Randomized Trials and Registries: all smoke and mirrors or clear enlightenment?
|
|
- Garry Hines
- 5 years ago
- Views:
Transcription
1 Randomized Trials and Registries: all smoke and mirrors or clear enlightenment? Laura Mauri, MD, MSc Brigham and Women s Hospital Associate Professor of Medicine, Harvard Medical School ADVANCED CARDIOVASCULAR INTERVENTION 2012
2 Disclosures Research support to Harvard Clinical Research Institute from: Abbott, Boston Scientific Corporation, Cordis Corporation, Medtronic, Inc., Bristol-Myers Squibb/Sanofi-Aventis Pharmaceuticals Partnership, Eli Lilly and Company and Daiichi Sankyo Company Limited Consulting: Abbott, Cordis Corporation, Medtronic
3 The Information Age In Cardiology Journals 2797 Clinical Reports 399 Randomized Trials
4 The Information Age From paper chart review to electronic health records From few labor-intensive studies to simple analysis of large comprehensive databases How does medical knowledge benefit from the availability of data? How do we judge the reliability of these sources particularly when results are contradictory?
5 The Information Age Can this new wealth of data improve medical care? Yes! Observational data fully represent the patients we treat and must be used to compare treatments No! Observational data have misled us time and time again. Randomized trials are the only way to go
6 6 Observational Studies vs Randomized Trials Randomized trials more likely to exclude children, elderly, and women based on inclusion criteria. (Van Spall HG. JAMA. 2007;;297(11): ). Randomized trials, even when large, often exclude patients with the most grave clinical presentations and the highest mortality. Maasland L. Stroke Aug;;40(8): Bahit MC. Am Heart J Jan;;145(1):109-17). Even when inclusion criteria are very broad ( Pragmatic, real world or all-comers trials), randomized trials can exclude ~50% of patients. (De Boer SP. Eur Heart J Sep;;32(17):2161-7).
7 December 2006 Advisory Panel to FDA Day 1: Randomized trials Day 2: Off-label and observational data September 2006
8 Pooled Randomized Trials of DES Target Vessel Failure Stone Stone, et al. NEJM NEJM ;; 356.
9 Pooled Randomized Trials of DES Definite and Probable Stent Thrombosis at 4 years 1.7 % 1.5 % 1.8 % 1.4 % Mauri, L. N Engl J Med 2007;;356:
10 SCAAR Cumulative Risk of Death Death Drug-eluting stent RR: 1.03 ( ) Bare-metal stent RR: 1.32 ( ) No. at Risk Years BMS 12,880 12,473 12,354 12,228 9,298 5,966 3,199 DES 5,770 5,605 5,541 5,471 3, , Lagerqvist B et al. N Engl J Med 2007;;356:
11 Ontario Registry DES vs BMS 5.5% 7.8% Tu J et al. NEJM 2007;;357:
12 Drug-Eluting and Bare Metal Stenting in Massachusetts 2-Year Outcome in Matched Patients Cumulative Incidence 30% 20% 10% 0% 0 Mortality Time after Initial Procedure (days) DES n=5,441 BMS n=5,441 Log Rank P value % 9.4% Days DES 5,441 5,338 5,219 5,123 BMS 5,441 5,279 5,105 4,995 Mauri et al. Circulation 2008 October 28.
13 . N Engl J Med 2008;;359:
14 Horizons Trial: MACE 10 TAXUS DES (n=2257) Safety MACE (%) EXPRESS BMS (n=749) Diff [95%CI] = 0.1% [-2.1, 2.4] HR [95%CI] = 1.02 [0.76, 1.36] P NI =0.01 P Sup = % 8.0% Number at risk TAXUS DES EXPRESS BMS Time in Months * Safety MACE = death, reinfarction, stroke, or stent thrombosis Stone, G. NEJM
15 Percentage standardized differences in clinical and procedural characteristics: DES vs BMS before and after matching on 63 pretreatment variables. Mauri L et al. Circulation 2008;;118: Copyright American Heart Association
16 Observational Studies of DES and BMS Total N DES patients DES (%) Follow up at publication Sweden* % 3y Western Denmark % 15m Ontario % 2y Massachusetts % 2y DESCover % 1y NHLBI NA 96% 1y Emilia Romagna % 100% 2y 16 Mauri L and Normand SL. Circulation. April 23, *Lagerqvist B et al. N Engl J Med 2007;;356:
17 SCAAR Update N= Cumulative risk of death BMS DES RR: 0.95 (0.83, 1.1) Time (years) BMS DES James, S. ESC 2007;; NEJM. May 2009.
18 The Information Age Metaanalysis Nested observational studies Cluster randomization Randomized trial with administrative data collection Instrumental variables
19 19 Observational vs Randomized Studies Randomized trials Every patient has a non-zero probability of receiving either the control or the experimental therapy Eliminate selection bias/ confounding by indication Require patients to satisfy inclusion and exclusion criteria Require patient consent Represent a narrower patient population than an observational study Standards for ensuring validity and minimizing bias: blinding, prospective statistical plan, endpoint definition, single vs multicenter, completeness of follow-up, ascertainment, adjudication
20 20 Observational Studies are Diverse Include any non-randomized study of treatments Include metaanalysis of randomized trial data May represent a broader spectrum of patients with greater generalizability and power Are varied in design (retrospective vs prospective, single center vs multicenter, population-based, unselected vs restricted by inclusion criteria) Also require rigor to ensure validity and minimize bias: (endpoint definition, completeness of follow-up, ascertainment, adjudication)
21 21 Observational Studies are Diverse Varied objectives Descriptive or hypothesis driven Description of treated patient population, of mode of utilization, concurrent treatments Prediction of and monitoring of adverse events Evaluation of treatment effectiveness Evaluation of adverse treatment effects
22 22 Methods to Reduce Selection Bias Regression Propensity Score (Matching simulates what would occur in a randomized trial) Instrumental Variables (a variable that is associated with the treatment of interest, but is not expected to be associated with the outcome apart from its relationship with that treatment. (e.g. time after introduction of DES)
23 23 Observational and RCT of DES What we knew from RCT DES prevent restenosis What we learned from registries - DES are not associated with increased mortality, and are associated with prevention of repeat procedures Still unknown: when is it safe to stop dual antiplatelet therapy before or after one year.
