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Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion
International Journal of Cardiology 179 (2015) 90–94
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International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion Jens Wiebe a, Christoph Liebetrau a,b, Oliver Dörr a, Astrid Most a, Kay Weipert a, Johannes Rixe a, Timm Bauer a, Helge Möllmann b, Albrecht Elsässer c, Christian W. Hamm a,b, Holger M. Nef a,⁎ a b c
University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany Klinikum Oldenburg, Department of Cardiology, Rahel-Straus-Strasse 10, 26133 Oldenburg, Germany
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Article history: Received 24 March 2014 Received in revised form 30 September 2014 Accepted 18 October 2014 Available online xxxx Keywords: Biodegradable Stent Percutaneous coronary intervention Chronic total coronary occlusion Coronary artery disease Bioresorbable vascular scaffold
a b s t r a c t Objective: This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions. Background: Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited. Methods: Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score. Results: A total of 23 patients were included. Mean age was 60.4 ± 9.0 years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7 ± 1.0. Median procedure time was 70 min (54–85), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1– 30.0). A total of 64 BVSs were implanted with a mean number of 2.8 ± 1.0 BVSs per patient, a mean total BVS length of 64.8 ± 24.2 mm per lesion, and a mean BVS diameter of 3.1 ± 0.2 mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5–214.5) days one in-scaffold thrombosis was noted 4 days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred. Conclusion: These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction According to the current guidelines on myocardial revascularization, treating a chronic total occlusion (CTO) of a coronary artery by percutaneous coronary intervention (PCI) is reasonable if the patient is experiencing clinical symptoms, the lesion is suitable for stenting, and the operator is adequately experienced [1,2]. Due to further refinements of existing equipment the success rates for CTO procedures have increased while the complication rates have decreased [3]. Compared with bare metal stents, the use of drug-eluting stents in CTO-PCI results in a significant reduction in major acute coronary events and total vascular revascularization rates as well as lower rates of in-stent restenosis [4]. Nevertheless, limitations such as late stent thrombosis, local inflammatory reactions, and the metallic cage of the vessel still exist [5–7]. New bioresorbable vascular scaffolds (BVSs), which disappear after approximately 2 years, are potentially able to overcome these shortcomings ⁎ Corresponding author at: Medizinische Klinik I, Department of Cardiology, University of Giessen, Klinikstrasse 33, 35392 Giessen, Germany. E-mail address: [email protected] (H.M. Nef).
http://dx.doi.org/10.1016/j.ijcard.2014.10.032 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
and furthermore offer numerous benefits, most notably restoration of the physiological vasomotion, vascular remodeling, and late lumen enlargement [8,9]. Whether these theoretically advantages result into a better clinical outcome has to be proved. However, this new approach has already shown to be safe in patients with stable coronary artery disease, and current results reveal feasibility and good mid-term outcome [9–11]. Beyond these data there is a general lack of experience in other clinical scenarios and more complex coronary lesions. Therefore, the aim of this case series was to evaluate the feasibility of PCI with BVS implantation in patients with CTO lesions. 2. Methods 2.1. Patient population Between October 2012 and December 2013 twenty-three patients with a CTO of a coronary artery who had been treated with everolimus-eluting BVS (ABSORB™, Abbott Vascular, USA) were included in this study (Fig. 1). Patients with unsuccessful CTO procedures as well as those treated with conventional drug-eluting stents were excluded. The enrollment scheme is illustrated in Fig. 1. A CTO lesion was defined according to the current ESC guidelines as a TIMI flow of zero for at least three months [1]. For patients who did not undergo previous catheterization the above definition was not applicable. Thus, the
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2.4. Statistical analysis Continuous variables were presented as mean with standard deviation (SD) or as median and interquartile range. Categorical variables were presented as counts and percentages. Analysis was performed with SPSS 20.0 (Statistical Package for the Social Sciences, Chicago, IL, USA).
3. Results 3.1. Procedural and in-hospital outcome
Fig. 1. Enrollment scheme. definition as a CTO was based on the patient's clinical history and the angiogram, especially the presence of severe calcification, which occurs more frequently with increasing CTO age (N1 year) [12]. To predict the difficulty of crossing the lesion the J-score was used, which includes five categories that each count one point: the presence of a blunt stump, any evidence of calcification, bending N45°, lesion length ≥20 mm, and a re-try lesion. Zero points were considered easy, 1 point intermediate, 2 points difficult, and ≥3 points very difficult [13]. Baseline evaluation contained documentation of the patients' medical history, physical examination, 12-lead ECG, and blood laboratory examination. Transthoracic echocardiography, cardiac MRI, and/or a CT scan were performed in advance to evaluate cardiac viability and coronary anatomy. All patients were followed up with either an office visit or a telephone interview 30 days and, if available, 6 months after the procedure. An angiographic follow-up was not mandatory and the indication for it was left to the implanting physician's discretion. All patients received and signed a written informed consent in order to participate in this study. This investigation was approved by the ethics board of the University of Giessen, Germany (AZ:246/12). All examinations were performed according to the Declaration of Helsinki.
