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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., Severe calcifications of vessel wall and atherosclerotic plaque hamper visual assessment of coronary arteries with coronary computed tomography angiography (CCTA) due to blooming artefacts.

The aim of this study was to evaluate the feasibility, safety and efficacy of transradial/brachial (TR/TB) carotid artery stenting (CAS) with proximal cerebral protection (PCP) as a first line of treatment of carotid artery stenosis.Among 556 patients with significant (50% if symptomatic or70% if asymptomatic by Doppler US) unilateral, lipid-rich carotid artery stenosis undergoing TR/TB CAS, 137 (24.5%) deemed at high-risk for periprocedural cerebral embolization were scheduled for PCP with Mo.MA Ultra or Mo.MA mono-balloon. In patients with very complex anatomy the standard technique was modified loading the Mo.MA catheter without mandrel on two-wire system (so called 'No MAndrel 2 wire' technique, No.MA2) to increase support and deliverability. Device, technical and procedural successes both acute and at follow-up were the main outcomes.Mean patients' age was 74±7 years (93% male), 15% were symptomatic and 59.6% owned 'high-surgical-risk' features. Stenosis degree was 85±7% with soft composition in all (by CT-angiography). TR and TB approach were selected in 92 (67%) and 45 (33%) patients, respectively. Target carotid axes were right, left bovine and left non bovine in 55%, 38% and 7% of patients. Procedures were successfully completed in all patients (intention-to-treat basis) with the standard Mo.MA Ultra system in 129 patients and the Mo.MA mono-balloon in 8 patients. No.MA2 technique was succesfully used in 16 patients as 'bailout' and in 27 patients as 'first line'). Device and technical success was 97% (133/137 patients) due to crossover to femoral access in 3 cases, and Mo.MA too short to engage the ECA in 1 patient. The procedural success was 96.7% (131/137, two minor strokes). Procedural time and fluoroscopy time were increased with No.MA2 technique. One major vascular complication occurred, in the TB group, while chronic radial occlusion was detected by Doppler ultrasound in 7/92 patients (7.1%) at 372±163 days of follow-up. The event-free survival was 9% and the stroke rate was 0%.TR/TB CAS with proximal protection is a feasible, safe and effective strategy and may be considered a first line strategy in all comer patients.

Introduction Female patients underrepresentation in clinical trials is a well known issue in clinical research, especially harming the assessment of interventional cardiovascular devices. Limited inclusion of women in such studies might lead to suboptimal care, as results derived from predominantly male populations might not hold true for female patients. In recent years, third generation drug-eluting stents have become the standard of care for percutaneous coronary interventions (PCI). Among them, the Orsiro sirolimus-eluting stent carries some promising features such some of the thinnest struts among commercially available devices (60-80 µm), a bioresorbable-polymer and an amorphous silicon carbide coating. We performed the presents study with the aim to assess if use of this stent in a real-world setting might lead to differential clinical outcomes in women compared to men. Methods This is a retrospective study conducted at a single, high-volume center, including all patients undergoing PCI with the implantation of at least one Orsiro for acute or chronic coronary syndromes between January 2017 and December 2019. Main clinical and procedural features were collected, as well as in hospital outcomes. Follow-up data were collected by outpatient visit or by telephone interview. Target lesion failure (TLF), a composite of cardiovascular death, target vessel myocardial infarction or target lesion revascularization, was the main outcome. Results Out of a total of 416 patients treated with at least an Orsiro stent, 66 (15.9%) were women and 349 (84.1%) men. No significant differences were observed at baseline, excepted for a higher age (median age 70 vs. 66, P=0.003) and a lower BMI (25.0 vs. 26.1, P=0.010) in women compared to men. No gender-related differences were observed in the indication for PCI, with most of the patients presenting with chronic coronary syndrome (329, 79.3%), rather than acute coronary syndrome in (86, 20.7%). The global number of treated lesions was 558 (90 in women, 468 in men); frequency of left main (5.3% vs. 3.0%) and left anterior descending (34.9% vs. 42.4%) PCI was similar (P=0.28). Treated vessels number of treated lesion per patients (1.36 vs. 1.34, P=0.83), cumulative stent length (33.6 mm vs. 38.4, P=0.078) and mean stent diameter (2.92 vs. 3.0 mm, P=0.39) was not different between men and women. Technical and clinical success was achieved in all cases. Two cases (0.5%) of stent thrombosis, one early and one late, were documented, all in men. After a median follow-up of 402 days, the main outcome of TLF was observed in 10 (2.9%) men and 2 (3.0%) women, with no significant differences at log-rank analysis (2.34 events per 100 patient-years in males, 2.53 in females; P=0.80). In the subgroup of patients undergoing small-vessel PCI (stent diameter ≤ 2.5 mm) no differences were observed in terms of TLF at follow-up between women and men (3.2% vs. 4.9%; P = 0.68). Similar findings emerged in the subgroup of patients presenting with acute coronary syndrome (6.3% vs. 4.3%, P = 0.74) Conclusions Ultrathin struts Orsiro stent did not show significant differences in terms of procedural, short-term and long-term outcomes in women compared to men in a real-world setting. This device may represent a viable option for female and male patients undergoing PCI.

