cabg clinical trial summary slides

CABGCABG

Clinical Trial Summary SlidesClinical Trial Summary Slides

www.cardiosource.com

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Amiodarone Prophylaxis for Atrial Fibrillation after CABG

AFp<0.0001

(%)

Trial Design: Randomized, double-blinded trial of treatment with amiodarone therapy (600 mg/day in 3doses plus pre-surgery IV dose; n=55) or placebo (n=55) in patients undergoing CABG and at high-riskfor AF. Primary endpoint was documented atrial fibrillation (AF) sustained >10 minutes post-operatively.

Results• Primary endpoint of AF in amiodarone arm vsplacebo (Figure)• No difference in symptomatic AF (22% vs 31%,p=0.49)• Length of hospital stay ↓ in amiodarone arm(Figure), as was ICU length of stay (1.8 days vs2.4 days, p=0.001)• Hospitalization costs ↓ in amiodarone arm(18428 € vs 19352 €, p=0.007)Conclusions• Among patients undergoing CABG surgery,prophylaxis treatment with amiodarone wasassociated with a reduction in post-operative AFcompared with placebo• Results similar to larger PAPABEAR trial, whichshowed reduction in postoperative AF/atrial f lutterassociated with prophylaxis amiodarone therapy

Amiodarone Placebo

Eur Heart J 2006;27:1584-1591

Length of hospital stayp=0.03

(day

s)


Results• CABG group had ↑ event-free survival, attributable to incidence of repeat revascularization in stent arm• No statistically significant difference in incidence of death (2.8% vs. 2.5%), CVA (2.0% vs. 1.5%), or MI (4.0 vs. 5.3)• Study of diabetic subgroup revealed trend towards ↓ 1 year mortality in diabetics in CAGB arm (3.1%) compared to stent arm (6.3%), although not statistical significantConclusions• Among patients with multivessel coronary artery disease, treatment with CABG was associated with an improvement in primary composite endpoint of freedom from MACE at 1 years compared with stenting • Similar to previous studies of PTCA alone, PTCA with stent placement was associated with higher incidence of revascularization than CABG at 1 yearLimitations• Trial preceeded use of drug-eluting stents

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1001 year event-free

survivalp<0.001

ARTS

N Engl J Med 2001; 344: 1117-24.

Trial Design: ARTS was a multicenter randomized trial of coronary stenting vs CABG inpatients with 2 vessel coronary disease amenable to stent placement. Patients werefollowed for 5 years. Primary endpoint was survival free from MI, cerebrovascular event, orrepeat revascularization at 1 year.

%

CABG Stent


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Results• Delivery success of ASMT 100%• PET scans after myoblast transplantation demonstrated significant conversion of scar area to viable muscle tissue in 4 patients• NYHA class heart failure improved at 1 year (Figure) • LVEF significantly at 1 year (Figure)• Four patients had serious adverse events possibly related to transplantationConclusions• Among patients with prior MI scheduled for elective CABG, ASMT was feasible and safe in this phase I study• Much larger randomized phase 2 and 3 clinical trials will be needed to assess efficacy and a broader safety evaluation• Randomized trial would help determine if improvements in EF and NYHA class were related to transplantation or to CABG procedure

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Autologous Skeletal Myoblast Transplantation in Patients Undergoing CABG

NYHA Class

Trial Design: This was Phase 1 safety and feasibility trial of autologous skeletal myoblast (ASM)transplantation in patients (n=24) with prior MI scheduled to undergo elective coronary artery bypass grafting(CABG).

Presented at ACC Scientific Sessions 2005

Ejection Fraction

1 YearBaseline

%


Results• Device type ICD for 51% and CRT defibrillator for 49%• Of those who underwent VSM, 75.5% passed 21-J conversion; of those who underwent DSM, 81.3% passed 21-J conversion• Discrepancy between VSM and DSM screening following crossover in 65 patients, 94% of whom passed their 21-J confirmation testing• Testing results similar when randomized to VSM vs. DSM screening first• Majority of clinical VT/VF episodes (86%) terminated by the first shock, with no difference by randomization group (Figure)Conclusions• Among patients receiving ICD or CRT defibrillator, device testing at time of implantation using either vulnerability safety margin or defibrillation safety margin screening at 14 J were associated with similar rates of termination of clinical VT/VF episodes by first shock• VSM or DSM screening at 14 J both shown to have similar positive predictive accuracy in present trial

