`
`3!“; 0.1 nM ‘
`
`' 3ME10nM
`
`3ME 0.5 nM
`l’t'l in Patients With Renal Failure
`..................... 3960
`
`Mar/I" ll. RIt/N'Ilh'lt'HL MI), ('l 11/ ..............
`
`
`atIents Having ( AME
`Morbidity and Mortality in Dialysis l’
`JUN/I )f Lil]. All), ('I (I/ ..................................................... 3073‘
`
`
`
`Circulation
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`Fighting Heart Disease and Stroke
`
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`
`I Circulation
`
`‘v
`
`JOURNAL OF THE AMERICAN HEART ASSOCIATION
`
`173 0.5 MI
`
`TAM 50 nM
`
`(! (incubation Electronic Pages
`(Voliespondence i
`............................................. ('INU I'M}
`ardloyasenlar News i
`F Editorial
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`H' “THU"."llll/t’liVl/l. Ml); [flute :1, ('tzlzllw/ln, All)
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`UlllDill‘lStm olil>rimarv Stenting and l’l‘twisional Angioplasty
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`”UN, (1 Hill/mm: All), U! u/ ........................................... 3945
`‘
`‘
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`'
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`l’illlllmtide and ( oronaI'y Artery Bypass Surgery
`,‘“TWIPAAmeInland.mnmemnmnnnmum.mmum3uv
`I Images in Cardiovascular Medicine
`( Ullalei'
`altous Aortitis Presenting as AMI
`ill ( Ireulalion in Chronic (‘oronary ()CClUSiUHS '|'vl1i_=,I'I'Ia‘lse‘l'ial'lnlllxa'[Elltllill'lil‘l'IE1
`("TU/d 5'
`lli'i'nt'i: MI), (’1 tl/ ...........................................ataq‘émManfiHWBg-l ll, (Io/(Immi, MI), (’I (I, ......................................W133
`#—
`Subject USvBDpyrigl'lt Laws
`¥
`
`”39/0
`
`('hagas‘ Disease in Patients llaving Cardiac Surgery
`Darn/Ht, Lei/Ii: l’lil), L'IUI ........................................... 3978
`
`I Basic Science Reports
`Acute and Chronic lél‘l‘eets ol‘HstI‘ogen Following Ml
`Pun/(1.1lit/Smith. I’ll/J. ('r «I .............................................. 39M
`
`It)”
`
`Estrogen and Human CylonIegalovirus
`[fr/ill] Spell: MS. ('l (l/ ......................................................... 39W)
`Siltlenalil and Coronary Blood Flow
`.luvll. Tltll't’liw’, MI). ('I u/........................................... 3997
`
`(‘lieinoltine and N() l’I’oduetimI by (‘aI‘dionIyoeers
`I‘il/Ii(lll(l S, AIH<'/Im/u. MS, ('I u/ .........................................MU}
`
`Marinobulagenin and ()nabain in Salt~Loaded Dalil Rats
`U/gu If I'i'rlw'm‘rl, PM), ('1 (l/ ..............................................WU‘)
`lindotoxin—lndueed Mortality in ll()—l Null Miee
`/’/Ii/i/I/I<' l’lit'.\'('/, MI), (’I u/..............................................I’ll/5
`
`(
`
`If
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`Page 1
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`Circulation
`
`JOURNAL or .TIIE'AMERICAN HEART ASSOCIATION
`
`
`
`
`
`Volume 102 I Number 24
`
`December 12, 2000
`
`Circulation Electronic Pages
`
`
`Correspondence
`Fen/Phen and Valvular Heart Disease: The Final Link Has Now Been Established
`Letter ..... Tsung 0. Chang, MD Web Site Feature ............................................... *0180
`
`The Naming OfJUgular Venous Valves
`Letter ..... Jeffrey Fisher, MD
`Response .......... Charles F. Bab/)5, MD, PhD Web Site Feature ................................. *elSl
`
`Ventilatory and Heart Rate Responses to Exercise: Better Predictors of Heart Failure Mortality Than Peak
`Exercise Oxygen Consumption
`Letter ..... Guy A. MacGowan, MD, FACC; Srinivas Murali, MD, FACC
`Response ..... Michael S. Latter, MD; Mark Robbins, MD; Fredric Posh/(ow, MD; Kathy Hoercher, RN;
`Claire E. Sllmler, MA; James B. Young, MD; Gary Francis, MD
`...................... *0182
`
`Smoking and Aldosterone Synthase Polymorphism
`.
