Impact of Completeness of Revascularization on the Five-year Outcome in Percutaneous Coronary...

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Impact of Completeness of Revascularization on the Five-Year Outcome in Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Patients (from the ARTS-II Study) Giovanna Sarno, MD, PhD a , Scot Garg, MB, ChB a , Yoshinobu Onuma, MD a , Juan-Luis Gutiérrez-Chico, MD, PhD a , Marcel J.B.M. van den Brand, MD, PhD b , Benno J.W.M. Rensing, MD c , Marie-angele Morel, BSc b , and Patrick W. Serruys, MD, PhD a, * on Behalf of the ARTS-II Investigators The aim of this study was to compare clinical outcome at 5 years in patients with complete and incomplete revascularization treated with coronary artery bypass grafting (CABG) and percu- taneous coronary intervention (PCI) with drug-eluting stents. Baseline and procedural angio- grams and surgical case-record forms were centrally assessed for completeness of revascular- ization. Patients treated with PCI for incomplete revascularization were stratified according to Synergy between Percutaneous Coronary Intervention with Taxus and Cardiac Surgery (SYN- TAX) score tertiles. Complete revascularization was achieved in 360 of 588 patients (61.2%) in the PCI with sirolimus-eluting stent group and 477 of 567 patients (84.1%) in the CABG group (p <0.05). There was no significant difference in 5-year survival without major adverse cardiac and cerebrovascular events (MACCEs; death, cerebrovascular accident, myocardial infarction, and any revascularization) between patients with complete and incomplete revascularization treated with PCI or CABG. Survival free from MACCEs in patients with incomplete revas- cularization treated with PCI was significantly lower than those with complete revasculariza- tion treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p 0.001). The 5-year MACCE-free survival in patients with incomplete revascularization treated with PCI stratified according to SYNTAX score tertiles showed a significantly lower MACCE survival in the higher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p 0.04) and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p 0.02) tertiles, whereas survival between the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio 1.13, 0.60 to 2.13, log-rank p 0.71). In conclusion, this study suggests that patients with complex coronary disease, in whom complete revascularization cannot be achieved with PCI, should be offered surgical revascularization. However, in those patients with less complex disease, PCI is a valid alternative even if complete revascularization cannot be achieved. © 2010 Elsevier Inc. All rights reserved. (Am J Cardiol 2010;106:1369 –1375) The aim of this study was to compare differences in clinical outcome at 5-year follow-up in patients with com- plete and incomplete revascularization treated with coro- nary artery bypass grafting (CABG) and percutaneous cor- onary intervention (PCI) with drug-eluting stents (DESs). Methods The method of the part-II Arterial Revascularisation Therapies (ARTS-II) study has been published previously. 1 In brief, the study was a multicenter, nonrandomized, open- label trial designed to compare the safety and efficacy of the sirolimus-eluting stent in patients with de novo multivessel coronary artery disease, using the surgical group of the ARTS-I study as historical controls. The ARTS-I and ARTS-II studies used the same inclusion criteria. 1,2 Patients with stable angina, unstable angina, or silent ischemia who had 2 coronary lesions in different major epicardial vessels and/or their side branches (excluding the left main coronary artery) that were potentially amenable to stent implantation were eligible for inclusion. All patients were required to have a lesion with a diameter stenosis 50% in the left anterior descending coronary artery and 1 other major epicardial coronary artery. The goal was to achieve complete anatomic revascular- ization. One totally occluded major epicardial vessel or side branch could be included. Coronary lesions were required to be amenable to stenting using a sirolimus-eluting stent with diameter of 2.5 to 3.5 mm and length of 13 to 33 mm; there was no restriction on total implanted stent length. The major exclusion criteria were patients with previous coronary intervention, left main coronary disease, overt congestive heart failure, left ventricular ejection fraction 30%, history of a cerebrovascular accident, transmural myocardial infarction in the preceding week, severe hepatic a Thoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands; b Cardialysis BV, Rotterdam, The Netherlands; and c Antonius Hospital, Nieuwegein, The Netherlands. Manuscript received April 4, 2010; revised manuscript received and accepted June 28, 2010. *Corresponding author: Tel: 31-10-463-5260; fax: 31-10-463-5260. E-mail address: [email protected] (P.W. Serruys). 0002-9149/10/$ – see front matter © 2010 Elsevier Inc. All rights reserved. www.ajconline.org doi:10.1016/j.amjcard.2010.06.069

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  • Impact of Completeness of Revascularization on the Five-YearOutcome in Percutaneous Coronary Intervention and Coronary

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    tion treated with CABG (hazard ratio 1.66, 0.96 to 1.80, log-rank p 0.001). The 5-yearMACCE-free survival in patients with incomplete revascularization treated with PCI stratified

