Search

Objective The aim of this study was to investigate the clinical relevance of bilateral peripheral arterial disease (PAD) patterns. Background No prior study has evaluated the clinical significance of symmetrical lesion patterns, particularly the coexistence of same-level significant plaques in both lower extremities ("mirror lesions"). Methods We conducted a single-facility, primary data analysis involving 225 patients with symptomatic PAD. Results Eighty-two percent of the patients had bilateral lesions: 14.2% had femoropopliteal, 38.7% had infrapopliteal, and 27.1% had both femoropopliteal and infrapopliteal lesions. The lesions were found in the exact same arteries bilaterally in 24.9% of the patients, while 26.7% had a local mirror pattern limited to the femoropopliteal (13.7%) or infrapopliteal (12.9%) arteries. Having a lesion in an artery was a risk factor for occlusive disease of the corresponding artery on the other side. Patients presenting with critical limb ischemia (CLI) had a history of resting pain (17%), ulceration/gangrene (13%), or prior amputation (26%) of the contralateral limb. Patients with significant bilateral disease had unilateral false-negative ABI results in 11.6% of the cases. The arterial Doppler study results were unilaterally false-negative in 19.6% and bilaterally false-negative in 2.8% of the patients. Conclusions Patients with known peripheral arterial disease need to have both limbs fully evaluated and monitored, even in cases with negative screening results. Mirror angiographic imaging is common and often accompanied by symptoms of claudication. Unilateral ischemia is a strong risk factor for contralateral disease. Patients with CLI are at high risk for occlusive lesions of the nonindex limb.

Item does not contain fulltext BACKGROUND: The Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial was a non-inferiority trial that compared percutaneous coronary intervention (PCI) using first-generation paclitaxel-eluting stents with coronary artery bypass grafting (CABG) in patients with de-novo three-vessel and left main coronary artery disease, and reported results up to 5 years. We now report 10-year all-cause death results. METHODS: The SYNTAX Extended Survival (SYNTAXES) study is an investigator-driven extension of follow-up of a multicentre, randomised controlled trial done in 85 hospitals across 18 North American and European countries. Patients with de-novo three-vessel and left main coronary artery disease were randomly assigned (1:1) to the PCI group or CABG group. Patients with a history of PCI or CABG, acute myocardial infarction, or an indication for concomitant cardiac surgery were excluded. The primary endpoint of the SYNTAXES study was 10-year all-cause death, which was assessed according to the intention-to-treat principle. Prespecified subgroup analyses were performed according to the presence or absence of left main coronary artery disease and diabetes, and according to coronary complexity defined by core laboratory SYNTAX score tertiles. This study is registered with ClinicalTrials.gov, NCT03417050. FINDINGS: From March, 2005, to April, 2007, 1800 patients were randomly assigned to the PCI (n=903) or CABG (n=897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (hazard ratio 1.17 [95% CI 0.97-1.41], p=0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (hazard ratio 1.41 [95% CI 1.10-1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68-1.20], pinteraction=0.019). There was no treatment-by-subgroup interaction with diabetes (pinteraction=0.66) and no linear trend across SYNTAX score tertiles (ptrend=0.30). INTERPRETATION: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease. FUNDING: German Foundation of Heart Research (SYNTAXES study, 5-10-year follow-up) and Boston Scientific Corporation (SYNTAX study, 0-5-year follow-up).

Objective This study aimed to evaluate the pharmacokinetic profile and tissue effects of everolimus delivered into arterial wall using biodegradable nanospheres. Background Delivery of everolimus into the arterial wall is challenging due to its low-lipophilic profile. Methods A pharmacokinetic study included 28 porcine coronary arterial segments initially injured with balloon angioplasty followed by the local delivery of everolimus encapsulated in nanospheres (EEN) via injection through a microporous delivery catheter. The animals were sacrificed at 1 hour, 1,7,28, and 90-day follow-up. In the tissue effects study 16 coronary bare metal stent (BMS) were implanted following EEN delivery, 15 BMS following nanospheres delivery without the drug (reference group) and 16 implanted BMS served as a control. Angiographic and histology follow-up was scheduled at 28 and 90-day. Results The study showed high-everolimus concentrations in arterial tissue early after nanoparticles delivery followed by its gradual decrease to 1.15 ± 0.40 ng/mg at 90 days. Histology analysis showed favorable biocompatibility and healing profile with comparable area stenosis between groups at both time-points. Conclusions The present study demonstrates for the first time the safety, biocompatibility, and long-term retention of everolimus in arterial tissue after single local delivery of biodegradable nanospheres.

