The Case for Multivessel Revascularization in Shock
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1 The Case for Multivessel Revascularization in Shock Emmanouil S. Brilakis, MD, PhD Minneapolis Heart Institute am
2 Disclosures Consulting/speaker honoraria: Abbott Vascular, American Heart Association (associate editor Circulation), Amgen, Boston Scientific, CSI, Elsevier, GE Healthcare, Medtronic. Research support: Osprey, Regeneron, Siemens. Shareholder: MHI Ventures. Board of Directors: Cardiovascular Innovations Foundation Board of Trustees: Society of Cardiovascular Angiography and Interventions
3 Incidence of multivessel disease in cardiogenic shock
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5 Multivessel PCI in Cardiogenic Shock Metaanalysis Mortality Registry-Data: 10 observational studies published between 2003 and ,051 patients: IABP-SHOCK II, ALKK, KAMIR, Yang et al., Cavender et al.; Mylotte et al., van der Schaaf et al., EHS-PCI, NCDR, SHOCK 19.7% Culprit only-pci (n=4,857) Multivessel-PCI (n=1,194) 80.3% de Waha et al. Eur Heart J Acute Cardiovasc Care. 2017; epub
6 Multivessel PCI in Cardiogenic Shock? Metaanalysis Mortality Registry-Data MV-PCI C-PCI Events Total Events Total Short-term follow-up RR 95%CI IABP-SHOCK II [ ] ALKK [ ] KAMIR [ ] Yang et al [ ] Cavender et al [ ] EHS-PCI [ ] NCDR [ ] Overall [ ] Heterogeneity: τ 2 =0.007, I 2 =31.0%, p=0.19 Test for overall effect: p= Multivessel PCI better Culprit only PCI better MV-PCI C-PCI Long-term follow-up RR 95%CI Events Total Events Total IABP-SHOCK II [ ] KAMIR [ ] Yang et al [ ] Cavender et al [ ] Mylotte et al [ ] van der Schaaf et al [ ] SHOCK [ ] Overall [ ] Heterogeneity: τ 2 =0.043, I 2 =67.8%, p=0.005 Test for overall effect: p= Multivessel PCI better Culprit only PCI better de Waha et al. Eur Heart J Acute Cardiovasc Care. 2017; epub
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8 Hypothesis Culprit lesion only PCI (with possible staged revascularization) is superior to immediate multivessel PCI in multivessel coronary artery disease ( 2 mm in diameter, >70% stenosis incl. CTO) patients with cardiogenic shock complicating acute myocardial infarction. Thiele et al. Am Heart J. 2016;172:
9 Primary Study Endpoint: 30-day all-cause mortality or renal replacement therapy Secondary Study Endpoints: Statistical Methodology 30-day all-cause mortality Renal failure with requirement of renal replacement therapy Time to hemodynamic stabilization Duration of catecholamine therapy Serial creatinine-clearance Length of ICU-stay SAPS-II score Requirement and length of mechanical ventilation All-cause death within 6 and 12 months follow-up Recurrent infarction within 30-days, 6 and 12 months follow-up Death or recurrent infarction at 6 and 12 months follow-up Rehospitalization for congestive heart failure within 30 days, 6-, and 12-months follow-up Death/recurrent infarction/rehospitalization for congestive heart failure within 30 days, 6-, and 12-months follow-up Need for repeat revascularization (PCI and/or CABG) within 30 days, 6-, and 12-months follow-up Peak creatine kinase, creatine kinase-mb and troponin level during hospital stay Sample Size: Estimated 50% event rate in multivessel PCI versus 38% in culprit lesion only group for primary endpoint 1 interim analysis (50% of patients) 2-sided Chi 2 -test; power: 80%, alpha=0.048 for final analysis 684 patients To compensate losses in follow-up 706 patients Thiele et al. Am Heart J. 2016;172:
