Percutaneous coronary intervention can be safely performed in patients with acute coronary syndromes (ACS), including those with non-ST-segment elevation myocardial infarction (MI), and unstable ...angina. Although there remains debate about whether an aggressive strategy involving early coronary arteriography and revascularization should be
routinely performed in patients who present with non-ST-segment elevation MI and unstable angina, recent clinical trials suggest that an aggressive approach should be taken in both intermediate- and high-risk patients with ACS. There have been 4 clinical trials that have compared the outcomes of patients presenting with non-ST-segment elevation MI or unstable angina who were assigned to invasive or conservative strategies. The Thrombolysis in Myocardial Infarction (TIMI) IIIB trial and the Veterans Affairs Non-Q-Wave Infarction Strategies in Hospital (VANQWISH) trial failed to demonstrate a reduction in death or MI in patients assigned to an invasive approach, but it did demonstrate an important reduction in the frequency of rehospitalization. However, these studies were performed before the availability of coronary stents or the use of glycoprotein IIb/IIIa inhibitors. In contrast, the Fragmin and Fast Revascularisation During Instability in Coronary Artery Disease (FRISC) II and the Treat Angina with Aggrastat and Determine Cost of Therapy with an Invasive or Conservative Strategy (TACTICS) trials demonstrated significant improvements in the rates of death or MI in patients with non-ST-segment elevation MI or unstable angina assigned to an invasive strategy. Event reductions were greatest in patients with non-ST-segment elevation MI or unstable angina at intermediate or high risk for an adverse outcome. Understanding that these subgroups comprise approximately 75% of patients presenting with non-ST-segment elevation MI or unstable angina, we believe that an invasive approach is indicated in most patients who develop non-ST-segment elevation MI or unstable angina. Regardless of the strategy used in ACS patients, lipid-lowering therapy is necessary to reduce recurrent ischemia events at the site of plaque instability and in atherosclerotic disease remote to the target lesion.
This registry collected the 30-day and 9-month clinical outcomes of patients whose coronary stent implantation was suboptimal, and compared them with the cohort of patients with "optimal" stenting in ...the randomized portion of the STent Anti-thrombotic Regimen Study (STARS) trial.
Although "optimal" stenting combined with an aspirin and ticlopidine regimen carries a low (0.5%) incidence of subacute stent thrombosis, only limited data are available for patients in whom stents are deployed suboptimally.
In the STARS, 312 (15.9%) of 1,965 patients enrolled were excluded from participation in the randomized trial based on a perceived "suboptimal" result of coronary stenting. Of these, 265 patients met prespecified criteria for suboptimal stenting, and were followed in a parallel registry, which was compared with the randomized STARS optimal stenting cohort. The primary end point was a 30-day composite of death, emergent target lesion revascularization, angiographic thrombosis of the target vessel without revascularization and nonfatal myocardial infarction (MI) unrelated to direct procedural complications.
Registry patients had a similar frequency of the primary end point compared with the overall randomized cohort (3.0% vs. 2.2%), with this end point correlating to use of multiple stents, smaller final lumen diameter and absence of ticlopidine from the poststent regimen. Overall 30-day mortality (1.1% vs. 0.06%, p = 0.009) and periprocedural non-Q wave MI (8.7% vs. 4.2%, p = 0.003) were more frequent in registry patients, and appeared to be related to acute procedural complications. Clinical restenosis was significantly higher for registry patients (26.8% vs. 16.0%, p = 0.001), relating to greater prevalence of independent predictors such as smaller final lumen diameter and multiple stent use.
In the STARS registry, the inability to perform optimal stenting correlated with smaller final lumen diameter and longer stent length. With ticlopidine-containing regimens, the acute clinical results of "suboptimal" stent deployment are clinically acceptable, although they are not quite as good as those of optimal stenting using similar drug therapy.
Polymer-Based, Paclitaxel-Eluting TAXUS Liberté Stent in De Novo Lesions: The Pivotal TAXUS ATLAS Trial Mark A. Turco, John A. Ormiston, Jeffrey J. Popma, Lazar Mandinov, Charles D. O’Shaughnessy, ...Tift Mann, Thomas F. McGarry, Chiung-Jen Wu, Charles Chan, Mark W. I. Webster, Jack J. Hall, Gregory J. Mishkel, Louis A. Cannon, Donald S. Baim, Joerg Koglin The TAXUS ATLAS study is the pivotal clinical trial evaluating the next-generation TAXUS Liberté stent versus a historic control of TAXUS Express patients. Despite similar inclusion criteria, quantitative coronary angiography-determined baseline lesion characteristics were significantly more complex in patients with TAXUS Liberté than TAXUS Express. At 9 and 12 months, all angiographic and clinical variables were similar between the 2 stents, and the primary end point was met. Therefore, TAXUS Liberté is non-inferior to TAXUS Express.