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.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.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.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.

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.The role of both stent type and brain protection during carotid artery stenting (CAS) remains unsettled.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.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.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).

Introduction Preliminary reports from the early phase of COVID-19 epidemic in Italy reported a dramatic reduction in hospital admission rates for acute coronary syndromes (ACS) coupled with longer times from symptoms onset to hospital presentation. Purpose To assess the impact of COVID-19 on hospital admission rates and ACS patterns, as well as time to presentation and clinical outcomes, following the acute pandemic phase in 2020 compared to previous year. Methods We conducted a single institution retrospective analysis conducted in a cardiovascular hub serving a large metropolitan area in Italy. Number and monthly distribution of hospital admissions for ACS from January 1 to December 31, 2020 were compared to the respective figures in 2019. Baseline clinical features, time from symptoms onset to hospital admission and main clinical outcomes were collected. Results A total of 599 ACS cases were recorded in 2020 vs. 386 cases in 2019, with a net 55% increase. ACS presentation rate in 2020 showed a bimodal pattern, paralleling the most contagious outbreak periods (Figure 1). SARS-CoB-2 nasopharyngeal swab or specific antibody tests were positive in 34 (5.7%) patients. Time from symptoms onset to hospital presentation tended to be longer in 2020 than in 2019, being two-fold longer during the peak epidemic phase (February 21-May 3, 2020; median time 2.0 vs. 5.0 hours, p=0.030). The proportion of late-presenting STEMI (>8 hrs from symptoms onset) was higher in 2020 compared to 2019 (30% vs. 18%, p=0.003),as well as higher was in-hospital mortality (15% in 2020 vs 6% in 2019, p=0.001), partly due to a three-fold increase in cardiogenic shock on ACS presentation. Conclusions ACS admission rate significantly increased during the 2020 COVID-19 epidemic outbreak for several reasons only partially explained by a SARS-CoV-2 infection trigger effect on ACS. Longer presentation times and higher rates of cardiogenic shock and mortality were observed, urging the need health-care systems to keep a high priority on cardiovascular emergencies response networks. Funding Acknowledgement Type of funding sources: None. Figure 1

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 Conclusions FFRCT and stress-CTP in addition to cCTA are valid and comparable tools to evaluate the functional relevance of CAD.

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.

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.

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.

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.

The safety and effectiveness of the everolimus-eluting stent (EES) have been previously demonstrated.To assess very long-term performance and outcomes of the EES in a real-world population.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.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) in1 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).This large, prospective registry confirms the very long-term safety and efficacy of the EES in unselected real-world and complex coronary lesions.

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.

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 ± 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 ± 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.

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.

