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Outcomes and Computed Tomography Scan Follow-Up of Bioresorbable Vascular Scaffold for the Percutaneous Treatment of Chronic Total Coronary Artery Occlusion
Outcomes and Computed Tomography Scan Follow-Up of Bioresorbable Vascular Scaffold for the Percutaneous Treatment of Chronic Total Coronary Artery Occlusion Soledad Ojeda, MD, PhDa,*, Manuel Pan, MD, PhDa, Miguel Romero, MD, PhDa, Javier Suárez de Lezo, MD, PhDa, Francisco Mazuelos, MD, PhDa, José Segura, MD, PhDa, Simona Espejo, MDb, Carmen Morenate, MDa, Marta Blanco, MDb, Pedro Martín, MD, PhDc, Alfonso Medina, MD, PhDc, and José Suárez de Lezo, MD, PhDa Everolimus-eluting bioresorbable vascular scaffold (BVS) implantation in chronic total occlusion (CTO) could provide theoretical advantages at follow-up compared with metallic stents. This study aimed to assess the feasibility of BVS use for the percutaneous treatment of CTO by analyzing clinical outcomes and patency at midterm follow-up. From February 2013 to June 2014, 42 patients with 46 CTOs were treated by BVS implantation. Once the guidewire reached the distal lumen, all the occluded segments were predilated. Postdilation was performed in all patients. A multislice computed tomography was scheduled for all patients at 6 months. The mean age was 58 – 9 years, 41 (98%) were men and 14 (33%) diabetic. The target vessel was predominantly the left anterior descending artery (22, 48%). According to the Japanese-CTO score, 21 CTOs (46%) were difficult or very difficult. Most cases were treated with an anterograde strategy (34 lesions, 74%). A hybrid procedure with a drug-eluting stent at the distal segment was the applied treatment in 7 CTOs (15%). The mean scaffold length was 43 – 21 mm. Technical success was achieved in 45 lesions (98%), and 1 patient (2.4%) presented a non-Q periprocedural myocardial infarction. Re-evaluation was obtained in all patients at 6 – 1 months. Two re-occlusions and a focal restenosis were identified. After 13 – 5 months of follow-up, there were 2 repeat revascularizations (4.8%). Neither death nor myocardial infarction was documented. In conclusion, BVS for CTO seems to be an interesting strategy with a high rate of technical success and low rate of cardiac events at midterm follow-up in selected patients. Ó 2015 Elsevier Inc. All rights reserved. (Am J Cardiol 2015;115:1487e1493) Coronary chronic total occlusion (CTO) currently represents the most challenging type of lesion for percutaneous coronary intervention (PCI). Although technological improvements and the development of specific skills by the operators have considerably increased the success rate, it continues to be low compared with non-CTO PCI.1e3 In addition, after recanalization, a long coronary segment must usually be stented. It is known that the stented length is a strong predictor of events at follow-up, such as stent thrombosis and need for repeat revascularization.4,5 Additionally, the permanent caging of the artery inhibits the recovery of the physiological proprieties of the vessel. Everolimus-eluting bioresorbable vascular scaffold (BVS) (Absorb; Abbott Vascular, Santa Clara, California) implantation in this type of lesion may be an attractive alternative. The reabsorption of the device could provide theoretical advantages at long-term follow-up compared Departments of aCardiology and bRadiology, Reina Sofia Hospital, University of Córdoba (IMIBIC), Córdoba, Spain and cDr. Negrin Hospital, Department of Cardiology, University of Las Palmas, Las Palmas de Gran Canaria, Córdoba, Spain. Manuscript received January 18, 2015; revised manuscript received and accepted February 26, 2015. See page 1492 for disclosure information. *Corresponding author: Tel: þ34-957-010-438; fax: þ34-957-760-237. E-mail address: [email protected] (S. Ojeda). 0002-9149/15/$ - see front matter Ó 2015 Elsevier Inc. All rights reserved. http://dx.doi.org/10.1016/j.amjcard.2015.02.048
with metallic drug-eluting stents (DES).6 The present study aimed to assess the feasibility of BVS for the percutaneous treatment of CTO and to analyze the clinical outcomes and BVS patency by multislice computed tomography scan (MSCT) at midterm follow-up. Methods From February 2013 to June 2014, 121 CTOs in 116 patients were recanalized and treated percutaneously in our center. Among them, 42 patients with 46 CTOs were successfully treated by BVS implantation, and they constitute the study group. Whether to implant a BVS was based on clinical data and anatomical characteristics of the lesion and was taken during the procedure. Exclusion criteria for treating with BVS were as follows: patients >70 years, vessel diameter >4 mm, very heavily calcified lesions together with extreme tortuosity, and patients with a contraindication to 1 year of dual antiplatelet therapy. Concurrent DES implantation was allowed at the operator’s discretion. Written informed consent for treatment and for data analysis was obtained from all patients. The complexity of the lesion and difficulty of crossing was graded according to the Japanese-CTO score.7 The decision of an antegrade or retrograde approach was taken by the operator after a thorough study of the CTO anatomy www.ajconline.org
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Figure 1. A CTO of the proximal left circumflex artery. Retrograde approach through an epicardial collateral after an initial failed antegrade attempt (A). Difficulty accessing the true lumen with the retrograde guidewire. Intravascular ultrasound (IVUS) located the retrograde guidewire in the subintimal space (yellow arrows) (B). Reverse controlled antegrade and retrograde subintimal tracking with a larger balloon according to the vessel diameter measured by IVUS (C). Retrograde guidewire reaches the true lumen (D). Final result after 2 nonoverlapped BVS implantations (3 28 þ 3.5 28 mm) by angiography and IVUS (E). Follow-up at 10 months with very good result by angiography (F) and optical coherence tomography (G).
