Clinical research European Heart Journal (2007) 28, 433–442 doi:10.1093/eurheartj/ehl539 Interventional cardiology The clinical outcome of percutaneous treatment of bifurcation lesions in multivessel coronary artery disease with the sirolimus-eluting stent: insights from the Arterial Revascularization Therapies Study part II (ARTS II) `vre3, Keith G. Oldroyd4, Victor Guetta5, Keiichi Tsuchida1, Antonio Colombo2, Thierry Lefe 6 7 Giulio Guagliumi , Wolfgang von Scheidt , Witold Ruzyllo8, Christian W. Hamm9, Marco Bressers10, Hans-Peter Stoll11, Kristel Wittebols11, Dennis J. Donohoe11, and Patrick W. Serruys1* 1 Thoraxcenter, Ba 583, Erasmus Medical Center, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands; 2EMO Centro Cuore Columbus and San Raffaele Hospital, Milan, Italy; 3Institut Cardiovasculaire Paris Sud, Massy, France; 4Lanarkshire Acute Hospitals, Glasgow, UK; 5Chaim Sheba Medical Center, Tel Hashomer, Israel; 6Azienda Ospedaliera Ospedali Riunitit di Bergamo, Bergamo, Italy; 7Klinikum Augsburg, Augsburg, Germany; 8Institute of Cardiology Warsaw, Warsaw, Poland; 9 Kerckhoff Klinik, Kardiologie, Bad Nauheim, Germany; 10Cardialysis, B.V., Rotterdam, The Netherlands; and 11Cordis Corporation, Miami Lakes, FL, USA See page 383 for the editorial comment on this article (doi:10.1093/eurheartj/ehl252) KEYWORDS Bifurcation lesion; Multivessel disease; Stent; Sirolimus; Multicentre trial Aims Little is known about the impact of treating bifurcations on the overall outcome of multivessel coronary artery disease treated with stenting. This analysis was made to investigate the 1 year clinical outcome of the treatment of bifurcation lesions using sirolimus-eluting stents (SES) in patients with multivessel disease. Methods and results Among a total of 607 patients (2160 lesions) in the Arterial Revascularization Therapies Study part II (ARTS II), there were 324 patients in whom at least one bifurcation lesion was treated (465 lesions). Patients with bifurcations were compared with those without bifurcations in terms of baseline characteristics and major adverse cardiac and cerebrovascular events (MACCE). Patients with ‘true’ (200 patients) vs. ‘partial’ bifurcations (124 patients) and usage of a one- (263 patients) vs. two-stent strategy (61 patients) were also evaluated. The bifurcation group was associated with more complex lesion and procedural characteristics than the non-bifurcation group. However, there was no significant difference in 1 year MACCE rates between the bifurcation group and the non-bifurcation group (13.3 vs. 11.0%, P ¼ 0.46). MACCE in patients with true bifurcations was 13.0 vs. 13.7% for partial bifurcations (P ¼ 0.87) and 14.1 vs. 9.8% for one- vs. two-stent strategy (P ¼ 0.53). Conclusions In this trial without angiographic follow-up, the presence of bifurcations did not affect 1 year outcomes after SES implantation. The outcomes in true vs. partial bifurcations and using one vs. two stents were similar when the treatment strategies were left to the operator’s discretion. Introduction Percutaneous coronary intervention (PCI) in bifurcation lesions remains problematic. Even in the modern era of PCI with stent implantation, treatment of bifurcations is hampered by a higher event rate1–3 and requires longer procedure time, more radiation exposure, and higher volumes of contrast material4 compared with non-bifurcation lesions. The interventional approach is more complicated and may include initial adjunctive debulking, double guidewire * Corresponding author. Tel: þ31 10 463 5260; fax: þ31 10 436 9154. E-mail address: [email protected] placement, re-crossing of stent struts towards the side branch (SB), and final kissing balloon inflation. Therefore, in the treatment of multivessel disease, bifurcation lesions can become a crucial obstacle to complete revascularization, with a potentially negative impact on long-term outcomes. Numerous pivotal randomized trials have now shown that PCI using drug-eluting stents (DES) significantly reduces the need for repeat revascularization in patients with coronary artery disease.5–8 The efficacy of sirolimus-eluting stents (SES) in multivessel disease9,10 and bifurcation lesions11,12 has recently been reported. Nevertheless, these trials have focused on the treatment of single-discrete lesions & The European Society of Cardiology 2007. All rights reserved. For Permissions, please e-mail: [email protected] Downloaded from by guest on November 20, 2014 Received 15 May 2006; revised 13 January 2007; accepted 22 January 2007; online publish-ahead-of-print 31 January 2007 434 with relatively simple morphology.5–7 In spite of this recent progress, the presence of bifurcation lesions in multivessel disease may still be seen as a reason to prefer surgical revascularization. Interestingly, a retrospective angiographic analysis of 158 coronary bypass operations revealed that multivessel stenting would have been technically feasible in 77 (49%) of patients with bifurcation lesions.13 However, the practical impact of DES utilization on bifurcation lesions in patients with multivessel