A universal drug delivery catheter for the treatment of infrapopliteal arterial disease using liquid therapy.

OBJECTIVE: The objective of this study was to investigate the safety and feasibility of treating infrapopliteal lesions using a novel drug delivery catheter locally delivering liquid paclitaxel. BACKGROUND: Balloon angioplasty is currently the Gold Standard to treat below-the-knee disease; however, restenosis continues to be a great challenge following these percutaneous revascularization procedures. METHODS: The Occlusion Perfusion Catheter for Optimal Delivery of Paclitaxel for the Prevention of Endovascular Restenosis (COPPER-A) study-Below-the-Knee Cohort was a prospective, nonrandomized, multicenter, feasibility, and safety study that enrolled 35 patients at 11 participating sites. The safety endpoints at 1, 3, and 6 months were freedom from thrombosis, major amputation in the target limb and target limb related death. The efficacy endpoints were primary patency and freedom from clinically driven target lesion revascularization at 6 months. RESULTS: All patients tolerated the procedure well with no reports of adverse procedural events. Thirty-five patients were treated with a mean lesion length of 112 ± 81.2 mm with the lesion length range of 20-286 mm. At 6-month follow-up, primary patency was 89.3% and freedom from clinically driven target lesion revascularization was 96.4%. No patients demonstrated thrombosis, major amputation in the target limb and target limb related death at the 1-, 3- and 6-months follow-up intervals. CONCLUSIONS: The results of this multi-center study demonstrated that infrapopliteal arteries can be safely and effectively treated with liquid paclitaxel using the occlusion perfusion catheter.

Clinical Conference Proceedings: 15th Biennial International Andreas Gruentzig Society Meeting.

The International Andreas Gruentzig Society is an educational society of physicians and scientists interested in cardiovascular and related fields. Members cooperate in the advancement of knowledge and education through research, publication, study, and teaching in the fields of cardiovascular disease. This summary reflects the proceedings from the recent scientific meeting to assess current clinical problems and propose future directions and possible solutions.

Multidisciplinary approach to the diagnosis and management of patients with peripheral arterial disease.

Peripheral arterial disease (PAD) is frequently diagnosed after permanent damage has occurred, resulting in a high rate of morbidity, amputation, and loss of life. Early and ongoing diagnosis and treatment is required for this progressive disease. Lifestyle modifications can prevent or delay disease progression and improve symptoms. Limb-sparing endovascular interventions can restore circulation based on appropriate diagnostic testing to pinpoint vascular targets, and intervention must occur as early as possible to ensure optimal clinical outcomes. An algorithm for the diagnosis and management of PAD was developed to enable a collaborative approach between the family practice and primary care physician or internist and various specialists that may include a diabetologist, endocrinologist, smoking cessation expert, hypertension and lipid specialist, endovascular interventionalist, vascular surgeon, orthopedist, neurologist, nurse practitioner, podiatrist, wound healing expert, and/or others. A multidisciplinary team working together has the greatest chance of providing optimal care for the patient with PAD and ensuring ongoing surveillance of the patient's overall health, ultimately resulting in better quality of life and increased longevity for patients with PAD.

Randomized controlled study of excimer laser atherectomy for treatment of femoropopliteal in-stent restenosis: initial results from the EXCITE ISR trial (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis).

