Objectives This study sought to evaluate the safety and feasibility of zotarolimus-eluting stent implantation in focal atherosclerotic lesions of the internal pudendal arteries among men with ...erectile dysfunction (ED) and a suboptimal response to phosphodiesterase-5 inhibitors. Background ED, a common condition, is often mediated by atherosclerosis. Current treatment options are limited. Methods Male subjects with atherosclerotic ED and a suboptimal response to phosphodiesterase-5 inhibitors were enrolled in this prospective, multicenter, single-armed safety and feasibility trial. A novel combination of clinical, duplex ultrasound, and invasive angiographic factors were used to determine eligibility for stent therapy. The primary safety endpoint was any major adverse event 30 days after the procedure. The primary feasibility end point was improvement in the International Index of Erectile Function (Erectile Dysfunction Domain) score greater than or equal to 4 points in greater than or equal to 50% of subjects at 3 months. We report 6-month follow-up results, including duplex ultrasound and angiography. Results Forty-five lesions were treated with stents in 30 subjects. Procedural success was 100% with no major adverse events through follow-up. The primary feasibility endpoint at 6 months was achieved by 59.3% of intention-to-treat subjects (95% confidence interval: 38.8% to 77.6%) and 69.6% of per-protocol subjects (95% confidence interval: 47.1% to 86.8%). Duplex ultrasound peak systolic velocity of the cavernosal arteries increased from baseline by 14.4 plus or minus 10.7 cm/s at 30 days and 22.5 plus or minus 23.7 cm/s at 6 months. Angiographic binary restenosis ( greater than or equal to 50% lumen diameter stenosis) was reported in 11 (34.4%) of 32 lesions. Conclusions Among patients with ED and limited response with pharmacologic therapy, percutaneous stent revascularization of the internal pudendal artery is feasible and is associated with clinically meaningful improvement in both subjective and objective measures of erectile function. (Safety and Feasibility of the Zotarolimus Stent in Treating Males With Erectile Dysfunction (ED) (ZEN); NCT01643200).
TAXUS Liberté Attenuates the Risk of Restenosis in Patients With Medically Treated Diabetes Mellitus: Results From the TAXUS ATLAS Program Ehtisham Mahmud, John A. Ormiston, Mark A. Turco, Jeffrey J. ...Popma, Neil J. Weissman, Charles D. O'Shaughnessy, Tift Mann, Jack J. Hall, Thomas F. McGarry, Louis A. Cannon, Mark W. I. Webster, Lazar Mandinov, Donald S. Baim To determine the efficacy and safety of the TAXUS Liberté paclitaxel-eluting stent in patients with diabetes, a pooled analysis of all 4 TAXUS ATLAS studies (1,116 nondiabetic and 413 diabetic subjects) was conducted. Angiographic restenosis, late luminal loss, and neointimal hyperplasia were similar for diabetic subjects and nondiabetic subjects. After propensity score and multivariate adjustments, 1-year target lesion revascularization rates were also similar between groups, with no differences in mortality, myocardial infarction, or stent thrombosis. These results suggest that the TAXUS Liberté stent attenuates the effect of diabetes on restenosis and provides similar results in diabetic and nondiabetic patients.
Despite their potential advantages, new coronary angioplasty devices may be associated with more frequent vascular complications than noted after standard balloon angioplasty, theoretically due to ...the larger sheaths and prolonged periods of anticoagulation required by some of these devices. This study sought to identify the incidence, predictors, and clinical outcome of vascular complications after new device angioplasty.
The clinical course of 1413 patients was reviewed after balloon or new device angioplasty. Vascular complications were defined as formation of a pseudoaneurysm, arteriovenous fistula, retroperitoneal hematoma, or groin hematoma associated with a > 15-point hematocrit drop or the need for surgical repair. Stepwise logistic regression was used to identify independent predictors for vascular complications. Vascular complications developed after 84 (5.9%) procedures; they occurred more frequently after intracoronary stenting (14.0%) and extraction atherectomy (12.5%) than after balloon angioplasty (3.2%) (odds ratios, 4.86; P < .001, and 4.26, P < .05, respectively). Independent predictors of vascular complications included the use of intraprocedural thrombolytic agents (P < .01), intracoronary stenting (P < .005), or extraction atherectomy (P < .05); high maximum creatinine level (P < .005); low nadir platelet count (P < .001); longer periods of excess anticoagulation (P < .05); and the need for repeat coronary angioplasty (P < .005). Vascular complications were not related to the size of the arterial sheath used.
