The Detrimental Impact of Chronic Renal Insufficiency

The Detrimental Impact of Chronic Renal Insufficiency

Management of ST-segment Elevation Myocardial Infarction Gregg W. Stone, MD Columbia University Medical Center The Cardiovascular Research Foundation TERMS OF USE This site has been developed solely for use by members and authorized guests of the Society for Cardiovascular Angiography and Interventions (SCAI), henceforth referred to as "the users." The users are authorized to view, copy, download and print materials from this website subject to the following terms, conditions and exceptions: 1. The materials are to be used solely for noncommercial educational purposes directed toward students ("fellows") in interventional cardiology training programs accredited by the Accreditation Council for Graduate Medical Education (ACGME) or physicians preparing to take the examination for the ABIM Certification in Interventional Cardiology. Any other use is expressly prohibited. 2. The materials are not to be reproduced or included in any way in any textbooks, journals, other enduring materials, presentations (other than described in item #1 above) without the prior written permission of the authors. 3. The materials are not to be modified. They are to be used for instructional or self-study purposes in the format provided with the source clearly identified. 4. The materials are to be used free of charge. Neither the users nor SCAI shall charge a fee for use of these materials. 5. The materials remain the sole intellectual property of the individual contributors, who retain copyright to those materials and have granted SCAI a license to post them on this website for the purposes described in item #1. 6. Copyright information or other proprietary notices on the materials or elsewhere on this website may not be removed, changed, or altered in any way. 7. The site design, layout and individual elements are not to be reproduced, copied or redistributed except as indicated above in item #1 above. The information on this site should not be used as a substitute for medical evaluation, advice, and/or treatment by a qualified healthcare provider. The materials are not intended for public or patient education, but rather for education of fellows in training programs as described in item #1 above. Information in text files, slides, graphs or articles on this website do not replace consultations with qualified healthcare professionals to meet medical needs. If you are not a health care provider, you should not use this site. We encourage you instead to consult a healthcare professional. The authors, contributors and editorial staff have made every effort to contact holders of copyright to obtain permission to reproduce copyright material. However, if any permissions have been inadvertently overlooked, SCAI will be pleased to make the necessary and reasonable arrangements. If you wish to use the presentation for any purpose other than that outline above, please contact SCAI at [email protected]

23 Randomized Trials of PCI vs. Lysis N = 7,739 12% Lysis Event rate 10% 8% PCI 9.3% 7.0% 6% 7.4% 6.8% 5.3% 4% 2.5% 2% 0% p=0.0002 p=0.0003 p<0.0001 Death

Death (excl shock) Reinfarction Keeley, Grines. Lancet 2003;361:13-20 23 Randomized Trials of PCI vs. Lysis N = 7,739 3% Lysis PCI Event rate 2.2% 2% 1% 0% p=0.0002 1.1% P<0.0001 1.0% 0.08% Hemorrhagic stroke Total stroke Keeley, Grines. Lancet 2003;361:13-20

Hosp. Mortality 1994-1998 in Reperfused AMI 2 German AMI registries pooled: Maximal Individual Therapy in AMI (MITRA) and Myocardial Infarction Registry (MIR) 54 and 217 hospitals, respectively (w/o overlap) Rx of 10,118 lytic eligible pts with AMI <12 Thrombolysis 86.3% Primary PTCA 13.7% Zahn R et al. JACC 2000;36:2064-71 Adjusted mortality odds ratios with 95% CI ALL age<75 years age75 years male female posterior MI anterior MI resuscitation no resuscitation no cardiogenic shock cardiogenic shock no heart failure on ad. heart failure on ad. no prior MI prior MI no diagnostic ECG diagnostic ECG 0

0.2 0.4 0.6 0.8 primary angioplasty better Zahn, et al. JACC 2001;37:1827-35 1 1.2 1.4 thrombolysis better 1.6 PTCA vs. Lysis: Absolute risk reduction (%) 35 30 25 20 15 10 r=0.082, P<0.0001 5 0

