2003TRANSCATHETER

CARDIOVASCULARTHERAPEUTICS

Oral Abstract Presentations12:00–2:15 PM

Intervention in Acute MyocardialInfarction

Monday, September 15, 2003

12:00-2:15 PM

Room 201

(Abstract nos. 1-9)

TCT-1A Randomized Trial of a Rapamycin-Eluting Stent in AcuteMyocardial Infarction: Preliminary Results. V. Pasceri,A. Granatelli, C. Pristipino, F. Pelliccia, G. Speciale, B. Pironi,A. Roncella, G. Richichi. Emodinamica, San Filippo Neri Hospital,Rome, Italy

Background: Several clinical trials have shown that rapamycin-elutingstents are highly effective in reducing restenosis following percutane-ous transluminal coronary angioplasty. No study to date, however, hasassessed the safety and effectiveness of drug-eluting stents in acutemyocardial infarction (AMI). Indeed, AMI has been an exclusioncriteria in previous trials because of the risk of stent thrombosis.

Methods: We performed a randomized, controlled trial comparingthe CYPHER rapamycin-eluting stent with the BX Sonic stent in AMI.Inclusion criteria were ST-elevation AMI within 24 hours of symptomonset and 2.5- to 3.0-mm vessel size. We excluded patients withcardiogenic shock and with obvious contraindications to ticlopidinetreatment. Preliminary results of the first 34 patients (aged 62 � 9years, 74% men, 23% with diabetes) are presented.

Results: Of our sample, 18 patients received an average of 1.5 �0.7 CYPHER stents (diameter 2.9 � 0.2, total length 30 � 13 mm), and15 patients received an average of 1.4 � 0.7 BX stents (diameter 2.9 �0.2, total length 28 � 10 mm). Abciximab was used in 97% of cases.Angiographic follow-up at 6 months is ongoing (it has been performedin 40% of cases and will be available at the time of presentation). Therewere no in-hospital events. All patients with the CYPHER stent re-ceived ticlopidine for 6 months (1 month only for BX stent). Afterdischarge, however, 3 patients in the CYPHER group and 1 in the BXgroup stopped ticlopidine due to noncompliance or contraindications.At 4 � 2 months’ follow-up, there were 2 subacute thrombosis in theCYPHER group (at 7–10 days after discharge); both patients had

stopped ticlopidine treatment. No subacute thrombosis occurred in theBX group. There were no cases of clinical restenosis or other events inthe 16 CYPHER patients who continued ticlopidine treatment. Overall,there were 10% new target vessel revascularizations in the CYPHERgroup and 13% in the BX group, but 0% and 14%, respectively, amongpatients taking ticlopidine.

Conclusion: Use of CYPHER stent in AMI appears to be a pos-sibility, but there is a high risk of stent thrombosis in patients who donot take ticlopidine. Further studies using drug-eluting stents shouldtake into account the problem of noncompliance to ticlopidine andclopidogrel treatment, which can increase the risk of thrombosis.

TCT-2Facilitated Percutaneous Coronary Intervention ReducesMortality in Patients With Cardiogenic Shock Due to AcuteMyocardial Infarction. S. Rux, K. Lenßen, S. Sonntag, L. Bruch,P.E. Waurick, F.X. Kleber. Department of Internal Medicine,Division of Cardiology, UKB, Academic Teaching Hospital FreeUniversity, Berlin, Germany.

Background: Acute myocardial infarction (AMI) mortality in patients(pts) suffering from cardiogenic shock (CS) is high (50–60%). Recentstudies suggest that the addition of GPIIb/IIIa inhibitors to eitherthrombolysis (reduced dosage) or primary percutaneous coronary in-tervention (PCI) offers advantages in myocardial salvage and possiblyimproved prognosis.

Methods: We investigated the effects of facilitation of PCI in ptspresenting with cardiogenic shock. Pts were pretreated with GPIIb/IIIainhibitors before cardiac cath and, if cardiac cath was delayed beyond60 minutes, also with a reduced dose of rPA (rtPA). CS was defined asa systolic blood pressure �90 mm Hg for at least 30 minutes withsevere organ hypoperfusion or the need to use catecholamines tostabilize hemodynamics.