disease has not been assessed. The objective of the analysis of the Arterial Revascularization Therapies Study part II (ARTS II)14,15 was to investigate the 1 year clinical outcome of patients with bifurcation lesions treated with SES and to compare it with the outcome of non-bifurcation lesions, without having mandated or pre-specified a particular treatment strategy. Methods Patient population stenosis involving a main branch (MB) and/or contiguous SB with a diameter of 2.0 mm by visual estimate. An SB was required to be within a distance that was less than three times the diameter of the reference vessel of the SB measured from the branching point. ‘True’ bifurcation lesions were defined as lesions with significant stenoses present in both the MB and the ostium of the SB. ‘Partial’ bifurcation lesions were defined as lesions in which a branch vessel did not have significant ostial stenosis. The SYNTAX Score was used to classify the lesions in more detail (Figure 1).16 Both the MB and the SB needed to have at least a Thrombolysis in Myocardial Infarction (TIMI) flow grade 1 pre-procedure. A total of 324 patients with 465 bifurcation lesions met the criteria for inclusion in this analysis (210 patients with one bifurcation lesion; 114 patients with two or more bifurcation lesions) and were compared with the remaining 283 patients without bifurcations. We also analysed two additional subgroups on the basis of lesion morphology and stenting strategy and compared (i) 200 patients with at least one true bifurcation vs. 124 with only partial bifurcations and (ii) 263 patients treated with a one-stent strategy (stenting only MB or SB) in any of the bifurcations vs. 61 treated with a two-stent strategy (stenting in both branches) in at least one of the bifurcations. Procedure All the lesions were treated with an SES (Cypherw; Cordis Corp., Johnson & Johnson, Warren, NJ, USA) with a diameter of 2.5– 3.5 mm and a length of 13–33 mm, without restriction on the total length of stents implanted in an overlapping manner. The decision to choose a specific strategy of stent implantation in the bifurcation lesions was left to the operators’ discretion: one-stent strategy, or two-stent strategy using any of the four main techniques (T-, V-, culotte-, and crush-stenting techniques).17,18 Recommendations concerning the antiplatelet regimen have been described previously.14,15 Angiographic analysis of bifurcation lesions The following baseline lesion and procedural characteristics were evaluated by angiography: plaque distribution; take-off angle of the SB; stenting techniques; significant stenosis (50% diameter stenosis) remaining in the SB left post-procedure in true bifurcations; Figure 1 SYNTAX Score bifurcation classification. Type A, pre-branch stenosis not involving the ostium of the SB; type B, post-SB stenosis of the main vessel not involving the origin of the SB; type C, stenosis encompassing the SB but not involving its ostium; type D, stenosis involving the main vessel and ostium of the SB; type E, stenosis involving only the ostium of the SB; type F, stenosis directly involving the main vessel (pre-SB) and the ostium of the SB; and type G, stenosis directly involving the main vessel (post-SB) and the ostium of the SB. Downloaded from by guest on November 20, 2014 Principal inclusion and exclusion criteria of the ARTS II study have been described previously.14,15 Clinical manifestations of coronary artery disease were stable angina (Canadian Cardiovascular Society class I, II, III, or IV), unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, or IIIC), or silent myocardial ischaemia.14,15 Patients were required to have multivessel disease, with a need for treatment of the left anterior descending (LAD) artery and at least one other significant lesion (.50% diameter stenosis by visual estimate) in another major epicardial coronary artery.14,15 Patients with any previous coronary intervention, left main coronary disease, overt congestive heart failure, or a left ventricular ejection fraction of ,30% were excluded. A total of 607 patients with 2160 lesions were treated with SES. The patient selection and recruitment procedures and associated patient numbers were described in the main manuscript.15 All 607 patients gave written informed consent. Of these patients, 602 were treated with PCI, and the remaining five patients underwent bypass surgery. Finally, 1 year follow-up analyses were performed in 601 patients (99.0%). In this analysis, bifurcation lesions were defined as a lesion 50% diameter K. Tsuchida et al. Multivessel stenting and bifurcation lesions 435 Table 1 Baseline patient demographics and clinical characteristics (n ¼ 607 patients) of the non-bifurcation group and the bifurcation group Variables Non-bifurcation (n ¼ 283) Bifurcation (n ¼ 324) P-value Age, years Body mass index, kg/m2 Male, % (n) Diabetes mellitus, % (n) Hypertension, % (n) Hypercholesterolaemia, % (n) History of cerebrovascular accident Family history of MI/sudden death ,55 years, % (n) Peripheral vascular disease, % (n) Previous MI, % (n) Previous