10 CULPRIT-SHOCK Trial Investigator-initiated European multicenter trial; 1:1 randomization PI + Coordination: Holger Thiele Co-PI: Uwe Zeymer Steffen Desch Thiele et al. Am Heart J. 2016;172: National Coordinators (83 centers): Kurt Huber Gilles Montalescot Jan Piek Holger Thiele Pranas Serpytis Janina Stepinska Christiaan Vrints Marko Noc Keith Oldroyd Stefan Windecker Stefano Savonitto
11 Study Flow Chart 1075 patients with acute myocardial infarction (STEMI and NSTEMI) and cardiogenic shock screened 369 excluded 706 randomized 351 randomized to culprit lesion only PCI 344 full informed consent 301 culprit lesion only PCI 43 immediate multivessel PCI 60 staged PCI 1 staged CABG 13 urgent PCI Allocation Informed consent Revascularization 355 randomized to immediate multivessel PCI 342 full informed consent 310 immediate multivessel PCI 32 culprit lesion only PCI 8 staged PCI 0 staged CABG 5 urgent PCI Follow-up 344 with 30-day follow-up 341 with 30-day follow-up 1 lost to follow-up Primary endpoint analysis 344 primary endpoint analysis 341 primary endpoint analysis
12 Baseline Characteristics Characteristic Culprit only PCI (n=344) Multivessel PCI (n=342) Age (years); median (IQR) 70 (60-78) 70 (60-77) Male sex; n/total (%) 257/343 (74.9) 267/342 (78.1) Prior myocardial infarction; n/total (%) 60/339 (17.7) 53/335 (15.8) Prior PCI; n/total (%) 64/339 (18.9) 63/335 (18.8) Prior coronary arterial bypass surgery; n/total (%) 20/341 (5.9) 13/337 (3.9) Signs of impaired organ perfusion; n/total (%) Altered mental status Cold, clammy skin and extremities Oliguria Arterial lactate >2.0 mmol/l 237/341 (69.5) 233/338 (68.9) 80/334 (24.0) 216/334 (64.7) 224/341 (65.7) 236/335 (70.4) 93/326 (28.5) 224/330 (67.9) Fibrinolysis <24 h before randomization; n/total (%) 19/341 (5.6) 15/341 (4.4) Resuscitation before randomization; n/total (%) 177/341 (51.9) 189/342 (55.3) ST-elevation myocardial infarction; n/total (%) 206/335 (61.5) 209/330 (63.3) No. of diseased vessels; n/total (%) /343 (0.9) 122/343 (35.6) 218/343 (63.6) 2/342 (0.6) 124/342 (36.3) 216/342 (63.2) Patients with at least one CTO; n/total (%) 77/344 (22.4) 82/342 (24.0) Left ventricular ejection fraction (%); median (IQR) 33 (25-40) 30 (21-40)
13 Treatment Characteristic Culprit only PCI (n=344) Multivessel PCI (n=342) Femoral access; n/total (%) 287/343 (83.7) 277/342 (81.0) 0.36 Radial access; n/total (%) 61/343 (17.8) 66/342 (19.3) 0.61 Stent implanted in culprit lesion; n/total (%) 326/343 (95.0) 324/342 (94.7) 0.86 Drug-eluting stent in culprit lesion; n/total (%) 305/326 (93.6) 308/324 (95.1) 0.41 TIMI-flow III post PCI of culprit lesion; n/total (%) 289/342 (84.5) 293/338 (86.7) 0.46 Immediate PCI of non-culprit lesions; n/total (%) 43/344 (12.5) 310/342 (90.6) <0.001 Immediate complete revascularization; n/total (%) 26/344 (7.6) 277/342 (81.2) <0.001 Total amount of contrast agent (ml); median (IQR) 190 ( ) 250 ( ) <0.001 Staged PCI of non-culprit lesions; n/total (%) 60/344 (17.4) 8/341 (2.3) <0.001 Staged coronary artery bypass surgery; n/total (%) 1/344 (0.3) 0/341 >0.99 Mechanical circulatory support; n/total (%) 99/344 (28.8) 95/342 (27.8) 0.77 Intraaortic balloon pump; n/total (%) 25/99 (25.3) 26/95 (27.4) 0.74 Impella 2.5; n/total (%) 16/99 (16.2) 18/95 (18.9) 0.61 Impella CP; n/total (%) 30/99 (30.3) 18/95 (18.9) 0.07 TandemHeart; n/total (%) 2/99 (2.0) 0/ ECMO; n/total (%) 18/99 (18.2) 27/95 (28.4) 0.09 Mild hypothermia; n/total (%) 111/344 (32.3) 118/340 (34.7) 0.50 Mechanical ventilation; n/total (%) 273/344 (79.4) 282/339 (83.2) 0.20 Duration of mechanical ventilation (days); median (IQR) 3 (1-7) 3 (1-7) 0.97 Duration of intensive care treatment (days); median (IQR) 5 (2-12) 5 (2-11) 0.61