Table 1 Baseline clinical characteristics of the study population Variables Age (years) Men Diabetes mellitus Hypertension* Hypercholesterolemia† Current smoker Prior myocardial infarction Prior percutaneous coronary intervention
Patients (n¼42) 589 41 (98%) 14 (33%) 24 (57%) 27 (64%) 8 (19%) 12 (28%) 15 (36%)
* Repeated systemic blood pressure measurements >140/90 mmHg or treatment with antihypertensive drugs for a known diagnosis of hypertension. † Baseline cholesterol > 200 mg/dl or LDL-cholesterol >130 mg/dl or previously diagnosed and treated hypercholesterolemia.
using simultaneous double injection when applicable. Once the guidewire reached the distal lumen, all the occluded segments were painstakingly predilated with balloons of increasing diameter while testing the uniform expansion of
them. After BVS implantation, postdilation using noncompliant balloons with a maximum diameter 0.5 mm more than the BVS diameter was systematically performed. Intravascular ultrasound was used in some procedures to facilitate the access to the guidewire to the true lumen (Figure 1) or to determine the vessel diameter. Optical coherence tomography was performed when the BVS platform was manipulated or some complication was suspected. All patients were pretreated with dual antiplatelet medication. In the hemodynamic laboratory, weight-adjusted heparin was administered to maintain activated clotting time for >300 seconds. After the procedure, the patients received aspirin 100 mg/day indefinitely and a maintenance dose of clopidogrel (75 mg/day), prasugrel (10 mg/day), or ticagrelor (90 mg twice daily) for at least 12 months. In all patients, serial determinations of the troponin I and creatine kinase levels were performed before and every 6 hours after the procedure for the first 24 hours. CTO was defined as complete obstruction of the vessel with Thrombolysis In Myocardial Infarction flow grade 0 through the affected segment of >3 months estimated duration.2 Technical success was considered when a patent
Coronary Artery Disease/BVS for the CTO Percutaneous Treatment Table 2 Angiographic data Variables
Patients (n¼42)/Lesions (n¼46)
LV ejection fraction (%) Target coronary artery: Left anterior descending artery Right Left circumflex Multivessel disease CTO complexity (J-CTO score): Easy Intermediate Difficult Very difficult Estimated duration of the CTO (months) Main vessel reference (mm) Lesion length (mm) Minimal lumen diameter (mm) Diameter stenosis pre (%) Minimal lumen diameter post (mm) Diameter stenosis post (%)
548 22 13 11 28
(48%) (28%) (24%) (67%)
6 (13%) 19 (41%) 14 (31%) 7 (15%) 3542 3.030.4 3519 00 1000 2.70.4 116
Table 3 Procedural data
Femoral approach Seath 8Fr Double injection Strategy: Antegrade Retrograde Predilation Bioresorbable vascular scaffold diameter (mm) Scaffold length (mm) Number of bioresorbable vascular scaffolds/lesion Hybrid strategy Scaffold postdilation Bifurcation lesion involved: Side branch predilationþMain vessel scaffold Isolated side branch postdilation Intravascular ultrasound: To access to the true lumen To determine vessel size Optical coherence tomography
catheterization was recommended in the presence of clinical recurrence. Descriptive analyses were used. Discrete variables are presented as counts and percentages, whereas continuous data are presented as the mean SD (interquartile range 25 to 75). All analyses were performed using SPSS 20.0.0 software (IBM). Results
CTO ¼ chronic total occlusion.
Variables
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n¼46 46 (100%) 46 (100%) 26 (56%) 00 34 (74%) 12 (26%) 46 (100%) 3.030.38 4321 2.61.9 7 (15%) 46 (100%) 11 (24%) 5 (45%) 6 (55%) 5 (11%) 1 (20%) 4 (80%) 14 (30%)
vessel with <30% residual stenosis and a Thrombolysis In Myocardial Infarction flow grade 3 was achieved.3 Major adverse cardiac events (MACEs) were defined as a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization. Periprocedural MI was defined according to the new definition of clinically relevant MI after coronary revascularization,8 and scaffold thrombosis was defined according to the Academic Research Consortium criteria.9 After the treatment, the patients were monitored closely by scheduled visits and phone calls. To study the patency of the treated CTO at follow-up, an MSCT was scheduled for all patients 6 months after the treatment.10 A new cardiac
Baseline clinical and angiographic data are listed in Tables 1 and 2. All patients had stable angina despite optimal medical treatment. Unlike the patients treated exclusively with DES, those treated with BVS were younger (58 9 vs 67 8; p <0.05) and with a lower prevalence of diabetes mellitus (14, 33% vs 39, 53%; p <0.05). According to the Japanese-CTO score of complexity, 59 CTOs (78%) were classified as difficult or very difficult in the DES group, whereas in the BVS group 21 CTOs (46%) were difficult or very difficult (p <0.05). Table 3 summarizes the procedural characteristics. In 34 lesions (74%), an antegrade approach with a microcatheter and different dedicated wires was the strategy used to cross the CTO, whereas in 12 (26%), a retrograde approach was needed. In these cases, reverse controlled antegrade and retrograde subintimal tracking (it consists on inflating a balloon on the antegrade wire to enlarge the antegrade subintimal/subadventitial space, whereas the retrograde wire is then manipulated to enter the enlarged antegrade space) was the technique used in most of the procedures. Twentytwo recanalized CTOs (48%) were treated with 1 single BVS, 18 (39%) were treated with 2, and 6 (13%) received 3 BVSs. Regarding in-hospital outcomes, technical success was achieved in 45 of 46 lesions (98%). In 1 patient with a very complex CTO (J-CTO score >3 points), a residual distal lesion >30% was left because of the impossibility of passing through the several BVSs. No major complications related to the procedure were registered. One patient (2.4%) presented with significant troponin elevation in the range associated with a non-Q periprocedural MI. No other in-hospital adverse clinical events were recorded, and all patients were discharged free of symptoms. At midterm follow-up (mean: 13 5 months, median: 12, IQ25e75: 9.75 to 16 months), the overall MACE rate was 4.8% because of 2 repeat revascularizations. Neither death nor AMI were documented. Re-evaluation by coronary MSCT scan (Figures 2 and 3) or angiography (Figure 1) in cases of clinical recurrence was obtained in all patients at 6 1 months after the treatment. An asymptomatic complete scaffold re-occlusion was detected at 6 months in a patient who had a significant residual stenosis that was not treated. Two patients had restenosis, which was focal in one of them and treated by balloon dilation, whereas in the other a re-occlusion was observed. That re-occlusion was again recanalized, and a DES was implanted. The rest of the treated CTOs continued being open, without restenosis and the patients remain free of symptoms. In the DES group, the MACE rate at follow-up was 8%. Two patients (2.7%) died from heart failure and 4 (5.4%) required repeat revascularization.