`Letter ..... Pitt 0. Lim, Ml)
`ReSponse ..... Aarno Harnanen, MD; M. Miinttiiri. MD; Mrrrkku Kupari, MD; V~ Man/unen, MD;
`Petri Toivanen, PM); Leena Tenkanen, PhD; Kathleen M. Kayes, PhD; Scott Rosenfela’, BS; Perrin C. White, MD
`
`Web Site Feature .......................................................................... * e183
`
`Editorial
`
`
`Provisional Versus Routine Stenting: Routine Stenting Is Here To Stay
`H. Vernon Anderson. MD; Blase A. Carabel/o, MD .................................................. 2910
`
`Brief Rapid Communications
`__\____—____
`
`Effect of Intraeoronary y-Radiation Therapy on In-Stent Restenosis: An Intravascular Ultrasound Analysis
`from the Gamma-1 Study
`CW." 5‘ Mintz, MD; Neil J. Weissman, MD; Paul S. Teirstein, MD; Steven G. Ellis, MD; Ron Waksntan, MD;
`Robert J. Russo, MD; Issom Moussa, MD; Prahhaker Tripnraneni, MD; Shrish Joni, MD;
`VHS/”'0 Kobnyashi, MDi JOSE/Ill A. Giorgianni, BA; Chrysoula Pap/ms, MD: RiC/Im‘d A. Kltlllz, MD:
`J‘flu't’)’ Mm“: MD" Marlin 13- Leon. MD ........................................................... 2915
`
`Transfer of CD4+ T Cells Aggravates Atherosclerosis in Immunodelieient Apolipoprotein E Knockout Mice
`Xinglnm Zhou, MD, PhD; Antonino Nieoletti, PhD; Rima Elhage, PhD; Goran K. Hansson, MD, PhD ........ 2919
`
`Clinical Investigation and Reports*M—
`Economic Assessment of Platelet Glycoprotein IIl)/IIIa Receptor Blockade With Abciximab and Low-Dose
`Ileparin During l’erentaneous Coronary Revascularization: Results From the EPILOG Randomized Trial
`A. Michael Lincofl; MD; Daniel B. Mark, MD, MPH; James E. Tcheng, MD; Robert M. Califfi MD;
`Mohan V. Bola, PhD; Kern'en M. Anderson, PhD; Linda Davidson-Ray, BA; J. David Knight, MS;
`Catherine F. Cabot, MD; Eric J. Topol, MD; for the EPILOG Investigators .............................. 2923
`
`”Supported in concept by an unrestricted gilt from Merck & Co. Pfizer provides an unrestricted gift for subscriptions to Circulation for Cardiology
`Fellows in training.
`
`
`EIRCULATION (lSSN 0009-7322) is published weekly except combined the first two weeks in Ianuary and the last two weeks in December by Lippincott Williams 5r Wilkins at 12107
`Insurance Way, Hagerstown,
`MD 21740. Business offices are located at 227 East Washington Square, Philadelphia, PA 19106-3780. Production offices are located at 351 West
`Camden Street, Baltimore, MD 21201—2436. Individuals may subscribe for their personal use at the following rates: $177 for members of an American Heart Association scientific
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`Hagerstown, MD, and additional mailing offices. POSTMASTER: Send address changes to CIRCULATION. American Heart Association, Lippincott Williams 51 Wilkins, 12107 Insurance
`Way, Hagerstown. MD 21740.
`This material was cooled
`at the NLM and maybe
`Subject USEprright‘ Laws
`
`Page 2
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`Randomized Comparison of Primary Stenting and Provisional Balloon Angioplasty Guided by Flow
`Velocity Measurement
`Patrick W. Serruys, MD; Bernard de Bruyne, MD; Stéphane Carlier, MD; Jose’ Eduardo Sousa, MD;
`Jan Piek, MD; Toshiya Muramatsu, MD; Chris Vrints, MD; Peter Probst, MD; Ricardo Seabra-Gonzes, MD;
`Ian Sin'zpson, MD; Vasilis Voudris, MD; Olivier Gurné, MD; Nico Pijls, MD; Jorge Belardi, MI);
`Gerrit-Anne van Es, PhD; Eric Boersma, PhD; Marie-Angela Morel, MS; Ben van Hout, PhD; on behalf of the
`Doppler Endpoints Balloon AngiOplasty Trial Europe (DEBATE) [I Study Group .......................... 2930
`
`Randomized Comparison of Elective Stent Implantation and Coronary Balloon Angioplasty Guided by
`Online Quantitative Angiography and Intracoronary Doppler
`Carlo Di Mario, MD, PhD; Jeffrey W. Moses, MD; Todd J. Anderson, MD, MRCP; Raoul Bonan, MD;
`Toshiya Muramatsu, MD; Abnash Chander Jain, MD; Jose Suarez de Lezo, MD; Seung Yan Cho, MD;
`Morton Kern, MD; Ian T. Meredith, MBBS, PhD; David Cohen, Ml), MSc; Issaln Moussa, MI);
`Antonio Colombo, MD; on behalf of the DESTINI Study Group (Doppler Endpoint STenting INternational
`Investigation) .................................................................................