Objectives This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial. Background The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown. Methods In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients. Results At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99). Conclusions In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

Background/Aims: Clinical benefits of percutaneous treatment of renal artery stenosis (RAS) remain controversial. The aim of this study was to evaluate the effects of renal artery stenting on kidney function and blood pressure (BP) control in the log-term follow-up. Additionally angiographic follow up was performed in selected subgroup of patients. Methods: The study was designed as international registry of 265 consecutive patients with RAS treated with renal artery stenting. The primary end-point of the study was the change in renal function and blood pressure at long-term follow-up as compared with baseline values. Evaluation of the renal function was based on estimated glomerular filtration rate (eGFR) with the use of the modification of diet in renal disease (MDRD) formula. Results: All patients had clinical follow-up at the median time of 23.8 (interquartile range: 3-90) months during ambulatory visits. At follow-up eGFR improved in 53,9% of patients. These patients had lower pre-procedural systolic BP, more severe lesion type at baseline and lower diameter stenosis in control angiography. At follow up visits, SBP improvement was observed in 77,4% of patients. The average number of anti-hypertensive medications before the procedure and at follow up did not change significantly (2,70±1,0 vs 2,49±0,9, p=0,1). Restenosis rate based on control angiography performed at median time of 15 months was 12%. Conclusion: The results of the study suggest that interventional treatment of RAS may preserve renal function and improve blood pressure control at long-term follow-up.

Percutaneous coronary intervention (PCI) utilizing drug-eluting stents is becoming a very common revascularization technique in the dialysis cohort; therefore, we sought to identify the impact of dialysis on outcomes in this group of patients. This is a multicenter registry comparing results of 290 patients (186 with normal kidney function, 104 on dialysis) who underwent PCI with exclusive use of paclitaxel-eluting TAXUS stent. The primary endpoint was an assessment of major adverse cardiac events (MACE) at 1- and 2-year observation. Mean follow-up was 23.3 ± 6.1 months. Results at 12 months showed: MACE 11.8% vs. 7.7% (P = not significant [ns]), composite major adverse cardiac and cerebrovascular events (MACCE) 12.4% vs. 11.5% (P = ns), all-cause death 2.7% vs. 8.6% (P

Background In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce. Methods Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29–93) with SilverHawkTM plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR). Results The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with

To present a prospective, single-center trial of the Cardiva Catalyst II, a vascular closure device that provides temporary hemostasis after the procedure and is removed under manual compression, leaving no material behind.During a 16-month period between April 2008 and July 2009, 400 procedures (100 interventions, 300 diagnostic procedures) were performed on 351 nonconsecutive patients (185 men; mean age 60.2 ± 12.0 years, range 27-93). All interventions were performed utilizing bivalirudin for anti-thrombin therapy. Initial follow-up was done at a mean 1.3 ± 0.7 days after the index procedure in all patients. Final follow-up, for diagnostic procedures as well as interventions, was performed at a mean 15.4 ± 7.1 days. The primary and secondary endpoints were the rate of major and minor vascular complications, respectively.Successful deployment of the device was reported in 397 (99.3%) procedures, which were primarily in retrograde fashion (97.0%) from the right groin (92.5%). In most cases (309, 77.2%), a 5-F sheath was used. A major vascular complication occurred after 1 intervention; none was noted after diagnostic procedures. Minor vascular complications were recorded after 2 interventions and 5 diagnostic procedures. Overall vascular complication rates were 0.25% for major sequelae and 1.75% for minor events. Mean time to discharge after diagnostic procedures was 145.0 ± 21.2 minutes versus 295.1 ± 44.1 minutes after interventional procedures (p0.05). There was no death, stroke, myocardial infarction, or urgent hospital transfer in the study cohort.Cardiva Catalyst is safe and effective device in achieving local hemostasis after percutaneous diagnostic procedures and interventions performed under bivalirudin anticoagulation. The use of this device with an appropriate protocol facilitates same-day discharge.