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Figure 2. Long occlusion of the right coronary artery (RCA) with distal filling by collaterals from the left coronary artery (A). Successfully recanalized by retrograde approach and treated by the hybrid strategy: a short DES distally implanted and 3 overlapped BVSs with complete reconstruction of the artery (B). An MSCT scan performed 6 months later showed excellent status of the RCA (C).
Discussion The advent of the BVS and their promising results in selected lesions has awakened great enthusiasm in the interventional community.11,12 However, there is scant information about the safety and efficacy of this novel technology in complex lesions. The present study provides meaningful information regarding the feasibility of using the BVS for the percutaneous treatment of CTO. In our experience, in this group of selected patients, the technical success rate was high and the MACE rate at midterm was acceptable considering the complexity of the treated lesions. BVS could have obvious advantages over metallic stents by fully avoiding the problems arising from having permanent metal caging in the vessel.13 When an occluded artery is recanalized, it may be difficult to know the true size of the vessel. Moreover, segments distal to a successfully recanalized CTO can show significant lumen and vessel enlargement at follow-up.14 Both facts can lead to an underestimation of the diameter of the chosen stent with the resulting risk of late stent malapposition and stent thrombosis.15 The disappearance of the scaffold struts implies the liberation of the vessel, and therefore, this problem can be avoided. After guidewire crossing in the CTO, the lesion to be stented is usually long. The stented length is a factor known to be associated with a major risk of events at follow-up and unfavorably influences the physiological properties of the vessel.16 Theoretically, treatment by BVS would eliminate these limitations. The elution and scaffolding are temporary; so this can facilitate the return of vessel vasomotion,
adaptive shear stress, late luminal enlargement, and late expansive remodeling6,13 and would avoid the traditional triggers for late events. Despite the advantages described, the BVS approach in CTO is not exempt from difficulties. The crossing profile is 1.4 mm, and the crossability is worse compared with the new DES. This aspect is especially relevant in this type of lesion where the calcification and tortuosity of the vessel are frequent. In our series, scaffolds were implanted in all CTOs selected for BVS because of selection of the patients and thorough predilation of the lesion segment (Figure 3). Another potential drawback with this technology is the risk of strut fractures in the overlapped segment in between 2.5-, 3-, and 3.5-mm devices when a distal to proximal BVS implantation strategy is undertaken. The compliant balloon of the 3.5-mm BVS could damage the smaller distally implanted BVS. The introduction of DES has dramatically reduced restenosis rates after PCI compared with BMS. Regarding CTO, a meta-analysis showed that DES use was associated with lower target vessel revascularization, but there was also a statistical trend toward a higher risk of stent thrombosis compared with BMS. This fact was most likely related to the exclusive use of first-generation DES in the studies included.17 Secondgeneration DES with better platforms and more biocompatible polymers have improved long-term results, reducing the incidence of late stent thrombosis18e22 (Table 4). Focusing on BVS, 2 small studies recently published have assessed procedures and clinical outcomes in CTO. Wiebe and colleagues23 included 23 patients, and the incidence of
Coronary Artery Disease/BVS for the CTO Percutaneous Treatment
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Figure 3. Right coronary artery occluded (orange arrows) with distal filling shown by contralateral injection (A). Retrograde strategy through a septal channel. Retrograde guidewire reaches the true lumen after reverse controlled antegrade and retrograde subintimal tracking (B). After predilation, 2 overlapped BVSs (3.5 28 þ 3.5 18 mm) were implanted with proximal postdilation with a 4-mm noncompliant balloon (C). Very good final result noted by angiography (D). Re-evaluation by MSCT scan showed a vessel calcified and patent (E).
Table 4 Second generation of drug-elutintg stents and bioresorbable vascular scaffold for the treatment of coronary chronic total occlusion. Comparison with previous studies. Author/Study Almalla et al18 CATOS trial19 Wöhrle et al20 CIBELES study21 TWENTE Trial22 Wiebe et al23 Vaquerizo et al24 Ojeda et al.
Number of patients
Age (years)
Diabetes
Type of stent
Stent length (mm)
Follow-up
MACE
97 160 53 207 59 23 35 42 /46 CTOs
6312/6312 6210 6311/6510 6310 609 6110 589
29% vs 35% 28% 32% vs 41% 17% 35% 20% 33%
SES vs EES SES vs ZES EES SES vs EES ZES and EES BVS BVS BVS
4520/4321 79 36 4725/5023 6635* 6524 5223 4321
2 years 1 year 1 year 1 year 3 years 108 days 6 months 1 year
17.4% vs 15.7% 10% vs 17.5% 6% 15.8% vs 11.3% 15.3% 4% 0%† 4.8%
BVS ¼ bioresorbable vascular scaffold; CTO ¼ chronic total occlusion; DES ¼ drug eluting-stents; EES ¼ everolimus eluting-stents; MACE ¼ major adverse cardiac events; SES ¼ sirolimus eluting-stents; ZES¼zotarolimus eluting-stents. * Per patient. † Two in-scaffold reocclusion.