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    000doiaccording to SYNTAX score tertiles showed a significantly lower MACCE survival in thehigher SYNTAX tertile compared to the low (hazard ratio 0.56, 0.32 to 0.96, log-rank p 0.04)and intermediate (hazard ratio 0.50, 0.28 to 0.91, log-rank p 0.02) tertiles, whereas survivalbetween the low and intermediate SYNTAX tertiles was not significantly different (hazard ratio1.13, 0.60 to 2.13, log-rank p 0.71). In conclusion, this study suggests that patients withcomplex coronary disease, in whom complete revascularization cannot be achieved with PCI,should be offered surgical revascularization. However, in those patients with less complexdisease, PCI is a valid alternative even if complete revascularization cannot beachieved. 2010 Elsevier Inc. All rights reserved. (Am J Cardiol 2010;106:13691375)

    The aim of this study was to compare differences innical outcome at 5-year follow-up in patients with com-te and incomplete revascularization treated with coro-

    ry artery bypass grafting (CABG) and percutaneous cor-ary intervention (PCI) with drug-eluting stents (DESs).

    ethodsThe method of the part-II Arterial Revascularisationerapies (ARTS-II) study has been published previously.1brief, the study was a multicenter, nonrandomized, open-el trial designed to compare the safety and efficacy of theolimus-eluting stent in patients with de novo multivesselronary artery disease, using the surgical group of the

    ARTS-I study as historical controls. The ARTS-I andARTS-II studies used the same inclusion criteria.1,2

    Patients with stable angina, unstable angina, or silentischemia who had 2 coronary lesions in different majorepicardial vessels and/or their side branches (excluding theleft main coronary artery) that were potentially amenable tostent implantation were eligible for inclusion. All patientswere required to have a lesion with a diameter stenosis50% in the left anterior descending coronary artery and1 other major epicardial coronary artery.

    The goal was to achieve complete anatomic revascular-ization. One totally occluded major epicardial vessel or sidebranch could be included. Coronary lesions were required tobe amenable to stenting using a sirolimus-eluting stent withdiameter of 2.5 to 3.5 mm and length of 13 to 33 mm; therewas no restriction on total implanted stent length.

    The major exclusion criteria were patients with previouscoronary intervention, left main coronary disease, overtcongestive heart failure, left ventricular ejection fraction30%, history of a cerebrovascular accident, transmuralmyocardial infarction in the preceding week, severe hepatic

    aThoraxcenter, Erasmus Medical Center, Rotterdam, The Netherlands;rdialysis BV, Rotterdam, The Netherlands; and cAntonius Hospital,uwegein, The Netherlands. Manuscript received April 4, 2010; revisednuscript received and accepted June 28, 2010.*Corresponding author: Tel: 31-10-463-5260; fax: 31-10-463-5260.E-mail address: [email protected] (P.W. Serruys).

    2-9149/10/$ see front matter 2010 Elsevier Inc. All rights reserved. www.ajconline.org:10.1016/j.amjcard.2010.06.069Artery Bypass Graft PatientGiovanna Sarno, MD, PhDa, Scot Garg

    Juan-Luis Gutirrez-Chico, MD, PhDa, MBenno J.W.M. Rensing, MDc, Marie-angele Mor

    Behalf of the ART

    The aim of this study was to compare clinical oincomplete revascularization treated with corontaneous coronary intervention (PCI) with druggrams and surgical case-record forms were cenization. Patients treated with PCI for incompleSynergy between Percutaneous Coronary InterTAX) score tertiles. Complete revascularizationthe PCI with sirolimus-eluting stent group and(p

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    1370 The American Journal of Cardiology (www.ajconline.org)renal disease, neutropenia or thrombocytopenia, an intol-nce or contraindication to acetylsalicylic acid or thien-yridines, need for concomitant major surgery, and life-iting major concomitant noncardiac diseases.Surgical techniques for patients randomized to surgeryre also standardized. The left anterior descending coro-ry artery and/or diagonal branches were revascularizedng the left internal mammary artery. Other vessels werepassed with venous bypass grafts.This study analyzed clinical outcomes from the 567

    tients with CABG from ARTS-I and 588 patients fromTS-II treated with DESs who had completeness of re-

    scularization assessed.After the index revascularization procedure an indepen-

    nt core laboratory (Cardialysis BV, Rotterdam, The Neth-ands) reviewed all diagnostic coronary angiograms toess completeness of revascularization. The coronary ar-ial tree was subdivided into 15 segments according toerican Heart Association/American College of Cardiol-

    y criteria.3 All lesions with diameter stenosis 50% in assel with a reference diameter 1.50 mm were scored astentially amenable to treatment. If all such defined seg-nts had been treated according to the surgical report oncase-record form, the surgical procedure was scored as

    omplete revascularization. If 1 segment was left unby-ssed, the patient was considered to have incomplete re-scularization. Any patient with grafts bypassing 1 non-

    le 1nical and angiographic characteristics per patient

    iable(n

    Complete(n 477)

    n 367 (76.9%)e (years), mean SD 61 9ble angina pectoris 280 (58.7%)stable angina pectoris 197 (41.3%)vious myocardial infarct 33 (36.7%)vious percutaneous coronary intervention 10 (2.1%)vious smoker 221 (46.3%)rent smoker 127 (26.6%)betes mellitus 72 (15.0%)percholesterolemia (190 mg/dl) 286 (60.0%)pertension (165/95 mm Hg) 208 (43.6%)istic EuroSCORE (%), mean SD 2.02 1.63