Objectives The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups. Background PCI is an increasingly utilized method of revascularization in patients with ULMCA. Methods This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non–ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients. Results Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction Conclusions Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.

This study has reported 10-year clinical follow-up of patients enrolled in the prospective, randomized LE MANS (Left Main Stenting) trial.The very long-term outcome after left main stenting in comparison with surgical revascularization remains unknown.In this prospective, multicenter trial, we randomly assigned 105 patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease according to SYNTAX (Synergy Between Percutaneous Coronary Intervention With Taxus and Cardiac Surgery) score to percutaneous coronary intervention (PCI) with stenting (n = 52) or coronary artery bypass grafting (CABG) (n = 53). Drug-eluting stents were implanted in 35%, whereas arterial grafts to the left anterior descending artery were utilized in 81%. Currently, the mean long-term follow-up was collected at 9.8 ± 1.0 years. Follow up for all-cause mortality is complete, whereas the incidence of major adverse cardiovascular and cerebral events (MACCE) was reported from 90% of patients. Ambulatory follow-up was completed in 46 (43.9%) patients.At 10 years, there was a trend toward higher ejection fraction in stenting when compared with surgery (54.9 ± 8.3% vs. 49.8 ± 10.3%; p = 0.07). The mortality (21.6% vs. 30.2%; p = 0.41) and MACCE (51.1% vs. 64.4%; p = 0.28) were statistically not different between groups; however, numerically the difference was in favor of stenting. Similarly, there was no difference in the occurrence of myocardial infarction (8.7 vs. 10.4%; p = 0.62), stroke (4.3 vs. 6.3%; p = 0.68), and repeated revascularization rates (26.1% vs. 31.3%; p = 0.64). The probability of very long-term survival up to 14 years was comparable between PCI and CABG (74.2% vs. 67.5%; p = 0.34; hazard ratio: 1.45, 95% confidence interval: 0.67 to 3.13); however, there was a trend toward higher MACCE-free survival in the PCI group (34.7% vs. 22.1%; p = 0.06; hazard ratio: 1.71, 95% confidence interval: 0.97 to 2.99).In patients with unprotected left main coronary artery stenosis with low and medium complexity of coexisting coronary artery disease, stenting offers numerically, but statistically nonsignificant, favorable long-term outcome up to 10 years in terms of safety and efficacy outcome measures, therefore, constitutes an alternative therapy for CABG.

Percutaneous coronary intervention (PCI) utilizing drug-eluting stents is becoming a very common revascularization technique in the dialysis cohort; therefore, we sought to identify the impact of dialysis on outcomes in this group of patients. This is a multicenter registry comparing results of 290 patients (186 with normal kidney function, 104 on dialysis) who underwent PCI with exclusive use of paclitaxel-eluting TAXUS stent. The primary endpoint was an assessment of major adverse cardiac events (MACE) at 1- and 2-year observation. Mean follow-up was 23.3 ± 6.1 months. Results at 12 months showed: MACE 11.8% vs. 7.7% (P = not significant [ns]), composite major adverse cardiac and cerebrovascular events (MACCE) 12.4% vs. 11.5% (P = ns), all-cause death 2.7% vs. 8.6% (P 0.05), cardiac death 2.7% vs. 1.9% (P = ns), target vessel revascularization (TVR) 9.1% vs. 6.7% (P = ns), acute myocardial infarction (AMI) 3.8% vs. 2.9% (P = ns), cerebrovascular events (CVA) 0.5% vs. 1.0% (P = ns); and results at 24 months showed: MACE 17.7% vs. 18.3% (P = ns), MACCE 21.5% vs. 26.0% (P = ns), all-cause death 4.3% vs. 14.4% (P 0.01), cardiac death 3.2% vs. 1.9% (P = ns), TVR 14.0% vs. 16.3% (P = ns), AMI 5.4% vs. 5.8% (P = ns), CVA 3.2% vs. 2.9% (P = ns) for non-end-stage renal disease (ESRD) and dialysis group, respectively. Prior coronary artery bypass graft (CABG) was found to be single risk factor for MACE, TVR, and MACCE in patients with ESRD, while dialysis and prior CABG were found to be single risk factors for death in the entire population. PCI with TAXUS is a feasible procedure and presents promising results in dialysis-dependent patients.