PCI, % (n) Previous carotid surgery, % (n) Chronic obstructive pulmonary disease, % (n) Smoking history, % (n) Previous Current Unstable angina, % (n) Stable angina, % (n) Silent ischaemia, % (n) 62.5 + 9.9 27.5 + 4.0 76.7 (217/283) 24.4 (69/283) 65.0 (184/283) 73.1 (207/283) 1.1 (3/283) 31.0 (87/281) 8.5 (24/283) 36.0 (102/283) 0.7 (2/283) 0.7 (2/283) 4.9 (14/283) 63.2 + 9.5 27.5 + 4.2 76.5 (248/324) 27.8 (90/324) 69.1 (224/324) 74.5 (240/322) 0.6 (2/323) 40.2 (130/323) 5.6 (18/323) 33.0 (107/324) 0.3 (1/324) 1.9 (6/323) 2.5 (8/323) 0.37 0.90 1.00 0.36 0.30 0.71 0.67 0.022 0.20 0.44 0.60 0.29 0.13 42.4 21.6 38.5 50.5 11.0 39.5 (128/324) 17.3 (56/324) 34.6 (112/324) 55.6 (180/324) 9.9 (32/324) 0.51 0.22 0.35 0.22 0.69 (120/283) (61/283) (109/283) (143/283) (31/283) CABG, coronary artery bypass graft; MI, myocardial infarction. Variables Angiographic characteristics Number of vessels with a lesion .50% DS Number of lesions .50% DS Ejection fraction, % Vessel territory with stenosis, % (n) RCA LAD LCX Diffuse lesion (lesion length .20 mm), % (n) Small vessels (1.5 mm and ,2.5 mm), % (n) Lesion angulation, % (n) Moderate Severe Irregular contour, % (n) Ostial lesion, % (n) Calcification: moderate to heavy, % (n) Thrombus containing lesions, % (n) Chronic total occlusion, % (n) Lesion classification, % (n) Type A Type B1 Type B2 Type C Procedural characteristics Post-procedural hospital stay, days Duration of procedure, min Number of stents implanted Number of stented lesions Average stent length, mm Total stent length, mm Usage of glycoprotein IIb/IIIa inhibitor, % Total number of bifurcation lesions LCX, left circumflex; RCA, right coronary artery. Non-bifurcation (283 patients, 909 lesions) Bifurcation (324 patients, 1251 lesions) P-value 2.5 + 0.5 3.2 + 1.2 59.4 + 11.7 2.6 + 0.5 3.9 + 1.2 60.9 + 11.5 0.008 ,0.001 0.15 30.9 (281/909) 40.5 (368/909) 28.6 (260/909) 8.7 (75/867) 7.0 (64/909) 27.7 42.3 30.0 14.2 10.8 (347/1251) (529/1251) (375/1251) (170/1199) (135/1251) 0.11 0.43 0.50 ,0.001 0.003 10.5 (91/867) 0.1 (1/867) 9.0 (78/864) 4.6 (40/866) 32.6 (282/865) 0.7 (6/878) 3.1 (28/900) 12.3 (147/1197) 0.1 (1/1197) 8.1 (97/1191) 4.1 (49/1199) 30.1 (361/1198) 0.4 (5/1221) 1.8 (22/1239) 0.24 1.00 0.52 0.58 0.25 0.54 0.058 8.1 (73/900) 26.8 (241/900) 53.6 (482/900) 11.6 (104/900) 5.9 (73/1239) 20.9 (259/1239) 57.6 (714/1239) 15.6 (193/1239) 0.046 0.002 0.06 0.008 3.5 + 3.2 76.5 + 41.3 3.3 + 1.4 2.9 + 1.1 19.2 + 3.5 64.1 + 27.0 27.6 — 3.3 + 2.1 92.6 + 43.5 4.0 + 1.6 3.4 + 1.1 19.8 + 3.5 79.7 + 34.3 36.7 465 0.50 ,0.001 ,0.001 ,0.001 0.024 ,0.001 0.019 Downloaded from by guest on November 20, 2014 Table 2 Baseline lesion and procedural characteristics (n ¼ 607 patients) of the non-bifurcation group and the bifurcation group 436 K. Tsuchida et al. significant plaque shift (50% diameter stenosis) into the SB (or MB) in partial bifurcations; final kissing balloon inflation; angiographic success in lesion, MB, as well as SB; persistent major dissection in SB after procedure; and final TIMI flow grade in SB. Plaque distribution was described on the basis of SYNTAX Score bifurcation lesion types.16 Take-off angle of SB was measured as the angle between MB distal to the branching point and SB by visual assessment in a non-foreshortened projection (Figure 1). Significant plaque shift was defined as 50% diameter stenosis in ostia of SBs (or MBs) subsequent to stenting in partial bifurcations. Angiographic success was defined as a residual stenosis of ,50% of the luminal diameter by visual assessment with TIMI 3 flow in the MB, SB, or lesion (both branches). Endpoints and clinical definitions Statistical analysis Patients with bifurcation lesions (bifurcation group) were compared with those without bifurcation lesions (non-bifurcation group) with respect to clinical, lesion, and procedural characteristics, as well as the freedom from MACCE. Additional subgroup comparisons were also performed between patients with true vs. partial bifurcations and between patients treated with the one-stent vs. two-stent strategy. Continuous variables were expressed as mean + SD. Categorical variables were presented as frequency (%). Patient demographics and procedural characteristics of the groups were compared with the Student’s t-test and with the x2 test or the Fisher’s exact test for categorical variables. Kaplan– Meier analyses and survival rates between groups were compared using the log-rank test. A two-sided P-value , 0.05 was considered statistically significant. Analyses were performed using SAS version 8.02 (SAS Institute, Inc., Cary, NC, USA). Results Baseline patient demographics and clinical characteristics: the non-bifurcation group vs. the bifurcation group Table 1 shows the patient baseline demographics and clinical characteristics of the non-bifurcation and the bifurcation groups. None of the clinical characteristics except for family history differed between the non-bifurcation and the bifurcation groups. Table 3 Clinical endpoints and stent thrombosis at 30 days and 1 year: the non-bifurcation group vs. the bifurcation group Variables Thirty day