Results: Among 600 AMI pts treated at our institution betweenJanuary 1999 and March 2003, 76 (12.7%) required cardiopulmonaryresuscitation (before hospital arrival or in hospital), 86 (14.3%) pre-sented with CS, and 21 of the remaining pts (4.1%) developed cardio-genic shock during hospitalization. Of the total 600 pts, 199 werepretreated with GP inhibitors and reduced-dosage thrombolytics forfacilitation before cardiac cath. Of these pts, 16.1% presented with CS,and 1.2% of the initially hemodynamically stable pts developed CS.Among 401 pts treated with GP inhibitors alone for facilitation, 54(13.5%) presented with CS, and 5.5% of the remaining pts developedCS. Therefore, significantly fewer pts developed CS after additionalpretreatment with a half dose of thrombolytics (p �0.03). Overallhospital mortality was 3.3% and 15.9% in pts suffering from CS.Overall mortality after 180 days was 6.4% in 471 pts who havecurrently reached this follow-up and 20.7% in pts suffering from CS.

Conclusion: We conclude that facilitated PCI in AMI with cardio-genic shock reduces hospital and long-term mortality. The addition ofreduced doses of thrombolytics can prevent the development of CS.

TCT-3Feasibility of Endovascular Cooling as an Adjunct to PrimaryPercutaneous Coronary Intervention: Results of the LOWTEMPPilot Study. E. Kandzari1, A. Chu2, B.R. Brodie3, T.A. Stuckey3,J. Hermiller4, G. Vetrovec5, K.L. Hannan1, M.W. Krucoff1,R.H. Christenson6, R. Gibbons7, K.N. Sigmon1, K. Collins8,R.A. Harrington1, R.M. Califf1. 1Duke Clinical Research Institute,Durham, North Carolina, USA; 2HeartCare Midwest, Peoria,Illinois, USA; 3Moses Cone Heart and Vascular Center, Greensboro,North Carolina, USA; 4St Vincent Hospital, Indianapolis, Indiana,USA; 5Medical College of Virginia, Richmond, Virginia, USA;6University of Maryland School of Medicine, Baltimore, Maryland,

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USA; 7Mayo Clinic, Rochester, Minnesota, USA; 8AlsiusCorporation, Irvine, California, USA

Background: Restoring myocardial perfusion and metabolism is fun-damental to limiting infarct size and enhancing survival. Early expe-rience with therapeutic hypothermia during acute myocardial infarction(AMI) has demonstrated cardioprotective effects.

Methods: Twenty AMI patients with high-risk characteristics wererecruited to undergo adjunctive endovascular cooling (Alsius, Irvine,California) immediately prior to primary percutaneous coronary inter-vention (PCI) to achieve a target core body temperature of 32° to 34°C.In addition to safety and tolerability, the primary endpoint was definedas a composite of infarct size (area under the curve [AUC] CK-MB andTc-99m SPECT sestamibi) and quality of myocardial perfusion (24-hour continuous ST-segment monitoring).

Results: Eighteen patients underwent catheter-based hypothermiato achieve a mean core body temperature of 33.7 � 0.9 °C (mean �SD) for a total cooling period of 4.5 � 1.8 hours. By 7 days, 1 (5.6%)patient developed ventricular fibrillation, and 3 (16.7%) patients expe-rienced bradycardia requiring intervention. Median infarct size (25th,75th percentiles was 4.0% (0, 19.0) by 30-day SPECT sestamibi and3232.8 (1671.4, 6729.1) hours ng/mL by AUC CK-MB. The medianextent of ST-segment recovery was 78.8% (68.1, 95.8), and recurrentischemia occurred in 2 (11.1%) patients per electrocardiographic mon-itoring. At 30 days, 1 death occurred, and 4 patients underwent urgentrepeat revascularization. There were no episodes of stroke, reinfarction,or major bleeding.

Conclusion: In this nonrandomized feasibility study, endovascularcooling in high-risk AMI patients successfully reduced core bodytemperature as an adjunct to primary PCI. These results support theevaluation of adjunctive hypothermia in pivotal trials to limit infarctsize and reduce reperfusion injury.