Background Aim of the study was to evaluate image quality, radiation exposure and diagnostic accuracy of coronary CT angiography (CCTA) performed with a novel cardiac CT scanner in patients with very high heart rate (HR). Methods We prospectively enrolled 202 patients (111 men, mean age 66±8years) with suspected coronary artery disease who underwent CCTA with a whole-organ volumetric CT scanner. The HR during the scan was ≥80bpm in 100 patients (Group 1), while it was ≤65bpm in the remaining 102 patients (Group 2). In all patients, image quality score and coronary interpretability were evaluated and effective dose (ED) was recorded. In 86 of the 202 enrolled patients (40 patients in Group 1, 46 patients in Group 2) who were referred for a clinically indicated invasive coronary angiography (ICA) within 6months, diagnostic accuracy of CCTA vs. ICA was evaluated. Results Mean image quality and coronary interpretability were very high in both Groups (Likert=3.35 vs. 3.39 and 97.3% [1542/1584 segments] and 98% [1569/1600 segments] in Group 1 and Group 2, respectively). Mean ED was lower in Group 2 (1.1±0.5mSv) compared to Group 1 (2.9±1.6mSv). In Group 1, sensitivity and specificity of CCTA for detection of >50% stenosis vs. ICA were 95.2% and 98.9% in a segment-based analysis and 100% and 81.8% in a patient-based analysis, respectively. Conclusions The whole organ high-definition CT scanner allows evaluating coronary arteries in patients with high HR with excellent image quality, coronary interpretability and low radiation exposure.

Patients with symptomatic carotid artery disease should be managed by a multidisciplinary team including neurologists, vascular surgeons and interventionalists. Duplex ultrasound is the most widely used diagnostic modality to assess carotid disease, followed by additional imaging tests (CT- or MR-angiography) to confirm the severity of the stenosis, detect brain lesions, and assess intracranial circulation as well as the supra-aortic anatomy. Although overall randomized trial results favored (CEA) over carotid artery stenting (CAS) in symptomatic patients, this was likely related to the insufficient expertise of the endovascular specialists in several of the trials. CAS should be considered as a valid alternative to CEA in patients with favorable anatomy and in those at high-surgical risk, provided it is performed by experienced operators in high volume centers. Under those circumstances, it is reasonable to offer the patients the two options (CEA or CAS) after description of pros and cons of each therapy. CAS results may be further improved by better patient selection, new techniques, and technology advancements.

Objectives To characterize the treatment of complex bifurcation lesions (BL) with the Tryton Bifurcation Stent (TBS) paired with an everolimus-eluting stent (EES). Background Complex BL are associated with higher procedural complications and poorer long-term outcomes. The TBS is a dedicated side-branch (SB) stent designed to be used in conjunction with a standard drug-eluting stent. Methods Prospectively identified, consecutive patients underwent TBS+EES stenting of BL using a protocol which included TBS postdilation and simultaneous final kissing balloon inflations (FKBI). All lesions were systematically evaluated with coronary angiography and IVUS, obtained at procedure completion and at 9 months, and were assessed by independent core laboratories. Results Thirty-three BL were treated in 32 patients presenting primarily (87.5%) with stable angina and complex BL with angiographic apparent disease in the main vessel (MV) and SB in 87.9% and 75% by site and core evaluation, respectively. Procedural success was 100% and high postprocedure percent stent expansion (MV 96 [93, 109]%, SB 88 [77, 100]%, carina MV 135 [99, 166]%, carina SB 116 [91, 130]%) was demonstrated by IVUS. At 9-month angiographic follow-up (n = 28 patients), one MV in-segment restenosis and one SB in-stent restenosis were observed. SB in-stent late lumen loss was 0.41 ± 0.27 mm. IVUS assessment revealed the absence of stent recoil; percent carinal neointimal hyperplasia (NIH) was 1.8 [0.0,11.2]% in MV and 15.0 [6.7,23.5]% in SB, with NIH volume obstruction of 2.0 [0.7,4.3]% in MV and 14.2 [7.5,29.6]% in SB. Conclusions Stenting of complex BL with the TBS+EES provides high acute success with sustained clinical, angiographic, and IVUS results at 9 months. These excellent results are likely due to the extent of stent expansion at the carina. © 2014 Wiley Periodicals, Inc.