Table 1 shows the baseline characteristics of all patients (19 males, 4 female, mean [±SD] age 60.4 ± 9.0 years) enrolled in the study. The transfemoral approach with a 7F sheath was used in all patients. In two patients a repeat procedure was performed since the first attempt failed. The mean J-score was 1.7 ± 1.0, mean lesion length was 21.6 ± 10.4, and 2.8 ± 1.0 scaffolds were used per CTO (minimum one BVS, maximum five BVSs) with a mean total length of 64.8 (±24.1) mm (minimum 28 mm, maximum to 104 mm). Final TIMI flow was 3 in all cases. The following strategies were used for recanalization: single-wire technique in 17.4% (4/23), double-wire technique in 52.2% (12/23) and dissection and subintimal tracking technique in 30.4% (7/23). Additional intravascular imaging was applied in 60.9% (14/23), OCT was performed in 26.1% (6/23) and IVUS in 34.8% (8/23). Median procedure time was 70 min (54–84.5), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1–30.0). Neither a scaffold-related dissection nor any other intra-procedural complication occurred. All patients received dual antiplatelet therapy with aspirin and additional clopidogrel (59.1%) or, due to prior PCI for acute coronary syndrome within the last 12 months, ticagrelor (18.2%) or prasugrel (27.3%). Median hospital stay was 2.0 (1.0–3.0) days. Additional pre-procedural, procedural and in-hospital data are given in Tables 2 and 3. Representative angiographic and optical coherence tomography images are shown in Figs. 2 and 3. 3.2. Follow-up Median follow-up duration was 108 (79.5–214.5) days. During this time one scaffold thrombosis was observed 4 days after the procedure, most probably because the patient did not take the prescribed antiplatelet
2.2. Device and procedure The circumferential and cross-linked struts of the BVS are made of poly-L-lactic acid (PLLA) and have a thickness of 150 μm. The elution of the BVS consists of poly-D,L-lactic acid (PDLLA) and the anti-proliferative drug everolimus in a 1:1 relationship. Radiopaque markers at the tip of both ends ensure visualization of the BVS during the intervention. Resorption of the entire scaffold was observed after two years in a porcine model [8]. Different CTO methods such as retrograde, single, and parallel wire or subintimal tracking techniques were used according to the operator's discretion. Typical guidewires used were Fielder XT (Asahi Intecc, Aichi, Japan), HAT Progress 140T and 200T (Abbott Vascular, Abbott Park, IL, USA), Miracle 3 and Miracle 6 (Asahi Intecc, Aichi, Japan) and Confianza Pro 12 (Asahi Intecc, Aichi, Japan). In selected cases optical coherence tomography (OCT) or intravascular ultrasound (IVUS) were used for measurement of the lumen diameter and vessel characteristics (e.g. calcification, dissection). Implantation of at least one BVS was performed according to standard clinical practice. If more than one BVS was necessary, the BVSs were implanted in a marker-to-marker fashion from the distal to the proximal part of the target vessel. For assessment of malapposition OCT (St. Jude ILUMIEN OPTIS, Dragonfly™, St. Jude Medical, Inc., St. Paul, MN, USA) was performed. In the case of malapposition of BVS, post-dilation with a non-compliant balloon was performed within the expansion level of the BVS.
2.3. Target parameters The aim of this observational study was to evaluate safety and feasibility of the BVS in patients with CTO lesions. Therefore, the following target parameters were determined: Procedural success was defined as successful deployment of the scaffold at the target lesion and an estimated residual stenosis of equal to or less than 30% on angiography and optical coherence tomography. Cardiac death, myocardial infarction, and unscheduled percutaneous and surgical target lesion revascularization were summarized as major adverse cardiac events (MACE). Target vessel failure (TVF) included cardiac death, target vessel myocardial infarction, and percutaneous or surgical target vessel revascularization (TVR).
Table 1 Baseline characteristics. Number of patients Age (years, ±SDa) BMIb (kg/m2, ±SDa) Female Hypertension Diabetes Former/current smoker Hyperlipidemia Coronary artery disease 1—vessel disease 2—vessel disease 3—vessel disease Left ventricular ejection fraction (%, ±SDa) NYHAc functional class I II III IV CCSd classification of chest pain I II III IV a b c d
Standard deviation. Body mass index. New York Heart Association. Canadian Cardiovascular Society.