TCT-4Late Primary Angioplasty: Is “Early” Left Ventricular FunctionRecovery Achievable? J.L. Szarfer, A. Garcia Escudero,S. Massone, S. Affatatto, R. Sarmiento. M.A. Riccitelli HospitalArgerich, Buenos Aires, Argentina.

Background: Improvement of left ventricular function (LVF) afterperforming a primary angioplasty is a major achievement. The TAMI-6trial has demonstrated that coronary reperfusion �6 hours after onset(ie, late) in patients with acute myocardial infarction (AMI) does notimprove LVF during the chronic phase of infarction. However, the lowpatency rate (only 60%) of the infarct-related artery during the chronicphase in the TAMI-6 trial raises a new hypothesis that late reperfusionwith a higher patency rate may improve LVF. The aim of this study wasto evaluate the achievement of early recovery in LVF after a successful“late” primary percutaneous coronary intervention (PCI), performed 6hours after symptom onset.

Methods: End diastolic volume in mL/m2 (EDV), end systolicvolume in mL/m2 (ESV), ejection fraction (EF), and regional wallmotion were evaluated in 2 ventriculograms performed immediatelybefore and 24 hours after PCI in 100 consecutive patients (pts) withAMI, undergoing the procedure between 6 and 12 hours followingsymptom onset. TIMI 3 flow grade was achieved in all patients,remaining unchanged at the 24-hour angiography. Ventricular volumesand EF were assessed through the area-length method; regional wallmotion was evaluated through the centerline chord method. Patients(pts) were aged 59 � 11.3 years; 81 pts were men; 28 pts had aprevious myocardial infarction history, 52 pts had 1-vessel disease, 32pts had 2-vessel disease, and 16 pts had 3-vessel. The procedure wasperformed on the anterior descending artery in 51 pts, the circumflexartery in 14 pts, and the right coronary artery in 35 pts. Statistical

analysis included 2-tailed Student t test, analysis of variance, andchi-square test.

Results: EDV remained unchanged (73.4 � 2.3 vs 68.9 � 2.2, p �NS), and ESV decreased 24 hours after from 39.2 � 1.4 to 33.5 � 1.1(p �0.01). EF improved from 45.4 � 1.9% to 50.5 � 1.7% at 24 hourspostangioplasty (p �0.001). The Table shows the regional wall motionimprovement achieved.

Inferior AMI, n � 45; 35 Right Coronary and 10 Circumflex Artery

Segment 0–10 11–20 21–30 31–40 41–50 51–60 61–70 71–80 81–90

Previous 62.8 � 19.8 68.4 � 26.8 57.2 � 26.7 55.3 � 27.3 55.6 � 27.8 38.7 � 21 28.9 � 18.2 26.4 � 22.5 20.3 � 24

24 hours 67.5 � 26.3 68.4 � 26.8 55.4 � 21.5 59.3 � 23.1 57.0 � 24.6 50.9 � 28.6 43.7 � 28.1 38.5 � 29.2 32.7 � 28.9

p NS NS NS NS NS �0.03 �0.01 �0.02 �0.02

Anterior AMI, n � 55; 51 Anterior Descending and 4 Circumflex Artery

Segment 0–10 11–20 21–30 31–40 41–50 51–60 61–70 71–80 81–90

Previous 59.0 � 24.4 29.3 � 23.5 13.9 � 18.7 15.5 � 21.2 16.4 � 18.1 23.8 � 21.6 45.9 � 26.2 65.7 � 22.5 57.7 � 23.1

24 hours 56.6 � 25.6 30.3 � 23.2 18.8 � 17.9 23.1 � 19.1 30.1 � 21.1 34.4 � 22.3 48.5 � 26.2 68.4 � 21.3 56.8 � 21.8

p NS NS �0.02 �0.01 �0.003 �0.01 NS NS NS

Conclusion: Successful “late” primary PCI improves LVF througha reduction of ESV, increasing EF measured 24 hours after performed,probably as a consequence of the improvement achieved at regionalwall motion of jeopardized myocardial areas, with neutral effect onunaffected segments. It is remarkable that the improvement achievedwas detectable only 24 hours after coronary reperfusion despite theextended time interval between symptom onset and procedure.