outcome, % (n) Death CVA Non-fatal MI Q-wave MI Non Q-wave MI Death/CVA/MI Revascularization CABG PCI MACCE Stent thrombosis One year outcome Death CVA Non-fatal MI Q-wave MI Non-Q-wave MI Death/CVA/MI Revascularization CABG PCI MACCE Stent thrombosis CVA, cerebrovascular accident. Non-bifurcation (n ¼ 283 patients) Bifurcation (n ¼ 324 patients) P-value 0.0 (0/283) 0.0 (0/283) 2.5 (7/283) 0.7 (2/283) 2.1 (6/283) 2.5 (7/283) 2.5 (7/283) 2.1 (6/283) 0.4 (1/283) 4.2 (12/283) 0.4 (1/283) 0.0 (0/324) 0.3 (1/324) 5.2 (17/324) 0.9 (3/324) 4.3 (14/324) 5.6 (18/324) 2.5 (8/324) 0.6 (2/324) 1.9 (6/324) 6.2 (20/324) 1.2 (4/324) 1.00 0.10 1.00 0.17 0.07 1.00 0.15 0.13 0.36 0.38 1.1 (3/283) 0.7 (2/283) 2.8 (8/283) 0.7 (2/283) 2.5 (7/283) 4.2 (12/283) 7.8 (22/283) 2.8 (8/283) 4.9 (14/283) 11.0 (31/283) 0.7 (2/283) 0.9 (3/324) 0.9 (3/324) 5.9 (19/324) 0.9 (3/324) 4.9 (16/324) 7.1 (23/324) 9.0 (29/324) 1.5 (5/324) 7.7 (25/324) 13.3 (43/324) 1.5 (5/324) 1.00 1.00 0.08 1.00 0.14 0.16 0.66 0.40 0.19 0.46 0.46 Downloaded from by guest on November 20, 2014 The primary endpoint of this analysis was freedom from any major adverse cardiac and cerebrovascular event (MACCE) at 30 days and 1 year, defined as death from any cause, cerebrovascular accident, documented non-fatal myocardial infarction, and any revascularization by percutaneous intervention or surgery after the index procedure. Because this analysis does not compare patients undergoing PCI using SES (ARTS II) with the historical surgical cohort in ARTS I,15,19 the incidence of myocardial infarction was determined as follows: in the first 7 days after the intervention, a definite diagnosis of myocardial infarction was made if there was documentation of new abnormal Q-waves (according to the Minnesota code) and either a ratio of serum creatine kinase MB (CK-MB) isoenzyme to total cardiac enzyme that was greater than 0.1 or a CK or CK-MB value that was three times the upper limit of normal,20 whereas five times the upper limit of normal was used as the diagnostic threshold in the main report of this study14,15,19 to enable comparison with the surgical cohort. Serum CK and CK-MB isoenzyme concentrations were measured 6, 12, and 18 h after the intervention. Apart from MACCE, we reported the occurrence of stent thrombosis at bifurcation lesions, which was defined as either angiographic documentation of a complete occlusion (TIMI flow 0 or 1) or angiographic documentation of a flow-limiting thrombus (TIMI flow 1 or 2). Stent thrombosis was categorized depending on the timing of occurrence into acute (peri-procedure), subacute (post-procedure to 30 days), and late (.30 days). Multivessel stenting and bifurcation lesions 437 Overall lesion and procedural characteristics: the non-bifurcation group vs. the bifurcation group The bifurcation group had more extensive disease and more complex lesion characteristics compared with the nonbifurcation group [diffuse lesion, P , 0.001 (95% CI 2.8–8.2); type C lesion, P ¼ 0.008 (95% CI 1.1–6.9)] (Table 2). There was a concomitant increase in procedural complexity in the bifurcation group as reflected by a higher number of stents implanted [P , 0.001 (95% CI 0.5–1.0)], longer total stent length per patient [P , 0.001 (95% CI 10.5–20.6)], or longer procedural time [P , 0.001 (95% CI 9.4–23.0)] (Table 2). Thirty day and 1 year outcomes and incidence of stent thrombosis: the non-bifurcations vs. the bifurcations MACCE and the incidence of stent thrombosis at 30 days and at 1 year are shown in Table 3. The MACCE rate at each time point was not significantly different between the bifurcation group and the non-bifurcation group (6.2 vs. 4.2% at 30 days, P ¼ 0.36; 13.3 vs. 11.0% at 1 year, P ¼ 0.46). Five stent thromboses (subacute four and late one) occurred in the bifurcation group vs. two (one subacute and one late) in the non-bifurcation group up to 1 year. Among the five events in the bifurcation group, four subacute thromboses (two patients on day 1; one on day 22; one on day 28) were related to bifurcation lesions and one late thrombosis developed in a non-bifurcation lesion. Of these four bifurcation lesions, three were stented only in the MB. The remaining one stent thrombosis was associated with a lesion treated with stenting in both the LAD artery and the diagonal branch (provisional T-stenting without kissing balloon inflation). One patient who had never been placed on aspirin therapy developed subacute thrombosis 22 days after the index PCI. Baseline and procedural characteristics: true vs. partial bifurcations and one-stent vs. two-stent strategy In terms of patient characteristics, only hypertension was significantly more frequent in patients with true vs. partial Table 4 Baseline lesion and procedural characteristics: true or partial bifurcation and one- or two-stent strategy Variables a Partial bifurcation (124 patients)b 62.9 + 9.0 77.5 (5/200) 27.0 (54/200) 73.5 (147/200) 77.4 (154/199) 40.7 (81/199) 63.6 + 10.2 75.0 (93/124) 29.0 (36/124) 62.1 (77/124) 69.9 (86/123) 39.5 (49/124) 0.49 0.69 0.70 0.036 0.15 0.91 63.2 + 9.6 76.4 (201/263) 28.9 (76/263) 67.7 (178/263) 72.4 (189/261) 38.5 (101/261) 63.0 + 9.1 77.0 (47/61) 23.0 (14/61) 75.4 (46/61) 83.6 (51/61) 47.5 (29/61) 0.87 1.00 0.43 0.28 0.07 0.25 34.0 (68/200) 19.0 (38/200) 33.0 (66/200) 57.0 (114/200) 10.0 (20/200) 31.5 (39/124) 14.5 (18/124) 37.1 (46/124) 53.2 (66/124) 9.7 (12/124) 0.72 0.36 0.47 0.57 1.00 33.5 (88/263) 17.1 (45/263) 36.5 (96/263) 53.2 (140/263) 10.3 (27/263) 31.1 (19/61) 18.0 (11/61) 26.2 (16/61) 65.6 (40/61) 8.2 (5/61) 0.76 0.85 0.14 0.09 0.81 264 4.3 + 1.4 0.001 810 4.1 + 1.3 441 3.6 + 1.1 P-value ,0.001 987 3.8 + 1.2 Two-stent strategy (n ¼ 61 patients)d P-value 25.9 (210/810) 43.7 (354/810) 30.4 (246/810) 31.1 (137/441) 39.7 (175/441) 29.3 (129/441) 0.055 0.19 0.70 28.7 (283/987) 41.7 (412/987) 29.6 (292/987) 24.2 (64/264) 44.3 (117/264) 31.4 (83/264) 0.16 0.48 0.60 6.1 (49/801) 20.8 (167/801) 57.1 (457/801) 16.0 (128/801) 96.0 + 44.0 4.1 + 1.6 3.6 + 1.2 81.9 + 34.5 36.0 5.5 (24/438) 21.0 (92/438) 58.7 (257/438) 14.8 (65/438) 87.3 + 42.5 3.8 + 1.5 3.2 + 1.0 76.1 + 33.9 37.9 0.71 0.94 0.59 0.62 0.08 0.08 0.002 81.9 + 34.5 36.0 5.8 (57/979) 21.0 (206/979) 57.1 (559/979) 16.0 (157/979) 86.1 + 38.2 3.7 + 1.3 3.2 + 1.0 74.3 + 30.0 34.6 6.2 (16/260) 20.4 (53/260) 59.6 (155/260) 13.8 (36/260) 121.1 + 53.4 5.3 + 1.9 4.2 + 1.3 102.5 + 42.1 45.9 0.88 0.86 0.48 0.44 ,0.001 ,0.001 ,0.001 ,0.001 0.11 Patients with at least one true bifurcation lesion. Patients with only partial bifurcation lesions. c Patients whose bifurcation lesions treated only with one-stent strategy. d Patients whose at least one of the bifurcation lesions treated with two-stent strategy. b One-stent strategy (n ¼ 263 patients)c Downloaded from by guest on November 20, 2014 Baseline patient characteristics Age, years Male, % (n) Diabetes mellitus, % (n) Hypertension, % (n) Hypercholesterolaemia, % (n) Family history of MI/sudden death , 55 years, % (n) Previous MI, % (n) Current smoking, % (n) Unstable angina, % (n) Stable angina Silent ischaemia, % (n) Lesion and procedural characteristics Number of overall lesions Number of lesions . 50% DS Vessel territory with stenosis, % (n) RCA LAD LCX Lesion classification, % (n) Type A Type B1 Type B2 Type C Duration of procedure, min Number of stents implanted Number of stented lesions Total stent length, mm Usage of glycoprotein IIb/IIIa inhibitor, % True bifurcation (200 patients)a 438 K. Tsuchida et al. bifurcations (Table 4). Patients with true bifurcations and two-stent strategy also had a significantly higher number of lesions than the corresponding companion subgroup. Patients treated with two-stent strategy had more complex procedural characteristics with longer procedural time, a higher number and longer length of stents used than those with one stent (P , 0.001). The procedural characteristics did not differ between patients with true or partial bifurcations except for the number of stented lesions (3.6 vs. 3.2, P ¼ 0.002) (Table 4). two-stent strategy and final kissing balloon, are described in Figure 2. The angiographic success (,50% residual stenosis) of the MB was 98.1% (456/465), whereas the SB angiographic success rate was only 51.2% (238/465). Nevertheless, the final patency of the SB with TIMI 3 flow was 92.9% (432/ 465). In the non-true bifurcations (types A, B, C, and E, Figure 1), significant narrowing of the SB was present after the procedure in 28.5% (63/221), whereas the percentage was 64.3% (157/244) in the SB of true bifurcations. Thirty day and 1 year outcome: true vs. partial bifurcations and one-stent vs. two-stent strategy Discussion There was no difference in any of the endpoints that were evaluated between the two groups, including stent thrombosis (Table 5). Lesion and procedural demographics of 465 bifurcation lesions Bifurcation lesions in multivessel disease The expanded use of PCI to multivessel disease has raised the issue of how to handle complex lesions in terms of complete revascularization. The restenosis risk of patients with Table 5 Clinical endpoints and stent thrombosis at 30 days and 1 year: true or partial bifurcation and one- or two-stent strategy True bifurcation (n ¼ 200 patients)a Thirty day outcome, % (n) Death CVA Non-fatal MI Q-wave MI Non-Q-wave MI Death/CVA/MI Revascularization CABG PCI MACCE Stent thrombosis One year outcome, % (n) Death CVA Non-fatal MI Q-wave MI Non-Q-wave MI Death/CVA/MI Revascularization CABG PCI MACCE Stent thrombosis a Partial bifurcation (n ¼ 124 patients)b P-value Two-stent strategy (n ¼ 61)d P-value 0.0 (0/200) 0.5 (1/200) 5.5 (11/200) 0.5 (1/200) 5.0 (10/200) 6.0 (12/200) 3.0 (6/200) 0.5 (1/200) 2.5 (5/200) 7.0 (14/200) 1.5 (3/200) 0.0 (0/124) 0.0 (0/124) 4.8 (6/124) 1.6 (2/124) 3.2 (4/124) 4.8 (6/124) 1.6 (2/124) 0.8 (1/124) 0.8 (1/124) 4.8 (6/124) 0.8 (1/124) 1.00 1.00 0.56 0.58 0.80 0.72 1.00 0.41 0.49 1.00 0.0 0.4 5.7 1.1 4.6 6.1 2.7 0.8 1.9 6.8 1.1 (0/263) (1/263) (15/263) (3/263) (12/263) (16/263) (7/263) (2/263) (5/263) (18/263) (3/263) 0.0 0.0 3.3 0.0 3.3 3.3 1.6 0.0 1.6 3.3 1.6 (0/61) (0/61) (2/61) (0/61) (2/61) (2/61) (1/61) (0/61) (1/61) (2/61) (1/61) 1.00 0.75 1.00 1.00 0.54 1.00 1.00 1.00 0.39 0.57 0.5 (1/200) 