23 60.4 ± 9.0 27.8 ± 3.9 18.2% (4/23) 91.3% (21/23) 34.8% (8/23) 47.8% (11/23) 65.2% (15/23) 17.4% (4/23) 39.1% (9/23) 43.5% (10/23) 55.7 ± 15.5 8.7% (2/23) 69.6% (16/23) 21.7% (5/23) 0.0% (0/23) 13.0% (3/23) 52.2% (12/23) 34.8% (8/23) 0.0% (0/23)
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Table 2 J-score assessment.
Total J-score Blunt entry shape Presence of calcification Bending N45° Occlusion length ≥20 mm Re-try lesion
Successful CTO procedure with bioresorbable scaffolds
Unsuccessful CTO procedure
Successful CTO procedure with drug-eluting stents
1.7 ± 1.0 30.4% (7/23) 65.2% (15/23) 13.0% (3/23) 52.2% (12/23) 8.7% (2/23)
3.3 ± 0.8 50.0% (5/10) 90.0% (9/10) 40.0% (4/10) 80.0% (8/10) 70.0% (7/10)
2.6 ± 0.9 40.0% (2/5) 100.0% (5/5) 40.0% (2/5) 60.0% (3/5) 20.0% (1/5)
medication. Thus, this event represents a combined TVF, TLF, and TVR. Thirteen patients (59.1%) underwent elective coronary angiography, during which 6 planned PCIs of previously known stenosed vessels were performed. No evidence of TVF, TLF or TVR was found. None of the patients died or experienced any further MACE. An overview of the follow-up findings is given in Table 4. 4. Discussion CTO-PCI is associated with an increased survival rate and a lower incidence of coronary artery bypass grafting [3,14,15], whereas untreated CTO lesions are associated with a higher mortality rate [16]. The results of CTO procedures are consistently improving regarding procedural success, complication rates, and quality of life with respect to clinical symptoms [3,17,18]. The success rate in the present study is 71.8%. However, all patients with an unsuccessful procedure had a J-score of 3.3, which is extraordinarily high, and most of the cases were even re-try lesions. Nevertheless, the success rate seems acceptable, especially when compared with previous investigations on CTOs [3,18]. The success rate could possibly be further increased with a more common use of the retrograde approach. For the CTO-PCI approach, continuous long-segment stenting (N60 mm) is often needed, although it should be optimally as short as possible. The length of the stented segment is an independent predictor of in-stent restenosis and stent thrombosis [19]. In addition, the use of very long and overlapping DES is also associated with higher rates of late in-stent restenosis [20]. Moreover, the characteristics of the CTO
Table 3 Procedural data. Total BVSa implanted BVSa per patient (n, ±SDb) Total BVSa length per lesion (mm, ±SD) Mean BVSa diameter (mm, ±SDb) Culprit vessel – LADc – RCXd – RCAe Contralateral injection angiography Antegrade approach Retrograde approach Use of microcatheters Pre-dilatation balloons used per lesion Number of pre-dilatations per lesion Post-dilation Median procedure time (min, IQRf) Mean contrast volume (mL, ±SDb) Median fluoroscopy time (min, IQRf) Median hospital stay (days, IQRf) Severe in-hospital adverse events a b c d e f
Bioresorbable vascular scaffold. Standard deviation. Left anterior descending artery. Ramus circumflexus. Right coronary artery. Interquartile range.
