total, 479 STEMI patients were included, of which 64.5% were during the pandemic. Relative to before the pandemic, primary percutaneous coronary intervention (PCI) declined (87.7 vs. 94.7%, p = 0.014) during the pandemic. Compared to those admitted before the pandemic (10/2019 to 2/2020), STEMI patients admitted during the second wave (10/2020 to 2/2021) presented with a symptom onset-to-door time greater than 24 h (26.1 vs. 10.3%, p = 0.009) and a reduction of primary PCI (85.2 vs. 97.1%, p = 0.009). MC occurred more often in patients admitted during the second wave of the pandemic than in those admitted before the pandemic (7.0 vs. 0.0%, p = 0.032). In-hospital mortality increased during the second wave (10.6 vs. 2.9%, p = 0.058). Conclusion: Although the experience gained during the first wave and a more advanced hub-and-spoke system for cardiovascular emergencies persists, late hospitalizations and a high incidence of mechanical complications in STEMI were observed even in the second wave.

Whole-Blood Transcriptional Profiles Enable Early Prediction of the Presence of Coronary Atherosclerosis and High-Risk Plaque Features at Coronary CT Angiography.

Existing tools to estimate cardiovascular (CV) risk have sub-optimal predictive capacities. In this setting, non-invasive imaging techniques and omics biomarkers could improve risk-prediction models for CV events. This study aimed to identify gene expression patterns in whole blood that could differentiate patients with severe coronary atherosclerosis from subjects with a complete absence of detectable coronary artery disease and to assess associations of gene expression patterns with plaque features in coronary CT angiography (CCTA). Patients undergoing CCTA for suspected coronary artery disease (CAD) were enrolled. Coronary stenosis was quantified and CCTA plaque features were assessed. The whole-blood transcriptome was analyzed with RNA sequencing. We detected highly significant differences in the circulating transcriptome between patients with high-degree coronary stenosis (≥70%) in the CCTA and subjects with an absence of coronary plaque. Notably, regression analysis revealed expression signatures associated with the Leaman score, the segment involved score, the segment stenosis score, and plaque volume with density <150 HU at CCTA. This pilot study shows that patients with significant coronary stenosis are characterized by whole-blood transcriptome profiles that may discriminate them from patients without CAD. Furthermore, our results suggest that whole-blood transcriptional profiles may predict plaque characteristics.

Sustained Safety and Efficacy of Magnesium Reabsorbable Scaffold: 2-Year Follow-Up Analysis From First Magmaris Multicenter Italian Registry.

BACKGROUND: Magnesium Reabsorbable Scaffold (MRS), is the newest reabsorbable technology with low thrombogenicity, short scaffolding time and almost complete resorption at 12-months (95%). Preliminary 12-months data in selected patients has shown that safety and efficacy are comparable with second generation Drug Eluting Stent (DES). Magmaris Multicenter registry showed 1-and 2-years clinical outcome on the first patients suitable for MRS enrolled in 4 Italian centers. METHODS: We evaluated 12- and 24-months clinical results in "real world" experience with Magnesium Reabosrbable Scaffold in terms of Target Lesion Failure (TLF) and scaffold thrombosis (ST). TLF is the primary endpoint and was defined as composite of cardiac mortality, target vessel myocardial infarction (MI), and ischemia-driven target lesion revascularization (ID-TLR). 4P's strategy (Patient/lesion selection, Pre-dilatation, Proper scaffold sizing and Post-dilatation) was strongly recommended. Dual Antiplatelet Therapy (DAPT) has been recommended for 12 months. RESULTS: Data from 207 patients, including initial experience, have been collected. Patients were 83% male, 20% diabetic and Acute Coronary Syndrome (ACS) in 23%. Lesion type were A-B1 in 54% and B2C in 46%. 4P's strategy was respected in 94%. Procedural success was 98% (2% peri-procedural MI). Compliance at 12-months follow up was 97.6%, TLF rate was 5.4% (including 1 case of myocardial infarction with late scaffold thrombosis (ST), all patients were successfully treated with in-scaffold segment DES implantation). At 24-months compliance was 92.8% (192 patients) and TLF was 7.4%. In the period between 13 and 24 months only 4 patients had TLF (including 1 case of myocardial infarction, all patients were successfully treated with in-scaffold segment DES implantation). None of the patients died for a cardiac reason. CONCLUSION: Our 2-years results confirm safety and efficacy showed at 12-months, reinforcing long-term performance with only 2% rate of TLF increase and no ST after 1 year.

