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Coronary Artery Disease: HELP
Articles by Laura Mauri
Based on 67 articles published since 2008
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Between 2008 and 2019, Laura Mauri wrote the following 67 articles about Coronary Artery Disease.
 
+ Citations + Abstracts
Pages: 1 · 2 · 3
26 Article Long-Term Outcomes of Stenting the Proximal Left Anterior Descending Artery in the PROTECT Trial. 2017

Roguin, Ariel / Camenzind, Edoardo / Kerner, Arthur / Beyar, Rafael / Boersma, Eric / Mauri, Laura / Steg, Ph Gabriel / Wijns, William. ·Rambam Medical Center, Haifa, Israel; Technion-Israel Institute of Technology, Haifa, Israel. Electronic address: aroguin@technion.ac.il. · Institut Lorrain du Coeur et des Vaisseaux, Vandoeuvre-les-Nancy, France; Université de Lorraine, Nancy, France. · Rambam Medical Center, Haifa, Israel; Technion-Israel Institute of Technology, Haifa, Israel. · Erasmus Medical Center, Rotterdam, the Netherlands. · Harvard Medical School, and Brigham and Women's Hospital, Boston, Massachusetts. · Département Hospitalo-Universitaire FIRE, Paris, France; Université Paris-Diderot, Sorbonne-Paris Cité, Paris, France; Assistance Publique - Hôpitaux de Paris, Hôpital Bichat, Paris, France; NHLI Imperial College, ICMS, Royal Brompton Hospital, London, United Kingdom. · Cardiovascular Research Center, OLV Hospital, Aalst, Belgium. ·JACC Cardiovasc Interv · Pubmed #28335893.

ABSTRACT: OBJECTIVES: This study sought to compare the outcomes of patients undergoing drug-eluting stent implantation according to lesion location within or outside the proximal left anterior descending (LAD) artery. BACKGROUND: Proximal LAD artery involvement is considered uniquely in revascularization guidelines. The impact of LAD lesion location on long-term outcomes after revascularization is poorly understood in context of current percutaneous coronary intervention and medical therapy. METHODS: Among 8,709 patients enrolled in PROTECT (Patient Related Outcomes with Endeavor Versus Cypher Stenting Trial), a multicenter percutaneous coronary intervention trial, we compared the outcomes of 2,534 patients (29.1%) (3,871 lesions [31.5%]) with stents implanted in the proximal LAD to 6,172 patients (70.9%) (8,419 lesions [68.5%]) with stents implanted outside the proximal LAD. RESULTS: At the 4-year follow-up, death rates were the same (5.8% vs. 5.8%; p > 0.999), but more myocardial infarctions occurred in the proximal LAD group (6.2% vs. 4.9%; p = 0.015). The rate of clinically driven target vessel failure (TVF) (14.8% vs. 13.5%; p = 0.109), major adverse cardiac event(s) (MACE) (15.0% vs. 13.7%; hazard ratio: 1.1; 95% confidence interval: 0.97 to 1.31; p = 0.139), and stent thrombosis (2.1% vs. 2.0%; p = 0.800) were similar. Drug-eluting stent type had no interaction with MACE or TVF. In multivariate analysis, the proximal LAD was a predictor of myocardial infarction (p = 0.038) but not of TVF (p = 0.149) or MACE (p = 0.069). CONCLUSIONS: In this study of contemporary percutaneous coronary intervention, proximal LAD location was associated with higher rates of myocardial infarction during the long-term follow-up, but there were no differences in stent thrombosis, death, TVF, or overall MACE. This finding may suggest that, in the drug-eluting stent era, proximal LAD no longer confers a different prognosis than other lesion sites. (Randomized Study Comparing Endeavor With Cypher Stents [PROTECT]; NCT00476957).

27 Article Mortality Following Cardiovascular and Bleeding Events Occurring Beyond 1 Year After Coronary Stenting: A Secondary Analysis of the Dual Antiplatelet Therapy (DAPT) Study. 2017

Secemsky, Eric A / Yeh, Robert W / Kereiakes, Dean J / Cutlip, Donald E / Cohen, David J / Steg, P Gabriel / Cannon, Christopher P / Apruzzese, Patricia K / D'Agostino, Ralph B / Massaro, Joseph M / Mauri, Laura / Anonymous381214. ·Division of Cardiology, Massachusetts General Hospital, Boston 2Harvard Medical School, Boston, Massachusetts 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts 4Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Christ Hospital Heart and Vascular Center, Cincinnati, Ohio 8Lindner Center for Research and Education, Cincinnati, Ohio. · Harvard Medical School, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 6Division of Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Saint Luke's Mid America Heart Institute, Kansas City, Missouri10University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. · Université Paris-Diderot, Institut National de la Santé et de la Récherche Médicale U-1148, Hôpital Bichat, Paris, France 12Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique, Hôpitaux de Paris, Paris, France 13National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, England. · Harvard Medical School, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 14Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts. · Baim Institute for Clinical Research, Boston, Massachusetts 15Boston University School of Public Health, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts 3Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts 5Baim Institute for Clinical Research, Boston, Massachusetts 14Division of Cardiology, Brigham and Women's Hospital, Boston, Massachusetts. ·JAMA Cardiol · Pubmed #28297015.

ABSTRACT: Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective: To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participants: This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multicenter trial involving 220 US and international clinical sites from 11 countries. The study dates were August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Results: In total, 25 682 individuals older than 18 years with an indication for coronary stenting were enrolled, and 11 648 (mean age, 61.3 years; 25.1% female) were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52 (10.9%) died. The annualized mortality rate after an ischemic event was 27.2 (95% CI, 20.3-35.7) per 100 person-years. The cumulative incidence of death after an ischemic event among the total randomized study population was 0.5% (0.3% with myocardial infarction, 0.1% with stent thrombosis, and 0.1% with ischemic stroke). Among individuals with bleeding events, 41 (17.7%) died. The annualized mortality rate after a bleeding event was 21.5 (95% CI, 15.4-29.1) per 100 person-years. The cumulative incidence of death after a bleeding event among the total randomized study population was 0.3% (0.1% with moderate and 0.2% with severe bleeding). Conclusions and Relevance: In patients treated with dual antiplatelet therapy for at least 1 year after coronary stenting, ischemic events were more frequent than bleeding events, and both events were associated with high risk of mortality. Trial Registration: clinicaltrials.gov Identifier: NCT00977938.

28 Article 5-Year Safety and Efficacy of Resolute Zotarolimus-Eluting Stent: The RESOLUTE Global Clinical Trial Program. 2017

Yeh, Robert W / Silber, Sigmund / Chen, Lianglong / Chen, Shaoliang / Hiremath, Shirish / Neumann, Franz-Josef / Qiao, Shubin / Saito, Shigeru / Xu, Bo / Yang, Yuejin / Mauri, Laura. ·Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts. Electronic address: ryeh@bidmc.harvard.edu. · Department of Cardiology, Heart Centre at the Isar, Munich, Germany. · Union Hospital, Fujian Medical University, Fujian, China. · Nanjing First Hospital, Jiangshu, China. · Ruby Hall Clinic, Pune, India. · University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany. · Fu Wai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences, Beijing, China. · Shonan Kamakura General Hospital, Kamakura, Japan. · Division of Cardiovascular Medicine, Baim Institute for Clinical Research, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts. ·JACC Cardiovasc Interv · Pubmed #28109872.

ABSTRACT: OBJECTIVES: The authors evaluated the 5-year cumulative incidence of cardiovascular events following Resolute zotarolimus-eluting stent (R-ZES) implantation. BACKGROUND: Individual trials are often underpowered to show differences for low-frequency adverse events. The R-ZES was studied in 10 prospective clinical trials, designed with identical adverse event definitions, ascertainment, and adjudication. METHODS: The RESOLUTE Global Clinical Trial Program includes 7,618 patients treated with R-ZES: RESOLUTE first-in-human study (N = 139), RESOLUTE All Comers (N = 1,140), RESOLUTE International (N = 2,349), RESOLUTE US (N = 1,402), RESOLUTE US 38 mm (N = 114), RESOLUTE Japan (N = 100), RESOLUTE Japan Small Vessel Study (N = 65), RESOLUTE Asia (N = 311), RESOLUTE China Randomized Controlled Trial (N = 198), and RESOLUTE China Registry (N = 1,800). The 5-year cumulative incidence of events was calculated. RESULTS: The 5-year cumulative incidence of cardiac events was 13.4% for target lesion failure and included 5.0% cardiac death, 4.4% target vessel myocardial infarction, and 6.3% clinically driven target lesion revascularization. Dual-antiplatelet therapy at 1, 3, and 5 years was 91%, 37%, and 32%, respectively. The 5-year cumulative incidence of definite or probable stent thrombosis was 1.2%, which comprised 0.7% at 1 year and an annualized rate of 0.1% thereafter. Five-year use of dual-antiplatelet therapy varied geographically from 63% in Japan to 11% in Europe. CONCLUSIONS: In the largest group of R-ZES patients examined to date, the majority of stent-related events, including target vessel myocardial infarction and stent thrombosis, occurred within the first year of implantation with much lower risks of these events out to 5 years.

