Drug-Eluting Stents and the Future of Coronary Artery Bypass Surgery: Facts and Fiction
2006; Elsevier BV; Volume: 81; Issue: 3 Linguagem: Inglês
10.1016/j.athoracsur.2005.08.002
ISSN1552-6259
Autores Tópico(s)Cardiac and Coronary Surgery Techniques
ResumoThe treatment of patients with coronary artery disease continues to evolve. Recent, exciting data on the use of drug-eluting stents in diseased coronary vessels has generated immense enthusiasm within the interventional community leading to claims that "drug-eluting stents will put bypass surgeons out of business." However, despite promising short-term and midterm outcomes of this revolutionary new technology, valid concerns regarding long-term safety and efficacy of drug-eluting stents persist. This review article evaluates current status of drug-eluting stents with special emphasis on real and potential drawbacks of this emerging percutaneous coronary interventional modality and its impact on the practice of coronary artery bypass surgery. The treatment of patients with coronary artery disease continues to evolve. Recent, exciting data on the use of drug-eluting stents in diseased coronary vessels has generated immense enthusiasm within the interventional community leading to claims that "drug-eluting stents will put bypass surgeons out of business." However, despite promising short-term and midterm outcomes of this revolutionary new technology, valid concerns regarding long-term safety and efficacy of drug-eluting stents persist. This review article evaluates current status of drug-eluting stents with special emphasis on real and potential drawbacks of this emerging percutaneous coronary interventional modality and its impact on the practice of coronary artery bypass surgery. The potential for multivessel percutaneous coronary intervention (PCI) to be a competitor of coronary artery bypass graft surgery (CABG) early on led to randomized trials demonstrating equivalent survival outcomes for balloon PCI compared with CABG [1Vetrovec G.W. Don't blame the stents.J Am Coll Cardiol. 2004; 43: 1355-1357Abstract Full Text Full Text PDF PubMed Scopus (4) Google Scholar]. However, patients undergoing balloon PCI frequently required additional revascularization later on compared with CABG patients. More recently the impact of coronary stents, with their potential for more durable revascularization, has been investigated [2SoS InvestigatorsCoronary artery bypass surgery versus percutaneous coronary intervention with stent implantation in patients with multivessel coronary artery disease (the Stent or Surgery trial) a randomised controlled trial.Lancet. 2002; 360: 965-970Abstract Full Text Full Text PDF PubMed Scopus (504) Google Scholar, 3Morrison D.A. Sethi G. Sacks J. et al.Angina With Extremely Serious Operative Mortality Evaluation (AWESOME)Percutaneous coronary intervention versus coronary artery bypass graft surgery for patients with medically refractory myocardial ischemia and risk factors for adverse outcomes with bypass: a multicenter, randomized trial. Investigators of the Department of Veterans Affairs Cooperative Study #385, the Angina With Extremely Serious Operative Mortality Evaluation (AWESOME).J Am Coll Cardiol. 2001; 38: 143-149Abstract Full Text Full Text PDF PubMed Scopus (252) Google Scholar, 4Pocock S.J. Henderson R.A. Rickards A.F. et al.Meta-analysis of randomised trials comparing coronary angioplasty with bypass surgery.Lancet. 1995; 346: 1184-1189PubMed Scopus (468) Google Scholar, 5Hoffman S.N. TenBrook J.A. Wolf M.P. Pauker S.G. Salem D.N. Wong J.B. A meta-analysis of randomized controlled trials comparing coronary artery bypass graft with percutaneous transluminal coronary angioplasty one- to eight-year outcomes.J Am Coll Cardiol. 