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      Relationship Between Intravascular Ultrasound Guidance and Clinical Outcomes After Drug-Eluting Stents : Two-Year Follow-Up of the ADAPT-DES Study

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          Abstract

          Background In the large-scale ADAPT-DES study (Assessment of Dual Antiplatelet Therapy With Drug-Eluting Stents), drug-eluting stent implantation with intravascular ultrasound (IVUS) guidance was associated with a reduction in 1-year rates of stent thrombosis, myocardial infarction (MI), and major adverse cardiac events (cardiac death, MI, or stent thrombosis) compared with angiography guidance alone. We assessed whether the benefits of IVUS guidance were maintained, reduced, or increased at 2 years. Methods and Results ADAPT-DES was a prospective, multicenter, nonrandomized all-comers study of 8582 consecutive patients at 11 US and German sites designed to determine the frequency, timing, and correlates of adverse events after drug-eluting stents. Propensity-adjusted multivariable analysis was performed to examine the impact of IVUS guidance on 2-year outcomes. IVUS guidance (n=3361; 39%) compared with angiography guidance (n=5221; 61%) was associated with reduced 2-year adjudicated rates of (1) major adverse cardiac events (cardiac death, MI, or stent thrombosis; 4.9% versus 7.5%; adjusted hazard ratio, 0.72; 95% CI, 0.59-0.89; P=0.003), (2) definite/probable stent thrombosis (0.55% versus 1.16%; adjusted hazard ratio, 0.40; 95% CI, 0.22-0.73; P=0.003), and (3) MI (3.5% versus 5.6%; adjusted hazard ratio, 0.65; 95% CI, 0.51-0.83; P=0.0006). By landmark analysis, IVUS guidance compared with angiography guidance was also associated with significantly reduced rates of major adverse cardiac events, MI, stent thrombosis, and clinically driven target lesion revascularization between 1 and 2 years after drug-eluting stent implantation. The number needed to treat with IVUS guidance to prevent 1 major adverse cardiac event was reduced from 64 (42-137) at 1 year to 41 (29-69) at 2 years. Conclusions In ADAPT-DES, the early improvement in event-free survival after drug-eluting stent implantation with IVUS guidance compared with angiography guidance was further increased with longer term follow-up to 2 years. Clinical Trial Registration URL: https://www.clinicaltrials.gov . Unique identifier: NCT00638794.

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          Comparison of zotarolimus-eluting and everolimus-eluting coronary stents.

          New-generation coronary stents that release zotarolimus or everolimus have been shown to reduce the risk of restenosis. However, it is unclear whether there are differences in efficacy and safety between the two types of stents on the basis of prospectively adjudicated end points endorsed by the Food and Drug Administration. In this multicenter, noninferiority trial with minimal exclusion criteria, we randomly assigned 2292 patients to undergo treatment with coronary stents releasing either zotarolimus or everolimus. Twenty percent of patients were randomly selected for repeat angiography at 13 months. The primary end point was target-lesion failure, defined as a composite of death from cardiac causes, any myocardial infarction (not clearly attributable to a nontarget vessel), or clinically indicated target-lesion revascularization within 12 months. The secondary angiographic end point was the extent of in-stent stenosis at 13 months. At least one off-label criterion for stent placement was present in 66% of patients. The zotarolimus-eluting stent was noninferior to the everolimus-eluting stent with respect to the primary end point, which occurred in 8.2% and 8.3% of patients, respectively (P<0.001 for noninferiority). There were no significant between-group differences in the rate of death from cardiac causes, any myocardial infarction, or revascularization. The rate of stent thrombosis was 2.3% in the zotarolimus-stent group and 1.5% in the everolimus-stent group (P=0.17). The zotarolimus-eluting stent was also noninferior regarding the degree (+/-SD) of in-stent stenosis (21.65+/-14.42% for zotarolimus vs. 19.76+/-14.64% for everolimus, P=0.04 for noninferiority). In-stent late lumen loss was 0.27+/-0.43 mm in the zotarolimus-stent group versus 0.19+/-0.40 mm in the everolimus-stent group (P=0.08). There were no significant between-group differences in the rate of adverse events. At 13 months, the new-generation zotarolimus-eluting stent was found to be noninferior to the everolimus-eluting stent in a population of patients who had minimal exclusion criteria. (ClinicalTrials.gov number, NCT00617084.) 2010 Massachusetts Medical Society
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            Optical Coherence Tomography Findings in Patients With Coronary Stent Thrombosis

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              Meta-analysis of outcomes after intravascular ultrasound-guided versus angiography-guided drug-eluting stent implantation in 26,503 patients enrolled in three randomized trials and 14 observational studies.