0 10 Zahn, et al. JACC 2001;37:1827-35 20 30 Mortality (%) 40 50 60 SHOCK Trial 302 pts with cardiogenic shock within 36 of AMI & ST/new LBBB randomized to emergency revasc. (n=152) or initial medical care (n=150) Medical stabilization Emergency revascularization Mortality (%) 80 60 56 70

63 47 50 55 40 20 p=NS P<0.05 P<0.05 30 days 6 months 12 months 0 Hochman J et al. NEJM The STOPAMI Trials STOPAMI-I: 140 pts with AMI rand. to acc t-PA v. stent/abcx STOPAMI-II: 162 AMI pts rand. to acc t-PA/abcx v. stent/abcx Myocardial salvage (% LV myocardium) t-PA +- Abcx

Stent/Abcx 100% 80% P<0.001 60% 57% 60% 40% P=0.001 41% 26% 20% Schomig A et al. NEJM and Lancet 0% STOPAMI-I STOPAMI-2 CADILLAC: Enrollment AMI <12 hours, any age, cardiogenic shock excluded n=2,681 at 76 centers in N.A., S.A. and Europe Angiography

Ye s ? met angiographic criteria No n=2,082 (78%) Registry (n=599) PTCA - 127 (5%) Stent - 142 (5%) CABG - 140 (5%) Med Rx - 190 (7%) Randomized: 89% of all PCI 94% of all stent Randomize Primary PTCA (n=518) Primary PTCA + Abciximab (n=528) Stone GW et al. NEJM 2002;346:957-66 MultiLink stent (n=512) MultiLink stent + Abciximab

(n=524) CADILLAC: TIMI Flows TIMI 3 TIMI 2 TIMI 0/1 100% 80% 96.1% 96.9% 94.7% 94.5% 60% 40% 20% P=NS 0% P P/A Stone GW et al. NEJM 2002;346:957-66 S S/A

- P P/A S S/A CADILLAC: 30-Day MACE PTCA, no abciximab PTCA, abciximab Stent, no abciximab Stent, abciximab 10% 8.3% 8% 5.7% 4.8% 4.4% 6% 4% 2% P=0.02

0% 0 5 10 15 Days to event Stone GW et al. NEJM 2002;346:957-66 20 25 30 CADILLAC: Subacute Thrombosis - 30 days 5% P=0.01 4% P=0.05 3% 2% P=0.03 1.9% 0.8%

1% 1.0% 0.0% 0% PTCA PTCA + Abciximab Stone GW et al. NEJM 2002;346:957-66 Stent Stent + Abciximab CADILLAC: 12 Month MACE PTCA, no abciximab PTCA, abciximab Stent, no abciximab Stent, abciximab 25% 22.4% 20.6% 20% 15%

14.5% 13.3% 10% 5% P<0.000001 0% 0 2 4 6 Months to event Stone GW et al. NEJM 2002;346:957-66 8 10 12 CADILLAC: 12 Month Ischemic TVR PTCA, no abciximab PTCA, abciximab Stent, no abciximab Stent, abciximab

20% 17.6% 17.4% 15% 11.0% 10% 7.2% 5% P<0.000001 0% 0 2 4 6 Months to event Stone GW et al. NEJM 2002;346:957-66 8 10 12 CADILLAC: Angiographic Restenosis PTCA

PTCA + Abciximab Stent Stent + Abciximab 60% 50% 40% 40.8% vs. 22.2% P<0.0001 44.8% 36.5% 11.3% vs. 5.7%, P=0.01 30% 23.7% 20% 20.8% 12.2% 10.4% 10% 6.5% 0% Restenosis Stone GW et al. NEJM 2002;346:957-66

