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• W2004611674 abstract "The hottest ongoing debate in the interventional cardiology community has focused on the efficacy and safety of the 2 approved-for-marketing drug-eluting stent platforms: the sirolimus-eluting stent (SES) Cypher (Cordis Corporation, Miami, Florida) and the paclitaxel-eluting stent (PES) Taxus, (Boston Scientific Corporation, Natick, Massachusetts). The 2 devices significantly reduce the rate of recurrent stenoses and the need for repeat revascularization, including those in complex patients and lesion populations; the issue is whether there are clinical differences when comparing these stents in head-to-head trials. Given the significant commercial interests at stake—the current worldwide market for drug-eluting stents is $6 billion and growing—and fierce competition between the manufacturers of the 2 main devices, this debate has recently intensified. The interest has prompted >6 randomized, head-to-head trials between the SES and PES systems, all of which were conducted outside the United States.1Morice M.C. Colombo A. Meier B. Serruys P. Tamburino C. Guagliumi G. Sousa E. Stoll H.P. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial.JAMA. 2006; 295: 895-904Crossref PubMed Scopus (435) Google Scholar, 2Windecker S. Remondino A. Eberli F.R. Juni P. Raber L. Wenaweser P. Togni M. Billinger M. Tuller D. Seiler C. et al.Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization.N Engl J Med. 2005; 353: 653-662Crossref PubMed Scopus (531) Google Scholar, 3Kastrati A. Mehilli J. von Beckerath N. Dibra A. Hausleiter J. Pache J. Schuhlen H. Schmitt C. Dirschinger J. Schomig A. Sirolimus-eluting stent or paclitaxel-eluting stent vs balloon angioplasty for prevention of recurrences in patients with coronary in-stent restenosis: a randomized controlled trial.JAMA. 2005; 293: 165-171Crossref PubMed Scopus (577) Google Scholar, 4Goy 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 (168) Google Scholar, 5Dibra A. Kastrati A. Mehilli J. Pache J. Schuhlen H. von Beckerath N. Ulm K. Wessely R. Dirschinger J. Schomig A. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients.N Engl J Med. 2005; 353: 663-670Crossref PubMed Scopus (499) Google Scholar, 6Mehilli J. Dibra A. Kastrati A. Pache J. Dirschinger J. Schomig A. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.Eur Heart J. 2006; 27: 260-266Crossref PubMed Scopus (189) Google Scholar The results of these trials have been pored over by professionals and industry personnel in an effort to convince cardiologists that 1 stent is better than the other. The 2 largest head-to-head trials, Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent (REALITY)1Morice M.C. Colombo A. Meier B. Serruys P. Tamburino C. Guagliumi G. Sousa E. Stoll H.P. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial.JAMA. 2006; 295: 895-904Crossref PubMed Scopus (435) Google Scholar and Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization (SIRTAX),2Windecker S. Remondino A. Eberli F.R. Juni P. Raber L. Wenaweser P. Togni M. Billinger M. Tuller D. Seiler C. et al.Sirolimus-eluting and paclitaxel-eluting stents for coronary revascularization.N Engl J Med. 2005; 353: 653-662Crossref PubMed Scopus (531) Google Scholar have been the most comprehensive, with broad inclusion criteria, each recruiting >1,000 patients, but strikingly conflicting results. In SIRTAX, the primary end point was clinical. The study was conducted at 2 centers and recruited 1,012 patients with no real exclusions (half of whom had planned angiographic follow-up) but assumed superiority of the Cypher stent. The primary end point, major adverse cardiac events (death from cardiac causes, myocardial infarction, and ischemia-driven revascularization of the target lesion) at 9 months, was significantly lower in the Cypher stent arm (6.2% SES vs 10.8% PES; hazard ratio 0.56, 95% confidence interval 0.36 to 0.86, p = 0.009). The difference was driven by a lower target lesion revascularization (TLR) rate in the Cypher stent group (4.8% SES vs 8.3% PES; hazard ratio 0.56, 95% confidence interval 0.34 to 0.93, p = 0.03). In the REALITY study, the primary end point was the rate of in-lesion binary restenosis, with a secondary clinical end point, major adverse cardiac events (death, myocardial infarction, and TLR combined). The study was powered on the assumption that the Cypher stent was superior. Patients with in-stent restenosis, ostial lesions, and total occlusions were excluded, and unlike in SIRTAX, quantitative angiographic analysis was carried out by an independent core laboratory. Despite more exclusions compared with SIRTAX, the REALITY study appeared