2003; 41: 1293-1304Abstract Full Text Full Text PDF PubMed Scopus (375) Google Scholar, 6Yusuf S. Zucker D. Peduzzi P. et al.Effect of coronary artery bypass graft surgery on survival overview of 10-year results from randomised trials by the Coronary Artery Bypass Graft Surgery Trialists Collaboration.Lancet. 1994; 344: 563-570Abstract PubMed Scopus (1845) Google Scholar, 7Biondi-Zoccai G.G. Abbate A. Agostoni P. et al.Stenting versus surgical bypass grafting for coronary artery disease systematic overview and meta-analysis of randomized trials.Ital Heart J. 2003; 4: 271-280PubMed Google Scholar]. Data from the Arterial Revascularization Therapies Study (ARTS) trial [8Serruys P.W. Unger F. Sousa J.E. et al.Arterial Revascularization Therapies Study GroupComparison of coronary-artery bypass surgery and stenting for the treatment of multivessel disease.N Engl J Med. 2001; 344: 1117-1124Crossref PubMed Scopus (1037) Google Scholar], which randomly assigned more than 1,200 patients with multivessel disease to bare metal stenting or CABG, demonstrated a nearly 20% absolute reduction in the need for late revascularization in the stented patients compared with earlier balloon PCI studies. Overall, 1-year mortality was not different between PCI using one or more bare metal stents and CABG. However, one of the major limitations of bare metal stents is in-stent restenosis [9Chu W.W. Waksman R. Contemporary use of drug-eluting stents.Curr Treat Options Cardiovasc Med. 2005; 7: 35-46Crossref PubMed Scopus (7) Google Scholar]. Some 250,000 patients experience in-stent restenotic lesions each year worldwide [10Schiele T.M. Krotz F. Klauss V. Vascular restenosis—striving for therapy.Expert Opin Pharmacother. 2004; 5: 2221-2232Crossref PubMed Scopus (19) Google Scholar]. In-stent restenosis has been recognized as very difficult to manage, with a repeat restenosis rate of 50%, regardless of the angioplasty device used [10Schiele T.M. Krotz F. Klauss V. Vascular restenosis—striving for therapy.Expert Opin Pharmacother. 2004; 5: 2221-2232Crossref PubMed Scopus (19) Google Scholar]. Despite an exhaustive search for an effective pharmacotherapy to treat or prevent restenosis, hundreds of clinical trials have failed to identify a pharmacologic agent with proven therapeutic benefit [11Rajagopal V. Rockson S.G. Coronary restenosis a review of mechanisms and management.Am J Med. 2003; 115: 547-553Abstract Full Text Full Text PDF PubMed Scopus (127) Google Scholar]. Experience with systemically administered drugs, such as antiplatelet agents, anticoagulants, calcium-channel blockers, angiotensin-converting enzyme inhibitors, cholesterol-lowering agents, and antioxidants, has proven almost universally negative [12Bhatia V. Bhatia R. Dhindsa S. Drug-eluting intra-coronary stents have we got the magic bullet?.J Postgrad Med. 2003; 49: 291-296PubMed Google Scholar]. Similarly, the results with oral administration of an antiproliferative agent, sirolimus, have failed to show any benefit, and in fact there was a higher incidence of adverse events in the recipients of such a therapy [12Bhatia V. Bhatia R. Dhindsa S. Drug-eluting intra-coronary stents have we got the magic bullet?.J Postgrad Med. 2003; 49: 291-296PubMed Google Scholar]. Vascular brachytherapy over the years, by convincingly reducing the incidence of repeat in-stent restenosis (by 50%), has emerged as the gold standard of therapy [10Schiele T.M. Krotz F. Klauss V. Vascular restenosis—striving for therapy.Expert Opin Pharmacother. 2004; 5: 2221-2232Crossref PubMed Scopus (19) Google Scholar]. However, larger studies and long-term follow-up showed alarming long-term sequelae such as edge restenosis and late thrombosis, raising some concerns about the potential toxicity of a cytotoxic approach [13Costa M.A. Sabate M. van der Giessen W.J. et al.Late coronary occlusion after intracoronary brachytherapy.Circulation. 