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`
`Subject U5 Capvri ght Laws
`
`Medtronic Exhibit 1036
`
`(
`I
`
`¥ P
`
`age 1
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`Page 1
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`Medtronic Exhibit 1036
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`

`

`Circulation
`
`JOURNAL or ,TIIE'AMERICAN 'HEART ASSOCIATION
`
`
`
`
`
`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 ............................................... *e180
`
`The Naming 0f .lllglllar Venous Valves
`Letter ......lef/i-ey Fisher, MD
`Response .......... Charles F. Babbs, MD, PhD Web Site Feature ................................. *eltl]
`
`Ventilatory and Heart Rate Responses to Exercise: Better Predictors of Heart Failure Mortality lhan 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. Snader, MA; James B. Young, MD; Gary Francis, MD Web Site Feature ...................... *e182
`
`Smoking and Aldosterone Synthase Polymorphism
`Letter ..... Pitt 0. Lim, MD
`_
`ReSpOHSC ..... Aarno Hautanen, MD; M. Mr'i'nltr‘iri, MD; Mark/cu Kupari, MD; V. [Will/11.116", MD;
`Pet/"i Toimnen, PhD; Leena Ten/(alien, I’hD; Kathleen M. Kayes, PhD; 5601! RO-S‘L’ltffld, 35: Perrm 0 WM"), MD
`............................................................... * e183
`
`Editorial
`
`
`Provisional Versus Routine Stenting: Routine Stenting Is Here To Stay
`H- WWW” ”WWW", MD: B/use A. Carabel/o, MD .................................................. 2910
`
`Brief Rapid CommunicationsM
`Effect of' Intracoronary y-Radiation Therapy on In-Stent Restenosis: An Intravascular Ultrasound Analysis
`from the Gamma-1 Study
`'l‘eirstein, MD; Steven G. Ellis, MD; Ron Waksman, MD;
`Gary S. Mintz, MD; Neil J. Weiss/nan, MD; Paul S.
`Robert J. lt’usso, MD; Issam Marissa, MD; Prob/taker Tripuraneni, MD; Shrish Jani, MD;
`Yoshio Kobayashi, MI); Joseph A. Giorgianni, BA; Chrysoula I’appas, MD; Richard A- KW“! MD"
`Jiflfl‘t‘)’ MOM“, MD! Marlin 13. L60". MD ........................................................... 2915
`Transfer of CD4+ T Cells Aggravates Atherosclerosis in Immunodeficient Apolipoprotein E Knockout Mice
`Xing/ma 2’10”, MD, PhD; Antonino Nicolelti, PhD; Rinia Elizage, PhD; GUM" K- Hansson, MD, PhD -------- 2919
`
`Clinical Investigation and Reports*M—
`Economic Assessment of Platelet Glycoprotein IIb/lHa Receptor Blockade With Abciximab and Low-Dose
`Heparin During Percutaneous Coronary Revascularization: Results From the EPILOG Randomized Trial
`A. Michael Lincojf; MD; Daniel B. Mark, MD, MPH; James E. Tcheng, MD; Robert M. Califi, MD;
`Malian V. [Ia/a, PhD; Keaven M. Anderson, PhD: Linda Davidson-Ray, BA; J. David Knight, MS;
`Catherine F. Cabot, MD; Eric J. Topol, MD; for the EPILOG Investigators .............................. 2923
`
`*Supportcd in concept by an unrestricted gift from Merck & Co. Pfizer provides an unrestricted gift for subscriptions to Circulation l‘or Cardiology
`l’cllows in training.