MACE at short-term follow-up was low (4.3%). The study of Vaquerizo and others24 with 35 patients showed 2 cases (5.7%) of scaffold re-occlusion at 6 months. These findings are concordant with those reported by us. In our study, with a
slightly larger sample size and also performing systematic re-evaluation by MSCT at 6 months, the rate of events was 4.8% despite not using imaging techniques routinely during BVS implantation. Although the information provided by
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imaging techniques can be useful, in our experience, their use is not mandatory except when some complication is suspected or when a bifurcation lesion is involved and the platform is manipulated. Compared with DES, the initial BVS experience in CTO lesions seems to be favorable, without an increase of device failure and even less incidence of adverse events at midterm follow-up (Table 4). A hybrid strategy was the treatment used in 7 CTOs (15%). This strategy consists of implanting a DES distally followed by a BVS until all the occluded segments are treated (Figure 2). This approach, not previously described, can provide several benefits. It allows us to check the possibility of having difficulty passing the BVS, and if the distal diameter of the vessel is unknown, a metallic stent, which can be safety expanded, can be a good option. Additionally, if the distal metallic device’s diameter is 2.5 mm, several overlapped 3.5-mm BVSs can be implanted proximally without any risk of strut fractures, creating in this way a reconstructed vessel from 2.5 (distal) up to 4 mm (proximal) if required. This strategy can simplify the procedure, it avoids implanting a long length of metal, and in the future, only a small distal part of the artery would remain caged. Limitations of the study include that it is an observational nonrandomized study with a relatively small number of patients included. However, it constitutes the basis for future investigations. The decision to implant a BVS after CTO recanalization was left to the operator’s discretion, and therefore, these findings cannot be extended to all types of CTO. Moreover, a longer follow-up is required to confirm these results. Disclosures Dr. Pan has received minor lectures fees from Abbot Vascular (Santa Clara, California). All other authors have no conflicts of interest to declare. 1. Kimura M, Katoh O, Tsuchikane E, Nasu K, Kinoshita Y, Ehara M, Terashima M, Matsuo H, Matsubara T, Asakura K, Asakura Y, Nakamura S, Oida A, Takase S, Reifart N, Di Mario C, Suzuki T. The efficacy of a bilateral approach for treating lesions with chronic total occlusions the CART (controlled antegrade and retrograde subintimal tracking) registry. JACC Cardiovasc Interv 2009;2:1135e1141. 2. Sianos G, Werner GS, Galassi AR, Papafaklis MI, Escaned J, Hildick-Smith D, Christiansen EH, Gershlick A, Carlino M, Karlas A, Konstantinidis NV, Tomasello SD, Di Mario C, Reifart N; EuroCTO Club. Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club. EuroIntervention 2012;8:139e145. 3. Yamane M, Muto M, Matsubara T, Nakamura S, Muramatsu T, Oida A, Igarashi Y, Nozaki Y, Kijima M, Tuschikane E. Contemporary retrograde approach for the recanalisation of coronary chronic total occlusion: on behalf of the Japanese Retrograde Summit Group. Eurointervention 2013;9:102e109. 4. Shirai S, Kimura T, Nobuyoshi M, Morimoto T, Ando K, Soga Y, Yamaji K, Kondo K, Sakai K, Arita T, Goya M, Iwabuchi M, Yokoi H, Nosaka H, Mitsudo K; for the j-Cypher Registry Investigators. Impact of multiple and long sirolimus-eluting stent implantation on 3-year clinical outcomes in the j-Cypher registry. JACC Cardiovasc Interv 2010;3:180e188. 5. Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation results from the 8,061-Patient XIENCE V United States study. JACC Cardiovasc Interv 2012;5:626e635.
