R. Stefan Kiesz

Early and Long-Term Results of Unprotected Left Main Coronary Artery Stenting: The LE MANS (Left Main Coronary Artery Stenting) Registry

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 <50% was the only independent risk factor influencing long-term survival. 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.

Procedural and Clinical Outcomes with Catheter-Based Plaque Excision in Critical Limb Ischemia

Purpose: 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). Methods: Between August 2003 and August 2004, a prospective evaluation was conducted of consecutive patients with CLI (Rutherford category ≥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. Results: 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. Conclusion: 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.

Local Delivery of Enoxaparin to Decrease Restenosis After Stenting: Results of Initial Multicenter Trial Polish-American Local Lovenox NIR Assessment Study (The POLONIA Study)

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 <0.001). Restenosis, using a binary definition, occurred in 10% of patients in the enoxaparin group and in 24% of patients in the systemic heparinization group (P <0.05). Target lesion revascularization rates occurred in 8% of the enoxaparin group and 22% of the systemic heparinization group (P <0.05). There were no deaths and no emergent CABGs were performed. The only subacute stent closure and non–Q-wave infarction occurred in a patient assigned to the systemic heparinization group. 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.

Plaque Excision in Management of Lower Extremity Peripheral Arterial Disease with the SilverHawk Atherectomy Catheter.

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.

Cardiva Catalyst II Vascular Access Management Device in Percutaneous Diagnostic and Interventional Procedures with Same-Day Discharge (CATALYST II Trial):

Purpose: 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. Methods: 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. Results: 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 145.0621.2 minutes versus 295.1±44.1 minutes after interventional procedures (p<0.05). There was no death, stroke, myocardial infarction, or urgent hospital transfer in the study cohort. Conclusion: 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.

Long-term results of plaque excision combined with aggressive pharmacotherapy in high-risk patients with advanced peripheral artery disease (SAVE a LEG registry).

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.

Renal Artery Stenting Associated With Improvement in Renal Function and Blood Pressure Control in Long-Term Follow-Up.

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.

Long-term results of cephalad arteries percutanoeus transluminal angioplasty with stent implantation (The CAPTAS registry)†

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 <30 mm increased the risk of MACCE, while implantation of Acculink stent decreased the risk of CVA. Conclusions: CAS is safe and successful procedure with low early and long‐term adverse events. Special attention should be put on patients with bilateral and left ICA stenoses. If possible, longer stents should be applied.

TCT-803 Long term outcomes in diabetic patients treated with atherectomy for peripheral artery disease

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

TCT-348 Long term outcomes of same-day discharged patient after percutaneous coronary intervention in stand-alone centers

TCT-347 Independent Predictors of Mace at Different Time Points After the Treatment of Non-Selected Patients With Drug-Eluting Stents: An Analysis of the Desire Registry Jose Costa, Jr., Amanda Sousa, Adriana Moreira, Ricardo Costa, Galo Maldonado, Manuel Cano, J. Eduardo Sousa Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil; Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil; Hospital do Coracao, São Paulo, São Paulo, Brazil; Instituto Dante Pazzanese de Cardiologia, São Paulo, São Paulo, Brazil; Hospital Beneficencia Portuguesa, São Paulo, São Paulo, Brazil; Hospital do Coração, São Paulo, São Paulo, Brazil; Uknown, Sao Paulo, São Paulo, Brazil