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ASSURE%

Trial Design: ASSURE was a randomized, crossover trial of single vs. multiple ventricular fibrillation (VF)induction/defibrillation tests at implantation on the device's ability to sense, detect, and convert VF in patientsreceiving an ICD or CRT defibrillator. Patients were randomized to vulnerability safety margin (VSM) ordefibrillation safety margin (DSM) screening at 14 J. Each group then crossed over to opposite testing.

VSM DSM

Termination Success of VT/VF Episode with

First Shock

Circulation. 2007;115:2382-2389


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BARI

N Engl J Med 1996; 335: 217-225

%

Results• Median hospital stay 12 days for CABG vs 7 days for PTCA• All-cause mortality trended ↓ in CABG arm, while cardiac mortality significantly ↓ (Figure)• Initial cost of PTCA ↓ than CABG, but gap narrowed at 5 years• Repeat revascularization ↓ in CABG group through 5 years (8% vs 54%)Conclusions• Among patients with multivessel coronary artery disease, treatment with CABG was not associated with a difference in all-cause mortality but was associated with a lower rate of cardiac mortality compared with PTCA• Additionally, need for repeat revascularization was higher with PTCA vs CABG

Trial Design: BARI was a multicenter randomized trial of CABG vs PTCA in patients withmultivessel coronary artery disease. Patients were followed for 5 years. Primary endpointwas all-cause mortality.

CABG PTCA

All-cause mortalityp=0.19

Cardiac mortalityRR 1.55p=0.02


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Best Bypass Surgery – Cognitive Study

Cognitive dysfunction(≥2 of 7 possible deficits)

p=0.7

(%)

Trial Design: Elderly, high-risk patients from the BBS trial were randomized to off-pump CABG (OPCAB;n=61) or conventional CABG (CCAB; n=59) and enrolled in the cognitive study. Follow-up was obtainedat 3 months to evaluate cognitive change compared with baseline.

Results• Mean age 76 years and mean EuroSCORE 6.68• No difference in cognitive dysfunction betweentreatment groups regardless of definition used(Figures)Conclusions• Among elderly high-risk patients undergoingCABG surgery, there was no difference incognitive outcomes at 3 months associated withoff-pump compared with conventional bypasssurgery• Prior studies have evaluated cognitive outcomesbetween OPCAB and CCAB with varied results,but many were conducted in lower risk, youngerpatients• Present study is one of first randomized studiesto focus on elderly patients, whom are thought tobe at highest-risk for cognitive impairment• Unknown if similar results would be shown withlonger follow-upOPCAB CCB

Circulation. 2006;113:2790-2795

Cognitive Decline of ≥20%

p=0.8


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CABG PATCH

ICD Control

HR 1.07(95% CI 0.81, 1.42)

New Engl J Med 1997;337:1569-75

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Results• 724 pt enrolled, NYHA class average 2.5, mean age 63.4, 15% female• No significant difference in mortality (Figure)

Conclusions

• Among patients with coronary heart disease, a depressed left ventricular ejection fraction, and an abnormal signal-averaged electrocardiogram undergoing CABG, prophylactic ICD implantation was not associated with an improvement in survival compared with control

Trial Design: CABG PATCH was a multi-center randomized trial of prophylactic ICDimplantation vs control in high risk patients undergoing CABG. Patients were followed fora mean of 3216 months. The primary endpoint was death of any cause during follow-up.

p=0.64


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Results• Type of surgery predominantly isolated CABG (81%) • Primary endpoint of post-operative AF ↓ in hydrocortisone group (Figure), as was in-hospital AF (36.7% vs. 51.7, p = 0.02)• No difference in death, stroke or perioperative MI • Superficial wound infections occurred in 14% of each group• Post-operative CRP ↓ in hydrocortisone group (Figure)Conclusions• Among patients without AF undergoing either CABG surgery, aortic valve replacement, or combined surgery, treatment with IV hydrocortisone after cardiac surgery associated with reduction in atrial fibrillation by 84 hours compared with placebo• Mechanism of reduction in AF not known, although authors hypothesized there may be inflammatory mechanism and point to reduction in CRP in hydrocortisone group

