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`Dar/(Isl, Lei/{i1 I’ll/J. el u/ ............................................... 3075’
`
`”393x
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`Medtronic Exhibit 1236
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`Circu]atiOn
`
`JOURNAL or ,TIIE'AMERICAN HEART ASSOCIATION
`
`
`
`
`
`Volume 102 I Number 24
`
`December 12, 2000
`
`Circulation Electronic Pages
`
`Correspondence
`Fen/I’hen and Valvular Heart Disease: The Final Link Has Now Been Established
`Letter ..... Trimg 0. Chang, MD Web Site Feature ............................................... *e180
`
`The Naming of .Iugular Venous Valves
`Letter ......Icffrey Fisher, MD
`Response .......... Charles F. Bab/2x, MD, PhD Web Site Feature ................................. *e181
`
`Ventilatory and Heart Rate Responses to Exercise: Better Predictors of Heart Failure Mortality Than Peak
`Exercise Oxygen Consumption
`Letter ..... Guy A. MacGowan, Ml), I’ACC; Srinivas Mara/i, MD, FACC
`Response ..... Michael S. Latter, MD; Mark Robbins, MD; Fredric Pashkow, MD; Kathy Hoerclzer, RN;
`Claire E. Snadcr, MA; James B. Young, MD; Gary Francis, MD Web Site Feature ...................... *0182
`
`Smoking and Aldosterone Synthase Polymorphism
`Letter ..... Pitt 0. Lim, MD
`’
`Response ..... Aarno Nauru/zen, MD; M. Miinttiiri, MD; Mark/(u Kupari, MD; V. Man/linen, MD;
`1’)!”- 7001111811, PhD; Leena Ten/amen, PhD; Kathleen M. Kayes, PhD; Scott Rosenfeld, BS; Perrin C White, MD
`.................................................................. * 0183
`
`Editorial
`
`
`Provisional Versus Routine Stenting: Routine Stenting Is Here To Stay
`H. WWW” Anderson, MD; Blase A. Carabel/o, MD .................................................. 2910
`
`Brief Rapid Communications——\____—___—
`Effect of Intracoronary y-Radiation Therapy on In-Stent Restenosis: An lntravascular Ultrasound Analysis
`from the Gamma-I Study
`Gary S. Mintz, MD; Neil J. Weiss/nan, MD; Paul S. Teirstein, MD; Steven G. Ellis, MD; Ron Waksman, MD;
`Robert J. Russo, MD; lssam Moussa, MD; Prabhaker Tripuraneni, MD; Shrish Jani, MD;
`Yoshio Kobayashi, MD; Joseph A. Giorgianni, BA; Chrysoula Pappas, MD; Richard A. Kmttz, MD;
`Jéilh‘fly Matt’s: MD; Marlin 13- Leon, MD ........................................................... 2915
`
`Transfer of CD4+ T Cells Aggravates Atherosclerosis in Immunodeficient Apolipoprotein E Knockout Mice
`Xinghua Zhou, MD, PhD; Antonino Nicoletti, PhD; Rima Elhage, PhD; Goran K. Hansson, MD, PhD ,,,,,,,, 2919
`
`Clinical Investigation and Reports*M
`Economic Assessment of Platelet Glycoprotein lib/Illa Receptor Blockade With Abciximab and Low-Dose
`Heparin During Percutaneous Coronary Revascularization: Results From the EPILOG Randomized Trial
`A. Michael Lincojl,‘ MD; Daniel B. Mark, MD, MPH; James E. Tcheng, MD; Robert M. Califfi MD;
`Mohan V. Bala, PhD; Keaven M. Anderson, PhD; Linda Davidson-Ray, BA; J. David Knight, MS;
`Catherine F. Cabot. MD; Eric J. Topal, MD: for the EPILOG Investigators .............................. 2923
`
`*Supporled in concept by an unrestricted gilt l‘rom Merck & Co. Pfizer provides an unrestricted gilt for subscriptions to Circulation for Cardiology
`I’cllows in training.