OBJECTIVES This study compared survival after percutaneous coronary intervention (PCI) with survival after coronary artery bypass graft surgery (CABG) among diabetics in the Veterans Affairs AWESOME (Angina With Extremely Serious Operative Mortality Evaluation) study randomized trial and registry of high-risk patients. BACKGROUND Previous studies indicate that CABG may be superior to PCI for diabetics, but no comparisons have been made for diabetics at high risk for surgery. METHODS Over five years (1995 to 2000), 2,431 patients with medically refractory myocardial ischemia and at least one of five risk factors (prior CABG, myocardial infarction within seven days, left ventricular ejection fraction 70 years, or an intra-aortic balloon being required to stabilize) were identified. A total of 781 were acceptable for CABG and PCI, and 454 consented to be randomized. The 1,650 patients not acceptable for both CABG and PCI constitute the physician-directed registry, and the 327 who were acceptable but refused to be randomized constitute the patient-choice registry. Diabetes prevalence was 32% (144) among randomized patients, 27% (89) in the patient-choice registry, and 32% (525) in the physician-directed registry. The CABG and PCI survival rates were compared using Kaplan-Meier curves and log-rank tests. RESULTS The respective CABG and PCI 36-month survival rates for diabetic patients were 72% and 81% for randomized patients, 85% and 89% for patient-choice registry patients, and 73% and 71% for the physician-directed registry patients. None of the differences was statistically significant. CONCLUSIONS We conclude that PCI is a relatively safe alternative to CABG for diabetic patients with medically refractory unstable angina who are at high risk for CABG.

Second generation paclitaxel coated balloons (PCB) with improved coating technology and novel carrier molecules have been proposed and have shown improved vascular response in the preclinical setting, however clinical trial data are lacking. The aim of this study was to prove the superiority of a

We describe a patient who underwent bilateral internal carotid artery stenting and three-vessel percutaneous coronary intervention during the same procedure. Stenting of carotid arteries was performed employing our innovative technique combining coronary and peripheral devices. No complications occurred. The patient was discharged home 1 day after the intervention and remains asymptomatic, leading a fully active life. To our knowledge, unstaged bilateral carotid stenting combined with three-vessel coronary intervention has not been reported previously.

Ablation technique and adjunctive strategy may affect restenosis after rotational atherectomy. To minimize trauma to the vascular wall, we changed the technique of rotablation as follows: the RPM range was decreased to 140,000-160,000 RPM, the ablation was performed using a repetitive pecking motion, avoiding a decrease in the rotational speed of the burr greater than 3,000 RPM, long lesions were divided into segments and each segment was separately ablated, and the burr-to-artery ratio was intended to be approximately 0.75. To prevent coronary spasm, before and after each pass, 100-200 microg nitroglycerin and 100-200 microg verapamil i.c. boluses were administered. Adjunctive PTCA was performed using a closely sized 1.1:1 balloon-to-artery ratio with a noncompliant balloon at low pressures for 120 sec. The study incorporated 111 patients with a combined total of 146 calcified lesions. Results. A total of 31.5% of patients underwent a multivessel procedure. No deaths occurred. Q-wave MI and/or creatine kinase elevation greater than three times baseline levels occurred in 4.5% of patients. By quantitative coronary angiography (QCA), the reference vessel diameter was 3.13+/-0.59 mm, mean lesion length was 33.41+/-18.58 mm. Percent stenosis and mean luminal diameter were as follows: at baseline 75.7%+/-10.8%, or 0.76+/-0.41mm, Post-rotational atherectomy 41.5%+/-3.6%, or 1.83+/-0.43 mm, Post-PTCA 18.2%+/-11.9%, or 2.56+/-0.50 mm. Six-month angiographic follow-up was available in 64 (57.7%) pts. Net luminal gain was 1.15+/-0.76 mm, with a late luminal loss of 0.65+/-0.84 mm. The mean diameter stenosis at follow-up was 37.6%+/-28.5%, with MLD 1.91+/-1.21 mm. The binary restenosis rate was 28.1%. Therefore, modification of rotational atherectomy technique with adjunctive PTCA resulted in a favorable restenosis rate in long, calcified lesions. Cathet. Cardiovasc. Intervent. 48:48-53, 1999.

