Chronic stable angina revascularization drug eluting stents
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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-In-Chief: Lakshmi Gopalakrishnan, M.B.B.S.
Overview
The hierarchical Bayesian meta-analysis (2004) demonstrated a significant reduction in the rate of angiographic restenosis and major adverse cardiac events observed with the drug-eluting stent (sirolimus or paclitaxel) in comparison to the bare-metal stents; however, there was no evidence that they affect mortality or myocardial infarction rates.[1] A recent update on drug-eluting stents (2008), reported similar success rates and side effects associated with both the Cypher (sirolimus eluting) and the TAXUS (paclitaxel eluting) stents; hence, suggested a similar benefit may be replicated in routine clinical practice.[2] The prevention of neointimal hyperplasia is no longer the ultimate goal and has been replaced by the development of more biocompatible and bioabsorbable stents that facilitate adequate endothelialization.[3]
Paclitaxel-Eluting Stent Studies
The clinical outcome with the use of paclitaxel depends on whether it is a polymer-based or not.[4] Based on the results of the DELIVER-I study, paclitaxel without a polymer carrier did not demonstrate a positive clinical outcome despite an improvement noted in the angiographic parameters. However, on the contrary a polymer-based paclitaxel significantly improved clinical outcomes demonstrated by the TAXUS-IV and TAXUS-VI trials.
- The DELIVER trial (2004) demonstrated a significant reduction only in the angiographic late lumen loss (0.81 versus 0.98; p=0.003) at follow-up with non-polymer-based paclitaxel-coated stent compared to bare metal stent respectively among 1043 patients with focal denovo coronary lesions. Thus, the study concluded paclitaxel-coated stent decreased the neointimal proliferation compared with the bare-metal stent; however, this reduction was insufficient to meet the prespecified primary end-point of target-vessel failure (11.9% in the polymer-coated stent group versus 14.5% in the bare metal stent group; p=0.12) and the secondary end point of binary restenosis (14.9% in the polymer-coated stent group versus 20.6% in the bare metal stent group; p=0.076).[5]
- In the TAXUS-IV trial (2004), 1314 patients who were receiving a stent in a single, previously untreated coronary artery stenosis with a mean vessel diameter of 2.75 mm and a mean lesion length of 13.4 mm at baseline, were randomized to receive either a bare-metal stent (n=652) or a slow-release polymer-based, paclitaxel-eluting stent (n=662), to assess the incidence of neointimal hyperplasia and restenosis with paclitaxel. At 9-month follow-up, a significant reduction in the rate of ischemia-driven target-vessel (12% in the BMS group versus 4.7% in the TAXUS group; relative risk 0.39; 95% CI, 0.26 to 0.59; p=less than 0.001), target-lesion revascularization (11.3% in the BMS group versus 3% in the TAXUS group; relative risk 0.27; 95% CI, 0.16 to 0.43; p=less than 0.001) and the rate of angiographic restenosis (26.6% in the BMS group versus 7.9% in the TAXUS group; relative risk 0.30; 95% CI, 0.19 to 0.46; p=less than 0.001) was observed in the TAXUS group. However, the rate of all cause of mortality including MI (4.7% in the BMS goup and 4.3% in the TAXUS group; p=NS) and stent thrombosis (0.6% in the BMS goup and 0.8% in the TAXUS group; p=NS) during a 9-month follow-up did not differ between the two groups. Thus, the study concluded in comparison with bare-metal stents, the slow-release, polymer-based, paclitaxel-eluting stent is safe and markedly reduced the rates of clinical and angiographic restenosis at nine months.[6]
- In the TAXUS-VI trial (2005), 448 patients with long, complex coronary artery lesions were randomized to receive either a drug-eluting TAXUS Express-2 stent or an uncoated Express-2 control stent, to assess the efficacy of paclitaxel-eluting stent in the treatment of complex coronary stenoses with a mean lesion length of 20.6mm at baseline. At 9-month follow-up, a significant 53% reduction of target-vessel revascularization (9.1% in the TAXUS group and 19.4% in the control group; p=0.0027) and a significant reduction from 32.9% in the control group to 9.1% in the TAXUS for the binary restenosis at the stented area was observed in the TAXUS group (p=less than 0.0001). However, the incidence of major adverse cardiac events at 9-month follow-up, was similar among both the groups: 16.4% in TAXUS and 22.5% in the control group (p=NS). Thus, the study concluded that the TAXUS Moderate Release stent system is safe and effective in the treatment of long, complex coronary artery lesions; hence, providing the evidence base for more widespread use of drug-eluting stents in contemporary clinical practice.[7]