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`
`CIRCULATION (ISSN 0009—7322) is published weekly except combined the first two weeks in January and the last two weeks in December by Lippincott Williams & Wilkins at 12107
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`Eu bject U3 {isapy‘rigltt Laws
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`Randomized Comparison of Primary Stcnting and Provisional Balloon Angioplasty Guided by Flow
`Velocity Measurement
`Patrick W. Serrays, MD; Bernard de Bruyne, MD; Stéphane Carlier, MD; Jose Eduardo Sousa, MD;
`Jan Pick, MD; Toshiya Maramatsu, MD; Chris Vrints, MD; Peter Probst, MD; Ricardo Seabra—Gomes, MD;
`Ian Simpson, MD; Vasiiis Voudris, MD; Olivier Gurné, MD; Nico Pijis, MD; Jorge Beiara’i, MD;
`Gerrit—Anne van Es, PhD; Erie Boersma, PhD; Marie-Angéle 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 lntracoronary Doppler
`Carlo Di Mario, MD, PhD; Jeffrey W. Moses, MD; Todd J. Anderson, MD, MRCP; Raoul Bonan. MD;
`Toshiya Muramatsa, MD; Abuaslz Chander Jain, MD; Jose Suarez de Lezo, MD; Seung Yun Cho, MD;
`Morton Kern, MD; Ian T. Meredith, MBBS. PhD; David Cohen, MD, MSe; Issam Moussa, MD;
`Antonio Colombo, MD; on behalf of the DESTINI Study Group (Doppler Endpoint STenting INternational
`Investigation) ................................................................................. ..
`
`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 Dorros, MD; David Faxon, MD; David R. Holmes, MD; Alice Jacobs, MD; Sheryl F. Kelse ', PhD;
`Spencer 8. King 11/, MD; Richard Myler, MD; James Slater, MD; Vladimir Stanek, MD; Helen A. Vlaehos, MS;
`Katherine M. Detre, MD, DrPH; for the Coinvestigators .............................................. 2945
`
`Enhanced Efficacy of Eptifibatide Administration in Patients With Acute Coronary Syndrome Requiring
`ln-Hospital Coronary Artery Bypass Grafting
`Steven P. Marso, MD; Deepak L. Bhatt, MD; Matthew T. Roe. MD; Penny L. Houghtaling, MS;
`Marina Labinaz, MD; Neal S. Kleiman, MD; Cornelius Dyke, MD; Maarten L. Simmoons, MD;
`Robert M. Calijf, MD; Robert A. Harrington, MD; Eric J. Topol, MD;_/or the PURSUIT Investigators ,,,,,,,, 2952
`
`Immediate Changes of Collateral Function After Successful Reeanalization of Chronic ’l‘otal
`Coronary Occlusions
`Gerald S. Werner, MD; Barbara M. Richartz, MD; Oliver Gastmann, MD; Markus Ferrari, MD;
`Hans R. Figulltt. MD ........................................................................... 2959
`Are Patients With Renal Failure Good Candidates for Pereutaneous Coronary Revascularization in the
`New Device Era?
`Mark H. Rubenstein, MD; Lari C. Harrell, MS; Boris V. Sheynberg, MD; Heribert Schuukert. MD;
`Hasan Bazari, Ml); Igor/'1 l’a/acios. MD ..........................................................
`Risks of Morbidity and Mortality in Dialysis Patients Undergoing Coronary Artery Bypass Surgery
`Jean Y. Liu, MD; Nancy J.(). liirkmeyer, PM); John I]. Sanders, MI); Jeremy R. Morton, MD;
`Horace F. Henrir/ues, MD; Stephen J. Lahey. MD; Richard W. Dow, MD; Christopher Maloney, MD;
`Anthony W. DiScipio. MD; Robert Clough, MI); Bruce J. Leavitt, MD; Gerald T. O'Connor, PhD, DSc; for the
`Northern New England Cardiovascular Disease Study Group ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, 2973
`Evidence of Trypanosoma cruzi Infection (Chagas’ Disease) Among Patients Undergoing Cardiac Surgery
`David A. Leiby, PhD; Francisco J. Rentas, MS; Kenrad E. Nelson, MD; Veronica A. Stambolis, MA;
`Paul M. Ness, MD; Cheryl Parnis, RN; Hugh A. Me/lllister, Jr, Ml); David II. Yawn, MD;
`Robert J. Stump/I BS; Louis V. Kirchhoff MD ,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,,, 2978
`
`2966
`
`Basic Science Reports
`
`Effects of Estrogen Replacement on Infarct Size, Cardiac Remodeling, and the Endothelin System After
`Myocardial Infarction in Ovariectoniized Rats
`Paula .I.W. Smith, PhD; Olga Ornatsky, PhD; Duncan J. Stewart, MD; Pierre Ricard, PhD;
`Fayez Dawood, DVM; Wen-Ha Wen, MD; Peter P. Liu, MD; David J. Webb, MD; Juan Carlos Mange, MD .