To assess the safety and efficacy of carotid artery stenting (CAS) of the left internal carotid artery (LICA) from a right radial/brachial approach in patients with bovine aortic arch.Among 505 consecutive CAS patients treated at our facility between June 2007 and December 2012, 60 (11.9%) patients (44 men; mean age 73±9 years) with LICA stenosis and bovine arch were treated from a right radial (n=32) or brachial (n=28) approach. Three quarters of the patients had characteristics qualifying them at high surgical risk; 52 were asymptomatic. The types of cerebral protection (a distal filter or proximal MO.MA system), stent, and technique were at the operation's discretion.The radial/brachial approach was successful in 59 (98.3%) of 60 procedures; 1 case was converted to a femoral approach. Proximal protection was used in 15 cases (11 brachial, 4 radial) with severe, soft plaques, although the MO.MA system proved too short in a tall patient having a radial approach and a filter was used. Clinical success with no adverse events was 96.7% owing to 1 retinal embolism and 1 minor stroke. Vascular complications occurred in 2 (3.3%) brachial group patients. No major bleeding was encountered. Over a mean follow-up of 18.7±17.5 months, midterm event-free survival was 93%. No target vessel revascularization was necessary.CAS via a right radial or brachial approach is safe and effective in patients with LICA stenosis and types 1 or 2 bovine arch.

Magnesium bioabsorbable metallic scaffold (Magmaris), with low thrombogenicity, short scaffolding time, and complete reabsorption at 12 months, is completely different from PLLA-based scaffolds. We evaluate 24-month clinical results in “real world” pooled patients with lesions suitable for

Patent foramen ovale closure has been demonstrated to be superior to medical therapy and recommended for the secondary prevention of stroke by current guidelines. However, long-term clinical and echocardiography data are not commonly available. Between January 2012 and December 2018, 688

PurposeTo evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS).MethodsAmong 830 consecutive patients un...

Spontaneous coronary artery dissection (SCAD) accounts approximately for 0.2% of cases of acute coronary syndrome. It is defined "spontaneous" in absence of any coronary wall damage. This disease affects primarily young women in good health, with no risk factors for coronary artery disease, especially during the postpartum period. Since the clinical presentation varies widely from no symptoms to typical angina and sudden cardiac death, SCAD incidence is underestimated.A 40-year-old woman, in the 8th week after delivery, was admitted to our emergency department because of acute chest pain, and a diagnosis of inferior and posterior non-ST-elevation myocardial infarction was made. Emergency coronary angiography showed a small SCAD of the distal segment of a little marginal branch. Because of the small dimension of the dissection, optimal medical therapy was started. However, two days later, symptoms recurred and the ECG showed an anterior ST-elevation myocardial infarction. The patient was therefore transferred to the cath lab and coronary angiography showed extensive dissection of the left anterior descending coronary artery with good angiographic result. Percutaneous coronary intervention was performed and three drug-eluting stents were implanted.No retrospective studies or randomized clinical trials are available to guide the best treatment option in patients with SCAD, because of the wide variety of clinical presentation and the rarity of the pathology. Early and correct diagnosis of SCAD is key for adequate management. First, the site and precise quantification of lesion severity should be assessed with multiple angiographic projections. Intravascular ultrasound and optical coherence tomography can provide additional information about the entry point of the lesion. Hemodynamic status and extension of the myocardium at risk should be also evaluated to determine the best therapeutic strategy. Since the presence of SCAD may be associated with aneurysm formation and dissections of other arteries, screening of the arterial tree may be useful, especially of the supra-aortic trunks and splanchnic circulation.

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.

Objectives The goal of this study was to compare the rate of cerebral microembolization during carotid artery stenting (CAS) with proximal versus distal cerebral protection in patients with high-risk, lipid-rich plaque. Background Cerebral protection with filters partially reduces the cerebral embolization rate during CAS. Proximal protection has been introduced to further decrease embolization risk. Methods Fifty-three consecutive patients with carotid artery stenosis and lipid-rich plaque were randomized to undergo CAS with proximal protection (MO.MA system, n = 26) or distal protection with a filter (FilterWire EZ, n = 27). Microembolic signals (MES) were assessed by using transcranial Doppler during: 1) lesion wiring; 2) pre-dilation; 3) stent crossing; 4) stent deployment; 5) stent dilation; and 6) device retrieval/deflation. Diffusion-weighted magnetic resonance imaging was conducted before CAS, after 48 h, and after 30 days. Results Patients in the MO.MA group had higher percentage diameter stenosis (89 ± 6% vs. 86 ± 5%, p = 0.027) and rate of ulcerated plaque (35% vs. 7.4%; p = 0.019). Compared with use of the FilterWire EZ, MO.MA significantly reduced mean MES counts (p Conclusions In patients with high-risk, lipid-rich plaque undergoing CAS, MO.MA led to significantly lower microembolization as assessed by using MES counts. (Carotid Stenting in Patients With High Risk Carotid Stenosis [“Soft Plaque”] [MOMA]; NCT01274676 )