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Corticosteroids for Prevention of AF after Cardiac Surgery%

Trial Design: The study was a randomized, double-blind trial of hydrocortisone (100 mg; n = 120) or placebo (n= 121) in patients without AF undergoing first on-pump CABG surgery, aortic valve replacement, or combinedCABG and aortic valve replacement. Primary endpoint was occurrence of AF during the first 84 hours aftercardiac surgery.

Hydrocortisone Placebo

AF during the first 84 hours after surgery

p = 0.004

Day 1 Post-operative CRP

p = 0.02

JAMA. 2007;297:1562-1567

mg/

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CQI in CABG

Pre-intervention

Post-intervention

Pre-op Beta-Blocker Use

p = 0.04*

%

Trial Design: CQI in CABG was a randomized trial testing whether a low-intensity CQI intervention ofidentifying a surgeon leader for each site and providing education materials and feedback wouldimprove the use of two treatments associated with improved outcomes in CABG. Sites wererandomized to preoperative beta-blocker use (n=124), internal mammary artery (IMA) grafts for CABG inpatients age >75 (n=120), or 3) control (n=115). The primary endpoint was improvement in use of thespecified intervention at 2 year follow-up.

%

Results• in pre-op BB use occurred morequickly in CQI intervention arm thancontrol arm (p=0.04)• IMA graft use in the elderly but wasnot significantly different from controlarm (p=0.20)• Lower volume sites improved in bothpre-op BB use (p=0.04) and IMA graftuse in the elderly (p=0.02) with theinterventionConclusions• Minimal intervention of physicianleader identification and education canincrease use of therapies previouslyshown to be clinically effective

JAMA. 2003;290:49-56

IMA Graft Usein Pts Age >75

p = 0.20*

Pre-intervention

Post-intervention

* p-value for comparison of change in treated group vs change in control group


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EXPEDITION

Death/MI at day 5RRR 18.3%p=0.0002

(%)

Trial Design: EXPEDITION was a randomized, double-blinded trial of treatment with cariporide (n=2,870)or placebo (n=2,891) for 2 hours prior to surgery and continuing for 49 hours after surgery in patientsundergoing CABG. The primary endpoint was death or MI by day 5.

Results• Trial discontinued early by DSMB to explore risksand benefits seen with cariporide therapy• Primary endpoint of death or MI at day 5 incariporide arm vs placebo (Figure)• Similar results at 30 days (18.3% vs 21.8%, RRR16.1%, p=0.0009) and 6 months (20.2% vs 23.9%,RRR 15.7%, p=0.0006)• Composite driven by MI in cariporide arm(14.4% vs 18.9% at 5 days, p<0.0001; 13.8% vs18.5% at 6 months, p<0.0001)• Cerebrovascular events in cariporide arm atboth 5 days (Figure) and 6 months (4.5% vs 2.4%,p<0.0001), and were primarily ischemic strokesConclusions• Among high-risk patients undergoing CABGsurgery, treatment with cariporide was associatedwith a reduction in death or MI at day 5 vs placebobut was associated with an increase incerebrovascular adverse events, prompting the trialto be discontinued early to weigh the risk-benefitprofile

Cariporide Placebo n=2,870 n=2,891

AHA 2003 Late Breaking Trials

CerebrovascularEvents at day 5

p<0.0001

(%)


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Results• Median time waiting for surgery 8.2 weeks in IMT group and 7.0 weeks in usual care group• Duration of exercise in IMT group 29.7 days• Mean inspiratory muscle strength and respiratory muscle endurance ↑ from baseline in IMT group but not in usual care group• Primary endpoint of post-surgery PPCs ↓ in IMT group vs usual care group, as was pneumonia (Figures)• Duration of hospitalization shorter in IMT group (median 7 days vs 8 days, p = 0.02)Conclusions• Among patients undergoing elective CABG, pre-operative intensive inspiratory muscle training was associated with reduction in post-operative pulmonary complications• While results very favorable for pre-operative IMT, length of time waiting for CABG quite long (7-8 weeks) and unclear if similar results would occur in shorter time frame• Likely most US patients undergo CABG more quickly

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Intensive Inspiratory Training in CABG Patients

Pulmonary ComplicationsOR 0.52, p = 0.02

%

Trial Design: The study was a randomized, single center trial of pre-operative inspiratory muscle training (IMT)(n = 140) or usual care (n = 139) in patients undergoing elective CABG. Primary endpoint was incidence ofpost-operative pulmonary complications (PPCs) by hospital discharge.