`Antioxidant Effect of Estrogen on Cytomegalovirus-lndueed Gene Expression in Coronary Artery
`Smooth Muscle Cells
`Edith Speir, MS; Zu-Xi Ya, MD, PhD; Kazayo Takeda, MD, PhD; Victor J. Ferrans, MI), Phi);
`Richard 0. Carmen III. MD ..................................................................... 2990
`
`. 2983
`
`,
`
`Cyclic Nucleotide Phosphodiesterase Type 5 Activity Limits Blood Flow to Ilypoperfused
`Myocardium During Exercise
`Jay H. Traverse, MD; Ying .lie Chen, MD, PhD; Ruisheng Du, PhD; Robert J. Bache, MI)
`
`................. 2997
`
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`Trypanosoma cruzi—Infccted Cardiomyocytes Produce Chemokines and Cytokines That Trigger Potent
`Nitric Oxide—Dependent Trypanocidal Activity
`Fabiana S. Machado, MS; Gisldine A. Martins. PhD; Jillio C.S. Aliberti, PhD; Fabiola L.A.C. Mestriner, BS;
`Fernando Q. Cunhn, PhD; 10:70 5. Silva, PhD ...................................................... 3003
`
`Endogenous Na,K Pump Ligands Are Differentially Regulated During Acute NaCl Loading of Dahl Rats
`Olga V. Fedorova, 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 Oxygenase-l—Deficicnt Mice
`Philippe Wiesel, MD; Ammd P. Patel, MS; Nicole DiFonza, BS; Pooja B. Marria, BS; Chc'ing U. Sim, BS;
`Andrea I’ellacani, MD, PhD; Koji Maemura, MD, PhD; Brian W. LeBlanc, BS: Kathryn Marina, BS;
`Claire M. Doerschuk, MD; Shaw-Fang Yet, PhD; Mil-En 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
`B2
`
`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 l: SMCs were pretreated for 1 hour with indicated
`doses of E2, 17ct-Ez (17a), 3-ME, or tamoxifen (TAM). Cells were then infected for 1 hour with CMV at 5 M01, followed
`by addition of DCFH-DA fluorescent dye. Both stereoisomers of estradiol and tamoxifen, but not 3—ME, dose-dependently
`
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`

`
`
`This material may be protected by Copyright law (Title 17 U.S. Code)
`
`
`
`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 Dorros, 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. Vlachos, MS; Katherine M. Detre, MD, DrPH; for the Coinvestigators
`
`Background—A1though 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 iii-hospital and I-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, 62 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%; F<0.001) and treated lesions were more severe (84.5% versus 82.5% diameter reduction;
`I’<0.001), thrombotic (22.1% versus 1 13%; P<0.001) or calcified (29.5% versus 10.8%; P<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<0.()0l) and the rate of iii-hospital death,
`myocardial infarction, and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%; P=0.001) than
`in the 1985—1986 Registry. The 1-year rate for CABG was lower in the Dynamic Registry (6.9% versus 12.6%; P<0.()Ol).
`Conclusions—Althottgh 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 percutancous 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
`pcrcutaneons coronary rcvascularization.l Patients were en-
`rolled from 19774980 and subsequently frorn 19854986.
`These 2 registries provided the first comprehensive descrip-
`tion of technical and clinical results, and in the mid-19805
`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 Revasculariza-
`tion Investigation (BARI)Z and EAST,3 found that
`in most
`patients with multivessel coronary artery disease (CAD).
