Artigo Acesso aberto Revisado por pares

The SYNTAX Trial

2009; Lippincott Williams & Wilkins; Volume: 2; Issue: 5 Linguagem: Inglês

10.1161/circinterventions.109.882670

ISSN

1941-7632

Autores

Rajiv Gulati, Charanjit S. Rihal, Bernard J. Gersh,

Tópico(s)

Statistical Methods in Clinical Trials

Resumo

HomeCirculation: Cardiovascular InterventionsVol. 2, No. 5The SYNTAX Trial Free AccessResearch ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissionsDownload Articles + Supplements ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toSupplementary MaterialsFree AccessResearch ArticlePDF/EPUBThe SYNTAX TrialA Perspective Rajiv Gulati, MD, PhD, Charanjit S. Rihal, MD, MBA and Bernard J. Gersh, MB, ChB, DPhil, FRCP Rajiv GulatiRajiv Gulati From the Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn. , Charanjit S. RihalCharanjit S. Rihal From the Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn. and Bernard J. GershBernard J. Gersh From the Division of Cardiovascular Diseases, Mayo Clinic, Rochester, Minn. Originally published1 Oct 2009https://doi.org/10.1161/CIRCINTERVENTIONS.109.882670Circulation: Cardiovascular Interventions. 2009;2:463–467The introduction of coronary artery bypass surgery (CABG) in 1968 resulted in a paradigm shift in the management of coronary artery disease. Subsequent randomized studies in patients with chronic stable angina established the superiority of CABG over medical therapy in patients with left main coronary artery disease and multivessel disease with left ventricular dysfunction, especially if the proximal left anterior descending artery was involved. The beneficial effect of CABG on the relief of angina was noted in all trials.1–3 In many respects, these trials are obsolete because medical therapy at that time was extremely limited, as were methods of secondary prevention. Nonetheless, the important message of these trials still applies—the greatest benefit of revascularization is among those subgroups at greater risk based on the severity of symptoms or ischemia, the presence of multivessel disease and left ventricular dysfunction, and the extent of myocardial jeopardy.4The introduction of percutaneous transluminal coronary angioplasty as a nonsurgical alternative in 1977 by Gruntzig5 dramatically altered the landscape. Although it is noteworthy that 2 of the first 5 coronary balloon dilations ever performed were in the left main, complications from acute vessel closure precluded the widespread use of multivessel percutaneous transluminal coronary angioplasty in patients with severe coronary disease. The demonstration that bare-metal stents markedly reduced such short-term complications6–8 and improved subsequent long-term outcome (primarily through a reduction in restenosis compared with balloon angioplasty alone) raised the possibility that percutaneous intervention may offer an appealing alternative to CABG in the management of patients with multivessel disease. This, in turn, spawned a new generation of well-conducted, albeit somewhat small, randomized trials. Nonetheless, the benefits of bare-metal stent and drug-eluting stents (DES) have been on the end points of restenosis and repeat target vessel revascularization and not on death or myocardial infarction (MI).9Percutaneous Coronary Intervention Versus CABG for Multivessel DiseaseA meta-analysis of 23 randomized trials comparing percutaneous coronary intervention (PCI) with surgery showed that after 10 years of follow-up, mortality was no different between the 2 groups.10 CABG did produce more procedure-related strokes (1.2% versus 0.6%) but offered greater freedom from angina at 5 years. Of note, PCI was performed with no stents at all in 9 of these trials. A collaborative analysis of individual patient data from 10 randomized trials showed that in nondiabetic patients, there was no difference in mortality whether treated by CABG or PCI.11 However, CABG offered a mortality advantage in diabetic and older patient subgroups. Once again, it is notable that in 6 of 10 trials, PCI was performed with balloon only The major difference between surgical and percutaneous intervention in all individual trials comparing the 2 modes of revascularization, and well-illustrated in meta-analyses, has been in rates of repeat revascularization, this being a significantly more frequent event after PCI.The advent of DES, with reduced rates of restenosis compared with bare-metal stents, was expected to narrow the gap between PCI and CABG in terms of repeat revascularization. The ARTS-II (Arterial Revascularization Therapies Study Part II) study, a single-arm multicenter observational series, recruited 607 patients to undergo multivessel PCI with Cypher DES. When compared with historical surgical controls from ARTS-I, there was no difference in survival at 3 years. Rates of repeat revascularization after PCI with DES, although markedly improved compared with bare-metal stent controls from ARTS-I, remained statistically higher than surgery. The New York State Registry study evaluated patients with multivessel disease treated with either DES or CABG between October 2003 and December 2004, excluding those with left main disease (LMD), recent MI, or previous revascularization. Although after statistical adjustment CABG seemed to be associated with marginally improved survival compared with PCI in patients with 3-vessel disease (3VD; 94% versus 92.7%) and 2-vessel disease (2VD; 96% versus 94.6%), there has been much discussion regarding the validity and appropriateness of the adjustment methodology used in this analysis. The unadjusted data indicated that patients nonrandomly referred for either CABG or PCI, based on physician choice, were equally likely to be alive at 18 months.12 The lack of consensus regarding superiority of 1 revascularization modality over another is illustrated by Park's registry findings, which contrasted with those from the New York State registry. Here, the unadjusted data showed PCI with DES to be associated with significantly lower mortality compared with CABG at 3 years, with the adjusted data showing equivalence.13PCI Versus CABG for LMDA meta-analysis of 16 observational studies of 1278 patients suggested PCI with DES to be safe in the short term, with a 2.3% rate of mortality in hospital and 5.5% at the time of last follow-up, a median of 10 months.14 Seung et al15 evaluated 1108 patients who underwent PCI with stents during a period of 6 years and compared these with