JAMA. 2006;296:1851-1857

Inspiratory Muscle Training Usual Care

PneumoniaOR 0.40, p = 0.01

%


Results• Trial discontinued early due to futility• Viability of cells 95% and purity 89• No difference in rates of ventricular arrhythmias at 6 months between groups • No difference in safety endpoint of MACE at 6 months for either dose vs placebo• No difference in primary endpoint of change in LVEF at 6 months (Figure)• Median change in LV end diastolic volume reduced to greater extent with high-dose injection vs. placebo (-23.0 mL vs. +9.0 mL, p = 0.006); no difference for low-dose vs. placebo (-9.0 mL vs. +9.0 mL, p = 0.62)Conclusions• Among post-MI patients with low EF undergoingCABG, injection of autologous myoblasts was notassociated with difference in change in LVEF at 6months compared with placebo injection• No evidence of adverse safety events including MACEand ventricular arrhythmia• Remodeling reversal somewhat improved in high-dosemyoblast group vs placebo

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MAGIC%

Trial Design: MAGIC was a randomized trial of autologous myoblasts in and around the infarct area in a lowdose (400 million cells; n = 33) or high dose (800 million cells; n = 30) or placebo injections (n = 34) in post-MIpatients with low ejection fractions undergoing CABG surgery. Primary efficacy endpoint was LVEF in thepreviously akinetic segments.

Presented at AHA 2006

High-dose

Increase in LVEF at 6 monthsp = NS for each vs. placebo

Low-dose

Placebo


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Meta-analysis of CABG vs Stenting for Treatment of Multivessel Disease

Death, MI or stroke p=NS

%

Trial Design: The meta-analysis included 3,051 patients from the ARTS, SoS, ERACI-2 and MASS-2 trials thatrandomized patients with multivessel disease to coronary bypass surgery or stenting. The primary endpointwas the composite of death, myocardial infarction or stroke at 1 year.

Presented at ESC 2003

Results• More than 50% of patients in meta-analysis had two-vessel disease• Glycoprotein IIb/IIIa inhibitors used in 7% of patients in stent group• No difference in primary endpoint of composite of death, myocardial infarction or stroke (Figure)• Mortality rates also did not differ between bypass surgery and stent groups (Figure)Conclusions• Among patients with multivessel coronary arterydisease, there was no statistical difference betweentreatment with bypass surgery vs stenting in primaryendpoint of death, MI or stroke at 1 year• Meta-analysis was conducting using trials thatenrolled patients from 1995 to 2000 and used baremetal stents and primarily traditional on-pump bypasssurgery• Several changes in practice in both groups, includingdrug-eluting stents and off-pump revascularizationsurgery

Bypass surgery

Deathp=NS

%

Stent


Results• Mean peak increase in serum creatinine ↓ in nesiritide group vs placebo (Figure)• Urine output in first 24 hours post-op ↑ in nesiritide group (2,926 ml vs. 2,350 ml; p < 0.001)• Length of hospitalization shorter in nesiritide group (mean 9.1 days vs. 11.5 days, p = 0.043)• Mortality at 180 days ↓ in nesiritide group (Figure)• No difference in serious adverse eventsConclusions• Among patients with LV dysfunction undergoing CABG with CPB, perioperative infusion of nesiritide was associated with improvements in renal function and reduction in death at 6 months compared with placebo• Benefit particularly evident in patients with pre-operative renal dysfunction• Results of present study differ from studies performed in patients undergoing medical therapy for heart failure, which did not show beneficial effect of nesiritide on serum creatinine

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NAPA

Peak increase in serum creatinine

p < 0.001

mg/

dl

Trial Design: NAPA was a randomized trial of nesiritide (n = 141) or placebo (n = 138) in patients with leftventricular dysfunction undergoing CABG. Patients were followed for 6 months.