- Clinical follow-up at 2 years (2007) post-stenting was available in 98.6% of the TAXUS group and 95.6% of the control group. The incidence of major adverse cardiac event at one- and two-year follow-up was 16.4% and 21.3% in the TAXUS group when compared with 22.5 and 25.1% in the control group, respectively. A significant difference in the target-vessel revascularization was maintained at two-year follow-up (TAXUS 13.9%; control 21.9%; P=0.0335). There was also a significant reduction in the cumulative one- and two-year survival rates free from target-vessel revascularization (91.7 and 90.3% in the TAXUS group versus 80.0 and 79.0% in the control group; p=less than 0.001).[8]
- At 5-year follow-up (2009), the overall rate of major adverse cardiac events was found to be similar among both the groups (27.8% in control and 31.3% in TAXUS; p=0.61), including similar rates for stent thrombosis, target-vessel revascularization (23.7% in control and 22.2% in TAXUS; P=0.45). Thus, the study concluded since the TAXUS MR stent demonstrated similar rates of target-vessel revascularization, incidence of major cardiac event and reduced the rate of target-lesion revascularization in comparison to the control through five years, it is may be beneficial to use paclitaxel-eluting TAXUS moderate-release for long, complex coronary artery lesions. However, the cause for the increased rate of non-target lesion revascularization (5.1% in control and 10.9% in TAXUS; p=0.0274) associated with TAXUS remains unclear.[9]
Sirolimus-Eluting Stent Studies
In contrary to the paclitaxel-eluting stent studies, the trials that assessed the effect of sirolimus have tested only the polymer-based sirolimus-eluting stent.
- In the SIRIUS study (2003), 1058 patients with complex coronary artery disease due to the presence of diabetes, mean lesion length of 14.4 mm and a mean vessel diameter of 2.80 mm at baseline, were randomized to receive either a sirolimus-eluting stent or a standard stent to evaluate the effect of sirolimus in the reduction of restenosis after PCI. At 9-month follow-up, a significant reduction in the frequency of neointimal hyperplasia within the stent was observed with the sirolimus-eluting stents, as assessed by both angiography and intravascular ultrasonography. Subgroup analyses revealed a significant reduction in the rates of angiographic restenosis and target-lesion revascularization in all subgroups examined. Thus, the study concluded that sirolimus-eluting stent provided beneficial results in patients with complex coronary lesions and also significantly reduced the rate of neointimal proliferation, restenosis and associated clinical events.[10][11]
- In the SIRIUS trial, 459 with an LAD stenosis and a mean length of 14.0mm at baseline, were randomized to percutaneous intervention with either sirolimus-eluting stent or bare-metal stents, to evaluate the benefit of drug-eluting stent secondary to the reduction of restenosis rate in the management of LAD stenosis. The study reported a significant reduction in the rate of binary in-stent restenosis in the SES group (2% in the SES group versus 41.6% in the BMS group; RR 0.05; p=less than 0.001). A significant 59% reduction in the one-year major adverse events including death, MI or target vessel revascularization was noted in the SMS group (9.8% SMS group versus 24.9% BMS; RR 0.39; p=less than 0.001). Thus, the study concluded for LAD stenosis, the revascularization rate with sirolimus-eluting stent was similar to that of the single vessel bypass surgery at one-year.[12]
- Both the RESEARCH registry and the Swiss registry demonstrated significant benefit with the use of sirolimus in routine clinical practice. The RESEARCH registry (2004) reported a significant reduction in the rate of target-vessel revascularization for sirolimus group (3.7% in the sirolimus versus 10.9% in the BMS; p=less than 0.001).[13] The Swiss registry (2004) also demonstrated a 95.6% significant event-free survival noted in the sirolimus group as observed during a 6-9 month follow-up.[14]