    NTAX score, mean SD ly main branch untreated/patient ly side branch untreated/patient in and side branches untreated/patient mber of diseased vessels/patient, mean SD 2.30 0.50mber of lesions/patient, mean SD 2.60 0.80mber of stents implanted/patient, mean SD al stent length (mm), mean SD Not significant for PCI DES complete versus PCI DES incomplete.Post hoc multiple comparison analysis: p 0.05 for PCI DES incompletp 0.05 for CABG incomplete versus PCI DES incomplete.p 0.05 for CABG complete versus CABG incomplete.uroSCORE European System for Cardiac Operative Risk Evaluation.nificant lesion and all significant lesions was included incompletely revascularized subgroup. Patients treated

    ofproth grafts bypassing nonsignificant lesions who also hadnificant lesions that were left untreated were included inincompletely revascularized subgroup.

    For patients treated with PCI, diagnostic and proceduralgiograms were reviewed. Patients were considered tove complete revascularization if all lesions with 50%meter stenosis had been successfully treated. Those pa-nts in whom attempt was made to treat 1 significantion or whose treatment resulted in a final diameter ste-sis 50% were considered to have incomplete revascu-ization.Degree of incompleteness of revascularization with ei-r technique was further specified by dividing coronaryery segments into main and side branches. The proximalt anterior descending coronary artery (segments 6 and 7),ximal left circumflex artery (segment 11 and, in case of

    t dominance, segment 13), and proximal right coronaryery (segments 1, 2, and 3) were scored as main branches.l other segments were scored as side branches (12). Thempleteness of revascularization was then scored for thein branches, the side branches, or a combination of such

    fined vessels.In addition, a detailed coronary risk score that has beenviously published and tested in a subgroup of ARTS-II

    tients with 3-vessel disease (Synergy between Percutane-s Coronary Intervention with Taxus and Cardiac Surgery

    NTAX] score) was used to characterize the complexity4

    )PCI With DES*

    (n 588)Incomplete Complete Incomplete(n 90) (n 360) (n 228)

    63 (68.9%) 277 (76.1%) 176 (77.2%)62 10 62 10 63 10

    53 (58.9%) 181 (50.3%) 134 (58.8%)37 (41.1%) 179 (49.7%) 94 (41.2%)

    204 (46.9%) 116 (32.2%) 82 (36.0%)3 (3.3%) 2 (0.6%) 0 (0.0%)

    33 (48.9%) 151 (41.9%) 91 (39.9%)17 (18.9%) 70 (19.4%) 46 (20.2%)21 (23.3%) 91 (25.3%) 61 (26.8%)42 (46.7%) 276 (69.7%) 159 (77.1%)49 (54.4%) 232 (64.4%) 162 (64.4%)2.22 1.64 2.13 1.48 2.21 1.63

    18.8 8.9 23.5 9.6*4/90 (26.7%) 3/228 (1.3%)3/90 (70.0%) 143/228 (62.8%)3/90 (3.3%) 82/228 (35.9%)

    2.70 0.50 2.47 0.49 2.62 0.48*3.70 1.10 3.22 1.11 4.05 1.30*

    3.62 1.49 3.72 1.52 71.20 30.91 73.62 32.72

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    prepaou[SYthe coronary anatomy. In brief, each coronary lesionducing 50% luminal obstruction in vessels 1.5 mm

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    1371Coronary Artery Disease/Completeness of Revascularization in Multivessel Coronary Diseases separately scored and added to provide the overallNTAX score. The SYNTAX score was calculated usingedicated software that integrates the number of lesions

    th their specific weighting factors based on the amount ofocardium distal to the lesion according to the score ofaman et al5 and the morphologic features of each singleion, as previously reported.6 Baseline SYNTAX scores inARTS-I study were not calculated because the baseline

    e angiograms are no longer available.Deaths included death from any cause. Cerebrovascularidents included transient ischemic attacks, reversible

    urologic deficits, intracranial hemorrhage, and ischemicoke.Myocardial infarction was defined in the first 7 days afterintervention, if there was documentation of new abnor-

    l Q waves and a ratio of serum creatinine kinase-MBenzyme to total creatinine kinase that 0.1 or a creati-e kinase-MB value that was 5 times the upper limit of

    rmal. Serum creatinine kinase and creatinine kinase-MBenzyme concentrations were measured 6, 12, and 18urs after the intervention. Commencing 8 days after theervention (length of hospital stay after surgery), abnor-l Q waves or enzymatic changes, as described earlier,re sufficient for a diagnosis of myocardial infarction.ocardial infarction was confirmed only after the relevantctrocardiograms had been analyzed by the core labora-y and adjudicated by the clinical events committee. In-ence of stent thrombosis was determined according toademic Research Consortium definitions.7Continuous variables are expressed as mean SD andre compared using analysis of variance and Tukey postc test for multiple comparisons of all pairs. Categoricalta are presented as frequency (percentage) and were com-red using chi-square test or Fischers exact test. Survival

