STEMI直接PCI时该不该处理 “非罪犯”病变? 广东省人民医院 陈纪言 杨峻青 • PCI患者完全重建优于不完全重建 不完全重建和死亡率 propensity-matched analysis of 6,511 pairs 95% CI P Value HR Incomplete 1.16 1.06-1.27 0.001 One-Vessel Incomplete 1.13 1.02-1.25 0.01 Multivessel Incomplete 1.27 1.03-1.57 0.03 • STEMI患者完全重建也显优势 Meta-analysis of 19 trials: Multivessel PCI Comparable to Culprit-Only Approach in STEMI Early outcomes (≤ 30 days) 2.0 ± 1.1 years follow-up OR 95% CI Repeat PCI 0.57 0.43-0.77 0.40-0.73 CABG 0.47 0.32-0.68 0.57-0.82 Stent Thrombosis 1.28 0.62-2.61 MACE 0.60 0.50-0.72 OR 95% CI Repeat PCI 0.56 0.32-0.98 CABG 0.54 MACE 0.68 Bangalore S, Am J Cardiol. 2011. • 然而既往指南:直接PCI时只干预罪犯病变 指南2012:直接PCI ESC2012 Guideline on STEMI 指南2013:直接PCI ACCF/AHA 2013 Guideline on STEMI APEX-AMI trial: complete intervention in Primary PCI harms Clinical Outcomes at 90 Days Complete Culprit intervention Vessel PCI P Value Death 12.5% 5.6% < 0.001 Death, CHF, Shock 18.9% 13.1% 0.011 Toma M, Eur Heart J. 2010 • 除非心源性休克或严重心衰 Multivessel vs. Culprit-Only Primary PCI in STEMI Patients with Shock, Cardiac Arrest • 169 STEMI patients with resuscitated cardiac arrest and cardiogenic shock and multivessel disease. – Six-month survival was improved with multivessel PCI compared with culprit-only PCI (43.9% vs. 20.4%; P = 0.0017). – The survival advantage was driven by a reduction in the composite of recurrent cardiac arrest and death from shock (50.0% vs. 68.0%; P = 0.024). • 非罪犯血管: – 延迟干预 – 狭窄程度、症状、功能学检查 欧洲指南2012:非梗塞支处理 ESC2012 STEMI 指南2013:非罪犯血管 ACCF/AHA 2013 Guideline on STEMI 指南2013:非罪犯血管 ACCF/AHA 2013 Guideline on STEMI 非罪犯血管:FFR可信 All Patients (n=101) STEMI Patients (n=75) NSTEMI Patients (n=26) Ntalianis A, JACC CI. 2010;3:1274 Acute Phase 1-month Follow-up P Value 0.77 ± 0.13 0.77 ± 0.13 NS 0.78 ± 0.10 0.76 ± 0.10 NS 0.77 ± 0.10 0.77 ± 0.20 NS • 新证据支持直接PCI时完全重建 Propensity-Matched Mortality Rates by Revascularization Strategy During Index Procedure Mortality In-Hospital 24 Months 42 Months Culprit Multivessel Vessel at Time of Alone at Primary PCI Time of (n = 458) Primary PCI (n = 458) 0.9% 2.4% 4.9% 7.2% 6.7% 10.4% Hannan EL, JACC CI. 2010;3:22-31 P Value 0.04 0.07 0.08 • 新证据支持直接PCI时完全重建 – PRAMI研究 Preventive Angioplasty in Myocardial Infarction N Engl J Med September 1st 2013;369. DOI: 10.1056/NEJMoa1305520 Acute STEMI Exclusions Previous CABG Cardiogenic Shock Left main stem >50% Chronic total occlusion Successful Infarct-artery PCI Multivessel Disease (>50% stenosis in noninfarct-artery suitable for PCI) Randomise 600 (target) 300 Preventive PCI 300 No Preventive PCI Follow-up at 6 weeks and then annually Trial stopped early • On 24th Jan 2013, after 465 patients • Recommendation of Data and Safety Monitoring Committee • Clear result PRAMI Freedom from Primary Outcome (%) Primary endpoint: Cardiac death, MI or refractory