Sirolimus-Eluting Stents for Treatment of In-Stent Restenosis

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1 Clinical Investigation Alfonso Medina, MD José Suárez de Lezo, MD Manuel Pan, MD Antonio Delgado, MD José Segura, MD Djordje Pavlovic, MD Francisco Melián, MD Miguel Romero, MD Federico Segura, MD Enrique Hernández, MD Isabel Ureña, MD Juan Herrador, MD Key words: Coronary restenosis/drug therapy/ pathology/prevention & control; delayed-action preparations; drug implants/adverse effects; graft occlusion, vascular/prevention & control; human; recurrence/ prevention & control; sirolimus/therapeutic use; stents; ultrasonography, intravascular From: Department of Cardiology (Drs. Delgado, Hernández, Medina, Melián, and F. Segura), University Hospital Dr Negrin, Las Palmas; and Department of Cardiology (Drs. Herrador, Pan, Pavlovic, Romero, J. Segura, Suárez de Lezo, and Ureña), University Hospital Reina Sofía, Córdoba; Spain Address for reprints: Dr. José Suárez de Lezo, Department of Cardiology, University Hospital Reina Sofía, Avda. Menéndez Pidal 1, Córdoba, Spain by the Texas Heart Institute, Houston Sirolimus-Eluting Stents for Treatment of In-Stent Restenosis Immediate and Late Results We analyzed the clinical, angiographic, and late intravascular ultrasonographic findings from 140 patients whose in-stent restenosis was treated with sirolimus-eluting stents. In-stent restenosis remains the main limitation to percutaneous coronary revascularization and has a high recurrence rate after bare stent implantation. From May 2002 through July 2003, we studied 140 patients with clinical restenosis after bare-stent treatment. In 107 patients, in-stent restenosis occurred de novo; in 28 patients, this was the 2nd restenosis; and in another 5, it was the 3rd occurrence. A sirolimus-eluting stent was implanted directly after angiographic evaluation of the instent restenosis in 79 patients and after pre-dilation in 61 patients. All patients were given the following antithrombotic regimen: low-molecular-weight heparin, ticlopidine, and aspirin for 1 month, followed by clopidogrel and aspirin for 1 year. Primary success was achieved in 137 patients. Three patients had a non-q wave myocardial infarction. At the 1-month evaluation, 2 patients had died: 1 due to subacute stent thrombosis and another due to acute mesenteric ischemia. After a mean followup of 16 ± 4 months, the major adverse cardiac events were acute myocardial infarction due to late stent thrombosis in 2 patients and the need for target lesion revascularization in 15 patients. Late angiographic evaluation was performed in 97 patients (69%), 16 of whom had new restenosis: 14 of the restenoses were intrastent, and 2 were at the edges of the stent. Our results suggest that sirolimus-eluting stents are effective in the prevention of instent restenosis and, therefore, may become the leading treatment alternative for patients with in-stent restenosis. (Tex Heart Inst J 2005;32:11-5) In-stent restenosis (ISR) is the main limitation to percutaneous coronary revascularization. The incidence of ISR is high after bare-stent implantation. 1 The use of drug-eluting stents to control neointimal proliferation could substantially modify outcome. Initial experiences in small cohorts of patients have shown excellent results. 2-4 We performed this study to prospectively analyze the clinical, angiographic, and late intravascular ultrasonographic (IVUS) findings in a large series of consecutive patients who presented with in-stent restenosis after bare-stent treatment and were then treated with sirolimus-eluting stents (SESs). Patients and Methods We studied 140 patients who presented at our institutions with clinical occurrence of restenosis after bare-stent treatment from May 2002 through July The mean age was 65 ± 9 years. Ninety-nine patients were men (71%). In 107 patients (76%), this was the 1st occurrence of in-stent restenosis; in 28 (20%), this was the 2nd occurrence; and in another 5 (4%), it was the 3rd occurrence. As a result, 33 patients had more than 1 in-stent stent within the lesion. The use of drug-eluting stents has been approved at our institutions and is regulated by the institutional and ethics committees. All patients signed informed consent forms. Table I summarizes the baseline clinical and angiographic data in 140 patients. After angiographic assessment of the ISR, the Cypher sirolimus-eluting coronary stent (Cordis Corporation, a Johnson & Johnson company; Miami Lakes, Fla) was implanted directly in 79 patients and after pre-dilation in 61. The ISR was always completely covered, and the SES length always exceeded the length of the previous- Texas Heart Institute Journal Sirolimus-Eluting Stent for In-Stent Restenosis 11