Vascular complications developed more frequently after new device angioplasty than after balloon angioplasty, with the risk for vascular complications directly related to the degree of periprocedural anticoagulation.
The field of myocardial regeneration (angiogenesis and myogenesis) might prove to play an important role in the future management of cardiovascular disease. Stem cells are currently undergoing ...testing in Phase I and Phase II clinical trials. Methods of delivery will affect the outcome of such therapies, perhaps significantly. This document provides suggested guidance in 4 methods of delivery: endocardial, intracoronary, coronary sinus, and epicardial.
A Novel Filter-Based Distal Embolic Protection Device for Percutaneous Intervention of Saphenous Vein Graft Lesions: Results of the AMEthyst Randomized Controlled Trial Dean J. Kereiakes, Mark A. ...Turco, Jeffrey Breall, Naim Z. Farhat, Robert L. Feldman, Brent McLaurin, Jeffrey J. Popma, Laura Mauri, Peter Zimetbaum, Joseph Massaro, Donald E. Cutlip, on behalf of the AMEthyst Study Investigators In this noninferiority trial, patients undergoing percutaneous coronary intervention with stenting of degenerative saphenous vein graft stenoses were randomly assigned (2:1) to either the Interceptor PLUS (n = 533) Coronary Filter System (Medtronic Vascular, Santa Rosa, California) or to an approved control embolic-protection device (Guardwire, n = 191, Medtronic Vascular; FilterWire EZ, n = 73, Boston Scientific, Natick, Massachusetts) at investigator discretion. The trial primary end point (composite occurrence of death, myocardial infarction, or urgent repeat revascularization through 30 days) was similar in Interceptor PLUS (8%) and control device (7.3%) patients (p = 0.025 for noninferiority; p = 0.77 for difference). The Interceptor PLUS Coronary Filter System is noninferior in safety and efficacy to 30 days compared with currently approved distal protection devices.
Reduced Risk of Restenosis in Small Vessels and Reduced Risk of Myocardial Infarction in Long Lesions With the New Thin-Strut TAXUS Liberté Stent: One-Year Results From the TAXUS ATLAS Program Mark ...A. Turco, John A. Ormiston, Jeffrey J. Popma, Jack J. Hall, Tift Mann, Louis A. Cannon, Mark W. I. Webster, Gregory J. Mishkel, Charles D. O'Shaughnessy, Thomas F. McGarry, Lazar Mandinov, Keith D. Dawkins, Donald S. Baim The TAXUS ATLAS Small Vessel and TAXUS ATLAS Long Lesion trials are multicenter studies comparing the thinner-strut TAXUS Liberté 2.25-mm (Boston Scientific, Natick, Massachusetts) diameter stent and the TAXUS Liberté 38-mm long stent, respectively, with the thicker-strut TAXUS Express (Boston Scientific) in historical control groups from the TAXUS IV and V trials. Each study met its primary end point of noninferiority of 9-month in-segment diameter stenosis. In addition, there were significant reductions in clinical and angiographic restenosis in small vessels, and reduced risk of myocardial infarction in patients with long lesions treated with the TAXUS Liberté stent compared to that of the earlier TAXUS Express stent.
Unfractionated heparin remains an essential component of the antithrombotic regimen in patients undergoing coronary intervention, although the timing, dosing, and duration of heparin therapy have ...evolved over the past several years. Complications associated with heparin use include bleeding events, which occur in 3.9–16.4% of patients receiving conventional heparin. Less commonly, clinically significant thrombocytopenia develops, related to the duration of heparin administration. In patients undergoing coronary intervention who do not receive platelet glycoprotein (GP) IIb/IIIa inhibitors, sufficient heparin should be given to achieve an activated clotting time (ACT) of 250–300 seconds with the HemoTec device and 300–350 seconds with the Hemochron device. There is a general trend to use lower, weight-adjusted heparin dosing (70–100 units/kg) to avoid excessive levels of anticoagulation, with additional heparin boluses to achieve a therapeutic ACT level. When GP IIb/IIIa inhibitors are used, weight-adjusted heparin dosing can be decreased to 70 units/kg to achieve a target ACT of 200 seconds with either the HemoTec or Hemochron device. After uncomplicated coronary intervention, there appears to be little value associated with continued heparin therapy, and the risk of bleeding complications clearly increases with longer durations and higher levels of anticoagulation after coronary intervention.