Impact of coronary calcification assessed by coronary CT angiography on treatment decision in patients with three-vessel CAD: insights from SYNTAX III trial.

OBJECTIVES: The aim of this study was to determine Syntax scores based on coronary computed tomography angiography (CCTA) and invasive coronary angiography (ICA) and to assess whether heavy coronary calcification significantly limits the CCTA evaluation and the impact of severe calcification on heart team's treatment decision and procedural planning in patients with three-vessel coronary artery disease (CAD) with or without left main disease. METHODS: SYNTAX III was a multicentre, international study that included patients with three-vessel CAD with or without left main disease. The heart teams were randomized to either assess coronary arteries with coronary CCTA or ICA. We stratified the patients based on the presence of at least 1 lesion with heavy calcification defined as arc of calcium >180° within the lesion using CCTA. Agreement on the anatomical SYNTAX score and treatment decision was compared between patients with and without heavy calcifications. RESULTS: Overall, 222 patients with available CCTA and ICA were included in this trial subanalysis (104 with heavy calcification, 118 without heavy calcification). The mean difference in the anatomical SYNTAX score (CCTA derived-ICA derived) was lower in patients without heavy calcifications [mean (-1.96 SD; +1.96 SD) = 1.5 (-19.3; 22.4) vs 5.9 (-17.5; +29.3), P = 0.004]. The agreement on treatment decision did not differ between patients with (Cohen's kappa 0.79) or without coronary calcifications (Cohen's kappa 0.84). The agreement on the treatment planning did not differ between patients with (concordance 80.3%) or without coronary calcifications (concordance 82.8%). CONCLUSIONS: An overall good correlation between CCTA- and ICA-derived Syntax score was found. The presence of heavy coronary calcification moderately influenced the agreement between CCTA and ICA on the anatomical SYNTAX score. However, agreement on the treatment decision and planning was high and irrespective of the presence of calcified lesions.

Absolute and relative contraindications to proximal protection: do they really matter? A case-illustrative approach.

Carotid artery stenting (CAS) is an established technique to treat carotid artery stenosis. Favorable results have been reported in different subsets of patients in both acute and long-term settings. Among the CAS periprocedural variables the type of cerebral protection - distal filter and proximal protection - play a pivot role to reduce cerebral embolization. Accumulating evidence is in favor of better performance of proximal protection vs. distal filters. However, the rate of worldwide penetration of this devise is low. Potential reasons include a lengthy list of technical issues that may account for the reluctance of filter-oriented operators to change systems. This paper shows how to identify, treat, and overcome these technical obstacles.

Intolerance to occlusion during carotid artery stenting with proximal protection: causes, mechanisms, treatment and prevention.

Periprocedural cerebral microembolization is the most important complication of carotid artery stenting. Among several variables that play a role to reduce this risk, brain protection (proximal vs. distal) plays a pivot role. Data are accumulating in favor of a better performance of proximal vs. distal especially in symptomatic patients and high-risk carotid plaques. A prerequisite for the technique to be safe and effective is the presence of a valid intracranial collateral circulation to compensate for the target vessel hemisphere avoiding patient intolerance. This complication may occur either soon after the common carotid balloon occlusion or slowly developing during the procedure peaking at the stent post-dilation step. While Willis' circle anatomic variants are the most frequent cause of acute intolerance, a mix of anatomic, hemodynamic and patient cerebral condition play a role for the late developing form. Prevention is the best treatment of intolerance through a pre- and procedural imaging with different techniques (CT angiography, NMR angiography, transcranial Doppler assessment, digital subtraction angiography and back pressure monitoring).