    le 2giographic and procedural characteristics per lesion

    iable CAB(n 1,635

    Complete(n 1,312 lesions)

    rowed coronary arteryight 397 (30.3%)eft circumflex 375 (28.6%)eft anterior descending 540 (41.1%)ion characteristicsesion length (visual) (percent lesions)iscrete (10 mm) 840 (67.2%)ubular (1020 mm) 329 (26.3%)iffuse (20 mm) 81 (6.5%)mall vessels (2.5 mm)oderate/heavy calcium 177 (14.2%)

    hrombus containing lesions 19 (1.5%)ong-term total occlusion 76 (5.8%)ifurcation with side branch involvement 384 (36.0%)p 0.05 for CABG incomplete versus PCI incomplete.p 0.05 for PCI complete versus PCI incomplete.p 0.05 for CABG complete versus CABG incomplete.rves were constructed for time-to-event variables usingplan-Meier estimates and compared by log-rank test.

    cusults

    Angiograms from 1,155 patients (97.4%) were availablecentral analysis. In the PCI DES group, 588 (96.9%) of

    7 angiograms were reviewed, whereas for bypass surgery,7 (97.9%) of 579 angiograms were available. Completeascularization was achieved in 360 of 588 patients.2%) in the PCI DES group and 477 of 567 patients.1%) in the CABG group (p 0.05).Baseline demographics of patients with complete andomplete revascularization from the CABG and PCI DESups are presented in Table 1. Patients in the PCI groupose revascularization was incomplete were significantlyer than those treated with CABG whose revasculariza-n was complete.Angiographic characteristics are presented in Table 2.mber of diseased vessels and number of lesions per

    tient were significantly higher in the incompletely revas-larized groups compared to the completely revascularizedups irrespective of type of revascularization. Patients

    th incomplete revascularization who were treated withI had significantly more lesions that were 20 mm ingth and moderately/heavily calcified and totally occluded

    mpared to those with incomplete revascularization treatedth CABG. Number of calcified and totally occluded le-ns was significantly higher in patients with PCI DESsd incomplete revascularization compared to patients withI DES and complete revascularization. Procedural suc-s rate for PCI of calcified and totally occluded lesionss 65.6% (22 of 32).Five-year Kaplan-Meier curves for major adverse car-c and cerebrovascular events (MACCEs; composite of

    ath, cerebrovascular accident, myocardial infarction, andy revascularization) after complete and incomplete revas-

    )PCI With DES

    (n 2,160 lesions)Incomplete Complete Incomplete 323 lesions) (n 1,175 lesions) (n 985 lesions)

    84 (26.0%) 353 (30.2%) 275 (27.9%)03 (32.8%) 337 (28.7%) 297 (30.2%)33 (41.2%) 483 (41.1%) 413 (41.9%)

    17 (72.3%)* 715 (60.9%) 543 (55.1%)62 (20.7%)* 291 (24.8%) 272 (27.6%)21 (7.0%)* 125 (10.6%) 120 (12.2%)

    71 (6%) 128 (13%)52 (17.3%)* 321 (27.3%) 322 (32.7%)4 (1.3%)* 9 (0.8%) 2 (0.2%)

    23 (7.1%)* 18 (1.5%) 32 (3.2%)08 (30.7%) 364 (31.0%) 337 (34.2%)growholdtio

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    diadeanlarization with CABG and PCI are shown in Figure 1.Survival free from MACCEs (Figure 1) in patients with

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    1372 The American Journal of Cardiology (www.ajconline.org)omplete revascularization and PCI was numericallyer than in patients with incomplete revascularization andBG (hazard ratio 1.52, 0.91 to 0.2.52, log-rank p 0.10)

    d significantly lower than the completely revascularizedBG group (hazard ratio 1.66, 0.96 to 1.80, log-rank p 01). The Kaplan-Meier curve for MACCEs of the PCIS incompletely revascularized group shows a crossing

    int with the incompletely revascularized CABG group atonths, whereas the survival curve of the PCI DES com-

    tely revascularized group diverges from the CABG com-

    ure 1. Kaplan-Meier survival curves at 5-year follow-up for compositeeath, cerebrovascular accident [CVA], myocardial infarction [MI], andrevascularization (A) in the CABG completely revascularized (CR)

    rple line), CABG incompletely revascularized (IR) (yellow line), PCI(green line), and PCI IR (blue line) groups and (B) for the incompletely

    ascularized PCI subgroup stratified according to low (19) (blue line),rmediate (19 to 26.5) (green line), and high (26.5) (red line)NTAX score tertiles. HR hazard ratio.tely revascularized group after 2 years with a decrease ofvival rate free from MACCEs in the PCI completely

    allticascularized group from 87% at 2 years up to 75% atear follow-up.Figure 1 shows 5-year survival free from MACCEs inincompletely revascularized PCI DES group stratified

    ording to SYNTAX score tertile distribution. Of note,5-year event-free survival in the low (SYNTAX score