`
`
`CIRCULATION (lSSN 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
`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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`Th is material was copied
`at the NLM and may be
`Subject; U3£ia~pyright Laws
`
`
`
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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; Ste’phane Carlier, MD; Jose Eduardo Sousa, MD;
`Jan Pick, MD; Toshiya Maramatsu, MD; Chris Vrints, MI); Peter Probst, MD; Ricardo Seabra—Gomes, MD;
`[an Simpson, MD; Vasilis Voudris, MD; Olivier Gurné. MD; Nico Pijls, MD; Jorge Belardi, MD;
`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, Ml);
`Toslziya Muramatsu, MD; Abnash Chander Jain, MD; Jose Suarez de Lezo, MD; Seung Yun Clio, MD;
`Morton Kern, MD; lan T. Meredith, MBBS, PM); David Cohen, MD, MSc; lssam Moussa, MD;
`Antonio Colombo, MD; on behalf of the DESTINI Study Group (Doppler Endpoint STenting thernational
`Investigation) ................................................................................. 2938
`Pcrcutaneous 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, M1); Michael Cowley, MD;
`Gerald Dorros, MD; David Faxon, MD; David R. Holmes, MD; Alice Jacobs, MD; Sheryl F. Kelsey, PhD;
`Spencer B. King 11/, MD; Richard Myler, MD; Jatnes Slater, MD; Vladimir Stanck, MD; Helen A. Vlachos, MS:
`Katherine M. Detre, MD, DrPH,‘ for the Coinvestigators .............................................. 2945
`
`Enhanced Efficacy of Eptifibatidc Administration in Patients With Acute Coronary Syndrome Requiring
`In-Ilospital Coronary Artery Bypass Grafting
`Steven P. Marso, MD; Deepak L. Blunt, MD; Matthew T. Roe, MD; Penny L. Houghtaling. MS;
`Maritza Labinaz, MD; Neal S. Kleiman, MD; Cornelius Dyke, MD; Maarten L. Simntoons, MD;
`Robert M. Cali/ff MD; Robert A. Harrington, MD; Eric J. Topol, MD;_/'or the PURSUIT Investigators ________ 2952
`
`Immediate Changes of Collateral Function After Successful Recanalization of Chronic Total
`Coronary Occlusions
`Gerald S. Werner, MD; Barbara M. Richartz, MD; Oliver Gastmann, MD; Markus Ferrari, MD;
`Hans R. Flgllllll, MD ........................................................................... 2959
`Are Patients With Renal Failure Good Camlidates for Percutaneous Coronary Revaseularization in the
`New Device Era?
`Mark H. Rubenstein, Ml); Lari C. Ilarrell, MS: Boris V. Sheynberg, MD; Heribert Schunkert, MD;
`Ham/z Bazari. MD; Igor l". I’ll/acids. MI) ..........................................................
`Risks of Morbidity and Mortality in Dialysis Patients Undergoing Coronary Artery Bypass Surgery
`Jean Y. Liu, MI); Nancy J.(). Birkmeyer, PM); John ll. Sanders, MD; Jeremy R. Morton, MD;
`Horace F. Henriaues, MD; Stephen .1. Lahey, MI); Richard W. Dow, MD; Christopher Maloney, MD;
`Anthony W. DiSeipio, MD; Robert Clough. MD; Bruce J. Leavitt, MD; Gerald T. O’Connor, PhD, DSc; for the
`Northern New England Cardiovascular Disease Study Group ..........................................
`Evidence of 'l'rypanosoma cruzi Infection (Chagas’ Disease) Among Patients Undergoing Cardiac Surgery
`David A. Leiby, PhD; Francisco J. Rentas, MS; Kenrad E. Nelson, MD; Veronica A. Stanibolis, MA;
`Paul M. Ness, MD; Cheryl Parnis, RN; Hugh A. McAI/ister. .lr, MD; David H. Yawn, Ml);
`Robert J. Stump]; BS; Louis V. Kirchhofl; MD ....................................................... 2978
`
`2966
`
`2973
`
`Basic Science Reports
`
`Effects of Estrogen Replacement on Infarct Size, Cardiac Remodeling, and the Endothelin System After
`Myocardial Infarction in Ovariectomized Rats
`Paula J. W. Smith, PhD; Olga Ornatsky, PhD; Duncan J. Stewart, MD; Pierre Picard, PhD;
`Fayez Dawood, DVM; Wen-Ha Wen, MD; Peter P. Liu, MD; David J. Webb, MD; Juan Carlos Mange, Ml)
`Antioxidant Effect of Estrogen on Cytomegalovirus-Induced Gene Expression in Coronary Artery
`Smooth Muscle Cells
`Edit/2311c)”, MS; Zu-Xi Yu. MD. PhD: Kazuyo Takeda. MD, PhD; Victor J. Ferrans, MI), rho,-
`Richard O. Cannon III. MD ..................................................................... 2990
`
`,
`
`,
`
`. 2983
`
`Cyclic Nucleotide Pliosphodiesterase 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, M1)
`
`................. 2997
`
`Page 3
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`

`Trypanosoma cruzi—Infected Cardiomyocytes Produce Chemokines and Cytokines That Trigger Potent
`Nitric Oxide—Dependent Trypanocidal Activity
`Fabiana S. Machado, MS; Gisltiine A. Martins, PhD; Jzilio C.S. Alibern', PhD; Fabiola LAC. Mestriner, BS;
`F3""0’1610 Q- Clmlm, PM); 10170 5- Silva, PhD ...................................................... 3003
`
`Endogenous Na,K Pump Ligands Arc Differentially Regulated During Acute NaCl Loading of Dahl Rats
`Olga V. Fedorovu, 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; Ammu' P. Patel, MS; Nicole DiFonzo, BS; Pooja B. Marria, BS; Cht'z'ng U. Sim, BS;
`Andrea Pellacani, MD, PhD; Koji Maemura, MD, PhD; Brian W. LeBlanC, BS; Kathryn Marina, BS;
`Claire M. Doerschuk, MD; Shaw-Fang Yet, PhD; Mu-En Lee, MD, PhD; Mark A. Perrella, MD ,,,,,,,,,,,,, 3015
`
`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
`
`The cover figure is from the article in this issue by Speir et al. Figure l: SMCs were pretreated for 1 hour with indicated
`doses of E2, l7ot-E2 (17:1), 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 stcrcoisomers of estradiol and tamoxifen, but not 3-ME, dose-dependently
`
`inhibited fluorescence, as determined by confocal laser microscopy. See page 2990.