OBJECTIVES: The purpose of this study was to evaluate the safety and efficacy of excimer laser atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA) versus PTA alone for treating patients with chronic peripheral artery disease with femoropopliteal bare nitinol in-stent restenosis (ISR). BACKGROUND: Femoropopliteal stenting has shown superiority to PTA for lifestyle-limiting claudication and critical limb ischemia, although treating post-stenting artery reobstruction, or ISR, remains challenging. METHODS: The multicenter, prospective, randomized, controlled EXCITE ISR (EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis) trial was conducted across 40 U.S. centers. Patients with Rutherford Class 1 to 4 and lesions of target lesion length ≥4 cm, vessel diameter 5 to 7 mm were enrolled and randomly divided into ELA + PTA and PTA groups by a 2:1 ratio. The primary efficacy endpoint was target lesion revascularization (TLR) at 6-month follow up. The primary safety endpoint was major adverse event (death, amputation, or TLR) at 30 days post-procedure. RESULTS: Study enrollment was stopped at 250 patients due to early efficacy demonstrated at a prospectively-specified interim analysis. A total of 169 ELA + PTA subjects (62.7% male; mean age 68.5 ± 9.8 years) and 81 PTA patients (61.7% male; mean age 67.8 ± 10.3 years) were enrolled. Mean lesion length was 19.6 ± 12.0 cm versus 19.3 ± 11.9 cm, and 30.5% versus 36.8% of patients exhibited total occlusion. ELA + PTA subjects demonstrated superior procedural success (93.5% vs. 82.7%; p = 0.01) with significantly fewer procedural complications. ELA + PTA and PTA subject 6-month freedom from TLR was 73.5% versus 51.8% (p < 0.005), and 30-day major adverse event rates were 5.8% versus 20.5% (p < 0.001), respectively. ELA + PTA was associated with a 52% reduction in TLR (hazard ratio: 0.48; 95% confidence interval: 0.31 to 0.74). CONCLUSIONS: The EXCITE ISR trial is the first large, prospective, randomized study to demonstrate superiority of ELA + PTA versus PTA alone for treating femoropopliteal ISR. (Randomized Study of Laser and Balloon Angioplasty Versus Balloon Angioplasty to Treat Peripheral In-stent Restenosis [EXCITE ISR]; NCT01330628).

Pilot trial of cryoplasty or conventional balloon post-dilation of nitinol stents for revascularization of peripheral arterial segments: the COBRA trial.

OBJECTIVES: The purpose of this study is to compare post-dilation strategies of nitinol self-expanding stents implanted in the superficial femoral artery of diabetic patients with peripheral arterial disease. BACKGROUND: Endovascular treatment of superficial femoral artery disease with nitinol self-expanding stents is associated with high rates of in-stent restenosis in patients with diabetes mellitus. METHODS: We conducted a prospective, multicenter, randomized, controlled clinical trial of diabetic patients to investigate whether post-dilation of superficial femoral artery nitinol self-expanding stents using a cryoplasty balloon reduces restenosis compared to a conventional balloon. Inclusion criteria included diabetes mellitus, symptomatic peripheral arterial disease, and superficial femoral artery lesions requiring implantation of stents>5 mm in diameter and >60 mm in length. Primary endpoint was binary restenosis at 12 months, defined as ≥2.5-fold increase in peak systolic velocity by duplex ultrasonography. RESULTS: Seventy-four patients, with 90 stented superficial femoral artery lesions, were randomly assigned to post-dilation using cryoplasty (n=45 lesions) or conventional balloons (n=45 lesions). Mean lesion length was 148±98 mm, mean stented length was 190±116 mm, mean stent diameter was 6.1±0.4 mm, and 50% of the lesions were total occlusions. Post-dilation balloon diameters were 5.23±0.51 mm versus 5.51±0.72 mm in the cryoplasty and conventional balloon angioplasty groups, respectively (p=0.02). At 12 months, binary restenosis was significantly lower in the cryoplasty group (29.3% vs. 55.8%, p=0.01; odds ratio: 0.36, 95% confidence interval: 0.15 to 0.89). CONCLUSIONS: Among diabetic patients undergoing implantation of nitinol self-expanding stents in the superficial femoral artery, post-dilation with cryoplasty balloon reduced binary restenosis compared to conventional balloon angioplasty. (Study Comparing Two Methods of Expanding Stents Placed in Legs of Diabetics With Peripheral Vascular Disease [COBRA]; NCT00827853).

Treatment of subacute and chronic thrombotic occlusions of lower extremity peripheral arteries with the excimer laser: a feasibility study.

