Third- versus Second-Generation Stent Graft for Endovascular Aneurysm Repair: A Device-Specific Analysis.

PURPOSE: Our purpose is to analyze the outcomes of endovascular aneurysm repair (EVAR) in patients treated with Excluder endograft (W.L. Gore and Associate, Flagstaff, AZ), comparing second generation, featuring SIM-PULL delivery system (ExSP) and third generation, featuring C3 (ExC3), concerning intraprocedural data and long-term outcomes. METHODS: In our single-center, comparative study, we retrospectively analyzed all patients undergoing elective EVAR with Excluder from May 2008 to December 2015. This cohort was firstly divided according to the design of the endograft used, and then, two subgroups of complex procedures were identified according to International Standards. Preliminary end points were early- and mid-term outcomes. Primary end point was procedural data (i.e., procedural and fluoroscopy time, radiation dose (DAP), and contrast medium amount). RESULTS: The study included 64 patients (24 ExSP and 40 ExC3) with a mean follow-up of 31.6 ± 22.9 months. Patients in ExC3 group had significantly more risk factors (past or present history of smoking, P = 0.019), comorbidities (chronic heart failure and chronic kidney disease, both P = 0.032), as well as a more unfavorable anatomy (neck angulation, P = 0.035). Concerning preliminary outcome, no significant between-group difference was noted. As for intraoperative data, procedure duration was significantly shorter: 120 vs. 151 min (P = 0.002) in the overall population and 129 vs. 173 min (P = 0.004) in complex cases. A significant reduction was also found in fluoroscopy time and radiation exposure: 24,084 vs. 32,548 cGy/cm2 (P = 0.020) in the overall population and 26,770 vs. 41,104 cGy/cm2 (P = 0.003) in complex cases. No significant difference was found for contrast volume. CONCLUSIONS: The study shows that new C3 excluder enables to reduce radiation exposure and procedural time compared to the previous device. C3 excluder results are comparable to those of the previous device in spite of more comorbidities and complex anatomy of the treated patients. Further studies are needed to assess device performance on longer-term follow-up.

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

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

Carotid artery stenting in patients with left ICA stenosis and bovine aortic arch: a single-center experience in 60 consecutive patients treated via the right radial or brachial approach.

PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: CAS via a right radial or brachial approach is safe and effective in patients with LICA stenosis and types 1 or 2 bovine arch.

Drug-eluting balloon for treatment of in-stent restenosis after carotid artery stenting: preliminary report.

PURPOSE: To evaluate the safety and efficacy of drug-eluting balloons (DEB) for the treatment of in-stent restenosis (ISR) after carotid artery stenting (CAS). METHODS: Among 830 consecutive patients undergoing CAS between November 2001 and June 2012, significant ISR (>80% stenosis) occurred in 10 (1.2%) asymptomatic patients. Angioplasty with DEB treatment was performed in 7 patients (6 internal and 1 common carotid arteries) at a mean of 20.9 ± 19.4 months (median 12.1) after CAS. Intravascular ultrasound (IVUS)-guided predilation with distal cerebral protection was carried out with a cutting balloon followed by inflation of a DEB with a 1:1 stent-to-balloon size ratio. RESULTS: Technical/procedural success was achieved in all cases. Angiographic stenosis decreased from 83%± 5% to 18%± 6%. At IVUS evaluation, minimal lumen area increased from 3.19 ± 1.73 to 12.78 ± 1.97 mm(2) (p=0.0001), stent area was unchanged (from 17.36 ± 4.36 to 17.52 ± 4.34 mm(2), p=0.70), and the restenosis area decreased from 13.58 ± 5.27 to 4.71 ± 3.06 mm(2) (p=0.0005). At a mean follow-up of 13.7 ± 1.5 months (median 13.7), 1 patient had a minor stroke ipsilateral to the ISR vessel 2 months after DEB treatment; the stent was widely patent on duplex ultrasound and angiographic images. Overall, the average PSV decreased from 4.0 ± 1.0 to 0.9 ± 0.1 m/s (p=0.0001). At 6 and 12 months, PSVs after DEB treatment were significantly lower compared to those assessed at comparable intervals after CAS. CONCLUSION: The use of DEBs to treat ISR after CAS shows promising acute and midterm results.