    9) and intermediate (SYNTAX score 19 to 26.5)tiles was significantly better than in the higher tertile

    NTAX score 26.5) and similar to the completely andompletely CABG groups or the completely revascular-d PCI group.Five-year Kaplan-Meier curves for death, for the com-site of death, cerebrovascular accident, and myocardialarction, for any revascularization, and for the compositedefinite/probable stent thrombosis after complete andomplete revascularization with CABG and PCI arewn in Figure 2.Table 3 presents the 5-year cumulative incidence ofjor adverse events in the 4 subgroups. Need for repeatascularization and rate of nontarget lesion revasculariza-n in the incompletely revascularized PCI DES groupre significantly higher compared to the completely revas-larized PCI DES group.Definite stent thrombosis according to Academic Re-rch Consortium definitions occurred in 6 of 228 patients6%) in the PCI incompletely revascularized group versusof 360 patients (3.9%) in the PCI completely revascu-

    ized group (p 0.45), whereas the composite of definiteprobable stent thrombosis occurred in 15 of 228 patients5%) in the PCI incompletely revascularized group versusof 360 patients (8.6%) in the PCI completely revascu-

    ized group (p 0.41).

    scussionThe main finding of this study is that in patients withomplete revascularization and PCI, only those in thehest SYNTAX score tertile had a higher rate of adverse

    ents at 5 years compared to patients treated with CABG.nversely, outcomes in patients with incomplete revascu-ization and PCI with low/intermediate SYNTAX scoresre not significantly different from those patients who hadmplete revascularization with CABG or PCI. These find-s reiterate the need for a careful assessment of the ana-ic complexity and lesion characteristics in patients with

    ltivessel coronary disease to facilitate the decision on thest appropriate revascularization strategy.This study provides complementary evidence to recentdies4,810 that have demonstrated that surgical revascu-ization is the most appropriate method of revasculariza-n in patients with complex anatomy and a high SYNTAXre, a group of patients in whom complete revasculariza-

    n is least likely to be achieved percutaneously. However,se studies are limited by a relatively short follow-up. To

    te, there is no study with such long-term outcome (5ars) comparing the effect of completeness of revascular-tion between CABG and PCI with DESs.There are many possible explanations why a patient mayt have complete revascularization after PCI or CABG. By

    intents and purposes, complete revascularization is an-

    ipated when patients undergo surgical revascularization.

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    1373Coronary Artery Disease/Completeness of Revascularization in Multivessel Coronary Diseasewever, at the time of surgery factors such as a lack oftable conduits or presence of small native vessels maycome apparent that prevent complete revascularization. Indition, previous PCI with stents, particularly in patientsth a full-metal jacket, may limit the location at whichpasses can be attached.Incomplete percutaneous revascularization may occurintentionally, for example, after a failed attempt at open-

    a calcified and totally occluded vessel. Intentionally ity occur if operators have decided to stage the PCI, orrocedural time has been prolonged in view of the risk ofiation or after an excessive contrast load. It is likely thatse were the main reasons for the incomplete revascular-tion of patients with PCI in this study. Indeed, the rate ofled calcified and totally occluded vessels was signifi-tly higher in the PCI incompletely revascularized group

    mpared to the PCI completely revascularized group.In this study use of the SYNTAX score enabled the

    ure 2. Kaplan-Meier survival curves at 5-year follow-up up for death (A), f, for any revascularization (C), and for the composite of definite/probableI CR (green line), and PCI IR (blue line) groups. Abbreviations as in Figntification of those patients (SYNTAX score 26.5)th incomplete revascularization who do not develop sig-

    tretrecant adverse events at long-term follow-up compared totients with complete revascularization.The SYNTAX score6,11 was initially designed to better

    ticipate the risks of percutaneous or surgical revascular-tion, taking into account the functional impact of theronary circulation with all its anatomic components suchbifurcations, total occlusions, thrombus, calcifications,all vessels, etc. Therefore, it is not merely an anatomicre but it also takes into account the functional relevancea lesion according to its location and relative amount ofod supply to the myocardium. Recent studies have dem-

    strated that it has also a role in short- and long-term riskatification of patients having PCI.1,4,810,12,13In the study protocol the definition of incomplete revas-

    larization required the presence, after the procedure, ofnosis 50% in a vessel with a reference diameter 1.5. However, use of only an anatomic definition is limiting

    understand the clinical implications when leaving un-

    omposite of death, cerebrovascular accident, and myocardial infarctionrombosis (D) in the CABG CR (purple line), CABG IR (yellow line),nifipa

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    or the cstent thure 1.ated lesions. It is not difficult to recognize that an un-ated lesion in a diagonal branch or a distal right coronary

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    1374 The American Journal of Cardiology (www.ajconline.org)ery is less prognostically significant compared to an un-ated proximal left anterior descendent artery.14 TheNTAX score is able to discriminate between lesions withferent vessel location and angiographic characteristics.The results of this study confirm previous findings of theTS-I substudy that showed no significant difference insafety end point (death, cerebrovascular accident, myo-

    dial infarction) at 1 year between the CABG and PCIups, whereas the only difference was in need for repeatascularization at 1 year.15 The greater requirements foreat revascularization after PCI compared to CABG arell known.1,8,12,16,17 Indeed, this study has shown thatvival free from any revascularization was significantlyer in the 2 PCI groups compared to the 2 CABG groups,

    th a steep decrease in survival rate in the 2 PCI groups atonths and after 1 year.