The purpose of this study was to determine the results of directional coronary atherectomy (DCA) combined with stenting in a high-risk patient population. The use of stenting or DCA alone for aorto-ostial lesions, total chronic occlusions, long lesions, and lesions containing thrombus is associated with lowered success and a relatively high restenosis rate. Between July 1993 and October 1996, we treated 89 lesions with the combined approach of DCA and stenting in 60 consecutive patients. Thirty-one (51.7%) patients were treated because of unstable angina, 11 (18.3%) for post-myocardial infarction (MI) angina, 3 (5.0%) for acute MI, and 15 (25.0%) patients for stable angina. A total of 43 (71.7%) patients had multivessel disease, 19 (31.7%) had undergone previous coronary artery bypass graft (CABG), and 17 (28.3%) patients had undergone multivessel revascularization. The procedure was successful in all patients; and no postprocedural deaths or emergent CABG occurred. Two patients (3.3%) had non-Q-wave MI after the procedure and 1 patient (1.7%) experienced Q-wave MI due to subacute stent closure 7 days after the procedure. During follow-up ranging from 6 months to 3 years, 2 (3.3%) patients died, 2 (3.3%) required CABG surgery, 1 (1.7%) patient had an MI, and 6 patients (10.0%) required target vessel revascularization. By the quantitative coronary angiography, the initial minimal luminal diameter (MLD) averaged 0.91 ± 0.45 mm (74.7 ± 11.8% stenosis) increasing to 3.80 ± 0.44 mm (−6.7 ± 12.1%) after the combined approach procedure. Thirty patients (50.0%) met criteria for late (≥6 months) angiographic follow-up. Late MLD loss averaged 1.13 ± 1.07 mm, for a mean net gain of 1.61 ± 1.23 mm. Available angiographic follow-up evaluation showed a restenosis rate of 13.3%. A combined approach, defined as the use of both DCA and stenting, is safe and yields a low restenosis rate in high-risk patients who have lesions known to respond less favorably to stenting or DCA alone. Cathet. Cardiovasc. Diagn. 45:105–112, 1998. © 1998 Wiley-Liss, Inc.

The diabetic patients are more hazarded for the restenosis after revascularization of arteries of lower extremities. The long term outcome after atherectomy revascularization in diabetic patients in not known. The aim of this study is to compare outcomes of atherectomy treatment in diabetic (DM) vs

In United States alone there are more than 12 million people with peripheral artery disease (PAD). Long-term outcomes of plaque excision in high-risk population (patients with diabetes and patients with end stage renal disease on dialysis) are scarce.Since November 2003, we treated 225 consecutive patients (138 male, mean age: 66.3 ± 12.4, range: 29-93) with SilverHawk(TM) plaque excision for critical limb ischemia or disabling claudication. A total of 367 procedures were performed treating 832 lesions (157 restenotic, 675 de novo). One hundred fifty-five patients (68.9%) were diabetics, 74 (32.9%) were on dialysis. All patients were treated with statins, clopidogrel, aspirin, and aggressive glycemic control. The primary endpoint for our study was target lesion revascularization (TLR), and the secondary endpoint was an assessment of major adverse events (all cause death, amputation, TLR).The average time of observation was 2.2 ± 1.2 years. Procedural success rate was 99.4% with30% residual stenosis achieved in 818 (98.9%) lesions. SilverHawk was used alone in 86.7%. No acute limb loss or major perforation occurred. Sixty (26.6%) patients had TLR. Long-term mortality was 16.4%. Seven (3.1%) patients had to undergo major amputations and 7 (3.1%) minor amputations. Seventy (31.1%) patients had a major adverse event. Atorvastatin 80 mg was found to be independent predictor of survival, and major amputation was found to be independent predictor of mortality.SilverHawk Plaque Excision combined with aggressive pharmacotherapy in this presented high-risk population is associated with promising long-term outcomes that compare favorably with accepted standards of care.