24 Duration of Dual Antiplatelet Therapy after DES There is broad variation in practice regarding actual duration of therapy worldwide, and among physicians Until recently, all data regarding duration of therapy were observational, not randomized
25 Prescription of DAPT after 12 m is highly variable across regions TIMI 38 C R Percent Continuing Thienopyridine Time from Index ACS Bonaca M. ACC 2011
26 Duke Registry: comparison of patients treated with and without clopidogrel beyond 12m 24-Month Events With Without Clopidogrel Clopidogrel Difference (95% CI) P Value Drug-Eluting Stent (DES) Patients (n) Death 2.0% 5.3% -3.3% (-6.3% to -0.3%) 0.03 Death or MI 3.1% 7.2% -4.1% (-7.6% to -0.6%) 0.02 Bare-Metal Stent (BMS) Patients (n) 417 1,976 Death 3.7% 4.5% -0.7% (-2.9% to 1.4%) 0.50 Death or MI 5.5% 6.0% -0.5% (-3.2% to 2.2%) 0.70 *Exclusions: DES group (Death 62, nonfatal MI 18, revasc 76, meds not reported 129 (total 285/1502) BMS group (Death 123, nonfatal MI 94, revasc 289, meds not reported 266 (total 772/3165) Eisenstein EL et al. JAMA. 2007;;297:
27 Comparing Durations of Antiplatelet Therapy Goal is to define the balance of risk of ischemic vs bleeding risk Stent thrombosis is a rare event, that requires data review and adjudication, but has profound clinical significance, not available in most registries The presence of a small confounder could reverse the findings of an observational study on this rare event DAPT Study designed as a pragmatic and inclusive randomized study
28 Study Design Eligible for Enrollment after PCI Any PCI with DES or BMS >18 years of age No contradictions to dual antiplatelet therapy Able and willing to provide written informed consent Eligible for Randomization at 12 m Stratified by DES v BMS, drug type, and complexity (ACS or lesion-based) Not Eligible for Randomization at 12 m Death MI or repeat PCI at > 6 weeks CABG Stroke Major Bleed Total 33 month follow-up 12 m DAPT Arm Aspirin + blinded placebo 30 m DAPT Arm Aspirin + blinded thienopyridine Study treatment period m Study observation period 30-33m Total 33 month follow-up Mauri, Kereiakes et al AHJ 2010;; 160(6): Primary analysis of DES treated subjects, 12-33m Secondary analysis of propensity matched BMS to DES subjects 0-33m 2 co-primary endpoints: stent thrombosis and MACCE (death, myocardial infarction or stroke) Powered safety endpoint: major bleeding (GUSTO) 28
29 Randomized Antiplatelet Rx Duration Trials REAL+ZEST LATE EXCELLENT PRODIGY Inclusion Group, N month event free 1443 Non-STEMI month event free DAPT Duration ~12 vs 24 All DES 6 vs 12 SES or EES 6 vs 24 DES Type 1º Endpoint 2º Endpoint DES and BMS ITALIC vs 12 EES ISAR-SAFE OPTIMIZE month event free 3120 non-stemi DAPT 20, month event free 6 vs 12 All DES 3 vs 12 ZES 12 vs 30 1.DES 2.BMS 2-year cardiac death/mi 1-year cardiac death/mi/tvr 2-year death/mi Presented ARC ACC ST, 2010 bleeding Death/MI/CVA/ Presented ST/major ACC 2011 bleeding Presented ARC ESC ST, 2011 bleeding 1-year death/mi/repeat urgent Enrolling revasc/stroke/majorbleeding Death/MI/stroke/ TIMI major bleed at 15 months 1-year death/mi/ stroke/bleed 1. Death/MI/stroke at 33 months 2. Def/prob ST at 33 months Individual component Enrolling endpoints Enrolling ARC ST Enrollment Major bleeding Complete PES = paclitaxel-eluting stent ZES = zotarolimus-eluting stent SES = siroliumus-eluting stent EES = everolimus-eluting stent
30 REAL-LATE/ZEST-LATE: 2-Year Endpoints 2701 patients with DES from two trials HR, 1.65 ( ) HR, 1.73 ( ) Cardiac death or MI(%) P = DAPT 1.8 ASA Park SJ, et al. N Engl J Med. 2010;;362: Primary Endpoint Number at Risk Baseline 1 year 2 year DAPT ASA Lack of difference not interpretable because of insufficient power and follow-up: <1/4 reached 2y follow up
31 REAL-LATE/ZEST-LATE: Timing of Randomization Characteristic Time to randomization Clopidogrel + Aspirin (n = 1357) Aspirin Alone (n = 1344) P value mo. 18 mo. after procedure 18 mo. 24 mo. after procedure >24 months after procedure Median (interquartile range) ( ) 12.8 ( ) Time of Randomization varied from m post PCI Park SJ, et al. N Engl J Med. 2010;;362:
32 PRODIGY Study: 6 vs 24m DAPT after DES or BMS, randomized at 30 days 2,013 randomly allocated to recieve one of the four study stent types 499 randomized to and received EES 498 randomized to and received PES 500 randomized to and received ZES 502 randomized to and received BMS (1497 DES) 1,970 DES and BMS randomized at 30 days Months DAPT Months DAPT year follow- up year follow- up Valgimigli ESC 2011.
33 Primary Endpoint Overall Death, MI or CVA mo DAPT 6 mo DAPT P=0.91 % 4 Hazard Ratio: 0.98 ( ) No. at Risk 24-Month Clopidogrel Valgimigli 6-Month ESC Clopidogrel
34 Type II, III or V BARC bleeding mo DAPT 6 mo DAPT P= % Hazard Ratio: 0.46 ( ) No. at Risk 24-Month Clopidogrel Valgimigli 6-Month ESC Clopidogrel
35 Bleeding endpoint in PRODIGY Investigators changed bleeding endpoint from TIMI major to Bleeding Academic Research Consortium* (BARC) type II, III, IV before final analysis BARC definitions provide potential for uniform definition across trials and are hierarchical BARC type II includes any bleeding that triggers testing or treatment, even if no change in hemoglobin, blood transfusion or hemodynamic sequelae are present. *Mehran et al. Circulation Jun 14;;123(23):
36 EXCELLENT Trial: Stent Thrombosis (Definite or probable stent thrombosis by ARC definition) Cumulative incidence rate (%) P=0.327 HR = 2.00 (95% CI ) 6-mo DAT 12-mo DAT 0.8% 0.4% Months after initial procedure Patient Number at Risk 6-month month Circulation Jan 24;;125(3): Gwon H-C. ACC 2011
37 EXCELLENT Trial: TIMI Major Bleeding (Overt clinical bleeding with a drop of Hb > 5 g/dl or Hct > 15%) Cumulative incidence rate (%) P=0.419 HR = 0.50 (95% CI ) 6-mo DAT 12-mo DAT 0.6% 0.3% Months after initial procedure Patient Number at Risk 6-month month Circulation Jan 24;;125(3): Gwon H-C. ACC 2011