Reocclusion 5.2% CADILLAC: Myocardial Recovery LVEF (median) 100% Baseline 7 months P = NS` Infarct zone RWM (st.d./chord) 0.0 PTCA PTCA + Abcx Stent + Abcx Stent 75% 61.9% 59.4% 59.3% 60.5% 58.8% 58.1% 56.8%

56.4% -0.5 50% -1.0 25% -1.5 0% -0.77 -0.80 -1.27 -1.21 Baseline PTCA PTCA + Abcx Stent Stone GW et al. NEJM 2002;346:957-66 Stent + Abcx 7 months

-2.0 -0.86 -1.26 -0.85 -1.24 P = NS Stent PAMI: 6 Month Quality of Life Stent PTCA N Seattle Angina Questionnaire Angina frequency Disease perception Angina stability Treatment satisfaction SF-36 Pain Vitality p 232 231 93.1 78.1 82.6 86.0 87.4 71.3

75.3 82.7 0.0005 0.003 0.008 0.02 80.8 63.2 74.0 58.6 0.003 0.03 Abciximab in Primary PCI 3,666 pts with AMI within 12 undergoing primary PTCA or stenting randomized to abciximab vs. placebo or control (RAPPORT [n=483], ISAR-2 [401], ADMIRAL [300], CADILLAC [2,082]), ACE [400] 30-day events (%) No abciximab 8% p=NS OR 0.73 [0.45,1.15] Abciximab p=NS OR 0.58 [0.30,1.16]

6% 4% 2% P<0.01 OR 0.46 [0.28,0.68] 4.6% 3.0% 2.2% 1.9% 1.1% 2.1% 0% Death Reinfarction U/I TVR Abciximab in Primary PCI 3,666 pts with AMI within 12 undergoing primary PTCA or stenting randomized to abciximab vs. placebo or control (RAPPORT [n=483], ISAR-2 [401], ADMIRAL [300], CADILLAC [2,082]), ACE [400] 30-day adverse events (%) No abciximab 10%

8% p=0.02 OR 1.67 [1.10,2.58] Abciximab p=0.03 OR 1.49 [1.09,2.27] 6.1% 6% 4% 2% 2.0% 3.2% p=NS 4.1% 0.5% 1.1% 0% 0.06% 0% Major bleed ICB P=NS

OR 2.13 [0.78,5.76] Transfusion Plat <50k Abciximab in Primary PCI 3,666 pts with AMI within 12 undergoing primary PTCA or stenting randomized to abciximab vs. placebo or control (RAPPORT [n=483], ISAR-2 [401], ADMIRAL [300], CADILLAC [2,082]), ACE [400] No abciximab 6-month events (%) 20% p=NS OR 0.78 [0.52,1.11] Abciximab p=NS OR 0.88 [0.60,1.32] P=NS OR 0.94 [0.78,1.16] 13.8% 12.7% 15% 10% 5% 4.9% 3.8%

3.1% 2.7% Death Reinfarction 0% Late TVR Effect of Post PCI Epicardial TIMI flow N = 2,507 pts in PAMI-1, PAMI-2, PAMI Stent Pilot and PAMI Stent Randomized Survival (%) 100% 6 Month Mortality 2.8% 7.5% 92.5% 6.0% 90% 80% 1.5% 70% TIMI 3

TIMI 2 TIMI 0/1 60% 22.2% log-rank p for trend = 0.0003 50% 0 1 2 3 Months 4 5 6 CADILLAC: Impact of ST Segment Resolution Summed ST segment resolution in 700 patients 75% 12% 50%

28% 25% 10% 0% 30 Day Mortality Incidence 62% P<0.01 9% 8.5% 6% 3.1% 3% 1.6% 0% Complete Partial (>70% ) (30% -70% ) McGlaughlin M et al. JACC 2004 in press None (<30% )

Complete Partial (>70% ) (30% -70% ) None (<30% ) CADILLAC: Impact of ST Segment Resolution Summed ST segment resolution in 700 patients 75% 66% 63% 57% Incidence PTCA PTCA+Abcx Stent Stent+Abcx 67% P=NS 50% 29% 25% 21%