29 Article Prevention of Stroke with Ticagrelor in Patients with Prior Myocardial Infarction: Insights from PEGASUS-TIMI 54 (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54). 2016

Bonaca, Marc P / Goto, Shinya / Bhatt, Deepak L / Steg, P Gabriel / Storey, Robert F / Cohen, Marc / Goodrich, Erica / Mauri, Laura / Ophuis, Ton Oude / Ruda, Mikhail / Špinar, Jindřich / Seung, Ki-Bae / Hu, Dayi / Dalby, Anthony J / Jensen, Eva / Held, Peter / Morrow, David A / Braunwald, Eugene / Sabatine, Marc S. ·From TIMI Study Group, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.P.B., D.L.B., E.G., D.A.M., E.B., M.S.) · Tokai University School of Medicine · Institute of Medical Science, Isehara, Japan (S.G.) · FACT, DHU-FIRE INSERM Unité 1148, Assistance Publique-Hôpitaux de Paris and Université Paris Diderot, Paris, France, and NHLI Imperial College, Royal Brompton Hospital, London, UK (P.G.S.) · University of Sheffield, United Kingdom (R.F.S.) · Division of Cardiology, Newark Beth Israel Medical Center, Rutgers-New Jersey Medical School, Newark (M.C.) · Brigham and Women's Hospital and Harvard Clinical Research Institute, Harvard Medical School, Boston, MA (L.M.) · CWZ Hospital, Nijmegen, The Netherlands (T.O.O.) · Cardiology Research and Production complex MH RF, Moscow, Russia (M.R.) · Internal Cardiology Department, University Hospital and Medical faculty, Brno, Czech Republic (J.S.) · Seoul St. Mary's Hospital, College of Medicine, The Catholic University of Korea (K.-B.S.) · Heart Institute, Intervention Center, People Hospital of Peking University, China (D.H.) · Life Fourways Hospital, Randburg, South Africa (A.J.D.) · and AstraZeneca, Mölndal, Sweden (E.J., P.H.). ·Circulation · Pubmed #27576775.

ABSTRACT: BACKGROUND: In the PEGASUS-TIMI 54 trial (Prevention of Cardiovascular Events in Patients With Prior Heart Attack Using Ticagrelor Compared to Placebo on a Background of Aspirin-Thrombolysis in Myocardial Infarction 54), ticagrelor reduced the risk of major adverse cardiovascular events when added to low-dose aspirin in stable patients with prior myocardial infarction, resulting in the approval of ticagrelor 60 mg twice daily for long-term secondary prevention. We investigated the incidence of stroke, outcomes after stroke, and the efficacy of ticagrelor focusing on the approved 60 mg twice daily dose for reducing stroke in this population. METHODS: Patients were followed for a median of 33 months. Stroke events were adjudicated by a central committee. Data from similar trials were combined using meta-analysis. RESULTS: Of 14 112 patients randomly assigned to placebo or ticagrelor 60 mg, 213 experienced a stroke; 85% of these strokes were ischemic. A total of 18% of strokes were fatal and another 15% led to either moderate or severe disability at 30 days. Ticagrelor significantly reduced the risk of stroke (hazard ratio, 0.75; 95% confidence interval, 0.57-0.98; P=0.034), driven by a reduction in ischemic stroke (hazard ratio, 0.76; 95% confidence interval, 0.56-1.02). Hemorrhagic stroke occurred in 9 patients on placebo and 8 patients on ticagrelor. A meta-analysis across 4 placebo-controlled trials of more intensive antiplatelet therapy in 44 816 patients with coronary disease confirmed a marked reduction in ischemic stroke (hazard ratio, 0.66; 95% confidence interval, 0.54-0.81; P=0.0001). CONCLUSIONS: High-risk patients with prior myocardial infarction are at risk for stroke, approximately one-third of which are fatal or lead to moderate-to-severe disability. The addition of ticagrelor 60 mg twice daily significantly reduced this risk without an excess of hemorrhagic stroke but with more major bleeding. In high-risk patients with coronary disease, more intensive antiplatelet therapy should be considered not only to reduce the risk of coronary events, but also of stroke. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique Identifier: NCT01225562.

30 Article Impact of Optimal Medical Therapy in the Dual Antiplatelet Therapy Study. 2016

Resor, Charles D / Nathan, Ashwin / Kereiakes, Dean J / Yeh, Robert W / Massaro, Joseph M / Cutlip, Donald E / Gabriel Steg, P / Hsieh, Wen-Hua / Mauri, Laura / Anonymous7520879. ·From Division of Cardiology and Center for Clinical Biometrics, Department of Medicine, Brigham and Women's Hospital, Boston, MA (C.D.R., L.M.) · Harvard Clinical Research Institute, Boston, MA (R.W.Y., D.E.C., W.-H.H., L.M.) · Harvard Medical School, Boston, MA (R.W.Y., L.M.) · Division of Cardiology, University of Pennsylvania Medical Center, Philadelphia (A.N.) · Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, MA (R.W.Y., D.E.C.) · Department of Biostatistics, Boston University School of Public Heath, MA (J.M.M.) · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, OH (D.J.K.) · Université Paris-Diderot, INSERM U-1148, Hôpital Bichat, Département Hospitalo-Universitaire Fibrosis, Inflammation, and Remodeling, Assistance Publique-Hôpitaux de Paris, Paris, France (P.G.S.) · and National Heart and Lung Institute, Institute of Cardiovascular Medicine and Science, Royal Brompton Hospital, Imperial College, London, UK (P.G.S.). ·Circulation · Pubmed #27576774.

ABSTRACT: BACKGROUND: Continued dual antiplatelet therapy and optimal medical therapy (OMT) improve outcomes in selected patient populations with established coronary heart disease, but whether OMT modifies the treatment effect of dual antiplatelet therapy is unknown. METHODS: The DAPT (Dual Antiplatelet Therapy) Study, a double-blind trial, randomly assigned 11 648 patients who had undergone coronary stenting and completed 1 year of dual antiplatelet therapy without major bleeding or ischemic events to an additional 18 months of continued thienopyridine or placebo. OMT was defined as a combination of statin, β-blocker, and angiotensin-converting enzyme inhibitor/angiotensin receptor blocker use in patients with an American College of Cardiology/American Heart Association class I indication for each medication. Per protocol, all patients were treated with 75 to 325 mg aspirin daily. End points included myocardial infarction, major adverse cardiovascular and cerebrovascular events, and Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries moderate or severe bleeding events. RESULTS: Of 11 643 randomly assigned patients with complete medication data, 63% were on OMT. Between 12 and 30 months, continued thienopyridine reduced myocardial infarction in comparison with placebo in both groups (on OMT 2.1% versus 3.3%, hazard ratio [HR], 0.64; 95% confidence interval [CI], 0.48-0.86; P=0.003; off OMT 2.2% versus 5.2%, HR, 0.41; CI, 0.29-0.58; P<0.001; interaction P=0.103). Comparing continued thienopyridine versus placebo, rates of major adverse cardiovascular and cerebrovascular events were 4.2% versus 5.0% among patients on OMT (HR, 0.82; CI, 0.66-1.02; P=0.077) and 4.5% versus 7.0% among those off OMT (HR, 0.63; CI, 0.49-0.82; P<0.001; interaction P=0.250); rates of bleeding for thienopyridine versus placebo in patients on OMT were 2.2% versus 1.0% (HR, 2.13; CI, 1.43-3.17; P<0.001), and in patients off OMT were 2.8% versus 2.2% (HR, 1.30; CI, 0.88-1.92; P=0.189; interaction P=0.073). Overall, patients on OMT had lower rates of myocardial infarction (2.7% versus 3.7%, P=0.003), major adverse cardiovascular and cerebrovascular events (4.6% versus 5.7%, P=0.007), and bleeding (1.6% versus 2.5%, P<0.001) in comparison with patients off OMT. Rates of stent thrombosis (0.8% versus 1.0%, P=0.171) and death (1.6% versus 1.9%, P=0.155) did not differ. CONCLUSIONS: Continued thienopyridine therapy reduced the rate of myocardial infarction regardless of OMT status and had consistent effects on reduction in major adverse cardiovascular and cerebrovascular events and increased bleeding. CLINICAL TRIAL REGISTRATION: URL: http://clinicaltrials.gov. Unique identifier: NCT00977938.