BACKGROUND: Thrombus is highly prevalent in patients with recent symptoms (< 6 months) of claudication or limb ischemia due to an occluded culprit lower extremity vessels. Treatment of these thrombotic occlusions is challenging. In this feasibility study, the excimer laser (Spectranetics, Colorado Springs, CO) has been tested for its safety and ability to ablate thrombus in patients with recent arterial occlusions. METHODS: Angiographic operator assessment and volumetric core lab quantitation of the thrombus were performed at baseline and after excimer laser but prior to definitive treatment of the vessel to evaluate thrombus resolution. Consecutive patients were prospectively enrolled at a single site. Procedural success was defined as achieving a residual stenosis of <30% after final treatment with no intraprocedural complications requiring additional treatment. RESULTS: 20 consecutive patients were enrolled in this study (8 males, mean age 69.5±11.1 years). Based on patients symptom onset, 12 patients were subacute (> 24 h, < 30 days), and 8 chronic (between 1 to 6 months). 15/20 (75%) had restenotic occlusions. Due to the long, occlusive nature of these lesions, only 8 patients had complete intravascular ultrasound images at each time point which allowed volumetric analysis by the core lab. There was no statistical difference in plaque/thrombus volume between baseline (pretreatment) and excimer laser (P=.68). There was however a significant reduction in residual angiographic stenosis post laser alone (100% vs. 66.75%±23.9%, P=.001). Procedural success was 100%. There were no deaths or amputations. Bail out stenting was performed in 10/20 (50%) patients. Embolic filters were used in 15/20 (75%) of patients. Macrodebris>2 mm were seen in 85.7% of filters. There was no in-hospital or 30-day reocclusion of the treated vessel but one patient had a vascular access complication (small AV fistula) conservatively managed. No other serious adverse events were noted. CONCLUSION: Using the excimer laser appears safe in this small feasibility study of subacute and chronic thrombotic occlusions. Angiographically, there was a significant reduction in percent stenosis with the laser alone. The limited IVUS data did not show a reduction in plaque/thrombus volume but the number of interpretable ultrasounds was small. Further data are needed to address the effectiveness of the laser in treating these thrombotic occlusions and its advantages over balloon angioplasty.

Excimer laser with adjunctive balloon angioplasty and heparin-coated self-expanding stent grafts for the treatment of femoropopliteal artery in-stent restenosis: twelve-month results from the SALVAGE study.

OBJECTIVES: The aim of the study is to evaluate the safety and effectiveness of treating femoropopliteal in-stent restenosis (ISR) with debulking with excimer laser followed by implantation of a VIABAHN endoprosthesis. BACKGROUND: The optimal treatment strategy for femoropopliteal ISR is unclear. METHODS: The SALVAGE study is a multicenter prospective registry involving nine US centers. Patients with femoropopliteal ISR with moderate to severe intermittent claudication or critical limb ischemia (Rutherford categories 2-5) and an ankle-brachial index (ABI) =0.8 were treated with excimer laser and the VIABAHN endoprosthesis. The primary efficacy endpoint is primary patency at 12 months as measured by duplex ultrasonography. The primary safety endpoint is the major adverse event (MAE) rate at 30 days. RESULTS: Twenty-seven patients were enrolled. The mean lesion length was 20.7 ± 10.3 cm. The majority of lesions were TASC (TASC I) C and D (81.4%). All lesions were pretreated with excimer laser and percutaneous transluminal angioplasty (PTA) prior to VIABAHN implantation. Technical success was achieved in 100% of cases. There were no MAE at 30 days. Primary patency at 12 months was 48%. The ankle brachial index increased from 0.58 ± 0.24 at baseline to 0.90 ± 0.17 at 12 months. There was improvement in all quality-of-life parameters. The 12-month TLR rate was 17.4%. CONCLUSIONS: The strategy of excimer laser atherectomy and PTA followed by implantation of a self-expanding stent graft for the treatment of femoropopliteal ISR is safe and associated with high procedural success. Primary patency rate at 12-months was suboptimal; however, the TLR rate was low.

Percutaneous lower-extremity arterial interventions with primary balloon angioplasty versus Silverhawk atherectomy and adjunctive balloon angioplasty: randomized trial.