`
`2938
`
`Percutaneous Coronary Intervention in the Current Era Compared With 1985—1986: The National Heart,
`Lung, and Blood Institute Registries
`David 0. Williams, MD; Richard Holubkov, PhD; Wanlin Yell, MS; Martial G. Bourassa, MD;
`Mahdi Al-Bassam, MD; Peter C. Block, MD; Paul Coady, MD; Howard Cohen, MD; Michael Cowle , MD;
`Gerald Dorros, MD; David Faxon, MD; David R. Holmes, MD; Alice Jacobs, MD; Sheryl F. Kelsey, PhD;
`Spencer R. King III, MD; Richard Myler, MD; James Slater, MD; Vladimir Stanek, MD; Helen A. Vlachos, MS;
`Katherine M. Detre, MD, DrPH; for the Coinvestigators .............................................. 2945
`Enhanced Efficacy of Eptifibatide Administration in Patients With Acute Coronary Syndrome Requiring
`In-Hospital Coronary Artery Bypass Grafting
`Steven P. Marso, MD; Deepak L. Blzatt, MD; Matthew T. Roe, MD; Penny L. Houghtaling, MS;
`Marino Labinaz, MD; Neal S. Klei/nan, MD; Cornelius Dyke, MD; Maarten L. Simmoons, MD;
`Robert M. Califl, MD; Robert A. Harrington, MD; Eric J. Topol, MD;_/'or the PURSUIT Investigators ,,,,,,,, 2952
`
`Immediate Changes of Collateral Function After Successful Reeanalization of Chronic Total
`Coronary Ocelusions
`Gerald S. Werner, MD; Barbara M. Richartz, MD; Oliver Gastmann, MD; Markus Ferrari, MD;
`Hans R. Figullu, Ml) ........................................................................... 2959
`Are Patients With Renal Failure Good Candidates for I’ercutaneous Coronary Revaseularization in the
`New Device Era?
`Mark H. It’ulwnstein, MI); Lari C. Harrell, MS: Boris V. Sheynherg, MD; Heribert Schunkert, MD;
`Hasan Bazari, MD; Igor F. l’alacios, MI) ..........................................................
`
`2966
`
`Risks of Morbidity and Mortality in Dialysis Patients Undergoing Coronary Artery Bypass Surgery
`Jean Y. Lin, MI); Nancy J.(). Iiirknleyer, Phl); John II. Sanders, MD; Jeremy R. Morton, MD;
`Horace P. Henriques, MI); Stephen J. Lahey, MI); Richard W. Dow, MD; Christophw Maloney, MD;
`Anthony W. DiScipio, MD; Robert Clough, MI); Bruce J. Leavitt, MI); Gerald T. O’Connor, PhD, DSc; for the
`Northern New England Cardiol'ascular Disease Study Group .......................................... 2973
`Evidence of 'I'rypanosoma cruzi Infection (Chagas’ Disease) Among Patients Undergoing Cardiac Surgery
`David A. Leiby, PhD: Francisco J. Rentas, MS; Kenrad 15. Nelson, MD; Veronica A. Stantlmlis, MA;
`Paul M. Ness, MI); Cheryl Parnis, RN; Ilugh A, McAIIister, .Ir, MD; David II. Yawn, MI);
`Robert J. Stump]: BS; Louis V. Kirchhojl; MD ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, 2978
`
`Basic Science Reports
`
`Effects of Estrogen Replacement on Infarct Size, Cardiac Remodeling, and the Eudothelin System After
`Myocardial Infarction in Ovariectomized Rats
`Paula J. W. Smith, PhD; Olga Ornatsky, PhD; Duncan J. Stewart, MD; Pierre Picurd, PhD;
`Fayez Dawood, DVM; Wen-Ha Wen, MD; Peter P. Lin, MD; David J. Webb, MI); Juan Carlos Mongc, MI)
`Antioxidant Effect of Estrogen on Cytomegalovirus-Imlueed Gene Expression in Corollary Artery
`Smooth Muscle Cells
`Edith Speir, MS; Zu-Xi Yu, MD, PhD; Kazuyo Takeda, MD, PhD; Victor J. Ferrans, MI), PhD;
`Richard 0. Cannon III, MD ..................................................................... 2990
`
`,
`
`,
`
`_ 2983
`
`Cyclic Nucleotide I’hosphodiesterase Type 5 Activity Limits Blood Flow to Ilypoperfused
`Myocardium During Exercise
`Jay H. Traverse, MD; Ying .lie Chen, MD, PhD; Ruisheng Du, PhD; Robert .l. [lac/1e, MD ,,,,,,,,,,,,,,,,, 2997
`
`Page 3
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`Trypanosoma cruzi—Infccted Cardiomyocytes Produce Chemokines and Cytokines That Trigger Potent
`Nitric Oxide—Dependent Trypanocidal Activity
`Fabiana S. Mac/zado, MS: Gislaine A. Martins, PhD; Jiilio C.S. Aliberti. PhD; Fabiola L.A.C. Mestriner, BS;
`Fernando Q. Can/ta, PhD; Judo S. Silva, PhD ...................................................... 3003
`
`Endogenous Na,K Pump Ligands Are Differentially Regulated During Acute NaCl Loading of Dahl Rats