    Of note, survival rate free from the composite of definiteprobable stent thrombosis in the 2 PCI groups showed anly decrease with a further decrease at 1 year. Surpris-ly, a further decrease was observed in the PCI com-tely revascularized group after 2 years with a decrease ofvival rate from 97.3% to 91.1%. There is not a clear

    planation for this finding and particularly the number ofplanted stent per patient was similar in the completelyd incompletely revascularized PCI groups.At variance with previous studies16,1821 was the absenceany significant difference in MACCEs and subsequenteat revascularization rate between the incompletely and

    mpletely revascularized CABG groups. This may be theult of the sample size, which was underpowered to detectignificant difference, or because assessment of complete-ss of revascularization in the CABG group relied on theeration note prepared by the cardiac surgeon and not onronary angiogram after CABG. Therefore, it is likely that

    e surgical patients, deemed to have had a complete

    le 3ulative incidence of major adverse events at five years in the four subgr

    iable

    Compl(n 4

    ath 33 (6.9ebrovascular accident 17 (3.6ocardial infarction 23 (4.8ath/cerebrovascular accident/myocardial infarction 63 (13.y revascularization 36 (7.5arget lesion percutaneous coronary intervention 23 (4.8arget lesion coronary artery bypass graft 2 (0.4ontarget lesion percutaneous coronary intervention 14 (2.9ontarget lesion coronary artery bypass graft 0 (0.0jor adverse cardiovascular and cerebrovascular events

    (death/cerebrovascular accident/myocardialinfarction/any revascularization)

    94 (19.

    alues are numbers of patients (percentages).p 0.05 for PCI DES complete versus PCI DES incomplete.p 0.05 for PCI DES incomplete versus CABG complete.p 0.05 for CABG complete versus CABG incomplete.p 0.05 for CABG incomplete versus PCI DES incomplete.p 0.05 for PCI DES complete versus CABG complete.ascularization according to the surgical report, wouldve been assigned to the incompletely revascularizedup if a coronary angiogram had been obtained afterBG. In a recent study coronary angiography immedi-ly after CABG indicated the presence of significant an-graphic defects (conduit defects, anastomotic defects,get vessel errors) in 12% of coronary grafts.22The concept of completeness of revascularization is cur-tly evolving; as reported by Ong et al,23 several defini-ns of completeness of revascularization (anatomic,ctional, numeric, conditional/unconditional, and func-

    nal based on jeopardy score) are still in use and it is notaightforward to make definite conclusions on the impactachieving complete revascularization with PCI or CABG.The results of this study, showing no significant differ-

    ces in 5-year outcome between patients with completed incomplete revascularization in the CABG and PCIups, highlight the need of a new standardized definitioncompleteness of revascularization that should take intoount the anatomic or functional severity of the lesions

    d help the clinical decision on the appropriateness ofascularization in patients with multivessel coronary dis-e. Indeed, PCI of nonhemodynamically significant ste-

    ses has been shown not to improve a patients prognosissymptoms while increasing health care costs.2426The absence of SYNTAX scores in patients treated withBG is a limitation that otherwise would have allowed are effective comparison of anatomic complexity in thegical group.In addition, ARTS-II was a registry and as such has theerent limitation of this type of study. Moreover, this

    hort of patients represents a subgroup analysis and there-e end points were not adequately powered to providefinitive results.

    Serruys PW, Ong ATL, Morice M-C, Bruyne BD, Colombo A, Ma-caya C, Richardt G, Fajadet J, Hamm C, Dawkins K, OMalley AJ,

    (n 567) PCI With DES* (n 588)Incomplete Complete Incomplete(n 90) (n 360) (n 228)8 (8.9%) 16 (4.4%) 16 (6.0%)1 (1.1%) 15 (4.2%) 7 (3.1%)7 (7.8%) 18 (8.0%) 16 (7.0%)

    14 (15.6%) 43 (12.0%) 32 (14.0%)7 (7.8%) 61 (16.9%) 56 (25.6%)*4 (4.4%) 41 (11.4%) 32 (14%)1 (1.1%) 3 (0.8%) 2 (0.9%)3 (3.3%) 25 (6.9%) 28 (12.3%)*0 (0.0%) 2 (0.6%) 3 (1.3%)

    19 (21.1%) 91 (25.3%) 71 (31.1%)enangroofaccanreveasnoor

    CAmosur

    inhcoforde

    1.Bressers M, Dennis D, on behalf of the ARTS II Investigators. ArterialRevascularisation Therapies Study Part IIsirolimus-eluting stents

  • for the treatment of patients with multivessel de novo coronary arterylesions. Eurointervention 2005;1:147156.