Thrombosis and Drug-Eluting Stents Holmes, David R., MD; Kereiakes, Dean J., MD; Laskey, Warren K., MD ...
Journal of the American College of Cardiology,
07/2007, Letnik:
50, Številka:
2
Journal Article
Recenzirano
Odprti dostop
Thrombosis and Drug-Eluting Stents: An Objective Appraisal David R. Holmes, MD, Dean J. Kereiakes, MD, Warren K. Laskey, MD, Antonio Colombo, MD, Stephen G. Ellis, MD, Timothy D. Henry, MD, Jeffrey ...J. Popma, MD, Patrick W. J. C. Serruys, MD, Takeshi Kimura, MD, David O. Williams, MD, Stephan Windecker, MD, Mitchell W. Krucoff, MD Stent thrombosis is an infrequent but severe complication of both bare-metal stents (BMS) and drug-eluting stents (DES). In randomized controlled trials, during 4-year follow-up there is no apparent difference in overall stent thrombosis frequency although the time course for occurrence appears to differ, with a relative numeric excess of thrombosis late after DES. Despite this imbalance, there are no differences in death or death and infarction between DES and BMS. Longer-term follow-up with these patients as well as larger angiographic and clinical subsets of patients who receive DES outside of randomized trials are required to fully study this issue.
Saphenous vein graft (SVG) angioplasty using 15-mm articulated, tubular slotted stents results in low (0% to 20%) residual diameter stenoses and infrequent (< 5%) major complications. A "biliary" ...stent design with greater radial compressive strength, enhanced visibility, and more variable sizing (diameter and length) has been approved for noncoronary indications. A comparison of outcomes after coronary versus biliary stent placement in SVG stenoses has not been performed. The purpose of this study was to compare the angiographic and clinical results after SVG angioplasty using these two balloon-expandable, tubular slotted stent designs.
During a 3-year period, 231 patients with 305 SVG lesions were treated using Palmaz-Schatz coronary (n = 108) or biliary (n = 123) stents. Cineangiograms were reviewed using qualitative morphological and quantitative angiographic methods. Time-dependent clinical outcome (freedom from death, Q-wave myocardial infarction, or the need for repeat coronary bypass surgery or SVG angioplasty) was assessed using Kaplan-Meier life-table methods. Unstable angina (P < .001) and recent myocardial infarction (P = .001) were present more often in patients undergoing biliary stent versus coronary stent placement. Biliary stent-treated SVG lesions were more frequently de novo (P = .001), ostial in location (P = .002), > or = 10 mm in length (P = .009), thrombus containing (P = .001), and ulcerated (P < .001) than coronary stent-treated SVG lesions. Angiographically, biliary stent-treated lesions had larger reference vessel diameter (3.43 +/- 0.59 mm versus 3.10 +/- 0.64 mm, P < .001), higher balloon-to-artery ratio (1.15 +/- 0.16 mm versus 1.07 +/- 0.19, P = .0001), and lower residual diameter stenosis (6 +/- 17% versus 14 +/- 11% in coronary stent-treated patients; P < .001). Procedural success rates were high (95%), in-hospital major complications were uncommon (< 3%), and follow-up clinical outcomes were favorable (6-month event-free survival approximately 80%) in both groups.
Despite frequent short-term ischemic syndromes and unfavorable lesion characteristics, both biliary and coronary cohorts have similarly favorable short-term procedural results and long-term clinical outcomes. The increased strut thickness of the biliary stent confers greater fluoroscopic visibility and radial compressive strength in exchange for decreased stent flexibility and added technical demand in stent deployment. Extreme caution is recommended with biliary stent placement in the treatment of SVG lesions as clinical results are highly operator dependent.
PDF