1.0 (2/200) 6.0 (12/200) 0.5 (1/200) 5.5 (11/200) 6.5 (13/200) 9.0 (18/200) 1.5 (3/200) 8.0 (16/200) 13.0 (26/200) 2.0 (4/200) 1.6 (2/124) 0.8 (1/124) 5.6 (7/124) 1.6 (2/124) 4.0 (5/124) 8.1 (10/124) 8.9 (11/124) 1.6 (2/124) 7.3 (9/124) 13.7 (17/124) 0.8 (1/124) 0.56 1.00 1.00 0.56 0.61 0.66 1.00 1.00 1.00 0.87 0.65 1.1 0.8 6.1 1.1 4.9 7.2 9.9 1.9 8.4 14.1 1.5 (3/263) (2/263) (16/263) (3/263) (13/263) (19/263) (26/263) (5/263) (22/263) (37/263) (4/263) 0.0 1.6 4.9 0.0 4.9 6.6 4.9 0.0 4.9 9.8 1.6 (0/61) (1/61) (3/61) (0/61) (3/61) (4/61) (3/61) (0/61) (3/61) (6/61) (1/61) 1.00 0.47 1.00 1.00 1.00 1.00 0.32 0.59 0.59 0.53 1.00 Patients with at least one true bifurcation lesion. Patients with only non-true bifurcation lesions. c Patients whose bifurcation lesions treated only with one-stent strategy. d Patients whose at least one of the bifurcation lesions treated with two-stent strategy. b One-stent strategy (n ¼ 263)c Downloaded from by guest on November 20, 2014 Table 6 summarizes lesion and procedural characteristics of the 465 bifurcation lesions. Figure 2 delineates the profile of the 465 lesions. Lesions located in the LAD/diagonal branching point were the most frequent. True bifurcations (types D, F, and G, Figure 1) accounted for 52.5% (244/465). Overall, a double guidewire technique was used in 39.8% (185/465), whereas in true bifurcations, the use was 53.7% (131/244). The other technical aspects, such as the use of The main findings of this analysis are (i) SES implantation to treat bifurcation lesions in patients with multivessel disease yields similar outcomes as in those with non-bifurcation lesions; (ii) there is no difference in outcome between patients with true bifurcation lesions and partial bifurcation lesions and in patients treated with a one-stent vs. two-stent strategy; (iii) these excellent results were obtained despite the fact that many SBs were left with a significant narrowing at the end of the procedure. Multivessel stenting and bifurcation lesions 439 Table 6 Lesion and procedural characteristics of bifurcation lesions Variables Repeat revascularization (n ¼ 28) No repeat revascularization (n ¼ 437) 5.6 (26/465) 53.8 (250/465) 29.9 (139/465) 6.2 (29/465) 4.5 (21/465) 14.3 (4/28) 53.6 (15/28) 28.5 (8/28) 0 3.6 (1/28) 5.0 (22/437) 53.8 (235/437) 30.0 (131/437) 6.6 (29/437) 4.6 (20/437) 43.0 (200/465) 17.6 (82/465) 15.7 (73/465) 7.3 (34/465) 7.1 (33/465) 7.1 (33/465) 2.2 (10/465) 52.5 (244/465) 47.5 (221/465) 64.9 (302/465) 22.2 (103/465) 46.4 (13/28) 21.4 (6/28) 25.0 (7/28) 0 3.6 (1/28) 3.6 (1/28) 0 46.4 (13/28) 53.6 (15/28) 85.7 (24/28) 42.9 (12/28) 42.8 (187/437) 17.4 (76/437) 15.1 (66/437) 7.8 (34/437) 7.3 (32/437) 7.3 (32/437) 2.3 (10/437) 52.9 (231/437) 47.1 (206/437) 62.7 (274/437) 20.8 (91/437) 39.8 (185/465) 14.6 (68/465) 35.7 (10/28) 10.7 (3/28) 40.0 (175/437) 14.9 (65/437) 45.6 (31/68) 4.4 (3/68) 22.0 (15/68) 26.5 (18/68) 1.5 (1/68) 78.9 (367/465) 6.5 (30/465) 4 0 2 0 0 85.7 (24/28) 3.6 (1/28) 27 3 13 18 1 78.5 (343/437) 6.6 (29/437) 12.3 (57/465) 12.9 (60/465) 0.9 (4/465) 7.1 (2/28) 14.3 (4/28) 0 12.6 (55/437) 12.8 (56/437) 0.9 (4/437) 64.3 (157/244) 25.0 (7/28) 34.3 (150/437) 28.5 (63/221) 10.7 (3/28) 13.7 (60/437) 98.1 (456/465) 51.2 (238/465) 49.9 (232/465) 85.7 (24/28) 50.0 (14/28) 42.9 (12/28) 98.9 (432/437) 51.3 (224/437) 50.3 (220/437) 3.4 (16/465) 3.7 (17/465) 92.9 (432/465) 1.7 (8/465) 3.6 (1/28) 10.7 (3/28) 85.7 (24/28) 0 3.4 (15/437) 3.2 (14/437) 93.4 (408/437) 1.8 (8/437) a RCA with right ventricular branch, 8; LAD with major septal branch, 6; LAD with intermediate artery, 5; RCA with acute marginal branch, 2. multivessel interventions is higher if a companion lesion develops restenosis, regardless of the presence or absence of conventional patient risk factors or lesion complexity.21 The existence of inter-lesion dependence for the risk of restenosis in multilesion stenting has been hypothesized.21 However, the impact of bifurcation lesions in multivessel intervention remains to be determined. A few studies in the bare metal stent era demonstrated that treatment of bifurcation lesions resulted in a lower success rate and higher late adverse event rate than nonbifurcation lesions.1–3 However, these studies included not only multivessel intervention but also single-vessel treatment (target lesion per patient, 1.4),2,3 and stents were only used in 70% of patients.1–3 Because patients in the Downloaded from by guest on November 20, 2014 Baseline lesion characteristics, % (n) Lesion location LAD/left circumflex LAD/diagonal Left circumflex/marginal Distal RCA Othersa Plaque distribution (SYNTAX Score class) Type D B C G A E F True bifurcations (types D, F, and G) Partial bifurcations (types A, B, C, and E) Take-off angle of SB , 70 degree Calcification: moderate to heavy Procedural characteristics, % (n) Double guidewires Stenting in both the MB and the SB Two-stent strategies T-stenting Culotte V-stenting Crush Not classifiable Stenting only in MB Stenting only in SB Post-dilatation technique Kissing balloon inflation Post-dilatation only in SB Sequential dilatation of both branches