OBJECTIVES
This study sought to determine the safety, feasibility and outcome of local delivery of cytochalasin B at the site of coronary angioplasty.
BACKGROUND
Previous failures in the ...pharmacologic prevention of restenosis may have been related to inadequate dosing at the angioplasty site as a result of systemic drug administration. Alternatively, although previous experimental protocols have typically targeted control of excess tissue growth (intimal hyperplasia), it now appears that overall arterial constriction (vascular remodeling) is the major contributor to late lumen loss. Cytochalasin B inhibits the polymerization of actin and has proved to be a potent inhibitor of vascular remodeling in animal models.
METHODS
In this phase I, multicenter, randomized, controlled trial, cytochalasin B (or matching placebo) was administered to the site of a successful balloon angioplasty using a microporous local delivery infusion balloon.
RESULTS
The rate of drug delivery at a constant infusion pressure varied significantly from patient to patient (range 1.7 to 20.2 ml/min), perhaps related to a variable constricting effect of the atherosclerotic plaque on the infusion balloon. The minimal stenosis diameter after the procedure was slightly better in the active drug group (1.86 ± 0.44 vs. 1.49 ± 0.63 mm, p < 0.03), but this difference was not seen at four to six weeks. Although the study was not powered for clinical outcomes (n = 43), the combined end point (death, nonfatal infarction or repeat revascularization) was encountered in 20% of the patients receiving cytochalasin B and in 38% of the patients receiving placebo. Clinical restenosis occurred in 18% of the treatment group and 22% of the placebo group. There were no significant differences between groups in biochemical or electrocardiographic variables.
CONCLUSIONS
Cytochalasin B can be safely administered by local delivery after successful coronary angioplasty and warrants further study of its efficacy in reducing restenosis.
Higher complication rates and lower success rates for treatment of women compared with men have been reported in prior studies of coronary angioplasty and in most early reports of outcome with new ...coronary interventional devices. In multivariate analysis this has been attributed largely to older age and other unfavorable clinical characteristics. These results are reflected in the current guidelines for coronary angioplasty. Women in prior studies have also had different distributions of vessel and lesion characteristics, but the influence of these differences on the outcome of new-device interventions have not been adequately evaluated. This article evaluates the influence of gender on clinical and angiographic characteristics, interventional procedure and complications, angiographic success, and clinical outcomes at hospital discharge and 1-year follow-up, as observed in the New Approaches to Coronary Intervention (NACI) registry. The NACI registry methodology has been reported in detail elsewhere in this supplement. This study focuses on the 90% of patients—975 women and 1,880 men—who had planned procedures with a single new device and also had angiographic core laboratory readings. Women compared with men were older, had more recent onset of coronary ischemic pain that was more severe and unstable, and had more frequent histories of other adverse clinical conditions. The distributions of several but not all angiographic characteristics before intervention were considered more favorable to angioplasty outcome in women. Differences were observed in device use and procedure staging. Angiographically determined average gain in lumen diameter after new-device intervention, with or without balloon angioplasty, was significantly less in women (1.38 mm) than in men (1.53 mm; p <0.001); this 0.15 mm difference is consistent with the 0.16-mm smaller reference vessel lumen diameter of women. However, final percent diameter stenoses and TIMI flow and lesion compliance characteristics were similar. Among procedural complications, only treatment for hypotension, blood transfusion, and vascular repair occurred more often in women. More women than men were clinically unstable (2.1% vs 1.1%) or went directly to emergent coronary artery bypass graft surgery (CABG; 1.2% vs 0.6%) on leaving the interventional laboratory. However, in-hospital death (1.4% vs 1.1%), Q-wave myocardial infarction (MI) (0.9% vs 1.1%), and emergent CABG (1.5% vs 1.0%, for women and men, respectively) were not significantly different. Nonemergent CABG was more frequent in women (1.8% vs 0.9%; p <0.05) and length of hospital stay after device intervention was longer (4.4 days vs 3.8 days in men; p <0.01). In both univariate and multivariate analyses gender did not emerge as a significant variable in relation to the combined endpoint, death, Q-wave MI, or emergent CABG at hospital discharge. At 1-year follow-up more women than men reported improvement in angina (70% vs 62%) and fewer women than men had had repeat revascularization (32% vs 36%). Similar proportions were alive and free of angina, Q-wave MI and repeat revascularization (46% of women vs 45% of men). Although several procedure-related complications were more frequent in women than men after coronary interventions with new devices, no important disadvantages were observed for women in the rates of major clinical events at hospital discharge and at 1-year clinical follow-up. Additional studies are needed to evaluate the complex interplay of clinical, vessel, and lesion characteristics on success and complications of specific interventional techniques and to determine whether gender, per se, is a risk factor and whether gender specific interventional strategies may be beneficial.