1999; 100: 789-792Crossref PubMed Scopus (393) Google Scholar]. The recent introduction of drug-eluting stents (DES) in clinical practice has shown a great deal of promise for the treatment of both de novo and restenotic lesions, with reduction in in-stent neointimal proliferation that causes restenosis, thereby reducing the incidence of symptomatic recurrence to less than 5%, rivaling that of bypass surgery [14Baim D.S. New devices for percutaneous coronary intervention are rapidly making bypass surgery obsolete.Curr Opin Cardiol. 2004; 19: 593-597Crossref PubMed Scopus (11) Google Scholar]. Since Food and Drug Administration (FDA) approval of the first DES in April 2003, referrals for stenting have increased by more than 40%, and correspondingly, bypass surgery rates have begun to decline [15Teirstein P.S. A chicken in every pot and a drug-eluting stent in every lesion.Circulation. 2004; 109: 1906-1910Crossref PubMed Scopus (21) Google Scholar]. The early encouraging results and less invasive nature of DES coupled with the trauma involved in surgical access ("cracking the chest") and conduit harvest, the systemic inflammatory response associated with cardiopulmonary bypass, the threat of postoperative neurocognitive dysfunction, and vein graft attrition has resulted in many physicians going to great lengths to avoid recommending surgical revascularization to their patients [16Cohn W.E. Surgical coronary revascularization remains relevant in the era of stents.Curr Opin Cardiol. 2004; 19: 589-592Crossref PubMed Scopus (8) Google Scholar]. Despite enthusiastic speculation of the interventionalists that probably CABG will soon become a relic of the past, reality is that valid concerns exist regarding long-term efficacy of DES [17Raja S.G. Drug-eluting stents is it the beginning of the end for coronary artery bypass surgery?.Chin Med J (Engl). 2004; 117: 1377-1387PubMed Google Scholar]. Furthermore important safety issues such as thrombosis, late stent malapposition, aneurysm formation, edge effect, late inflammation due to choice of polymer used to bind the drug, the release of toxins, and potential interaction with brachytherapy have not yet been completely addressed [18Raja S.G. Drug-eluting stents the myth, the reality.CML Interv Cardiol Monit. 2005; 12: 1-7Google Scholar]. This review article evaluates current status of DES with special emphasis on real and potential drawbacks of this emerging PCI modality and its impact on the practice of coronary artery bypass surgery. More than 40 substances, some that inhibit thrombotic, inflammatory, proliferative, or migratory processes and some that enhance endothelial healing, have been or are in the process of being evaluated as possible agents for DES [19Sousa J.E. Serruys P.W. Costa M.A. New frontiers in cardiology: drug-eluting stents: part I.Circulation. 2003; 107: 2274-2279Crossref PubMed Scopus (311) Google Scholar, 20Sousa J.E. Serruys P.W. Costa M.A. New frontiers in cardiology: drug-eluting stents: part II.Circulation. 2003; 107: 2383-2389Crossref PubMed Scopus (153) Google Scholar]. Sirolimus, an immunosuppressant used in solid organ transplantation, has been found to delay endothelialization of stented surfaces. Sirolimus-eluting stents (SES) are coated with 140 μg/cm of sirolimus, which is released over either 14 or 28 days. Paclitaxel, a cancer chemotherapeutic agent used to treat ovarian and breast tumors, also has been found to delay healing processes. Paclitaxel-eluting stents (PES) are coated with 3 μg/mm of paclitaxel, which is released over at least 10 days [21Stanik-Hutt J.A. Drug-coated stents preventing restenosis in coronary artery disease.J Cardiovasc Nurs. 2004; 19: 404-408Crossref PubMed Scopus (4) Google Scholar]. Both SES and PES are at present the only DES that have FDA approval for use in de novo stenotic lesions less than 28 mm