Post-procedural lesion characteristics, % (n) Remaining significant stenosis of SB in true bifurcations (types D, F, and G) after procedure Remaining significant plaque shift into SB (or MB) after stenting in MB (or SB) in partial bifurcations (types A, B, C, and E) after procedure Angiographic success in MB SB Lesion Final TIMI flow grade in SB 0 or 1 2 3 Major dissection in SB persisted after procedure Bifurcation lesions (n ¼ 465) 440 K. Tsuchida et al. present study underwent multivessel treatment with SES as a default strategy, these results may not be directly comparable with those of previous studies.1–3 Nevertheless, in the light of the promising results from major randomized trials,5,6 it could be hypothesized that the SES could potentially equalize the treatment risk between patients with bifurcation lesions and those without bifurcation lesions. Changing impact of bifurcation lesions in DES era Our findings seem to contradict a number of prior studies12,22–24 evaluating DES in bifurcation lesions where a high target lesion revascularization (TLR) rate was found for the SB and in many instances when two stents were implanted. We believe that a number of the TLRs reported in these studies12,22–24 were triggered by the stenoses detected during protocol-mandated angiographic follow-up. The ARTS I and ARTS II studies are clinical outcome trials without any mandatory angiographic investigation at follow-up, thereby reflecting the natural course of the disease and its treatment and avoiding the so-called ‘oculo-stenotic reflex’, as illustrated in the BENESTENT II trial.25 This reflex may be even more pronounced when treating bifurcation lesions.2 The fact that residual stenoses in the SB were left untreated and did not result in recurrent angina or other clinical events at follow-up speaks to the benign nature of these persisting SB stenoses. This view is supported by the findings that only 51% of the SBs had an optimal result after the procedure (Table 6). Moreover, according to a fractional flow reserve analysis, it appears that many of the SB lesions that seem to be angiographically significant may not be haemodynamically significant.26 It is also worth noting that our results were obtained with a conservative usage of a two-stent strategy, even in true bifurcations. We cannot ignore the fact that this approach accepts a certain level of incomplete revascularization on many SBs, which were probably correctly judged by the interventionalists as being clinically unimportant, provided that they showed TIMI 3 flow (92.9%) (Table 6). Therefore, even the concept of ‘incomplete revascularization’ needs to be revisited. It is also worth noting that the threshold criteria for enzyme elevation used to define non-Q-wave myocardial infarction applied in this analysis, namely three times CK or CKMB elevation, are similar to that used routinely in other studies.22–24 However, it is more sensitive than five times CK or CKMB elevation described in the ARTS I and II original protocols14,15,19 that was used to enable comparison of the results of PCI with surgery for multivessel disease.19 The occurrence of stent thrombosis did not differ between the bifurcation and non-bifurcation groups. Three out of the four bifurcation lesions that developed stent thrombosis had a poor angiographic result at the end of the procedure (only one bifurcation achieved lesion success). Recently, bifurcation lesions were reported as one of the independent predictors of stent thrombosis of DES.27,28 The relatively small number of patients evaluated in this analysis and the low overall frequency of thromboses in this study do not allow for any definitive statement with respect to these observations by other investigators. Downloaded from by guest on November 20, 2014 Figure 2 Bifurcation lesion profile (n ¼ 465). Asterisk denotes SYNTAX Score lesion classification. KB, final kissing balloon inflation; Seq, sequential postdilatation of both the MB and the SB; three lesions (2, true; 1, partial) underwent prior debulking (rotational atherectomy in all cases). Multivessel stenting and bifurcation lesions 441 Study limitation 3. 4. 5. 6. 7. 8. 9. Conclusions This analysis of treating bifurcation lesions in multivessel disease with SES showed that these lesions were associated with increased procedural complexity but not with more adverse events compared with non-bifurcation lesions. In contemporary interventional practice, when operators are allowed to decide the best strategy to employ, which resulted in a conservative implantation of two stents, no difference in outcome was found among different types of bifurcations. The suboptimal angiographic results in the SB did not increase the risk of MACCE. However, this result may warrant further investigation in a larger, appropriately designed study in the light of the trend towards a higher rate of myocardial infarction in the bifurcation group. Acknowledgements This study was supported by Cordis Corporation, a Johnson & Johnson Company. A complete list of investigators and committees of the ARTS II has been previously reported.15 We are indebted to Brian G. Firth, Marco Valgimigli, and Neville Kukreja for their careful review of the manuscript and constructive comments, and to He ´ctor M. Garcı´a-Garcı´a for his assistance with statistical analysis. H.