12/1/17 PCI for STEMI in Patients with Outline Multivessel - - PDF document

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PCI for STEMI in Patients with Multivessel Disease: Culprit Vessel

• r Complete Revascularization?

December 1, 2017

John S. MacGregor, M.D., Ph.D. Professor of Medicine University of California San Francisco

Outline

• Review recent studies of treatment of MVD in STEMI: PRAMI,

CvLPRIT, DANAMI-3, PRAGUE-13.

• ACC/AHA Guideline Change.
• CULPRIT-SHOCK Trial.
• ORBITA
• FAME2

Mortality in Patients with STEMI: Multivessel Disease v. Single Vessel Disease

Park et al., JAMA (2014) 312:2019- 2027.

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Potential Strategies

Aggressive Approach: Acute treatment of all angiographically significant lesions. Conservative Approach: Acute treatment of only the infarct- related artery, with medical therapy for the other lesions unless ischemia occurs. In Between: Acute treatment of only the infarct-related artery, with staged treatment of the other lesions.

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Acute Multivessel PCI During STEMI

Widimsky and Holmes Eur. Hrt. J. 2011, 32:396-403

Treat Infarct-Related Artery Only

Widimsky and Holmes

• Eur. Hrt. J. 2011,

32:396-403

Acute Treatment of Infarct-Related Artery with Staged Treatment of Other Lesions

Widimsky and Holmes Eur.

• Hrt. J. 2011,

32:396-403

Practice Variability in the Use of Multivessel PCI in Primary PCI for STEMI

Cavender et al., AJC (2009) 104:507-513.

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ACC/AHA Guidelines for MV-PCI in Patients with MVD and STEMI: 2013 v. 2015 Recommendation

JACC (2016) 67:1235-1250.

ACC/AHA Guidelines: Class of Recommendation

JACC (2016)67:1235- 1250.

Acute MV-PCI v. Staged MV-PCI for MVD in STEMI: One Year Mortality Outcomes - HORIZONS-AMI

Kornowski et al., JACC (2011) 58:704-11.

Meta-Analysis of Studies Comparing Acute MV-PCI to Staged PCI for Mortality in Patients with STEMI

Vlaar et al., JACC (2011) 58:692-703.

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PRAMI

465 patients with STEMI and MVD. Randomized to IRA PCI only or IRA plus MV-PCI. End point: cardiac death, non-fatal MI, refractory angina.

Kaplan-Meier Curves for Primary Outcome in the PRAMI Study

Wald et al., NEJM (2013) 369:1115- 1123.

DANAMI-3-PRIMULTI

627 patients with STEMI and MVD. After successful treatment of the IRA, randomized to no further treatment (313) or complete FFR guided revascularization (314). Primary end point: death, non-fatal MI, ischemia driven revascularization.

Event Rate: IRA Only v. MV-PCI in DANAMI-3- PRIMULTI

Engstrom et al., Lancet (2015) 386:665-71.

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Recent Trials of Complete v. Culprit Lesion Only Revascularization in Patients with STEMI

Binder et al., Eur. Hrt. J.( 2016) 37:217-220.

Meta-Analysis: Cardiovascular Mortality – Multivessel PCI v. Culprit Only

Villablanca et al., Int. J. Cardiol. (2016) 220:251-259.

Culprit-Shock

706 patients with multivessel disease, acute MI and cardiogenic shock. Randomized to: PCI of culprit vessel only or multivessel PCI. Primary End Point: Death or severe renal failure within 30 days.

Mortality at 30 Days: Multivessel PCI v. Culprit Lesion Only in Cardiogenic Shock (CULPRIT-SHOCK)

Thiele et al., NEJM (2017)

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Al-Lamee et al., Lancet, Published

• nline November

2, 2017.

ORBITA: Design

Chronic stable angina patients with 70% or more stenosis in a single vessel. 6 week period of medical optimization. Randomized 200 patients: 105 PCI/OMM, 95 OMM alone. OMM alone group (no PCI) got a sham PCI. Primary End Point: Change in exercise time at 6 weeks. Secondary End Point: Change in DSE wall motion score.

ORBITA: Results

PCI Placebo Exercise Time Increment 28.4 s 11.8 s p=0.2 Duke Treadmill score Inc. 1.22 0.10 p=0.1 Wall motion score (DSE) improved significantly in PCI group v. Placebo, p=0.0011.

Immediate Press Coverage of ORBITA

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Lancet “Comment” Accompanying ORBITA Article

Brown and Redberg, Lancet, Published on Line November 2, 2017. www.thelancet.com

Considerations Regarding ORIBITA

Strengths: Double-blind; Randomized; Sham operated control. Limitations: Small sample size with trend toward benefit (beta error?); short term outcome (6 weeks); 29% of patients had FFR greater than 0.80 and 32% had iFR greater than 0.89; cross over (four patients in placebo group got stents); 62% of patients had relatively mild angina (CCS class I or II); study only included chronic stable angina patients with single vessel disease. Positive Finding: Stents significantly reduced ischemia (improved wall motion score on stress echo: p value 0.0011).

Clinical Outcomes at Three Years in FAME 2 Trial

888 patients with chronic stable angina. Randomized to best medical therapy or FFR guided stent treatment plus medical therapy. Nearly 60% had single vessel disease. Primary end point – Death, non-fatal MI or unplanned hospitalization leading to urgent revascularization (MACE).

FAME-2

888 patients with chronic stable angina and at least one vessel with FFR of 0.80 or less. Randomized to: Stents plus MT for all lesions with FFR of 0.80 or less (447), or MT alone (441). Registry: patients with FFR >0.80 for all lesions. Primary end point: MACE (death, MI, urgent revascularization).

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MACE in Patients with Chronic Stable Angina: FFR Guided PCI v. Medical Therapy Alone

Fearon et al., (2017) Circulation (published

• nline).

Angina Control in Patients with Chronic Stable Angina: FFR Guided PCI v. Medical Therapy Alone

Fearon et al., (2017) Circulation (published online).

Cost Comparison: FFR Guided PCI v. Medical Therapy Alone

Fearon et al., (2017) Circulation (pub. online).

Conclusions

• IRA PCI alone, for almost all patients with STEMI and MVD.
• Avoid acute MV PCI in STEMI patients with MVD.
• Staged PCI of non-infarct lesions is preferable.
• Above points are also true for patients in cardiogenic shock.
• There is still a role for PCI in patients with chronic stable

angina.