14 Primary Study Endpoint All-Cause Mortality or Renal Replacement Therapy All-cause mortality or renal replacement therapy (%) Number at risk: Culprit lesion only PCI Relative risk 0.83; 95% confidence interval ; P= Days after randomization Immediate multivessel PCI 55.4% Culprit lesion only PCI 45.9% Immediate multivessel PCI
15 All-Cause Mortality Immediate multivessel PCI 51.5% All-cause mortality (%) Culprit lesion only PCI 43.3% 10 Relative risk 0.84; 95% confidence interval ; P= Days after randomization Number at risk: Culprit lesion only PCI Immediate multivessel PCI
16 Renal Replacement Therapy 60 Renal replacement therapy (%) Number at risk: Culprit lesion only PCI Immediate multivessel PCI 16.4% Culprit lesion only PCI 11.6% Relative risk 0.71; 95% confidence interval ; P= Days after randomization Immediate multivessel PCI
17 Arterial Lactate 9 8 P=0.78* P=0.13* P=0.89* P=0.39* P=0.78* P=0.07* P=0.16* P=0.26* Arterial lactate (mmol/l) Culprit lesion only PCI Immediate multivessel PCI 1 0 *No adjustment for multiple testing Pre PCI Post PCI 8h 16h 24h 32h 40h 48h
18 Glomerular Filtration Rate Estimated glomerular filtration rate (ml/min) P=0.87* P=0.56* P=0.12* P=0.04* P=0.04* *No adjustment for multiple testing Culprit lesion only PCI Immediate multivessel PCI Baseline Day 1 Day 2 Day 3 Day 4
19 Subgroup Analysis Primary Endpoint Baseline Variable Multivessel PCI Culprit lesion only PCI Relative Risk (95% CI) P Value for Interaction Sex Male 148/266 (55.6) 109/257 (42.4) 0.76 ( ) 0.11 Female 41/75 (54.7) 48/86 (55.8) 1.02 ( ) Age <50 years 3/16 (18.8) 6/17 (35.3) 1.88 ( ) years 114/226 (50.4) 82/212 (38.7) 0.77 ( ) >75 years 72/99 (72.7) 70/115 (60.1) 0.84 ( ) Diabetes No 116/218 (53.2) 93/235 (39.6) 0.74 ( ) 0.08 Yes 66/116 (56.9) 59/102 (57.8) 1.02 ( ) Hypertension No 68/129 (52.7) 65/139 (46.8) 0.89 ( ) 0.47 Yes 114/205 (55.6) 88/200 (44.0) 0.79 ( ) Type of infarction NSTEMI 54/97 (55.7) 45/98 (45.9) 0.82 ( ) 0.96 STEMI 128/233 (54.9) 108/237 (45.6) 0.83 ( ) STEMI type Anterior infarction 59/113 (52.2) 57/108 (52.8) 1.01 ( ) 0.07 Non-anterior infarction 48/92 (52.2) 34/97 (35.0) 0.67 ( ) Previous infarction No 154/281 (54.8) 128/279 (45.9) 0.84 ( ) 0.83 Yes 28/53 (52.8) 25/60 (41.7) 0.79 ( ) Coronary artery disease 2-vessel disease 64/124 (51.6) 48/122 (39.3) 0.76 ( ) vessel disease 124/215 (57.7) 109/218 (50.0) 0.87 ( ) Chronic total occlusion No 146/259 (56.4) 131/267 (49.1) 0.87 ( ) 0.26 Yes 43/82 (52.4) 27/77 (35.1) 0.67 ( ) Culprit 0 lesion only 1 PCI better 2 3 Multivessel PCI better
20 Conclusions In patients with multivessel coronary artery disease and cardiogenic shock complicating acute myocardial infarction culprit lesion only PCI with possible staged revascularization reduced the composite of mortality or requirement for renal replacement therapy at 30 days. This effect in the primary outcome was mainly driven by a 30-day mortality reduction. This largest randomized European multicenter trial in cardiogenic shock complicating myocardial infarction challenges current guideline recommendations.