in length in native coronary arteries with reference vessel diameters between 2.5 and 3.5 mm [21Stanik-Hutt J.A. Drug-coated stents preventing restenosis in coronary artery disease.J Cardiovasc Nurs. 2004; 19: 404-408Crossref PubMed Scopus (4) Google Scholar]. This section briefly presents current outcomes of DES from randomized controlled trials as well as "real world" registries. A search of Medline, Embase, Cochrane Controlled Trials Register, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Science Citation Index, Current Contents, NHS Economic Evaluation Database, and International Network of Agencies for Health Technology Assessment databases from the date of their inception to the last week of May 2005 using medical subject headings search terms "randomized controlled trials," "meta-analysis," "stents," and nonmedical subject headings search terms "drug-eluting stents," "sirolimus," and "paclitaxel" yielded a total of 11 randomized controlled trials comparing DES and bare metal stents, recruiting 5,287 patients (2,731 allocated to DES, and 2,556 to bare metal stents) and reporting at least one pertinent clinical, radiologic, or economic outcome with at least 6 months of follow-up. These included the following: RAVEL (RAndomized study with sirolimus-coated Bx VELocity balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions) [22Morice M.C. Serruys P.W. Sousa J.E. et al.Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med. 2002; 346: 1773-1780Crossref PubMed Scopus (3938) Google Scholar]; SIRIUS (SIRolImUS-eluting balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions) [23Moses J.W. Leon M.B. Popma J.J. et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323Crossref PubMed Scopus (4124) Google Scholar]; E-SIRIUS (European multicenter randomized double-blind study of the SIRolImUS-eluting balloon-expandable stent in the treatment of patients with de novo native coronary artery lesions) [24Schofer J. Schluter M. Gershlick A.H. et al.Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries double-blind, randomised controlled trial (E-SIRIUS).Lancet. 2003; 362: 1093-1099Abstract Full Text Full Text PDF PubMed Scopus (960) Google Scholar]; C-SIRIUS (Canadian multicenter randomized double-blind study of the SIRolImUS-Eluting balloon-expandable stent in the treatment of patients with de novo native coronary artery lesionsS) [25Schampaert E. Cohen E.A. Schluter M. et al.The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS).J Am Coll Cardiol. 2004; 43: 1110-1115Abstract Full Text Full Text PDF PubMed Scopus (579) Google Scholar]; SES-SMART (Sirolimus-Eluting Stent in the prevention of restenosis in SMall coronary ARTeries) [26Ardissino D. Cavallini C. Bramucci E. et al.Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries a randomized trial.JAMA. 2004; 292: 2727-2734Crossref PubMed Scopus (315) Google Scholar]; TAXUS (Treatment of de novo coronary disease using a single pAclitaXel elUting Stent)−I, −II, and −IV [27Grube E. Silber S. Hauptmann K.E. et al.TAXUS I six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions.Circulation. 2003; 107: 38-42Crossref PubMed Scopus (863) Google Scholar, 28Colombo A. Drzewiecki J. Banning A. et al.Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.Circulation. 2003; 108: 788-794Crossref PubMed Scopus (994) Google Scholar, 29Stone G.W. Ellis S.G. Cox D.A. et al.A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med. 2004; 350: 221-231Crossref PubMed Scopus (2677) Google Scholar]; ELUTES (European evaLUation of pacliTaxel-Eluting Stent) [30Gershlick A. De Scheerder I. Chevalier B. et al.Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial.Circulation. 2004; 109: 487-493Crossref PubMed Scopus (230) Google Scholar]; ASPECT (ASian Paclitaxel-Eluting stent Clinical Trial) [31Hong M.K. Mintz G.S. Lee C.W. 