31 Article Frequency of Stent Thrombosis Risk at 5 Years in Women Versus Men With Zotarolimus-Eluting Compared With Sirolimus-Eluting Stent. 2016

Ten Haaf, Monique / Appelman, Yolande / Wijns, William / Steg, Gabriel / Mauri, Laura / Rademaker-Havinga, Tessa / Wetzels, Gwenn / Bousquette, Lisa / Camenzind, Edoardo / Boersma, Eric / Anonymous5340879. ·Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands; Netherlands Heart Institute, Utrecht, The Netherlands. · Department of Cardiology, VU University Medical Center, Amsterdam, The Netherlands. · Cardiovascular Center, OLV Hospital, Aalst, Belgium. · Department of Cardiology, Hopital Bichat Assistance Publique, Paris, France. · Department of Cardiology, Harvard Medical School and Brigham and Women's Hospital, Boston, Massachusetts. · Cardialysis BV, Rotterdam, The Netherlands. · Medtronic Bakken Research Center, Medtronic Cardiovascular, Maastricht, The Netherlands. · Medtronic Cardiovascular, Santa Rosa, California. · Department of Cardiology, University Hospital of Nancy, Vandoeuvre-lès-Nancy, France. · Department of Cardiology, Erasmus MC, Rotterdam, The Netherlands; Cardiovascular research school COEUR, Erasmus MC, Rotterdam, The Netherlands. Electronic address: h.boersma@erasmusmc.nl. ·Am J Cardiol · Pubmed #27569387.

ABSTRACT: The prevalence of factors that are associated with an increased risk of stent thrombosis (ST), including smoking, diabetes mellitus, and small stent size, is different in women and men who underwent percutaneous coronary intervention. Thus, gender may potentially modify the relation between stent type and the incidence of ST during long-term follow-up. We explored the data of Patient Related Outcomes With Endeavor Versus Cypher stenting Trial (PROTECT) to evaluate this hypothesis. PROTECT randomized 2,061 women and 6,648 men who underwent percutaneous coronary intervention for various indications to Endeavor zotarolimus-eluting stenting (E-ZES) or Cypher sirolimus-eluting stenting (C-SES). Dual antiplatelet therapy was prescribed for at least 3 months. Data on study end points were collected until 5 years after randomization, including ST, death, and cardiovascular events. We analyzed end points and treatment effect (E-ZES vs C-SES) in relation to gender. Women were on average 4.7 years older (65.8 vs 61.1), had a higher prevalence of insulin-dependent diabetes mellitus, were less often smokers, and had a shorter total stent length than men. At discharge and throughout follow-up, a slightly lower fraction of women were using dual antiplatelet therapy. During 5-year follow-up, definite or probable ST was observed in 36 women (1.8%) and 152 men (2.4%; log-rank p = 0.15). E-ZES reduced the incidence of ST compared with C-SES in women (hazard ratio 0.58) and men (hazard ratio 0.61), with no evidence of heterogeneity (p = 0.89). In conclusion, in PROTECT, women and men had similar cumulative incidence of ST at 5 years after stent placement. The favorable effect of the study stent E-ZES over C-SES was not modified by gender.

32 Article Focused Update on Duration of Dual Antiplatelet Therapy for Patients With Coronary Artery Disease. 2016

Mauri, Laura / Smith, Sidney C. ·Brigham and Women's Hospital, Department of Cardiovascular Medicine, Harvard Medical School, Boston, Massachusetts2Harvard Clinical Research Institute, Boston, Massachusetts. · University of North Carolina School of Medicine, Chapel Hill, North Carolina4University of North Carolina Center for Heart and Vascular Care, Chapel Hill, North Carolina. ·JAMA Cardiol · Pubmed #27548911.

ABSTRACT: -- No abstract --

33 Article Temporal Trends in the Risk Profile of Patients Undergoing Outpatient Percutaneous Coronary Intervention: A Report from the National Cardiovascular Data Registry's CathPCI Registry. 2016

Vora, Amit N / Dai, Dadi / Gurm, Hitinder / Amin, Amit P / Messenger, John C / Mahmud, Ehtisham / Mauri, Laura / Wang, Tracy Y / Roe, Matthew T / Curtis, Jeptha / Patel, Manesh R / Dauerman, Harold L / Peterson, Eric D / Rao, Sunil V. ·From the Duke Clinical Research Institute, Duke University Medical Center, Durham, NC (A.N.V., D.D., T.Y.W., M.T.R., M.R.P., E.D.P., S.V.R.) · Department of Cardiovascular Medicine, University of Michigan, Ann Arbor (H.G.) · Division of Cardiology, Washington University School of Medicine, St. Louis, MO (A.P.A.) · Department of Medicine, University of Colorado Anschutz Medical Campus, Aurora (J.C.M.) · Division of Cardiovascular Medicine, Department of Medicine, University of California-San Diego (E.M.) · Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (L.M.) · Harvard Clinical Research Institute, Boston, MA (L.M.) · Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, CT (J.C.) · and University of Vermont Cardiovascular Research Institute, Burlington, VT (H.L.D.). ·Circ Cardiovasc Interv · Pubmed #26957417.

ABSTRACT: BACKGROUND: Because of recent changes in criteria for coverage for inpatient hospital stays, most nonacute percutaneous coronary intervention (PCI) procedures are reimbursed on an outpatient basis regardless of underlying patient risk. Downstream effects of these changes on the risk profile of patients undergoing outpatient PCI have not been evaluated. METHODS AND RESULTS: Using the American College of Cardiology National Cardiovascular Data Registry's CathPCI Registry, we assessed temporal trends in risk profiles and rates of hospital admission among 999 279 patients undergoing PCI qualifying for outpatient reimbursement. We estimated mortality and bleeding risk using validated models from the registry. From 2009 to 2014, the proportion of outpatients not admitted to a hospital after PCI increased from 32.8% to 66.3% (P<0.001). Patients who were admitted after PCI were older, had greater comorbidities, and experienced more post-PCI complications (all P<0.001). Among those not admitted, the proportion of patients at high risk for predicted mortality increased significantly from 17.0% to 19.8% during the study period (P<0.001). In contrast, 16.7% of patients admitted after PCI were at low risk for mortality. CONCLUSIONS: Among patients undergoing PCI procedures that qualify for outpatient reimbursement, there has been a temporal decrease in postprocedure hospital admission. Concomitantly, the proportion of these outpatients at high risk for mortality has significantly increased over time. These data suggest that current reimbursement classification could be improved by incorporating patient risk to appropriately match the necessary resources to the needed level of care.

34 Article Benefits and Risks of Extended Dual Antiplatelet Therapy After Everolimus-Eluting Stents. 2016

Hermiller, James B / Krucoff, Mitchell W / Kereiakes, Dean J / Windecker, Stephan / Steg, P Gabriel / Yeh, Robert W / Cohen, David J / Cutlip, Donald E / Massaro, Joseph M / Hsieh, Wen-Hua / Mauri, Laura / Anonymous6250855. ·St. Vincent Heart Center, Indianapolis, Indiana. · Department of Medicine, Duke University Medical Center, Durham, North Carolina. · The Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. · Department of Cardiology, Bern University Hospital, Bern, Switzerland. · Université Paris-Diderot, INSERM U-1148, and Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; National Heart & Lung Institute, Imperial College, Royal Brompton Hospital, London, United Kingdom. · The Smith Center for Outcomes Research in Cardiology, Beth Israel Deaconess Medical Center, Boston, Massachusetts; Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts. · Department of Cardiology, Saint Luke's Mid America Heart Institute, University of Missouri-Kansas City School of Medicine, Kansas City, Missouri. · Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Department of Medicine, Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts; School of Public Health, Boston University School of Medicine, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts. · Harvard Medical School, Boston, Massachusetts; Harvard Clinical Research Institute, Boston, Massachusetts; Division of Cardiovascular Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·JACC Cardiovasc Interv · Pubmed #26793956.