`Olga V. Fedorava, PhD; Edward G. Lakatta, MD; Alexei Y. Bagrov, MD, PhD ,,,,,,,,,,,,,,,,,,,,,,,,,,, 3009
`
`Endotoxin-Induced Mortality Is Related to Increased Oxidative Stress and End-Organ Dysfunction, Not
`Refractory Hypotension, in Heme Oxygenasc-l—Defieicnt Mice
`Philippe Wiesel, MD; Anand P. Patel, MS; Nicole DiFonzo, BS; Paoja B. Marria, BS; Chang U. Sim, BS;
`Andrea Pellacani, MD, PhD; Koji Maemara, MD, PhD; Brian W. LeBlanc, BS: Kathryn Marina, BS;
`Claire M. Doerschuk, MD; Shaw-Fang Yet, PhD; MLl-EIZ Lee, MD, PhD; Mark A. Perrella, MD ,,,,,,,,,,,,, 3015
`
`1
`‘
`
`Images in Cardiovascular Medicine
`
`
`Granulomatous Aortitis Presenting as an Acute Myocardial Infarction in Crohn’s Disease
`Michael H. Goldman, MD; Bechara Akl, MD; Shayryar Mafi, MD: Lucia Pastore, MD ..................... 3023
`
`
`Annotated Table of Contents ...........................................................
`Classified Advertising .................................................................
`
`A8
`BZ
`
`L
`
`inhibited fluorescence, as determined by confocal laser microscopy. See page 2990.
`
`The cover figure is from the article in this issue by Speir et a]. Figure 1: SMCs were pretreated for 1 hour with indicated
`doses of E2, 17ct-E2 (17a), 3-ME, or tamoxifen (TAM). Cells were then infected for 1 hour with CMV at 5 MO]. followed
`by addition of DCFH-DA fluorescent dye. Both stereoisomers of estradiol and tamoxifen, but not 3—ME, dose-dependently
`
`Page 4
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`
`Percutaneous Coronary Intervention in the Current Era
`Compared With 1985—1986
`
`The National Heart, Lung, and Blood Institute Registries
`
`David 0. Williams, MD; Richard Holubkov, PhD; Wanlin Yeh, MS; Martial G. Bourassa, MD;
`Mahdi Al-Bassam, MD; Peter C. Block, MD; Paul Coady, MD; Howard Cohen, MD;
`Michael Cowley, MD; Gerald DOITOS, MD; David Faxon, MD; David R. Holmes, MD; Alice Jacobs, MD;
`Sheryl F. Kelsey, PhD; Spencer B. King III, MD; Richard Myler, MD; James Slater, MD;
`Vladimir Stanek, MD; Helen A. Vlaehos, MS; Katherine M. Detre, MD, DrPH; for the Coinvestigators
`
`Background—Although refinements have occurred in coronary angioplasty over the past decade, little is known about
`whether these changes have affected outcomes.
`Methods and Results—Baseline features and in-hospital and l-year outcomes of 1559 consecutive patients in the
`1997—1998 Dynamic Registry who were having first coronary intervention were compared with 2431 patients in the
`1985—1986 National Heart, Lung, and Blood Institute Registry. Compared with patients in the 1985—1986 Registry,
`Dynamic Registry patients were older (mean age, ()2 versus 58 years; P<0.001) and more often female (32.1% versus
`25.5%; P<0.001). In the Dynamic Registry, procedures were more often performed for acute myocardial infarction
`(22.9% versus 9.9%; I’<0.001) and treated lesions were more severe (84.5% versus 82.5% diameter reduction;
`I’<0.001), thrombotic (22.1% versus 1 1.3%; P<0.00l) or calcified (29.5% versus 10.8%; I’<0.001). Stents were used
`in 70.5% of Dynamic Registry patients, whereas 1985—1986 patients received balloon angioplasty alone. Procedural
`success was higher in the Dynamic Registry (92.0% versus 81.8%; P<().00l) and the rate of iii—hospital death,
`myocardial infarction, and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%; P:0.00|) than
`in the 1985—1986 Registry. The 1—year rate for CABG was lower in the Dynamic Registry (6.9% versus 12.6%; l’<0.001).
`(,‘olrclusiansfiAlthough Dynamic Registry patients had more unstable and complex coronary disease than those in the
`1985—1986 Registry, their rate of procedural success was higher whereas rates of complications and subsequent CABG
`were lower. Results of percutaneous coronary intervention have improved substantially over the past decade.
`(Circulation. 2000;102:2945-2951.)
`
`Key Words: angioplasty I coronary disease I arteries I balloon I stents
`
`the National Heart, Lung, and Blood Institute
`n 1979.