33% 23% 13% 8% 10% 10% 0% Complete (>70%) McGlaughlin M et al. JACC 2004 in press Partial (30%-70%) None (<30%) Impact of Macroscopic Distal Emboli DE occurred in 27 of 178 (15%) pts after primary PTCA PLCX filling defect at primary PCI site Distal thromboemboli Henriques JPS et al. EHJ 2002;23:1112-7 Impact of Macroscopic Distal Emboli DE no DE p value

Anterior MI 63% 36% 0.01 Blush 0/1 68% 7% <0.001 9% 60% <0.001 1612 847 <0.05 Pre-d/c LVEF (%) 42 + 14 51 + 9

<0.01 5-year mortality 44% 9% <0.001 Complete ST res. LDH Q72 Multivariate analysis: DE was an independent predictor of 5-year mortality (OR [95% CI] = 8.6 [3.7, 20.1]) Henriques JPS et al. EHJ 2002;23:1112-7 Microvascular Obstruction Morphology & Histology of Emboli Embolic particles may consist of a variety of substances: Thrombotic Material Platelets, Fresh Thrombus, Organized Clot Atherosclerotic Plaque Components Cholesterol Crystals, Foam Cells, Necrotic Core

Vasoactive Constituents Serotonin, ADP, Thromboxane A2 Mechanical Approaches to Thrombus Thrombectomy - Transluminal extraction catheter (IVT) - AngioJet (Possis) - X-Sizer (EndiCOR), etc. Thromboablation - Laser (holmium, excimer) - Hot balloon - Ultrasound thrombolysis (Acolysis, etc.) Distal protection - GuardWire, FilterWire, AngioGuard, EmboShield, etc. Survival Benefit by Time to Treatment with Lytics FTT Lives Saved (35d) per 1000 Treated Group (9 Randomized Lytic Trials) 40 35 30 (N = 58,600) 25 19 20

16 10 0 5 0-2 Lancet 1994;343:311 2-4 4-6 6-12 Total time to Needle (hrs) 12-24 Mortality by Time to Reperfusion with Primary Cannon C et al. PTCA JAMA 2000; 283:2941 Multivariate Adjusted Odds Ratio In-hospital Mortality NRMI-2 Registry (N=27,080) 1.6 1.4 1.2 1

0.8 0.6 1.00 0.99 1.17 1.13 1.19 1.07 <2 2-3 3-4 4-6 6-12 >12 Time to Reperfusion (hrs) Odds Ratio NRMI-2 Primary PCI (n=27,080): Door to Balloon Times vs. Mortality Mortality (%)

10 8 N=27,080 P < 0.00001 8.5 6 4 7.9 6.7 4.2 4.6 0-60 61-90 5.1 2 0 Cannon C et al. JAMA 2000; 283:2941 91-120 121-150 151-180

Door-to-Balloon Time (minutes) >180 NRMI-2 Primary PCI MV adjusted odds of death N=27,080 P=NS 2.2 P=NS 1.8 P=0.01 P=0.0007 P=0.0003 1.62 1.61 1.41 1.4 1.14 1.15

1 0.6 0.2 N=2,230 5,734 0-60 61-90 Cannon C et al. JAMA 2000; 283:2941 6,616 4,461 2,627 91-120 121-150 151-180 Door-to-Balloon Time (minutes) 5,412 >180 CADILLAC: Door-to-Balloon Time and One Year Mortality Stratified by Time to Presentation N=2,082 One Year Mortality %

6 5 5.1 p = 0.12 3.9 4 DB Time <1.5 hrs 4.8 p = NS 3 2 1.9 1 0 < 2 hrs >2 hrs Time To Presentation DB Time >1.5 hrs Why is primary PCI less time dependent than thrombolysis?