The bimodal "rise and fall" ACS curve overlapping COVID-19 pandemic peaks.

BACKGROUND: The COVID-19 outbreak harmed acute coronary syndromes. During the national lockdown in Italy, the fear of post-admission contagion translated into significant delays in seeking medical help among STEMI (ST-elevation myocardial infarction) patients. OBJECTIVE AND METHODS: Our analysis aimed to assess the ACS (Acute Coronary Syndromes) admissions during the pandemic, together with time to presentation and clinical outcomes compared to 2019 in a cardiovascular hub in Milan. Data of ACS patients admitted during the pandemic year 2020 were extracted by the hospital's database and compared to a historical cohort of patients admitted for the same clinical indications in 2019. RESULTS: A total of 599 ACS cases were recorded in 2020 vs. 386 cases in 2019, with a net 55% increase, associated with late clinical presentations, a threefold increase in cardiogenic shock, and a more than two-fold higher mortality rate. CONCLUSIONS: The ultimate goal of this analysis is to preserve the life-saving focus on universal and prompt STEMI diagnosis and treatment, even in a time of dynamic global crisis.

Gender-Associated Outcomes Following Percutaneous Coronary Intervention With a Third-Generation, Ultrathin-Strut Drug-Eluting Stent: A Real-World, Single-Center Experience.

INTRODUCTION: In recent years, the new third-generation ultrathin bioresorbable-polymer sirolimus-eluting stent (BP-SES), characterized by some of the thinnest struts among commercially available devices (60-80 µm) and an amorphous silicon carbide coating, has been introduced for the treatment of coronary artery disease (CAD). The present study aimed to assess different clinical outcomes and safety of this drug-eluting stent in male and female patients in a real-world setting. METHODS: The present study is a retrospective analysis including all patients treated with BP-SES between January 2017 and December 2019 at a single high-volume center. Follow-up data, including stress test results and clinical setting, were collected during outpatient visits or by telephone contact. Patients symptomatic for angina or with a positive stress test were addressed to CT scan/coronary angiogram. The main study outcome was target lesion failure (TLF), defined as a composite of cardiovascular death, target vessel myocardial infarction, or target lesion revascularization. RESULTS: Overall, 66 (15.9%) female and 349 (84.1%) male patients were included; women were older (median age 70 vs. 66, P = 0.003) and with a lower body mass index (BMI) (25.0 vs. 26.1, P = 0.010) compared to men, with no other relevant differences in baseline characteristics. Indication for percutaneous coronary intervention (PCI) was acute coronary syndrome in 86 (20.7%) of the cases, with no significant differences between male and female patients. A total of 558 lesions were treated with BP-SES stents, 90 in women and 468 in men (1.36 vs. 1.34 lesions per patient, P = 0.83); cumulative stent length (33.6 vs. 38.4 mm, P = 0.078), and mean stent diameter (2.92 vs. 3.0 mm, P = 0.39) did not differ in women compared to men. Technical and clinical successes were achieved in all patients. Stent thrombosis (ST) occurred in 2 (0.5%) patients, both men. TLF occurred in 10 (2.9%) men and 2 (3.0%) women after a median follow-up of 402 days, without significant differences at log-rank analysis (2.34 events per 100 patient-years in men, 2.53 in women; P = 0.80). CONCLUSION: Ultrathin struts BP-SES showed to be a safe and effective option for the treatment of CAD in both women and men, with a very low ST rate and favorable long-term outcomes.

Carotid Wallstent Versus Roadsaver Stent and Distal Versus Proximal Protection on Cerebral Microembolization During Carotid Artery Stenting.