    2. Serruys PW, Unger F, van Hout BA, van den Brand MJ, van Herw-erden LA, van Es GA, Bonnier JJ, Simon R, Cremer J, Colombo A,Santoli C, Vandormael M, Marshall PR, Madonna O, Firth BG, Bree-man A, Morel MA, Hugenholtz PG. The ARTS study (Arterial Re-

    3.

    4.

    5.

    6.

    7.

    8.

    9.

    10.

    11.

    12.

    13.

    14.

    15. van den Brand MJ, Rensing BJ, Morel MA, Foley DP, de Valk V,Breeman A, Suryapranata H, Haalebos MM, Wijns W, Wellens F,Balcon R, Magee P, Ribeiro E, Buffolo E, Unger F, Serruys PW. Theeffect of completeness of revascularization on event-free survival atone year in the ARTS trial. J Am Coll Cardiol 2002;39:559564.

    16. Bell MR, Gersh BJ, Schaff HV, Holmes DR Jr, Fisher LD, Alderman

    17.

    18.

    19.

    20.

    21.

    22.

    23.

    24.

    25.

    26.

    1375Coronary Artery Disease/Completeness of Revascularization in Multivessel Coronary Diseasevascularization Therapies Study). Semin Interv Cardiol 1999;4:209219.Austen WG, Edwards JE, Frye RL, Gensini GG, Gott VL, Griffith LS,McGoon DC, Murphy ML, Roe BB. A reporting system on patientsevaluated for coronary artery disease. Report of the Ad Hoc Commit-tee for Grading of Coronary Artery Disease, Council on Cardiovascu-lar Surgery, American Heart Association. Circulation 1975;51:540.Valgimigli M, Serruys PW, Tsuchida K, Vaina S, Morel MA, van denBrand MJ, Colombo A, Morice MC, Dawkins K, de Bruyne B, Kor-nowski R, de Servi S, Guagliumi G, Jukema JW, Mohr FW, KappeteinAP, Wittebols K, Stoll HP, Boersma E, Parrinello G. Cyphering thecomplexity of coronary artery disease using the SYNTAX score topredict clinical outcome in patients with three-vessel lumen obstruc-tion undergoing percutaneous coronary intervention. Am J Cardiol2007;99:10721081.Leaman DM, Brower RW, Meester GT, Serruys P, van den Brand M.Coronary artery atherosclerosis: severity of the disease, severity ofangina pectoris and compromised left ventricular function. Circulation1981;63:285299.Serruys P, Onuma Y, Garg S, Sarno G, Van Den Brand M, KappeteinAP, van Dyck N, Mack MJ, Holmes DR Jr, Feldman TE, Morice MC,Colombo A, Bass EJ, Leadley K, Dawkins K, van Es GA, Morel MA,Mohr F. Assessment of the SYNTAX score in the Syntax study.Eurointervention 2009;5:5056.Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es GA,Steg PG, Morel MA, Mauri L, Vranckx P, McFadden E, Lansky A,Hamon M, Krucoff MW, Serruys PW. Clinical end points in coronarystent trials: a case for standardized definitions. Circulation 2007;115:23442351.Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR,Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, VanDyck N, Leadley K, Dawkins KD, Mohr FW. Percutaneous coronaryintervention versus coronary-artery bypass grafting for severe coro-nary artery disease. N Engl J Med 2009;360:961972.Capodanno D, Di Salvo ME, Cincotta G, Miano M, Tamburino C,Tamburino C. Usefulness of the SYNTAX score for predicting clinicaloutcome after percutaneous coronary intervention of unprotected leftmain coronary artery disease. Circ Cardiovasc Interv 2009;2:302308.Capodanno D, Capranzano P, Di Salvo ME, Caggegi A, Tomasello D,Cincotta G, Miano M, Patane M, Tamburino C, Tolaro S, Patane L,Calafiore AM. Usefulness of SYNTAX score to select patients withleft main coronary artery disease to be treated with coronary arterybypass graft. JACC Cardiovasc Interv 2009;2:731738.Sianos G, Morel MA, Kappetein AP, Morice MC, Colombo A,Dawkins K, van den Brand M, Van Dyck N, Russell ME, Serruys P.The SYNTAX score: an angiographic tool grading the complexity ofcoronary artery disease. Eurointervention 2005;1:219227.Serruys PW, Unger F, Sousa JE, Jatene A, Bonnier HJ, SchonbergerJP, Buller N, Bonser R, van den Brand MJ, van Herwerden LA, MorelMA, van Hout BA. Comparison of coronary-artery bypass surgery andstenting for the treatment of multivessel disease. N Engl J Med 2001;344:11171124.Singh M, Rihal CS, Gersh BJ, Lennon RJ, Prasad A, Sorajja P,Gullerud RE, Holmes DR Jr. Twenty-five-year trends in in-hospitaland