- The Cypher stent registry (2004), demonstrated similar benefits such as survival-free of major adverse cardiac event (96.4% in the SES group versus 82.8% in the BMS group; p=less than 0.05) and significant reduction in the rate of restenosis observed with the use of sirolimus-eluting stent for the treatment chronic total coronary obstruction.[15]
References
- ↑ Babapulle MN, Joseph L, Bélisle P, Brophy JM, Eisenberg MJ (2004) A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents. Lancet 364 (9434):583-91. DOI:10.1016/S0140-6736(04)16850-5 PMID: 15313358
- ↑ Galløe AM, Thuesen L, Kelbaek H, Thayssen P, Rasmussen K, Hansen PR et al. (2008) Comparison of paclitaxel- and sirolimus-eluting stents in everyday clinical practice: the SORT OUT II randomized trial. JAMA 299 (4):409-16. DOI:10.1001/jama.299.4.409 PMID: 18230778
- ↑ Daemen J, Serruys PW (2007) Drug-eluting stent update 2007: part I. A survey of current and future generation drug-eluting stents: meaningful advances or more of the same? Circulation 116 (3):316-28. DOI:10.1161/CIRCULATIONAHA.106.621342 PMID: 17638940
- ↑ Silber S (2003) Paclitaxel-eluting stents: are they all equal? An analysis of six randomized controlled trials in de novo lesions of 3,319 patients. J Interv Cardiol 16 (6):485-90. PMID: 14632945
- ↑ Lansky AJ, Costa RA, Mintz GS, Tsuchiya Y, Midei M, Cox DA et al. (2004) Non-polymer-based paclitaxel-coated coronary stents for the treatment of patients with de novo coronary lesions: angiographic follow-up of the DELIVER clinical trial. Circulation 109 (16):1948-54. DOI:10.1161/01.CIR.0000127129.94129.6F PMID: 15078794
- ↑ Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT et al. (2004) A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med 350 (3):221-31. DOI:10.1056/NEJMoa032441 PMID: 14724301
- ↑ Dawkins KD, Grube E, Guagliumi G, Banning AP, Zmudka K, Colombo A et al. (2005) Clinical efficacy of polymer-based paclitaxel-eluting stents in the treatment of complex, long coronary artery lesions from a multicenter, randomized trial: support for the use of drug-eluting stents in contemporary clinical practice. Circulation 112 (21):3306-13. DOI:10.1161/CIRCULATIONAHA.105.552190 PMID: 16286586
- ↑ Grube E, Dawkins KD, Guagliumi G, Banning AP, Zmudka K, Colombo A et al. (2007) TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions. Eur Heart J 28 (21):2578-82. DOI:10.1093/eurheartj/ehm424 PMID: 17938126
- ↑ Grube E, Dawkins K, Guagliumi G, Banning A, Zmudka K, Colombo A et al. (2009) TAXUS VI final 5-year results: a multicentre, randomised trial comparing polymer-based moderate-release paclitaxel-eluting stent with a bare metal stent for treatment of long, complex coronary artery lesions. EuroIntervention 4 (5):572-7. PMID: 19378676
- ↑ Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C et al. (2003) Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med 349 (14):1315-23. DOI:10.1056/NEJMoa035071 PMID: 14523139
- ↑ Teirstein PS (2001) Living the dream of no restenosis. Circulation 104 (17):1996-8. PMID: 11673334
- ↑ Sawhney N, Moses JW, Leon MB, Kuntz RE, Popma JJ, Bachinsky W et al. (2004) Treatment of left anterior descending coronary artery disease with sirolimus-eluting stents. Circulation 110 (4):374-9. DOI:10.1161/01.CIR.0000136580.34604.B8 PMID: 15249503
- ↑ Lemos PA, Serruys PW, van Domburg RT, Saia F, Arampatzis CA, Hoye A et al. (2004) Unrestricted utilization of sirolimus-eluting stents compared with conventional bare stent implantation in the "real world": the Rapamycin-Eluting Stent Evaluated At Rotterdam Cardiology Hospital (RESEARCH) registry. Circulation 109 (2):190-5. DOI:10.1161/01.CIR.0000109138.84579.FA PMID: 14691037
- ↑ Goy JJ, Urban P, Seydoux C, De Benedetti E, Stauffer JC (2004) Use of sirolimus-eluting coronary stents in routine clinical practice. Catheter Cardiovasc Interv 62 (1):26-9; discussion 62. DOI:10.1002/ccd.10744 PMID: 15103595
- ↑ Hoye A, Tanabe K, Lemos PA, Aoki J, Saia F, Arampatzis C et al. (2004) Significant reduction in restenosis after the use of sirolimus-eluting stents in the treatment of chronic total occlusions. J Am Coll Cardiol 43 (11):1954-8. DOI:10.1016/j.jacc.2004.01.045 PMID: 15172397