38 Recent Studies of DAPT Duration in Context Questions continue regarding benefit vs risk of longer thienopyridine therapy on MACCE Recent study results have not been definitive Not powered to determine differences in stent thrombosis Variable treatment durations Not blinded Yet each of these studies highlights the remaining clinical question regarding DAPT: Is there a benefit (stent thrombosis or MACCE prevention) that outweighs the risk (bleeding) or cost
39 NCT United Kingdom Germany Poland Romania France United States Hungary Czech Republic New Zealand Australia Principal Investigators: PI: Laura Mauri, MD, MSc, Brigham and Women s Hospital, Boston, MA, USA Co- PI: Dean Kereiakes, MD, Christ Hospital, Cincinnati, OH, USA National Coordinating Investigators: Anthony Gershlick, MD, University Hospitals of Leicester, United Kingdom Andrzej Hoffman, MD, Wielospecj Szpital Miedjski im.dr. E Warminsigo SPZOZ, Poland Ian Meredith, MD, Monash Cardiovascular Research Centre, Australia John Ormiston, MD, Mercy Angiography, New Zealand Wolfgang Rutsch, MD, Charite Univeitaetsmedizin Berlin, Germany P.Gabriel Steg, MD, Hospital Bichat, France
40 Total Enrollment Complete August July 1, , ,645 Actual Projected Projected
41 Total Subject Enrollment Medtronic EDUCATE Don Cutlip, Harold Dauerman 2274 Cordis CYPRESS Daniel Simon, David Kandzari Boston Scientific Liberte PAS David Lee, Kirk Garratt DES n = 23,212 Abbott Xience V USA James Hermiller, Mitch Krucoff 2998 HCRI DAPT-DES Laura Mauri, Dean Kereiakes HCRI DAPT-BMS Laura Mauri, Dean Kereiakes BMS n = 2,986
42 Patient Characteristics Age DES N=23,212 BMS N=2,986 All Patients N=26,198 Mean ± SD 62.1 ± ± ± 10.7 Sex (Female) 28.2% 25.9% 27.9% Diabetes Mellitus 33.0% 24.0% 32.0% Previous PCI 34.9% 20.4% 33.3% Previous CABG 13.9% 7.6% 13.2%
43 Complexity DES N=23,212 BMS N=2,986 All Patients N=26,198 Any Clinical Complexity Factors 35.2% 66.6% 38.7% Any Anatomic Complexity Factors 32.3% 38.5% 33.0% Complexity (any clinical or anatomic) 53.6% 73.2% 55.8% Clinical Complexity= acute coronary syndrome (including STEMI), renal insufficiency, or EF<30% Anatomic Complexity= 3 vessels stented, in-stent restenosis of DES, prior brachytherapy, unprotected left main, > 2 lesions stented per vessel, lesion length 30m, bifurcation lesion with sidebranch > 2.5mm, vein bypass graft, or thrombuscontaining lesions
44 Thienopyridine DAPT Trial Enrolled Subjects 44 All Subjects N=26,198
45 Stent Type DAPT Trial Enrolled Subjects 45 All Subjects N=26,198 DES Type* Cypher (n=3056) 13.2% DES n = 23,212 BMS n = 2,986 Endeavor (n=3458) TAXUS (n=5216) Xience/ PROMUS (n=11752) 14.9% 22.5% 50.6% *Some patients have received more than one DES type
46 Can observational data be used to compare safety of different DES? SCAAR 2012 BMS old DES new DES <50% 12m followup and <10% 24m follow up for new DES group trend to improved outcomes over time in all groups Sarno et al. EHJ
47 Drug-eluting Stent Components are Varied Metal alloy (stainless steel, cobalt chromium, platinum) Polymer durable (PEVA, PBMA, SIBS, phosphorylcholine), bioerodable (PLGA, PLA) Drug sirolimus, paclitaxel, zotarolimus, everolimus Yet the optimal constituents are not well-understood Materials science, polymer chemistry Pharmaco-kinetics Bench and animal studies not yet closely tied to adverse clinical outcomes (restenosis, stent thrombosis)
48 PROTECT - STUDY DESIGN Prospective, international, multi-center, randomized trial of Zotarolimus-eluting vs Sirolimus-eluting stent Patients: Single and Multiple Coronary Artery Lesions Endeavor Stent N=4400 8,800 patients 200 sites Cypher Stent N=4400 Procedure 30d 6mo 1yr 1½yr 2yrs 2½yr 3yrs 4yrs 5yrs Clinical FU Primary Endpoint: stent thrombosis (ARC definite and probable) at 3y Main Secondary Endpoint: composite endpoint of death or MI at 3y Dual Anti-platelet therapy for 3 months minimum, extended use prespecified according to operator discretion Camnezind, Wins, Mauri AHJ 2009.
49 ENDEAVOR IV Trial 5-Year Final Clinical Results 30% p = 0.06 p = 0.22 p = 0.70 p = 0.69 p = p = 0.75 p = % 21.3% Incidence Rate (%) 20% 15% 10% 17.3% 12.7% 15% 7.8% 8.4% 5% 0% 4.3% 3.8% TVF TVR TLR Cardiac Death Non-Q MI Q-wave MI ARC Stent Thrombosis 2.1% 5.3% 0.6% 0.7% 1.4% 1.9 % Endeavor TM Stent (n = 722) TAXUS Express Stent (n = 718) TVF=Cardiac Death, MI and TVR. Kandzari D TCT 2011.
50 SPIRIT IV Trial 3-Year Clinical Results p=0.02 p=0.06 p=0.02 p=0.31 p=0.03 p= % Incidence Rate (%) 10% 5% 0% 9.2% 11.7% 6.2% 7.8% 3.2% 5.1% 1.4% 1.9% 2.7% 4.0% 0.6% TLF ID TLR All Death Cardiac Death TV MI ARC ST (def/prob) 1.6% XIENCE V ä (PROMUS ä ) Stent (n = 2458) TAXUS Express Stent (n = 1229) *n=patients at risk. Rates (%) are from Kaplan Meier estimates TVF=Cardiac Death, MI, or Ischemia Driven TVR. TLF=Cardiac Death, Target Vessel MI or Ischemia-driven TLR. Stone G. TCT 2011.
51 ARC Stent Thrombosis to 1 year % (n) R-Zotarolimus stent n = 1119 Everolimus stent n = 1126 P Definite ST Acute: (0 1 day) 0.4% (4) 0.1% (1) NS Sub-Acute: (2 30 days) 0.4% (5)* 0.0% (0) 0.03 Late: (31 days 360 days) 0.4% (5)* 0.2% (2) NS All: (0 days 360 days) 1.2% (13) 0.3% (3) 0.01 Definite/Probable ST Acute: (0 1 day) 0.4% (5) 0.2% (2) NS Sub-Acute: (2 30 days) 0.7% (8) * 0.4% (4) NS Late: (31 days 360 days) 0.6% (7)* 0.2% (2) NS All: (0 days 360 days) 1.6% (18) 0.7% (8) NS *One patient had a definite ST at day 4 and 31 One patient had a probable ST on day 0 and a definite ST on day 5 Serruys et al. PCR NEJM 2010.
52 Stent Thrombosis (ARC Definite/Probable) Through 2 Years Cumulative Incidence of ARC def/prob ST 5% 4% 3% 2% 1% 0% R-ZES EES Pooled patient level data, 5 Trials* Adjusted P = Hazard Ratio = % CI (0.66,2.71) % 1.0% Time After Initial Procedure (days) Outcomes remain consistent when adjusted for duration of DAPT Days No. at risk %CI No. at risk % CI Mauri et al. PCR 2011.
53 Stent Thrombosis in Patients With and Without DAPT Interruption Through 2 Years N = 11,219 Xience V pts 3.0 ST through 2 years (%) % N ST events = 58 N at risk = 7,139 Never interrupted DAPT through the 2-year study period (or until a ST event) Unadjusted comparison 0.63% N ST events = 25 N at risk = 4,080 One or more DAPT interruptions through the 2-year study period Gregg W. Stone, MD, TCT 2011.