64 2.8 ± 1.0 64.8 ± 24.2 3.1 ± 0.2 43.5% (10/23) 8.7% (2/23) 47.8% (11/23) 100.0% (23/23) 95.7% (22/23) 4.3% (1/23) 100% (23/23) 2.2 ± 0.7 3.1 ± 2.3 69.6% (16/23) 70 (54.0–84.5) 213.5 ± 94.2 19.1 (13.1–30.0) 2.0 (1.0–3.0) 0.0% (0/23)
lesion itself independently predict the occurrence of in-stent restenosis. Other factors also affect the restenosis rate after DES implantation, including vessel diameter, stent diameter, and the number of implanted stents [19]. The use of BVSs in CTO patients represents a new approach, as current results for BVS implantation are primarily only available for patients with stable coronary artery disease [8–11]. Only a few case reports, including one describing the successful utilization of BVS (a “full bioresorbable jacket”) in a CTO patient, have been published thus far [21–24], despite the fact that BVS have several advantages over bare metal and drug-eluting stents. Beyond the acute effect of re-opening and scaffolding an occluded vessel, full resorption of the BVS occurs after two years [8]. Subsequently, there is no caging of the vessel. Restoration of the physiological vessel vasomotion has been observed as well as a late lumen enlargement [9]. Furthermore, late stent thrombosis is most probably reduced as the BVS completely disappears. Finally, the treated vessel can still be a potential, or in case of a CTO, a new goal for further surgical revascularization. Treating a CTO lesion with stents can result in a “full-metal jacket” procedure with well-known disadvantages [25,26]; these may be for the most part resolved owing to the advantages of BVS mentioned above. The mean number of scaffolds implanted in this study is comparable to the number of stents used in other current studies, whereas the mean scaffold length per patient is slightly higher in our registry despite the CTO length being lower [15,27]. It could be that this more generous behavior is a result of discretion on the part of the physician, who may have in mind the dissolving characteristic of BVS. There are some peculiarities of the BVS that should be noted. The expansion of the BVS can be difficult in some specific anatomical subsets and the use of BVS in the presence of heavy calcification or severe tortuosity is even contraindicated. Consequently in 2 patients successful delivery of the BVS was not possible and 3 patients were treated directly with DES instead of BVS. Thorough pre-dilatation should be performed. Furthermore, visualization of the radiopaque markers of the BVS can be difficult; although this can be remedied by increasing the frames per second, this has the disadvantage of a higher radiation dose. Thus, the right choice of patient is also essential, that is why the J-score was used. Patients treated successfully with BVS had a mean J-score of 1.7 ± 1.0, and, accordingly, the difficulty was considered between “intermediate” and “difficult”. Patients with an unsuccessful CTO procedure had an almost twofold-higher mean J-score (3.3 ± 0.9), which is considered to be “very difficult” [13]. This implies that a thorough selection of patients is essential and the use of BVS should be reserved for patients with a low J-score, especially since there is as yet little experience available in the treatment of CTOs with BVS. This is the first study of BVS use in patients with CTO that demonstrates reasonable procedural and clinical short-term outcome. In all cases no severe procedural or in-hospital complications were encountered. This low complication rate is consistent with previous findings demonstrating that the incidence of complications is comparable for PCI in CTO and non-occlusive lesions [27,28]. During follow-up one scaffold thrombosis appeared, most probably due to discontinued antiplatelet medication. There were no further target vessel or target lesion failures as well as other MACE. However, the small number of enrolled
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Fig. 2. Intra-procedural angiographic imaging. (A) Angiography showing a chronic total occlusion lesion of the LAD before PCI. (B) Angiographic result after recanalization and BVS implantation from the distal to the mid-section of the LAD.
consecutive patients is a major limitation of our study that must be considered. Additionally, the short follow-up period and its observational character should be mentioned.
In conclusion, the results of this small observational study suggest that the implantation of everolimus-eluting bioresorbable vascular scaffolds in patients with a total chronic occlusion of the coronary artery can
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Fig. 3. Optical coherence tomography imaging after implantation of BVS revealing the procedural success and excluding malapposition. 3D imaging of the proximal and mid LAD (A). Crosssection of the mid-LAD (B) and distal LAD (C).
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Table 4 Follow-up. Median follow-up (days, IRa) Total MACEb – Death – Myocardial infarction – TLRd TVFe TLFc a b c d e
108 (79.5–214.5) 4.3% (1/23) 0.0% (0/23) 0.0% (0/23) 4.3% (1/23) 4.3% (1/23) 4.3% (1/23)
Interquartile range. Major adverse cardiac event. Target lesion failure. Target lesion revascularization. Target vessel failure.
be performed in highly selected cases with reasonable procedural success and clinical short-term outcome. It will be necessary to obtain long-term data, however, and this study needs to be validated in a large-scale, randomized, multi-center trial.
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Conflict of interest Helge Möllmann, Christian Hamm, and Holger Nef received honoraria for lectures from Abbott Vascular. All other authors have no potential conflict of interest.