PURPOSE: Target lesion revascularization (TLR) with primary percutaneous transluminal angioplasty (PTA) versus SilverHawk atherectomy and adjunctive PTA of de novo infrainguinal disease has not been well defined. This study was conducted to compare the two approaches. MATERIALS AND METHODS: In this prospective, two-center randomized trial of PTA versus atherectomy of infrainguinal vessels, the primary endpoint of TLR was evaluated at 1 year. Secondary endpoints included the rate of "bailout" stent placement for suboptimal acute angiographic results and the rate of target vessel revascularization (TVR). RESULTS: Fifty-eight patients were included in the study. Of these, 29 (36 vessels) were randomized to the atherectomy arm and 29 (48 vessels) to the PTA arm. Final acute angiographic success rates were 100% in the PTA arm and 97.2% in the atherectomy arm (P value not significant). There was no statistical difference in TLR (16.7% vs 11.1%) or TVR (21.4% vs 11.1%) between the PTA and atherectomy groups, respectively. Bailout stent placement was performed in 18 of 29 patients (62.1%) in the PTA arm and eight of 29 patients (27.6%) in the atherectomy arm (P = .017). Major adverse events were similar between the PTA and atherectomy arms. Finally, when embolic filter protection was used, distal macroembolization occurred in 11 of 17 patients (64.7%) treated with atherectomy versus none of 10 in the PTA group (P < .001). CONCLUSIONS: TLR and TVR at 1 year were statistically similar in atherectomy and primary PTA. Atherectomy reduced the need for bailout stent placement compared with primary PTA.

In-hospital safety and effectiveness of bivalirudin in percutaneous peripheral interventions: data from a real-world registry.

PURPOSE: To present real-world data to evaluate the safety and effectiveness of bivalirudin, a direct thrombin inhibitor, in an unselected group of patients undergoing percutaneous peripheral interventions (PPI). METHODS: Data were extracted from a prospectively collected peripheral vascular registry developed for quality assurance measures at 2 centers. Of 398 consecutive patients (195 men; mean age 69.4+/-11.3 years) who underwent PPI in a 2-year period, 369 (92.7%) received bivalirudin (0.75 mg/kg bolus followed by a 1.75 mg/kg/h infusion) and 29 (7.3%) received unfractionated heparin (UFH). In the bivalirudin sample, critical limb ischemia was present in 28.0% of patients, TASC D lesion in 29.5%, and angiographic thrombus in 7.8% of vessels. Demographic, clinical, procedural, and angiographic variables and in-hospital complications were analyzed. All in-hospital adverse events were independently adjudicated. RESULTS: Procedural success (<30% residual narrowing) was achieved in 359 (97.3%) patients receiving bivalirudin. Adverse events included stroke (1, 0.3%), acute renal failure (1, 0.3%), major bleeding (3, 0.8%), distal embolization (11, 3.0%), vascular access complications (2, 0.5%), and minor amputation (2, 0.5%). CONCLUSION: Bivalirudin had an excellent safety profile in a real-life cohort of patients undergoing PPI, including high-risk patients with critical limb ischemia and TASC D lesions. In-hospital major bleeding and other adverse events were infrequent. A randomized trial of bivalirudin versus UFH is needed to verify these results and establish bivalirudin as a standard anticoagulant in PPI.

Carotid artery stenting in high surgical risk patients using the FiberNet embolic protection system: the EPIC trial results.