6. Onuma Y, Serruys PW. Bioresorbable scaffold: the advent of a new era in percutaneous coronary and peripheral revascularization? Circulation 2011;123:779e797. 7. Morino Y, Abe M, Morimoto T, Kimura T, Hayashi Y, Muramatsu T, Ochiai M, Noguchi Y, Kato K, Shibata Y, Hiasa Y, Doi O, Yamashita T, Hinohara T, Tanaka H, Mitsudo K; for the J-CTO Registry Investigators. Predicting successful guidewire crossing through chronic total occlusion of native coronary lesions within 30 minutes. The j-CTO (Multicenter CTO registry in Japan) score as a difficulty grading and time assessment tool. JACC Cardiovasc Interv 2011;4:213e221. 8. Moussa ID, Klein LlW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol 2013;62:1563e1570. 9. 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; on behalf of the Academic Research Consortium. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation 2007;115:2344e2351. 10. Onuma Y, Dudek D, Thuesen L, Webster M, Nieman K, GarciaGarcia HM, Ormiston JA, Serruys PW. Five-year clinical and functional multislice computed tomography angiographic results after coronary implantation of the fully resorbable polymeric everolimuseluting scaffold in patients with de novo coronary artery disease. The ABSORB Cohort a trial. JACC Cardiovasc Interv 2013;6: 999e1009. 11. Abizaid A, Costa JR Jr, Bartorelli AL, Whitbourn R, van Geuns RJ, Chevalier B, Patel T, Seth A, Stuteville M, Dorange C, Cheong WF, Sudhir K, Serruys PW. The ABSORB EXTEND study: preliminary report of the twelve-month clinical outcomes in the first 512 patients enrolled. Eurointervention 2014; pii: 20130827e06. 12. Serruys PW, Chevalier B, Dudek D, Cequier A, Carrié D, Iñiguez A, Dominici M, van der Schaaf RJ, Haude M, Wasungu L, Veldhof S, Peng L, Staehr P, Grundeken MJ, Ishibashi Y, García-García HM, Onuma Y. A bioresorbable everolimus-eluting scaffold versus a metallic everolimus-eluting stent for ischaemic heart disease caused by de-novo native coronary artery lesions (ABSORB II): an interim 1-year analysis of clinical and procedural secondary outcomes from a randomised controlled trial. Lancet 2015;385:43e54. 13. Iqbal J, Onuma Y, Ormiston J, Abizaid A, Waksman R, Serruys P. Bioresorbable scaffolds: rationale, current status, challenges, and future. Eur Heart J 2014;35:765e776. 14. Gomez-Lara J, Teruel L, Homs S, Ferreiro JL, Romaguera R, Roura G, Sánchez-Elvira G, Jara F, Brugaletta S, Gomez-Hospital JA, Cequier Angel. Lumen enlargement of the coronary segments located distal to chronic total occlusions successfully treated with drug-eluting stents at follow-up. Eurointervention 2014;9:1181e1188. 15. Valenti R, Vergara R, Migliorini A, Parodi G, Carrabba N, Cerisano G, Dovellini EV, Antoniucci D. Predictors of reocclusion after successful drug-eluting stent-supported percutaneous coronary intervention of chronic total occlusion. J Am Coll Cardiol 2013;61:545e550. 16. Basavarajaiah S, Naganuma T, Latib A, Hasegawa T, Sharp A, Rezq A, Sticchi A, Figini F, Amato A, Colombo A. Extended follow-up following “full-metal jacket” percutaneous coronary interventions with drug-eluting stents. Catheter Cardiovasc Interv 2014;84: 1042e1050. 17. Colmenarez HJ, Escaned J, Fernández C, Lobo L, Cano S, del Angel JG, Alfonso F, Jimenez P, Bañuelos C, Gonzalo N, Garccía E, Hernández R, Macaya C. Efficacy and safety of drug-eluting stents in chronic total coronary occlusion recanalization: a systematic review and meta-analysis. J Am Coll Cardiol 2010;55:1854e1866. 18. Almalla M, Hennings V, Marx N, Hoffmann R. Long-term clinical and angiographic outcome after treatment of chronic total occlusion with everolimus or sirolimus eluting stents. Int J Cardiol 2012;157: 451e452. 19. Park HJ, Kim HY, Lee JM, Choi YS, Park CS, Kim DB, Her SH, Koh YS, Park MW, Kwon BJ, Kim PJ, Chang K, Chung WS, Seung KB. Randomized comparison of the efficacy and safety of zotarolimuseluting stents vs. sirolimus-eluting stents for percutaneous coronary intervention in chronic total occlusion—CAtholic Total Occlusion Study (CATOS) trial. Circ J 2012;76:868e875.
Coronary Artery Disease/BVS for the CTO Percutaneous Treatment 20. Wohrle J, Rottbauer W, Imhof A. Everolimus-eluting stents for treatment of chronic total coronary occlusions. Clin Res Cardiol 2012;101: 23e28. 21. Moreno R, García E, Teles R, Rumoroso JR, Cyrne Carvalho H, Goicolea FJ, Moreu J, Mauri J, Sabaté M, Mainar V, Patricio L, Valdés M, Fernández Vázquez F, Sánchez-Recalde A, Galeote G, JimenezValero S, Almeida M, Lopez de Sa E, Calvo L, Plaza I, Lopez-Sendón JL, Martín JL; CIBELES Investigators. Randomized comparison of sirolimus-eluting and everolimus-eluting coronary stents in the treatment of total coronary occlusions: results from the chronic coronary occlusion treated by everolimus-eluting stent randomized trial. Circ Cardiovasc Interv 2013;6:21e28. 22. Gert van Houwelingen K, Sen H, Lam MK, Tandjung K, Löwik MM, de Man FH, Louwerenburg JH, Stoel MG, Hartmann M, Linssen GC,
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Doggen CJ, von Birgelen C. Three-year clinical outcome after treatment of chronic total occlusions with second-generation drug-eluting stents in the TWENTE trial. Catheter Cardiovasc Interv 2015;85: E76eE82. 23. Wiebe J, Liebetrau C, Dörr O, Most A, Weipert K, Rixe J, Bauer T, Möllmann H, Elsässer A, Hamm CW, Nef HM. Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion. Int J Cardiol 2015;179:90e94. 24. Vaquerizo B, Barros A, Pujadas S, Bajo E, Estrada D, MirandaGuardiola F, Rigla J, Jiménez M, Cinca J, Serra A. Bioresorbable everolimus-eluting vascular scaffold for the treatment of chronic total occlusions: CTO-ABSORB pilot study. EuroIntervention 2014. pii: 20140601-04, http://dx.doi.org/10.4244/ EIJY14M12_07.