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Contents lists available at ScienceDirect
International Journal of Cardiology journal homepage: www.elsevier.com/locate/ijcard
Feasibility of everolimus-eluting bioresorbable vascular scaffolds in patients with chronic total occlusion Jens Wiebe a, Christoph Liebetrau a,b, Oliver Dörr a, Astrid Most a, Kay Weipert a, Johannes Rixe a, Timm Bauer a, Helge Möllmann b, Albrecht Elsässer c, Christian W. Hamm a,b, Holger M. Nef a,⁎ a b c
University of Giessen, Medizinische Klinik I, Department of Cardiology, Klinikstrasse 33, 35392 Giessen, Germany Kerckhoff Heart and Thorax Center, Department of Cardiology, Benekestrasse 2-8, 61231 Bad Nauheim, Germany Klinikum Oldenburg, Department of Cardiology, Rahel-Straus-Strasse 10, 26133 Oldenburg, Germany
a r t i c l e
i n f o
Article history: Received 24 March 2014 Received in revised form 30 September 2014 Accepted 18 October 2014 Available online xxxx Keywords: Biodegradable Stent Percutaneous coronary intervention Chronic total coronary occlusion Coronary artery disease Bioresorbable vascular scaffold
a b s t r a c t Objective: This study evaluates the feasibility of percutaneous coronary intervention with bioresorbable vascular scaffolds (BVSs) in chronic total occlusion (CTO) lesions. Background: Everolimus-eluting BVSs represent a new approach to treating coronary artery disease, but experience with CTO is limited. Methods: Patients with a previously diagnosed CTO who had been treated with BVS were included. Patients with unsuccessful CTO procedures and patients treated with drug-eluting stents were excluded. Difficulty of the CTO procedure was assessed by the J-score. Results: A total of 23 patients were included. Mean age was 60.4 ± 9.0 years, 17.4% were female, 91.3% suffered from hypertension and 34.8% from diabetes. Mean J-score was 1.7 ± 1.0. Median procedure time was 70 min (54–85), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1– 30.0). A total of 64 BVSs were implanted with a mean number of 2.8 ± 1.0 BVSs per patient, a mean total BVS length of 64.8 ± 24.2 mm per lesion, and a mean BVS diameter of 3.1 ± 0.2 mm. Neither a scaffold-related dissection nor any other intra-procedural complication occurred. During a follow-up of 108 (79.5–214.5) days one in-scaffold thrombosis was noted 4 days after the CTO procedure due to a lack of dual antiplatelet therapy. No further major adverse cardiac events occurred. Conclusion: These results suggest that BVS implantation in CTO lesions can be performed with good procedural success and reasonable clinical short-term outcome in highly selected cases. © 2014 Elsevier Ireland Ltd. All rights reserved.
1. Introduction According to the current guidelines on myocardial revascularization, treating a chronic total occlusion (CTO) of a coronary artery by percutaneous coronary intervention (PCI) is reasonable if the patient is experiencing clinical symptoms, the lesion is suitable for stenting, and the operator is adequately experienced [1,2]. Due to further refinements of existing equipment the success rates for CTO procedures have increased while the complication rates have decreased [3]. Compared with bare metal stents, the use of drug-eluting stents in CTO-PCI results in a significant reduction in major acute coronary events and total vascular revascularization rates as well as lower rates of in-stent restenosis [4]. Nevertheless, limitations such as late stent thrombosis, local inflammatory reactions, and the metallic cage of the vessel still exist [5–7]. New bioresorbable vascular scaffolds (BVSs), which disappear after approximately 2 years, are potentially able to overcome these shortcomings ⁎ Corresponding author at: Medizinische Klinik I, Department of Cardiology, University of Giessen, Klinikstrasse 33, 35392 Giessen, Germany. E-mail address: [email protected] (H.M. Nef).
http://dx.doi.org/10.1016/j.ijcard.2014.10.032 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
and furthermore offer numerous benefits, most notably restoration of the physiological vasomotion, vascular remodeling, and late lumen enlargement [8,9]. Whether these theoretically advantages result into a better clinical outcome has to be proved. However, this new approach has already shown to be safe in patients with stable coronary artery disease, and current results reveal feasibility and good mid-term outcome [9–11]. Beyond these data there is a general lack of experience in other clinical scenarios and more complex coronary lesions. Therefore, the aim of this case series was to evaluate the feasibility of PCI with BVS implantation in patients with CTO lesions. 2. Methods 2.1. Patient population Between October 2012 and December 2013 twenty-three patients with a CTO of a coronary artery who had been treated with everolimus-eluting BVS (ABSORB™, Abbott Vascular, USA) were included in this study (Fig. 1). Patients with unsuccessful CTO procedures as well as those treated with conventional drug-eluting stents were excluded. The enrollment scheme is illustrated in Fig. 1. A CTO lesion was defined according to the current ESC guidelines as a TIMI flow of zero for at least three months [1]. For patients who did not undergo previous catheterization the above definition was not applicable. Thus, the
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2.4. Statistical analysis Continuous variables were presented as mean with standard deviation (SD) or as median and interquartile range. Categorical variables were presented as counts and percentages. Analysis was performed with SPSS 20.0 (Statistical Package for the Social Sciences, Chicago, IL, USA).