`
`
`
`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 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—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 1-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<0.0()l). 1n the Dynatnie Registry, procedures were more often performed for acute myocardial infarction
`(22.9% versus 9.9%; P<().00l) and treated lesions were more severe (84.5% versus 82.5% diameter reduction;
`P<0.00l), thrombotic (22.1% versus 11.3%; P<0.()()l) 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<().()()l) and the rate of in-hospital death,
`myocardial infarction. and emergency coronary bypass surgery combined was lower (4.9% versus 7.9%; P:0.()01) 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.()01).
`Conclusions—Although 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 stcnts
`
`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
`percutaneotrs coronary revascularization.1 Patients were en-
`rolled from 1977-1980 and subsequently from 1985—1986.
`These 2 registries provided the first comprehensive descrip—
`tion of technical 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 Revasculariza-
`tion Investigation (BARI)2 and EAST,“ found that in most
`patients with mrrltivessel coronary artery disease (CAD),
`balloon angioplasty (lid not compromise survival and proved
`to save costs slightly relative to CABG brrt 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 (l).O.W.), Rhode Island Hospital, Brown University, Providence, R1; the Department of Epidemiokwy (R.ll. W Y
`S.l’.K.. ll.A.V., K,M.D.), University of Pittsburgh, Pittsburgh; Lankenau Hospital (P.C.). Philadelphia, Pa; Montreal Heart Institute (M611), Morttr'eaf
`Quebec, Canada; Cardiovascular Medical Associates (MA-13.), llorrston, Tex; Providence/St. Vincent Hospitals (P.C.B.), Portland, Ore; University of
`Pittsburgh Medical Center (H.C.), Pittsburgh, Pa; Medical College of Virginia (M.C.), Richmond, Va; Arizona Heart Institute tGD.) Phoenix A7.
`University of Southern California Medical Center (DE). Los Angclcs. Calif; Mayo Clinic Foundation (D.R.H.), Rochester, NY; Bosion University
`Medical Center (A.J.), Boston. Mass: Emory University Hospital
`lS.B.K. 111), Atlanta, Ga: Seton Medical Center (R.M.), Daly City. Calit‘ Si
`Luke‘s/Roosevelt Hospital (1.5.), New York, NY; and Institute for Clinical and Experimental Medicine (V.S.), Prague, Czech Republic.
`i
`Additional coinvestigalors are listed in the Appendix.
`Correspondence to Katherine M. Detre. MD, DrPll. University of Pittsburgh/GSPH, 130 DeSoto St. 127 Parran Hall, Pittsburgh, PA 15261. E-rnail
`Dctt'e(medcgsphpitt.edu
`© 20le American Heart Association, Inc.
`
`‘
`
`(,‘irrulutr'mr is available at lrtlp://w\\'\\'.cireulationaha.org
`
`This materialwas copied
`at the N Livymnay‘ be
`Subject U5 {spyright Law;
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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 subgroupsficx
`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 pereutaneous coronary interven-
`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 percutaneous coronary intervention, (2)
`types of devices used in various settings, and (3) changes in
`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 15 clinical centers (ll) participants in
`the l985—l986 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 ofenrollmcnt. which began July 1997 and
`was completed February 1998. recruited 2526 patients, of whom
`2206 were consecutively enrolled. Because patients with prior
`angioplasty were excluded from the 1985—1986 Registry. for the
`sake ofcomparability, 647 Dynamic Registry patients with history of
`prior pcrcutancous 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 information. tncdical history, and risk factor
`profile. Coronary angiographic information before and after inter-
`vctttion was obtained according to definitions developed in previous
`registries and the Bypass Angioplasty RevascuIariaalion investiga-
`tion.” Procedural strategy data included device use, procedural
`staging. and success of each coronary lesion attempted. Successful
`lesion dilatation was defined as an absolute 20% reduction in lesion
`severity with final stcnosis <5()%. Angiographic success was clas-
`sified as either partial (some but not all altetnpted lesions success-
`fully treatcd) or total (all attempted lesions successfully treated).