54 Randomized Antiplatelet Rx Duration Trials REAL+ZEST LATE EXCELLENT PRODIGY Inclusion Group, N month event free 1443 Non-STEMI month event free DAPT Duration ~12 vs 24 All DES 6 vs 12 SES or EES 6 vs 24 DES Type 1º Endpoint 2º Endpoint DES and BMS ITALIC vs 12 EES ISAR-SAFE OPTIMIZE month event free 3120 non-stemi DAPT 20, month event free 6 vs 12 All DES 3 vs 12 ZES 12 vs 30 1.DES 2.BMS 2-year cardiac death/mi 1-year cardiac death/mi/tvr 2-year death/mi ARC ST, bleeding Death/MI/CVA/ ST/major bleeding ARC ST, bleeding 1-year death/mi/repeat urgent revasc/stroke/majorbleeding Death/MI/stroke/ TIMI major bleed at 15 months 1-year death/mi/ stroke/bleed 1. Death/MI/stroke at 33 months 2. Def/prob ST at 33 months Individual component endpoints ARC ST Major bleeding PES = paclitaxel-eluting stent ZES = zotarolimus-eluting stent SES = siroliumus-eluting stent EES = everolimus-eluting stent
55 SYNERGY Stent Abluminal Bioabsorbable Polymer Polymer Mass Remaining (%) Polymer resorption is complete within 4 months Bioabsorbable polymer (PLGA) + Everolimus Applied only to the abluminal surface (rollcoat) Thin strut ( ) PtCr Stent
56 EVOLVE First in Human Trial Late Loss at 6 Months Target Lesion Failure at 6 Months P=0.19* P=0.56* 10 8 Late loss, mm PROMUS Element SYNERGY SYNERGY ½ Dose Patients, % PE SYN SYNERGY ½ PROMUS Element SYNERGY ½ Dose P value for noninferiority <0.001, both comparisons Meredith 2011 TCT
57 EVOLVE Short DAPT Trial All patients treated with SYNERGY Stent (PtCr-PLGA-everolimus) Except subjects requring coumadin or 12 m DAPT Randomized 1:1 4m DAPT 12m DAPT Double-blind, placebo controlled, noninferiority design Endpoints: cardiac death and myocardial infarction;; definite and probable stent thrombosis;; major bleeding Mauri ACI 2011
58 Treatment Strategy: High Impact Cardiovascular Intervention Studies Can we improve coronary intervention Interaction of coronary devices with antiplatelet therapy Extension vs reduction in the need for medications Valvular heart disease intervention Multivessel coronary intervention Comparison to standards of care (medical, surgical)
59 COURAGE Patients with stable angina randomized to Optimal Medical Therapy (OMT) PCI + OMT Survival Free of Death and MI PCI+OMT Hazard Ratio 1.05, 95% CI , P=0.62 OMT Years Criticisms -Not representative of daily practice, angiography after randomization - Low risk population - High level of cross over to PCI - Many non-significant stenoses stented - Many significant stenoses left alone - > 95% BMS, POBA Unrealistic hypothesis reduction of death and MI in stable, low risk patients, already disproven in POBA era
60 FAME II Independent Data Safety Monitoring Board Recommends St. Jude Medical s FAME II Clinical Trial Stop Enrollment Following Positive Interim Analysis Follow-up trial to landmark FAME trial examines benefits of using FFR-guided assessment for stent procedures with optimal medical treatment compared to optimal medical treatment alone ST. PAUL, Minn. Jan. 18, 2012 St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, announced today that an interim analysis of the FAME II trial has found a highly statistically significant reduction in the need for hospital readmission and urgent revascularization when Fractional Flow Reserve (FFR)-guided assessment was used to direct treatment in patients with coronary artery disease. As a result of the positive interim analysis, the FAME II independent Data Safety Monitoring Board (DSMB) has recommended investigators stop patient enrollment in this trial as the DSMB considers it unethical to continue to randomize patients to optimal medical therapy (OMT) alone.
61 Courtesy Bernard Debruyne, FAME 2 PI. FAME II FAME 2 Trial
62 FAME II Courtesy Bernard Debruyne, FAME 2 PI. COURAGE FAME II No/limited Ischemia 71% Ischemia 29% Ischemia 100% Shaw L et al JACC 2010;;55:A /1388 (29%) Multiple vascular territories or 10% ischemia
63 Cumulative Event Rate (%) Repeat Revasc CABG (N=897) SYNTAX Repeat Revascularization at 12 Months CABG Months Serruys PW et al. NEJM 2009;;360(10): PCI PCI 4.7% 11.4% CABG 1.3% 2.8% PCI (N=903) 13.7% P< * 5.9%
64 Cumulative Event Rate (%) p= % 3.5% CABG, PCI Similar Safety Months CABG (N=897) PCI (N=903) 20 p= % 3.2% Death Myocardial Infarction Serruys PW et al. NEJM 2009;;360(10):
65 CABG vs PCI (POBA or BMS) Metaanalysis, N=7812, 10 RCT 5-year event rate (%) CABG PCI p value Death Death or MI Death, MI, or repeat revascularization < Hlatky MA et al. Lancet 2009;; 373:
66 Treatment Strategy Trials How to understand PCI vs CABG for multivessel disease beyond Syntax and observational data favoring CABG Consider change in strategy to FFR-guided PCI Consider change in endpoints repeat revascularization at 1 year not the same as 30d death and MI Consider patient centered outcomes quality of life
67 Conclusions We know what makes a good RCT We need to apply equally rigorous standards to observational data particularly when used to determine treatment effects or safety Observational designs may be complementary, yet fundamental treatment strategy questions continue to require randomized trials to define new paradigms
68 Conclusions Sharing of data from administrative and randomized trial sources will allow medical care to benefit from increasing access to information Powerful studies of treatment strategy may result from collaboration of diverse stakeholders to answer treatment strategy questions
1. Whether the risks of stent thrombosis (ST) and major adverse cardiovascular and cerebrovascular events (MACCE) differ from BMS and DES
1 Comparison of Ischemic and Bleeding Events After Drug- Eluting Stents or Bare Metal Stents in Subjects Receiving Dual Antiplatelet Therapy: Results from the Randomized Dual Antiplatelet Therapy (DAPT)
More informationEXCEL vs. NOBLE: How to Treat Left Main Disease in 2017 AATS International Cardiovascular Symposium December 8-9, 2017
EXCEL vs. NOBLE: How to Treat Left Main Disease in 2017 AATS International Cardiovascular Symposium December 8-9, 2017 Igor F. Palacios, MD Director of Interventional Cardiology Professor of Medicine Massachusetts
More informationNew Generation Drug- Eluting Stent in Korea
New Generation Drug- Eluting Stent in Korea Young-Hak Kim, MD, PhD Department of Cardiology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea Purpose To briefly introduce the
More informationDual Antiplatelet Therapy Beyond One Year After Drug-eluting Coronary Stent Procedures
Dual Antiplatelet Therapy Beyond One Year After Drug-eluting Coronary Stent Procedures Laura Mauri, Dean J. Kereiakes, Robert W. Yeh, Priscilla Driscoll-Shempp, Donald E. Cutlip, P. Gabriel Steg, Sharon-Lise
More informationDrug Eluting Stents Sometimes Fail ESC Stockholm 29 Set 2010 Stent Thrombosis Alaide Chieffo
Drug Eluting Stents Sometimes Fail ESC Stockholm 29 Set 2010 Stent Thrombosis 11.45-12.07 Alaide Chieffo San Raffaele Scientific Institute, Milan, Italy Historical Perspective 25 20 15 10 5 0 Serruys 1991
More informationDavid E. Kandzari, MD Director, Interventional Cardiology Research Scripps Clinic La Jolla, California
38 RCTs 18,000 pts Identifying the Optimal Duration of DAPT Less is More, More or Less David E. Kandzari, MD Director, Interventional Cardiology Research Scripps Clinic La Jolla, California kandzari.david@scrippshealth.org
More informationLeft Main Intervention: Where are we in 2015?
Left Main Intervention: Where are we in 2015? David A. Cox, MD FSCAI Director, Cardiology Research Associate Director, Cardiac Cath Lab Lehigh Valley Health Network Allentown, PA Fall Fellows Course Laa
More informationHCS Working Group Seminars Macedonia Pallas Hotel, Friday 21 st February Drug-eluting stents Are they all equal?
HCS Working Group Seminars Macedonia Pallas Hotel, Friday 21 st February 2014 Drug-eluting stents Are they all equal? Vassilis Spanos Interventional Cardiologist, As. Director 3 rd Cardiology Clinic Euroclinic
More informationMoins de 6 mois d antiagrégants après DES?