OBJECTIVES: The aim of this study was to randomly compare the double-layer Roadsaver stent (RS) (Terumo, Tokyo, Japan) with the single-layer Carotid Wallstent (CW) (Boston Scientific, Santa Clara, California) in association with either distal embolic protection with the FilterWire (FW) device (Boston Scientific) or proximal protection with the Mo.Ma Ultra device (Medtronic, Santa Rosa, California) in patients with lipid-rich carotid plaques. BACKGROUND: The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled. METHODS: A total of 104 consecutive patients with carotid artery stenosis were randomized to CAS with FW + RS (group 1, n = 27), FW + CW (group 2, n = 25), Mo.Ma + RS (group 3, n = 27), or Mo.Ma + CW (group 4, n = 25). The primary endpoint was the number of microembolic signals (MES) on transcranial Doppler among groups in the following CAS steps: 1 and 2) target vessel access; 3) lesion wiring; 4) pre-dilation; 5) stent crossing; 6) stent deployment; 7) stent dilation; and 8) device retrieval and deflation. RESULTS: No significant differences in baseline characteristics were found among the 4 groups. Compared with the FW device, the Mo.Ma Ultra device significantly reduced mean MES count (p < 0.0001) during lesion crossing, stent crossing, stent deployment, and post-dilation. Compared with the CW, the RS significantly reduced MES count (p = 0.016) in steps 6 to 8, including spontaneous MES (29% of patients). The combination of Mo.Ma + RS performed significantly better than Mo.Ma + CW (p = 0.043). Clinical major adverse cardiac and cerebrovascular events occurred in 3 patients (p = 0.51). After CAS, peak systolic velocity significantly decreased in all patients. In-stent restenosis developed in 1 patient (0.98%) at 6-month follow-up. The RS was an independent predictor of external carotid artery patency over time. CONCLUSIONS: In patients with high-risk, lipid-rich plaque undergoing CAS, Mo.Ma + RS led to the lowest microembolic signals count. (Role of the Type of Carotid Stent and Cerebral Protection on Cerebral Microembolization During Carotid Artery Stenting. A Randomized Study Comparing Carotid Wallstent vs Roadsaver® Stent and Distal vs Proximal Protection; NCT02915328).

Plaque quantification by coronary computed tomography angiography using intravascular ultrasound as a reference standard: a comparison between standard and last generation computed tomography scanners.

AIMS: The emerging role of coronary computed tomography angiography (CCTA) as a non-invasive tool for atherosclerosis evaluation is supported by data reporting a good correlation between CCTA and intravascular ultrasound (IVUS) for plaque volume quantification. Aim of the present study was to evaluate whether a last generation CT-scanner may improve coronary plaque volume assessment using IVUS as standard-of-reference. METHODS AND RESULTS: From a registry of 1915 consecutive, all-comers, patients who underwent a clinically indicated IVUS evaluation we enrolled 59 patients who underwent CCTA with a 64-slice CT (Group 1) and 59 patients who underwent CCTA with whole-heart coverage CT scanner (Group 2). Patients who underwent CCTA with unfavourable heart rhythm were not excluded from the analysis. Image quality (4-point Likert scale) focused on plaque analysis was evaluated. Plaque volume quantification by CCTA was compared to IVUS. No difference in clinical characteristics was found between Group 1 and Group 2. Plaque volume quantification by CCTA was considered not feasible in 11 plaques of Group 1 and in 4 plaques of Group 2 (P = 0.09). Higher correlation for plaque volume quantification by CCTA vs. IVUS was demonstrated in Group 2 when compared with Group 1 (r = 0.9888 vs. 0.9499; P < 0.0001). The Bland-Altman analysis showed plaque volume overestimation by CCTA of 11.9 mm3 in Group 1 and 4 mm2 in Group 2 (P < 0.001). Effective radiation dose of CCTA was significantly lower in Group 2 vs. Group 1 (2.7 ± 0.9 vs. 8.1 ± 3.6 mSv, respectively; P < 0.001). CONCLUSIONS: CCTA using a new scanner generation showed to be an accurate non-invasive tool to assess and quantify coronary plaque volume.

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.

Comparison of the Effectiveness of Percutaneous Intervention of the Left-Main Coronary Artery With Everolimus-Eluting Stents in Women -Vs- Men.