-P.S., K.W., and D.J.D. are employees of Cordis. 10. 11. 12. 13. 14. 15. 16. Conflict of interest: none declared. 17. References 1. Al Suwaidi J, Yeh W, Cohen HA, Detre KM, Williams DO, Holmes DR Jr. Immediate and one-year outcome in patients with coronary bifurcation lesions in the modern era (NHLBI Dynamic Registry). Am J Cardiol 2001; 87:1139–1144. 2. Garot P, Lefevre T, Savage M, Louvard Y, Bamlet WR, Willerson JT, Morice MC, Holmes DR Jr. Nine-month outcome of patients treated by 18. 19. Downloaded from by guest on November 20, 2014 Given the strong trend towards a higher incidence of MI in the bifurcation group (P ¼ 0.08), this subanalysis may have been underpowered to demonstrate the potential adverse impact of bifurcation lesion treatment in multivessel disease when using a DES. More than 1000 patients with bifurcations were required to show only 3% difference of adverse cardiac event rate compared with those without bifurcations even in bare metal stent era.2 The present analysis is a post hoc subanalysis of non-randomized subgroups of bifurcations and non-bifurcations. Therefore, no power or sample size calculation could be performed. Operators treated most lesions using a one-stent strategy (85.4% of bifurcations) without SB protection (application of double guidewire in 39.8% of the lesions) and adjunctive debulking (rotablation in only three lesions). In order to save procedural and radiation time or contrast media for multivessel treatment, it is likely that operators tended to choose or prefer the simplest treatment strategy. Thus, it is largely an analysis of the success of a one-stent strategy rather than a comparison of different treatment strategies for treating bifurcation lesions with SES. 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Kuchulakanti PK, Chu WW, Torguson R, Ohlmann P, Rha SW, Clavijo LC, Kim SW, Bui A, Gevorkian N, Xue Z, Smith K, Fournadjieva J, Suddath WO, Satler LF, Pichard AD, Kent KM, Waksman R. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation 2006;113: 1108–1113. doi:10.1093/eurheartj/ehl232 Online publish-ahead-of-print 4 September 2006 Periaortitis complicating chronic aortic dissection * Corresponding author. Tel: þ 44 2890633703; fax: þ 44 2890634821. E-mail address: [email protected] A 34-year-old man with Marfan’s syndrome was admitted with fever, weight loss, night sweats, low-back pain, and altered bowel habit. Three years earlier, he had suffered a type A aortic dissection involving the entire length of his aorta. He required aortic root replacement and resuspension of his aortic valve and was being followed-up with moderate aortic regurgitation. Infective endocarditis was excluded. A CT scan of the aortic graft was normal, but there was considerable soft tissue surrounding the entire abdominal aorta and there were mild back-pressure changes on the left kidney (Panel A). The appearance was in keeping with periaortitis. A PET scan demonstrated extensive, abnormal FDG uptake in a ‘cuff’ of soft tissue around the abdominal aorta, extending from the level of the renal hila to the aortic bifurcation (Panels B and C). He developed progressive dilatation of his left kidney and significant impairment of renal function. He was commenced on high-dose oral steroids (60 mg prednisolone), resulting in a rapid improvement in both renal function and inflammatory markers. However, a MAG3 isotope scan demonstrated an obstructed left kidney with associated functional loss, and consequently, a ureteric stent was placed percutaneously. Periaortitis has been characterized as an exaggerated inflammatory response to advanced atherosclerosis. This is the first report of this condition in a patient with a chronic aortic dissection. This case demonstrates the clinical presentation of periaortitis, the utility of PET scanning and the major complication of obstructive uropathy, which can be managed with steroids and ureteric stenting. Panel A. A contrast-enhanced CT scan of the abdomen demonstrating a dissection flap in the abdominal aorta (solid arrow), a cuff of tissue surrounding the aorta (dotted arrow), and dilatation of the left renal pelvis. Panel B. A coronal maximum intensity projection (MIP) of the PET scan. There is abnormal uptake of FDG to the right of the ascending aorta graft and extensive, abnormal FDG uptake in a cuff of soft tissue around the abdominal aorta, extending from the level of the renal hila to the aortic bifurcation (arrow). Panel C. A transaxial MIP of the PET scan. There is abnormal uptake of FDG in a cuff of soft tissue around the abdominal aorta (arrow). Downloaded from by guest on November 20, 2014 Paul W. Johnston*, Peter T. Kennedy, and Paul H. Blair Regional Medical Cardiology Centre, First Floor, West Wing, Royal Victoria Hospital, Grosvenor Road, Belfast BT12 6BA, UK
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