Balloon-pump assisted Coronary Intervention Study BCIS-1 Simon Redwood Divaka Perera, Rod Stables, Martyn Thomas

Disclosure Statement of Financial Interest This trial was supported by unrestricted grants from: Datascope Eli Lilly Cordis

During High-Risk PCI ACC/AHA 2001 guidelines for PCI, JACC 2001, 37(8)2239 i-lxvi “… reserved only for patients at the extreme end of the spectrum of hemodynamic compromise… … it should be noted that in patients with borderline hemodynamics, ongoing ischemia, or cardiogenic shock, insertion of an intra-aortic balloon just prior to coronary instrumentation has been associated with improved outcomes” ACC/AHA/SCAI Practice Guidelines Update 2005 “ Elective high-risk PCI can be performed safely without IABP or CPS in most circumstances …. Emergency high-risk PCI such as primary PCI can usually be performed without IABP or CPS…” Current Indications for IABP

Current IABP use : Benchmark Registry Stone et al 2003, JACC 41(11) Cardiogenic Shock 27% CABG 17% VSD / MR 12% Angina / LVF / VT 16% High Risk PCI Non Shock 28%

Elective vs provisional IABP in high-risk PCI 133 pts EF <30, elective PCI Group A: elective IABP, 61 pts. JS Group B: Provisional IABP, 72 pts. JS (p=0.008) Jeopardy score: coronary tree divided into 6 segments: LAD, D1, Cx, OM, RCA, PDA. 2 points for each lesion + 2 for each vessel distal to lesion Elective IABP Conventional PCI P value EF Jeopardy score Type B2/C 87% 64% Severe ↓BP or shock 0% 15% Procedural MACE 0% 17% Correlates of procedural events Odds ratio Elective IABP0.11 ( ) Jeopardy score5.37 ( )0.040 Female sex2.72 ( ) Briguori et al, AHJ 2003;145:700-7

IABP Use in High-Risk PCI N = 114 Elective PCI Non-Randomized 68 Prophylactic 48 Rescue IABP P<0.001 P = 0.02 Mishra et al, Am J Cardiol 2006

Objectives: To compare the efficacy and safety of elective Intra-Aortic Balloon Pump (IABP) insertion prior to high-risk PCI vs. conventional treatment (with no planned IABP use) Structure: Prospective, open, randomised trial UK centres + 4 Polish centres n=300 (150 in each arm) Predicted MACE of 5% v 15%, 274 pts 80% power, sign 5% B alloon-pump assisted C oronary I ntervention S tudy

Primary Outcome Measure Major Adverse Cardiovascular Events at hospital discharge or 28 days (whichever is sooner), including All-Cause Death Acute MI (CKMB > 3xULN) Further revascularization by PCI or CABG CVA BCIS-1

Secondary Outcome Measures 1. Six month mortality 2. Procedural Complications VT/VF requiring cardioversion cardiac arrest requiring CPR/ventilation prolonged hypotension (including IABP insertion in “No planned IABP” group) 3. Procedural success 4. Bleeding complications 5. Vascular complications 6. Duration of hospital stay

Inclusion Criteria 1.Impaired LV function (EF<30%) 2.Extensive Myocardium at Risk LMS lesion Jeopardy Score > 8 Exclusion Criteria Cardiogenic Shock Acute STEMI within preceding 48hours VSD, MR or intractable VT/VF Contraindications to IABP insertion

Jeopardy Score Coronary tree divided into 6 segments: LAD, D1, Cx, OM, RCA, PDA. 2 points for each lesion + 2 for each vessel distal to lesion

Distribution of BCIS-1 20 UK Centres

BCIS-1 Polish Centres National Co- ordinator Dr Pawel Buszman 0

BCIS-1 Recruitment Completed 21 st Jan 09 Total 301 patients

Baseline Characteristics n = 260 % Age mean (sd) 70.8 (9.5) Male20980 Diabetic9235 Prior MI Elective12247 Urgent / Emerg13854

Inclusion Criteria Ejection Fraction (Mean + SD) JeopardyN=247%

Procedural Details Lesions per patient (mean)2.1 N% DES only370- BMS only141- DES & BMS9- GP 2b3a10540

Unajudicated Clinical Events to Discharge/ 28 days n = 260% Death31.2 CVA20.8 MI24/ PCI31.2 CABG10.4 Minor Bleed 2-4g Major Bleed > 4g41.5 LOS Median 2 days

Summary The exact role of haemodynamic support for high-risk PCI is unclear BCIS have designed and completed the first randomised trial of elective vs ‘bailout’ IABP in patients with poor LV function and severe coronary disease Full trial results due Q3 2009

Definition of Myocardial Infarction In BCIS-1 CKMB ≥ 3 X ULN. No ECG changes or symptoms are required Patients with admission MI CKMB ≥ 50% of pre-procedure value Patients with MI 24 hrs after CABG either a) the CKMB value ≥ 5 X ULN and new Q waves b) CKMB ≥10 X ULN (with or without Q waves), no symptoms are required Patients who die but no cardiac markers are available Presence of new ST segment elevation and new chest pain For all other circumstances, standard ESC/AHA definitions apply