ABSTRACT: OBJECTIVES: The purpose of this study was to characterize outcomes for everolimus-eluting stent (EES)-treated subjects according to treatment with continued thienopyridine plus aspirin versus aspirin alone 12 to 30 months after stenting. BACKGROUND: In the DAPT (Dual Antiplatelet Therapy) study, continued thienopyridine plus aspirin beyond 1 year after coronary stenting reduced ischemic events. Given low rates of stent thrombosis and myocardial infarction (MI) for current drug-eluting stents, we examined outcomes among EES-treated subjects in the DAPT study. METHODS: The DAPT study enrolled 25,682 subjects (11,308 EES-treated) after coronary stenting. Following 12 months of treatment with thienopyridine and aspirin, eligible subjects continued treatment with aspirin and 9,961 (4,703 with EES) were randomized to 18 months of continued thienopyridine or placebo. Stent type was not randomized, and the EES subset analysis was post hoc. RESULTS: Among EES-treated patients, continued thienopyridine reduced stent thrombosis (0.3% vs. 0.7%, hazard ratio [HR]: 0.38, 95% confidence interval [CI]: 0.15 to 0.97; p = 0.04) and MI (2.1% vs. 3.2%, HR: 0.63, 95% CI: 0.44 to 0.91; p = 0.01) versus placebo but did not reduce a composite of death, MI, and stroke (4.3% vs. 4.5%, HR: 0.89, 95% CI: 0.67 to 1.18; p = 0.42), and increased moderate/severe bleeding (2.5% vs. 1.3%, HR: 1.79, 95% CI: 1.15 to 2.80; p = 0.01), and death (2.2% vs. 1.1%, HR: 1.80, 95% CI: 1.11 to 2.92; p = 0.02). Death due to cancer and not related to bleeding was increased (0.64% vs. 0.17%; p = 0.01). CONCLUSIONS: In EES-treated subjects, significant reductions in stent thrombosis and MI and an increase in bleeding were observed with continued thienopyridine beyond 1 year compared with aspirin alone. (The Dual Antiplatelet Therapy Study [DAPT Study]); NCT00977938).

35 Article Stent Thrombosis in Drug-Eluting or Bare-Metal Stents in Patients Receiving Dual Antiplatelet Therapy. 2015

Kereiakes, Dean J / Yeh, Robert W / Massaro, Joseph M / Driscoll-Shempp, Priscilla / Cutlip, Donald E / Steg, P Gabriel / Gershlick, Anthony H / Darius, Harald / Meredith, Ian T / Ormiston, John / Tanguay, Jean-François / Windecker, Stephan / Garratt, Kirk N / Kandzari, David E / Lee, David P / Simon, Daniel I / Iancu, Adrian Corneliu / Trebacz, Jaroslaw / Mauri, Laura / Anonymous5040846. ·Christ Hospital Heart and Vascular Center and The Lindner Center for Research and Education, Cincinnati, Ohio. · Harvard Clinical Research Institute, Boston, Massachusetts; Massachusetts General Hospital, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts; Boston University School of Public Health, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts. · Harvard Clinical Research Institute, Boston, Massachusetts; Beth Israel Deaconess Medical Center, Department of Medicine, Cardiology Division, Boston, Massachusetts. · Université Paris-Diderot, Paris, France, INSERM U-1148, Paris, France; Hôpital Bichat, Département Hospitalo-Universitaire FIRE, Assistance Publique-Hôpitaux de Paris, Paris, France; NHLI, Imperial College, Royal Brompton Hospital, London, United Kingdom. · Department of Cardiovascular Sciences, University of Leicester and National Institute of Health Research Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester, Leicester, United Kingdom. · Vivantes Neukoelln Medical Center, Department of Cardiology, Angiology, Nephrology and Intensive Care Medicine, Berlin, Germany. · Monash Heart, Monash Health, Monash University, Victoria, Australia. · Mercy Hospital, Auckland, New Zealand. · Montreal Heart Institute, Department of Medicine/Division of Interventional Cardiology, Université de Montréal, Department of Medicine, Montreal, Canada. · Bern University Hospital, Department of Cardiology, Bern, Switzerland. · Center for Heart and Vascular Health, Christiana Care, Wilmington, Delaware. · Piedmont Heart Institute, Atlanta, Georgia. · Stanford University, Department of Medicine, Division of Cardiovascular Medicine, Stanford, California. · University Hospitals Case Medical Center, Harrington Heart and Vascular Institute, Cleveland, Ohio. · Heart Institute, University of Medicine Iuliu Hatieganu, Cluj Napoca, Romania. · Jan Pawel II Hospital Krakow, Krakow, Poland. · Harvard Clinical Research Institute, Boston, Massachusetts; Brigham and Women's Hospital, Division of Cardiovascular Medicine, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·JACC Cardiovasc Interv · Pubmed #26493248.

ABSTRACT: OBJECTIVES: This study sought to compare rates of stent thrombosis and major adverse cardiac and cerebrovascular events (MACCE) (composite of death, myocardial infarction, or stroke) after coronary stenting with drug-eluting stents (DES) versus bare-metal stents (BMS) in patients who participated in the DAPT (Dual Antiplatelet Therapy) study, an international multicenter randomized trial comparing 30 versus 12 months of dual antiplatelet therapy in subjects undergoing coronary stenting with either DES or BMS. BACKGROUND: Despite antirestenotic efficacy of coronary DES compared with BMS, the relative risk of stent thrombosis and adverse cardiovascular events is unclear. Many clinicians perceive BMS to be associated with fewer adverse ischemic events and to require shorter-duration dual antiplatelet therapy than DES. METHODS: Prospective propensity-matched analysis of subjects enrolled into a randomized trial of dual antiplatelet therapy duration was performed. DES- and BMS-treated subjects were propensity-score matched in a many-to-one fashion. The study design was observational for all subjects 0 to 12 months following stenting. A subset of eligible subjects without major ischemic or bleeding events were randomized at 12 months to continued thienopyridine versus placebo; all subjects were followed through 33 months. RESULTS: Among 10,026 propensity-matched subjects, DES-treated subjects (n = 8,308) had a lower rate of stent thrombosis through 33 months compared with BMS-treated subjects (n = 1,718, 1.7% vs. 2.6%; weighted risk difference -1.1%, p = 0.01) and a noninferior rate of MACCE (11.4% vs. 13.2%, respectively, weighted risk difference -1.8%, p = 0.053, noninferiority p < 0.001). CONCLUSIONS: DES-treated subjects have long-term rates of stent thrombosis that are lower than BMS-treated subjects. (The Dual Antiplatelet Therapy Study [DAPT study]; NCT00977938).

36 Article Balancing Long-Term Risks of Ischemic and Bleeding Complications After Percutaneous Coronary Intervention With Drug-Eluting Stents. 2015

Matteau, Alexis / Yeh, Robert W / Camenzind, Edoardo / Steg, P Gabriel / Wijns, William / Mills, Joseph / Gershlick, Anthony / de Belder, Mark / Ducrocq, Gregory / Mauri, Laura. ·Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. · Cardiology Division, Department of Medicine, Massachusetts General Hospital, Boston, Massachusetts. · Cardiology Department, University of Geneva, Geneva, Switzerland. · Cardiology Department, DHU-FIRE, Hôpital Bichat, Paris, France; Université Paris-Diderot, Paris, France; INSERM U1148, Paris, France. · Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. · Cardiology Department, Cardiothoracic Centre, Liverpool, United Kingdom. · Department of Cardiovascular Sciences, University of Leicester, Leicester, United Kingdom; NIHR Leicester Cardiovascular Biomedical Research Unit, University Hospitals of Leicester Glenfield Hospital, Leicester, United Kingdom. · Cardiology Department, The James Cook University Hospital, Middlesbrough, United Kingdom. · Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts. Electronic address: lmauri1@partners.org. ·Am J Cardiol · Pubmed #26187674.

ABSTRACT: Although trials comparing antiplatelet strategies after percutaneous coronary intervention report average risks of bleeding and ischemia in a population, there is limited information to guide choices based on individual patient risks, particularly beyond 1 year after treatment. Patient-level data from Patient Related Outcomes With Endeavor vs Cypher Stenting Trial (PROTECT), a broadly inclusive trial enrolling 8,709 subjects treated with drug-eluting stents (sirolimus vs zotarolimus-eluting stent), and PROTECT US, a single-arm study including 1,018 subjects treated with a zotarolimus-eluting stent, were combined. The risk of ischemic events, cardiovascular death/non-periprocedural myocardial infarction (MI)/definite or probable stent thrombosis, and bleeding events, Global Use of Strategies to Open Occluded Arteries moderate or severe bleed, were predicted using logistic regression. At median follow-up of 4.1 years, major bleeding occurred in 260 subjects (2.8%) and ischemic events in 595 (6.3%). Multivariate predictors of bleeding were older age, smoking, diabetes mellitus, congestive heart failure, and chronic kidney disease (all p <0.05). Ischemic events shared all the same predictors with bleeding events and gender, body mass index, previous MI, previous coronary artery bypass graft surgery, ST-segment elevation MI on presentation, stent length, and sirolimus-eluting stent use (all p <0.05). Within individual subjects, bleeding and ischemic risks were strongly correlated; 97% of subjects had a greater risk of ischemic events than bleeding. In conclusion, individual patient risks of ischemia and bleeding are related to many common risk factors, yet the predicted risks of ischemic events are greater than those of major bleeding in the large majority of patients in long-term follow-up.