`(NHLBI) established a voluntary registry to characterize
`coronary angioplasty, at the time an emerging technique of
`pcreutaneous coronary rcvascularization.‘ Patients were en-
`rolled from 1977—1980 and subsequently from 1985—1986.
`These 2 registries provided the first comprehensive descrip-
`tion of tcclmical and clinical results, and in the mid-1980s
`identified that angioplasty had matured to the point
`that
`clinical trials were necessary to resolve the genuine dilemma
`as to potential comparability to CABG.
`
`
`
`See p 2910
`
`These trials, including Bypass Angioplasty Rcvasculariza-
`tion Investigation (BARI)2 and EAST,3 found that
`in tnost
`patients with tnultivcssel coronary artery disease (CAD).
`balloon angioplasty did not compromise survival and proved
`to save costs slightly relative to CABG but many patients
`who received PTCA required repeat revascularization. Since
`that
`time, new devices have been developed as potential
`adjuncts or replacements for the balloon catheter.4 Although
`
`
`Received May 22, 2000; revision received July 20. 2000: accepted July 25, 2000.
`[From the Division of Cardiology (D.O.W.), Rhode Island Hospital, Brown University. Providence, R1; the Department of Epidemioltwy (R.H.. W.Y
`S.li‘.l(.. |l.A.V.. K.M.D.), University of Pittsburgh. Pittsburgh; Lankenau Hospital (P.C.), Philadelphia, Pa; Montreal Heart Institute (MODE), Montreal’
`Quebec. Canada: Cardiovascular Medical Associates (M.A-B.), Houston, Tex; Providence/St. Vincent Hospitals (P.C.B.). Portland, Ore; University of
`Pittsburgh Medical Center (11.0), Pittsburgh. Pa; Medical College of Virginia (M.C.). Richmond. Va: Arizona Heart Institute (G.D.'), Phoenix A'I'
`University of Southern California Medical Center (DE), Los Angeles. Calif; Mayo Clinic Foundation (D.R.H.). Rochester, NY; Boston University
`Medical Center (Al). Boston. Mass: Emory University Hospital (S.B.K. 111), Atlanta, Ga: Seton Medical Center (RM.), [)aly City. Calif- St.
`Lakes/Roosevelt Hospital 0.5.), New York, NY; and Institute for Clinical and Experimental Medicine (VS), [’1'
`‘
`ague. Czech Republic.
`Additional coinvcstigators are listed in the Appendix.
`(.‘orrespondence to Katherine M. Detrc. MD, Dt'Pll. University of I’ittsburgh/GSPH, 130 DeSoto St, 127 Parran Hall, Pittsburwh PA 15261 E-mail
`I)ctrc("Fedegspli.pitt.edu
`c l
`l —
`I
`© 2000 American Heart Association, Inc.
`Circulation is available at Itttp:llwwwxirculationalta.org
`
`This material wascnpied
`at. the N Liam av be
`Subject. US Capyrig’ht Law:
`
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`2946
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`Circulation
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`December 12, 2000
`
`a few randomized clinical trials have helped to clarify tlte
`value of these new devices in limited patient subgroups?“
`little is known of the extent of their use in overall clinical
`
`practice or of their effect on patient selection and outcomes.
`The primary goal of the recently established Dyrtamie
`Registry is to characterize peretttancous coronary interven-
`tion in the new device era. The Registry provides the optimal
`design to assess and to compare with the [985—1986 Registry
`the following: (1) contemporary patients and disease cltarac—
`teristics selected for percutaneous coronary intervention, (2)
`types of devices used in various settings, and (3) changes itt
`interventional strategy as well as iii-hospital and l-ycar
`outcomes. The present report describes the findings from
`these comparisons.
`
`Methods
`
`Design and Study Population
`The Dynamic Registry includes [5 clinical centers ( l0 participants in
`the 1985—1986 Registry and 5 added to augment enrollment of
`minorities) and a Coordinating Center. Thrcc sequential waves of
`2000 patients, spaced 18 months apart, are to be enrolled. Each
`patient who is ltaving percutaneous coronary catheter-based inter-
`vention performed by a Dynamic Registry investigator is registered.
`Informed consent is obtained to collect
`information after hospital
`discharge. The first wave of enrollment, which began July 1997 attd
`was cotnplctcd February 1998, recruited 2526 patients, of whom
`2206 were consecutively enrolled. Because patients with prior
`angioplasty were excluded from the 19854986 Registry. for the
`sake of comparability, 647 Dynamic Registry patients with history of
`prior pereutancous coronary intervention are excluded front
`this
`report.