TCT-5Adjusting the Benefits of Primary Angioplasty AgainstThrombolytic Therapy for Acute Myocardial Infarction: TheRole of Time. G. Tarantini, A. Ramondo, M. Napodano,G. Isabella, C. Bilato, R. Razzolini, S. Iliceto. Vivision odCardiology, University of Padua, Italy.

Background: Regardless of the method of reperfusion that is used, timeto treatment remains a critical determinant of outcome following acutemyocardial infarction. We explored the relationship between primaryangioplasty (PTCA)-related delay and the benefits of PTCA, using theresults of randomized trials comparing PTCA with thrombolytic therapy (Rx).

Methods: Of 23 published studies, we excluded the SHOCK trialand those for which analyzed data were not available. For 19 trials, wecalculated the following: PTCA-related delay (median “door-to-bal-loon” time); median “door-to-needle” time survival benefit (30-daymortality after Rx); and 30-day mortality after PTCA. The relationshipbetween delay and benefit was assessed with linear regression.

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Results: The reported PTCA-related delay ranged from 7 to 63minutes, and the absolute survival benefit ranged from –4 (favoringRx) to 15 (favoring PTCA). Across trials, the survival benefit decreasedas the PTCA-related delay increased; change in benefit per 10-minutedelay was 0.9% (p � 0.02) (Figure). PTCA-related delay of 72.5minutes lead to an equivalent mortality rate between PTCA and Rx.After the exclusion of the outlier trials with the longest and shortestdelays, 57 minutes was the PTCA delay leading to equipoise: change inbenefit per 10-minute delay was 1.4% (p � .002).

Conclusion: In clinical trials with short PTCA-related delays,PTCA produced better outcomes, whereas trials with longer delaysfavored Rx. At experienced cardiac centers and for very high-riskpatients, primary PTCA is probably still preferable, even with delayslonger than 60 minutes.

TCT-6Multivessel, 1-Stage Percutaneous Coronary Intervention inPatients With Acute Myocardial Infarction—PRIMA Trial:Safety, Efficacy, and Costs in 12-Month Follow-up. A. Ochala,G. Smolka, W. Wojakowski, M. Krol, M. Skowerski, Z. Gasior,M. Tendera. Department of Cardiology, Silesian Medical School,Katowice, Poland.

Background: Currently a 2-step approach is advised in patients (pts)with multivessel disease undergoing percutaneous coronary interven-tion (PCI) for acute myocardial infarction (AMI). We hypothesized thata 1-stage procedure might be safe and effective in this patient group.

Methods: Subjects included consecutive AMI pts who had under-gone optimal primary PCI of infarct-related arteries and who werehemodynamically stable. Pts with significant stenosis in non–infarct-related arteries (�70%) were randomized to group A (1-stage completePCI) or group B (planned 2-stage procedure). Left ventricle functionwas measured before revascularization and again 30 and 180 daysfollowing the procedure. All serious adverse events (SAE) were mon-itored. During 12-month follow-up, the number of hospitalizations,days in hospital, and estimated costs of PCI and hospital stays werecompared.

Results: Seventy-two pts were randomized, 37 to group A and 35to B. No deaths occurred in the hospital or during follow-up. In groupA, left ventricle ejection fraction (LVEF) increased from 41.2 � 3.43to 47.2 � 4.33 over 180 days. In group B, LVEF improved from 42.7 �3.21 before the procedure to 45.3 � 4.4 over 180 days. The number ofSAEs in both groups was similar (6 for group A, 7 for group B). Duringfollow-up, mean number of hospital admissions for cardiac problemswas 1.2 for group A versus 1.7 group B. The total number of dayshospitalized was 4.7 � 2.1 in group A and 7.6 � 2.2 in group B ; p �0.05. The number of PCI in group A was 1.1 during 12-month fol-low-up and 2.18 in the multistage group. The mean cost of 1 patienthospitalization in group B was almost double that of group A.