37 Article Evaluating the generalizability of a large streamlined cardiovascular trial: comparing hospitals and patients in the dual antiplatelet therapy study versus the National Cardiovascular Data Registry. 2015

Yeh, Robert W / Czarny, Matthew J / Normand, Sharon-Lise T / Kereiakes, Dean J / Holmes, David R / Brindis, Ralph G / Weaver, W Douglas / Rumsfeld, John S / Roe, Matthew T / Kim, Sunghee / Driscoll-Shempp, Priscilla / Mauri, Laura. ·From the Cardiology Division, Department of Medicine, Massachusetts General Hospital (R.W.Y), Department of Health Care Policy (Biostatistics) (S.-L.T.N.), and Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital (L.M.), Harvard Medical School, Boston, MA (R.W.Y., S.-L.T.N., L.M.) · Harvard Clinical Research Institute, Boston, MA (R.W.Y., P.D.S., L.M.) · Cardiology Division, Department of Medicine, Johns Hopkins Hospital, Johns Hopkins University School of Medicine, Baltimore, MD (M.J.C.) · Department of Biostatistics, Harvard University School of Public Health, Boston, MA (S.-L.T.N.) · The Christ Hospital Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH (D.J.K.) · Cardiology Division, Mayo Clinic, Rochester, MN (D.R.H., Jr) · Philip R. Lee Institute for Health Policy Studies, Department of Medicine, University of California, San Francisco (R.G.B.) · Heart and Vascular Institute, Henry Ford Health System, Detroit, MI (W.D.W.) · Cardiology Division, Denver VA Medical Center/Veterans Health Administration, CO (J.S.R.) · and Duke Clinical Research Institute, Durham, NC (M.T.R., S.K.). ·Circ Cardiovasc Qual Outcomes · Pubmed #25399847.

ABSTRACT: BACKGROUND: The Dual Antiplatelet Therapy Study is large streamlined clinical trial designed to evaluate antiplatelet treatment strategies in a broadly inclusive population of subjects treated with coronary stents. Whether large streamlined trials can successfully include a representative group of study sites and patients has not been formally assessed. METHODS AND RESULTS: Within the National Cardiovascular Data Registry CathPCI Registry, we compared characteristics and outcomes of hospitals participating versus not participating in the Dual Antiplatelet Therapy Study. We also compared clinical and procedural characteristics of trial subjects undergoing percutaneous coronary intervention (PCI) with drug-eluting stents to contemporaneous patients within the National Cardiovascular Data Registry CathPCI Registry. Standardized differences between groups were estimated. Between September 2009 and July 2011, 1.1 million PCIs were performed among 1276 hospitals, of which 309 (24.2%) participated in the Dual Antiplatelet Therapy Study. Participating hospitals were larger (468 versus 311 beds), more frequently located in urban settings (61.2% versus 42.6%), and had higher annual PCI volumes (858 versus 378) compared with nonparticipating hospitals, although hospital case mix and procedural outcomes were similar. Compared with CathPCI patients, trial patients undergoing PCI with drug-eluting stents were similar with respect to race, sex, and rates of diabetes mellitus, hypertension, and smoking, although they had lower rates of prior cardiovascular disease. CONCLUSIONS: Within the Dual Antiplatelet Therapy Study, clinical trial sites had similar patient case mix and clinical outcomes as nonparticipating sites. Although trial participants were representative of PCI patients with respect to race, sex and most comorbidities, they had a lower prevalence of chronic cardiovascular disease compared with registry patients. Although a streamlined cardiovascular clinical trial may successfully involve a large number of hospitals and rapidly enroll a diverse population of patients, differences between eligible patients and those actually enrolled remained. CLINICAL TRIAL REGISTRATION URL: http://www.clinicaltrials.gov. Unique identifier: NCT00977938.

38 Article Evolving antithrombotic strategies in patients with atrial fibrillation undergoing percutaneous coronary intervention: results from a survey among US cardiologists. 2014

Vardi, Moshe / Debidda, Marcella / Bhatt, Deepak L / Mauri, Laura / Cannon, Christopher P. · ·Clin Cardiol · Pubmed #24672813.

ABSTRACT: BACKGROUND: Many patients treated with oral anticoagulants for atrial fibrillation undergo percutaneous stent implantation, where dual antiplatelet therapy (DAPT) is also recommended. The current evidence to support triple oral antithrombotic therapy (TOAT) in these patients is limited, and new strategies are being discussed to optimize outcomes. HYPOTHESIS: There will be variation in antithrombotic strategies in patients with atrial fibrillation needing stenting. METHODS: We surveyed US-based cardiologists serving as clinical investigators in academic sites and posted an online "question of the month" on cardiosource.org. RESULTS: Seventy-five (10.7%) responses were received to the email survey and 119 to the online question. Bare-metal stenting (BMS) was a priori preferred over drug-eluting stenting (DES) for 50.6% of patients. Only 8.8% of the responders chose newer anticoagulants in addition to DAPT as the preferred oral anticoagulant. For duration of TOAT, 79.4% of physicians recommended stopping DAPT at 1 month when BMS was used in patients presenting without acute coronary syndrome (ACS) vs 57.4% in patients with ACS. In patients implanted with a DES, 73.5% and 76.5% preferred stopping DAPT at 6 to 12 months (no ACS vs ACS, respectively). When asked which of the 2 antiplatelet agents they would recommend stopping after the above durations, 50% chose to quit aspirin. CONCLUSIONS: The survey highlights an interest in the new strategy of dropping aspirin, but the lack of concrete evidence triggers undesired diversity in clinical approaches. High-quality data on the efficacy and safety of such interventions are needed to further consolidate these approaches.

39 Article Causes of short-term readmission after percutaneous coronary intervention. 2014

Wasfy, Jason H / Strom, Jordan B / O'Brien, Cashel / Zai, Adrian H / Luttrell, Jennifer / Kennedy, Kevin F / Spertus, John A / Zelevinsky, Katya / Normand, Sharon-Lise T / Mauri, Laura / Yeh, Robert W. ·From the Cardiology Division (J.H.W., C.O'B., R.W.Y.), Department of Medicine (J.H.W., C.O'B., R.W.Y., J.B.S.), and Laboratory of Computer Science (A.H.Z., J.L.), Massachusetts General Hospital, Harvard Medical School, Boston · Saint Luke's Mid America Heart Institute/UMKC, Kansas City, MO (K.F.K., J.A.S.) · Department of Biostatistics, Harvard School of Public Health, Boston, MA (K.Z., S.-L.T.N.) · Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (L.M.) · and Harvard Clinical Research Institute, Boston, MA (L.M., R.W.Y.). ·Circ Cardiovasc Interv · Pubmed #24425587.

ABSTRACT: BACKGROUND: Rehospitalization within 30 days after an admission for percutaneous coronary intervention (PCI) is common, costly, and a future target for Medicare penalties. Causes of readmission after PCI are largely unknown. METHODS AND RESULTS: To illuminate the causes of PCI readmissions, patients with PCI readmitted within 30 days of discharge between 2007 and 2011 at 2 hospitals were identified, and their medical records were reviewed. Of 9288 PCIs, 9081 (97.8%) were alive at the end of the index hospitalization. Of these, 893 patients (9.8%) were readmitted within 30 days of discharge and included in the analysis. Among readmitted patients, 341 patients (38.1%) were readmitted for evaluation of recurrent chest pain or other symptoms concerning for angina, whereas 59 patients (6.6%) were readmitted for staged PCI without new symptoms. Complications of PCI accounted for 60 readmissions (6.7%). For cases in which chest pain or other symptoms concerning for angina prompted the readmission, 21 patients (6.2%) met criteria for myocardial infarction, and repeat PCI was performed in 54 patients (15.8%). The majority of chest pain patients (288; 84.4%) underwent ≥1 diagnostic imaging test, most commonly coronary angiography, and only 9 (2.6%) underwent target lesion revascularization. CONCLUSIONS: After PCI, readmissions within 30 days were seldom related to PCI complications but often for recurrent chest pain. Readmissions with recurrent chest pain infrequently met criteria for myocardial infarction but were associated with high rates of diagnostic testing.

40 Article Safety and efficacy outcomes of first and second generation durable polymer drug eluting stents and biodegradable polymer biolimus eluting stents in clinical practice: comprehensive network meta-analysis. 2013

Navarese, Eliano P / Tandjung, Kenneth / Claessen, Bimmer / Andreotti, Felicita / Kowalewski, Mariusz / Kandzari, David E / Kereiakes, Dean J / Waksman, Ron / Mauri, Laura / Meredith, Ian T / Finn, Aloke V / Kim, Hyo-Soo / Kubica, Jacek / Suryapranata, Harry / Aprami, Toni Mustahsani / Di Pasquale, Giuseppe / von Birgelen, Clemens / Kedhi, Elvin. ·Department of Cardiology and Internal Medicine, Ludwik Rydygier Collegium Medicum, Nicolaus Copernicus University, Bydgoszcz, Poland. ·BMJ · Pubmed #24196498.