              There are conflicting data regarding the benefit of intravascular ultrasound (IVUS)-guided percutaneous coronary intervention (PCI) over angiography-guided PCI. Since the last meta-analysis was published, several new studies have been reported. We performed a comprehensive meta-analysis to evaluate the clinical impact of IVUS-guided PCI with drug-eluting stent compared with conventional angiography-guided PCI. This meta-analysis included 26,503 patients from 3 randomized and 14 observational studies; 12,499 patients underwent IVUS-guided PCI and 14,004 underwent angiography-guided PCI. Main outcome measures were total mortality, myocardial infarction (MI), stent thrombosis, and target lesion revascularization (TLR). IVUS-guided PCI was significantly associated with more stents, longer stents, and larger stents. Regarding clinical outcomes, IVUS-guided PCI was associated with a significantly lower risk of TLR (odds ratio [OR] 0.81, 95% confidence interval [CI] 0.66 to 1.00, p=0.046). In addition, the risk of death (OR 0.61, 95% CI 0.48 to 0.79, p<0.001), MI (OR 0.57, 95% CI 0.44 to 0.75, p<0.001), and stent thrombosis (OR 0.59, 95% CI 0.47 to 0.75, p<0.001) were also decreased. In conclusion, our meta-analysis demonstrated that IVUS-guided PCI was associated with lower risk of death, MI, TLR, and stent thrombosis after drug-eluting stent implantation.
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                Author and article information

                Journal
                Circulation: Cardiovascular Interventions
                Circ: Cardiovascular Interventions
                Ovid Technologies (Wolters Kluwer Health)
                1941-7640
                1941-7632
                November 2018
                November 2018
                : 11
                : 11
                Affiliations
                [1 ]Center for Interventional Vascular Therapy, Division of Cardiology, NewYork–Presbyterian Hospital, Columbia University Medical Center, New York, NY (A.M., A.J.K., G.W.S.).
                [2 ]Clinical Trials Center, Cardiovascular Research Foundation, New York, NY (A.M., G.S.M., G.W., T.M., P.G., R.M., A.J.K., G.W.S.).
                [3 ]Department of Cardiology and Pneumology, Helios Amper-Klinikum, Dachau, Germany (B.W.).
                [4 ]Montefiore Medical Center, Bronx, NY (G.W.).
                [5 ]Universitäts-Herzzentrum Freibrug Bad Krozingen, Germany (F.-J.N.).
                [6 ]Sanger Heart &amp; Vascular Institute, Carolinas HealthCare System, Charlotte, NC (M.J.R.).
                [7 ]Wellmont CVA Heart Institute, Kingsport, TN (D.C.M.).
                [8 ]Cedars-Sinai Heart Institute, Los Angeles, CA (T.D.H.).
                [9 ]Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, MN (T.D.H.).
                [10 ]CVA Brookwood Baptist Hospital, Birmingham, AL (D.A.C.).
                [11 ]Reid Heart Center, FirstHealth of the Carolinas, Pinehurst, NC (P.L.D.).
                [12 ]LeBauer-Brodie Center for Cardiovascular Research and Education, Cone Health, Greensboro, NC (B.R.B., T.D.S.).
                [13 ]The Ohio State University Wexner Medical Center, Columbus (E.L.M.).
                [14 ]Gagnon Cardiovascular Institute, Morristown Medical Center, NJ (P.G.).
                [15 ]Hôpital du Sacré-Coeur de Montréal, Québec, Canada (P.G.).
                [16 ]The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
                Article
                10.1161/CIRCINTERVENTIONS.117.006243
                30571206
                8d377d1f-4fa6-4010-9242-b2d19f9f87e8
                © 2018
                History

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