Conclusion: These results support the hypothesis that multivessel,complete PCI in a 1-stage procedure in AMI pts may improve completestabilization and left ventricle function recovery. Reduction in thenumber of PCIs without concurrent increases in SAEs, together withshorter hospital stays and lower costs, support our hypothesis. This isa safe and efficient treatment, and should be considered for this groupof pts with AMI.

TCT-7Aqueous Oxygen Therapy for ST-Segment Elevation MyocardialInfarction; AMIHOT Trial Design and Interim ReportJ.L. Martin1, F. Day1, S. Dixon2, S. David3, C. Pensyl1,J. Hermiller4, P.V. Oemrawsingh5, A. Bartorelli6, W. O’Neill2.1Main Line Health System, Bryn Mawr, Pennsylvania, USA;2William Beaumont Hospital, Detroit, Michigan, USA; 3Providence

Hospital, Southfield, Michigan, USA; 4St. Vincent Hospital,Indianapolis, Indiana, USA; 5Leiden University Medical Center,Leiden, The Netherlands; 6Institute of Cardiology, Milan, Italy.

Background: Although rapid coronary reperfusion in ST-segmentelevation myocardial infarction (STEMI) improves left ventricularfunction and mortality, epicardial vessel patency does not fully ensurenutrient flow at the tissue level. Animal and Phase I human testing ofthe TherOx Aqueous Oxygen (AO) System (TherOx, Irvine, Califor-nia) suggests that percutaneous coronary infusion of autologous bloodmixed with hyperoxemic saline may help overcome the downstreambarrier to oxygen delivery in ischemic zones and improve myocardialsalvage following percutaneous intervention for STEMI.

Methods: A Phase II randomized international trial is designed toevaluate the efficacy of regional AO therapy in STEMI. A subselectivecatheter positioned in the infarct artery delivers AO for 90 minutes at75 mL/min. Contrast echocardiography performed following interven-tion and before randomization is repeated at 24 hours, and days 30 and90. Resting SPECT myocardial perfusion scans are obtained on day 14.Primary endpoints include regional wall motion scores, SPECT perfu-sion defects, and ST-segment resolution.

Results: One hundred forty patients have been randomized after 17run-in cases. None of the 85 patients assigned to treatment haveexperienced hemodynamic or electrophysiologic instability during in-fusion. Repeat angiography when performed following AO therapydocumented perfusion catheter stability and maintenance of thrombol-ysis in myocardial infarction 3 flow. Planned interim analysis per-formed after randomization of the first 90 patients demonstrated nosafety concerns. Enrollment of the 270 patient cohort is to be completedby fall of 2003.

Conclusion: Preliminary results suggest that regional hyperoxemictherapy appears to be safe and can be readily applied in institutionsperforming primary angioplasty for STEMI. Conclusions regarding thepromise of this new therapeutic modality to improve recovery of leftventricular function requires longer term follow-up.

TCT-8The Unprotected Left Main Trunk Angioplasty Registry(ULTRA) in Japan: Initial and Midterm Results in AcuteMyocardial Infarction Patients. H. Nishikawa1, H. Tamai2,K. Kosuga2, O. Katoh3, T. Kobayashi4, E. Tsuchikane4, K. Ueda5,Y. Yokoi6, K. Nakajima1, T. Suzuki. 1Yamada Red Cross Hospital,Watarai, Japan; 2Shiga Medical Center for Adults, Shiga, Japan;3Kyoto Katsura Hospital, Kyoto, Japan; 4Osaka Medical Center forAdults, Osaka, Japan; 5Takeda Hospital, Kyoto, Japan; 6KishiwadaTokushukai Hospital, Osaka, Japan.

Background: Coronary artery bypass grafting has been considered theabsolute indication for patients with unprotected left main trunk disease(LMD). Recently, however, some selected centers have reported fea-sible results of catheter interventions for unprotected LMD. We eval-uated the immediate and midterm outcomes of consecutive patientsundergoing unprotected left main coronary artery angioplasty in casesof acute myocardial infarction.

Methods: All cases (N � 50) undergoing emergent angioplasty forunprotected LMD were registered between January 1, 1996, and De-cember 31, 2000. This registry is a multicenter prospective study.