Treatment strategy of coronary artery disease (CAD) before transcatheter aortic valve replacement (TAVR) is still debated. Moreover, proper timing of percutaneous coronary intervention (PCI) is not jet established. Aim of the study was to assess safety and effectiveness of PCI before TAVR in a large

Aim of the study is to assess the diagnostic performance of CCTA alone, CTP alone and CCTA plus CTP performed with the latest scanner generation that combine a whole-heart coverage with high spatial and temporal resolution, by using invasive coronary angiography (ICA) as standard of reference. A

Magnesium bioabsorbable metallic scaffold (MagmarisTM), with low trombogenicity, short scaffolding time, metallic performance and complete reabsorption at 12 months, is completely different from PLLA-based scaffold. We evaluate 12 months clinical results in “real world” pts with lesions

Background A controversial aspect of carotid artery stenting (CAS) is the placement of a stent with or without predilation. The study was designed to test the hypothesis that direct stenting (DS) was not inferior to CAS with predilation. Methods Elective CAS with filter protection was performed in 205 consecutive, unselected patients with carotid artery stenosis (>50% if symptomatic and ≥75% if asymptomatic by Doppler assessment) who were randomly assigned to CAS with predilation ( n =100) or direct stenting (DS, n =105). Filter and stent selection were left to the operator's discretion. The study end-point was the angiographic success, defined as ≤30% angiographic residual stenosis after CAS without abnormal angiographic findings in cerebral circulation and without cross-over to predilation in the DS group. Results At baseline, patient clinical characteristics and stenosis anatomic features did not differ between groups. Angiographic success was 99% and 97%, p =0.33, in predilation and DS, respectively. No cross-over to predilation occurred in the DS group. Procedural time was shorter in DS as compared to predilation (24.3±7% versus 19.9±6%, p =0.001) and visible debris were more frequently captured in predilation as compared to DS (50% versus 36%, p =0.003). No peri-procedural and 30-day death or major stroke occurred in both groups. Minor stroke and TIA rates were similar in either group (2% versus 0% and 8% versus 5.7%, p =ns, respectively). Conclusion In an unselected, consecutive series of patients submitted to CAS, DS is a feasible technique and is not inferior to CAS with predilation.

Unfavorable complex anatomy or congenital anomalies of supra-aortic vessel take-off may increase carotid artery stenting (CAS) procedural difficulties and complications through the femoral route. We assessed the feasibility, safety, and efficacy of CAS through the right brachial approach in patients in whom left internal carotid artery stenosis and bovine aortic arch configuration were identified with computed tomography (CT) angiography. Bovine configuration of the aortic arch and left carotid artery stenosis were easily identified by CT angiography and successfully treated through the right brachial approach technique.

Aims Although well supported by postmortem studies, the reliability of carotid atherosclerosis as surrogate marker of coronary atherosclerosis has been put in doubt by in vivo studies showing a poor correlation between carotid intima-media thickness (IMT) detected by external carotid ultrasound (ECU) and coronary stenosis assessed by quantitative coronary angiography (QCA). In the present study, we have investigated whether a stronger in vivo correlation between the two arteries can be obtained by using homogeneous variables such as carotid and coronary IMT, detected by ECU and intravascular ultrasound (IVUS), respectively. Methods and results ECU, QCA, and IVUS measurements were made in 48 patients. Carotid IMT was correlated with both angiographic and IVUS findings. A significant but weak correlation was observed between ECU and QCA variables (r � 0.35, P , 0.05); the correlation between ECU and IVUS measurements of IMT was higher, with correlation coefficients ranging from 0.49 to 0.55. In patients with a QCA diagnosis of normal/intermediate coronary atherosclerosis, the presence of a carotid-IMTmean . 1m m was associated with an 18-fold increase in risk of having a positive IVUS test (OR = 17.99, 95% CI 1.83–177.14, P = 0.013) and with a seven-fold increased risk of having a significant IVUS coronary stenosis (OR = 7.4, 95% CI 1.27–44.0, P = 0.028). Conclusion Carotid atherosclerosis correlates better with coronary atherosclerosis when both circulations are investigated by the same technique (ultrasound) using the same parameter (IMT). This supports the concept that carotid IMT is a good surrogate marker of coronary atherosclerosis.