21 Trial Flow 1075 patients with acute myocardial infarction and cardiogenic shock screened 706 randomized 369 excluded Allocation 351 randomized to culprit-lesion-only PCI 355 randomized to immediate multivessel PCI Informed consent 344 full informed consent 342 full informed consent 301 culprit lesion only PCI 43 immediate multivessel PCI - 60 staged PCI - 1 staged CABG - 13 urgent PCI Revascularization 310 immediate multivessel PCI 32 culprit lesion only PCI - 8 staged PCI - 0 staged CABG - 5 urgent PCI 30-day follow-up 344 with 30-day follow-up 341 with 30-day follow-up 1 lost to follow-up 30-day endpoint analysis 344 primary endpoint analysis 341 primary endpoint analysis 343 with 12-month follow-up 1 lost to follow-up (30 days 6 months) 12-month follow-up 341 with 12-month follow-up 0 lost to follow-up
22 100 1-Year All-Cause Mortality or Renal Replacement Therapy Relative Risk (95% CI) 0.87 ( ); P=0.048 o Died o cement Immediate multivessel PCI Culprit-lesion-only PCI 59.5% 52.0% Number at risk: Days since randomization Culprit-lesion-only PCI Immediate multivessel PCI
23 1-Year All-Cause Mortality Relative Risk (95% CI) 0.88 ( ); P= s Who Di y Cause Culprit-lesion-only PCI Immediate multivessel PCI 56.9% 50.0% Days since randomization Number at risk: Multivessel PCI Culprit-lesion-only PCI
24 1-Year All-Cause Mortality or Reinfarction 100 o Died farctio Relative Risk (95% CI) 0.87 ( ); P=0.048 Immediate multivessel PCI Culprit-lesion-only PCI 58.4% 50.9% Number at risk: Multivessel PCI Days since randomization Culprit-lesion-only PCI
25 1-Year Rehospitalization Congestive Heart Failure Relative Risk (95% CI) 0.22 ( ); P= Exp e Hos p Culprit-lesion-only PCI 5.2% Immediate multivessel PCI 1.2% Number at risk: Days since randomization Culprit-lesion-only PCI Multivessel PCI
26 1-Year Repeat Revascularization Relative Risk (95% CI) 0.29 ( ); P<0.001 o Under ulariza t 30 Culprit-lesion-only PCI 32.3% Immediate multivessel PCI Days since randomization Number at risk: Culprit-lesion only PCI Multivessel PCI %
27 1-Year Clinical Endpoints and Safety Culprit-lesiononly PCI (n=344) Multivessel PCI (n=341) Relative Risk 95% CI P-Value All-cause mortality; n/total (%) 172/344 (50.0) 194/341 (56.9) Renal replacement therapy; n/total (%) 40/344 (11.6) 56/341 (16.4) Reinfarction; n/total (%) 6/344 (1.7) 7/341 (2.1) Death/reinfarction; n/total (%) 175/344 (50.9) 199/341 (58.4) Rehospitalization for congestive heart failure; n/total (%) 18/344 (5.2) 4/341 (1.2) Death/reinfarction/rehospitalization for congestive heart failure; n/total (%) 190/344 (55.2) 203/341 (59.5) Repeat revascularization; n/total (%) 111/344 (32.3) 32/341 (9.4) <0.001 Repeat PCI; n/total (%) 107/344 (31.1) 29/341 (8.5) Repeat CABG; n/total (%) 4/344 (1.2) 3/341 (0.9) All-cause mortality or renal replacement therapy; n/total (%) 179/344 (52.0) 203/341 (59.5) Stroke; n/total (%) 15/344 (4.4) 14/341 (4.1) Bleeding (BARC 2, 3 or 5); n/total (%) 65/344 (18.9) 79/341 (23.2) Any bleeding event; n/total (%) 75/344 (21.8) 86/341 (25.2)
28 Summary and Conclusions In patients with acute myocardial infarction and cardiogenic shock culprit-lesion-only PCI - with possible staged revascularization - compared with immediate multivessel PCI is associated with a reduction in all-cause death or renal replacement therapy at 30 days. This effect in the composite endpoint is persistently observed at 12 months follow-up. The 30-day difference in all-cause mortality is attenuated over time. However, there is no increase in mortality after 30-days until 1-year follow-up. Culprit-lesion-only PCI is possibly associated with a higher incidence of heart failure hospitalizations and more frequent repeat revascularization at 1-year. The 1-year results of CULPRIT-SHOCK support the recent change in ESC guideline recommendations.
29 Multivessel PCI in Shock - Guideline Evolution ESC STEMI Guidelines 2017 Revascularization Guidelines 2018 STEMI (NSTEMI), Cardiogenic Shock I IIa IIb III I IIa IIb III Ibanez et al. Eur Heart J 2018;39: Neumann et al. Eur Heart J 2018;epub
30 Revascularization in cardiogenic shock 100% occlusion Culprit? Do not treat Treat Post PCI risk stratification
31 Culprit? STEMI culprit criteria 1. Corresponds to area of ST-elevation 2. Thrombus 3. Contrast staining 4. Poor or no collaterals 5. Easy wiring Manual of non-cto PCI: case 14
32 Multiple culprits? LAD: 100% proximal LCX: 70% proximal 80% ulcerated mid
33 Inflation of 2.5 mm balloon in LAD Severe diffuse disease in mid-lad
34 PLAN Proximal circumflex disease: treat mid circumflex before stenting proximal LAD
35 Mid circumflex stenting
36 No-reflow
37 After implantation of a 2 nd DES proximally, flow was improved in LCX Implantation of 1 DES in prox-lad followed
38
39 Antegrade flow restored
40
41 PEA arrest: Lucas + VA ECMO
42 The Case for Multivessel Revascularization in Shock
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