Atherectomy, the removal of plaque from diseased vessels, is theoretically appealing with respect to various procedures used for revascularization of lower extremity vessels. Instead of damaging the native vessel by pushing aside plaque with a balloon or stent, the plaque is removed. Many atherectomy devices have been designed in attempts to achieve this goal. The SilverHawk device is the latest percutaneous device employing this treatment strategy. We discuss patient selection, technical considerations, and strategies for both above and below the knee revascularization, as well as pitfalls in each location based on our experience with over 200 patients.

Introduction: Carotid artery stenting (CAS) has become an alternative to carotid endarterectomy. Moreover, percutaneous transluminal angioplasty (PTA) allows other cephalad arteries revascularization. The aim of this study was to evaluate late outcomes of cephalad arteries PTA. Methods: This is an international multicenter registry of 434 consecutive patients in which 497 PTAs were performed. Patients with symptomatic >50% stenosis or asymptomatic >70% stenosis were enrolled. Stenting of 577 internal carotid arteries (ICA) and 13 common carotid arteries was performed, 20.7% procedures were complex in which bilateral carotid stenoses or carotid and vertebral arteries stenoses were revascularized at one stage. In 15.9% patients, one-stage coronary intervention was carried out. Distal protection devices were used in 69.6% of cases. PTAs were divided into high (n = 330) and low (n = 167) risk of major adverse coronary and cerebral events (MACCE). Results: At 30 days, there were 15 (3.5%) cases of MACCE [0.9% deaths, 2.1% strokes, and 0.9% myocardial infarction (MI)]. TIAs were observed in 15 (3.9%) patients. There was no significant difference in stroke incidence between procedures with or without neuroprotection (1.8 vs. 3%; P = 0.66) as well as in MACCE occurrence between high and low-risk groups (4.3 vs. 2%; P = 0.34). Bilateral stenoses increased while hypertension decreased the risk of MACCE. Left ICA lesions increased the risk of cerebrovascular accidents (CVA). At 4 years (1–11 years), the mortality rate was 11.5%, 6% of patients had stroke, and 3% MIs. Restenosis occurred in 3%. There was a trend toward higher mortality rate (13.3 vs. 6.9%; P = 0.07) and MACCE risk in high-risk group (23.5 vs.14.7% P = 0.06). Age > 65 y.o. and stent length < 24 mm increased, while the statin therapy on admission decreased the risk of long-term death. Structural valve disease and stent length

The aim of the study was to evaluate early and late outcomes after percutaneous coronary intervention (PCI) of unprotected left main coronary artery disease (ULMCA) and to compare bare-metal stent (BMS) and drug-eluting stent (DES) subgroups.PCI is an increasingly utilized method of revascularization in patients with ULMCA.This multicenter prospective registry included 252 patients after ULMCA stenting enrolled between March 1997 and February 2008. Non-ST-segment elevation acute coronary syndrome was diagnosed in 58% of patients; ST-segment elevation myocardial infarction cases were excluded. Drug-eluting stents were implanted in 36.2% of patients.Major adverse cardiovascular and cerebral events (MACCE) occurred in 12 (4.8%) patients during the 30-day period, which included 4 (1.5%) deaths. After 12 months there were 17 (12.1%) angiographically confirmed cases of restenosis. During long-term follow-up (1 to 11 years, mean 3.8 years) there were 64 (25.4%) MACCE and 35 (13.9%) deaths. The 5- and 10-year survival rates were 78.1% and 68.9%, respectively. Despite differences in demographical and clinical data in favor of BMS patients, unmatched analysis showed a significantly lower MACCE rate in DES patients (25.9% vs. 14.9%, p = 0.039). This difference was strengthened after propensity score matching. The DES lowered both mortality and MACCE for distal ULMCA lesions when compared with BMS. Ejection fraction50% was the only independent risk factor influencing long-term survival.Stenting of ULMCA is feasible and offers good long-term outcome. Implantation of DES for ULMCA decreased the risk of long-term MACCE, and particularly improved survival in patients with distal ULMCA disease.