Everolimus-eluting stents are largely used for left main (LM) percutaneous coronary interventions (PCI). Long-term follow-up of patients who underwent LM PCI in a real world clinical setting, in particular women, have been scarcely reported. Consecutive patients who underwent unprotected LM PCI with EES at a single Institution from December 2006 to April 2016 were included. Main outcome assessed was the occurrence of major adverse cardiovascular events (MACE) as a composite of death, myocardial infarction or target lesion revascularization at follow-up. Overall, 589 patients (20.8% women) were included in the present analysis. Women were older, had lower body mass index and more frequently hypertensive compared with men. Main clinical presentation was stable coronary artery disease (CAD); unstable angina was more frequently observed in women compared with men, whereas ST-elevation myocardial infarction was less frequent. After 69.7 ± 28.3 months of follow-up, 47 patients overall experienced MACE (1.43 per 100*patients/year). MACE rate was higher in women compared with male patients, with a rate of 2.49 and 1.17 per 100*patients/year, respectively (p = 0.015). The difference was driven mainly by higher mortality in women (0.89 vs 0.15 per 100*patients/years, p = 0.002). At multivariable Cox regression, female gender was independently associated with an increased risk of MACE at follow-up (hazard ratio 2.21, 95% confidence interval 1.20 to 4.08, p = 0.011). In conclusion, EES can be safely and effectively adopted for LM PCI.

Dynamic Stress Computed Tomography Perfusion With a Whole-Heart Coverage Scanner in Addition to Coronary Computed Tomography Angiography and Fractional Flow Reserve Computed Tomography Derived.

OBJECTIVES: The aims of the study were to test the diagnostic accuracy of integrated evaluation of dynamic myocardial computed tomography perfusion (CTP) on top of coronary computed tomography angiography (cCTA) plus fractional flow reserve computed tomography derived (FFRCT) by using a whole-heart coverage computed tomography (CT) scanner as compared with clinically indicated invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR). BACKGROUND: Recently, new techniques such as dynamic stress computed tomography perfusion (stress-CTP) emerged as potential strategies to combine anatomical and functional evaluation in a one-shot scan. However, previous experiences with this technique were associated with high radiation exposure. METHODS: Eighty-five consecutive symptomatic patients scheduled for ICA were prospectively enrolled. All patients underwent rest cCTA followed by stress dynamic CTP with a whole-heart coverage CT scanner (Revolution CT, GE Healthcare, Milwaukee, Wisconsin). FFRCT was also measured by using the rest cCTA dataset. The diagnostic accuracy to detect functionally significant coronary artery disease (CAD) in a vessel-based model of cCTA alone, cCTA+FFRCT, cCTA+CTP, or cCTA+FFRCT+CTP were assessed and compared by using ICA and invasive FFR as reference. The overall effective dose of dynamic CTP was also measured. RESULTS: The prevalence of obstructive CAD and functionally significant CAD was 77% and 57%, respectively. The sensitivity and specificity of cCTA alone, cCTA+FFRCT, and cCTA+CTP were 83% and 66%, 86% and 75%, and 73% and 86%, respectively. Both the addition of FFRCT and CTP improves the area under the curve (AUC: 0.876 and 0.878, respectively) as compared with cCTA alone (0.826; p < 0.05). The sequential strategy of cCTA+FFRCT+CTP showed the highest AUC (0.919; p < 0.05) as compared with all other strategies. The mean effective radiation dose (ED) for cCTA and stress CTP was 2.8 ± 1.2 mSv and 5.3 ± 0.7 mSv, respectively. CONCLUSIONS: The addition of dynamic stress CTP on top of cCTA and FFRCT provides additional diagnostic accuracy with acceptable radiation exposure.

A Long-Term Single-Center Registry of 6893 Patients Undergoing Elective Percutaneous Coronary Intervention With the Xience Everolimus-Eluting Stent.