to have more complex lesions and patients (Table 1), a greater number of participating centers (>80), and a greater number of patients (n = 1,353) randomized to receive either Cypher or Taxus stents, all of which would minimize bias. The primary end point was not reached, but unlike in SIRTAX, the rate of in-lesion binary restenosis for both Cypher and Taxus was found to be similar (9.6% SES vs 11.1% PES; p = 0.31), and there was no difference in the rates of all clinical parameters, even for an extended follow-up of 1 year.Table 1Comparison of Randomized Study With the Sirolimus-Eluting Bx Velocity Balloon-Expandable Stent and Sirolimus-Eluting Stent Compared With Paclitaxel-Eluting Stent for Coronary Revascularization trialsVariableREALITYSIRTAXNo. of centers882No. of patients1,3531,012Independent core laboratoryYesNoStudy power95%90%Complexity (%B2/C)84%35%Diabetes mellitus28%20%Reference vessel diameter (mm)2.42.82Lesion length (mm)17.212.9Stents/lesion1.41.2Stents/patient1.91.5Total stent length (mm)2818Acute coronary syndrome AMI (ST-segment-elevation)0227/1,012 Stable AP947/1,353492/1,012 Unstable AP406/1,01258/1,012⁎Two hundred thirty-five patients with non-ST-segment-elevation AMI were not counted, because such patients were excluded from REALITY.AMI = acute myocardial infarction; AP = angina pectoris. Two hundred thirty-five patients with non-ST-segment-elevation AMI were not counted, because such patients were excluded from REALITY. Open table in a new tab AMI = acute myocardial infarction; AP = angina pectoris. How can we reconcile the different conclusions of SIRTAX and REALITY? The conversion rate from in-lesion binary restenosis to repeat TLR has historically been approximately 50% across the pivotal trials of drug-eluting stents.7Stone G.W. Ellis S.G. Cox D.A. Hermiller J. O’Shaughnessy C. Mann J.T. Turco M. Caputo R. Bergin P. Greenberg J. et al.A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease.N Engl J Med. 2004; 350: 221-231Crossref PubMed Scopus (2641) Google Scholar, 8Moses J.W. Leon M.B. Popma J.J. Fitzgerald P.J. Holmes D.R. O’Shaughnessy C. Caputo R.P. Kereiakes D.J. Williams D.O. Teirstein P.S. 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 (4073) Google Scholar The REALITY trial was consistent with this, with a conversion rate of in-segment binary restenosis to TLR of 52% in the Cypher group (9.6% binary restenosis, 5% TLR) and 49% in the Taxus group (11.1% binary restenosis, 5.4% TLR). In SIRTAX,8Moses J.W. Leon M.B. Popma J.J. Fitzgerald P.J. Holmes D.R. O’Shaughnessy C. Caputo R.P. Kereiakes D.J. Williams D.O. Teirstein P.S. 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 (4073) Google Scholar however, this conversion rate was, unusually, far greater, at >70% for the 2 stents (6.6% binary restenosis, 4.8% TLR, 73% Cypher vs 11.7% binary restenosis, 8.3% TLR, 73% Taxus). The most probable explanation for the SIRTAX results is the influence of the “oculostenostic” reflex in the management of the 504 patients who returned for follow-up angiograms by a few investigators from 2 centers, thus distorting the clinical outcomes data. Although the investigators adjusted for this in their analyses and claimed that the degree of ischemia-driven revascularization was still significantly higher in the Taxus arm, it is difficult to square this with data from the pivotal studies and from REALITY. The powerful effect of routine angiographic follow-up was clearly demonstrated in the Belgian Netherlands Stent II (BENESTENT II) study, in which bare-metal stenting was compared with balloon angioplasty.9Ruygrok P.N. Melkert R. Morel M.A. Ormiston J.A. Bar F.W. Fernandez-Aviles F. Suryapranata H. Dawkins K.D. Hanet C. Serruys P.W. Benestent II InvestigatorsDoes angiography six months after coronary intervention influence management and outcome?.J Am Coll Cardiol. 1999; 34: 1507-1511Abstract Full Text Full Text PDF PubMed Scopus (111) Google Scholar The rates of revascularization (percutaneous and surgical) were significantly higher in the subgroup of patients who had angiographic follow-up versus clinical follow-up alone. In contrast to SIRTAX and REALITY, Intracoronary Stenting and Angiographic Results–Paclitaxel-Eluting and Sirolimus-Eluting Stents to Prevent Restenosis in Diabetic Patients (ISAR-DIABETES)5Dibra A. Kastrati A. Mehilli J. Pache J. Schuhlen H. von Beckerath N. Ulm K. Wessely R. Dirschinger J. Schomig A. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients.N Engl J Med. 2005; 353: 663-670Crossref PubMed Scopus (499) Google Scholar and Intracoronary Stenting and Angiographic Results–Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries 3 (ISAR-SMART 3)6Mehilli J. Dibra A. Kastrati A. Pache J. Dirschinger J. Schomig A. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.Eur Heart J. 2006; 27: 260-266Crossref PubMed Scopus (189) Google Scholar took a different approach by investigating patient- and lesion-specific subgroups at higher risk for restenosis, and therefore, repeat revascularization. In ISAR-DIABETES, 250 diabetics from a single center were randomized to receive either Cypher or Taxus stents. The study was designed to show the noninferiority of the Taxus stent compared with Cypher.5Dibra A. Kastrati A. Mehilli J. Pache J. Schuhlen H. von Beckerath N. Ulm K. Wessely R. Dirschinger J. Schomig A. Paclitaxel-eluting or sirolimus-eluting stents to prevent restenosis in diabetic patients.N Engl J Med. 2005; 353: 663-670Crossref PubMed Scopus (499) Google Scholar The primary end point was in-segment late loss at 6 months, with a secondary end point of TLR at 9 months. The Cypher stent had significantly lower late loss than Taxus (6.9% vs 16.5%, respectively; p = 0.03), with a corresponding significantly lower rate of TLR in the Cypher group. The conversion rate to TLR, as the investigators also conceded, was extremely high at 72% to 92% (6.4% Cypher, 12% Taxus), implying a significant influence of the “oculostenotic” reflex. Mindful of the limitations when comparing subgroup analyses of randomized trials with other randomized studies, it is noteworthy that the TLR rate in the Taxus arm of ISAR-DIABETES was much higher than that in the diabetic subgroup of TAXUS IV (7.9% in tablet-treated patients, 6.2% in insulin-treated patients).10Hermiller J.B. Raizner A. Cannon L. Gurbel P.A. Kutcher M.A. Wong S.C. Russell M.E. Ellis S.G. Mehran R. Stone G.W. Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial.J Am Coll Cardiol. 2005; 45: 1172-1179Abstract Full Text Full Text PDF PubMed Scopus (239) Google Scholar In a meta-analysis of the diabetic patients in TAXUS II, TAXUS III, TAXUS IV, and TAXUS VI, presented at the European Society of Cardiology Congress in 2004, in which the TLR rate was 6.2% in tablet-treated diabetics and 5.6% in insulin-treated diabetics. Furthermore, the REALITY study recruited 50% more diabetics (378; 28% of the total) than ISAR-DIABETES, yet there was no difference in clinical outcomes between the 2 stents. This again implicates confounding factors, such as fewer centers (n = 2) and the effect of angiographic follow-up, which distorts the analysis of ISAR-DIABETES. The data on patients with small vessels, however, would appear to show clear superiority of the Cypher stent. The recently published ISAR-SMART 3 study randomized 360 patients from a single center to receive either Cypher or Taxus stents, with a mean vessel size of 2.42 mm and a mean length of 12.3mm.6Mehilli J. Dibra A. Kastrati A. Pache J. Dirschinger J. Schomig A. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coronary vessels.Eur Heart J. 2006; 27: 260-266Crossref PubMed Scopus (189) Google Scholar The in-lesion binary restenosis rates were 11.4% in the Cypher arm and 19% in the Taxus arm, translating to a significantly lower rate of TLR for Cypher (6.6%) compared with Taxus (14%). This trial was well designed and executed, but the high conversion rate in this study, particularly for the Taxus arm (58% Cypher, 74% Taxus), again implicates but does not prove a confounding effect of angiographic follow-up on the results. Interestingly, the mean vessel size in REALITY was 2.4 mm (lesion length 17.2 mm), with no significant difference in clinical outcomes for the whole cohort. It is possible that if ISAR-SMART 3 had been a multicenter study, the TLR rate may have been lower; TLR for the Cypher stent in the small vessel European Sirolimus-Eluting Stent in Coronary Lesions (E-SIRIUS)11Schofer J. Schluter M. Gershlick A.H. Wijns W. Garcia E. Schampaert E. Breithardt G. 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 (950) Google Scholar and Canadian Sirolimus-Eluting Stent in Coronary Lesions (C-SIRIUS)12Schampaert E. Cohen E.A. Schluter M. Reeves F. Traboulsi M. Title L.M. Kuntz R.E. Popma J.J. 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 (570) Google Scholar trials was 4%. Similarly, the multicenter (20 Italian hospitals) Sirolimus-Eluting and an Uncoated Stent in the Prevention of Restenosis in Small Coronary Arteries (SES-SMART) study, which randomized 275 patients with vessel diameters <2.75mm (mean vessel length 11.8 mm) to either Cypher or bare-metal stents, had a TLR rate of 7% in the Cypher group.13Ardissino D. Cavallini C. Bramucci E. Indolfi C. Marzocchi A. Manari A. Angeloni G. Carosio G. Bonizzoni E. Colusso S. 