To determine midterm clinical outcomes among patients with lower extremity peripheral arterial disease who underwent revascularization with catheter-based plaque excision (PE).Between August 2003 and February 2005, 19 institutions participating in the observational, nonrandomized, multicenter TALON registry enrolled 601 consecutive patients (353 men; mean age 70+/-11, range 36-98) with 1258 symptomatic lower extremity atherosclerotic lesions (748 limbs) treated by plaque excision with the SilverHawk catheter. Approximately 50% of the patients had diabetes, and nearly one third of the procedures were indicated for Rutherford ischemia categoryor =4. Mean lesion lengths above and below the knee, respectively, were 62.5+/-68.5 mm (interquartile range [IQR], 20.0-80.0) and 33.4+/-42.7 mm (IQR 15.0-37.5). The primary endpoints of the study were target lesion revascularization (TLR) at 6 and 12 months.The device achievedor =50% residual diameter stenosis in 94.7% of lesions; procedural success was 97.6%. Nearly half (41.9%) of the procedures involved PE ofor =2 lesions. Nearly three quarters (73.3%) of the lesions did not require adjunctive therapy, and stent placement following PE occurred in only 6.3% of lesions. The 6- and 12-month rates of survival free of TLR were 90% and 80%, respectively. Rates of TLR were similar among patients with diabetes (11%) and without diabetes (9%). In the multivariate analysis, significant predictors of TLR at 6 months were a history of MI or coronary revascularization (HR 5.49, 95% CI 1.87 to 16.10, p=0.0008), multiple (or =2) lesions (HR 1.37, 95% CI 1.11 to 1.70, p=0.0019), and increasing Rutherford category (HR 1.84, 95% CI 1.28 to 2.65, p=0.0003). Lesion length50 mm was associated with a 2.9-fold increased risk for TLR (HR 2.88, 95% CI 1.18 to 7.01, p=0.012); lesion length100 mm was associated with a 3.3-fold increase in TLR (HR 3.32, 95% CI 1.15 to 9.56, p=0.016).In patients undergoing revascularization for lower extremity atherosclerotic disease, catheter-based PE achieves favorable procedural success and avoids the need for repeat revascularization at midterm follow-up. These findings support PE as a primary endovascular therapy for patients undergoing lower extremity arterial revascularization.

To examine the safety and efficacy of catheter-based plaque excision as an alternative therapy to surgery, conventional angioplasty, and/or stenting in high-risk patients with critical limb ischemia (CLI).Between August 2003 and August 2004, a prospective evaluation was conducted of consecutive patients with CLI (Rutherford categoryor=5) who were treated with endovascular plaque excision at 7 institutions. This study enrolled 69 patients (37 women; mean age 70+/-12 years, range 43-93) with CLI involving 76 limbs. Clinical outcomes were prospectively followed for 6 months. The primary endpoint was major adverse events (death, myocardial infarction, unplanned amputation, or repeat target vessel revascularization) at 30 days. Visible healing of ulcerated tissue, avoidance of any amputation, and performance of less extensive amputation than initially planned were also assessed.Procedural success was achieved in 99% of cases. Major adverse events occurred in 1% of patients at 30 days and 23% at 6 months. The target lesion revascularization rate was 4%, and there were no unplanned limb amputations. Amputation was less extensive than initially planned or avoided altogether in 92% of patients at 30 days and 82% at 6 months.Catheter-based plaque excision is a safe and effective revascularization method for patients with CLI. These findings support further study of this modality as a singular or adjunctive endovascular therapy for limb salvage in CLI.

Background —Enoxaparin inhibits smooth muscle cell proliferation in experimental models. Intimal hyperplasia has been found to be the principal cause of restenosis after coronary stent implantation. We sought to determine whether the intramural delivery of enoxaparin before stenting of de novo lesions decreases restenosis. Methods and Results —One hundred patients who were undergoing stenting were randomly assigned to either local administration of enoxaparin during predilation with reduced systemic heparinization or stenting with standard, systemic heparinization. All patients were treated with the same type of stent (NIR). The primary study end point was late luminal loss. The secondary end points were major adverse cardiac events, target lesion revascularization, and angiographic restenosis at 6 months. Angiographic follow-up at 6 months was completed in all except 1 patient. Late luminal loss was reduced to 0.76±0.42 mm in the local enoxaparin delivery group versus 1.07±0.49 mm in the systemic heparinization group ( P P P Conclusions —This is the first prospective randomized trial in which the local delivery of a drug, enoxaparin, resulted in significant reduction in late luminal loss and restenosis after stent implantation in de novo coronary lesions.