Frailty is a geriatric syndrome that diminishes the potential for functional recovery after a transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) procedure; ...however, its integration in clinical practice has been limited by a lack of consensus on how to measure it.
This study sought to compare the incremental predictive value of 7 different frailty scales to predict poor outcomes following TAVR or SAVR.
A prospective cohort of older adults undergoing TAVR or SAVR was assembled at 14 centers in 3 countries from 2012 to 2016. The following frailty scales were compared: Fried, Fried+, Rockwood, Short Physical Performance Battery, Bern, Columbia, and the Essential Frailty Toolset (EFT). Outcomes of interest were all-cause mortality and disability 1 year after the procedure.
The cohort was composed of 1,020 patients with a median age of 82 years. Depending on the scale used, the prevalence of frailty ranged from 26% to 68%. Frailty as measured by the EFT was the strongest predictor of death at 1 year (adjusted odds ratio OR: 3.72; 95% confidence interval CI: 2.54 to 5.45) with a C-statistic improvement of 0.071 (p < 0.001) and integrated discrimination improvement of 0.067 (p < 0.001). Moreover, the EFT was the strongest predictor of worsening disability at 1 year (adjusted OR: 2.13; 95% CI: 1.57 to 2.87) and death at 30 days (adjusted OR: 3.29; 95% CI: 1.73 to 6.26).
Frailty is a risk factor for death and disability following TAVR and SAVR. A brief 4-item scale encompassing lower-extremity weakness, cognitive impairment, anemia, and hypoalbuminemia outperformed other frailty scales and is recommended for use in this setting. (Frailty Assessment Before Cardiac Surgery & Transcatheter Interventions; NCT01845207)
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Revascularization for Unprotected Left Main Disease Kandzari, David E., MD; Colombo, Antonio, MD; Park, Seung-Jung, MD, PhD ...
Journal of the American College of Cardiology,
10/2009, Letnik:
54, Številka:
17
Journal Article
Recenzirano
Odprti dostop
Determining the most appropriate revascularization strategy for patients presenting with unprotected left main coronary (UPLM) disease has been a topic of great recent interest. During this current ...decade, there have been multiple clinical trials and registries addressing this subject. Previously, UPLM disease has almost exclusively resulted in utilizing a surgical revascularization treatment strategy. However, recent improvements in percutaneous coronary intervention (PCI) techniques in parallel with the benefits of drug-eluting stents (DES) to reduce clinical restenosis have enabled further investigation in catheterization-based treatment strategies as possible alternative therapeutic options. These advances as well as an increased understanding of both the procedural and anatomical challenges involved with complex coronary interventions have allowed further advancements in the field. Better adjunctive antithrombotic pharmacological therapy in the PCI setting has favored such progress. American College of Cardiology/American Heart Association/Society for Coronary Angiography and Interventions guidelines do not currently endorse the performance of PCI as an appropriate alternative to surgical revascularization for patients with UPLM disease. This paper is a review of the current evidence on UPLM PCI and proposes future directions in this evolving field.
Restenosis, Statistics, and Reasonable Inferences Ellis, Stephen G.; Popma, Jeffrey J.; Stone, Gregg W. ...
Journal of the American College of Cardiology,
01/2006, Letnik:
47, Številka:
2
Journal Article
Recenzirano
Odprti dostop
The large-scale REALITY trial, comparing the sirolimus-eluting and paclitaxel-eluting stents, found significantly greater in-stent late loss with the latter (0.09 vs. 0.31 mm, respectively, p < ...0.001), but nearly identical eight-month TLR rates (5.0% vs. 5.4%, p = 0.81). ...given the patient and lesion complexity studied in the pivotal DES trials to date, an "acceptable" TLR can be achieved with a relatively high in-stent late loss, providing that a homogeneous response is seen.
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