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: 517-520Crossref PubMed Scopus (184) Google Scholar]; and DELIVER (Drug-ELuting coronary stent system In the treatment of patients with de noVo nativE coronaRy lesions) [32Lansky A.J. Costa R.A. Mintz G.S. et al.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. 2004; 109: 1948-1954Crossref PubMed Scopus (204) Google Scholar]. A 3-year follow-up of the RAVEL trial has also been published recently, suggesting maintenance of long-term clinical benefits [33Fajadet J. Morice M.C. Bode C. et al.Maintenance of long-term clinical benefit with sirolimus-eluting coronary stents three-year results of the RAVEL trial.Circulation. 2005; 111: 1040-1044Crossref PubMed Scopus (217) Google Scholar]. In addition the TAXi (Paclitaxel and sirolimus stents in the real world of interventional cardiology) trial [34Goy J.J. Stauffer J.C. Siegenthaler M. Benoit A. Seydoux C. A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology the TAXi trial.J Am Coll Cardiol. 2005; 45: 308-311Abstract Full Text Full Text PDF PubMed Scopus (170) Google Scholar], comparing SES with PES, and seven meta-analyses [35Kittleson M.M. Needham D.M. Kim S.J. Ravindran B.K. Solomon S.S. Guallar E. The efficacy of sirolimus- and paclitaxel-eluting stents a meta-analysis of randomized controlled trials.Can J Cardiol. 2005; 21: 581-587PubMed Google Scholar, 36Indolfi C. Pavia M. Angelillo I.F. Drug-eluting stents versus bare metal stents in percutaneous coronary interventions (a meta-analysis).Am J Cardiol. 2005; 95: 1146-1152Abstract Full Text Full Text PDF PubMed Scopus (83) Google Scholar, 37Katritsis D.G. Karvouni E. Ioannidis J.P. Meta-analysis comparing drug-eluting stents with bare metal stents.Am J Cardiol. 2005; 95: 640-643Abstract Full Text Full Text PDF PubMed Scopus (88) Google Scholar, 38Shafiq N. Malhotra S. Pandhi P. Grover A. Uboweja A. A meta-analysis of clinical trials of paclitaxel- and sirolimus-eluting stents in patients with obstructive coronary artery disease.Br J Clin Pharmacol. 2005; 59: 94-101Crossref PubMed Scopus (19) Google Scholar, 39Biondi-Zoccai G.G. Agostoni P. Abbate A. et al.Adjusted indirect comparison of intracoronary drug-eluting stents evidence from a metaanalysis of randomized bare-metal-stent-controlled trials.Int J Cardiol. 2005; 100: 119-123Abstract Full Text Full Text PDF PubMed Scopus (58) Google Scholar, 40Babapulle M.N. Joseph L. Belisle P. Brophy J.M. Eisenberg M.J. A hierarchical Bayesian meta-analysis of randomised clinical trials of drug-eluting stents.Lancet. 2004; 364: 583-591Abstract Full Text Full Text PDF PubMed Scopus (615) Google Scholar, 41Scheen A.J. Warzee F. Legrand V.M. Drug-eluting stents meta-analysis in diabetic patients.Eur Heart J. 2004; 25: 2167-2168Crossref PubMed Scopus (70) Google Scholar] as well as three systematic reviews [42Oliva G. Espallargues M. Pons J.M. Antiproliferative drug-eluting stents systematic review of the benefits and estimate of economic impact.Rev Esp Cardiol. 2004; 57: 617-628PubMed Google Scholar, 43Hill R. Bagust A. Bakhai A. et al.Coronary artery stents a rapid systematic review and economic evaluation.Health Technol Assess. 2004; 8: 1-242Google Scholar, 44Hill R.A. Dundar Y. Bakhai A. Dickson R. Walley T. Drug-eluting stents an early systematic review to inform policy.Eur Heart J. 2004; 25: 902-919Crossref PubMed Scopus (120) Google Scholar] of clinical trials of SES and PES in patients with obstructive coronary artery disease have also been published. Analysis of all published randomized controlled trials comparing SES or PES with bare metal stents shows that in general, the patients enrolled in the trials of DES with sirolimus or paclitaxel were young and predominantly male. The trials were well conducted, with random allocation of treatment, masking of treatment assignment in most