©2015 Elsevier
with metallic drug-eluting stents (DES).6 The present study aimed to assess the feasibility of BVS for the percutaneous treatment of CTO and to analyze the clinical outcomes and BVS patency by multislice computed tomography scan (MSCT) at midterm follow-up. Methods From February 2013 to June 2014, 121 CTOs in 116 patients were recanalized and treated percutaneously in our center. Among them, 42 patients with 46 CTOs were successfully treated by BVS implantation, and they constitute the study group. Whether to implant a BVS was based on clinical data and anatomical characteristics of the lesion and was taken during the procedure. Exclusion criteria for treating with BVS were as follows: patients >70 years, vessel diameter >4 mm, very heavily calcified lesions together with extreme tortuosity, and patients with a contraindication to 1 year of dual antiplatelet therapy. Concurrent DES implantation was allowed at the operator’s discretion. Written informed consent for treatment and for data analysis was obtained from all patients. The complexity of the lesion and difficulty of crossing was graded according to the Japanese-CTO score.7 The decision of an antegrade or retrograde approach was taken by the operator after a thorough study of the CTO anatomy www.ajconline.org
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Figure 1. A CTO of the proximal left circumflex artery. Retrograde approach through an epicardial collateral after an initial failed antegrade attempt (A). Difficulty accessing the true lumen with the retrograde guidewire. Intravascular ultrasound (IVUS) located the retrograde guidewire in the subintimal space (yellow arrows) (B). Reverse controlled antegrade and retrograde subintimal tracking with a larger balloon according to the vessel diameter measured by IVUS (C). Retrograde guidewire reaches the true lumen (D). Final result after 2 nonoverlapped BVS implantations (3 28 þ 3.5 28 mm) by angiography and IVUS (E). Follow-up at 10 months with very good result by angiography (F) and optical coherence tomography (G).
Table 1 Baseline clinical characteristics of the study population Variables Age (years) Men Diabetes mellitus Hypertension* Hypercholesterolemia† Current smoker Prior myocardial infarction Prior percutaneous coronary intervention
Patients (n¼42) 589 41 (98%) 14 (33%) 24 (57%) 27 (64%) 8 (19%) 12 (28%) 15 (36%)
* Repeated systemic blood pressure measurements >140/90 mmHg or treatment with antihypertensive drugs for a known diagnosis of hypertension. † Baseline cholesterol > 200 mg/dl or LDL-cholesterol >130 mg/dl or previously diagnosed and treated hypercholesterolemia.
using simultaneous double injection when applicable. Once the guidewire reached the distal lumen, all the occluded segments were painstakingly predilated with balloons of increasing diameter while testing the uniform expansion of
them. After BVS implantation, postdilation using noncompliant balloons with a maximum diameter 0.5 mm more than the BVS diameter was systematically performed. Intravascular ultrasound was used in some procedures to facilitate the access to the guidewire to the true lumen (Figure 1) or to determine the vessel diameter. Optical coherence tomography was performed when the BVS platform was manipulated or some complication was suspected. All patients were pretreated with dual antiplatelet medication. In the hemodynamic laboratory, weight-adjusted heparin was administered to maintain activated clotting time for >300 seconds. After the procedure, the patients received aspirin 100 mg/day indefinitely and a maintenance dose of clopidogrel (75 mg/day), prasugrel (10 mg/day), or ticagrelor (90 mg twice daily) for at least 12 months. In all patients, serial determinations of the troponin I and creatine kinase levels were performed before and every 6 hours after the procedure for the first 24 hours. CTO was defined as complete obstruction of the vessel with Thrombolysis In Myocardial Infarction flow grade 0 through the affected segment of >3 months estimated duration.2 Technical success was considered when a patent
Coronary Artery Disease/BVS for the CTO Percutaneous Treatment Table 2 Angiographic data Variables
Patients (n¼42)/Lesions (n¼46)
LV ejection fraction (%) Target coronary artery: Left anterior descending artery Right Left circumflex Multivessel disease CTO complexity (J-CTO score): Easy Intermediate Difficult Very difficult Estimated duration of the CTO (months) Main vessel reference (mm) Lesion length (mm) Minimal lumen diameter (mm) Diameter stenosis pre (%) Minimal lumen diameter post (mm) Diameter stenosis post (%)
548 22 13 11 28
(48%) (28%) (24%) (67%)
6 (13%) 19 (41%) 14 (31%) 7 (15%) 3542 3.030.4 3519 00 1000 2.70.4 116
Table 3 Procedural data
Femoral approach Seath 8Fr Double injection Strategy: Antegrade Retrograde Predilation Bioresorbable vascular scaffold diameter (mm) Scaffold length (mm) Number of bioresorbable vascular scaffolds/lesion Hybrid strategy Scaffold postdilation Bifurcation lesion involved: Side branch predilationþMain vessel scaffold Isolated side branch postdilation Intravascular ultrasound: To access to the true lumen To determine vessel size Optical coherence tomography
catheterization was recommended in the presence of clinical recurrence. Descriptive analyses were used. Discrete variables are presented as counts and percentages, whereas continuous data are presented as the mean SD (interquartile range 25 to 75). All analyses were performed using SPSS 20.0.0 software (IBM). Results
CTO ¼ chronic total occlusion.
