VCU Pauley Heart Center: A 2009 US News Top 50 Heart and Heart Surgery Hospital

Complex PCI: Multivessel Disease George W. Vetrovec, MD. Kimmerling Chair of Cardiology VCU Pauley Heart Center Virginia Commonwealth University Richmond, Virginia

Disclosures Grants: Cordis, Pfizer, Schering Plough. Consultant: Merck, Pfizer, Lilly, Boston Scientific, Cordis, Baxter. Speakers Bureau: Pfizer, Cordis, Lilly, Gilead I am an Interventional Cardiologist

CABG Trialists Collaboration: Survival Curve for Overall Population Improved Survival with Surgery up to 10 Years VA Coop Study CASS European Study Small Studies Medical vs Surgical Treatment Greatest Benefits in Highest risk subgroups The LANCET, Vol 344, 566, 1994.

PCI Outcomes in MV Disease

ARTS 5 Year Comparative Survival Serruys et al. J Am Coll Cardiol 2005;46:575 81

ARTS 5 Year Event Free Survival From Revascularization Serruys et al. J Am Coll Cardiol 2005;46:575 81

SYNTAX Three Vessel Disease Only Subgroup One Year % MACCE Mortality: PCI 8.0%, CABG 6.6% p = 0.39 Revasc: PCI 14.6%, CABG 5.5% p < 0.001 PCI Filled CABG -Open P< 0.001 Serryus et al.n Engl J Med 2009;360:961-72.

DES vs. CABG in MV Hannon et al. N Engl J Med 2008;358:331-41.

DES vs. CABG in MV

DES vs. CABG in MV CABG PCI Hannon et al. N Engl J Med 2008;358:331-41.

DES vs. CABG in MV Hannon et al. N Engl J Med 2008;358:331-41.

Multivessel CAD: What do the Guidelines Recommend?

ACC/AHA Guidelines for Chronic Stable Angina 2002 Class I (PCI) Percutaneous coronary intervention for patients with two- or three-vessel disease with significant proximal LAD CAD, who have anatomy suitable for catheter based therapy and normal LV function and who do not have treated diabetes. (Level of Evidence: B) Percutaneous coronary intervention or CABG for patients with one- or two-vessel CAD without significant proximal LAD CAD but with a large area of viable myocardium and high-risk criteria on noninvasive testing. (Level of Evidence: B) In patients with prior PCI, CABG or PCI for recurrent stenosis associated with a large area of viable myocardium or high-risk criteria on noninvasive testing (Level of Evidence: C) Percutaneous coronary intervention or CABG for patients who have not been successfully treated by medical therapy (see text) and can undergo revascularization with acceptable risk. (Evidence: B)

ACC AHA SCAI Guidelines for Chronic Stable Angina 2002 Class IIa Repeat CABG for patients with multiple saphenous vein graft stenoses, especially when there is significant stenosis of a graft supplying the LAD. It may be appropriate to use PCI for focal saphenous vein graft lesions or multiple stenoses in poor candidates for reoperative surgery. (Level of Evidence: C) Use of PCI or CABG for patients with one- or two-vessel CAD without significant proximal LAD disease but with a moderate area of viable myocardium and demonstrable ischemia on noninvasive testing. (Level of Evidence: B) Use of PCI or CABG for patients with one-vessel disease with significant proximal LAD disease. (Level of Evidence: B)

ACC AHA SCAI Guidelines for Chronic Stable Angina 2002 Class IIb Compared with CABG, PCI for patients with two- or three-vessel disease with significant proximal LAD CAD, who have anatomy suitable for catheter-based therapy, and who have treated diabetes or abnormal LV function. (Level of Evidence: B) PCI for patients with one- or two-vessel CAD without significant proximal LAD CAD who have survived sudden cardiac death or sustained ventricular tachycardia. (Level of Evidence: C)

ACC AHA SCAI Guidelines for Chronic Stable Angina 2002 Class III Use of PCI or CABG for patients with one- or two vessel CAD without significant proximal LAD CAD, who have mild symptoms that are unlikely due to myocardial ischemia, or who have not received an adequate trial of medical therapy and a. have only a small area of viable myocardium or b. have no demonstrable ischemia on noninvasive testing. (Level of Evidence: C) Use of PCI or CABG for patients with borderline coronary stenoses (50% to 60% diameter in locations other than the left main coronary artery) and no demonstrable ischemia on noninvasive testing. (Level of Evidence: C) Use of PCI or CABG for patients with insignificant coronary stenosis (less than 50% diameter). (Level of Evidence: C)

Bare Metal vs. Drug Eluting Stents

Bare Metal vs. Coated Stents: The Stent Twins

DES BMS Medicare Database Malenka e al. JAMA. 2008;299(24):2868-2876

Balancing DES vs. BMS DES BMS Restenosis < 10% Less Late Revasc. LST 0.5%/Year Restenosis +20% More Repeat PCIs Lower LST Similar Late Mortality

Extent of Revascularization?

