Letters to the Editor
513
Early results following everolimus-eluting bioresorbable vascular scaffold implantation for the treatment of in-stent restenosis Alfonso Ielasi a, Azeem Latib b,d, Toru Naganuma b,d, Bernardo Cortese c, Katsumasa Sato b,d, Tadashi Miyazaki b,d, Vasileios F. Panoulas b,d, Maurizio Tespili a, Antonio Colombo b,d,⁎ a
Cardiology Department, Bolognini Hospital, Seriate (BG), Italy Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy Catetherization Laboratory, Fatebenefratelli Hospital, Milan, Italy d San Raffaele Scientific Institute, Milan, Italy b c
a r t i c l e
i n f o
Article history: Received 19 January 2014 Accepted 9 March 2014 Available online 15 March 2014 Keywords: Percutaneous coronary intervention Bioresorbable vascular scaffold In-stent restenosis
We read with great interest the recent article by Grasso et al. [1] on the use of everolimus-eluting bioresorbable vascular scaffold (BVS) for the treatment of in-stent restenosis (ISR) and we would like to share our experience with the use of the ABSORB (BVS; Abbott Vascular, Santa Clara, California) for the treatment of this complex lesion subset. There are currently limited published data on the use of BVS in routine clinical practice [2,3] and very little is known on the performance of this device when it is used for the treatment of ISR (defined as a luminal diameter stenosis more than 50% within the stent or within 5 mm of the stent edges). On this basis, we sought to investigate the feasibility and the early clinical outcomes following BVS implantation for the treatment of patients with ISR lesions. A collaborative, retrospective cohort analysis was performed on all consecutive patients that underwent percutaneous coronary intervention (PCI) with BVS implantation for ISR between April 2012 and December 2013 in 3 Italian Centers. All the patients received dual anti-platelet therapy (DAT) with aspirin 100 mg daily and clopidogrel 75 mg daily at least 5 days before PCI. DAT was prescribed for at least 12 months after BVS implantation. This study fulfilled local ethical requirements and written informed consent was obtained from all patients before angiography and PCI. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. During the study period, a total of 232 patients (295 lesions) underwent BVS implantation. Among these, 25 (10.7%) were treated for 30 ISR lesions with BVS implantation. The target ISR lesion was in a bare-metal stent (BMS) in 16 (53.4%) while in a drug-eluting stent (DES) in 14 (46.6%) cases respectively. Baseline clinical, lesion, and procedural characteristics are shown in Table 1. The mean patient age was 68.3 ± 12.3 years and 20 (80%) patients were male. Type 2 diabetes mellitus was present in 6 (24%) patients while chronic kidney disease in 4 (16%). All the patients underwent PCI for stable coronary (20, 80%) or unstable (5, 20%) angina. According to the Mehran classification [4], the angiographic ISR pattern was defined as focal in 15 (50%) and diffuse in 15 (50%) lesions respectively. No occlusive ISR was treated with BVS implantation. More than half of the ISR lesions (16, 53.4%) were first restenosis, while 14 (46.6%) recurrent. Intracoronary imaging evaluation was ⁎ Corresponding author at: EMO-GVM Centro Cuore Columbus, 48 Via M. Buonarroti, 20145 Milan, Italy. Fax: + 39 0248193433. E-mail address: [email protected] (A. Colombo).