Moins de 6 mois d antiagrégants après DES? High Tech - Marseille 25 au 27 janvier 2011 Marie-Claude MORICE, MD, FESC, FACC Massy, France Pas de conflit d interet Was optimal duration of DAPT already established
More informationKomplexe Koronarintervention heute: Von Syntax zu bioresorbierbaren Stents
Komplexe Koronarintervention heute: Von Syntax zu bioresorbierbaren Stents Prof. Dr. med. Julinda Mehilli Medizinische Klinik und Poliklinik I Klinikum der Universität München Campus Großhadern Key Factors
More informationPROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia study
ESC, Hotline III, Paris, August, 30, 2011 PROlonging Dual antiplatelet treatment after Grading stent-induced Intimal hyperplasia study M. Valgimigli, MD, PhD University of Ferrara, ITALY On behalf of the
More informationAssessing Myocardium at Risk: Applying SYNTAX
Assessing Myocardium at Risk: Applying SYNTAX Farouc Jaffer MD PhD FSCAI FACC FAHA Associate Professor of Medicine, Harvard Medical School Director, CAD Program and Chronic Total Occlusion PCI Program
More informationIan T. Meredith AM. MBBS, PhD, FRACP, FCSANZ, FACC, FSCAI, FAPSIC MonashHeart, Monash Medical Centre & Monash University Melbourne, Australia
Final five-year clinical outcomes in the EVOLVE trial: A randomised evaluation of a novel bioabsorbable polymer-coated, everolimus-eluting stent Ian T. Meredith AM MBBS, PhD, FRACP, FCSANZ, FACC, FSCAI,
More informationOptimal Duration and Dose of Antiplatelet Therapy after PCI
Optimal Duration and Dose of Antiplatelet Therapy after PCI Donghoon Choi, MD, PhD Severance Cardiovascular Center Yonsei University College of Medicine Optimal Duration of Antiplatelet Therapy after PCI
More informationMise à Jour sur le traitement du Pluritronculaire Philippe Généreux, MD
Mise à Jour sur le traitement du Pluritronculaire Philippe Généreux, MD Columbia University Medical Center and The Cardiovascular Research Foundation, New York, USA Hôpital du Sacré-Coeur de Montréal,
More informationA Large Prospective Randomized Trial of DES vs BMS in Patients with STEMI
HORIZONS-AMI: A Large Prospective Randomized Trial of DES vs BMS in Patients with STEMI Gregg W. Stone MD Columbia University Medical Center Cardiovascular Research Foundation Disclosures Gregg W. Stone
More informationSKG Congress, 2015 EVOLVE II. Stephan Windecker
SKG Congress, 2015 EVOLVE II Stephan Windecker Department of Cardiology Swiss Cardiovascular Center and Clinical Trials Unit Bern Bern University Hospital, Switzerland BIODEGRADABLE POLYMER DES Stefanini,
More informationInnovation in Cardiovascular Interventions. New DES, Scaffolds and other Devices Have Angioplasty Results Improved
Innovation in Cardiovascular Interventions New DES, Scaffolds and other Devices Have Angioplasty Results Improved Alexandra Lansky, MD Yale University School of Medicine University College of London DES
More informationDiabetic Patients: Current Evidence of Revascularization
Diabetic Patients: Current Evidence of Revascularization Alexandra J. Lansky, MD Yale University School of Medicine University College of London The Problem with Diabetic Patients Endothelial dysfunction
More informationThree-Year Clinical Outcomes with Everolimus-Eluting Bioresorbable Scaffolds: Results from the Randomized ABSORB III Trial Stephen G.
Three-Year Clinical Outcomes with Everolimus-Eluting Bioresorbable Scaffolds: Results from the Randomized ABSORB III Trial Stephen G. Ellis MD Dean J. Kereiakes MD and Gregg W. Stone MD for the ABSORB
More informationBiosensors Lunch Symposium
Are Current DES the Final Answer? BioFreedom TM : the Polymer-Free Biolimus A9TM Coated Stent Biosensors Lunch Symposium 25 th April 2013 Prof. Stephen WL Lee, JP 李偉聯 MD FRCP(Lon. Edin. Glas.) FHKCP FHKAM
More informationResolute in Bifurcation Lesions: Data from the RESOLUTE Clinical Program
Resolute in Bifurcation Lesions: Data from the RESOLUTE Clinical Program Prof. Ran Kornowski, MD, FESC, FACC Director - Division of Interventional Cardiology Rabin Medical Center and Tel Aviv University,
More informationANGIOPLASY SUMMIT 2007 TCT ASIA PACIFIC. Seoul, Korea: April The problem is exaggerated: Data from Real World Registries
ANGIOPLASY SUMMIT 007 TCT ASIA PACIFIC Seoul, Korea: 5-7 7 April 007 15 min Plenary Session: State-of of-the-art Lectures The problem is exaggerated: Data from Real World Registries Antonio Colombo Centro
More informationeluting Stents The SPIRIT Trials
Everolimus-eluting eluting Stents The SPIRIT Trials Gregg W. Stone, MD Columbia University Medical Center Cardiovascular Research Foundation Abbott XIENCE V Everolimus-eluting eluting Stent Everolimus
More informationElement Clinical Program Perseus Late Breaking News and the Platinum Study Design
Element Clinical Program Perseus Late Breaking News and the Platinum Study Design Ian T. Meredith MBBS, BSc(Hons), Ph.D, FRACP, FACC, FCSANZ, FSCAI, FAHA, FAPSIC Professor and Director of Monash HEART
More informationClinical Study Age Differences in Long Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at a Tertiary Medical Center
Aging Research Volume 2013, Article ID 471026, 4 pages http://dx.doi.org/10.1155/2013/471026 Clinical Study Age Differences in Long Term Outcomes of Coronary Patients Treated with Drug Eluting Stents at
More informationTCTAP Upendra Kaul MD,DM,FACC,FSCAI,FAMS,FCSI
Indian TUXEDO Trial In Medically Treated Diabetics Upendra Kaul MD,DM,FACC,FSCAI,FAMS,FCSI Executive Director and Dean Escorts Heart Institute & Medical Research Center and Fortis Hospitals, New Delhi
More informationCOMPARE Trial Elvin Kedhi Maasstad Ziekenhuis Rotterdam The Netherlands
COMPARE Trial Elvin Kedhi Maasstad Ziekenhuis Rotterdam The Netherlands TCTAP 2010 Seoul, Korea Disclosures Research Foundation of the Cardiology Department has received unrestricted research grants from:
More informationΑΓΓΕΙΟΠΛΑΣΤΙΚΗ ΣΤΟ ΔΙΑΒΗΤΙΚΟ ΑΣΘΕΝΗ
ΑΓΓΕΙΟΠΛΑΣΤΙΚΗ ΣΤΟ ΔΙΑΒΗΤΙΚΟ ΑΣΘΕΝΗ Νίκος Μεζίλης MD, FESC Κλινική Άγιος Λουκάς Why diabetes is associated with restenosis endothelial dysfunction metabolic alterations accelerated platelet deposition
More informationClinical Seminar. Which Diabetic Patient is a Candidate for Percutaneous Coronary Intervention - European Perspective
Clinical Seminar Which Diabetic Patient is a Candidate for Percutaneous Coronary Intervention - European Perspective Stephan Windecker Department of Cardiology Swiss Cardiovascular Center and Clinical
More informationStephen G. Ellis, M.D. Professor of Medicine Director Invasive Services Co-Director Cardiac Gene Bank
From ABSORB Cohort A to ABSORB III and IV Randomized Trials Stephen G. Ellis, M.D. Professor of Medicine Director Invasive Services Co-Director Cardiac Gene Bank Disclosures Consultant, Abbott Vascular
More informationPROMUS Element Experience In AMC
Promus Element Luncheon Symposium: PROMUS Element Experience In AMC Jung-Min Ahn, MD. University of Ulsan College of Medicine, Heart Institute, Asan Medical Center, Seoul, Korea PROMUS Element Clinical
More informationSCAAR: Lower late and very late stent thrombosis rates with new generation drug eluting stents compared to bare metal stents
SCAAR: Lower late and very late stent thrombosis rates with new generation drug eluting stents compared to bare metal stents Christoph Varenhorst, Giovanna Sarno, Göran Olivecrona, Per Tornvall, Johan
More informationAntiplatelet Therapy After PCI: How Much and How Long?