Variables
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n¼46 46 (100%) 46 (100%) 26 (56%) 00 34 (74%) 12 (26%) 46 (100%) 3.030.38 4321 2.61.9 7 (15%) 46 (100%) 11 (24%) 5 (45%) 6 (55%) 5 (11%) 1 (20%) 4 (80%) 14 (30%)
vessel with <30% residual stenosis and a Thrombolysis In Myocardial Infarction flow grade 3 was achieved.3 Major adverse cardiac events (MACEs) were defined as a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization. Periprocedural MI was defined according to the new definition of clinically relevant MI after coronary revascularization,8 and scaffold thrombosis was defined according to the Academic Research Consortium criteria.9 After the treatment, the patients were monitored closely by scheduled visits and phone calls. To study the patency of the treated CTO at follow-up, an MSCT was scheduled for all patients 6 months after the treatment.10 A new cardiac
Baseline clinical and angiographic data are listed in Tables 1 and 2. All patients had stable angina despite optimal medical treatment. Unlike the patients treated exclusively with DES, those treated with BVS were younger (58 9 vs 67 8; p <0.05) and with a lower prevalence of diabetes mellitus (14, 33% vs 39, 53%; p <0.05). According to the Japanese-CTO score of complexity, 59 CTOs (78%) were classified as difficult or very difficult in the DES group, whereas in the BVS group 21 CTOs (46%) were difficult or very difficult (p <0.05). Table 3 summarizes the procedural characteristics. In 34 lesions (74%), an antegrade approach with a microcatheter and different dedicated wires was the strategy used to cross the CTO, whereas in 12 (26%), a retrograde approach was needed. In these cases, reverse controlled antegrade and retrograde subintimal tracking (it consists on inflating a balloon on the antegrade wire to enlarge the antegrade subintimal/subadventitial space, whereas the retrograde wire is then manipulated to enter the enlarged antegrade space) was the technique used in most of the procedures. Twentytwo recanalized CTOs (48%) were treated with 1 single BVS, 18 (39%) were treated with 2, and 6 (13%) received 3 BVSs. Regarding in-hospital outcomes, technical success was achieved in 45 of 46 lesions (98%). In 1 patient with a very complex CTO (J-CTO score >3 points), a residual distal lesion >30% was left because of the impossibility of passing through the several BVSs. No major complications related to the procedure were registered. One patient (2.4%) presented with significant troponin elevation in the range associated with a non-Q periprocedural MI. No other in-hospital adverse clinical events were recorded, and all patients were discharged free of symptoms. At midterm follow-up (mean: 13 5 months, median: 12, IQ25e75: 9.75 to 16 months), the overall MACE rate was 4.8% because of 2 repeat revascularizations. Neither death nor AMI were documented. Re-evaluation by coronary MSCT scan (Figures 2 and 3) or angiography (Figure 1) in cases of clinical recurrence was obtained in all patients at 6 1 months after the treatment. An asymptomatic complete scaffold re-occlusion was detected at 6 months in a patient who had a significant residual stenosis that was not treated. Two patients had restenosis, which was focal in one of them and treated by balloon dilation, whereas in the other a re-occlusion was observed. That re-occlusion was again recanalized, and a DES was implanted. The rest of the treated CTOs continued being open, without restenosis and the patients remain free of symptoms. In the DES group, the MACE rate at follow-up was 8%. Two patients (2.7%) died from heart failure and 4 (5.4%) required repeat revascularization.
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Figure 2. Long occlusion of the right coronary artery (RCA) with distal filling by collaterals from the left coronary artery (A). Successfully recanalized by retrograde approach and treated by the hybrid strategy: a short DES distally implanted and 3 overlapped BVSs with complete reconstruction of the artery (B). An MSCT scan performed 6 months later showed excellent status of the RCA (C).
Discussion The advent of the BVS and their promising results in selected lesions has awakened great enthusiasm in the interventional community.11,12 However, there is scant information about the safety and efficacy of this novel technology in complex lesions. The present study provides meaningful information regarding the feasibility of using the BVS for the percutaneous treatment of CTO. In our experience, in this group of selected patients, the technical success rate was high and the MACE rate at midterm was acceptable considering the complexity of the treated lesions. BVS could have obvious advantages over metallic stents by fully avoiding the problems arising from having permanent metal caging in the vessel.13 When an occluded artery is recanalized, it may be difficult to know the true size of the vessel. Moreover, segments distal to a successfully recanalized CTO can show significant lumen and vessel enlargement at follow-up.14 Both facts can lead to an underestimation of the diameter of the chosen stent with the resulting risk of late stent malapposition and stent thrombosis.15 The disappearance of the scaffold struts implies the liberation of the vessel, and therefore, this problem can be avoided. After guidewire crossing in the CTO, the lesion to be stented is usually long. The stented length is a factor known to be associated with a major risk of events at follow-up and unfavorably influences the physiological properties of the vessel.16 Theoretically, treatment by BVS would eliminate these limitations. The elution and scaffolding are temporary; so this can facilitate the return of vessel vasomotion,
adaptive shear stress, late luminal enlargement, and late expansive remodeling6,13 and would avoid the traditional triggers for late events. Despite the advantages described, the BVS approach in CTO is not exempt from difficulties. The crossing profile is 1.4 mm, and the crossability is worse compared with the new DES. This aspect is especially relevant in this type of lesion where the calcification and tortuosity of the vessel are frequent. In our series, scaffolds were implanted in all CTOs selected for BVS because of selection of the patients and thorough predilation of the lesion segment (Figure 3). Another potential drawback with this technology is the risk of strut fractures in the overlapped segment in between 2.5-, 3-, and 3.5-mm devices when a distal to proximal BVS implantation strategy is undertaken. The compliant balloon of the 3.5-mm BVS could damage the smaller distally implanted BVS. The introduction of DES has dramatically reduced restenosis rates after PCI compared with BMS. Regarding CTO, a meta-analysis showed that DES use was associated with lower target vessel revascularization, but there was also a statistical trend toward a higher risk of stent thrombosis compared with BMS. This fact was most likely related to the exclusive use of first-generation DES in the studies included.17 Secondgeneration DES with better platforms and more biocompatible polymers have improved long-term results, reducing the incidence of late stent thrombosis18e22 (Table 4). Focusing on BVS, 2 small studies recently published have assessed procedures and clinical outcomes in CTO. Wiebe and colleagues23 included 23 patients, and the incidence of
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Figure 3. Right coronary artery occluded (orange arrows) with distal filling shown by contralateral injection (A). Retrograde strategy through a septal channel. Retrograde guidewire reaches the true lumen after reverse controlled antegrade and retrograde subintimal tracking (B). After predilation, 2 overlapped BVSs (3.5 28 þ 3.5 18 mm) were implanted with proximal postdilation with a 4-mm noncompliant balloon (C). Very good final result noted by angiography (D). Re-evaluation by MSCT scan showed a vessel calcified and patent (E).