angina Culprit PCI only 10 0 91% 80 60 40 HR 0.35 (95%CI 0.21-0.58) P<0.001 20 0 0 No. at Risk Preventive PCI No Preventive PCI 77% Complete revasc 6 12 18 24 30 36 118 96 89 74 67 50 Months 234 231 196 168 166 144 146 122 Wald DS et al. NEJM 2013 PRAMI Median FU 2.3 Years Complete revasc (N=234) Culprit PCI only (N=231) HR (95%CI) P value Cardiac death, MI, or refractory angina 21 53 0.35 (0.21-0.58) <0.001 Cardiac death or MI 11 27 0.36 (0.18-0.73) 0.004 Cardiac death 4 10 0.34 (0.11-1.08) 0.07 Nonfatal MI 7 20 0.32 (0.13-0.75) 0.009 Refractory angina w/o CD or MI 12 30 0.35 (0.18-0.69) 0.002 Noncardiac death 8 6 1.10 (0.38-3.18) 0.86 Repeat revascularization 16 46 0.30 (0.17-0.56) <0.001 Pre-specified outcomes Secondary outcomes Wald DS et al. NEJM 2013 • 新证据支持直接PCI时完全重建 – PRAMI研究 – CvLPRIT研究 CvLPRIT study • 298 STEMI patients • Randomised open-label study • Compared treatment of IRA only (146 pts) with complete revascularisation (150 pts) during index admission for ST-elevation Myocardial Infarction • Randomisation stratified for: - site of infarct (Anterior vs. non-anterior) - Symptom onset to balloon time (less than or greater than 3hrs) • 1o outcome: MACE – total mortality/recurrent MI/heart failure and ischaemia-driven revascularisation at 12 months Results 1: Percent MACE at 12 months The primary endpoint composite of total mortality, recurrent MI, heart failure and ischaemia-driven revascularisation at 12 months IRA Only Complete Revascularisation 26 MACE to 30 days Variable IRA only (N=146) Complete Revascularisation HR (95% CI) P value 15 (10.0) 0.45 (0.24, 0.84) 0.009 2 (1.3) 2 (1.3) 4 (2.7) 7 (4.7) 0.32 (0.06, 1.60) 0.48 (0.09, 2.62) 0.43 (0.13, 1.39) 0.55 (0.22, 1.39) 0.14 0.39 0.14 0.2 4 (2.7) 2 (1.3) 5 (3.3) 8 (5.3) 0.38 (0.12, 1.20) 0.47 (0.09, 2.59) 0.47 (0.16, 1.38) 0.46 (0.20, 1.08) 0.09 0.38 0.16 0.07 2 (1.3) 2 (1.3) 4 (2.7) 0.27 (0.06, 1.32) 0.95 (0.13, 6.77) 0.55 (0.16, 1.87) 0.11 0.96 0.34 (N=150) Time to First Event MACE 31 (21.2) All-cause mortality 6 (4.1) Recurrent MI 4 (2.7) Heart failure 9 (6.2) Repeat 12 (8.2) Revascularisation Total number of events reported All-cause mortality 10 (6.9) Recurrent MI 4 (2.7) Heart Failure 10 (6.9) Repeat 16 (11.0) Revascularisation Adverse Events reported CV mortality 7 (4.8) Stroke 2 (1.4) Major Bleed 7 (4.8) Limitations of CvLPRIT • Small study but significant outcome • No FFR or IVUS of the N-IRA lesions • Open study ITT Population Variable IRA only Complete HR (95% Revasculari CI) P sation All-cause mortality 14/146 6/150 0.41 (0.16, or Recurrent MI (9.6%) (4.0%) 1.07) All-cause mortality, 19/146 8/150 0.40 (0.18, Recurrent MI or (13.0%) (4.7%) 0.92) Heart Failure 0.060 0.025 • 新证据支持直接PCI时完全重建 – PRAMI研究 – CvLPRIT研究 – RCT荟萃分析 Meta-analysis of RCTs comparing complete and culprit-only