`
`Data Collection
`Registry research coordinators responsible for data collection partic-
`ipated iii a trainirtg session before patient enrollment, Data collection
`included demographic irtforrttalion, rrtcdicai history, and risk factor
`profile. Coronary angiograplric information before and after inter-
`verttiort was obtained according to definitions developed irt previous
`registries and the Bypass Angioplasty Revaseularination investiga-
`tion.'v" Procedural strategy data included device use, procedural
`staging, and success of caclt coronary lesion attempted. Successful
`lesion dilatation was defined as an absolute 20% rcductiott in lesion
`severity willt final stcnosis <50%. Angiographic success was clas-
`sified as either partial (some but not all attempted lesions success-
`fully treated) or total (all attcntptcd lesions successfully treated).
`Untoward events ittcludcd death front arty cause, myocardial infarc-
`tiort (Ml). or CABG. MI was defined as evidence of 22 of the
`following:
`(1)
`typical chest pairt >20 minutes not
`relieved by
`nitroglycerin,
`(2) serial ECG recordings showing changes from
`baseline or serially in ST-T and/or Q-waves in 22 contiguous leads,
`or (3) serum enzyme elevation of CK-MB>5% of total CK (total
`CK>2>< normal; LDli subtype l>LDll subtype 2). Congestive
`heart
`failure was defined as presence of paroxysmal nocturnal
`dyspnca, dyspttea on exertion, or radiographic pulmonary conges-
`tion. Risk for CABG was classified as low, moderate. high, or
`inoperable according to judgment of the interventionist. Procedures
`were classified according to clinical circumstances: cmcrgcrtt when
`required immediately because of clinical
`instability, urgcnl when
`required within 24 hours to minimize cardiac risk, and elective when
`deferrable >24 hours without cardiac risk. Procedural success was
`defined as achievement of either partial or total angiographic success
`without death. Q-wave Mi, or crnergcrtcy CABG.
`
`TABLE 1. Patient Demographics, Disease History, and
`Angiographic Characteristics
`
`Registry
`
`Dynamlc-
`Consecutive
`
`1985—1986
`PTCA
`
`Total patients. n
`Mean age. y
`Female. %
`Race, %1
`White
`Black
`Asian
`
`Hispanic
`Other
`
`Prior CABG, %
`Prior MI, %
`History of diabetes, %
`History of congestive heart failure, %
`History of hypertension, %
`Smoking, %'
`Never
`Current
`Former
`
`Patient Risk of CABG assessed by
`operator, %
`High/inoperable
`Not recorded
`
`Mean left ventricular ejection fraction, %
`Vessel disease, %
`Single
`Double
`
`1559
`62.1
`32.1
`
`83.6
`5.3
`2.7
`
`6.9
`1.6
`
`11.9
`33.7
`25.8
`8,2
`56.3
`
`33.6
`28.9
`37.5
`
`15.0
`8.7
`
`55.3
`
`45.9
`32.3
`
`2431
`58.2:
`25.5:
`
`91.6
`4.4
`1.3
`
`1.3
`1.4
`
`11.2
`38.4T
`13.51
`581
`45.51
`
`29.2
`30.9
`39.9
`
`8.81
`14.4
`
`58.0:
`
`47.6
`31.9
`
`20.6
`21.9
`Triple
`
`Mean significant lesions, n 2.6 2.7
`
`*P<0.05; TP<0.01; tP<U.001 tor comparison of patients in Dynamic Vs
`1985—1986 PTCA Registry.
`
`otttcotttcs were reported with Kaplan‘Meier cstitttates arid log rattk
`statistics. Standard stepwise procedures were used witlr Cox propor-
`tional Ira/.at'ds models to obtain adjusted relative risks comparing the
`2 registries. Consent
`to collect follow-up information after initial
`procedure hospitalization was not obtairtcd for 253 of the 1559
`Dynamic palicrtts, who were censored at
`the little of hospital
`discharge itt analyses of I-ycar cvcttt rates.
`
`Results
`Although tttost of the consecutively enrolled patients irt botit
`registries were white men of middle age, prevalcrtce of
`certain baseline characteristics differed betwccrt the 2 (Table
`1). Dynamic Registry patients were older; more often ferttalc
`and nonwhitc; more oftctt ltad history of diabetes tttcliitus,
`congestive heart
`failure, or hypertension; and more often
`were considered to be at high risk for CABG. Dynamic
`Statistical Methods
`Registry patients were less likely to have history of prior M]
`Differences between proportions were assessed by )8 test or Fisher's
`or cigarette smoking. No differences were noted iii the extent
`Exact Test when the number of patients in a group was small,
`of coronary disease.
`Continuous variables were compared by Student’s t test. ()ne- ear
`This ma erial wasmplacl
`at the NLM and may be
`Subject US Ecwy‘righti La W‘s
`
`Page 6
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`
`
`TABLE 2.