OBJECTIVE: The multicenter EPIC (FiberNet Embolic Protection System in Carotid Artery Stenting Trial) single-arm trial evaluated the 30-day outcomes of a new design concept for embolic protection during carotid artery stenting (CAS). BACKGROUND: Embolic protection filters available for use during CAS include fixed and over-the-wire systems that rely on embolic material capture within a "basket" structure. The FiberNet Embolic Protection System (EPS), which features a very low crossing profile, consists of a three-dimensional fiber-based filter distally mounted on a 0.014 inch guidewire with integrated aspiration during filter retrieval. METHODS: The trial enrolled 237 patients from 26 centers. Demographics, clinical and lesion characteristics, as well as adverse events through a 30-day follow-up were recorded. The mean age of the patients was 74 years, 64% were male and 20% had symptomatic carotid artery disease. RESULTS: The combined major adverse event (MAE) rate at 30 days for all death, stroke, and myocardial infarction was 3.0%. There were three major strokes (two ischemic and one hemorrhagic) and two minor strokes (both ischemic) for a 2.1% 30-day stroke rate. The procedural technical success rate was 97.5% and macroscopic evidence of debris was reported in 90.9% of the procedures. CONCLUSIONS: The FiberNet EPS, used with commercially available stents, produced low stroke rates following CAS in high surgical risk patients presenting with carotid artery disease. The unique filter design including aspiration during retrieval may have contributed to the low 30-day stroke rate reported during CAS in patients considered at high risk for complications following carotid endarterectomy (CEA).

Outcomes of unselected recipients of sirolimus-eluting stents: the Cypher stent U.S. post-marketing surveillance registry.

OBJECTIVE: To examine the 1-year safety and clinical outcomes associated with the post-marketing early unselected use of sirolimus-eluting stents (SES) in the United States. BACKGROUND: The safety and effectiveness of SES has been assessed in selected patients enrolled in pivotal randomized trials. This PMS registry was initiated to examine the safety and effectiveness of SES in an unselected population. METHODS: Consecutive patients who underwent implantation of > or = 1 SES at 38 participating U.S. centers were enrolled in this registry. Results were compared according to "off-" versus "on-label" use of SES. Multivariate regression analyses were carried out in search of predictors of 1- year MACE and stent thrombosis. RESULTS: The mean age of the 2,067 patients (3,367 treated lesions) was 63.7 years. The 12-month follow up was completed by 1,964 patients (95%). SES were implanted for "offlabel" indications in 1,173 patients (57%). The 12-month rates of MACE and TLR in that subgroup were 9.2% and 6.2% (p < 0.001 vs. "on-label" indications). Rate of definite/probable stent thrombosis was 1.6% ("off-label") vs. 0.6% ("on-label"), p = 0.026. The rates of MACE, TLR and stent thrombosis in 640 diabetics (31%) were 9.4%, 5.8% and 1.3% (p = 0.021, NS and NS vs. non-diabetics, respectively). Number of lesions, insulin-dependent diabetes and unstable angina were predictors of stent thrombosis. CONCLUSIONS: The "off-label" use of SES was associated with higher 1-year cumulative rates of MACE than "on-label" indications, although rates were similar to those seen in historical premarketing randomized trials. None of the "off-label" indications were independent predictors of MACE or stent thrombosis.

Excimer laser recanalization of femoropopliteal lesions and 1-year patency: results of the CELLO registry.

PURPOSE: To evaluate the safety and efficacy of a modified laser catheter designed for the endovascular treatment of peripheral artery disease (PAD) affecting the superficial femoral artery (SFA) and proximal popliteal artery. METHODS: The CliRpath Excimer Laser System to Enlarge Lumen Openings (CELLO) study was a single-arm, prospective registry conducted at 17 investigational sites in the United States. The primary endpoint was the reduction in index lesion percent diameter stenosis (% DS) measured by Doppler ultrasound following laser ablation prior to any adjunctive therapy. The primary safety endpoint was major adverse events at 6 months. Sixty-five patients (39 men; mean age 68.3+/-10.1 years) with intermittent claudication, stenotic lesions >70% by visual assessment, a reference vessel diameter >or=4.0 and or=1.0 and

Predictors of distal embolization in peripheral percutaneous interventions: a report from a large peripheral vascular registry.