Table 4 Second generation of drug-elutintg stents and bioresorbable vascular scaffold for the treatment of coronary chronic total occlusion. Comparison with previous studies. Author/Study Almalla et al18 CATOS trial19 Wöhrle et al20 CIBELES study21 TWENTE Trial22 Wiebe et al23 Vaquerizo et al24 Ojeda et al.
Number of patients
Age (years)
Diabetes
Type of stent
Stent length (mm)
Follow-up
MACE
97 160 53 207 59 23 35 42 /46 CTOs
6312/6312 6210 6311/6510 6310 609 6110 589
29% vs 35% 28% 32% vs 41% 17% 35% 20% 33%
SES vs EES SES vs ZES EES SES vs EES ZES and EES BVS BVS BVS
4520/4321 79 36 4725/5023 6635* 6524 5223 4321
2 years 1 year 1 year 1 year 3 years 108 days 6 months 1 year
17.4% vs 15.7% 10% vs 17.5% 6% 15.8% vs 11.3% 15.3% 4% 0%† 4.8%
BVS ¼ bioresorbable vascular scaffold; CTO ¼ chronic total occlusion; DES ¼ drug eluting-stents; EES ¼ everolimus eluting-stents; MACE ¼ major adverse cardiac events; SES ¼ sirolimus eluting-stents; ZES¼zotarolimus eluting-stents. * Per patient. † Two in-scaffold reocclusion.
MACE at short-term follow-up was low (4.3%). The study of Vaquerizo and others24 with 35 patients showed 2 cases (5.7%) of scaffold re-occlusion at 6 months. These findings are concordant with those reported by us. In our study, with a
slightly larger sample size and also performing systematic re-evaluation by MSCT at 6 months, the rate of events was 4.8% despite not using imaging techniques routinely during BVS implantation. Although the information provided by
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imaging techniques can be useful, in our experience, their use is not mandatory except when some complication is suspected or when a bifurcation lesion is involved and the platform is manipulated. Compared with DES, the initial BVS experience in CTO lesions seems to be favorable, without an increase of device failure and even less incidence of adverse events at midterm follow-up (Table 4). A hybrid strategy was the treatment used in 7 CTOs (15%). This strategy consists of implanting a DES distally followed by a BVS until all the occluded segments are treated (Figure 2). This approach, not previously described, can provide several benefits. It allows us to check the possibility of having difficulty passing the BVS, and if the distal diameter of the vessel is unknown, a metallic stent, which can be safety expanded, can be a good option. Additionally, if the distal metallic device’s diameter is 2.5 mm, several overlapped 3.5-mm BVSs can be implanted proximally without any risk of strut fractures, creating in this way a reconstructed vessel from 2.5 (distal) up to 4 mm (proximal) if required. This strategy can simplify the procedure, it avoids implanting a long length of metal, and in the future, only a small distal part of the artery would remain caged. Limitations of the study include that it is an observational nonrandomized study with a relatively small number of patients included. However, it constitutes the basis for future investigations. The decision to implant a BVS after CTO recanalization was left to the operator’s discretion, and therefore, these findings cannot be extended to all types of CTO. Moreover, a longer follow-up is required to confirm these results. Disclosures Dr. Pan has received minor lectures fees from Abbot Vascular (Santa Clara, California). All other authors have no conflicts of interest to declare. 1. Kimura M, Katoh O, Tsuchikane E, Nasu K, Kinoshita Y, Ehara M, Terashima M, Matsuo H, Matsubara T, Asakura K, Asakura Y, Nakamura S, Oida A, Takase S, Reifart N, Di Mario C, Suzuki T. The efficacy of a bilateral approach for treating lesions with chronic total occlusions the CART (controlled antegrade and retrograde subintimal tracking) registry. JACC Cardiovasc Interv 2009;2:1135e1141. 2. Sianos G, Werner GS, Galassi AR, Papafaklis MI, Escaned J, Hildick-Smith D, Christiansen EH, Gershlick A, Carlino M, Karlas A, Konstantinidis NV, Tomasello SD, Di Mario C, Reifart N; EuroCTO Club. Recanalisation of chronic total coronary occlusions: 2012 consensus document from the EuroCTO club. EuroIntervention 2012;8:139e145. 3. Yamane M, Muto M, Matsubara T, Nakamura S, Muramatsu T, Oida A, Igarashi Y, Nozaki Y, Kijima M, Tuschikane E. Contemporary retrograde approach for the recanalisation of coronary chronic total occlusion: on behalf of the Japanese Retrograde Summit Group. Eurointervention 2013;9:102e109. 4. Shirai S, Kimura T, Nobuyoshi M, Morimoto T, Ando K, Soga Y, Yamaji K, Kondo K, Sakai K, Arita T, Goya M, Iwabuchi M, Yokoi H, Nosaka H, Mitsudo K; for the j-Cypher Registry Investigators. Impact of multiple and long sirolimus-eluting stent implantation on 3-year clinical outcomes in the j-Cypher registry. JACC Cardiovasc Interv 2010;3:180e188. 5. Naidu SS, Krucoff MW, Rutledge DR, Mao VW, Zhao W, Zheng Q, Wilburn O, Sudhir K, Simonton C, Hermiller JB. Contemporary incidence and predictors of stent thrombosis and other major adverse cardiac events in the year after XIENCE V implantation results from the 8,061-Patient XIENCE V United States study. JACC Cardiovasc Interv 2012;5:626e635.
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