revascularisation • Search conducted in MEDLINE, EMBASE, PUBMED, ISI Web of Science, conference abstracts. • Only randomised controlled trials included • 4 RCTs identified • Total of 1,044 patients (478-culprit only, 687-complete revascularisation) • Pooled OR using a Fixed-effects model (Mantel-Haenszel) • Analysis performed for MACE, Death (all-cause and cardiac), repeat MI, repeat revascularisation. • Minimum follow-up 12 months (23 months PRAMI, 30 months Politi et al). MACE Study % All-cause Mortality ID OR (95% CI) Weight DiMario 2004 1.02 (0.04, 26.19) 1.79 Politi 2010 0.46 (0.19, 1.09) 36.05 Wald 2013 0.73 (0.34, 1.57) 37.77 Gershlick 2014 0.37 (0.11, 1.22) 24.39 Overall (I-squared = 0.0%, p = 0.745) 0.55 (0.33, 0.91) 100.00 .1 Favours Multi-vessel PCI 1 10 Favours Culprit-only PCI Study Repeat Revascularisation % ID OR (95% CI) Weight DiMario 2004 0.38 (0.11, 1.31) 7.76 Politi 2010 0.24 (0.12, 0.49) 31.52 Wald 2013 0.30 (0.16, 0.54) 44.78 Gershlick 2014 0.46 (0.19, 1.11) 15.94 Overall (I-squared = 0.0%, p = 0.715) 0.31 (0.21, 0.46) 100.00 .1 Favours Multi-vessel PCI 1 10 Favours Culprit-only PCI Study Repeat Myocardial Infarction % ID OR (95% CI) Weight DiMario 2004 0.31 (0.02, 5.20) 4.49 Politi 2010 0.53 (0.17, 1.64) 24.49 Wald 2013 0.33 (0.13, 0.79) 58.95 Gershlick 2014 0.48 (0.09, 2.66) 12.08 Overall (I-squared = 0.0%, p = 0.911) 0.39 (0.21, 0.73) 100.00 .1 Favours Multi-vessel PCI 1 10 Favours Culprit-only PCI Cardiovascular Mortality Study % ID OR (95% CI) Weight DiMario 2004 1.02 (0.04, 26.19) 2.48 Politi 2010 0.36 (0.13, 1.03) 39.68 Wald 2013 0.38 (0.12, 1.24) 33.87 Gershlick 2014 0.27 (0.05, 1.31) 23.97 Overall (I-squared = 0.0%, p = 0.911) 0.36 (0.18, 0.71) 100.00 .1 Favours Multi-vessel PCI 1 10 Favours Culprit-only PCI • 指南更新 欧洲重建指南2014 欧洲重建指南 2014:STEMI • 实践 Management of Non-Culprit Lesions Identified at the time of Primary PCI Immediate PCI Staged PCI 50-70% Medical therapy Immediate PCI Staged PCI 70-90% Medical therapy Immediate PCI Staged PCI >90% Medical therapy Procedure time and radiation Preventive PCI No Preventive PCI Increase Procedure time (minutes) 63 45 40% Radiation dose (Gycm2) 90 71 27% • 理解指南 可以 ≠ 必须 • It remains to be determined how clinicians can identify lesions that should be revascularized beyond the culprit lesion and whether complete revascularization should be performed in single- or multi-stage procedures. • At present, multivessel PCI during STEMI should be considered in patients with cardiogenic shock in the presence of multiple, critical stenoses or highly unstable lesions (angiographic signs of possible thrombus or lesion disruption), and if there is persistent ischaemia after PCI on the supposed culprit lesion. ESC guideline 2014 小结 • • • • • PCI完全重建显示获益 STEMI患者亦然 重建时机值得讨论 新的证据支持直接PCI时完全重建 应考虑患者耐受和治疗条件 谢谢!