`balloon angioplasty did not compromise survival and proved
`to save costs slightly relative to CABG btit many patients
`who received PTCA required repeat revascularixation. 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.), Rhodc Island Hospital. Brown University. Providence, RI; the Department of Epidemiolrwy (R.ll. W Y
`S.I".K., ll.A.V., K.M.D.). University of Pittsburgh. Pittsburgh; Lankenau Hospital (I’.C.). Philadelphia. Pa; Montreal Heart Institute (M.C°I.B.) Montreal
`Quebec. Canada; Cardiovascular Medical Associates (M.A-B.), Houston. Tex; Providence/St. Vincent Hospitals (PCB). Portland. Ore: University of
`Pittsburgh Medical Center (H.C.), Pittsburgh. Pa; Medical College of Virginia (M.C.), Richmond. Va; Arizona Heart Institute (G.D.), Phoenix Ar
`University of Southern California Medical Center (DP). Los Angeles. Calif: Mayo Clinic Foundation (D.R.}I.). Rochester, NY; Boston University
`Medical Center (Al). Boston, Mass; Emory University Hospital (SILK. Ill), Atlanta. Ga: Seton Medical Center (R.M.), Daly City Calif‘ St
`Luke‘s/Roosevelt Hospital U.S.). New York, NY; and Institute for Clinical and Experimental Medicine (VS), P
`l
`‘
`rague. Czech Republic.
`Additional coinvcstigators are listed in the Appendix.
`Correspondence to Katherine M. Detre. MD. DrPll, University of I’ittshurgh/GSI’H, I30 DeSoto St. 127 Parran Hall. Pittsburgh. PA 1526]. E-mail
`I)ctrc(modegsph.pittedu
`© 2000 American Heart Association. Inc.
`Circulation is aurilahle at http:l/wu‘u‘xircnlationaha.org
`
`.
`
`This material was copied
`at the NLIr/anay be
`Subject US Copyright Laws
`
`
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`2946
`
`Circulation
`
`December 12, 2000
`
`a few randomized clinical trials have helped to clarify the
`value of these new devices in limited patient stlbgmtlpsf’“
`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 Dynamic
`Registry is to characterize percutaneous coronary intervenv
`tion in the new device era. The Registry provides the optimal
`design to assess and to compare with the l985—l986 Registry
`the following: (1) contemporary patients and disease charac-
`teristics selected for perctrtaneotls coronary intervention, (2)
`types of devices used in various settings, and (3) changes in
`interventional strategy as well as iii-hospital and l-year
`outcomes. The present report describes the findings from
`these comparisons.
`
`Methods
`
`Design and Study Population
`The Dynamic Registry includes 15 clinical centers (10 participants in
`the 1985—1986 Registry and 5 added to augment enrollment of
`minorities) and a Coordinating Center. Three sequential waves of
`2000 patients, spaced 18 months apart, are to be enrolled. Each
`patient who is having 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 and
`was completed February 1998. recruited 2526 patients. of whom
`2206 were consecutively enrolled. Because patients with prior
`angioplasty were excltrded from the 1985—1986 Registry. for the
`sake ofcomparability, 647 Dynamic Registry patients with history of
`prior pcrcutaneous coronary intervention are excluded from this
`report.
`
`Data Collection
`Registry research coordinators responsible for data collection partic-
`ipated in a training session before patient enrollment. Data collection
`included demographic infortmttion. tnedical history, anti risk factor
`profile. Coronary angiographic information before and after inter-
`vention was obtained according to definitions developed in previous
`registries and the Bypass Angioplasty Revascularization Investiga-
`tion.” Procedural strategy data included device use, procedural
`staging, and success of each corollary lesion attempted. Successful
`lesion dilatation was defined as an absolute 20% rcdrrction in lesion
`severity with final stenosis <5t)%. Angiographic success was clas»
`sified as either partial (some but not all attempted lesions success-
`fully treatcd) or total (all attempted lesions successfully treated).
`Untoward events included death front any cause, myocardial infarc-
`tion (Ml), or CABG. MI was defined as evidence of 22 of the
`following:
`(1)
`typical chest pain >20 tnimrtes not
`relieved by
`nitroglycerin,
`(2) serial ECG recordings showing changes from
`baseline or serially in ST-T and/or Q-waves in 2” contiguous leads,
`or (3) serutn enzyme elevation of CK-MH>5% of total CK (total
`CK>2>< normal: LDll subtype l>LDll subtype 2). Congestive
`heart
`failure was defined as presence of paroxysmal nocturnal
`dyspnca, dyspnea 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: emergent when
`required immediately because of clinical
`instability, urgent when
`required within 24 hours to minimize cardiac risk, and elective when
`deferrablc >24 hours without cardiac risk. Procedural success was
`defined as achievement of either partial or total angiographic success
`without death. Q—wave Ml, or emergency CABG.