performed in 14 (46.6%) ISR lesions, of which 10 (71.4%) with intravascular ultrasound and 4 (28.6%) with optical coherence tomography. Pre-dilatation of the ISR lesion was performed in all the cases using non-compliant (NC) balloons (ratio 1:1 with the diameter of the restenotic stent) at high pressures while in 6 (20%) the Angiosculpt scoring balloon (AngioScore, Freemont, CA, USA) was used. The mean number of BVS implanted per lesion was 1.3 ± 0.6 while 1.6 ± 0.7 per patient. Mean BVS diameter per patient was 3.3 ± 0.3 mm, while 34.8 ± 18.4 mm was the BVS length per patient. Post-dilatation with NC balloons (with a maximum diameter of 0.5 mm higher than the BVS diameter) was performed after every BVS implantation. Procedural success (defined as BVS implantation at the ISR site with less than 30% angiographic residual stenosis and absence of inhospital major adverse events such as cardiac death, Q-wave myocardial infarction [MI] or need for emergent revascularization) was obtained for all the cases and no intra-procedural or acute BVS-instent thrombosis were reported as well as in-hospital BVS-related clinical events. At a median of 7 (IQR 1–13) month follow-up, 2 clinically-driven target lesion revascularizations (TLR: 8.0% per patient and 6.6% per lesion) were reported due to re-ISR at the BVSin-stent implantation site. One of these presented as a non-Q wave MI while both re-ISRs were successfully managed by re-PCI with drugeluting balloon (DEB) inflation. No cardiac death, Q-wave MI or BVSin-stent thrombosis occurred at follow-up (see Table 2). Table 1 Baseline clinical, lesion and procedural characteristics. Number of patients Age (years) mean ± SD Male, n (%) Ejection fraction, mean ± SD Diabetes mellitus, n (%) Chronic kidney disease (eGFR b 60 ml/min) Stable angina, n (%) Unstable angina, n (%) Target vessel LAD, n (%) LCx, n (%) RCA, n (%) Number of ISR lesions BMS-ISR, n (%) DES-ISR, n (%) “Recurrent” ISR, n (%) ISR restenosis pattern according to Mehran's classification Focal, n (%) Diffuse, n (%) Pre-dilatation, n (%) Scoring balloon pre-dilatation, n (%) Intracoronary imaging, n (%) Post-dilatation, n (%) BVS implanted per lesion (n°), mean ± SD BVS implanted per patient (n°), mean ± SD BVS diameter per patient (mm), mean ± SD BVS length per patient (mm), mean ± SD
25 68.3 ± 12.3 20 (80.0) 53.4 ± 9.3 6 (24.0) 4 (16.0) 20 (80.0) 5 (20.0) 17 (68.0) 4 (16.0) 4 (16.0) 30 16 (53.4) 14 (46.6) 14 (46.6) 15 (50.0) 15 (50.0) 30 (100) 6 (20.0) 14 (46.6) 30 (100) 1.3 ± 0.6 1.6 ± 0.7 3.3 ± 0.3 34.8 ± 18.4
Data are presented as percentages and absolute numbers or median ± standard deviation (SD). eGFR: estimated glomerular filtration rate; LAD: left anterior descending; LCx: left circumflex; RCA: right coronary artery; ISR: in-stent restenosis; BMS: bare-metal stent; DES: drug-eluting stent; and BVS: bioresorbable vascular scaffold.
514
Letters to the Editor
Table 2 In-hospital and early outcomes following BVS implantation for ISR. Number of patients
25
In-hospital events Peri-procedural MI, n (%) Death, n (%) Intraprocedural/acute “BVS-in-stent” thrombosis, n (%) Follow-up period (months), median (IQR)
1 (4.0) 0 0 7 (1–11)
Follow-up events Death, n (%) Cardiac death, n (%) MI, n (%) TVR, n (%) TLR per patient, n (%) TLR per lesion, n (%) ARC definite/probable “BVS-in-stent” thrombosis, n (%)
0 0 1 1 2 2 0
(4.0) (4.0) (8.0) (6.6)
MI: non ST-elevation myocardial infarction; IQR: interquartile range; BVS: bioresorbable vascular scaffold; ISR: in-stent restenosis; TVR: target vessel revascularization; TLR: target lesion revascularization; and ARC: Academic Research Consortium.
