��M The American Journal of Cardiology® | October 22-27, 2006 | TCT Abstracts/OrAl

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Monday, october 25, 2006, 2:00 PM - 6:00 PM

Confrontational Angioplasty - Fiercely Debating the Issues

Room 151 AB

Wednesday, October 25, 2006, 2:00 pm – 6:00 pm

(abstract nos. 115-118)

TCT-115

Where do Delays Occur in ST-Elevation Myocardial Infarction Patients Transferred for Primary Percutaneous Coronary Intervention?

Marc C Newell1, Katie M Menssen1, Joseph A Browning1, David M Larson2, Daniel L Lips1, Wes R Pedersen1, Michael R Mooney1, Barbara T Unger1, Timothy D Henry1 1Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN;2Ridgeview Medical Center/Minneapolis Heart Institute Foundation at Abbott Northwestern Hospital, Minneapolis, MN

Background: Trials demonstrate STEMI pts benefit from transfer for primary PCI compared to fibrinolysis. AHA/ACC guidelines recommend door-to-balloon of 90 min for SteMI pts receiving primary PcI. nrMI data indicate 4% are treated <90 min, and 16% <120 min. the reasons for delay have not been well studied.Methods: In our rapid transfer program for primary PcI in SteMI pts, detailed time data and reason for any delay are recorded. no pts are excluded from analysis, including cardiogenic shock, out of hospital cardiac arrest, and non-diagnostic initial eKG.Results: From 3/03 to 3/06, 750 pts were transferred ≤60 miles (Zone 1) or 60-210 miles (Zone 2) for primary PcI. Goals, median times and percent at goal for each segment are reported in the table. delays in the community hospital (in door 1-out door 1) were awaiting transport (35.4%), ed physician related delays (26.2%), diagnostic dilemmas (19.2%), non-diagnostic initial eKGs (12.1%), and cardiac arrest (5.8%). delays during transfer were weather (64.7%) or traffic (35.3%) related. Delays at the PCI center (door 2-to-balloon) were due to complex procedures (66%), cath lab team delays (26%), and diagnostic dilemmas (6%).

SteMI transfersIn door 1-out door 1

transferdoor 2-to-balloon (PcI center)

total door 1 to balloon

Goal Zone 1, n=471 ≤30 min ≤30 min ≤30 min ≤90 minGoal Zone 2, n=279 ≤30 min ≤60 min ≤30 min ≤120 min

% at goal Zone 112% ≤30 min; 43% ≤45 min

68% ≤30 min

80% ≤30 min41% ≤90 min;tct-81% ≤120 min

% at goal Zone 24% ≤30 min; 20% ≤45 min

44% ≤30 min;tct-89% ≤60 min

85% ≤30 min51% ≤120 min;tct-80%≤150 min

Median door-to-balloon Zone 1 (±Sd

49 (36, 62) 22 (16, 32) 20 (16, 29) 95 (83, 113)

Median door-to-balloon Zone 2 (±Sd)

60 (49, 80) 32 (25, 48) 18 (15, 24) 120 (101, 144)

Conclusions: A standardized, organized transfer system significantly improves door-to-balloon times, with a majority of patients near goal. the most common reasons for delay are waiting for transport and diagnostic dilemmas at the community hospital, weather and traffic during transfer, and complex procedures at the PcI hospital.