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 (312) Google Scholar In summary, these data clearly illustrate the limitations of using angiographic primary end points to determine clinical efficacy. When 1 stent type exhibits more late loss than another (in this case the Taxus stent), the use of angiographic primary end points inevitably results in the underpowered repeat revascularization measures being skewed in favor of the stent with lower late loss. Where do registry data fit in all of this? Registries cannot replace randomized, controlled trials, because hypothesis testing is not possible (they have no prespecified primary end points), and they are not powered to demonstrate superiority or inferiority. Analysis of differences in late loss are not part of their remit, so the serious confounding effects of angiographic follow-up do not influence the data. Provided there is sufficient follow-up, registries can provide a snapshot of real-world practice from which the clinical outcomes should approximate those of randomized trials. This is not the case when, for example, data from diabetic patients in the Taxus Stent Evaluated at Rotterdam Cardiology Hospital (T-SEARCH) and Rapamycin-Eluting Stent Evaluated at Rotterdam Cardiology Hospital (RESEARCH) registries14Ong A.T. Aoki J. van Mieghem C.A. Rodriguez Granillo G.A. Valgimigli M. Tsuchida K. Sonnenschein K. Regar E. van der Giessen W.J. de Jaegere P.P. et al.Comparison of short- (one month) and long- (twelve months) term outcomes of sirolimus- versus paclitaxel-eluting stents in 293 consecutive patients with diabetes mellitus (from the RESEARCH and T-SEARCH registries).Am J Cardiol. 2005; 96: 358-362Abstract Full Text Full Text PDF PubMed Scopus (56) Google Scholar are compared with the results of ISAR-DIABETES. The 9-month TLR rates were 8.8% for the Cypher stent in the RESEARCH registry and 5.7% for Taxus stent in the T-SEARCH registry. In contrast, these rates were 6.4% for Cypher and 12% for Taxus in ISAR-DIABETES. The 9-month follow-up results of the United States–based, multicenter Strategic Transcatheter Evaluation of New Therapies (STENT) registry was presented at the Transcatheter Cardiovascular Therapeutics Conference in October 2005. A total of 2,282 Cypher and 1,476 Taxus procedures completed follow-up (95%). Although most of the baseline characteristics of the 2 groups were similar, the Taxus stent appeared to be implanted in slightly higher risk patients and lesions. Despite this, there were no significant differences in all clinical outcome measures, including subacute stent thrombosis, between the 2 stent rates before and after adjustment for risk factors. Similar results were seen in the diabetic substudy data from the STENT registry presented at the 2006 i2 Summit sessions. One unusual finding, however, was that the insulin-treated diabetic group displayed a trend in favor of the Taxus stent over Cypher for late major adverse cardiac events. Nevertheless, well-run registries such as STENT have their limitations, such as the accuracy with which individual patient events were tracked. For example, the 9-month major adverse cardiac event rate for insulin-treated patients in STENT was 6%, whereas the 1-year major adverse cardiac event rate for such patients in TAXUS IV was far higher at 19.6%.10Hermiller J.B. Raizner A. Cannon L. Gurbel P.A. Kutcher M.A. Wong S.C. Russell M.E. Ellis S.G. Mehran R. Stone G.W. Outcomes with the polymer-based paclitaxel-eluting TAXUS stent in patients with diabetes mellitus: the TAXUS-IV trial.J Am Coll Cardiol. 2005; 45: 1172-1179Abstract Full Text Full Text PDF PubMed Scopus (239) Google Scholar Therefore, although comparing registry and trial data is fraught with obvious flaws, the lack of concordance between the results from registries and those from randomized, head-to-head trials further underlines the deficiencies of the current published randomized trial data. Apart from efficacy, the debate over Cypher and Taxus has also focused on differences in rates of stent thrombosis. These have ranged from 0% to 2% (Cypher) and from 0% to 1.6% (Taxus) in head-to-head studies, with no significant differences between the 2 stents. Nearest has been the REALITY study, in which the Taxus stent had a higher rate of thrombosis than Cypher (p = 0.06). Studies investigating possible predictors for drug-eluting stent thrombosis have also failed to identify stent type as 1 of them.15Kuchulakanti P.K. Chu W.W. Torguson R. Ohlman P. Seung-woon R. Clavijo L.C. Sang-wook K. Bui A.B. Gevorkian N. Xue Z. et al.Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents.Circulation. 2006; 113: 1108-1113Crossref PubMed Scopus (621) Google Scholar, 16Iakovou I. Schmidt T. Bonizzoni E. Ge L. Sangiorgi G.M. Stankovic G. Airoldi F. Chieffo A. Montorfano M. Carlino M. et al.Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents.JAMA. 2005; 293: 2126-2130Crossref PubMed Scopus (2930) Google Scholar There is, therefore, as of yet no convincing evidence for a significant difference in the rates of stent thrombosis between Cypher and Taxus. The 3-year follow-up data from Sirolimus-Eluting Stent in Coronary Lesions (SIRIUS) and TAXUS IV, presented at the 2006 i2 Summit and the Transcatheter Therapeutics Conference in 2005, respectively, have shown, however, a nonstatistically significant, but clear, 0.5% higher rate of stent thrombosis in the drug-eluting-stent arms compared with the control bare metal stent arms, virtually exclusively attributable to very late (>6 months) thrombosis. Although a sense of proportion is required, perhaps in those patients who have ≥1 independent risk factor for stent thrombosis, the decision to implant a drug-eluting stent should be carefully considered. Certainly, accurate long-term follow-up data for all such devices appears all the more important. A recent analysis of the clinical outcomes of these 2 drug-eluting stents in complex cases by Rogers and Edelman17Rogers C. Edelman E.R. Pushing drug-eluting stents into uncharted territory: simpler than you think—more complex than you imagine.Circulation. 2006; 113: 2262-2265Crossref PubMed Scopus (25) Google Scholar demonstrated that as lesion complexity increases, so does the relative difference in TLR rates for the 2 stents, with Cypher becoming noticeably superior. Two other meta-analyses, 1 of 1,703 lesions from 2 centers and the other of all comparative trials of drug-eluting stents, showed that the Taxus stent was an independent predictor of restenosis18Kastrati A. Dibra A. Mehilli J. Mayer S. Pinieck S. Pache J. Dirschinger J. Schomig A. Predictive factors of restenosis after coronary implantation of sirolimus- or paclitaxel-eluting stents.Circulation. 2006; 113: 2293-2300Crossref PubMed Scopus (252) Google Scholar and that the Cypher stent had clinically superior outcomes,19Kastrati A. Dibra A. Eberle S. Mehilli J. Suarez de Lezo J. Goy J.J. Ulm K. Schomig A. Sirolimus-eluting stents vs paclitaxel-eluting stents in patients with coronary artery disease: meta-analysis of randomized trials.JAMA. 2005; 294: 819-825Crossref PubMed Scopus (297) Google Scholar respectively. Our main criticism of all these studies is simple. All included studies, such as ISAR-SMART 3, had far higher conversion rates (70% for Cypher and 100% for Taxus) than the pivotal trials or REALITY. If these studies were removed from the analyses, it is uncertain if the original conclusions would still stand. Put another way, all meta-analyses and reviews are directly influenced by the methods used in the trials. If there are factors in many of the studies that lead to unavoidable bias, the results of such analyses are also skewed. In our opinion, many of the published comparative interventional trials are confounded by unavoidable bias due to angiographic follow-up. A dispassionate assessment of the current trial and registry data comparing Cypher with Taxus stents leads to only 1 logical conclusion: they are probably equally efficacious and safe. One would, however, expect 2 drug-eluting stent systems that use different stent platforms, polymers, and drugs to exhibit differences in efficacy. The key question is, what is the best method to accurately determine differences in efficacy? Although we suggest that the REALITY trial was most accurate, the clinical end points were nevertheless underpowered. The ideal randomized, controlled, comparative stent trial should be multicentered, powered to detect the superiority or inferiority of either stent (i.e., a 2-sided α value of 0.05), and not confounded by even partial angiographic follow-up. A comparative trial with all these characteristics with 80% power to detect a significant difference in major adverse cardiac events between Cypher and Taxus to a 5% significance level would require 7,143 patients per study arm (14,286 patients in total!). Such a definitive trial will almost certainly not be conducted. It is therefore inevitable that methods used to answer questions of comparative efficacy (meta-analysis or review) will also be confounded by factors such as angiographic follow-up that may have undermined any of the original studies included in the analysis." @default.
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• W2004611674 title "Cypher Versus Taxus: All Smoke and No Fire: Lessons for Future Comparative Drug-Eluting Stent Trials in Interventional Cardiology" @default.
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