BACKGROUND: Distal embolization (DE) commonly occurs during peripheral percutaneous interventions (PPI) of the lower-extremity arterial vessels. In this study we evaluate the predictors of DE in a large cohort of patients undergoing PPI at our center. METHODS: Patients who experienced clinically significant DE (requiring further mechanical or pharmacologic therapy as per operator judgment) were extracted from a peripheral vascular registry that prospectively tracks demographics, clinical, procedural and outcome variables on patients undergoing PPI at our medical center and compared these to patients in the same registry who did not experience DE. Univariate analysis was utilized to compare patients with and without DE. Logistic regression analysis was performed to determine the independent predictors of DE. RESULTS: Of 577 patients, 14 (2.4%) experienced clinically significant DE. By univariate analysis, patients who experienced DE had longer lesion length (130.0 +/- 123.35 mm vs. 90.05 +/- 104.94 mm; p = 0.049), more severe angiographic pretreatment lesion stenosis (91.71% +/- 14.76% vs. 85.65% +/- 14.26%; p = 0.027), reduced pretreatment TIMI flow (1.21 +/- 1.34 vs. 2.15 +/- 1.1; p = 0.001), a higher rate of prior amputations (21.4% vs. 5.9%; p = 0.052), a higher prevalence of TASC-D lesions (59.3% vs. 29.6%; p = 0.002), more angiographic thrombus (35.7% vs. 6.4%; p = 0.001), and less frequency of chronic onset of symptoms on presentation (64.3% vs. 90.6%; p = 0.009). Logistic regression analysis showed that a prior history of amputation (odds ratio [OR] 3.56, 95% confidence interval [CI] 0.87-14.47; p = 0.08), presence of thrombus (OR 5.02, 95% CI 1.53-16.42; p = 0.008) and TASC-D lesions (OR 4.31, 95% CI 1.24- 15.03; p = 0.022) were independent predictors of DE. CONCLUSION: Clinically significant DE requiring further mechanical or pharmacologic therapy occurs in approximately 2.4% of patients undergoing PPI. Patients with TASC-D lesions, angiographic thrombus and prior history of amputation are at high risk of DE.

Treatment of left main coronary trifurcation lesions with the paclitaxel drug-eluting stent: mid-term outcomes from a tertiary medical center.

BACKGROUND: Left main trifurcating coronary artery disease (LMTCAD) is a complex and challenging anatomy to treat percutaneously. We report on the immediate- and mid-term outcomes of 52 consecutive patients with LMTCAD treated with the Taxus(R) paclitaxel- eluting stent (PES) (Boston Scientific Corp., Natick, Mass.) in our center over a period of 2 years. METHODS: All patients (n = 52) who underwent LMTCAD at our center in 2006-2007 and treated with the PES form the basis of this report. Demographic, clinical, procedural and in-hospital outcome variables were reviewed. Angiograms were analyzed by an operator blinded to the patients' history. Mid-term follow up was achieved from medical records and/or phone calls. The primary endpoint of the study was either cardiac death, nonfatal myocardial infarction or target lesion revascularization (TLR) on follow up. Follow up was achieved in 47/51 patients (92.2%) at a mean of 292.8 +/- 104.6 days. Patients were classified as Type A (30.8%) disease involving the LM and origin of branches, or Type B (69.2%) disease involving the origin of the trifurcation branches only, but not the LM artery. All patients were treated with kissing balloon after stenting. Descriptive analysis was performed on all variables with mean +/- standard deviation for continuous variables and percentages describing dichotomous variables. Univariate and logistic regression analyses were performed to determine the predictors of the primary endpoint. RESULTS: The mean patient age was 67.6 +/- 12.7 years. The LM artery was unprotected in 88.5% of cases. On follow up, the primary endpoint was met in 34% of patients. TLR occurred in 31.9% of patients, and target vessel revascularization (TVR) in 40.4%. One patient had cardiac death (2.1%) 5 months after the index procedure, possibly related to acute stent thrombosis. By univariate analysis, Type A lesions (vs. Type B; p = 0.02) and the placement of a greater number of stents (p = 0.044) correlated with a higher event rate. Logistic regression analysis showed that Type A lesions are the only predictors of the combined endpoint (p = 0.011). CONCLUSION: LM trifurcation stenting carries an overall high rate of adverse events, mostly driven by a high TLR rate. Type A lesions and the number of stents placed predicted a higher combined endpoint of death, nonfatal MI and TLR. By logistic regression analysis, Type A lesions are the only independent predictors of the primary outcome.