`Untoward events included death from any cause, myocardial infarc—
`tion (Ml), or CAllG. MI was defined as evidence of 22 of the
`following:
`(1)
`typical chest pain >20 tninutes 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 cruymc elevation of CK-MB>5% of total CK (total
`CK>2>< normal; Ll)ll subtype l>LDll subtype 2). Congestive
`heart
`failure was delined as presence of paroxysmal nocturnal
`dyspnea, dyspnca 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
`dcfcrrable >24 hours without cardiac risk. Procedural success was
`defined as achievement ofeithcr partial or total angiographic success
`without death, Q.wave Ml, or emergency CABG.
`
`TABLE 1. Patient Demographics, Disease History, and
`Angiographic Characteristics
`
`Registry
`
`Dynamtc-
`1985—1986
`
`Consecutive
`PTCA
`
`Total patients, n
`Mean age. y
`Female. %
`Race. “/0:
`White
`Black
`Asian
`
`Hispanic
`Other
`
`Prior CABG, %
`Prior MI, %
`History of diabetes, %
`History of congestive heart tailure. "/o
`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. u/o
`
`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
`
`33.5
`28.9
`37.5
`
`15.0
`8.7
`
`55.3
`
`45.9
`32.3
`
`2431
`58.2:
`255:
`
`91.6
`4.4
`1.3
`
`1.3
`1.4
`
`11.2
`3841
`13.51
`5.8T
`45.5i
`
`29.2
`30.9
`39.9
`
`8.8:
`14.4
`
`58.01
`
`47.6
`31.9
`
`zoo
`21.9
`Triple
`
`Mean significant lesions, n 2.6 2.7
`
`*P<0.05; TP<0.01; ¢P<0.001 for comparison of patients in Dynamic Vs
`1985—1986 PTCA Registry.
`
`outcomes were reported with Kaplan-Meier cstilnatcs and log rank
`statistics. Standard stepwise procedures were used with Cox propor-
`tional hazards models to obtain adjusted relative risks comparing the
`2 registries. Consent to collect follow-up information after initial
`procedure hospitalization was not obtained 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 most of the consecutively enrolled patients in both
`registries were white then of tniddle 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 CAliG. Dynamic
`Statistical Methods
`Registry patients were less likely to have history of prior Ml
`Differences between proportions were assessed by X2 test or Fisher’s
`or cigarette smoking. No differences were noted in 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. One— ear
`This ma E-l’l-El was-copied
`attire NLM and may be
`Subject US £5~pyri§bt Laws
`
`Page 6
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`

`Williams et al
`
`NHLBI Dynamic Registry
`
`2947
`
`TABLE 2.
`
`Procedural Data
`
`TABLE 3. Characteristics of Attempted Lesions and Outcome
`
`Registry
`
`Registry
`
`Dynamic-
`Consecutive
`
`1985—1986
`PTCA
`
`Dynamic-
`1985—1986
`
`Consecutive
`PTCA
`
`Total patients, n
`Primary reason for revascularization, %1
`Asymptomatic CAD
`Stable angina
`CCSC [In
`(3080 Ill/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
`
`2.6
`37.7
`16.8
`20.2
`
`47.7
`9.9
`
`N/A
`3.9“
`2.1
`
`75.4
`
`Total lesions, n
`Lesion location, %1
`Right coronary artery
`Left main coronary artery
`Left anterior descending coronary artery
`Left circumflex artery
`Graft
`
`Diameter % stenosis, %1
`<50
`50-70
`70—90
`90—99
`Total occlusion
`
`Mean
`Lesion characteristics, %
`
`2224
`
`3787
`
`34.2
`0.9
`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
`
`11.31
`22.1
`Evidence of thrombus
`10.81
`29.5
`Calcification
`33.11
`11.0
`Mean final % stenosis
`80.91
`93.7
`Angiographic success. %
`2.61
`11.6
`Dissection, %
`0.41
`3.2
`Side-branch occlusion, "/0
`
`Abrupt in-laboratory closure, % 3.1“ 1.9
`
`
`*P<0.01; 1P<0.001 for comparison of patients
`1985—1986 PTCA Registry.