ABSTRACT: OBJECTIVES: To investigate the safety and efficacy of durable polymer drug eluting stents (DES) and biodegradable polymer biolimus eluting stents (biolimus-ES). DESIGN: Network meta-analysis of randomised controlled trials. DATA SOURCES AND STUDY SELECTION: Medline, Google Scholar, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) database search for randomised controlled trials comparing at least two of durable polymer sirolimus eluting stents (sirolimus-ES) and paclitaxel eluting stents (paclitaxel-ES), newer durable polymer everolimus eluting stents (everolimus-ES), Endeavor and Resolute zotarolimus eluting stents (zotarolimus-ES), and biodegradable polymer biolimus-ES. PRIMARY OUTCOMES: Safety (death, myocardial infarction, definite or probable stent thrombosis) and efficacy (target lesion and target vessel revascularisation) assessed at up to one year and beyond. RESULTS: 60 randomised controlled trials were compared involving 63,242 patients with stable coronary artery disease or acute coronary syndrome treated with a DES. At one year, there were no differences in mortality among devices. Resolute and Endeavor zotarolimus-ES, everolimus-ES, and sirolimus-ES, but not biodegradable polymer biolimus-ES, were associated with significantly reduced odds of myocardial infarction (by 29-34%) compared with paclitaxel-ES. Compared with everolimus-ES, biodegradable polymer biolimus-ES were associated with significantly increased odds of myocardial infarction (by 29%), while Endeavor zotarolimus-ES and paclitaxel-ES were associated with significantly increased odds of stent thrombosis. All investigated DES were similar with regards to efficacy endpoints, except for Endeavor zotarolimus-ES and paclitaxel-ES, which were associated with significantly increased the odds of target lesion and target vessel revascularisations compared with other devices. Direction of results beyond one year did not diverge from the findings for up to one year follow-up. Bayesian probability curves showed a gradient in the magnitude of effect, with everolimus-ES and Resolute zotarolimus-ES offering the highest safety profiles. CONCLUSIONS: The newer durable polymer everolimus-ES and Resolute zotarolimus-ES and the biodegradable polymer biolimus-ES maintain the efficacy of sirolimus-ES; however, for safety endpoints, differences become apparent, with everolimus-ES and Resolute zotarolimus-ES emerging as the safest stents to date.

41 Article Long-term efficacy and safety of Zotarolimus-eluting stent in patients with diabetes mellitus: pooled 5-year results from the ENDEAVOR III and IV trials. 2013

Vardi, Moshe / Burke, David A / Bangalore, Sripal / Pencina, Michael J / Mauri, Laura / Kandzari, David E / Leon, Martin B / Cutlip, Donald E. ·Harvard Clinical Research Institute, Boston, Massachusetts; Cardiology Division, Beth Israel Deaconess Medical Center, Boston, Massachusetts. ·Catheter Cardiovasc Interv · Pubmed #23737390.

ABSTRACT: OBJECTIVE: To assess long-term outcomes of Endeavor Zotarolimus-eluting stent (E-ZES) implantation in patients with diabetes mellitus (DM). BACKGROUND: Patients with DM and coronary artery disease have lower restenosis with drug-eluting stent (DES) compared with bare-metal stents. Recent data suggest that the E-ZES is inferior to other DES in this population. METHODS: Patient-level data for 601 patients with DM from the ENDEAVOR III and ENDEAVOR IV trials were pooled, of which 337 were treated with E-ZES and 264 were treated with other DES. The primary outcome was target vessel failure (TVF) in the course of 5 years. Outcomes are reported as rates using Kaplan-Meier (KM) survival method and differences between E-ZES and other stent types (sirolimus-eluting stent or paclitaxel-eluting stent) were compared using the log-rank statistic. The independent effect of stent type on TVF was assessed using Cox proportional hazards regression. RESULTS: Baseline characteristics were similar between the groups. Five-year TVF KM rate estimate was numerically lower for E-ZES, but the difference did not reach statistical significance (20.2 vs. 26.9%, P = 0.065). The 5-year KM rate estimates of major adverse cardiac events (17.7 vs. 26.6%, P = 0.012), death (7.6 vs. 15.0%, P = 0.004), and myocardial infarction (1.3 vs. 5.1%, P = 0.011) were also lower for E-ZES versus other DES. CONCLUSIONS: Patients with DM implanted with E-ZES have favorable long-term outcomes compared to first-generation DES. Long-term performance of DES should be assessed routinely and may differ from initial performance.

42 Article Clinical outcome of patients with and without diabetes mellitus after percutaneous coronary intervention with the resolute zotarolimus-eluting stent: 2-year results from the prospectively pooled analysis of the international global RESOLUTE program. 2013

Silber, Sigmund / Serruys, Patrick W / Leon, Martin B / Meredith, Ian T / Windecker, Stephan / Neumann, Franz-Josef / Belardi, Jorge / Widimsky, Petr / Massaro, Joe / Novack, Victor / Yeung, Alan C / Saito, Shigeru / Mauri, Laura. ·Heart Center at the Isar, Munich, Germany. sigmund@silber.com ·JACC Cardiovasc Interv · Pubmed #23523454.

ABSTRACT: OBJECTIVES: The aim of this study was to describe the process to obtain Food and Drug Administration (FDA) approval for the expanded indication for treatment with the Resolute zotarolimus-eluting stent (R-ZES) (Medtronic, Inc., Santa Rosa, California) in patients with coronary artery disease and diabetes. BACKGROUND: The R-ZES is the first drug-eluting stent specifically indicated in the United States for percutaneous coronary intervention in patients with diabetes. METHODS: We pooled patient-level data for 5,130 patients from the RESOLUTE Global Clinical Program. A performance goal prospectively determined in conjunction with the FDA was established as a rate of target vessel failure at 12 months of 14.5%. In addition to the FDA pre-specified cohort of less complex patients with diabetes (n = 878), we evaluated outcomes of the R-ZES in all 1,535 patients with diabetes compared with all 3,595 patients without diabetes at 2 years. RESULTS: The 12-month rate of target vessel failure in the pre-specified diabetic cohort was 7.8% (upper 95% confidence interval: 9.51%), significantly lower than the performance goal of 14.5% (p < 0.001). After 2 years, the cumulative incidence of target lesion failure in patients with noninsulin-treated diabetes was comparable to that of patients without diabetes (8.0% vs. 7.1%). The higher risk insulin-treated population demonstrated a significantly higher target lesion failure rate (13.7%). In the whole population, including complex patients, rates of stent thrombosis were not significantly different between patients with and without diabetes (1.2% vs. 0.8%). CONCLUSIONS: The R-ZES is safe and effective in patients with diabetes. Long-term clinical data of patients with noninsulin-treated diabetes are equivalent to patients without diabetes. Patients with insulin-treated diabetes remain a higher risk subset. (The Medtronic RESOLUTE Clinical Trial; NCT00248079; Randomized, Two-arm, Non-inferiority Study Comparing Endeavor-Resolute Stent With Abbot Xience-V Stent [RESOLUTE-AC]; NCT00617084; The Medtronic RESOLUTE US Clinical Trial (R-US); NCT00726453; RESOLUTE International Registry: Evaluation of the Resolute Zotarolimus-Eluting Stent System in a 'Real-World' Patient Population [R-Int]; NCT00752128; RESOLUTE Japan-The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent [RJ]; NCT00927940).

43 Article The "final" 5-year follow-up from the ENDEAVOR IV trial comparing a zotarolimus-eluting stent with a paclitaxel-eluting stent. 2013

Kirtane, Ajay J / Leon, Martin B / Ball, Michael W / Bajwa, Harpaul S / Sketch, Michael H / Coleman, Patrick S / Stoler, Robert C / Papadakos, Stylianos / Cutlip, Donald E / Mauri, Laura / Kandzari, David E / Anonymous5560753. ·Columbia University Medical Center/New York Presbyterian Hospital, New York, New York 10032, USA. akirtane@columbia.edu ·JACC Cardiovasc Interv · Pubmed #23523453.