`
`TABLE 1. Patient Demographics, Disease History, and
`Angiographic Characteristics
`
`Registry
`
`Dynamlc-
`Consecutive
`
`1985—1986
`PTCA
`
`Total patients, n
`Mean age, y
`Female,
`"/0
`Race, %t
`White
`Black
`Asian
`
`Hispanic
`Other
`
`Prior CABG, %
`Prior Ml, %
`History of diabetes, %
`History of congestive heart failure, “/a
`History of hypertension, D/u
`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
`621
`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
`323
`
`2431
`58.2:
`25.5:
`
`91.6
`4.4
`1.3
`
`1.3
`1.4
`
`11.2
`38.41
`1351
`581
`45.51
`
`29.2
`30.9
`39.9
`
`8.81
`14.4
`
`58.01
`
`476
`31.9
`
`20.6
`21.9
`Triple
`
`Mean significant lesions, n 2.6 2.7
`
`‘P<0.05; tP<0.01; tP<0.001 for comparison of patients in Dynamic Vs
`1985—1986 PTCA Registry.
`
`outcomes were reported with Kaplan‘Meier estimates and log rank
`statistics. Standard stepwise procedures were used with Cox propor»
`lional hazards models to obtain adjusted relative risks comparing the
`2 registries. Consent
`to collect
`follow—up information after initial
`procedure hospitalization was not obtaitted for 253 of the 155‘)
`Dynamic patients, who were censored at
`the time of hospital
`discharge in analyses of l-ycar event rates.
`
`Results
`Although rrrost of the consecutively enrolled patients in both
`registries were white men of middle age, prevalence of
`certain baseline characteristics differed between the 2 (Table
`1). Dynamic Registry patients were older; more often female
`and nonwhite; more often had history of diabetes mellitus,
`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 MI
`Differences between proportions were assessed by X2 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. Qne- ear
`Th IS ma arial was-{earpieed
`at the NLM and may be
`Subject US Copyright. Laws
`
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`

`TABLE 2.
`
`Procedural Data
`
`TABLE 3. Characteristics of Attempted Lesions and Outcome
`
`Williams ct al
`
`NHLBI Dynamic Registry
`
`2947
`
`Registry
`
`Dynamic-
`Consecutive
`
`1985—1986
`PTCA
`
`Total patients, n
`Primary reason for revascularization, %t
`Asymptomatic CAD
`Stable angina
`CCSC W
`CCSC III/lV
`
`Unstable angina
`Acute MI
`
`Cardiogenic shock
`Thrombolytic therapy
`Other
`
`Circumstances of procedure. %1
`Elective
`
`1559
`
`2.1
`24.5
`11.8
`12.3
`
`42.8
`22.9
`
`2.1
`5.5
`7.7
`
`63.1
`
`2431
`
`26
`37.7
`16.8
`20.2
`
`47.7
`9.9
`
`N/A
`3.9‘
`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
`45.6
`21.4
`3.2
`
`1.5
`15.0
`37.2
`34.2
`12.2
`
`62.5T
`
`Total lesions, n
`Lesion location, %T
`Right coronary artery
`Left main coronary artery
`Left anterior descending coronary artery
`Left circumflex artery
`Graft
`Diameter "4: stenosis, %t
`<50
`50-70
`70—90
`90—99
`Total occlusion
`
`Mean
`Lesion characteristics, %
`
`11.3t
`22.1
`Evidence of thrombus
`10.8T
`29.5
`Calcification
`33.11
`11.0
`Mean final % stenosis
`80.9T
`93.7
`Angiographic success. %
`2.6T
`11.6
`Dissection, %
`0.4T
`3.2
`Side-branch occlusion, %
`
`Abrupt in-Iaboratory closure, % 3.1‘ 1.9
`
`
`*P<0.D1; TP<0.001 for comparison of patients
`1985—1986 PTCA Registry.
`
`in the Dynamic vs
`
`sion procedures than in the 198541986 Registry. Multivessel
`attempt was 9% in the Dynatnic compared with 20.7% ill the
`19854986 Registry (P<(l.001). Balloon angioplasty,
`the
`only percutaneous intervention at the time of the 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 athcrectomy in 5.9% of patients.