3. Results 3.1. Procedural and in-hospital outcome
Fig. 1. Enrollment scheme. definition as a CTO was based on the patient's clinical history and the angiogram, especially the presence of severe calcification, which occurs more frequently with increasing CTO age (N1 year) [12]. To predict the difficulty of crossing the lesion the J-score was used, which includes five categories that each count one point: the presence of a blunt stump, any evidence of calcification, bending N45°, lesion length ≥20 mm, and a re-try lesion. Zero points were considered easy, 1 point intermediate, 2 points difficult, and ≥3 points very difficult [13]. Baseline evaluation contained documentation of the patients' medical history, physical examination, 12-lead ECG, and blood laboratory examination. Transthoracic echocardiography, cardiac MRI, and/or a CT scan were performed in advance to evaluate cardiac viability and coronary anatomy. All patients were followed up with either an office visit or a telephone interview 30 days and, if available, 6 months after the procedure. An angiographic follow-up was not mandatory and the indication for it was left to the implanting physician's discretion. All patients received and signed a written informed consent in order to participate in this study. This investigation was approved by the ethics board of the University of Giessen, Germany (AZ:246/12). All examinations were performed according to the Declaration of Helsinki.
Table 1 shows the baseline characteristics of all patients (19 males, 4 female, mean [±SD] age 60.4 ± 9.0 years) enrolled in the study. The transfemoral approach with a 7F sheath was used in all patients. In two patients a repeat procedure was performed since the first attempt failed. The mean J-score was 1.7 ± 1.0, mean lesion length was 21.6 ± 10.4, and 2.8 ± 1.0 scaffolds were used per CTO (minimum one BVS, maximum five BVSs) with a mean total length of 64.8 (±24.1) mm (minimum 28 mm, maximum to 104 mm). Final TIMI flow was 3 in all cases. The following strategies were used for recanalization: single-wire technique in 17.4% (4/23), double-wire technique in 52.2% (12/23) and dissection and subintimal tracking technique in 30.4% (7/23). Additional intravascular imaging was applied in 60.9% (14/23), OCT was performed in 26.1% (6/23) and IVUS in 34.8% (8/23). Median procedure time was 70 min (54–84.5), mean contrast volume was 213.5 mL (±94.2) and median fluoroscopy time was 19.1 min (13.1–30.0). Neither a scaffold-related dissection nor any other intra-procedural complication occurred. All patients received dual antiplatelet therapy with aspirin and additional clopidogrel (59.1%) or, due to prior PCI for acute coronary syndrome within the last 12 months, ticagrelor (18.2%) or prasugrel (27.3%). Median hospital stay was 2.0 (1.0–3.0) days. Additional pre-procedural, procedural and in-hospital data are given in Tables 2 and 3. Representative angiographic and optical coherence tomography images are shown in Figs. 2 and 3. 3.2. Follow-up Median follow-up duration was 108 (79.5–214.5) days. During this time one scaffold thrombosis was observed 4 days after the procedure, most probably because the patient did not take the prescribed antiplatelet
2.2. Device and procedure The circumferential and cross-linked struts of the BVS are made of poly-L-lactic acid (PLLA) and have a thickness of 150 μm. The elution of the BVS consists of poly-D,L-lactic acid (PDLLA) and the anti-proliferative drug everolimus in a 1:1 relationship. Radiopaque markers at the tip of both ends ensure visualization of the BVS during the intervention. Resorption of the entire scaffold was observed after two years in a porcine model [8]. Different CTO methods such as retrograde, single, and parallel wire or subintimal tracking techniques were used according to the operator's discretion. Typical guidewires used were Fielder XT (Asahi Intecc, Aichi, Japan), HAT Progress 140T and 200T (Abbott Vascular, Abbott Park, IL, USA), Miracle 3 and Miracle 6 (Asahi Intecc, Aichi, Japan) and Confianza Pro 12 (Asahi Intecc, Aichi, Japan). In selected cases optical coherence tomography (OCT) or intravascular ultrasound (IVUS) were used for measurement of the lumen diameter and vessel characteristics (e.g. calcification, dissection). Implantation of at least one BVS was performed according to standard clinical practice. If more than one BVS was necessary, the BVSs were implanted in a marker-to-marker fashion from the distal to the proximal part of the target vessel. For assessment of malapposition OCT (St. Jude ILUMIEN OPTIS, Dragonfly™, St. Jude Medical, Inc., St. Paul, MN, USA) was performed. In the case of malapposition of BVS, post-dilation with a non-compliant balloon was performed within the expansion level of the BVS.