In-hospital complications and long-term outcomes of the paclitaxel drug-eluting stent in acute ST-elevation myocardial infarction: a real-world experience from a high-volume medical center.

BACKGROUND: The paclitaxel drug-eluting stent (Taxus, Boston Scientific) is FDA approved for treatment of coronary artery disease in simple, noncomplex coronary lesions. In this registry, we sought to investigate the procedural success and long-term outcomes of patients receiving the Taxus stent in the setting of acute ST-elevation myocardial infarction (STEMI) in a busy single-center interventional program. METHODS: This is a single-center retrospective analysis of prospectively collected in-hospital data with postdischarge follow-up achieved by phone calls and review of medical records. Data were audited by an independent monitor, and outcomes were adjudicated by an experienced interventional cardiologist. All patients with STEMI over the period of 2 years (2005 and 2006) with native de novo lesions who received the Taxus stent were included. Patients receiving bare metal stents were excluded. The primary outcome was the combined end point of cardiac death, recurrent nonfatal MI, and target lesion revascularization (TLR) on follow-up. RESULTS: Of 198 patients included in this study, follow-up data were obtained in 172 (86.9%) patients. The mean age was 63+/-14.9 years. There were 59.1% males. Patients had the following cardiac risk factors: diabetes 20.7%, hypertension 60.6%, hyperlipidemia 87.8%, and current smoking 48%. In-hospital complications included death 5.1%, acute closure with stent thrombosis 1%, vascular complications 2.9%, and cardiogenic shock 6.6%. The mean follow-up period (days) was 317.3+/-239.3. The primary end point of cardiac death, nonfatal MI, and TLR was met in 12.4%. Individual end points on follow-up were cardiac death 2.5%, total death 4.9%, TLR 8.1%, target vessel revascularization 19.9%, stroke 1.2%, nonfatal MI 5%, and acute stent thrombosis 5.5% (definite 4.3%, probable 0.6%, possible 0.6%; Academic Research Consortium definition). CONCLUSION: The use of the Taxus stent in acute STEMI is associated with a low postdischarge combined end point of cardiac death, nonfatal MI, and TLR and a definite/probable 4.9% in-stent thrombosis rate, which is within the reported range of data published in "real-world" registry.

Predictors of target lesion revascularization in patients undergoing lower extremity percutaneous interventions.

BACKGROUND: Predictors of target lesion revascularization (TLR) have not been well defined in patients undergoing peripheral percutaneous interventions (PPI). In this study we analyze predictors of TLR in a consecutive cohort of patients from two medical centers. METHODS: Data were extracted from a prospectively collected peripheral vascular registry. Of 105 consecutive patients (175 vessels) undergoing PPI, follow up was achieved in 104 patients (172 vessels) at 8.06 +/- 4.51 months. Univariate analysis was performed between the groups with (n = 19, vessels = 25) and without (n = 85, vessels = 147) TLR. Logistic regression analysis was utilized to model for the predictors of TLR. RESULTS: TLR occurred in 14% of vessels treated at 8.06 +/- 4.51 months. By univariate analysis, vessels with TLR on follow up had longer treated segments (167.0 +/- 139.16 mm vs. 98.49 +/- 113.33 mm; p = 0.027), more severe lesions (91.96 +/- 12.56% vs. 85.51 +/- 14.43%; p = 0.037) and were younger (63.0 +/- 10.1 years vs. 69.1 +/- 11.1 years; p = 0.032). Also, there was a trend toward a higher hs-CRP (11.35 +/- 17.85 vs. 7.45 +/- 9.57 mg/L) and more total occlusions (44.0% vs. 22.6%) in the TLR group, but these did not reach statistical significance. Logistic regression analysis with backward elimination including all these variables showed that younger age (p = 0.007), female gender (p = 0.033) and treated vessel length (p = 0.028) were the only independent predictors of TLR. CONCLUSIONS: Younger age, female gender and longer treated vessel length are independent predictors of TLR in patients undergoing PPI. The cost-effectiveness in treating these patients with PPI versus surgery needs to be defined in future studies.