The atherosclerosis plaques have different morphology from soft neointimal plaques to hard calcified lesions. Therefore, we sought to evaluate the efficacy of percutaneous balloon angioplasty (PTA) versus atherectomy (AT) endovascular revascularization which type was attuned by operator. Between

Peripheral blood monocytes and monocyte-derived macrophages are believed to playa pivotal role in the development of early atherosclerotic lesions. Excessive smooth muscle cell (SMC) proliferation leads to coronary restenosis after interventional procedures. We postulate that monocyte chemotactic protein-1 (MCP-1), by attracting monocytes to the site of vascular injury may indirectly augment this process. We also hypothesize that MCP-1 expression by human SMC may be mediated bycytokines and growth factors. Accordingly, we studied SMC cultures derived from tissue obtained by directional coronary atherectomy, evaluating MCP-1 expression by Northern blot analysis. Cells were grow in M-199 medium to over 95% confluence, for the last 24 hrs in serumless medium. MCP-1 expression was assessed in unstimulated (control) cells, and after 6 hrs stimulation with platelet derived growth factor (PDGF), insulin-like growth factor-1 (IGF-1) and tumor necrosis factor alpha (TNFα). Autoradiographs were developed, scanned and digitized using NIH 1.53b10 software. Our findings suggest that unstimulated human coronary SMC derived cultures express MCP-1 and furthermore this expression is markedly increased after stimulation with cytokines (by 21.4% after stimulation with PDGF, 30.3% after IGF-1 and 119.1% after TNFα). Download : Download high-res image (118KB) Download : Download full-size image Conclusions SMC cultures derived from human coronary samples obtained by DCA express MCP-1 during their quiescent phase, and this expression is markedly increased by the cytokines PDGF, IGF-1 and TNFα. Thus by attracting monocytes to the area of vascular injury, MCP-1 may be intimately involved in coronary restenosis, playing an important role in the pathophysiology of this process.

Detection of atherosclerotic plaques within the thoracic aorta (TA) by transesophageal echocardiography(TEE) has been shown to be a useful marker to detect coronary artery disease (CAD). Dobutamine (Dob) stress echocardiography can induce segmental wall motion abnormalities (SWMA) in the presence of CAD. To determine the value of visualizing atherosclerotic plaques on the TA in conjunction with Dob-TEE, 60 pts (54 males, 6 females; mean age 59 ± 13 yrs) with chest pain syndrome were studied. All pts underwent coronary angiography. Dob was infused in 3-min increments from 5 to 40 mcg/kg/min, Dob-TEE was considered positive if new or worsening of previously present SWMA were noted. Atherosclerotic plaques visualized on TA were divided into simple and complex lesions. Simple lesions were defined as intimal thickening or luminal irregularities, and complex lesions were protruding, ulcerated or mobile plaques noted. Results Significant CAD (≥50% stenosis) was present in 49 pts and 11 pts had normal or non-significant disease. Sensitivity (SE), specificity (SP), positive ( +PV), negative ( -PV) predictive values, and diagnostic accuracy (DA) are: SE SP +PV -PV DA Dob-TEE 94% 73% 94% 73% 90% TA-TEE 90% 80% 93% 73% 88% The TA showed atherosclerotic plaques in 45 of 49 pts with positive DobTEE and it was free of disease in 9 of 11 pts with negative Dob-TEE (90% agreement). The presence of complex lesions was significantly higher in pts with multivessel disease (MVD) (21 of 32 pts 66%) than in those with single vessel disease (SVD) (3 of 17 pts 18%), p l 0.01. While simple lesions were more common in SVD (11 of 17 pts 65%) than in MVD (9 of 32 pts 28%), p l 0.01. In conclusion, TA-TEE and Dob-TEE highly concur in detecting CAD. Visualization of complex lesions on TA-TEE before Dob-TEE should alert for the possibility of MVD.