2.3. Target parameters The aim of this observational study was to evaluate safety and feasibility of the BVS in patients with CTO lesions. Therefore, the following target parameters were determined: Procedural success was defined as successful deployment of the scaffold at the target lesion and an estimated residual stenosis of equal to or less than 30% on angiography and optical coherence tomography. Cardiac death, myocardial infarction, and unscheduled percutaneous and surgical target lesion revascularization were summarized as major adverse cardiac events (MACE). Target vessel failure (TVF) included cardiac death, target vessel myocardial infarction, and percutaneous or surgical target vessel revascularization (TVR).
Table 1 Baseline characteristics. Number of patients Age (years, ±SDa) BMIb (kg/m2, ±SDa) Female Hypertension Diabetes Former/current smoker Hyperlipidemia Coronary artery disease 1—vessel disease 2—vessel disease 3—vessel disease Left ventricular ejection fraction (%, ±SDa) NYHAc functional class I II III IV CCSd classification of chest pain I II III IV a b c d
Standard deviation. Body mass index. New York Heart Association. Canadian Cardiovascular Society.
23 60.4 ± 9.0 27.8 ± 3.9 18.2% (4/23) 91.3% (21/23) 34.8% (8/23) 47.8% (11/23) 65.2% (15/23) 17.4% (4/23) 39.1% (9/23) 43.5% (10/23) 55.7 ± 15.5 8.7% (2/23) 69.6% (16/23) 21.7% (5/23) 0.0% (0/23) 13.0% (3/23) 52.2% (12/23) 34.8% (8/23) 0.0% (0/23)
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Table 2 J-score assessment.
Total J-score Blunt entry shape Presence of calcification Bending N45° Occlusion length ≥20 mm Re-try lesion
Successful CTO procedure with bioresorbable scaffolds
Unsuccessful CTO procedure
Successful CTO procedure with drug-eluting stents
1.7 ± 1.0 30.4% (7/23) 65.2% (15/23) 13.0% (3/23) 52.2% (12/23) 8.7% (2/23)
3.3 ± 0.8 50.0% (5/10) 90.0% (9/10) 40.0% (4/10) 80.0% (8/10) 70.0% (7/10)
2.6 ± 0.9 40.0% (2/5) 100.0% (5/5) 40.0% (2/5) 60.0% (3/5) 20.0% (1/5)
medication. Thus, this event represents a combined TVF, TLF, and TVR. Thirteen patients (59.1%) underwent elective coronary angiography, during which 6 planned PCIs of previously known stenosed vessels were performed. No evidence of TVF, TLF or TVR was found. None of the patients died or experienced any further MACE. An overview of the follow-up findings is given in Table 4. 4. Discussion CTO-PCI is associated with an increased survival rate and a lower incidence of coronary artery bypass grafting [3,14,15], whereas untreated CTO lesions are associated with a higher mortality rate [16]. The results of CTO procedures are consistently improving regarding procedural success, complication rates, and quality of life with respect to clinical symptoms [3,17,18]. The success rate in the present study is 71.8%. However, all patients with an unsuccessful procedure had a J-score of 3.3, which is extraordinarily high, and most of the cases were even re-try lesions. Nevertheless, the success rate seems acceptable, especially when compared with previous investigations on CTOs [3,18]. The success rate could possibly be further increased with a more common use of the retrograde approach. For the CTO-PCI approach, continuous long-segment stenting (N60 mm) is often needed, although it should be optimally as short as possible. The length of the stented segment is an independent predictor of in-stent restenosis and stent thrombosis [19]. In addition, the use of very long and overlapping DES is also associated with higher rates of late in-stent restenosis [20]. Moreover, the characteristics of the CTO
Table 3 Procedural data. Total BVSa implanted BVSa per patient (n, ±SDb) Total BVSa length per lesion (mm, ±SD) Mean BVSa diameter (mm, ±SDb) Culprit vessel – LADc – RCXd – RCAe Contralateral injection angiography Antegrade approach Retrograde approach Use of microcatheters Pre-dilatation balloons used per lesion Number of pre-dilatations per lesion Post-dilation Median procedure time (min, IQRf) Mean contrast volume (mL, ±SDb) Median fluoroscopy time (min, IQRf) Median hospital stay (days, IQRf) Severe in-hospital adverse events a b c d e f
Bioresorbable vascular scaffold. Standard deviation. Left anterior descending artery. Ramus circumflexus. Right coronary artery. Interquartile range.