A new kaolin-based haemostatic bandage compared with manual compression for bleeding control after percutaneous coronary procedures.

OBJECTIVE: Bleeding and vascular access site complications are an important cause of morbidity after percutaneous femoral procedures. New haemostatic dressings have been developed to control heavy bleeding. To evaluate the efficacy of a new kaolin-based haemostatic bandage for femoral artery closure after diagnostic or interventional procedures compared with manual compression. METHODS: The first pilot European trial using this haemostatic bandage was performed at the in Milan, Italy. Two-hundred patients (71% male, mean age 66 ± 11 years) undergoing angiography or PCI via a femoral approach were randomised to the haemostatic bandage (n = 100) or manual compression (n = 100) following sheath removal. The mean active clotting time (ACT) at haemostasis was 146 ± 24 s (range 98-198 s). Haemostasis was achieved in 5.4 ± 1.5 min with the bandage vs 25 ± 15 min after manual compression, p < 0.001. No haemostasis failure occurred in either group. No differences in oozing, minor and major haematomas and pseudoaneurysms were observed. All patients ambulated at 4 h. Major bleeding, re-bleeding or haematoma did not occur after early (4 h after the procedure) ambulation following use of the bandage. CONCLUSIONS: The haemostatic bandage obtained prompt and significantly shorter haemostasis than controls. This novel haemostatic device allowed for early ambulation without clinical complications.

Carotid stenting through the right brachial approach for left internal carotid artery stenosis and bovine aortic arch configuration.

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.

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.

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.

Low plasma glutathione levels after reperfused acute myocardial infarction are associated with late cardiac events.

OBJECTIVE: To clarify whether an altered redox state persists in the subacute phase of myocardial infarction and if specific redox patterns are associated with later cardiac events. METHODS: Ninety-seven patients [80 men, median 63 (interquartile range, 53, 69) years] with a first acute myocardial infarction, with (53%) or without ST segment elevation, treated with successful percutaneous interventions, were tested at 5-6 days after admission for plasma alpha-tocopherol, ascorbic acid, total and reduced homocysteine, cysteine, glutathione, cysteinylglycine and blood-reduced glutathione, all assessed by high-pressure liquid chromatography. Free malondialdehyde was evaluated by gas chromatography. A subgroup of 14 patients had adjunctive blood samples within 1 h and at 72 h after angioplasty. Blood samples from 44 patients matched for age, sex, and risk factors served as controls. Patients were followed up for median 15 (interquartile range, 9, 17) months for cardiac events. RESULTS: All plasma-reduced aminothiols, vitamins and plasma total glutathione were significantly lower in myocardial infarction at 5-6 days than in controls. In the 14 myocardial infarction patients sampled repeatedly, plasma-reduced glutathione, cysteinylglycine, total glutathione, and alpha-tocopherol significantly decreased, whereas blood-reduced glutathione, total homocysteine, and cysteine significantly increased over time. During follow-up, 20 of 97 (21%) patients had adverse cardiac events. Multivariate analysis revealed that only plasma-reduced glutathione was independently associated with events (hazard ratio 0.42, 95% confidence interval 0.18-0.99, P=0.04). CONCLUSIONS: Acute myocardial infarction patients have an altered redox state at 5-6 days after successful reperfusion with respect to controls. Low plasma levels of reduced glutathione at discharge are associated with cardiac events at follow-up.

[Peripartum spontaneous coronary artery dissection: a case report]. / Dissezione coronarica spontanea peripartum: un caso clinico.

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.