ABSTRACT: OBJECTIVES: This study sought to report the final 5-year outcomes of the ENDEAVOR IV (A Randomized, Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Taxus Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) trial comparing the Endeavor zotarolimus-eluting stent (E-ZES) (Medtronic, Santa Rosa, California) with the Taxus paclitaxel-eluting stent (PES) (Boston Scientific, Natick, Massachusetts) in patients with single de novo coronary lesions. BACKGROUND: Primary results of the ENDEAVOR IV trial demonstrated similar clinical outcomes with E-ZES and PES. Concerns with regard to late adverse clinical events with drug-eluting stents highlight the need for long-term follow-up with these devices. METHODS: Late outcomes after the use of E-ZES and PES were examined in the multicenter randomized ENDEAVOR IV trial in cumulative and landmark analyses. Assessed outcomes were related to device efficacy and patient safety. RESULTS: At 5 years, clinical data were available for 722 (93.4%) E-ZES patients and 718 (92.6%) PES patients. Overall rates of target lesion revascularization (7.7% vs. 8.6%, p = 0.70) and target vessel failure were similar (17.2% vs. 21.1%, p = 0.061) with E-ZES compared with PES. The incidence of cardiac death or myocardial infarction (MI) was lower with E-ZES (6.4% vs. 9.1%, p = 0.048), primarily driven by a lower rate of target vessel MI with E-ZES (2.6% vs. 6.0%, p = 0.002). Although overall definite/probable stent thrombosis rates were similar between stents (1.3% vs. 2%, p = 0.42), rates of very late stent thrombosis (0.4% vs. 1.8%, p = 0.012) and late MI events (1.3% vs. 3.5%, p = 0.008) were significantly lower with E-ZES compared with PES. CONCLUSIONS: These data demonstrate the durable efficacy and safety of E-ZES compared with PES for the treatment of de novo coronary lesions. Significant improvements in late safety outcomes were observed with E-ZES but should be considered hypothesis-generating, given the limited statistical power of the trial. (The ENDEAVOR IV Clinical Trial: A Trial of a Coronary Stent System in Coronary Artery Lesions; NCT00217269).

44 Article Two-year follow-up of the NEVO ResElution-I(NEVO RES-I) trial: a randomised, multicentre comparison of the NEVO sirolimus-eluting coronary stent with the TAXUS Liberté paclitaxel-eluting stent in de novo native coronary artery lesions. 2013

Abizaid, Alexandre / Ormiston, John A / Fajadet, Jean / Mauri, Laura / Schofer, Joachim / Verheye, Stefan / Dens, Joseph / Thuesen, Leif / Macours, Nathalie / Qureshi, Ayesha C / Spaulding, Christian / Anonymous4480753. ·Institute Dante Pazzanese of Cardiology, Sao Paulo, Brazil. ·EuroIntervention · Pubmed #23518218.

ABSTRACT: AIMS: To assess the two-year clinical follow-up of the NEVO RES-1 study, a randomised comparison between the NEVO™ sirolimus-eluting coronary stent system (NEVO SES) and the TAXUS Liberté™ paclitaxel-eluting stent (TAXUS PES). METHODS AND RESULTS: NEVO RES-I randomised 394 patients with single de novo lesions with a maximum length of 28 mm and diameter of 2.5-3.5 mm to NEVO SES (n=202) versus TAXUS PES (n=192). Six-month angiographic results demonstrated the superiority of the NEVO SES over the TAXUS PES for the primary endpoint, in-stent late loss. At one year, MACE (death, emergent CABG, TLR, and MI) in the NEVO SES group was 6.1% versus 10.6% in the TAXUS PES group (p=0.139). After two years, MACE was 7.2% in the NEVO SES group versus 13.0% in TAXUS PES group (p=0.086). Corresponding rates of TLR were 3.6% versus 7.6% (p=0.116). No ARC-defined definite or probable stent thromboses (ST) were reported with NEVO SES while two occurred with TAXUS PES. CONCLUSIONS: While not designed or powered for clinical endpoints, individual and composite clinical endpoints numerically favoured the NEVO SES over the TAXUS PES, with continued separation over time up to two years. No ARC-defined definite or probable ST was reported in the NEVO SES group at two years. Clinical trial identifier: NCT00606333 http://www.clinicaltrials.gov.

45 Article Nonemergency PCI at hospitals with or without on-site cardiac surgery. 2013

Jacobs, Alice K / Normand, Sharon-Lise T / Massaro, Joseph M / Cutlip, Donald E / Carrozza, Joseph P / Marks, Anthony D / Murphy, Nancy / Romm, Iyah K / Biondolillo, Madeleine / Mauri, Laura / Anonymous3080752. ·Boston University School of Medicine, Cardiovascular Medicine, Department of Medicine, Boston Medical Center, Boston, MA 02118, USA. alice.jacobs@bmc.org ·N Engl J Med · Pubmed #23477625.

ABSTRACT: BACKGROUND: Emergency surgery has become a rare event after percutaneous coronary intervention (PCI). Whether having cardiac-surgery services available on-site is essential for ensuring the best possible outcomes during and after PCI remains uncertain. METHODS: We enrolled patients with indications for nonemergency PCI who presented at hospitals in Massachusetts without on-site cardiac surgery and randomly assigned these patients, in a 3:1 ratio, to undergo PCI at that hospital or at a partner hospital that had cardiac surgery services available. A total of 10 hospitals without on-site cardiac surgery and 7 with on-site cardiac surgery participated. The coprimary end points were the rates of major adverse cardiac events--a composite of death, myocardial infarction, repeat revascularization, or stroke--at 30 days (safety end point) and at 12 months (effectiveness end point). The primary end points were analyzed according to the intention-to-treat principle and were tested with the use of multiplicative noninferiority margins of 1.5 (for safety) and 1.3 (for effectiveness). RESULTS: A total of 3691 patients were randomly assigned to undergo PCI at a hospital without on-site cardiac surgery (2774 patients) or at a hospital with on-site cardiac surgery (917 patients). The rates of major adverse cardiac events were 9.5% in hospitals without on-site cardiac surgery and 9.4% in hospitals with on-site cardiac surgery at 30 days (relative risk, 1.00; 95% one-sided upper confidence limit, 1.22; P<0.001 for noninferiority) and 17.3% and 17.8%, respectively, at 12 months (relative risk, 0.98; 95% one-sided upper confidence limit, 1.13; P<0.001 for noninferiority). The rates of death, myocardial infarction, repeat revascularization, and stroke (the components of the primary end point) did not differ significantly between the groups at either time point. CONCLUSIONS: Nonemergency PCI procedures performed at hospitals in Massachusetts without on-site surgical services were noninferior to procedures performed at hospitals with on-site surgical services with respect to the 30-day and 1-year rates of clinical events. (Funded by the participating hospitals without on-site cardiac surgery; MASS COM ClinicalTrials.gov number, NCT01116882.).

46 Article Repeat revascularization after contemporary percutaneous coronary intervention: an evaluation of staged, target lesion, and other unplanned revascularization procedures during the first year. 2012

Stolker, Joshua M / Cohen, David J / Kennedy, Kevin F / Pencina, Michael J / Lindsey, Jason B / Mauri, Laura / Cutlip, Donald E / Kleiman, Neal S / Anonymous2770740. ·Division of Cardiology, Saint Louis University, MO 63110, USA. jstolker@yahoo.com ·Circ Cardiovasc Interv · Pubmed #23093553.

ABSTRACT: BACKGROUND: Although drug-eluting stents and intensive secondary prevention have contributed to improved outcomes after percutaneous coronary intervention (PCI), repeat revascularization remains relatively common in contemporary practice. We used data from the multicenter Evaluation of Drug-Eluting Stents and Ischemic Events registry to evaluate the relative frequency and timing of staged revascularization, target lesion revascularization (TLR), and other nontarget revascularization during the first year after contemporary PCI. METHODS AND RESULTS: Patients with staged revascularization, TLR, and other unplanned procedures (elsewhere in the target vessel or in other coronary arteries) were evaluated in time-dependent models using Kaplan-Meier life-table estimation. Predictors of TLR and unplanned revascularization at nontarget sites were identified using logistic regression. Between July 2004 to June 2007, 10 144 patients undergoing PCI were enrolled at 55 US hospitals, of whom 86% were treated with at least 1 drug-eluting stent. Twelve percent required repeat revascularization within the first year (3% staged; 9% unplanned). More than 75% of staged revascularizations were performed <30 days after index PCI, although there was significant variation in this practice across hospitals (range, 0%-54%). TLR occurred in 4.5% of patients, with higher hazard rates between 2 to 9 months after PCI, whereas the risk of unplanned non-TLR (4.4% cumulative incidence) was constant over time. CONCLUSIONS: Among unselected patients undergoing PCI in the drug-eluting stent era, the incidence of repeat revascularization at 1 year is ≈12%. Among unplanned procedures, only half are performed for TLR. To achieve further improvements in PCI outcomes, future efforts should concentrate as much on identifying ischemia-producing lesions and intensifying secondary prevention therapies as on the prevention of restenosis.

47 Article Stent thrombosis and major clinical events at 3 years after zotarolimus-eluting or sirolimus-eluting coronary stent implantation: a randomised, multicentre, open-label, controlled trial. 2012

Camenzind, Edoardo / Wijns, William / Mauri, Laura / Kurowski, Volkhard / Parikh, Keyur / Gao, Runlin / Bode, Christoph / Greenwood, John P / Boersma, Eric / Vranckx, Pascal / McFadden, Eugene / Serruys, Patrick W / O'Neil, William W / Jorissen, Brenda / Van Leeuwen, Frank / Steg, Ph Gabriel / Anonymous750736. ·University of Geneva, Switzerland. edoardo@camenzind-cardio.net ·Lancet · Pubmed #22951082.