Initial experiences on the use of BVS for the treatment of complex coronary lesions (i.e. long calcified lesions, chronic total occlusions and bifurcation) are very limited [2,3,5]. In particular, the outcomes following BVS implantation in patients with ISR have yet to be reported. ISR after PCI has been historically considered one of the most challenging problems in the field of interventional cardiology [6]. The introduction of DES has significantly reduced the rates of ISR and TLR compared with BMS [7]. However, DES (even the newer generations) has not eradicated ISR [8,9], and the optimal treatment for DES-ISR is still not clearly defined. A variety of different treatment options (plain old balloon angioplasty, scoring balloons, DEB, new generation DES with more biocompatible or fully bioresorbable polymer or coronary artery bypass graft) are currently available for both BMS- and DES-ISR. In this context, the use of BVS appears very attractive because this device may avoid the limitations of the addition of a permanent http://dx.doi.org/10.1016/j.ijcard.2014.03.061 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
metallic stent-in-stent implantation. In particular, BVS enables transient vessel scaffolding and functions as a transient antirestenotic drug “carrier” [10]. These high biocompatible features may prevent the problems associated with the persistence of multiple metallic layers and polymers in the vessel wall and reduce the trigger of chronic inflammation that may lead to neointimal proliferation and delayed healing. The theoretical prevention of these phenomena may potentially be associated with a reduction in the risk of recurrent ISR and stent thrombosis at follow-up. Further larger studies with longer follow-up period and comparisons with DEB are required to fully assess the role for BVS in complex lesions such as ISR. References [1] Grasso C, Attizzani GF, Patane M, et al. First-in-human description of everolimuseluting bioabsorbable vascular scaffold implantation for the treatment of drugeluting stent failure: insights from optical coherence tomography. Int J Cardiol 2013;168:4490–1. [2] Latib A, Costopoulos C, Naganuma T, et al. Which patients could benefit the most from bioresorbable vascular scaffold implant: from clinical trials to clinical practice. Minerva Cardioangiol 2013;61:255–62. [3] Serruys PW, Onuma Y. Preliminary data from ABSORB EXTEND: a report of the 12-month clinical outcomes from the first 450 patients enrolled. Presented at: EuroPCR; May 23th 2013; Paris, France; 2013. [4] Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872–8. [5] Naganuma T, Basavarajaiah S, Latib A, et al. Use of BVS in a chronic total occlusion with bifurcation lesion. Int J Cardiol 2013;167:e129–31. [6] Dangas G, Fuster V. Management of restenosis after coronary intervention. Am Heart J 1996;132:428–36. [7] Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007;370:937–48. [8] Mauri L, Silbaugh TS, Wolf RE, et al. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation 2008;118:1817–27. [9] Sarno G, Lagerqvist B, Frobert O, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 2012;33:606–13. [10] Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009;373:897–910.
513
Early results following everolimus-eluting bioresorbable vascular scaffold implantation for the treatment of in-stent restenosis Alfonso Ielasi a, Azeem Latib b,d, Toru Naganuma b,d, Bernardo Cortese c, Katsumasa Sato b,d, Tadashi Miyazaki b,d, Vasileios F. Panoulas b,d, Maurizio Tespili a, Antonio Colombo b,d,⁎ a
Cardiology Department, Bolognini Hospital, Seriate (BG), Italy Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus, Milan, Italy Catetherization Laboratory, Fatebenefratelli Hospital, Milan, Italy d San Raffaele Scientific Institute, Milan, Italy b c
a r t i c l e
i n f o
Article history: Received 19 January 2014 Accepted 9 March 2014 Available online 15 March 2014 Keywords: Percutaneous coronary intervention Bioresorbable vascular scaffold In-stent restenosis
We read with great interest the recent article by Grasso et al. [1] on the use of everolimus-eluting bioresorbable vascular scaffold (BVS) for the treatment of in-stent restenosis (ISR) and we would like to share our experience with the use of the ABSORB (BVS; Abbott Vascular, Santa Clara, California) for the treatment of this complex lesion subset. There are currently limited published data on the use of BVS in routine clinical practice [2,3] and very little is known on the performance of this device when it is used for the treatment of ISR (defined as a luminal diameter stenosis more than 50% within the stent or within 5 mm of the stent edges). On this basis, we sought to investigate the feasibility and the early clinical outcomes following BVS implantation for the treatment of patients with ISR lesions. A collaborative, retrospective cohort analysis was performed on all consecutive patients that underwent percutaneous coronary intervention (PCI) with BVS implantation for ISR between April 2012 and December 2013 in 3 Italian Centers. All the patients received dual anti-platelet therapy (DAT) with aspirin 100 mg daily and clopidogrel 75 mg daily at least 5 days before PCI. DAT was prescribed for at least 12 months after BVS implantation. This study fulfilled local ethical requirements and written informed consent was obtained from all patients before angiography and PCI. The authors of this manuscript have certified that they comply with the Principles of Ethical Publishing in the International Journal of Cardiology. During the study period, a total of 232 patients (295 lesions) underwent BVS implantation. Among these, 25 (10.7%) were treated for 30 ISR lesions with BVS implantation. The target ISR lesion was in a bare-metal stent (BMS) in 16 (53.4%) while in a drug-eluting stent (DES) in 14 (46.6%) cases respectively. Baseline clinical, lesion, and procedural characteristics are shown in Table 1. The mean patient age was 68.3 ± 12.3 years and 20 (80%) patients were male. Type 2 diabetes mellitus was present in 6 (24%) patients while chronic kidney disease in 4 (16%). All the patients underwent PCI for stable coronary (20, 80%) or unstable (5, 20%) angina. According to the Mehran classification [4], the angiographic ISR pattern was defined as focal in 15 (50%) and diffuse in 15 (50%) lesions respectively. No occlusive ISR was treated with BVS implantation. More than half of the ISR lesions (16, 53.4%) were first restenosis, while 14 (46.6%) recurrent. Intracoronary imaging evaluation was ⁎ Corresponding author at: EMO-GVM Centro Cuore Columbus, 48 Via M. Buonarroti, 20145 Milan, Italy. Fax: + 39 0248193433. E-mail address: [email protected] (A. Colombo).