J Am Coll Cardiol 2007;49:epub before print

Nesiritide Placebo

Mortality at 6 months p = 0.046

%


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PAPABEAR

AF/AFLHR 0.52

95% CI 0.34-0.69p<0.001

(%)

Trial Design: PAPABEAR was a randomized, double-blinded trial of treatment with amiodarone therapy(10 mg/kg/d given in 2 doses; n=299) or placebo (n=301) given for 6 days prior to CABG. The primaryendpoint was atrial fibrillation (AF) or atrial flutter (AFL) sustained >5 minutes that precipitatedtreatment and occurred on day 0-6 post-operative.

Results• Primary endpoint of AF or AFL in amiodaronearm vs placebo (Figure)• Similar results in subgroup analysis of pts age<65 years or age 65, CABG surgery only or valve/CABG surgery, with or without pre-operative beta-blocker therapy• In patients who experienced AF, ventricularresponse rate slower in amiodarone arm (105 bpmvs 131 bpm, p<0.001)• No difference in number of AF episodes, AF/AFLburden, or onset day• Length of hospital stay trended in amiodaronearm (Figure)• Adverse events in amiodarone arm (11.4% vs5.3%, p=0.008)• No difference in 1 year mortalityConclusions• Among patients undergoing CABG surgery,prophylaxis treatment with amiodarone wasassociated with a reduction in post-operativeAF/AFL thru day 6 post-op compared with placeboAmiodarone Placebo n=299 n=301

JAMA. 2005;294:3093-3100

Length of hospital stayp=0.11

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Results• Among 2,400 patients in angiographic cohort, no difference between groups in primary endpoint (Figure)• Results similar in per graft analysis (failure 28.5% vs 29.7%, p=0.44)• No difference in mean vein graft diameter in non-occluded grafts (2.92 mm for edifoligide vs 2.97 mm for placebo, p=0.17)• At 1 year clinical follow-up, composite event trended ↓ in edifoligide group but NS (Figure)Conclusions• Among patients undergoing CABG surgery, treatment of vein grafts with edifoligide, an oligonucleotide decoy that binds to and inhibits E2F transcription factors and prevents neointimal hyperplasia, was not associated with a difference in vein graft failure at 12-18 months post-surgery compared with placebo• Although no benefit on angiographic parameters, clinical events at 1 year trended ↓ in edifoligide group, but finding may be spurious • Longer clinical follow-up through 5 years planned

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PREVENT IV

Vein graft failurep = 0.66

%

Trial Design: PREVENT IV was a randomized trial of treatment of vein grafts ex vivo with either edifoligide(n=1508) or placebo (n=1506) in a pressure-mediated delivery system among patients undergoing CABGsurgery. Primary endpoint was angiographic vein graft failure (stenosis ≥75%) at 12-18 months after surgery.

JAMA. 2005;294:2446-2454

Edifoligide Placebo

Death, MI orRevascularization

with Vein Graft Failure at 1 yearp = 0.16

%


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PRIMO-CABG

Death/MI at 4 daysRRR 26% in CABG-only pts, p=0.014

RRR 24% in all pts, p=0.008

CA

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Trial Design: PRIMO-CABG was a randomized, double-blind trial of treatment with pexelizumab(bolus+24 hour infusion; n=1,553) or matching placebo (n=1,546) in patients undergoing CABG surgerywith or without concomitant valve surgery. The primary endpoint was death or MI at 30 day in CABG-only cohort.