Rationale and design of the PERFECTION (comparison between stress cardiac computed tomography PERfusion versus Fractional flow rEserve measured by Computed Tomography angiography In the evaluation of suspected cOroNary artery disease) prospective study.

BACKGROUND: Non-invasive stress tests are commonly used as gatekeepers to invasive coronary angiography (ICA) in patients with suspected coronary artery disease (CAD). New computed tomography angiography (CTA) techniques such as fractional flow reserve calculated by CTA (FFRCT) and stress myocardial computed tomography perfusion (CTP) have emerged as potential strategies to combine anatomical and functional evaluation of CAD in one technique. The aim of this study is to compare per-vessel diagnostic accuracy of FFRCT versus stress myocardial CTP for the detection of functionally significant coronary artery disease (CAD), using invasive FFR as the reference standard. METHODS: Subjects with suspected CAD due to chest pain who have no contra-indications to FFRCT or stress myocardial CTP and who are referred for non-emergent, clinically indicated invasive coronary angiography (ICA), will be enrolled. A total of 300 subjects will be enrolled within 24 months. RESULTS: The primary study endpoint will be the comparison of per-vessel diagnostic accuracy of CTA versus FFRCT versus stress myocardial CTP for the diagnosis of hemodynamically significant stenosis as defined by invasive FFR ≤0.80. CONCLUSIONS: In the PERFECTION study, the comparison between FFRCT and stress myocardial CTP will provide understanding about which technology is more accurate for the diagnosis of functionally significant CAD.

Nitric oxide synthetic pathway in patients with microvascular angina and its relations with oxidative stress.

A decreased nitric oxide (NO) bioavailability and an increased oxidative stress play a pivotal role in different cardiovascular pathologies. As red blood cells (RBCs) participate in NO formation in the bloodstream, the aim of this study was to outline the metabolic profile of L-arginine (Arg)/NO pathway and of oxidative stress status in RBCs and in plasma of patients with microvascular angina (MVA), investigating similarities and differences with respect to coronary artery disease (CAD) patients or healthy controls (Ctrl). Analytes involved in Arg/NO pathway and the ratio of oxidized and reduced forms of glutathione were measured by LC-MS/MS. The arginase and the NO synthase (NOS) expression were evaluated by immunofluorescence staining. RBCs from MVA patients show increased levels of NO synthesis inhibitors, parallel to that found in plasma, and a reduction of NO synthase expression. When summary scores were computed, both patient groups were associated with a positive oxidative score and a negative NO score, with the CAD group located in a more extreme position with respect to Ctrl. This finding points out to an impairment of the capacity of RBCs to produce NO in a pathological condition characterized mostly by alterations at the microvascular bed with no significant coronary stenosis.

Nitric oxide synthetic pathway in red blood cells is impaired in coronary artery disease.

BACKGROUND: All the enzymatic factors/cofactors involved in nitric oxide (NO) metabolism have been recently found in red blood cells. Increased oxidative stress impairs NO bioavailability and has been described in plasma of coronary artery disease (CAD) patients. The aim of the study was to highlight a potential dysfunction of the metabolic profile of NO in red blood cells and in plasma from CAD patients compared with healthy controls. METHODS: We determined L-arginine/NO pathway by liquid-chromatography tandem mass spectrometry and high performance liquid chromatography methods. The ratio of oxidized and reduced forms of glutathione, as index of oxidative stress, was measured by liquid-chromatography tandem mass spectrometry method. NO synthase expression and activity were evaluated by immunofluorescence staining and ex-vivo experiments of L-[(15)N2]arginine conversion to L-[(15)N]citrulline respectively. RESULTS: Increased amounts of asymmetric and symmetric dimethylarginines were found both in red blood cells and in plasma of CAD patients in respect to controls. Interestingly NO synthase expression and activity were reduced in CAD red blood cells. In contrast, oxidized/reduced glutathione ratio was increased in CAD and was associated to arginase activity. CONCLUSION: Our study analyzed for the first time the whole metabolic pathway of L-arginine/NO, both in red blood cells and in plasma, highlighting an impairment of NO pathway in erythrocytes from CAD patients, associated with decreased NO synthase expression/activity and increased oxidative stress.