Antiplatelet Therapy After PCI: How Much and How Long? Adnan Kastrati Deutsches Herzzentrum, Munich, GERMANY Antiplatelet Therapy after PCI: How much and how long? The simplest and extreme response: Give
More informationBern-Rotterdam Cohort Study
Bern-Rotterdam Cohort Study Newer generation everolimus-eluting stents eliminate the risk of very late stent thrombosis compared with early generation sirolimus-eluting and paclitaxel-eluting stents Lorenz
More informationDisclosures. Theodore A. Bass MD, FSCAI. The following relationships exist related to this presentation. None
SCAI Fellows Course December 10, 2013 Disclosures Theodore A. Bass MD, FSCAI The following relationships exist related to this presentation None Current Controversies on DAPT in PCI Which drug? When to
More informationDUREE de la BITHERAPIE dans les ETUDES LEADERS. J BERLAND Clinique Saint Hilaire ROUEN
DUREE de la BITHERAPIE dans les ETUDES LEADERS J BERLAND Clinique Saint Hilaire ROUEN LEADERS all-comers Trial Design Stable and ACS Patients Undergoing PCI Assessor-blind 1:1 Randomisation N=1700 Patients
More informationFreedom to Treat Your High Bleeding Risk Patients. Tim Kinnaird University Hospital of Wales, Cardiff, UK
Freedom to Treat Your High Bleeding Risk Patients Tim Kinnaird University Hospital of Wales, Cardiff, UK Relevant Disclosures Honoraria for lectures from: o Eli Lilly & Co, Daiichi Sankyo, Boehringer,
More informationPCI for LMCA lesions A Review of latest guidelines and relevant evidence
HCS Working Group Seminars Met Hotel, Thursday 14 th February 2013 PCI for LMCA lesions A Review of latest guidelines and relevant evidence Vassilis Spanos Interventional Cardiologist, As. Director 3 rd
More informationLeft Main Intervention: Will it become standard of care?
Left Main Intervention: Will it become standard of care? David Cox, MD FSCAI, FACC Director, Interventional Cardiology Research Associate Director, Cardiac Cath Lab Lehigh Valley Health Network Allentown,
More informationPCI vs. CABG From BARI to Syntax, Is The Game Over?
PCI vs. CABG From BARI to Syntax, Is The Game Over? Seung-Jung Park, MD, PhD Professor of Medicine, University of Ulsan College of Medicine Asan Medical Center, Seoul, Korea PCI vs CABG Multi-Vessel Disease
More informationStent Thrombosis Importance of Pharmacotherapy
Stent Thrombosis Importance of Pharmacotherapy George D. Dangas, MD, FSCAI Columbia University Medical Center Cardiovascular Research Foundation New York City SCAI-2007 Orlando, FL Presenter Disclosure
More informationTRIAL UPDATE 1. ISAR TRIPLE SECURITY Trial. Dr Deven Patel Royal Free Hospital
TRIAL UPDATE 1 ISAR TRIPLE SECURITY Trial Dr Deven Patel Royal Free Hospital NO CONFLICT OF INTEREST TO DECLARE ISAR TRIPLE Comparison of 6 weeks vs 6 months Triple Therapy in patients on oral anticoagulation
More informationCurrent Status of BioresorbableScaffolds: Moving Forward or Backwards?
Evolving Science of Stents Current Status of BioresorbableScaffolds: Moving Forward or Backwards? Christian W. Hamm Kerckhoff Heart and Thorax Center Bad Nauheim and Medical Clinic I, University of Giessen,
More informationHyeon-Cheol Gwon, On the behalf of SMART-DATE trial investigators ACC LBCT 2018
Six-month versus 12-month or longer dual antiplatelet therapy after percutaneous coronary intervention in patients with acute coronary syndromes (SMART-DATE): a randomized, openlabel, multicenter trial
More informationDAPT in CAD, Acute & Chronic CAD, antiplatelet therapy non-responders
DAPT in CAD, Acute & Chronic CAD, antiplatelet therapy non-responders Annual Ohio ACC Conference October 14, 2017 Ernest L. Mazzaferri Jr, MD, FACC, FSCAI Disclosures No financial disclosures related to
More informationPerspective of LM stenting with Current registry and Randomized Clinical Data
Asian Pacific TCT Perspective of LM stenting with Current registry and Randomized Clinical Data Patrick W. Serruys MD PhD Yoshinobu Onuma MD Seung-Jung Park MD, PhD 14:48-15:00, 2009 Symposium Arena, Level
More informationChristian Spaulding. for the TYPHOON Investigators
Four-Year Follow-Up of the TYPHOON Study, a Multicenter, Randomized, Single-blind Trial To Assess The Use of the CYPHER Sirolimus-eluting Stent (SES) in Acute Myocardial Infarction Patients Treated With
More informationAbbott Vascular. PROTOCOL EXCEL Clinical Trial
Abbott Vascular PROTOCOL Clinical Trial Evaluation of XIENCE PRIME or XIENCE V versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization PCI (1 st gen DES) vs. CABG for Left
More informationNobori Clinical Studies Up-dates. Gian Battista DANZI, M.D. Ospedale Maggiore Policlinico University of Milan, Italy
Nobori Clinical Studies Up-dates Gian Battista DANZI, M.D. Ospedale Maggiore Policlinico University of Milan, Italy Drug Eluting Stents High benefit in preventing restenosis and improving quality of life
More informationTaking DES technology from concept to long term clinical evidence. Aurore Bouvier Global Product Manager Biosensors Europe
Taking DES technology from concept to long term clinical evidence Aurore Bouvier Global Product Manager Biosensors Europe My conflicts of interest are: Full time employee of Biosensors Europe SA BA9 shows
More informationTCT mdbuyline.com Clinical Trial Results Summary
TCT 2012 Clinical Trial Results Summary FAME2 Trial: FFR (fractional flow reserve) guided PCI in all target lesions Patients with significant ischemia, randomized 1:1 Control arm: not hemodynamically significant
More informationWhich drug do you prefer for stable CAD? - P2Y12 inhibitor
Which drug do you prefer for stable CAD? - P2Y12 inhibitor Jung Rae Cho, MD, PhD Cardiovascular Division, Department of Internal Medicine Kangnam Sacred Heart Hospital, Hallym University Medical Center,
More informationDAPT Management 2015 Michael Rinaldi, MD
DAPT Management 2015 Michael Rinaldi, MD The Sanger Heart and Vascular Institute Carolinas HealthCare System Charlotte NC Disclosures Advisory Board: Abbott, BSc Advisory Board: Abbott, BSc Speaker: Abbott,
More informationST-Elevation MI: Update on Bivalirudin and DES
ST-Elevation MI: Update on Bivalirudin and DES George D. Dangas, MD, FACC, FSCAI, FAHA Professor of Medicine Director, Cardiovascular Innovation Mount Sinai Medical Center, New York, NY Disclosure Research
More informationFrom STEMIs to Stents: Updates in PCI practice
From STEMIs to Stents: Updates in PCI practice Arnold Seto, MD, MPA Assistant Clinical Professor, UC-Irvine and Long Beach VA Director of Interventional Cardiology Research Hospitalizations in the U.S.