long-term outcome after percutaneous coronary intervention: asingle-institution experience. Circulation 2007;115:28352841.Chaitman BR, Ryan TJ, Kronmal RA, Foster ED, Frommer PL, KillipT. Coronary Artery Surgery Study (CASS): comparability of 10 yearsurvival in randomized and randomizable patients. J Am Coll Cardiol1990;16:10711078.EL, Myers WO, Parsons LS, Reeder GS. Effect of completeness ofrevascularization on long-term outcome of patients with three-vesseldisease undergoing coronary artery bypass surgery. A report from theCoronary Artery Surgery Study (CASS) Registry. Circulation 1992;86:446457.Serruys P, Onuma Y, Garg S, Vranckx P, De Bruyne B, Morice MC,Colombo A, Macaya C, Gert R, Fajadet J, Hamm C, Schuijer M,Rademaker T, Wittebols K, Stoll HP, on behalf of the ARTS-IIinvestigators. Five-year clinical outcomes of the arterial revasculari-sation therapies (ARTS-II) study of the sirolimus-eluting stent in thetreatment of patients with multivessel de novo coronary artery lesions.J Am Coll Cardiol 2010;55:10931101.Vander Salm TJ, Kip KE, Jones RH, Schaff HV, Shemin RJ, AldeaGS, Detre KM. What constitutes optimal surgical revascularization?Answers from the Bypass Angioplasty Revascularization Investigation(BARI). J Am Coll Cardiol 2002;39:565572.Kleisli T, Cheng W, Jacobs MJ, Mirocha J, Derobertis MA, Kass RM,Blanche C, Fontana GP, Raissi SS, Magliato KE, Trento A. In thecurrent era, complete revascularization improves survival after coro-nary artery bypass surgery. J Thorac Cardiovasc Surg 2005;129:12831291.Kozower BD, Moon MR, Barner HB, Moazami N, Lawton JS, PasqueMK, Damiano RJ Jr. Impact of complete revascularization on long-term survival after coronary artery bypass grafting in octogenarians.Ann Thorac Surg 2005;80:112117.Bourassa MG, Yeh W, Holubkov R, Sopko G, Detre KM. Long-termoutcome of patients with incomplete vs complete revascularizationafter multivessel PTCA. A report from the NHLBI PTCA Registry.Eur Heart J 1998;19:103111.Zhao DX, Leacche M, Balaguer JM, Boudoulas KD, Damp JA, Greel-ish JP, Byrne JG, Ahmad RM, Ball SK, Cleator JH, Deegan RJ, EagleSS, Fong PP, Fredi JL, Hoff SJ, Jennings HS III, McPherson JA, PianaRN, Pretorius M, Robbins MA, Slosky DA, Thompson A. Routineintraoperative completion angiography after coronary artery bypassgrafting and 1-stop hybrid revascularization results from a fully inte-grated hybrid catheterization laboratory/operating room. J Am CollCardiol 2009;53:232241.Ong AT, Serruys PW, Mohr FW, Morice MC, Kappetein AP, HolmesDR Jr, Mack MJ, van den Brand M, Morel MA, van Es GA, KleijneJ, Koglin J, Russell ME. The SYNergy between percutaneous coronaryintervention with TAXus and cardiac surgery (SYNTAX) study: de-sign, rationale, and run-in phase. Am Heart J 2006;151:11941204.Pijls NH, van Schaardenburgh P, Manoharan G, Boersma E, Bech JW,vant Veer M, Bar F, Hoorntje J, Koolen J, Wijns W, de Bruyne B.Percutaneous coronary intervention of functionally nonsignificant ste-nosis: 5-year follow-up of the DEFER Study. J Am Coll Cardiol2007;49:21052111.Tonino PA, De Bruyne B, Pijls NH, Siebert U, Ikeno F, vant Veer M,Klauss V, Manoharan G, Engstrom T, Oldroyd KG, Ver Lee PN,MacCarthy PA, Fearon WF. Fractional flow reserve versus angiogra-phy for guiding percutaneous coronary intervention. N Engl J Med2009;360:213224.Shaw LJ, Berman DS, Maron DJ, Mancini GB, Hayes SW, HartiganPM, Weintraub WS, ORourke RA, Dada M, Spertus JA, ChaitmanBR, Friedman J, Slomka P, Heller GV, Germano G, Gosselin G,Berger P, Kostuk WJ, Schwartz RG, Knudtson M, Veledar E, BatesER, McCallister B, Teo KK, Boden WE. Optimal medical therapy withor without percutaneous coronary intervention to reduce ischemicburden: results from the Clinical Outcomes Utilizing Revasculariza-tion and Aggressive Drug Evaluation (COURAGE) trial nuclear sub-study. Circulation 2008;117:12831291.

    Impact of Completeness of Revascularization on the Five-Year Outcome in Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Patients (from the ARTS-II Study)MethodsResultsDiscussionReferences