ABSTRACT: BACKGROUND: We sought to compare the long-term safety of two devices with different antiproliferative properties: the Endeavor zotarolimus-eluting stent (E-ZES; Medtronic, Inc) and the Cypher sirolimus-eluting stent (C-SES; Cordis, Johnson & Johnson) in a broad group of patients and lesions. METHODS: Between May 21, 2007 and Dec 22, 2008, we recruited 8791 patients from 36 recruiting countries to participate in this open-label, multicentre, randomised, superiority trial. Eligible patients were those aged 18 years or older undergoing elective, unplanned, or emergency procedures in native coronary arteries. Patients were randomly assigned to either receive E-ZES and C-SES (ratio 1:1). Randomisation was stratified per centre with varying block sizes of four, six, or eight patients, and concealed with a central telephone-based or web-based allocation service. The primary outcome was definite or probable stent thrombosis at 3 years and was analysed by intention to treat. Patients and investigators were aware of treatment assignment. This trial is registered with ClinicalTrials.gov, number NCT00476957. FINDINGS: PROTECT randomised 8791 patients, of whom 8709 provided consent to participate and were eligible: 4357 were allocated to the E-ZES group and 4352 patients to the C-SES group. At 3 years, rates of definite or probable stent thrombosis did not differ between groups (1·4% for E-ZES [predicted: 1·5%] vs 1·8% [predicted: 2·5%] for C-SES; hazard ratio [HR] 0·81, 95% CI 0·58-1·14, p=0·22). Dual antiplatelet therapy was used in 8402 (96%) patients at discharge, 7456 (88%) at 1 year, 3041 (37%) at 2 years, and 2364 (30%) at 3 years. INTERPRETATION: No evidence of superiority of E-ZES compared with C-SES in definite or probable stent thrombosis rates was noted at 3 years. Time analysis suggests a difference in definite or probable stent thrombosis between groups is emerging over time, and a longer follow-up is therefore needed given the clinical relevance of stent thrombosis. FUNDING: Medtronic, Inc.

48 Article Sources of hospital variation in short-term readmission rates after percutaneous coronary intervention. 2012

Yeh, Robert W / Rosenfield, Kenneth / Zelevinsky, Katya / Mauri, Laura / Sakhuja, Rahul / Shivapour, Daniel M / Lovett, Ann / Weiner, Bonnie H / Jacobs, Alice K / Normand, Sharon-Lise T. ·Cardiology Division, Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, MA 02114, USA. ryeh@partners.org ·Circ Cardiovasc Interv · Pubmed #22438431.

ABSTRACT: BACKGROUND: Risk-standardized all-cause 30-day readmission rates (RSRRs) after percutaneous coronary intervention (PCI) have been endorsed as a national measure of hospital quality. Little is known about variation in the performance of hospitals on this measure, and whether high hospital rates of readmission after PCI are due to modifiable deficiencies in quality of care has not been assessed. METHODS AND RESULTS: We estimated 30-day, all-cause RSRRs for all nonfederal PCI-performing hospitals in Massachusetts, adjusted for clinical and angiographic variables, between 2005 and 2008. We assessed if differences in race, insurance type, and PCI and post-PCI characteristics, including procedural complications and discharge characteristics, could explain variation between hospitals using nested hierarchical logistic regression models. Of 36 060 patients undergoing PCI at 24 hospitals and surviving to discharge, 4469 (12.4%) were readmitted within 30 days of discharge. Hospital RSRRs ranged from 9.5% to 17.9%, with 8 of 24 hospitals being identified as outliers (4 lower than expected and 4 higher than expected). Differences in race, insurance, PCI, and post-PCI factors accounted for 10.4% of the between-hospital variance in RSRRs. CONCLUSIONS: We observed wide variation in hospital 30-day all-cause RSRRs after PCI, most of which could not be explained by identifiable differences in procedural and postprocedural factors. A better understanding of etiologies of hospital variation is necessary to determine whether this measure is an actionable assessment of hospital quality, and, if so, how hospitals might improve their performance.

49 Article Rationale and design of the MASS COMM trial: A randomized trial to compare percutaneous coronary intervention between MASSachusetts hospitals with cardiac surgery on-site and COMMunity hospitals without cardiac surgery on-site. 2011

Mauri, Laura / Normand, Sharon-Lise T / Pencina, Michael / Cutlip, Donald E / Jeon, Cathy / Dreyer, Paul / Kuntz, Richard E / Baim, Donald S / Jacobs, Alice K. ·Division of Cardiovascular Medicine, Department of Medicine, Brigham and Women's Hospital, Boston, MA, USA. lmauri1@partners.org ·Am Heart J · Pubmed #22093197.

ABSTRACT: BACKGROUND: Emergency surgery has become an increasingly rare event after percutaneous coronary intervention (PCI). There have been no randomized trials evaluating whether cardiac surgery services on-site are essential for patient safety and optimal outcomes during and after PCI. STUDY DESIGN: The MASS COMM trial (ClinicalTrials.gov no. NCT01116882) is a randomized trial comparing the safety and effectiveness of nonemergency PCI at hospitals without surgery on-site (SOS) (non-SOS hospitals) and hospitals with SOS (SOS hospitals). A total of 3,690 subjects will be randomized in a 3:1 fashion to undergo PCI at non-SOS and SOS hospitals, with follow-up at hospital discharge, 30 days, and 12 months after PCI. The rate of major adverse cardiac events (all-cause mortality, myocardial infarction, repeat revascularization, and stroke) will serve as the primary safety end point at 30 days and the primary effectiveness end point at 12 months. The design is a 1-way randomized trial with a statistical hypothesis of noninferiority of nonemergency PCI at non-SOS hospitals for both safety and effectiveness end points. CONCLUSIONS: This multicenter, randomized trial will compare the relative safety and effectiveness of nonemergency PCI at sites with and without cardiac SOS.

50 Article Late-term clinical outcomes with zotarolimus- and sirolimus-eluting stents. 5-year follow-up of the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions). 2011

Kandzari, David E / Mauri, Laura / Popma, Jeffrey J / Turco, Mark A / Gurbel, Paul A / Fitzgerald, Peter J / Leon, Martin B. ·Department of Interventional Cardiology and Interventional Cardiology Research, Piedmont Heart Institute, Atlanta, Georgia 30309, USA. david.kandzari@piedmont.org ·JACC Cardiovasc Interv · Pubmed #21596327.

ABSTRACT: OBJECTIVES: This study sought to compare late safety and efficacy outcomes following percutaneous coronary revascularization with zotarolimus-eluting stents (ZES) and sirolimus-eluting stents (SES). BACKGROUND: Despite higher late lumen loss and binary restenosis with ZES compared with SES, it is uncertain whether differences in early angiographic measures translate into more disparate late clinical events. METHODS: Clinical outcomes were prospectively evaluated through 5 years in the ENDEAVOR III (A Randomized Controlled Trial of the Medtronic Endeavor Drug [ABT-578] Eluting Coronary Stent System Versus the Cypher Sirolimus-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions) that randomized 436 patients of relatively low anatomic and clinical risk to treatment with ZES (n = 323) or SES (n = 113) and evaluated a primary endpoint of 8-month angiographic late lumen loss. RESULTS: At 5 years (completeness of follow-up: 95.2%), pre-specified endpoints of all-cause mortality (5.2% vs. 13.0%, p = 0.02), myocardial infarction (1.0% vs. 4.6%, p = 0.03), and the composite event rates of cardiac death/myocardial infarction (1.3% vs. 6.5%, p = 0.009) and major adverse cardiac events (14.0% vs. 22.2%, p = 0.05) were significantly lower among patients treated with ZES. Rates of target lesion (8.1% ZES vs. 6.5% SES, p = 0.68) and target vessel revascularization were similar between treatment groups. Stent thrombosis was infrequent and similar in both groups (0.7% ZES vs. 0.9% SES, p = 1.0). Between 9 months and 5 years, progression of major adverse cardiac events was significantly more common with SES than with ZES (16.7% vs. 7.8%, p = 0.015). CONCLUSIONS: Despite initially higher angiographic late lumen loss, rates of clinical restenosis beyond the protocol-specified angiographic follow-up period remain stable with ZES compared with the rates for SES, resulting in similar late-term efficacy. Over 5 years, significant differences in death, myocardial infarction, and composite endpoints favored treatment with ZES. (The Medtronic Endeavor III Drug Eluting Coronary Stent System Clinical Trial [ENDEAVOR III]; NCT00217256).

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