`(Directional
`atherectomy, extraction atherectomy, and laser each were
`used in < 1% 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-
`tempted 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<0.()01)
`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
`5.1
`4.3
`1.61
`
`Urgent
`Emergent
`No. of lesions attempted, "/o'l'
`0
`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
`Graft only 2.6 4.1
`
`
`CCSC indicates Canadian Cardiovascular Society Classification.
`“P<0.05;
`tP<0.001 for comparison of patients in
`the Dynamic vs
`19854985 PTCA Registnj.
`
`Unstable angina was tlte 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 M] (22.9% versus
`9.9%; P<().()()l) and less frequently for stable angina. Also,
`interventions were more often emergent (13.0% versus 5.8%;
`1’<().{)()l) for Dynamic titan for 1985—1986 Registry patients.
`Among the 357 Dynamic patients with AMI 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 interventional 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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`
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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, %
`Mi
`
`Clinical symptoms
`ECG
`
`Enzymes (>2xnormal)
`CABG, %
`Elective/urgent
`Emergency
`Major entry-site complication,
`Death/any MI/any CABG, %
`Death/any Ml/emergency CABG, “/o
`Overall angiographic success, “/ot
`None
`Partial
`Total
`
`"/o
`
`Procedure success (partial or total angiographlc
`success without death/O-wave Ml/emergency
`CABG). %
`
`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
`
`92.0
`
`2431
`1.4
`4.9T
`
`3.9T
`3.5T
`
`4.5T
`5.01
`2.3‘
`3.7T
`3-3
`9.8T
`7.9T
`
`13.7
`12.1
`74.2
`
`81.81
`
`4.1T
`2.7
`Mean length of stay after procedure, daysi
`*P<0.01; tP<0.001 tor comparison of patients in Dynamic vs 1985—1986
`PTCA Registry.
`iFor patients alive at discharge.
`
`emergent CABG were significantly lower in the Dynatnic
`Registry. Both total angiographic success and procedural
`success were achieved significantly more often in the Dy-
`namic Registry.
`In addition. mean length of hospital stay
`decreased significantly, frotn 4.l
`to 2.7 days. Overall
`inci-
`dence of repeat revaseularixation during initial hospitalization
`was 5.6% (4.2% repeat pcrcutaneous intervention and 1.5%
`CABG).
`‘
`Crude mortality during 1 year of follow—up was higher tn
`the Dynatnic Registry compared with the 1985-1986 Regis—
`try (l-year rate. 5.4% versus 3.6%), whereas l~year death or
`Ml rate was similar (Figure l). After controlling for important
`baseline differences between registries (Table 5). death rates
` 40%
`
`EventRate 10%
`
`30%
`
`20%
`
`0% .
`0
`
`300
`240
`“50
`l20
`60
`Days after Study Entry
`. . -l"]‘CA - llealh
`— Dynamic - [Math
`- -
`.
`- PTCA - Death/MI
`
`—— Dynamic - Death/MI
`
`360
`
`became comparable. Lower adjusted mortality was not sig-
`nificant, although the 30% lower l-ycar risk for combined—
`cndpoint death or Ml achieved significance. Similarly, l-ycar
`CABG and repeat pcrctttaneous 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 tnortality (7.6%
`versus 4.4%; I’<0.05) and need for CABG (9.5% versus
`5.6%; P<().05)
`than men. Patients whose indication for
`intervention was AMI had higher
`l-year mortality (9.2%
`versus 4.3%; P<().00l) than those with other indications,
`primarily due to higher in-hospital mortality (5.9% versus
`0.7%; l’<().00l). Use of GP llb/llla receptor inhibitor was
`associated with increased l-ycar Ml rate (9.5% versus 4.0%;
`P<0.00l), due in part
`to more iii-hospital events (5.1%
`versus 2.0%; P<0.001). No differences were seen in l-yeat‘
`death, M1, or revascularization by stcnt use during initial
`procedure.
`
`Discussion
`In the contemporary Dynamic Registry, patients were older
`and more often had extensive cardiovascular morbidity com-
`pared with patients undergoing percutancous 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 requiring revascularization tend to be older and have
`tnore coronary risk factors than inert do.“’“'2
`Coronary intervention was more often performed in the
`setting of unstable coronary disease in the Dynatnic Registry.
`in fact, AMI was reported as the pritnary indication for
`intervention tnore than twice as often as in [985—1986.
`
`Because coronary angioplasty can be performed quickly and
`as an immediate adjunct
`to coronary angiography,
`it
`is
`part