Results• Pexelizumab treatment was associated with inperi-procedural CK-MB elevation vs placebo• Death or MI at 4 days in pexelizumab arm vsplacebo in both all patient analysis (9.1% vs 11.9%,RRR 24%, p=0.008) and CABG-only pts (Figure)• Death or MI by 30 days remained inpexelizumab arm in all patient analysis (11.5% vs14.0%, p=0.030) but did not reach significance inCABG-only cohort (Figure; primary endpoint)• In subgroup of patients with >1 cardiac risk factor,death/MI at 30 days in pexelizumab arm in CABGonly pts (11.7% vs 16.3%, RRR 28%, p=0.003)• No differences in adverse eventsConclusions• Among patients undergoing CABG surgery,treatment with pexelizumab was not associatedwith a significant reduction in primary endpoint ofdeath or MI at 30 day follow-up compared withplacebo but was associated with reductions indeath or MI at 4 days and peri-procedural CK-MBelevationsPexelizumab Placebo n=1,553 n=1,546

AHA 2003 Late Breaking Trials

Death/MI at 30 daysCABG-only pts, p=0.069

All pts, p=0.030


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Results• Urgent CABG performed in 72% of patients • Primary endpoint of death or MI at 30 days did not differ by treatment group (Figure)• Among components of composite, death trended ↓ with pexelizumab (Figure) but no difference in MI (12.6% vs 13.3%, p=0.311) • No difference in serious AEs (31.2% vs 32.5%) • Sepsis ↓ in pexelizumab group (2.1% for 3.1%)Conclusions• Among patients undergoing CABG surgery, treatment with pexelizumab was not associated with difference in death or MI at 30 days compared with placebo• In meta-analysis of all CABG patients in 3 randomized trials with pexelizumab, significant 21% risk reduction in mortality observed (p=0.043)• Unclear what mechanism of action is for mortality reduction given mixed results in reduction of MI

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PRIMO-CABG II

Death or MI at 30 daysp = 0.201

%

Trial Design: PRIMO-CABG II was a randomized, double-blind trial of pexelizumab (2.0 mg/kg bolus + 24 hourinfusion) or matching placebo immediately prior to surgery among patients undergoing CABG surgery.Primary endpoint was death or MI through 30 days post-operative.

Pexelizumab Placebo

Death at 30 daysp = 0.177

%

Presented at ACC 2006


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Propensity Analysis of Long-Term Survival After Surgical or Percutaneous Revascularization

Mortality at 5 yearsUnadjusted HR 1.13, p=0.07Adjusted HR 2.1, p<0.0001

%

Trial Design: The study evaluated long-term survival rates after percutaneous coronary intervention (PCI;n=872) or surgical coronary revascularization (CABG; n=5,161) in consecutive patients at the Cleveland Clinicwith multivessel coronary artery disease and high-risk clinical features. Patients were followed for a medianof 5.2 years. The primary endpoint was all-cause mortality.

Circulation. 2004;109:

Results• Patients undergoing CABG were generally higher risk than patients undergoing PCI, with higher rates of hypertension, prior MI, and left main, LAD, and triple vessel disease, and lower ejection fractions • Among PCI patients, stents used in 70% and GP IIb/IIIa inhibitors in 51%• Mortality in PCI cohort vs CABG cohort (Figure)• Similar results when adjusting for propensity score for performance of PCI (HR 2.3; 95% CI, 1.9-2.9; p<0.0001)• For stenting (n=609) vs CABG, stenting associated risk of death (adjusted HR 2.2; 95% CI 1.7-2.9, p<0.0001)Conclusions• Among patients with multivessel coronary artery disease and high-risk clinical features, revascularization with PCI was associated with an increased risk of death at 5 years compared with revascularization with CABGLimitations• Registry study• Single center with very low perioperative mortalityPCI CABG


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Results• Harvesting of radial artery well tolerated• Primary endpoint of graft occlusion ↑ in SVG vs radial artery grafts (Figure)• Diffuse graft narrowing (i.e., angiographic "string sign") ↑ in radial artery grafts vs SVGs (Figure)• No difference in perfect graft patency (i.e., TIMI flow grade 3) by graft type (87.7% for radial vs 85.7% for SVG)• Survival at 1 year 98.6%; perioperative MI occurred in region of radial artery graft in 3.2% of patients and in region of SVG in 3.0%Conclusions• Among patients undergoing CABG, graft occulusion at 1 year was lower in radial artery grafts compared with saphenous vein grafts• Prior studies have demonstrated internal thoracic artery to be superior to SVG, but randomized data evaluating radial artery grafts lacking• Patients will undergo angiographic follow-up at 5 years to evaluate long-term patency

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RAPS

Diffuse graftnarrowing at 1 year

p = 0.001

Trial Design: In the RAPS trial, patients undergoing coronary artery bypass surgery were randomized to one oftwo strategies: 1) radial artery grafting to the circumflex territory and SVG to the right coronary artery or 2)radial artery grafting to the right coronary artery and SVG to the circumflex territory. Primary endpoint wasgraft occlusion at 1 year.