Results: Mean age of patients was 72 years, and 72% were men.Mean left ventricular ejection fraction (LVEF) was 32%, and 46% ofpatients had cardiogenic shock. Intra-aortic balloon pumps were used in86% of patients, and percutaneous cardiopulmonary support systems in28%. Of the total sample, 14% had thrombolysis in myocardial infarc-tion flow 0, and 66% had distal, bifurcation lesions. Stents were usedin 76%. Mean DS was reduced from 70.2% to 14.6%, and 33.7% atfollow-up. Procedure success was achieved in 98% of patients, but

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in-hospital death was observed in 36%. Binary restenosis rate was 19%.Three-year event-free survival was 52%. LVEF on admission was theonly independent factor.

Conclusion: Catheter interventions for patients with acute myocar-dial infarction due to unprotected LMD have been accomplished withnew devices, particularly stents, in the ULTRA registry. The initialresults of angioplasty were acceptable. Midterm follow-up results arefavorable, with a low rate of repeat revascularization. Predictive factorfor overall cardiac death was poor left ventricular function on admis-sion.

TCT-9Incidence, Predictors, and Prognostic Implications of CoronaryArtery Dissection in the Setting of Primary PercutaneousCoronary Intervention for Acute Myocardial Infarction.P.S. Chowdhury1, K.J. Harjai1, J.A. Boura1, G. Stone2, D. Cox3,B. Brodie4, J.A. Goldstein1, W.W. O’Neill1, C.L. Grines.1 1WilliamBeaumont Hospital, Royal Oak, Michigan, USA; 2CardiovascularResearch Foundation, New York, New York, USA; 3Mid-CarolinaCardiology, Charlotte, North Carolina, USA; 4LebauerCardiovascular Research Foundation, Greensboro, North Carolina,USA.

Background: Primary percutaneous coronary intervention (PCI) foracute myocardial infarction (AMI) is sometimes complicated by coro-nary dissection. There are few data regarding the incidence, predictors,or prognostic implications of coronary dissection in this setting.

Methods: We pooled core lab angiographic data on 1,802 patientswho underwent PCI for AMI in the PAMI-2 and Stent PAMI studies.Coronary dissection was identified on the final angiogram in 423 (23%)patients (pts). We evaluated independent clinical and angiographicpredictors of coronary dissection. Furthermore, in subsets of pts whohad percutaneous transluminal coronary angioplasty without stenting

(POBA) (n � 1,287) and those who underwent stenting (n � 515), weassessed 30-day and 6-month outcomes of patients with and withoutcoronary dissection.

Results: Stenting was associated with a lower incidence of dissec-tion compared with POBA (13% vs 28%, p � 0.0003). Multivariatepredictors of dissection were POBA (odds ratio [OR] � 2.70, p�0.0001), longer door to balloon time (per hour delay, OR � 1.05, p �0.0097), and female gender (OR � 1.31, p � 0.036). Outcomes ofpatients with and without dissection are shown in the Table.

Events

POBA Stent

No Dissection(n � 929)

Dissection(n � 358)

No Dissection(n � 450)

Dissection(n � 65)

30 day death (%) 2.0 2.3 2.9 6.230 day re-MI (%) 3.2 6.4* 0.5 3.130 day I-TVR (%) 4.2 7.4* 0.9 3.16 mo. Death (%) 3.7 3.4 3.8 6.26 mo. re-MI (%) 4.9 6.7 2.2 3.16 mo. I-TVR (%) 9.6 15.6* 6.9 10.8

*p � 0.05 compared with no dissection.POBA � percutaneous transluminal coronary angioplasty without

stenting, re-MI � reinfarction, I-TVR � ischemia driven targetvessel revascularization.

Conclusion: In patients undergoing primary PCI for AMI, PTCAwithout stenting, longer door-to-balloon time, and female gender areindependent predictors of coronary dissection. In POBA patients withdissection, the increased risk of reinfarction peaks at 30 days, whereasischemia-driven target vessel revascularization progressively increasesover 6 months. Dissections after stenting lead to worse outcomes at 30days and 6 months, but this failed to reach statistical significancebecause of the small sample size. Our findings indicate that residualdissections should be aggressively treated in POBA and stent patientsin primary PCI for AMI.

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