Culprit PCI vs MultiVessel PCI for Acute Myocardial Infarction

Transcription

1 Culprit PCI vs MultiVessel PCI for Acute Myocardial Infarction Dipti Itchhaporia, MD, FACC, FESC Trustee, American College of Cardiology Director of Disease Management, Hoag Hospital Robert and Georgia Roth Endowed Chair for Excellence in Cardiac Care Newport Beach, CA 37 th PanHellenic Congress of Cardiology Athens, Greece

2 Disclosure I have no disclosures

3 Background IRA Non culprit IRA 30-50% of STEMI patients have additional stenoses other than the infarct related artery 1,2 Current guidelines support culprit vessel PCI only Contemporary studies have, however, suggested complete revascularization 3,4 Non culprit Options: Multivessel PCI at the same time 2 Muller DW et al. Am Heart J 1991 (preventive approach), delayed 3 Wald PCI et (staged) al. NEJM 2013or PCI 4 Gershlick et al. ESC 2014 later for sx or ischemia 1 Jong JA al. Coronary Artery disease 2006

4 2013 STEMI: ACC/AHA Guidelines I IIa IIb III B PCI of a non-infarct artery at the time of primary PCI in patients without hemodynamic compromise is not indicated I IIa IIb III PCI is indicated in a non-infarct artery at a time separate from primary PCI in patients who have spontaneous symptoms of myocardial ischemia. I IIa IIb III B PCI is reasonable in a non-infarct artery at a time separate from primary PCI in patients with intermediate- or high-risk findings on noninvasive testing O Gara PT S et al. JACC 2013

5 Rationale for ACC-AHA Guideline Recommendation Retrospective studies & meta-analysis of nonrandomized and observational studies Studies Supporting Class III rec Hannan JACC Int 2010 Toma EHJ 2010 Vlaar JACC 2011 N ,280 (meta analysis) Staged v late 259, 538 Non-IRA = 217 IRA only =1984 In hosp mort. Staged v late 1 yr mort, staged v IRA only 0.9 v 2.4%, p= d MACE 12.5 v. 5.6%, P= v 3.3%, p=0.04 Non-IRA increased hazard of 90d mort Culprit only: low mort. MV-PCI highest mort. staged PCI lowest mortality Take home Culprit only at index but finish job <60d Non-IRA PCI at STEMI increased mortality Non-IRA suitable for PCI only during a staged procedure

6 Rationale for ACC-AHA Guideline Recommendation Toma et al, EHJ (2010;31: )

7 But wait Let us talk about the new studies

8 Randomized Trial of Preventive Angioplasty in Myocardial Infarction (PRAMI) David S. Wald, M.D., Joan K. Morris, Ph.D., Nicholas J. Wald, F.R.S., Alexander J. Chase, M.B., B.S., Ph.D., Richard J. Edwards, M.D., Liam O. Hughes, M.D., Colin Berry, M.B., Ch.B., Ph.D., Keith G. Oldroyd, M.D., for the PRAMI Investigators N Engl J Med Volume 369(12): September 19, 2013

9 PRAMI: Preventative PCI of Non-culprit Lesions after Culprit Lesion Primary PCI in STEMI Pre-specified outcomes Complete revasc (N=234) Culprit PCI only (N=231) HR (95%CI) P value Cardiac death, MI, or refractory angina ( ) <0.001 Cardiac death or MI ( ) Cardiac death ( ) 0.07 Nonfatal MI ( ) Refractory angina w/o CD or MI ( ) Secondary outcomes Wald DS et al. N Engl J Med 2013;369: Median FU 2.3 Years Noncardiac death ( ) 0.86 Repeat revascularization ( ) <0.001

10 PRAMI cardiac death, non fatal MI, refractory angina HR 0.35, p<0.001 (95% CI ) 65% risk reduction N=234 N=231 Preventive PCI No preventive PCI Wald et al. NEJM 2013

11 PRAMI Trial Conclusions The preventive multivessel PCI group had a 65% reduction in the relative risk of the primary outcome ( composite of cardiac death, nonfatal MI, or refractory angina) as compared to Culprit PCI group. Relatively small population Distribution of composite endpoint differed significantly in their frequency, (e.g. cardiac death=14, nonfatal MI = 27, refractory angina = 42.) Thus, P values are extremely sensitive to the addition of few events. Only 3 more MIs in the preventive PCI arm would render nonfatal MI nonsignificant.

12 Randomized Trial of Complete Versus Lesion- Only Revascularization in Patients Undergoing Primary PCI for STEMI and Multivessel Disease: The CvLPRIT Trial A.H. Gershlick, G.P. McCann et al JACC MARCH 17, 2015

13 CvLPRIT study: Complete vs IRA PCI in STEMI STEMI pts-randomized to complete revascularization( n=150) vs infarct related revascularization (n=146) only. 2. Complete revascularization was performed either at the time of primary PCI or before hospital discharge. 3. Randomization was stratified by infarct location- anterior vs non-anterior and by symptom onset- less than 3 hours or more than 3 hours 4. Primary endpt was a composite of all cause death, recurrent myocardial infarction, heart failure, and ischemia driven revascularization within 12 months