64 2.8 ± 1.0 64.8 ± 24.2 3.1 ± 0.2 43.5% (10/23) 8.7% (2/23) 47.8% (11/23) 100.0% (23/23) 95.7% (22/23) 4.3% (1/23) 100% (23/23) 2.2 ± 0.7 3.1 ± 2.3 69.6% (16/23) 70 (54.0–84.5) 213.5 ± 94.2 19.1 (13.1–30.0) 2.0 (1.0–3.0) 0.0% (0/23)
lesion itself independently predict the occurrence of in-stent restenosis. Other factors also affect the restenosis rate after DES implantation, including vessel diameter, stent diameter, and the number of implanted stents [19]. The use of BVSs in CTO patients represents a new approach, as current results for BVS implantation are primarily only available for patients with stable coronary artery disease [8–11]. Only a few case reports, including one describing the successful utilization of BVS (a “full bioresorbable jacket”) in a CTO patient, have been published thus far [21–24], despite the fact that BVS have several advantages over bare metal and drug-eluting stents. Beyond the acute effect of re-opening and scaffolding an occluded vessel, full resorption of the BVS occurs after two years [8]. Subsequently, there is no caging of the vessel. Restoration of the physiological vessel vasomotion has been observed as well as a late lumen enlargement [9]. Furthermore, late stent thrombosis is most probably reduced as the BVS completely disappears. Finally, the treated vessel can still be a potential, or in case of a CTO, a new goal for further surgical revascularization. Treating a CTO lesion with stents can result in a “full-metal jacket” procedure with well-known disadvantages [25,26]; these may be for the most part resolved owing to the advantages of BVS mentioned above. The mean number of scaffolds implanted in this study is comparable to the number of stents used in other current studies, whereas the mean scaffold length per patient is slightly higher in our registry despite the CTO length being lower [15,27]. It could be that this more generous behavior is a result of discretion on the part of the physician, who may have in mind the dissolving characteristic of BVS. There are some peculiarities of the BVS that should be noted. The expansion of the BVS can be difficult in some specific anatomical subsets and the use of BVS in the presence of heavy calcification or severe tortuosity is even contraindicated. Consequently in 2 patients successful delivery of the BVS was not possible and 3 patients were treated directly with DES instead of BVS. Thorough pre-dilatation should be performed. Furthermore, visualization of the radiopaque markers of the BVS can be difficult; although this can be remedied by increasing the frames per second, this has the disadvantage of a higher radiation dose. Thus, the right choice of patient is also essential, that is why the J-score was used. Patients treated successfully with BVS had a mean J-score of 1.7 ± 1.0, and, accordingly, the difficulty was considered between “intermediate” and “difficult”. Patients with an unsuccessful CTO procedure had an almost twofold-higher mean J-score (3.3 ± 0.9), which is considered to be “very difficult” [13]. This implies that a thorough selection of patients is essential and the use of BVS should be reserved for patients with a low J-score, especially since there is as yet little experience available in the treatment of CTOs with BVS. This is the first study of BVS use in patients with CTO that demonstrates reasonable procedural and clinical short-term outcome. In all cases no severe procedural or in-hospital complications were encountered. This low complication rate is consistent with previous findings demonstrating that the incidence of complications is comparable for PCI in CTO and non-occlusive lesions [27,28]. During follow-up one scaffold thrombosis appeared, most probably due to discontinued antiplatelet medication. There were no further target vessel or target lesion failures as well as other MACE. However, the small number of enrolled
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Fig. 2. Intra-procedural angiographic imaging. (A) Angiography showing a chronic total occlusion lesion of the LAD before PCI. (B) Angiographic result after recanalization and BVS implantation from the distal to the mid-section of the LAD.
consecutive patients is a major limitation of our study that must be considered. Additionally, the short follow-up period and its observational character should be mentioned.
In conclusion, the results of this small observational study suggest that the implantation of everolimus-eluting bioresorbable vascular scaffolds in patients with a total chronic occlusion of the coronary artery can
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Fig. 3. Optical coherence tomography imaging after implantation of BVS revealing the procedural success and excluding malapposition. 3D imaging of the proximal and mid LAD (A). Crosssection of the mid-LAD (B) and distal LAD (C).
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Table 4 Follow-up. Median follow-up (days, IRa) Total MACEb – Death – Myocardial infarction – TLRd TVFe TLFc a b c d e
108 (79.5–214.5) 4.3% (1/23) 0.0% (0/23) 0.0% (0/23) 4.3% (1/23) 4.3% (1/23) 4.3% (1/23)
Interquartile range. Major adverse cardiac event. Target lesion failure. Target lesion revascularization. Target vessel failure.
be performed in highly selected cases with reasonable procedural success and clinical short-term outcome. It will be necessary to obtain long-term data, however, and this study needs to be validated in a large-scale, randomized, multi-center trial.
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Conflict of interest Helge Möllmann, Christian Hamm, and Holger Nef received honoraria for lectures from Abbott Vascular. All other authors have no potential conflict of interest.
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