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. © 2007 Wiley-Liss, Inc.

Transradial (TR) and transbrachial (TR) carotid stenting (CAS) has been shown to be a valid alternative to trans-femoral CAS in specific subsets of patients and vascular anatomies. The major limitations to this technique are the small size of the radial artery that may limit the use of a full CAS

Evidence is accumulating in favor of classifying erectile dysfunction (ED) as a vascular disorder. There are three main clinical scenarios in which ED and coronary artery disease (CAD) may coexist: the patient with ED who later develops CAD, the patient with overt CAD who is casually found to have ED, and the patient with acute coronary syndrome who has normal sexual function. This study presents three cases and discusses a "putative" pathophysiological mechanism underlying all these clinical presentations. Further studies, coupling functional and structural changes of coronary circulation with those of penile (i.e., dynamic penile test) circulation in each of these situations are mandatory to support this hypothesis.

Erectile dysfunction (ED) is defined as the inability to reach or maintain erection sufficient for satisfactory sexual performance. Evidence is accumulating to consider ED as a vascular problem. Common risk factors for atherosclerosis are frequently found in ED and ED is frequently found in vascular syndromes such as coronary artery disease, hypertension, cerebrovascular disease, peripheral arterial disease and diabetes. Finally, a similar pathogenic involvement of NO-pathway leading to impairment of endothelium-dependent vasodilatation and late structural vascular abnormalities is shared by ED and vascular disorders.

Stents represent a major step forward in the treatment of coronary artery disease since the introduction of balloon angioplasty. They have demonstrated the reduction of angiographic indexes of restenosis and rates of repeat revascularization. However, in-stent neointimal proliferation represents the persisting limitation and challenge. Local delivery using a stent platform for deposition of therapeutic drug concentration in the arterial wall has emerged as an effective strategy to reduce in-stent neointimal hyperplasia and restenosis. The purpose of this article is to describe the design characteristics of a new drug-eluting stent. Its unique features consist of integral Carbofilm™ thromboresistant coating combined with the capability to load the drug into and to release it from deep sculptures made on the external surface of the stent. The advantages of this design are the possibility to load higher amounts of drug, to selectively deliver it to the vessel wall without loss in the blood stream, and to improve the biocompatibility and thromboresistance of the stent. Preclinical studies, using tacrolimus as the biological agent, showed excellent vessel tissue response and mild inflammation scores. A significant reduction of intimal proliferation was observed in comparison with a control stent. The enrollment in a safety first-in-man evaluation has been successfully completed. A randomized, double-blind, multicenter study is expected to start at the completion of the “safety” evaluation. (J Interven Cardiol 2003;16:499–505)