1) Thrombolysis is less effective at restoring infarct artery patency as the clot ages Not so for primary PCI 2) Cardiac rupture increases as the time to thrombolysis increases Cardiac rupture is rare after primary PCI Effect of Time to Presentation on 30 Day Mortality with Primary PCI vs Lytic Therapy Analysis of 10 Randomized Trials 30 Day Mortality % 14 14 12.1 12.1 12 12 10 10 88 66 44 22 00 6.3 6.3

5.0 5.0 3.9 3.9 <2 4.1 4.1 2-4 Time to Presentation Time 4.7 4.7 >4 Zijlstra F et al. Eur Hear J 2002 5 RCTs of Lysis vs. Transport for PCI N = 2,909 Average transfer time 39 mins 20% Lysis PCI 15.8% Event rate

15% P<0.0001 10% 9.5% 9.1% 7.3% 7.2% P=0.25 P<0.05 5% P=0.057 2.2% 0% 0% Death Longest follow-up data used. 2.3% 1.9% Reinfarction Hemorrhagic

stroke 1.1% Total stroke P<0.0001 Death, reMI or stroke Keeley, Grines. Lancet 2003;361:13-20 PRAGUE 1+2: SK vs. transport (n=1250) RED = community hospitals BLUE = PCI centers Transport up to 120 km PRAGUE 1+2: SK vs. transport (n=1250) 20 30-Day Events (%) 18 16 SK Transport/PCI 16.7 16.5 14 12

10.8 10 8 6.8 8.3 8.0 7.6 5.4 6 4 2 P<0.04 P=NS P<0.002 P<0.0001 Death - present >3 hrs Death, reMI, stroke 0 Death Death - present <3 hrs

Effect of Pre PCI Epicardial TIMI flow N = 2,507 pts in PAMI-1, PAMI-2, PAMI Stent Pilot and PAMI Stent Randomized 6 Month Mortality Survival (%) 100% 0.5% 98% 2.8% 4.4% 96% 94% Grade 3 Grade 2 Grade 0/1 92% log-rank p for trend = 0.009 90% 0 1 2

3 Months Stone GW et al. Circulation 2001;104(6):636-41 4 5 6 Pharmacologic Facilitation of PCI Potential Advantages Earlier reperfusion Thrombus burden reduction ? Myocardial salvage ? CHF & Mortality Randomized Trials FINESSE ASSENT-IV CARESS-AMI CAVEATS Bleeding compl. Costs Drugs require time 8 small trials negative Facilitated regimens are not currently indicated except possibly

abciximab Relationship between primary PTCA volume and in-hospital mortality 10.0% 8.0% 7.5% P<0.001 6.1% 4.7% 5.0% 2.5% 0.0% <12 12-36 >36 # institutional primary PTCAs/yr Multivariate odds ratio The NRMI-2 Database (n=27,080) 1.2 1.0 0.8 0.6 14% P=0.03

0.4 33% P<0.001 0.2 0 <12 12-36 >36 # institutional primary PTCAs/yr I IIa IIb III Classification of Recommendations Intervention is useful and effective Weight of evidence/opinion is in favor of usefulness/efficacy Usefulness/efficacy is less well established by evidence/opinion Intervention is not useful/effective and may be harmful = Level of Evidence Effect consistent among multiple (35) population risk strata Limited (23) population risk strata evaluated

Very limited (12) population risk strata evaluated 2004 ACC/AHA STEMI Guidelines Primary PCI Class I STEMI (including posterior MI or presumably new LBBB) within 12 hours of symptom onset Door to balloon <90 minutes Skilled operator (>75 PCIs per year) Skilled team (>200 PCIs and >36 primary PCIs per year) Surgical facilities available www.aha.org; www.acc.org 2004 ACC/AHA STEMI Guidelines Class I Primary PCI: Specific considerations Door to balloon goal <90 If presentation <3 hours, and

