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.
The management of diabetic patients with restenosis after percutaneous coronary intervention remains a significant challenge. Diabetic patients remain at significant risk of restenosis despite stent ...implantation. This retrospective analysis was performed to determine the extent to which vascular brachytherapy improves late clinical and angiographic outcomes in diabetic patients compared to conventional therapy and compared to patients' nondiabetic counterparts.
Pooled data from two studies (START Stents and Radiation Trial and START-40 trials) of patients (204 diabetic, 477 nondiabetic) receiving vascular brachytherapy (VBT) with a
90Sr/
90Y source after conventional percutaneous coronary intervention for in-stent restenosis comprise the study population. The radiation delivery system used in both studies was the Beta-Cath system. The prescribed dose at 2 mm from the centerline of the source axis was 18.4 Gy or 23 Gy, depending on vessel diameter. The reference vessel diameter, minimal lumen diameter, and percent diameter stenosis were measured before the intervention, at the conclusion of the procedure, and at the 8-month follow-up examination. The Breslow-Day test was used to formally assess the similarity of treatment effect between diabetic and nondiabetic patients.
Target lesion and target vessel revascularization rates and angiographic restenosis rates in diabetic and nondiabetic patients treated with beta radiation or placebo were analyzed. Diabetic patients were more likely to have longer and more complex coronary lesions. In-hospital outcomes in diabetic and nondiabetic patients were similar, irrespective of treatment status. At 8 months, patients treated with beta radiation exhibited less target lesion revascularization (diabetic: 10.9% vs. 22.7%,
p = 0.02; nondiabetic: 12.8% vs. 22.3%,
p = 0.007) and less target vessel revascularization (diabetic: 14.7% vs. 25.3%,
p = 0.06; nondiabetic: 16.6% vs. 23.6%,
p = 0.06) compared to placebo. In-stent binary angiographic restenosis was lower in irradiated patients (diabetic: 19.4% vs. 37.3% for placebo,
p = 0.01; nondiabetic: 12.9% vs. 43% for placebo,
p < 0.001). However, restenosis beyond the stent site reduced the impact of VBT, regardless of diabetic status. The magnitude of the treatment effect for target lesion and target vessel revascularization rates was similar between diabetic and nondiabetic patients.
Previously published institutional experiences have suggested that diabetic patients benefit from the use of VBT in the management of in-stent restenosis. This analysis now provides direct evidence to support the role of beta radiation VBT in this patient population. Diabetic patients undergoing this therapy are just as likely to benefit from it as their nondiabetic counterparts.
Impact of Routine Angiographic Follow-Up on the Clinical Benefits of Paclitaxel-Eluting Stents: Results From the TAXUS-IV Trial
Duane S. Pinto, Gregg W. Stone, Stephen G. Ellis, David A. Cox, James ...Hermiller, Charles O’Shaughnessy, J. Tift Mann, Roxana Mehran, Yingbo Na, Mark Turco, Ronald Caputo, Jeffrey J. Popma, Donald E. Cutlip, Mary E. Russell, David J. Cohen, for the TAXUS-IV Investigators
We compared 1-year clinical outcomes among patients randomized to the Taxus paclitaxel-eluting stent (PES) or an identical-appearing bare-metal stent in the TAXUS-IV (2-Year Results of In-Stent Restenosis Treated With the Slow-Release Polymer-Based Paclitaxel-Eluting Taxus Stent) trial, stratified by assignment to mandatory angiographic follow-up or clinical follow-up alone. Compared with clinical follow-up alone, performance of mandatory angiographic follow-up increased rates of target vessel revascularization by ∼40% among patients receiving either bare metal or drug-eluting stents. Nonetheless, the rate of target vessel revascularization was reduced substantially by PES regardless of whether angiographic follow-up was mandated.
The objectives of the study were to evaluate the effect of angiographic follow-up on revascularization rates in the TAXUS-IV trial and to determine whether the relative benefit of paclitaxel-eluting stent implantation compared with bare metal stent implantation was modified by angiographic follow-up.
Although several clinical trials have demonstrated that drug-eluting stents (DES) reduce restenosis compared with bare-metal stents (BMS), virtually all of these studies have incorporated angiographic follow-up.
In the TAXUS-IV trial, 1,314 percutaneous coronary intervention patients were randomized to receive paclitaxel-eluting stents (PES) (n = 662) or identical-appearing BMS (n = 652). Clinical outcomes were compared, stratified by assignment to angiographic follow-up or clinical follow-up alone.
Compared with clinical follow-up alone, angiographic follow-up patients had a significantly higher rate of target vessel revascularization (TVR) at 1 year (adjusted hazard ratio HR 1.46; p = 0.04), with similar relative increases in PES and BMS patients. Because PES reduced TVR by ∼60% regardless of type of follow-up, assignment to angiographic follow-up tended to overestimate the absolute benefit of PES relative to clinical follow-up alone. In contrast, assessment of end points immediately before the time of follow-up angiography led to substantial underestimation of the absolute benefit of PES implantation.
Performance of mandatory angiographic follow-up increases rates of TVR among patients receiving both BMS and PES and overestimates the absolute clinical benefits of PES relative to clinical follow-up alone. Nonetheless, PES substantially reduces TVR regardless of assignment to mandatory angiographic follow-up or not. Future studies designed to determine the true clinical benefits of DES should either forgo routine angiographic follow-up or separate the time of repeat angiography from the primary clinical end point by as long as possible.
Rescue stenting was performed in 37 consecutive patients with unsuccessful thrombolytic therapy and a 46% rate of possible or definite intracoronary thrombus. Thrombus resolution was achieved in all ...patients after stent placement, without the need for adjunctive mechanical thrombectomy devices.
The accurate measurement of lumen dimensions is essential for guidance of interventional procedures and the assessment of acute and late results. This study compared intravascular ultrasound (IVUS) ...with quantitative coronary angiography (QCA) in the assessment of lumen dimensions before and after intervention, and at follow-up. Two hundred thirty-one consecutive patients treated with Palmaz-Schatz stents and evaluated using serial (before and after intervention, and follow-up) IVUS and QCA were screened. Because IVUS cannot measure dimensions smaller than the imaging catheter, patients having an angiographic minimal lumen diameter (MLD) less than the IVUS catheter (1.0 mm) during any study were excluded, leaving 71 patients in the final study group. IVUS and QCA measurements (reference dimensions and MLD) and calculations (percent diameter stenosis, acute lumen gain, late lumen loss, loss index, and restenosis rates) were compared. Correlation coefficients ranged from 0.641 to 0.816 for measured variables and from 0.280 to 0.680 for calculated variables. Reference lumen dimensions were consistently larger by IVUS than by QCA: 0.50 ± 0.52 mm before intervention (p <0.0001), 0.46 ± 0.45 mm after intervention (p <0.0001), and 0.38 ± 0.53 mm at follow-up (p <0.0001). MLDs measured by IVUS were larger before intervention (0.17 ± 0.28 mm, p <0.0001), smaller after intervention (0.17 ± 0.34 mm, p <0.0001), and larger at follow-up (0.14 ± 0.41 mm, p <0.0001). This resulted in a smaller acute gain and late loss measured by IVUS (0.33 ± 0.39 and 0.30 ± 0.47 mm, respectively, both p <0.0001). Although measures of restenosis (i.e., loss index and restenosis rates) were similar, the classification of lesions in individual patients (as restenotic vs nonrestenotic) was significantly different (p = 0.002, concordance rate = 73%). There are systematic differences between IVUS and QCA in the measurement of reference and lesion lumen dimensions. Although indexes of restenosis were similar, classification of lesions in individual patients was different.
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