`
`Procedural Data
`
`TABLE 3. Characteristics of Attempted Lesions and Outcome
`
`Williams ct a1
`
`NHLBI Dynamic Registry
`
`2947
`
`Registry
`
`Dynamic-
`Consecutive
`
`1965—1986
`PTCA
`
`Total patients, n
`Primary reason for revascularization, %’r
`Asymptomatic CAD
`Stable angina
`CCSC V"
`6080 Ill/lV
`
`Unstable angina
`Acute MI
`
`Cardiogenic shock
`Thrombolytic therapy
`Other
`Circumstances of procedure, 0AT
`Elective
`
`1559
`
`2.1
`24.5
`11.8
`12.3
`
`42.8
`22.9
`
`2.1
`5.5
`7.7
`
`63.1
`
`2431
`
`2.6
`37.7
`16.8
`20.2
`
`47.7
`9.9
`
`N/A
`39*
`2.1
`
`75.4
`
`Registry
`
`Dynamic-
`Consecutive
`
`1985—1986
`PTCA
`
`2224
`
`3787
`
`34.2
`09
`38.3
`21.9
`4.3
`
`1.9
`10.2
`31.2
`41.1
`15.6
`
`84.5
`
`29.4
`0.4
`456
`21.4
`3.2
`
`1.5
`15.0
`37.2
`34.2
`12.2
`
`82.51
`
`Total lesions, n
`Lesion location, %’r
`Right coronary artery
`Left main coronary artery
`Left anterior descending coronary artery
`Left circumflex artery
`Graft
`Diameter “/u stenosis, %t
`<50
`50-70
`70—90
`90—99
`Total occlusion
`
`Mean
`Lesion characteristics, %
`
`11.31
`22.1
`Evidence of thrombus
`10.8t
`29.5
`Calcification
`33.1t
`11.0
`Mean final % stenosls
`80.91
`93.7
`Angiographic success, %
`2.6T
`11.6
`Dissection, “/u
`0.4T
`3.2
`Side-branch occlusion, %
`
`Abrupt in‘laboratory closure, % 3.1‘ 1.9
`
`
`*P<0.01; TP<0.001 for comparison of patients
`1985—1986 PTCA Registnj.
`
`in
`
`the Dynamic vs
`
`sion procedures than in the 1985—1986 Registry. Multivcssel
`attempt was 9% in the Dynamic compared with 20.7% in the
`1985-1986 Registry (P<0.001). Balloon angioplasty,
`the
`only percutancous intervention at the time of thc 1985-1986
`Registry, was used as the sole device in 24.7% of Dynamic
`Registry patients, concomitantly with stent placement
`in
`63.7%, rotational athercctomy in 3.1%, and both stent and
`rotational athcrcctomy in 5.9% of patients.
`(Directional
`athcrectomy, extraction athercctomy, and laser each were
`used in <l% of patients.)
`Although the left anterior descending coronary artery was
`the most common location for an attempted lesion in both
`registries.
`lesions in other locations were more often at-
`tempth in the Dynamic compared with the 19854986
`Registry (Table 3). Attempted lesion stenosis in the Dynamic
`Registry was more severe, and lesions were more often total
`occlusions. These differences were independent of sex of the
`patient or whether AMI was the indication for intervention.
`Thrombus and calcification were reported far more fre-
`quently in the Dynamic Registry, yet angiographic success
`was achieved more often (93.7% versus 80.9%; P<O.()Ol)
`and final lesion narrowing was less severe. Although abrupt
`artery closure was less common in the Dynamic Registry,
`side-branch occlusion and local coronary dissection were
`more common.
`
`Iii-hospital mortality was not significantly different be-
`tween the registries (Table 4), whereas MI and need for
`
`23.9
`13.0
`
`0.3
`67.5
`23.9
`6.6
`1.7
`1.4
`
`18.8
`5.8
`
`0.0
`62.8
`24.6
`8.1
`4.3
`1.61
`
`Urgent
`Emergent
`No. of lesions attempted, "/01
`g
`1
`2
`3
`24
`Mean
`No. of vessels attempted, %T
`0.2
`0.4
`O/Unknown
`76.6
`86.5
`1 Native
`17.0
`7.9
`2 Native
`2.3
`0.2
`3 Native
`1.2
`0.8
`1 Native and 1 graft
`0.2
`0.1
`2 Native and 1 graft
`0.0
`0.0
`3 Native and 1 graft
`
`Gratt only 2.6 4.1
`
`0080 indicates Canadian Cardiovascular Society Classification.
`‘P<0.05; TP<0.001 for comparison of patients in the Dynamic vs
`19854986 PTCA Registry.
`
`Unstable angina was the most common procedural indica-
`tion for intervention in the Dynamic Registry (Table 2).
`Compared with the 1985—1986 Registry, procedures were
`more likely to be performed for acute Ml (22.9% versus
`9.9%; l’<().0()1) and less frequently for stable angina. Also,
`interventions were more often emergent (13.0% versus 5.8%;
`l’<().()()l) for Dynamic than for 1985—1986 Registry patients.