TCT-116

Off-label use of Drug Eluting Stents Appears to be Associated with Higher Rates of Acute Angiographic Complications Following PCI in “Real World” Clinical Practice

Htut K Win1, Angel E Caldera1, Kelly Maresh2, Sachin Marulkhar3, Deborah Nassif3, David J Cohen3, Neil S Kleiman2, for EVENT investigators

1Baylor College of Medicine, Houston, TX;2Methodist Debakey Heart Center, Houston, TX;3Harvard Research Institute, Boston, MA

Background: clinical trials of drug-eluting stents (deS) have generally excluded patients with high risk features. the eVent registry aims to assess “real world clinical practice” by performing a prospective evaluation of consecutive patients undergoing stent implantation. We sought to evaluate whether the off-label use of deS was associated with higher degree of acute angiographic complications (aac) following stent placement.Methods: From July ‘04 to March ‘05, 1755 patients enrolled in Wave 1 of the registry received at least 1 deS. these patients were considered “off-Label” if they had one or more of the following characteristics: eF< 25%, baseline cKMb> 3 times upper normal limit, unprotected left main, total occlusion, bifurcation, graft, > 1 lesion treated, maximum balloon diameter > 4mm and total stent length > 36mm. We compared the frequency of aac between patients with off-label vs. on-label indications for deS.Results: a total of 968 patients (55.1%) met the criteria for the off-label group. these patients in off-label group were more likely to have a side branch occlusion [Hr(95% cI)= 4.3(1.4-8.6), p=0.004) and dissection [Hr(95% cI)= 3.07(1.55-6.1), p <0.001]. the remaining aac are depicted in the table.

angiographic complications

Off-Label On-Label Hazard RatioTCT-95% CI

P value

distal embolization 0.2% (2/968) 0.0% (0/787) - -

abrupt closure 0.4% (4/968) 0.3% (2/787) 1.62 (0.25-12) 0.87

thrombus 0.7% (7/968) 0.1% (1/787) 5.7 (0.7-125) 0.137

No Reflow 1.0% (10/968) 0.3% (2/787) 4.0 (0.84-27) 0.09

Side-branch occlusion 3.0% (29/968) 0.9% (7/787) 3.4 (1.4-8.6) 0.004

dissection 4.5% (44/968) 1.5% (12/787) 3.07 (1.55-6.1) 0.001

Conclusions: In “real world” clinical practice, the off-label use of deS appears to be associated with higher degree of side branch occlusion and dissection when compared with the use for on-label indications as tested in clinical trials.

TCT-117

Outcomes Predictors Following Drug-Eluting Stent Implantation

Gloria Melzi1, John Cosgrave2, Simon Corbett2, Nuccia Morici3, Tiziana C. Aranzulla3, Alaide Chieffo3, Flavio Airoldi1, Alfredo Castelli1, Rade Babic2, Antonio Colombo1 1San Raffaele Scientific Institute and EMO Centro Cuore Columbus, Milan, Italy2EMO Centro Cuore Columbus, Milan, Italy3San Raffaele Scientific Institute, Milan, Italy

Background: Limited “real world” data exist on clinical and angiographic characteristics associated with the occurrence of events following drug-eluting stent (deS) implantation. We sought to determine the predictors of outcomes at one year after deS implantation.Methods: all consecutive patients who underwent elective deS implantation for de novo lesions in native coronary arteries between March 2003 and March 2005 were considered for analysis. the endpoints were major adverse cardiac events (MACE) defined as a composite of death, myocardial infarction, target lesion revascularization (tLr) and target vessel revascularization (tVr).Results: the study population consisted of 1283 patients (2269 lesions). diabetes was present in 342 (26.6%) patients and 962 (74.9%) had multivessel

The American Journal of Cardiology® | October 22-27, 2006 | TCT Abstracts/OrAl ��M

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Monday, october 25, 2006, 2:00 PM - 6:00 PM