BACKGROUND: The safety and effectiveness of the everolimus-eluting stent (EES) have been previously demonstrated. AIMS: To assess very long-term performance and outcomes of the EES in a real-world population. METHODS: This single-center registry prospectively enrolled 6893 patients (mean age, 66 ± 9.7 years; 81.4% men) undergoing elective coronary intervention with the EES over a decade. Clinical follow-up (FU) was performed at 1 year and then yearly thereafter. RESULTS: Multiple risk factors were present in 34%. Stable angina was the main stenting indication (78.1%), followed by unstable angina (5.3%) and positive stress test (16.6%) for 1-vessel (44%) or 2/3-vessel disease (56%). Multiple stents (stent/patient ratio: 2.1 ± 0.8) in >1 vessel were implanted in 36.9% (mean stent length, 43 ± 31.3 mm). At 1 year, 80% of patients were on dual-antiplatelet therapy, while only 3% were on therapy at 2 years. A low 1-year major adverse cardiac event (MACE) rate of 5.0% was observed; stent thrombosis (ST) occurred in 19 patients (0.3%), with a prevalence of early (n = 9) over late (n = 4) and very late events (n = 6; 0.08%). Clinically driven target- lesion revascularization/target-vessel revascularization (TLR/TVR) occurred in 3.3% at 1-year follow-up. Long-term FU (3 years) completed in 6210 patients (90.0%) showed a MACE rate of 5.9%, while very long-term FU (>5 years and up to 10 years), available in 3550 out of 4635 exposed patients (76.6%), showed a MACE rate of 8.6%. Independent MACE predictors were stented segment length (odds ratio [OR], 2.1; 95% confidence interval [CI] 1.57-2.82), small vessel stenting (OR, 1.34; 95% CI, 1.08-1.68), and multivessel disease (2-vessel disease: OR, 1.59; 95% CI, 1.21-2.08; 3-vessel disease: OR, 2.26; 95% CI, 1.72-2.97). CONCLUSIONS: This large, prospective registry confirms the very long-term safety and efficacy of the EES in unselected real-world and complex coronary lesions.

Incremental Diagnostic Value of Stress Computed Tomography Myocardial Perfusion With Whole-Heart Coverage CT Scanner in Intermediate- to High-Risk Symptomatic Patients Suspected of Coronary Artery Disease.

OBJECTIVES: The goal of this study was to evaluate the diagnostic accuracy of stress computed tomography myocardial perfusion (CTP) for the detection of functionally significant coronary artery disease (CAD) by using invasive coronary angiography (ICA) plus invasive fractional flow reserve (FFR) as the reference standard in consecutive intermediate- to high-risk symptomatic patients. BACKGROUND: Stress CTP recently emerged as a potential strategy to combine the anatomic and functional evaluation of CAD in a single scan. METHODS: A total of 100 consecutive symptomatic patients scheduled for ICA were prospectively enrolled. All patients underwent rest coronary computed tomography angiography (CTA) followed by stress static CTP with a whole-heart coverage CT scanner (Revolution CT, GE Healthcare, Milwaukee, Wisconsin). Diagnostic accuracy and overall effective dose were assessed and compared versus those of ICA and invasive FFR. RESULTS: The prevalence of obstructive CAD and functionally significant CAD were 69% and 44%, respectively. Coronary CTA alone demonstrated a per-vessel and per-patient sensitivity, specificity, negative predictive value, positive predictive value, and accuracy of 98%, 76%, 99%, 63%, and 83% and of 98%, 54%, 96%, 68%, and 76%, respectively. Combining coronary CTA with stress CTP, per-vessel and per-patient sensitivity, specificity, negative predictive value, positive predictive value, and accuracy were 91%, 94%, 96%, 86%, and 93% and 98%, 83%, 98%, 86%, and 91%, with a significant improvement in specificity, positive predictive value, and accuracy in both models. The mean effective dose for coronary CTA and stress CTP were 2.8 ± 1.4 mSv and 2.5 ± 1.1 mSv. CONCLUSIONS: The inclusion of stress CTP for the evaluation of patients with an intermediate to high risk for CAD is feasible and improved the diagnostic performance of coronary CTA for detecting functionally significant CAD.