`Among the 357 Dynamic patients with AM] as indication for
`intervention, 48.7% had emergent intervention. Glycoprotein
`llb/llla receptor inhibitors. not available in the 1985—1986
`Registry, were administered to 25.3% of Dynamic Registry
`patients.
`Comparison of inlerventional strategy revealed some inter-
`esting trends. Most patients had procedures attempted on only
`1
`lesion, and fewer Dynamic Registry patients had multile—
`
`Page 7
`
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`
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`
`
`
`2948
`
`Circulation
`
`December 12, 2000
`
`TABLE 4. Adverse Events and ln-Hospital Outcomes
`
`Registry
`
`Dynamic-
`1985—1986
`Consecutive
`PTCA
`
`
`Total patients, n
`Death, %
`Ml
`
`Clinical symptoms
`ECG
`
`Enzymes (>2xncrmal)
`CABG, %
`Elective/urgent
`Emergency
`Major entry-site complication, %
`Death/any MI/any CABG, %
`Death/any Ml/emergency CABG, %
`Overall angiographic success, %t
`None
`Partial
`Total
`
`1559
`1.9
`2.8
`
`1.7
`1.6
`
`2.4
`1.5
`1.0
`0.4
`3.5
`5.9
`4‘9
`
`3.7
`4.3
`92.0
`
`2431
`1.4
`4.9T
`
`3.91
`3.51
`
`4.51
`6.01
`23*
`3.7T
`3.3
`9.81
`7.9T
`
`13.7
`12.1
`74.2
`
`92.0
`
`Procedure success (partial or total angiographic
`success without death/Q-wave Ml/emergency
`CABG), %
`4.11
`2.7
`Mean length of stay after procedure, days:
`*P<0.01; tP<0.001 for comparison of patients in Dynamic vs 1985—1986
`PTCA Registry.
`iFor patients alive at discharge.
`
`81.81
`
`emergent CABG were significantly lower in the Dynamic
`Registry. Both total angiographic success and procedural
`success were achieved signifi 'antly more often in the Dy-
`namic Registry.
`In addition. mean length of hospital stay
`decreased significantly, from 4.l
`to 2.7 days. Overall
`Incr—
`dence of repeat revascularization during initial hospitalization
`was 5.6% (4.2% repeat percutancous intervention and l.5%
`CABG).
`Crude mortality during 1 year of follow—up was higher in
`the Dynamic Registry compared with the 1985—1986 Regis—
`try (l-ycar rate. 5.4% versus 3.6%). whereas l-ycar death or
`Ml rate was similar (Figure l). After controlling for important
`baseline differences between registries (Table 5), death rates
` 40%
`
`10% aw _.m
`
`30 %
`
`EventRate NC a}
`
`(l
`
`60
`
`240
`ISO
`l20
`Days after Sludy Entry
`
`300
`
`360
`
`became comparable. Lowcr adjusted mortality was not sig-
`nificant, although the 30% lower l—year risk for combined—
`cndpoint death or MI achieved significance. Similarly, l-year
`CABG and repeat percutancous procedure rates were signif—
`icantly lower in the Dynamic Registry both before and after
`adjustment for baseline inequalities (Figure 2). These find-
`ings were uniform regardless of number of lesions or vessels
`attempted during the initial procedure.
`Within the Dynamic Registry, differences were seen in
`unadjusted l-year event rates within several clinically impor—
`tant subgroups. Women had higher l-year mortality (7.6%
`versus 4.4%;
`l’<t).05) and need for CABG (9.5% versus
`5.6%; P<t).()5)
`than 1110]]. Patients whose indication for
`intervention was AMI had higher
`l-year mortality (9.2%
`versus 4.3%; P<().()t)l) than those with other indications,
`primarily due to higher in—hospital mortality (5.9% versus
`0.7%; P<().0()l). Use of GP lib/Illa receptor inhibitor was
`associated with increased l-year Ml rate (9.5% versus 4.0%;
`P<0.0()l), due in part
`to more ill-hospital events (5.1%
`versus 2.0%; I’<().001). No differences were seen in l-year
`death, Ml, or revascularization by stent use during initial
`procedure.
`
`Discussion
`
`In the contemporary Dynamic Registry. patients were older
`and more often had extensive cardiovascular morbidity cont-
`pared with patients undergoing pcrcutancous coronary inter-
`vention a decade ago. Some of these observed differences
`may relate to the larger proportion of women in the Dynamic
`Registry, given that women presenting with CAD and symp-
`toms rcquiring revaseularization tend to be older and have
`more coronary risk factors than [1101] do.'”"'2
`Coronary intervention was more often performed in the
`setting of unstable coronary disease in the Dynamic Registry.
`In fact. AMI was reported as the primary indication for
`intervention more than twice as often as in 1985—1986.
`Because coronary angioplasty can be performed quickly and
`as an immediate adjunct
`to coronary angiography,
`it
`is
`particularly well suited for coronary syndromes in which
`rapid revascularization is essentialJ-‘v'4 The