trials, and clinical follow-up rates of more than 90% (Table 1). Follow-up quantitative coronary angiography was done in 43% to 97% of enrolled patients 6 to 9 months after the index percutaneous coronary intervention with intravascular ultrasound done in 17% to 100% patients in 7 of the 11 randomized controlled trials (Table 1). Most trials were designed to assess the medium-term (6 to 12 months after index percutaneous coronary intervention) efficacy of DES at decreasing angiographic restenosis or clinical events. The inclusion criteria of all the trials specified that enrolled patients had de-novo (not restenotic) lesions in a native coronary artery with the exception of TAXUS I trial. Multilesion percutaneous coronary intervention with DES was not permitted in any trial. Patients with a recent myocardial infarction or a low ejection fraction were also excluded. Prevalence of diabetes ranged from 14% to 31%. Lesion lengths and reference-vessel diameters of the treated vessels varied between the trials, although in general the stented lesions were intermediate in length in medium-caliber vessels (Table 2). Depending on the study protocol, aspirin was given to all patients indefinitely and antiplatelet therapy with clopidogrel [22Morice M.C. Serruys P.W. Sousa J.E. et al.Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med. 2002; 346: 1773-1780Crossref PubMed Scopus (3938) Google Scholar, 23Moses J.W. Leon M.B. Popma J.J. et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323Crossref PubMed Scopus (4124) Google Scholar, 24Schofer J. Schluter M. Gershlick A.H. et al.Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries double-blind, randomised controlled trial (E-SIRIUS).Lancet. 2003; 362: 1093-1099Abstract Full Text Full Text PDF PubMed Scopus (960) Google Scholar, 25Schampaert E. Cohen E.A. Schluter M. et al.The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS).J Am Coll Cardiol. 2004; 43: 1110-1115Abstract Full Text Full Text PDF PubMed Scopus (579) Google Scholar, 26Ardissino D. Cavallini C. Bramucci E. et al.Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries a randomized trial.JAMA. 2004; 292: 2727-2734Crossref PubMed Scopus (315) Google Scholar, 27Grube E. Silber S. Hauptmann K.E. et al.TAXUS I six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions.Circulation. 2003; 107: 38-42Crossref PubMed Scopus (863) Google Scholar, 28Colombo A. Drzewiecki J. Banning A. et al.Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.Circulation. 2003; 108: 788-794Crossref PubMed Scopus (994) Google Scholar, 29Stone G.W. Ellis S.G. Cox D.A. et al.A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med. 2004; 350: 221-231Crossref PubMed Scopus (2677) Google Scholar, 30Gershlick A. De Scheerder I. Chevalier B. et al.Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial.Circulation. 2004; 109: 487-493Crossref PubMed Scopus (230) Google Scholar, 32Lansky A.J. Costa R.A. Mintz G.S. et al.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. 2004; 109: 1948-1954Crossref PubMed Scopus (204) Google Scholar], ticlopidine [24Schofer J. Schluter M. Gershlick A.H. et al.Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries double-blind, randomised controlled trial (E-SIRIUS).Lancet. 2003; 362: 1093-1099Abstract Full Text Full Text PDF PubMed Scopus (960) Google Scholar], or cilostazol [31Hong M.K. Mintz G.S. Lee C.W. 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: 517-520Crossref PubMed Scopus (184) Google Scholar] was recommended for at least 2 to 6 months after percutaneous coronary intervention. The use of glycoprotein IIb/IIIa inhibitors ranged from 0% to 64%. Glycoprotein IIb/IIIa inhibitors were used at the operator's discretion in most studies [22Morice M.C. Serruys P.W. Sousa J.E. et al.Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med. 2002; 346: 1773-1780Crossref PubMed Scopus (3938) Google Scholar, 23Moses J.W. Leon M.B. Popma J.J. et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323Crossref PubMed Scopus (4124) Google Scholar, 24Schofer J. Schluter M. Gershlick A.H. et al.Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries double-blind, randomised controlled trial (E-SIRIUS).Lancet. 2003; 362: 1093-1099Abstract Full Text Full Text PDF PubMed Scopus (960) Google Scholar, 25Schampaert E. Cohen E.A. Schluter M. et al.The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS).J Am Coll Cardiol. 2004; 43: 1110-1115Abstract Full Text Full Text PDF PubMed Scopus (579) Google Scholar, 26Ardissino D. Cavallini C. Bramucci E. et al.Sirolimus-eluting vs uncoated stents for prevention of restenosis in small coronary arteries a randomized trial.JAMA. 2004; 292: 2727-2734Crossref PubMed Scopus (315) Google Scholar, 28Colombo A. Drzewiecki J. Banning A. et al.Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions.Circulation. 2003; 108: 788-794Crossref PubMed Scopus (994) Google Scholar, 29Stone G.W. Ellis S.G. Cox D.A. et al.A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med. 2004; 350: 221-231Crossref PubMed Scopus (2677) Google Scholar, 30Gershlick A. De Scheerder I. Chevalier B. et al.Inhibition of restenosis with a paclitaxel-eluting, polymer-free coronary stent the European evaLUation of pacliTaxel Eluting Stent (ELUTES) trial.Circulation. 2004; 109: 487-493Crossref PubMed Scopus (230) Google Scholar], although in some of them these were either not used or discouraged [27Grube E. Silber S. Hauptmann K.E. et al.TAXUS I six- and twelve-month results from a randomized, double-blind trial on a slow-release paclitaxel-eluting stent for de novo coronary lesions.Circulation. 2003; 107: 38-42Crossref PubMed Scopus (863) Google Scholar, 31Hong M.K. Mintz G.S. Lee C.W. 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: 517-520Crossref PubMed Scopus (184) Google Scholar, 32Lansky A.J. Costa R.A. Mintz G.S. et al.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. 2004; 109: 1948-1954Crossref PubMed Scopus (204) Google Scholar].Table 1Characteristics of Randomized Controlled Trials of Drug-Eluting StentsTrialRegionDesignFollow-UpRestenosis RiskMale (%)Diabetes (%)% QCA Follow-UpRAVEL [22Morice M.C. Serruys P.W. Sousa J.E. et al.Randomized Study with the Sirolimus-Coated Bx Velocity Balloon-Expandable Stent in the Treatment of Patients with de Novo Native Coronary Artery Lesions. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization.N Engl J Med. 2002; 346: 1773-1780Crossref PubMed Scopus (3938) Google Scholar]EuropeDB, MC12 monthsaThree-year follow-up results published suggesting maintenance of long-term clinical benefits.Low761689SIRIUS [23Moses J.W. Leon M.B. Popma J.J. et al.Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery.N Engl J Med. 2003; 349: 1315-1323Crossref PubMed Scopus (4124) Google Scholar]United StatesDB, MC12 monthsLow712566E-SIRIUS [24Schofer J. Schluter M. Gershlick A.H. et al.Sirolimus-eluting stents for treatment of patients with long atherosclerotic lesions in small coronary arteries double-blind, randomised controlled trial (E-SIRIUS).Lancet. 2003; 362: 1093-1099Abstract Full Text Full Text PDF PubMed Scopus (960) Google Scholar]EuropeDB, MC9 monthsLow to intermediate712386C-SIRIUS [25Schampaert E. Cohen E.A. Schluter M. et al.The Canadian study of the sirolimus-eluting stent in the treatment of patients with long de novo lesions in small native coronary arteries (C-SIRIUS).J Am Coll Cardiol. 2004; 43: 1110-1115Abstract Full Text Full Text PDF PubMed Scopus (579) Google Scholar]CanadaDB, MC9 monthsLow to intermediate692488SES-SMART [26Ardissino D. Cavallini C. Bramucci E. et al.Sirolimus-eluting vs uncoated stents for prevent
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