performed in 14 (46.6%) ISR lesions, of which 10 (71.4%) with intravascular ultrasound and 4 (28.6%) with optical coherence tomography. Pre-dilatation of the ISR lesion was performed in all the cases using non-compliant (NC) balloons (ratio 1:1 with the diameter of the restenotic stent) at high pressures while in 6 (20%) the Angiosculpt scoring balloon (AngioScore, Freemont, CA, USA) was used. The mean number of BVS implanted per lesion was 1.3 ± 0.6 while 1.6 ± 0.7 per patient. Mean BVS diameter per patient was 3.3 ± 0.3 mm, while 34.8 ± 18.4 mm was the BVS length per patient. Post-dilatation with NC balloons (with a maximum diameter of 0.5 mm higher than the BVS diameter) was performed after every BVS implantation. Procedural success (defined as BVS implantation at the ISR site with less than 30% angiographic residual stenosis and absence of inhospital major adverse events such as cardiac death, Q-wave myocardial infarction [MI] or need for emergent revascularization) was obtained for all the cases and no intra-procedural or acute BVS-instent thrombosis were reported as well as in-hospital BVS-related clinical events. At a median of 7 (IQR 1–13) month follow-up, 2 clinically-driven target lesion revascularizations (TLR: 8.0% per patient and 6.6% per lesion) were reported due to re-ISR at the BVSin-stent implantation site. One of these presented as a non-Q wave MI while both re-ISRs were successfully managed by re-PCI with drugeluting balloon (DEB) inflation. No cardiac death, Q-wave MI or BVSin-stent thrombosis occurred at follow-up (see Table 2). Table 1 Baseline clinical, lesion and procedural characteristics. Number of patients Age (years) mean ± SD Male, n (%) Ejection fraction, mean ± SD Diabetes mellitus, n (%) Chronic kidney disease (eGFR b 60 ml/min) Stable angina, n (%) Unstable angina, n (%) Target vessel LAD, n (%) LCx, n (%) RCA, n (%) Number of ISR lesions BMS-ISR, n (%) DES-ISR, n (%) “Recurrent” ISR, n (%) ISR restenosis pattern according to Mehran's classification Focal, n (%) Diffuse, n (%) Pre-dilatation, n (%) Scoring balloon pre-dilatation, n (%) Intracoronary imaging, n (%) Post-dilatation, n (%) BVS implanted per lesion (n°), mean ± SD BVS implanted per patient (n°), mean ± SD BVS diameter per patient (mm), mean ± SD BVS length per patient (mm), mean ± SD
25 68.3 ± 12.3 20 (80.0) 53.4 ± 9.3 6 (24.0) 4 (16.0) 20 (80.0) 5 (20.0) 17 (68.0) 4 (16.0) 4 (16.0) 30 16 (53.4) 14 (46.6) 14 (46.6) 15 (50.0) 15 (50.0) 30 (100) 6 (20.0) 14 (46.6) 30 (100) 1.3 ± 0.6 1.6 ± 0.7 3.3 ± 0.3 34.8 ± 18.4
Data are presented as percentages and absolute numbers or median ± standard deviation (SD). eGFR: estimated glomerular filtration rate; LAD: left anterior descending; LCx: left circumflex; RCA: right coronary artery; ISR: in-stent restenosis; BMS: bare-metal stent; DES: drug-eluting stent; and BVS: bioresorbable vascular scaffold.