N Engl J Med 2004;351:2302-9

SVG Radial artery

Complete graftocclusion at 1 year

p = 0.009%

%


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Results• FilterWire used in 76% of control group cases• Visible debris retrieved in 63.5% of Spider group and 61.9% of control group• Device success high in both groups (Figure)• Primary endpoint of MACE at 30 days met criteria for non-inferiority (Figure)• No differences in components of MACE composite, including death (0.3% vs. 0.6%), myocardial infarction (MI) (8.5% vs. 7.6%), or target vessel revascularization (1.1% each)Conclusions• Among patients undergoing intervention for SVG lesions, use of Spider SVG distal protection device was non-inferior with regard to MACE at 30 days compared with distal protection using FilterWire or GuardWire device• Distal protection with filter devices requires lesion to be crossed before filter can be delivered• Spider device is preloaded filter with dual-ended catheter that allows for both delivery and recovery of filter

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SPIDER

MACE at 30 daysp = 0.012 for non-inferiority

%

Trial Design: SPIDER was a randomized trial of the Spider saphenous vein graft (SVG) distal protection devicecompared with distal protection using either the FilterWire or GuardWire device among patients undergoingintervention for SVG lesions. Primary endpoint was MACE at 30 days, evaluated for non-inferiority.

Presented at TCT 2005

Spider Group FilterWire or GuardWire Group

Device Success


Results• ~80% of patients had religious affiliation• Prayer performed by intercessors 1-4 times/day for 30 seconds to several hours • No difference in primary endpoint of any complication within 30 days among those uncertain of prayer status but IP certain had ↑ event rate (Figure)• No difference in mortality at 30 days in any group (2.6% for IP-uncertain, 2.4% for no IP-uncertain, 2.2% for IP-certain)Conclusions• Among patients undergoing CABG surgery, intercessory prayer, whether known or unknown, was not associated with reduced complications through 30 days compared with no intercessory prayer• Few studies evaluated impact of intercessory prayer in randomized, blinded manner• Present study makes no conclusion on prayer by family or friends, only on intercessory prayer by strangers

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STEP

Any postoperative complication by 30 daysp = 0.67 for IP-U vs no IP-Up = 0.025 for IP-U vs IP-C

%Trial Design: STEP was a randomized trial of intercessory prayer (IP), being told they may or may not receiveprayer (IP-uncertain; n=604); no IP, being told they may or may not receive prayer (no IP-uncertain; n=597); orIP, being told they will receive prayer (IP-certain; n=601) among patients undergoing CABG surgery. Primaryendpoint was any postoperative complication within 30 days of CABG.

Intercessory Prayer /

Uncertain

No Intercessory Prayer /

Uncertain Am Heart J 2006;151:934-42

Intercessory Prayer / Certain


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TIME

MedicalManagement

InvasiveStrategy

MACE at6 monthsp < 0.0001

Lancet 2001; 358: 951-7

n=155 n=150

Per

cent

Results• Major adverse cardiac events in optimal medical management group than invasive group (Figure)• Both groups experienced improvements in quality of life and angina, however, these improvements were significantly in patients in invasive group

Conclusions• Among patients with chronic angina treated with at least 2 anti-anginal medications and age 75 years, treatment with an invasive strategy was association with a reduction in MACE at 6 months• Similar data previously shown in younger patients

Trial Design: TIME was a multi-center randomized trial of an invasive approach (coronaryangiography followed by PCI or CABG if feasible) compared with optimal medical therapy inpatients aged 75 years or older with chronic angina in spite of at least two antianginal medications.Patients were followed for 6 months. The endpoints were MACE and quality of life at 6 months.

cabg clinical trial summary slides

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