Worse outcomes have been observed in women after PTCA. The present study was undertaken to compare clinical and angiographic results of coronary stenting among women and men. We retrospectively analyzed acute and 6-month results in a consecutive series of 940 men and 160 women undergoing coronary stent implantation between May 1992 and January 1998. Women were older (63 vs. 57 years; P = 0.001), more often hypertensive (46.9% vs. 31.4%; P < 0.001) and diabetic (13.2% vs. 8.3%; P = 0.05), and less often smokers than men (32.5% vs. 70.5%; P < 0.001). A previous history of Q-wave MI was less frequently present in women (28.2% vs. 40.2%; P = 0.003) who more often underwent coronary revascularization because of unstable angina (37.5% vs. 27.1%; P = 0.027). No difference was observed in coronary artery disease extension, lesion complexity, and stented vessel between the sexes. Bailout stenting was more frequently needed in women (28% vs. 17.8%; P = 0.001). No difference was observed in the number of stent implanted per vessel and per patient and average maximal inflation pressure used for stent postdilation. However, a smaller final balloon size was used in women. Procedural and clinical success was achieved in 94.4% and 92.5% of women and 96.7% and 94.5% of men (P = NS), respectively, without differences regarding in-hospital major adverse cardiac events. Bleeding complications occurred more often in women when anticoagulation was used (OR = 2.87; 95% CI = 1.38–5.74). At 6-month clinical follow-up, TLR was similar between the sexes and event-free survival was 75.5% in women and 81.5% in men (P = NS). Angiographic follow-up, performed in 71% of the patients, showed that restenosis was 64% higher in women (OR = 1.64; 95% CI = 1.02–2.61). Despite older age, higher incidence of comorbidities, and more unstable presentation, women treated with coronary stenting showed acute and mid-term clinical results similar to those observed in men. However, they were significantly more likely to develop angiographic restenosis. Cathet Cardiovasc Intervent 2003;58:20–28. © 2003 Wiley-Liss, Inc.

We investigated by intravascular ultrasound (IVUS) the mechanism of action of cutting balloon (CB) angioplasty in patients with in-stent restenosis. Seventy-one consecutive restenotic lesions of 66 patients were studied by quantitative coronary angiography (QCA) and IVUS before, immediately after, and, in 20 cases, at 24-hr time interval after CB. CB was selected according to 1:1 CB-to-stent ratio and inflated at 8 atm for 60-90 sec. Both IVUS planar and volumetric (Simpson's rule, 25 patients) analysis were carried out. IVUS measurements included external elastic membrane area (EEMA), stent area (SA), minimal lumen area (MLA), and restenosis area (RA). Following CB, QCA analysis showed increase of minimal lumen diameter (1.17 +/- 0.46 vs. 2.45 +/- 0.51 mm; P < 0.0001) and decrease of diameter stenosis (64% +/- 13% vs. 21% +/- 9%; P < 0.0001). IVUS measurements showed a significant increase of MLA (2.18 +/- 0.80 vs. 7.31 +/- 1.8 mm(2); P < 0.0001), SA (9.62 +/- 2.6 vs. 10.7 +/- 2.75 mm(2); P < 0.0001), and EEMA (17.27 +/- 5 vs. 18.1 +/- 5 mm(2); P < 0.0001) and a decrease of RA (7.43 +/- 2.63 vs. 3.45 +/- 1.39 mm(2); P < 0.0001). No significant change was observed in the original plaque + media area (7.65 +/- 3 vs. 7.38 +/- 2.9 mm(2); P = NS). Thus, of the total lumen enlargement (5.13 +/- 1.85 mm(2)), 23% was the result of increase in mean SA, whereas 77% was the result of a decrease in mean RA. These changes were associated with a 5% increase in EEMA. IVUS volumetric changes paralleled planar variations. Angiographic and IVUS changes were well maintained at 24 hr. CB enlarges coronary lumen mainly by in-stent tissue reduction associated with a moderate degree of additional stent expansion. Favorable QCA and IVUS acute results are maintained at 24 hr.

The effect of stent coatings in preventing early thrombotic occlusion remains to be proved. The purpose of this study was to evaluate the safety and efficacy of the Carbostent™, a new coronary stent with a nonthrombogenic coating (Carbofilm™), in 110 consecutive patients (73.6% men, mean age 61 ± 9 years) who met prespecified clinical and angiographic inclusion criteria and were treated with aspirin monotherapy after stenting. Stable angina (75.5%), unstable angina (18.2%), and silent ischemia (6.3%) were clinical indications for coronary revascularization. Patients received 10,000 U of heparin and no IIb/IIIa inhibitors or postprocedural heparin. Complex lesion characteristics (B2, C) were present in 39 out of 129 (30.2%) lesions. Mean lesion length was 15.6 ± 7.4 mm, and 32% of the lesions were >15 mm (range 16–52 mm). Small coronary vessels (