2 ly implanted stent or stents; 39 patients needed more than 1 overlapping SES for this purpose. Table II presents the main procedural data. All patients were given the following antithrombotic regimen: low-molecularweight heparin, ticlopidine, and aspirin for 1 month, followed by clopidogrel and aspirin for 1 year. After the procedure, patients were monitored closely by telephone interviews, and a 6-month evaluation and TABLE I. Clinical and Angiographic Data (n=140) Age (years) 65 ± 9 Sex (female) 41 (29%) Diabetes mellitus 71 (51%) Previous MI 53 (38%) Presentation Stable Angina 30 (21%) Unstable Angina 101 (72%) Non-Q wave MI 9 (6%) Recurrence time (months) 5 ± 5 Ejection fraction 0.57 ± 0.10 Multivessel disease 52 (37%) Type of restenosis Focal 49 (35%) Diffuse 50 (36%) Proliferative 30 (21%) Totally occluded 11 (8%) Minimal lumen diameter (mm) 0.6 ± 0.4 Mean lesion length (mm) 22 ± 12 Reference diameter (mm) 2.9 ± 0.4 Restenosis location LAD 64 (46%) Right coronary artery 44 (31%) Circumflex artery 19 (14%) Left main 4 (3%) Saphenous vein graft 9 (6%) LAD = left anterior descending coronary artery; MI = myocardial infarction TABLE II. Procedural Data Deployment pressure (mmhg) 14.3 ± 1.4 Final SES diameter (mm) 2.8 ± 0.4 Implanted SES length (mm) 29.3 ± 14 Number of stents per ISR 1.3 ± 0.5 Adjunctive IIb/IIIa therapy 21 (15%) ISR = in-stent restenosis; SES = sirolimus-eluting stent cardiac catheterization were scheduled and were to occur sooner if symptoms developed. At follow-up, IVUS analysis of the treated segment was performed in 40 of the 97 patients who were re-evaluated by angiography. Results Primary success was achieved in 137 patients (98%). Three patients (2%) had a non-q wave myocardial infarction. No other major in-hospital complications occurred. Two patients died within 1 month after treatment: 1 due to subacute stent thrombosis and another due to acute mesenteric ischemia. After a mean follow-up of 16 ± 4 months, the following major adverse cardiac events were recorded: 2 patients (1.4%) developed acute myocardial infarction due to late stent thrombosis (3 and 5 months after treatment), and 15 (11%) required target lesion revascularization. Late angiographic evaluation was performed in 97 patients (69%), 16 of whom had new restenosis: 14 of the restenoses were intrastent and 2 were at the edges of the stents. These new restenoses were all focal (length 4 ± 3 mm) and were treated with a short (8- mm) SES. Table III shows the quantitative serial angiographic data and the late IVUS findings. Figure 1 shows angiographic and late IVUS results in a patient with a successful late outcome. Figure 2 shows the angiographic and late IVUS findings in a patient who underwent full reconstruction of a totally occluded ISR in the right coronary artery with an SES and then developed focal in-stent restenosis. Figure 3 shows serial IVUS findings in a patient who developed initial ISR after bare-stent implantation and had a successful late outcome after SES implantation. Discussion Drug-eluting stents have been shown to inhibit neointimal proliferation after placement for the treatment of different types of coronary lesions. 5-8 However, information on the efficacy of SESs for patients who develop ISR is limited. Our findings confirm the efficacy of SESs for the treatment of ISR. In this consecutive series of patients, there was a high percentage of complex in-stent restenoses, including recurrent ISR, totally occluded arteries, and restenoses of a considerable lesion length (22 ± 12 mm), most of them of the proliferative or diffuse type. In addition, more than 50% of our patients had diabetes mellitus, a factor known for promoting restenosis after stenting. Furthermore, patients with ISR who undergo treatment with a new in-stent stent are at higher risk for recurent restenosis. 1 The repeated mechanical injury seems to lead to an increased proliferative response. However, implantation of an SES in cases of ISR ap- 12 Sirolimus-Eluting Stent for In-Stent Restenosis Volume 32, Number 1, 2005

3 TABLE III. Serial Angiographic and Late IVUS Results these encouraging late angiographic findings may be mitigated by the fact that only 69% of our patients had a follow-up angiographic evaluation. During the procedure, the previously stented segment was fully covered by the SES. In addition, direct stenting was performed in a high proportion of pa- Post- Baseline Procedure Follow-Up QCA (n=97) In-SES restenosis 16/97 (16%) Target lesion revascularization 15/140 (11%) In-SES total occlusion 3/140 (2.1%) Subacute 1/140 (0.7%) Late 2/140 (1.4%) Minimal luminal diameter (mm) 0.6 ± ± ± 0.8 Percent stenosis 79 ± ± ± 26 Late loss (mm) 0.48 ± 0.7 IVUS (at stented level) (n=40) Minimal stent diameter (mm) 2.64 ± 0.51 Neointimal thickening (mm) 0.21 ± 0.22 EEL area (mm 2 ) 17.5 ± 5.6 Stent area (mm 2 ) Minimal 5.76 ± 2.30 Maximal 7.80 ± 2.62 Lumen area (mm 2 ) Minimal 4.57 ± 1.80 Maximal 6.94 ± 2.46 Neointimal area (mm 2 ) Minimal 1.30 ± 1.54 Maximal 0.98 ± 0.62 EEL = external elastic laminae; IVUS = intravascular ultrasonography; QCA = quantitative coronary angiography; SES = sirolimuseluting stent Fig. 1 Serial angiographic images in a patient with intrastent restenosis of the proximal left anterior descending coronary artery, before (basal) and after (post) treatment with a sirolimus-eluting stent. In the image obtained after 6 months, the arrow shows the site of the intravascular ultrasonographic study (right), which in turn shows the struts of 2 overlapped stents and an absence of neointimal proliferation. pears to overcome this aggressive proliferation in most patients. The worst response focal restenosis in an SES, which occurred in 16 of our patients was considerably less aggressive than was the original response that caused the initial ISR (Fig. 2). Thus, SESs also seem to minimize reactive proliferation. Nonetheless, Texas Heart Institute Journal Sirolimus-Eluting Stent for In-Stent Restenosis 13