14 Cvlprit Primary Endpoint : 12 Month MACE: Total mortality, Recurrent MI, Heart failure, Revascularization Gershlick et al. ESC 2014

15 CvLPRIT Results 1. The primary endpoint occurred in 10% of the complete revascularization group versus 21.2% in the culprit only revascularization group 2. A trend toward benefit was seen early after complete revascularization 3. No significant reduction in death or MI, a nonsignificant reduction in all primary endpoint components was seen. 4. Small study but significant outcome

16 STEMI Meta-analysis 1. ESC- 2014: CvLPRIT investigator Dr. Anthony Gershlick of the University of Leicester (England) presented a metaanalysis combining the weighted results of PRAMI, CvLPRIT, and two earlier randomized trials: HELP AMI ( Int. J. Cardiovasc. Intervent. 2004;6: ) and an Italian trial ( Heart 2010;96:662-7 ). 2. The results strongly favored multivessel PCI, with a 45% reduction in mortality and a 61% decrease in recurrent MI, compared with culprit vessel only PCI at the time of admission for STEMI.

17 STEMI < 12 hours Randomise conventional PPCI, ipost, deferred stenting Successful infarct related artery PCI 627 Multivessel disease at two centres over a 3 year (>50% stenosis in non period IRA > 2 mm suitable for PCI) Randomise 313 IRA PCI only 314 FFR guided complete revascularisation

18 Primary endpoint- DANAMI3-PRIMULTI median follow up 27 months Composite 1. All-cause mortality 2. Nonfatal MI 3. Ischemia driven revascularization of non IRA lesions

19 DANAMI3-PRIMULTI IRA only (n = 313) Complete revascularization (n = 314) HR [95% CI] p Primary endpoint 68 (22%) 40 (13%) 0 56 [ ] All-cause death 11 (4%) 15 (5%) 1 4 [ ] 0 43 Nonfatal MI 16 (5%) 15 (5%) 0 94 [ ] 0 87 Ischemia-driven revascularisation* 52 (17%) 17 (5%) 0 31 [ ] <0 001 Secondary endpoints Cardiac death 9 (3%) 5 (2%) 0 56 [ ] 0 29 Cardiac death or nonfatal MI 25 (8%) 20 (6%) 0 80 [ ] 0 47 Urgent PCI 18 (6%) 7 (2%) 0 38 [ ] 0 03 Non-urgent PCI 27 (9%) 8 (3%) 0 29 [ ] * PCI or CABG

20 Individual components of primary endpoint Composite Revascularisation Non fatal MI All cause death

21 Subgroup analysis- DANAMI3-PRIMULTI Number of patients Events Hazard Ratio (95% CI) P interaction ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) ( ) * there were no events in patients with prior myocardial infarction randomized to complete revascularization

22 Conclusions : DANAMI3-PRIMULTI Complete FFR guided revascularization of multivessel CAD in STEMI pts, staged within the index admission, reduced all cause death, reinfarction and repeat revascularization 40% of repeat revascularizations were urgent Analysis of secondary endpoints showed no difference between groups with regards to all cause death or non fatal re-infarction

23 PRAGUE 13 Trial pts underwent complete revascularization ( staged day days after intervention) vs 108 pts who received Culprit only PCI 2. Primary composite endpt included all cause death, nonfatal MI and stroke 16% in the pts with multivessel PCI vs 13.9% culprit PCI 3. All cause mortality was 5.7% for multivessel PCI vs 6.5% culprit PCI

24 Contemporary Randomized STEMI MVD Trials Complete Revascularization? Do All now Do All, stage Do all now use FFR

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26 From: COMPLETE VERSUS CULPRIT-ONLY REVASCULARIZATION IN PATIENTS WITH ST-ELEVATION MYOCARDIAL INFARCTION AND MULTIVESSEL DISEASE: A META-ANALYSIS OF RANDOMIZED TRIALS J Am Coll Cardiol. 2016;67(13_S): doi: /s (16) Date of download: 8/7/2016 Copyright The American College of Cardiology. All rights reserved.

27 2015 New Focused PCI guidelines update- October 21, 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention A Report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions American College of Cardiology Foundation and American Heart Association, Inc. IIB

28 Conclusions 1. In the past, PCI of nonculprit vessel was Class III- harm 2. Now we have new evidence from recent clinical trials that treating nonculprit vessels maybe safe and beneficial in selected pts with multivessel disease. 3. ACC withdraws from its Choosing Wisely campaign its former recommendation discouraging multivessel revascularization at the time of primary PCI for STEMI. The college cited new science showing that complete revascularization of all significant blocked arteries leads to better outcomes in some heart attack patients.

29 Conclusions 1. New focused update published October 21, 2015 states that treating nonculprit vessel maybe considered in pts with STEMI (Class IIb recommendation) 2. The best timing to treat non-culprit arteries is not known 3. The focused update states physicians should integrate clinical data, lesion severity/complexity and risk of contrast nephropathy to determine optimal strategy. 4. Await Results of the COMPLETE Study- led by Dr Shamir Mehta at McMaster involves 4,000 pts with STEMI and have multivessel disease. Also Compare Acute Trial Randomized 885 patients, to be completed Nov 2016

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