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.

Diagnostic accuracy of simultaneous evaluation of coronary arteries and myocardial perfusion with single stress cardiac computed tomography acquisition compared to invasive coronary angiography plus invasive fractional flow reserve.

BACKGROUND: Coronary computed tomography angiography (cCTA) has limited diagnostic accuracy in patients with intermediate to high pre-test likelihood of coronary artery disease (CAD) that may have large amounts of coronary calcium. Stress computed tomography myocardial perfusion (CTP) has emerged as a valuable strategy, combining anatomical and functional assessment of CAD. Purpose of the study is to evaluate the diagnostic accuracy of combining coronary artery imaging and myocardial perfusion in a single stress dataset versus invasive coronary angiography (ICA) and invasive fractional flow reserve (FFR) as reference standard. METHODS: One-hundred-thirty consecutive symptomatic patients (age: 65 ±â€¯9 years; men: 70%) scheduled for clinically indicated ICA plus invasive FFR were prospectively enrolled. cCTA + CTP were simultaneously evaluated in a single stress-dataset by blinded readers and compared to ICA and invasive FFR findings. RESULTS: CTP was successfully performed in all patients. The most common artifacts observed in the stress dataset for coronary artery imaging were blooming effect and motion effect related. Overall evaluability of coronary arteries by using cCTA stress dataset was 93%. In a vessel and patient-based model, stress cCTA + stress CTP showed sensitivity, specificity, negative predictive value, positive predictive value and diagnostic accuracy of 93%, 94%, 97%, 85%, 94%, and 98%, 86%, 98%, 85%, 92%, respectively. The overall effective dose (ED) of stress protocol acquisition alone was 2.5 ±â€¯1.1 mSv. CONCLUSIONS: Simultaneous evaluation of coronary arteries and myocardial perfusion with single stress acquisition is feasible and it has diagnostic accuracy and low ED to identify functionally significant stenosis in patients with intermediate to high risk for CAD.

Quantitative vs. qualitative evaluation of static stress computed tomography perfusion to detect haemodynamically significant coronary artery disease.

Aims: To compare the diagnostic accuracy of stress computed tomography myocardial perfusion (CTP) for the detection of significant coronary artery disease with visual approach vs. quantitative analysis with transmural perfusion ratio (TPR) in consecutive symptomatic patients scheduled for invasive coronary angiography (ICA) plus invasive fractional flow reserve (FFR). Methods and results: Eighty-eight consecutive symptomatic patients underwent rest coronary computed tomography angiography (cCTA) followed by static stress-CTP. Diagnostic accuracy of cCTA + stress-CTP with visual evaluation and with TPR measurement was calculated and compared with ICA and invasive FFR. Addition of stress-CTP with qualitative evaluation to rest-cCTA showed sensitivity, specificity, negative and positive predictive values, and accuracy at a vessel and patient level of 92%, 92%, 97%, 82%, 92% and 98%, 80%, 97%, 82%, 89%, respectively indicating a significant improvement of specificity, positive predictive value, and accuracy values vs. rest-cCTA in both models. Similarly, addition of stress-CTP with TPR evaluation to rest-cCTA showed sensitivity, specificity, negative and positive predictive values, and accuracy at a vessel and patient level of 84%, 90%, 93%, 76%, 88% and 91%, 71%, 89%, 75%, 81%, respectively indicating a significant improvement of specificity, positive predictive value values vs. rest-cCTA only in a vessel-based model and of positive predictive value in a patient-based model. When cCTA + stress-CTP with qualitative evaluation was compared with cCTA + stress-CTP with TPR estimation, no differences were found in terms of diagnostic performance. Conclusion: The addition of stress-CTP with visual evaluation to cCTA imaging has similar diagnostic performance when compared with the quantitative analysis of myocardial perfusion based on TPR measurement.