4 Fig. 2 Serial angiograms in a patient with restenosis that caused total occlusion of the right coronary artery, subsequently treated with a sirolimus-eluting stent. In the follow-up angiogram, there is focal restenosis below the number 2. Numbers 1 4 correspond to the sites of intravascular ultrasonographic exploration (at right). In the 2nd ultrasonographic image, both concentric stents and neointimal tissue are shown. Fig. 3 Serial intravascular ultrasonographic images in a patient treated with a conventional baremetal stent in the proximal right coronary artery (1). At follow-up (2), in-stent restenosis can be observed, and another image is obtained after the deployment of a new SES (3). At the 6-month evaluation, images A, B, and C, obtained at 3 levels of the treated arterial segment, show concentric strut echoes and no intimal hyperplasia. RCA = right coronary artery 14 Sirolimus-Eluting Stent for In-Stent Restenosis Volume 32, Number 1, 2005

5 tients, which seemed to have no influence on the effectiveness of the sirolimus. As for potential complications, our series showed an incidence of 0.7% for subacute thrombosis and 1.4% for late thrombosis. Thrombosis can arise after antiproliferative strategies, as a result of the direct exposure of bare metal struts to the blood stream. 9 However, this proportion is small in comparison with the incidence after brachytherapy 10 and could remain low with long-term antithrombotic therapy (clopidogrel and aspirin in combination). Conclusion Our findings suggest that sirolimus-eluting stents may become the leading alternative for treating patients with in-stent restenosis. Although new restenosis may develop in sirolimus-eluting stents after implantation (16% in our study), its extent is always focal and is substantially less aggressive than is the original proliferative response. Nonetheless, subacute or late thrombosis can develop in a small proportion of patients. References 1. Bennett MR. In-stent stenosis: pathology and implications for the development of drug eluting stents. Heart 2003;89: Sousa JE, Costa MA, Abizaid A, Sousa AG, Feres F, Mattos LA, et al. Sirolimus-eluting stent for the treatment of instent restenosis: a quantitative coronary angiography and three-dimensional intravascular ultrasound study. Circulation 2003;107(1): Degertekin M, Regar E, Tanabe K, Smits PC, van der Giessen WJ, Carlier SJ, et al. Sirolimus-eluting stent for treatment of complex in-stent restenosis: the first clinical experience. J Am Coll Cardiol 2003;41: Tanabe K, Serruys PW, Grube E, Smits PC, Selbach G, van der Giessen WJ, et al. TAXUS III Trial: in-stent restenosis treated with stent-based delivery of paclitaxel incorporated in a slow-release polymer formulation. Circulation 2003; 107: Degertekin M, Serruys PW, Foley DP, Tanabe K, Regar E, Vos J, et al. Persistent inhibition of neointimal hyperplasia after sirolimus-eluting stent implantation: long-term (up to 2 years) clinical, angiographic, and intravascular ultrasound follow-up. Circulation 2002;106: Hong MK, Mintz GS, Lee CW, Song JM, Han KH, Kang DH, et al. Paclitaxel coating reduces in-stent intimal hyperplasia in human coronary arteries: a serial volumetric intravascular ultrasound analysis from the Asian Paclitaxel- Eluting Stent Clinical Trial (ASPECT). Circulation 2003; 107: Sousa JE, Costa MA, Sousa AG, Abizaid AC, Seixas AC, Abizaid AS, et al. Two-year angiographic and intravascular ultrasound follow-up after implantation of sirolimus-eluting stents in human coronary arteries. Circulation 2003;107: Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, et al. A randomized comparison of a sirolimuseluting stent with a standard stent for coronary revascularization. N Engl J Med 2002;346: Limpijankit T, Mehran R, Mintz GS, Dangas G, Lansky AJ, Kao J, et al. Long-term follow-up of patients after gamma intracoronary brachytherapy failure (from GAMMA-I, GAMMA-II, and SCRIPPS-III). Am J Cardiol 2003;92: Costa MA, Sabate M, van der Giessen WJ, Kay IP, Cervinka P, Ligthart JM, et al. Late coronary occlusion after intracoronary brachytherapy. Circulation 1999;100: Texas Heart Institute Journal Sirolimus-Eluting Stent for In-Stent Restenosis 15

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