More informationTwenty years of coronary angioplasty
08/12/2011 Twenty years of coronary angioplasty Michel E. BERTRAND, MD FESC,FRCP (London), FACC, FAHA Lille University Heart Hospital, Lille, France Presenter disclosure information Within the last ten
More informationComparison of Everolimus-Eluting and Paclitaxel- Eluting Coronary Stents in Patients Undergoing Multilesion and Multivessel Intervention
JACC: CARDIOVASCULAR INTERVENTIONS VOL. 3, NO. 12, 2010 2010 BY THE AMERICAN COLLEGE OF CARDIOLOGY FOUNDATION ISSN 1936-8798/$36.00 PUBLISHED BY ELSEVIER INC. DOI: 10.1016/j.jcin.2010.09.014 Comparison
More informationProtocol. This trial protocol has been provided by the authors to give readers additional information about their work.
Protocol This trial protocol has been provided by the authors to give readers additional information about their work. Protocol for: Mauri L, Kereiakes DJ, Yeh RW, et al. Twelve or 30 months of dual antiplatelet
More informationBIOFLOW-III an all comers registry with a Sirolimus Eluting Stent: Presentation of 1-Year TLF Data in patients with complex lesions
BIOFLOW-III an all comers registry with a Sirolimus Eluting Stent: Presentation of 1-Year TLF Data in patients with complex lesions Johannes Waltenberger, MD, F.E.S.C. Uniklinik Münster Münster, Germany
More informationBernard Chevalier Institut Jacques Cartier, Massy, France. Patrick W. Serruys Imperial College, London, UK Erasmus University MC, Netherlands
The 4-year Clinical Outcomes of the ABSORB II Trial: First Randomized Comparison between the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold and the Everolimus Eluting Stent Bernard Chevalier
More informationBIOFLOW V Comparison of UltraThin Sirolimus-Eluting Bioresorbable Polymer with Thin Everolimus- Eluting Durable Polymer Stents
Comparison of UltraThin Sirolimus-Eluting Bioresorbable Polymer with Thin Everolimus- Eluting Durable Polymer Stents David E Kandzari, MD; Laura Mauri, MD, MSc; Jacques Koolen, MD, PhD; Joseph M Massaro,
More informationDES in Diabetic Patients
DES in Diabetic Patients Charles Chan, M.D., FACC Gleneagles Hospital Singapore TCT ASIA PACIFIC 2007 Why do diabetics have worse outcome after PCI? More extensive atherosclerosis and diffuse disease Increase
More informationDisclosures. Dr. Scirica has also served as a consultant for Lexicon, Arena, Gilead, and Eisai.
Disclosures Benjamin M. Scirica, MD, MPH, is employed by the TIMI Study Group, which has received research grants from Abbott, AstraZeneca, Amgen, Bayer HealthCare Pharmaceuticals, Bristol-Myers Squibb,
More informationΔιάρκεια διπλής αντιαιμοπεταλιακής αγωγής. Νικόλαος Γ.Πατσουράκος Καρδιολόγος, Επιμελητής Α ΕΣΥ Τζάνειο Γενικό Νοσοκομείο Πειραιά
Διάρκεια διπλής αντιαιμοπεταλιακής αγωγής Νικόλαος Γ.Πατσουράκος Καρδιολόγος, Επιμελητής Α ΕΣΥ Τζάνειο Γενικό Νοσοκομείο Πειραιά International ACS guidelines: Recommendations on duration of dual
More informationClinical Study Everolimus-Eluting versus Paclitaxel-Eluting Stents in Percutaneous Coronary Intervention: Meta-Analysis of Randomized Trials
Thrombosis Volume 2012, Article ID 126369, 8 pages doi:10.1155/2012/126369 Clinical Study Everolimus-Eluting versus Paclitaxel-Eluting Stents in Percutaneous Coronary Intervention: Meta-Analysis of Randomized
More informationThe Interventional Trials of the Year: (TCT, AHA, and ACC)
The Interventional Trials of the Year: 2006-2007 2007 (TCT, AHA, and ACC) Roxana Mehran, MD Associate Professor of Medicine Columbia University Medical Center Cardiovascular Research Foundation New York
More informationColumbia University Medical Center Cardiovascular Research Foundation
STEMI and NSTEMI Pharmacology Confusion: How to Choose and Use Antithrombins (Unfractionated and Low Molecular Heparins, Bivalirudin, Fondaparinux) and Antiplatelet Agents (Aspirin, Clopidogrel and Prasugrel)
More informationCoronary drug-eluting stents (DES) were first approved
Thrombosis in Coronary Drug-Eluting Stents Report From the Meeting of the Circulatory System Medical Devices Advisory Panel of the Food and Drug Administration Center for Devices and Radiologic Health,
More informationControversies in Cardiac Surgery
Controversies in Cardiac Surgery 3 years after SYNTAX : Percutaneous Coronary Intervention for Multivessel / Left main stem Coronary artery disease Pro ESC Congress 2010, 28 August 1 September Stockholm
More informationAbsorbable Scaffolds the Future of Coronary Interventions?
Absorbable Scaffolds the Future of Coronary Interventions? Brock Cookman, DO, MSA Interventional Cardiology Mercy Heart and Vascular Institute April 8, 2017 None Disclosures Objectives History of cardiac
More informationClinical and Economic Value of Rivaroxaban in Coronary Artery Disease
CHRISTOPHER B. GRANGER, MD Professor of Medicine Division of Cardiology, Department of Medicine; Director, Cardiac Care Unit Duke University Medical Center, Durham, NC Clinical and Economic Value of Rivaroxaban
More informationLeft Main Disease: what is left to surgery? Prof. Jacques Monségu CardioVascular Institute Grenoble, France
Left Main Disease: what is left to surgery? Prof. Jacques Monségu CardioVascular Institute Grenoble, France Background on LM stenosis 5% of patients undergoing angiography Of the myocardium 80% Bifurcation
More informationSafety of Drug-Eluting Stents in Acute Coronary Syndromes
Rotterdam, June 11 th 2012 Safety of Drug-Eluting Stents in Acute Coronary Syndromes Stephan Windecker Department of Cardiology Swiss Cardiovascular Center and Clinical Trials Unit Bern Bern University
More informationBivalirudin Clinical Trials Update Evidence and Future Perspectives
Bivalirudin Clinical Trials Update Evidence and Future Perspectives Andreas Baumbach Consultant Cardiologist/ hon. Reader in Cardiology Bristol Heart Institute University Hospitals Bristol MY CONFLICTS
More informationUnprotected Left Main Stenting: Patient Selection and Recent Experience. Alaide Chieffo. S. Raffaele Hospital, Milan, Italy
Unprotected Left Main Stenting: Patient Selection and Recent Experience Alaide Chieffo S. Raffaele Hospital, Milan, Italy Class IIa (Level B) AHA/ACC 2005 Guidelines Left Main CAD The use of PCI for pts
More informationBIOFREEDOM: Polymer free Biolimus A9 eluting
TCTAP 2011 Seoul, April 27 29, 2011 BIOFREEDOM: Polymer free Biolimus A9 eluting Stents and Paclitaxel eluting stents Eberhard Grube MD, FACC, FSCAI Hospital Oswaldo Cruz - Dante Pazzanese, São Paulo,
More informationDECLARATION OF CONFLICT OF INTEREST. Lecture fees: AstraZeneca, Ely Lilly, Merck.