ARTS: Completeness of Revascularization Complete Revascularization in 84.1% of Surgery Patients Complete Revascularization in 70.5% Of PCI patients. (p<0.001). One year Event Free Survival in PCI: 69.4 vs. 76.6% in favor of greater revascularization. (p<0.05). Need for subsequent revascularization 10.0% vs. 2.0%. (p<0.05). Surgery with incomplete revascularization showed no significant difference. Mortality was not effected in either group.

NY Database Outcome for PCI based on Completeness of Revascularization Hannon :Circulation. 2006;113:2406-2412

COURAGE Outcome Based on Extent of Residual Ischemia Shaw: Circulation. 2008;117:1283-1291

Impact of FFR on Outcome for MV PCI: FAME Composite Endpoint of Death, MI, Revascularization Siebert et al: N Engl J Med 2009;360:213-24.

FAME One Year Results Siebert et al: N Engl J Med 2009;360:213-24.

Extent of Revascularization Eliminating significant ischemia goal with minimal stents. The greater the LV impairment the more important is eliminating ischemia.

Special Subgroups

Diabetes

BARI 2D: OMT and Revascularization in Patients With Diabetes At 5 years, rates of survival did not differ significantly between the revascularization group (88.3%) and the medical-therapy group (87.8%) OMT = optimal medical therapy. The BARI 2D Study Group. N Eng J Med. 2009;360:2503-2515.

Relative Benefit of DES Over BMS for Safety and Efficacy Mulukutla et al: J Am Coll Cardiol Intv 2008;1:139 47

Left Ventricular Dysfunction:

Frequency of PCIs by Severity of LV Dysfunction NY State Data Base for 1998-1999. Stable Patients undergoing PCI - 55,709. Percent by LVEF <25% 3.4% 26-35 7.6% 36-45 17.4% <55% 63% Age 63.8 yrs. Male 68%. White- 88% Prevalence of DM, PVD, CKD, Prior MI & CHF increased with worse LVEF Wallace et al. Am J Cardiol 2009;103:355 360

Stent Implantation in Patients with Severe LV Systolic Dysfunctionn Pts 337 1993-2004, LVEF<35%. Hosp Mort 1.5%; Death at 2 yrs 24.6%, 65% sudden. Death Grp: MI 18%, ICD: 6.7%, Alive Grp: MI 5.4%, ICD 20.7% P< 0.05 for both. Independent Predictors of Death: AMI, More Extensive CAD, Lack of BB, Lack of ICD, LVEF<25% & Completeness of Revascularization. LVEF significantly improved only in Survivors (29 to 35%) Briguori et al. Int J Cardiol. 2009. 3:376-84

Stent in Lesion vs PTCA in Patients with EF<40% 1.000 Survivorship: S(t) 0.850 0.700 0.550 0.400 0.0 1.8 3.5 5.3 7.0 YearsDeathFollowUp Lipinski, CCI 2006, Nusca, AJC 2008. PTCA Stent P<0.05 P<0.05 Current Review DES - 10% BMS - 25% P=0.003

Factors in Patient Selection for MV PCI Anatomic Lesion Morphology. Anatomic Complexity. Potential for Complete Revascularization. LV Function. Vein grafts. Patient Age Renal status Diabetes Potential for Medical Compliance Treatment Strategy: Minimize Complexity Optimal Results, Least Stents Limit Contrast Control Radiation Exposure

Optimizing Outcomes

PCI Outcomes Impact of Procedure Adverse outcomes PCI Procedure Restenosis Stent Thrombosis Disease Progression

Rate of Peri-Procedural CK-MB Elevation in ARTS I and II Subgroups CK Level ARTS II (%) ARTS I CABG (%) ARTS I PCI (%) 3 Fold 1.5 40.2 21.2 Increase 5 Fold 0.3 7.0 4.3 Increase >5 Fold Increase 1.5 12.7 6.2

ARTS II Adjunctive Medications Meds (%) ARTS II ARTS I CABG ARTS I PCI GP IIb/IIIa 33 - - Lipid 90 32 39 Lowering Beta 78 55 55 Blocker ACEI 50 15 26

Further Issues of Greater Relevance to Multivessel PCI

Radiation

Monitoring Outcomes

Mean Unadjusted Hospital Readmission Rates by Hospital Decile of Readmission Curtis, J. P. et al. J Am Coll Cardiol 2009;54:903-907 Copyright 2009 American College of Cardiology Foundation. Restrictions may apply.

Multivessel PCI PCI remains limited by complex anatomic and Patient subsets. Risk Assessment is critical to picking the optimal patients for MV PCI. Vascular Risk Management is an integral component of patient outcome. CABG remains an important treatment modality, particularly for high risk patients or patients requiring adjunctive procedures. Better technology offers promise for increasing opportunities for PCI.

VCU Pauley Heart Center: A 2009 US News Top 50 Heart and Heart Surgery Hospital