disease. the mean age was 63.3±10.8 years and LVeF 52.7±9.8%. b2-c type lesions were present in 1678 (73.9%), chronic total occlusions in 215 (9.5%) and bifurcations in 371 (16.4%) lesions. the mean total stent length per patient was 50.15±36.6 mm and the mean number of stents per lesion was 1.13±0.41. during one year follow-up Mace occurred in 272 (21.2%) patients. angiographic follow-up, available in 70.3% of the lesions, revealed a tLr rate of 11.4% (259 lesions). Multivariate analysis showed that the predictors of Mace were diabetes (or 2.04; 95% cI 1.43-2.89; p=0.001), renal failure requiring dialysis (or 17.8; 95% 95% cI 1.79-177.14; p=0.014), the need for intra-aortic balloon pump (or 2.9; 95% cI 1.43-5.9; p=0.003) and the total stent length per patient (or 1.00; 95% cI 1.003-1.01; p=0.001). Predictors of tLr were insulin-requiring diabetes (or 2.54; 95% cI 1.53-4.2; p=0.0001), intra-aortic balloon pump use(or 4.22; 95% cI 2.57-6.98; p=0.0001), the baseline reference vessel diameter (or 0.72; 95% cI 0.53-0.99; p=0.046) and the number of stents per lesion (or 2.08; 95% cI 1.21-3.54; p=0.007).Conclusions: In the deS era diabetes mellitus remains a strong predictor of Mace and tLr. not surprisingly complex patients and lesions are at greater risk for the occurrence of Mace as well as those with a greater stent burden and smaller vessels.

TCT-118

Influence Of Age On The Outcomes Of Percutaneous And Surgical Treatment In Patients With Multivessel Disease

Bernard De Bruyne1, Victor Legrand2, Shuzo Tanimoto3, Patrick W. Serruys3, Georg Szurawitski4, Alessandro Fontanelli5, Knut Endresen6, Igor Kranjec7, Kari Virtanen8, Christodoulos Stefanadis9 1Onze Lieve Vrouw Ziekenhuis, Aalst, Belgium2C.H.U. Sart Tilman, Liège, Belgium3Thoraxcenter, Rotterdam, The Netherlands4Elisabeth Krankenhaus, Essen, Germany5San Bartolo Hospital, Vicenza, Italy6Rikshospitalet, Oslo, Norway7Clinical Centre Ljubljana, Ljubljana, Slovenia8Helsinki University Hospital, Hus, Finland9Hippokratio Hospital, Athens, Greece

Background: the aim of this study is to evaluate the age-outcomes relationship in patients undergoing surgical or percutaneous revascularization, based on data of the artS trials.Methods: the artSI trial was a randomized trial comparing surgery (cabG, n=605) and bare metal stenting (bMS, n=600) for the treatment of patients with multivessel coronary disease. the artSII trial assessed the results of sirolimus eluting stenting (SeS, n=607) in a matched population with similar baseline characteristics. a total of 1812 patients were reviewed according to four age quartiles (n=453 in each quartile) based on the intension-to-treat principle. Mean age of each quartile was 48.8yrs +/-4.8; 58.5yrs+/-2.1; 65.6yrs+/-1.9; 73.3yrs+/-3.1.Results: older patients had more often hypertension, diabetes, peripheral vascular disease and coPd. the proportion of male, current smokers, hypercholesterolemia, family history and previous MI decreased with age. In general, the clinical presentation was similar among groups as well as the treatment at discharge.The use of LIMA in patients treated by CABG was not influenced by age, neither the number of stents implanted in bMS and SeS groups. Hospital stay was longer in older patients.

death and hierarchical Macce rates (death, stroke, MI, revascularization) rates among quartiles

Q1 Q2 Q3 Q4 p-value

death cabG 0.7% 1.9% 2.7% 5.6% 0.08

death bMS 1.7% 2.8% 3.3% 3.0% 0.80

death SeS 0.8% 0.7% 0.7% 1.7% 0.81

Macce cabG 4.7% 11.4% 15.3% 15.3% 0.007

Macce bMS 24.7% 23.2% 32.7% 25.4% 0.26

Macce SeS 5.5% 10.5% 10.5% 13.7% 0.13

Conclusions: technological advancements in PcI techniques and the use of SeS have completely offset the one year outcome difference seen between cabG and bMS, notably by abolishing the excess need for reintervention seen with bMS. PcI with SeS may even be safer and life saving in the elderly population as compare to cabG.