`
`in
`
`the Dynamic vs
`
`sion procedures than in the 1985—1986 Registry. Multivessel
`attempt was 9% in the Dynamic compared with 20.7% in the
`19854986 Registry (P<0.0()l). Balloon angioplasty,
`the
`only percutancous 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 atherectomy in 3.1%. anti both stent and
`rotational athcreetomy in 5.9% of patients.
`(Directional
`atherectomy, extraction athercctomy, 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 1985—1986
`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<().()()1)
`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
`52.8
`24.8
`8.1
`4.3
`1.61
`
`Urgent
`Emergent
`No. of lesions attempted, "/01
`0
`1
`2
`3
`24
`Mean
`No. of vessels attempted, n4,1
`0.2
`0.4
`O/Unknown
`76.6
`86.5
`1 Native
`17.0
`79
`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; 1P<0.001 for comparison of patients in
`the Dynamic vs
`19854 985 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 perfortned for acute Ml (22.9% versus
`9.9%; P<().()()l) and less frequently for stable angina. Also,
`interventions were more often emergent (13.0% versus 5.8%;
`P<().()()l) for Dynamic than 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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`
`

`

`2948
`
`Circulation
`
`December 12, 2000
`
`TABLE 4. Adverse Events and In-Hospital Outcomes
`Registry
`
`Dynamic-
`1985—1986
`Consecutive
`PTCA
`
`
`Total patients, n
`Death, %
`Ml
`
`Clinical symptoms
`ECG
`
`Enzymes (>2Xnormal)
`CABG, %
`Elective/urgent
`Emergency
`Major entry-site complication, %
`Death/any MI/any CABG. %
`Death/any Ml/emergency CABG, “/0
`Overall angiograplric success, “/u’r
`None
`Partial
`Total
`
`Procedure success (partial or total angiographic
`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
`6.0T
`2.3*
`3.7T
`3.3
`9.8T
`7.9T
`
`13.7
`12.1
`74.2
`
`81 .ST
`
`4.1T
`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.
`
`emergent CABG were significantly lower in the Dynamic
`Registry. Both total angiogl‘aphic strccess and procedural
`success were achieved significantly more oftert
`in the Dy-
`namic Registry.
`In addition. mean length of hospital .stay
`decreased significantly, front 4.l
`to 2.7 days. Overall Incr—
`dence of repeat revascularixation during initial hospitalization
`was 5.6% (4.2% repeat pcrcrrtaneorrs intervention and l.5"n
`CABG).
`Crtrde mortality during 1 year of follow—up was higher in
`the Dynamic 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%
`
`“1%
`
`30%
`
`EventRate Nc 53.
`
`0% ~ ,
`0
`
`300
`240
`1th
`l20
`60
`Days after Study Entry
`- - - I'TCA - "Halli
`; llynamie - Death
`- - -
`- PTCA - Death/Ml
`—— Dynamic - Death/MI
`
`
`
`360
`
`Figure 1. Kaplan-Meier estimates for death and death/MI in
`Dynamic vs 1985—1986 PTCA registries.
`
`Page 8
`
`became comparable. Lower adjusted mortality was not sig—
`nificant, although the 30% lower l-year risk for combined—
`cndpoint death or Ml achieved significartcc. Similarly, l-ycar
`CABG and repeat percutaneous 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 dtrring the initial procedure.
`Within the Dynamic Registry, differences were seen in
`unadjusted l-ycar event rates within several clinically impor-
`tant subgroups. Women had higher l-year mortality (7.6%
`versus 4.4%: I’<0.05) and need for CABG (9.5% versus
`5.6%; P<().()5)
`than men. 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—ycar Ml rate (9.5% versus 4.0%;
`P<0.0()l), due in part
`to rrrore iii-hospital events (5.1%
`versus 2.0%; P<0.0()l). No differences were seen irt
`l-year‘
`death, M1. or revascularization by stent use during initial
`procedure.
`
`Discussion
`in the contemporary Dynamic Registry, patients were older
`and more often had extensive cardim'ascular morbidity corn-
`pared with patients undergoing percutaneous corollary 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 Willi CAD and symp-
`toms requiring revascularization tend to be older and have
`more coronary risk factors than men 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
`l985—l986.
`
`Because coronary angioplasty can be performed qrriekly and
`as an immediate adjunct
`to coronary arrgiography.
`it
`is
`particularly well