(Door to Balloon) (Door to Needle) <1 hour Primary PCI generally preferred (Door to Balloon) (Door to Needle) >1 hour Thrombolysis generally preferred If presentation >3 hours, then primary PCI is generally preferred Primary PCI is preferred for cardiogenic shock (IA) and severe CHF and/or Killip class III (IB) 2004 ACC/AHA STEMI Guidelines Class IIa Primary PCI: Specific considerations Patients 75 years old who develop cardiogenic shock within 36 hours of MI onset who can be revascularized within 18 hours of shock Symptom onset 12-24 hours with Killip class III Hemodynamic or electrical instabiity Persistent ischemia

www.aha.org; www.acc.org 2004 ACC/AHA STEMI Guidelines Primary PCI: Specific considerations Class III PCI should not be performed in a non infarct artery at the time of primary PCI in patients without hemodynamic compromise Primary PCI should not be performed in asymptomatic patients >12 hours after onset of STEMI if they are hemodynamically and electrically stable. www.aha.org; www.acc.org 2004 ACC/AHA STEMI Guidelines Primary PCI without on-site surgery Class IIb May be considered in STEMI by skilled physicians (>75 PCI/yr) and team (>36 pPCI/yr) as long as door to balloon is <90 and: There exists a proven plan for rapid transport with appropriate hemodynamic support capability to a cardiac surgery OR in a nearby hospital III Otherwise www.aha.org; www.acc.org

2004 ACC/AHA STEMI Guidelines Class Rescue PCI in STEMI I In pts <75 yrs of age with cardiogenic shock I In pts with severe CHF and/or Killip class III IIa IIa developing within 36 if PCI can be performed within 18 of shock and onset of symptoms <12 hours In pts 75 yrs of age with cardiogenic shock developing within 36 if PCI can be performed within 18 of shock With either hemodynamic or electrical instability or persistent ischemia 2004 ACC/AHA STEMI Guidelines PCI after Fibrinolysis Class I In patients with suitable anatomy and:

Objective evidence of reinfarction, or Moderate or severe spontaneous or provocable myocardial ischemia during recovery from STEMI, or Cardiogenic shock or hemodynamic instability www.aha.org; www.acc.org 2004 ACC/AHA STEMI Guidelines Class IIa PCI after Fibrinolysis In pts with LVEF <40%, CHF, or serious ventricular arrhythmias IIa In pts with acute CHF during the acute IIb As part of an invasive strategy after episode, even if subsequent testing shows LVEF 40% fibrinolysis

www.aha.org; www.acc.org 2004 ACC/AHA Guidelines for Management of STEMI Choice of reperfusion therapy depends on: Time from onset of symptoms Lytic therapy within 2 can abort MI Reperfusion rates after lytics are time dependent; much less so with primary PCI Risk of STEMI (mortality) The higher the risk, the more PCI is favored Risk of bleeding The higher the risk, the more PCI is favored Time required for transport to a skilled PCI lab www.aha.org; www.acc.org 2004 ACC/AHA STEMI Guidelines Thrombolytic therapy is generally favored when: Early presentation

<3 from sx onset to ER, plus delay to invasive strategy Invasive strategy is not an option Cath lab unavailable Vascular access difficult Skilled PCI lab unavailable Operator >75 primary PCIs per yr; team >36 primary PCIs per yr Delay to invasive strategy Prolonged transport (Door to Balloon) (Door to Needle) >1 hour Door to Balloon >90 minutes 2004 ACC/AHA STEMI Guidelines Primary PCI is generally favored when: Skilled PCI lab is available with surgical back-up

(Door to Balloon) (Door to Needle) <1 hour Door to Balloon <90 minutes High risk STEMI Cardiogenic shock or Killip class III Contraindications to fibrinolysis, including increased risk of bleeding and ICH Late presentation (symptom onset to ER >3) Diagnosis of STEMI is in doubt 2004 ACC/AHA STEMI Guidelines If presentation is <3 hours and there is no delay to an invasive strategy, there is no preference for either strategy www.aha.org; www.acc.org

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