514
Letters to the Editor
Table 2 In-hospital and early outcomes following BVS implantation for ISR. Number of patients
25
In-hospital events Peri-procedural MI, n (%) Death, n (%) Intraprocedural/acute “BVS-in-stent” thrombosis, n (%) Follow-up period (months), median (IQR)
1 (4.0) 0 0 7 (1–11)
Follow-up events Death, n (%) Cardiac death, n (%) MI, n (%) TVR, n (%) TLR per patient, n (%) TLR per lesion, n (%) ARC definite/probable “BVS-in-stent” thrombosis, n (%)
0 0 1 1 2 2 0
(4.0) (4.0) (8.0) (6.6)
MI: non ST-elevation myocardial infarction; IQR: interquartile range; BVS: bioresorbable vascular scaffold; ISR: in-stent restenosis; TVR: target vessel revascularization; TLR: target lesion revascularization; and ARC: Academic Research Consortium.
Initial experiences on the use of BVS for the treatment of complex coronary lesions (i.e. long calcified lesions, chronic total occlusions and bifurcation) are very limited [2,3,5]. In particular, the outcomes following BVS implantation in patients with ISR have yet to be reported. ISR after PCI has been historically considered one of the most challenging problems in the field of interventional cardiology [6]. The introduction of DES has significantly reduced the rates of ISR and TLR compared with BMS [7]. However, DES (even the newer generations) has not eradicated ISR [8,9], and the optimal treatment for DES-ISR is still not clearly defined. A variety of different treatment options (plain old balloon angioplasty, scoring balloons, DEB, new generation DES with more biocompatible or fully bioresorbable polymer or coronary artery bypass graft) are currently available for both BMS- and DES-ISR. In this context, the use of BVS appears very attractive because this device may avoid the limitations of the addition of a permanent http://dx.doi.org/10.1016/j.ijcard.2014.03.061 0167-5273/© 2014 Elsevier Ireland Ltd. All rights reserved.
metallic stent-in-stent implantation. In particular, BVS enables transient vessel scaffolding and functions as a transient antirestenotic drug “carrier” [10]. These high biocompatible features may prevent the problems associated with the persistence of multiple metallic layers and polymers in the vessel wall and reduce the trigger of chronic inflammation that may lead to neointimal proliferation and delayed healing. The theoretical prevention of these phenomena may potentially be associated with a reduction in the risk of recurrent ISR and stent thrombosis at follow-up. Further larger studies with longer follow-up period and comparisons with DEB are required to fully assess the role for BVS in complex lesions such as ISR. References [1] Grasso C, Attizzani GF, Patane M, et al. First-in-human description of everolimuseluting bioabsorbable vascular scaffold implantation for the treatment of drugeluting stent failure: insights from optical coherence tomography. Int J Cardiol 2013;168:4490–1. [2] Latib A, Costopoulos C, Naganuma T, et al. Which patients could benefit the most from bioresorbable vascular scaffold implant: from clinical trials to clinical practice. Minerva Cardioangiol 2013;61:255–62. [3] Serruys PW, Onuma Y. Preliminary data from ABSORB EXTEND: a report of the 12-month clinical outcomes from the first 450 patients enrolled. Presented at: EuroPCR; May 23th 2013; Paris, France; 2013. [4] Mehran R, Dangas G, Abizaid AS, et al. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation 1999;100:1872–8. [5] Naganuma T, Basavarajaiah S, Latib A, et al. Use of BVS in a chronic total occlusion with bifurcation lesion. Int J Cardiol 2013;167:e129–31. [6] Dangas G, Fuster V. Management of restenosis after coronary intervention. Am Heart J 1996;132:428–36. [7] Stettler C, Wandel S, Allemann S, et al. Outcomes associated with drug-eluting and bare-metal stents: a collaborative network meta-analysis. Lancet 2007;370:937–48. [8] Mauri L, Silbaugh TS, Wolf RE, et al. Long-term clinical outcomes after drug-eluting and bare-metal stenting in Massachusetts. Circulation 2008;118:1817–27. [9] Sarno G, Lagerqvist B, Frobert O, et al. Lower risk of stent thrombosis and restenosis with unrestricted use of ‘new-generation’ drug-eluting stents: a report from the nationwide Swedish Coronary Angiography and Angioplasty Registry (SCAAR). Eur Heart J 2012;33:606–13. [10] Serruys PW, Ormiston JA, Onuma Y, et al. A bioabsorbable everolimus-eluting coronary stent system (ABSORB): 2-year outcomes and results from multiple imaging methods. Lancet 2009;373:897–910.