Sex difference in long-term clinical outcome after sirolimus-eluting stent implantation.

BACKGROUND: Coronary stenting in women has been associated with worse results in terms of morbidity, mortality, and restenosis rate in the bare-metal stent era, possibly due to higher risk profile and smaller coronary vessels. Although drug-eluting stents have equalized clinical results, no data are available on long-term outcomes between sexes. OBJECTIVES: To evaluate the role of sex in acute, mid-term, and long-term clinical outcome after sirolimus-eluting stent (SES) implantation. METHODS: We retrospectively evaluated 1186 patients, 970 (81.8%) male and 216 (18.2%) female, treated with SES implantation between April 2002 and December 2005. RESULTS: Women were older (P=0.049), more likely to have hypertension (43.5 vs. 33.7%, P=0.006), single-vessel disease (63.9 vs. 42.5%, P=0.03), and unstable angina (16.6% vs. 9.2%, P=0.001) and more frequently received small (≤ 2.75 mm) vessel stenting (39.3 vs. 28.2%, P=0.001). The two groups were similar for lesion and procedural characteristics. Overall, the stent thrombosis rate was 0.4% (0.5% in women vs. 0.3% in men, P=not significant). At 6-month follow-up, no significant difference in major adverse cardiac event was observed. Long-term follow-up (median time 33.2 months), available in 180 (83.3%) women and 720 (75%) men, showed higher angina recurrence rate (17.7 vs. 11%, P=0.013), percutaneous coronary re-intervention (16.1 vs. 8.7%, P=0.001) and target vessel revascularization (3.9 vs. 0.9%, P=0.001) in women compared with men. Late stent thrombosis, need for coronary artery bypass grafting, and mortality were similar in both groups. CONCLUSION: No sex difference was observed in acute and 6-month outcome after SES implantation despite older age, more unstable clinical presentation, and more frequent small vessel stenting in women. However, long-term clinical follow-up (up to 5 years) in women showed higher symptom recurrence and target vessel revascularization rate but no difference in overall major adverse cardiac events.

Randomized trial of predilation versus direct stenting for treatment of carotid artery stenosis.

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 > or =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 < or =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.

Use of multiple overlapping sirolimus-eluting stents for treatment of long coronary artery lesions: results from a single-center registry in 318 consecutive patients.

UNLABELLED: Drug-eluting stents (DES) are superior to bare metal stents in the prevention of restenosis and target lesion revascularization (TLR). This has led to a more aggressive use of DES in everyday interventional cardiology practice. METHODS: All consecutive patients who underwent coronary artery stenting with greater than 34 mm of overlapping, sirolimus-eluting stent (SES) were reviewed from a prospectively created database. A prespecified group of patients with greater than 60 mm of SES was also followed. RESULTS: 318 patients were followed up at a minimum of 6 months and a mean of 9 months. The mean target lesion stented length was over 55 mm. Use of IVUS was 19.8%. Forty patients (12.6%) suffered a peri-procedural CK-MB rise. The MACE rate at 9 months was 17% with 12.6% being periprocedural myocardial infarction (MI). Clinically driven TLR was 4.4% and cardiac death was 1.3%. There were 4 cases defined as late stent thrombosis. The independent predictors of periprocedural MI were the presence of a major side branch and longer target lesion stented length, with stable angina being a negative predictor. The independent predictors of in-stent restenosis were unstable angina and target lesion number per patient. There was a trend to increased MACE in the subgroup with longer than 60 mm of SES length. CONCLUSION: The use of multiple, overlapping SES is safe and effective with an acceptably low follow up MACE rate. A significant peri-procedural CK-MB rise appears to be a risk of long segment stenting. Whether this translates to long-term sequelae needs further investigation.