DECLARATION OF CONFLICT OF INTEREST Lecture fees: AstraZeneca, Ely Lilly, Merck. Risk of stopping dual therapy. S D Kristensen, FESC Aarhus Denmark Acute coronary syndrome: coronary thrombus Platelets
More informationHow to approach non-infarct related artery disease in patients with STEMI in a limited resource setting
How to approach non-infarct related artery disease in patients with STEMI in a limited resource setting Ahmed A A Suliman, MBBS, FACP, FESC Associate Professor, University of Khartoum Interventional Cardiologist,
More information2-Year Follow-Up of a Randomized Controlled Trial of Everolimus- and Paclitaxel-Eluting Stents for Coronary Revascularization in Daily Practice
Journal of the American College of Cardiology Vol. 58, No. 1, 2011 2011 by the American College of Cardiology Foundation ISSN 0735-1097/$36.00 Published by Elsevier Inc. doi:10.1016/j.jacc.2011.02.023
More informationUpdated and Guideline Based Treatment of Patients with STEMI
Updated and Guideline Based Treatment of Patients with STEMI Eli I. Lev, MD Director, Cardiac Catheterization Laboratory Hasharon Hospital, Rabin Medical Center Associate Professor of Cardiology Tel-Aviv
More informationPTCA 1979: : I
The SYNTAX Message is Clear: CABG is Preferred in Complex MVD Angioplasty Summit TCTAP 2012 Seoul, Korea April 2012 David R. Holmes, MD Mayo Clinic Rochester, MN Presenter Disclosure Information David
More informationBernard Chevalier Institut Jacques Cartier, Massy, France. Patrick W. Serruys Imperial College, London, UK Erasmus University MC, Netherlands
The 4-year Clinical Outcomes of the ABSORB II Trial: First Randomized Comparison between the Absorb Everolimus Eluting Bioresorbable Vascular Scaffold and the XIENCE Everolimus Eluting Stent Bernard Chevalier
More informationEXAMINATION trial. Manel Sabaté Hospital Clínic, Barcelona (On behalf of the Examination Investigators)
Manel Sabaté Hospital Clínic, Barcelona (On behalf of the Examination Investigators) Disclosures Investigator Initiated Trial: NCT00828087. Unrestricted grant from Abbott to the Spanish Heart Foundation.
More informationTLR des Stents Actifs
TLR des Stents Actifs No Conflict of Interest Target Lesion Revascularization DES vs BMS Stettler C et al. Lancet 2007;370:937-48 N=18,023 58% 70% SES vs BMS: HR=0.30 (0.24-0.37), p
More informationSurgery Grand Rounds
Surgery Grand Rounds Coronary Artery Bypass Grafting versus Coronary Artery Stenting Charles Ted Lord, R1 Coronary Artery Disease Stenosis of epicardial vessels Metabolic & hematologic Statistics 500,000
More information2-year outcome of the 3-arm BIO-RESORT randomized trial in all-comer patients treated with contemporary DES
2-year outcome of the 3-arm BIO-RESORT randomized trial in all-comer patients treated with contemporary DES Marlies M. Kok, MD Thoraxcentrum Twente, MST, Enschede, the Netherlands On behalf of the BIO-RESORT
More informationMichael Mack, M.D. Baylor Healthcare System Heart Hospital Baylor Plano Dallas, TX
Michael Mack, M.D. Baylor Healthcare System Heart Hospital Baylor Plano Dallas, TX Maquet, Inc.,- unpaid consultant Cordis, Inc.,- unpaid consultant Boston Scientific, Inc.,- travel expenses paid for Syntax
More informationSecond Generation Drug Eluting Stents: From Inhibition to Healing
Second Generation Drug Eluting Stents: From Inhibition to Healing Mitchell W. Krucoff MD, FACC Professor of Medicine / Cardiology Duke University Medical Center Director, Cardiovascular Devices Unit Duke
More informationThe Case for PCI as the Preferred Therapy in Most Patients with Chronic Stable Angina
The Case for PCI as the Preferred Therapy in Most Patients with Chronic Stable Angina Ajay J. Kirtane,, MD Columbia University Medical Center The Cardiovascular Research Foundation Conflict of Interest
More informationThe MAIN-COMPARE Study
Long-Term Outcomes of Coronary Stent Implantation versus Bypass Surgery for the Treatment of Unprotected Left Main Coronary Artery Disease Revascularization for Unprotected Left MAIN Coronary Artery Stenosis:
More informationBéla MERKELY MD, PhD, DSc, FESC. Stent thrombosis: patophysiology, predisposing factors, definition, classification, prevention and treatment
Semmelweis University Heart Center Budapest, Hungary Béla MERKELY MD, PhD, DSc, FESC Stent thrombosis: patophysiology, predisposing factors, definition, classification, prevention and treatment 10th Interventional
More informationWhat oral antiplatelet therapy would you choose? a) ASA alone b) ASA + Clopidogrel c) ASA + Prasugrel d) ASA + Ticagrelor
76 year old female Prior Hypertension, Hyperlipidemia, Smoking On Hydrochlorothiazide, Atorvastatin New onset chest discomfort; 2 episodes in past 24 hours Heart rate 122/min; BP 170/92 mm Hg, Killip Class
More informationCoronary Stent Choice in Patients With Diabetes Mellitus
Rome Cardiology Forum 2014 Coronary Stent Choice in Patients With Diabetes Mellitus Stephan Windecker Department of Cardiology Swiss Cardiovascular Center and Clinical Trials Unit Bern Bern University
More informationUtilities and Pitfalls of Composite and Surrogate Endpoints in Clinical Trials. Cardiovascular Research Foundation Columbia University Medical Center
Utilities and Pitfalls of Composite and Surrogate Endpoints in Clinical Trials Helen Parise,, ScD Cardiovascular Research Foundation Columbia University Medical Center Common CV Clinical Endpoints Death
More informationUltimaster clinical results in left main and bifurcations
Left main and complex bifurcation stenting clinical results in left main and bifurcations GENNARO SARDELLA MD, FACC,FESC O.U. of Interventional Cardiology Dept. of Cardiovascular and Pulmonary Sciences
More informationMINERVA MEDICA COPYRIGHT. Aspirin is accepted as standard antiplatelet. Dual antiplatelet therapy for primary and secondary prevention
This document is protected by international copyright laws. No additional reproduction is authorized. It is permitted for personal use to download and save only one file and print only one copy of this
More informationUnprotected LM intervention
Unprotected LM intervention Guideline for COMBAT Seung-Jung Park, MD, PhD Professor of Internal Medicine, Seoul, Korea Current Recommendation for unprotected LMCA Stenosis Class IIb C in ESC guideline
More informationBenefit of Performing PCI Based on FFR
Benefit of Performing PCI Based on FFR William F. Fearon, MD Associate Professor Director, Interventional Cardiology Stanford University Medical Center Benefit of FFR-Guided PCI FFR-Guided PCI vs. Angiography-Guided
More informationRazionale ed evidenze scientifiche di Doppia Antiaggregazione Piastrinica a lungo termine nel Paziente con Sindrome Coronarica Acuta
Razionale ed evidenze scientifiche di Doppia Antiaggregazione Piastrinica a lungo termine nel Paziente con Sindrome Coronarica Acuta Giuseppe Musumeci SC Cardiologia Ospedale Santa Croce e Carle Cuneo
More information