Distal embolic event protection using excimer laser ablation in peripheral vascular interventions: results of the DEEP EMBOLI registry.

PURPOSE: To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy. METHODS: Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.9+/-10.8 years) with 28 lesions (de novo 13, restenotic 15) were enrolled and underwent treatment with laser atherectomy. SpiderFx filters were utilized before laser treatment in 18 of 20 patients and before final definitive treatment with angioplasty +/- stenting in all 20 patients. The primary angiographic outcome was a residual narrowing of <30% or 30% to 50% with <20 mmHg gradient across lesion after final treatment. The primary safety endpoint was the embolization rate produced by the laser based on the presence of clinically significant (>or=2 mm long) macrodebris in the filter. RESULTS: Adjunctive angioplasty and stenting were performed in 27 (96.4%) and 17 (60.7%) lesions, respectively. All filters were deployed and retrieved successfully, with no complications. The primary angiographic endpoint was met in 100% of patients. Macrodebris was found in 12 (66.7%) of 18 patients after treatment with the laser [4 (22.2%) filters with clinically significant emboli] and in 7 (35%) of 20 patients after adjunctive treatment [4 (20.0%) clinically significant emboli]. One (5.0%) distal embolization occurred after filter removal prior to completion of definitive treatment. CONCLUSION: Embolization does occur with laser photoablation in the lower extremity, but the rate of clinically significant macrodebris is low ( approximately 20%) and similar to that found after angioplasty and stenting. Embolic filter protection appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. Problems with filter retrieval were not encountered.

Dethrombosis of the lower extremity arteries using the power-pulse spray technique in patients with recent onset thrombotic occlusions: results of the DETHROMBOSIS Registry.

PURPOSE: To assess the presence of thrombus using intravascular ultrasound (IVUS) and evaluate the feasibility of combined thrombolysis [power-pulse spray (P-PS)] and rheolytic thrombectomy (RT) in patients with recent-onset limb ischemia (<6 months) due to total occlusion of at least 1 infrainguinal vessel. METHODS: Seventeen patients (12 women; mean age 68.3+/-10.7 years) enrolled in a prospective registry underwent IVUS imaging at baseline, after treatment with P-PS using tissue plasminogen activator and RT (AngioJet), and prior to definitive treatment of the vessel. The primary safety endpoints were major bleeding, distal embolization, vascular access complications, and renal failure. Effectiveness outcomes were (1) procedural success with a residual stenosis <30%, (2) IVUS-documented resolution of the thrombus, and (3) the combined clinical endpoint of procedure-related death, stroke, unplanned amputation, and unplanned urgent revascularization of the treated limb. RESULTS: At baseline, the majority of patients (16, 94.1%) had a definite thrombus identified by IVUS; in the remaining patient (6.3%), thrombus was likely to be present according to the IVUS scan. By angiography, 2 (11.8%) patients had a definite grade 3 thrombus and 5 (29.4%) patients had a grade 1 thrombus (modified TIMI scale) at baseline. IVUS data were available pre and post P-PS/RT in 16 (94.1%) patients. In 10 (62.5%), the thrombus was partially resolved; in 5 (31.25%), there was no apparent change. The thrombus appeared to have completely resolved in only 1 (6.3%) patient. Embolization occurred in 3 (17.6%) patients with no adverse clinical sequelae. The combined clinical endpoint was met in 1 (5.9%) of 17 patients. After final definitive treatment of the vessel, acute procedural success was 100%, with no angiographic filling defects seen. CONCLUSION: Thrombus is present in most if not all patients with a recent history of limb ischemia who are found to have an occluded culprit vessel. The application of the P-PS/RT led to partial or complete thrombus resolution in about two thirds of the patients treated. The overall safety outcome was favorable, but large studies are needed to test the effectiveness of the P-PS/RT technique prior to routine use.

Preventing lower extremity distal embolization using embolic filter protection: results of the PROTECT registry.

PURPOSE: To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions. METHODS: Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris. RESULTS: Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p<0.001). Clinically significant (> or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p<0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection. CONCLUSION: Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.