a matched cohort of 1138 patients who underwent surgery. They found no significant difference in rates of death or the composite of death/stroke/MI between the groups but did find PCI to be associated with higher rates of repeat revascularization. A recently published small randomized study of 105 patients compared PCI with CABG for LMD and suggested similar major adverse cardiac and cerebrovascular event-free survival at 2 years.16 An argument occasionally made against the use of PCI for LMD is the risk of stent thrombosis and the resulting devastating consequences. However, given that 1-year graft closure rates are approximately 35% for vein grafts and 8% for left internal mammary artery grafts,17 there may be every rationale to consider DES for this type of anatomy.Although registry studies introduce "selection bias," randomized trials are disadvantaged by entry limitation, in that the inclusion criteria are in general restrictive, resulting in relatively underpowered studies because of small numbers of patients with inherently lower absolute risk. It is estimated that these trials resulted in recruitment of only a minority, typically around 10%, of screened patients, with patients entered into these trials being from an ethical standpoint suitable for both forms of therapy. Typically, high-risk subgroups with left ventricular dysfunction and CHF, chronic total occlusions, diffuse disease, and complex anatomy are excluded and sent for CABG.18,19SYNTAX Study Rationale and Design AspectsThe analyses outlined above primarily focused on lower-risk patients with multivessel disease as defined by a preponderance of 2VD and preserved ventricular function. Technical improvements in the performance of PCI and the introduction of DES have shifted the goalposts toward defining the role of PCI versus CABG in patients with 3VD and left main coronary artery disease disease. The wide range of opinions prevailing at the onset of this trial provides a strong justification for the timeliness of such a trial. This is reflected by the marked diversity of practice patterns between countries, as revealed in the synergy between PCI with Taxus and cardiac surgery (SYNTAX) run-in phase.20 For example, in patients with 3VD, PCI was performed in 30% in Europe but only 17% in North America. Within Europe, rates of CABG for 3VD ranged from 42% in France to 90% in the United Kingdom. For patients with LMD, CABG was 59% in the Netherlands and 87% in Belgium. The SYNTAX trial was designed with the intention to address some of the deficiencies of earlier trials and to offer clarification regarding optimal treatment strategies in patients with severe coronary disease.The stated principal goal of the SYNTAX study was to assess the optimal revascularization strategy for patients with de novo 3VD or LMD, by randomization to either CABG or PCI with TAXUS DES.21,22 The trial was a multicenter, prospective randomized clinical trial with an "all-comers" design. Patients with angina or asymptomatic myocardial ischemia were eligible. One thousand eight hundred patients (41% of those enrolled in the study) were deemed suitable for revascularization by either strategy and were randomized. Patients deemed suitable for only one of the treatment options were followed up in a nested registry.Five particular strengths of the SYNTAX study are worthy of note: Size. With 1800 patients randomized from 85 centers in the Europe and the United States, this has been the largest randomized controlled study of PCI versus CABG.Design as an "all-comers" study. With the only exclusion criteria being previous revascularization, acute MI, or need for concomitant cardiac surgery, a full 71% of screened patients were enrolled into one of the randomized or registry cohorts. In this regard, although accepting that certain clinical subgroups encountered in routing clinical practice were excluded, it can be argued that the results are more applicable to the clinical setting than any previous comparison of revascularization strategies.Heart-team concept. Each clinical case and angiogram was reviewed by a team consisting of an interventionist and a surgeon. After review, consensus agreement was obtained as to which procedure or procedures the patient may be eligible for.Inclusion of nested registries of either PCI or surgery in the study design has allowed for detailed characterization and outcome analysis of groups felt to be ineligible for one of the strategies.Use of state-of-the-art technology, with arterial grafts for CABG where possible, DES for all PCI, and aggressive secondary prevention in both groups.Principal FindingsThe principal finding of SYNTAX was that patients treated with PCI by DES were more likely to reach the primary end point of the study at 12 months after randomization: 17.8% suffering one of death (all causes), stroke, MI, or repeat revascularization compared with 12.4% of patients treated by CABG. Therefore, the conclusion of the study was that CABG remains the standard of care for patients with 3VD or LMD. Along these lines, the appropriateness criteria for revascularization recently jointly published by ACCF/SCAI/STS/AATS/AHA/ASNC classify revascularization by PCI for 3VD as uncertain and by PCI for LMD as inappropriate.23A closer look at the data within the SYNTAX study may offer a more nuanced interpretation based on individual perceptions and perhaps biases in regard to the components of the primary end point. The composite of all-cause death, MI, and stroke was no different between the groups at 12 months (7.6% with PCI and 7.7% with CABG). When separated, the individual components of death and MI were also no different between the groups. There was, however, a statistically significant excess of strokes after CABG compared with PCI (2.2% versus 0.6%). Given that stroke is arguably the complication most feared by patients, often graded as a fate worse than death,24 the reduction in rate of stroke with PCI compared with CABG is clinically relevant. In this regard, the timing of strokes in relation to the performance of both procedures is a critical element and hopefully the subject of future analyses. It is possible that some strokes occurred during the longer interval between randomization before CABG. Although it is correct to include these events under "the intention to treat principle of analysis," the fact remains that some of these events might not be directly attributable to the surgical procedure. What also needs to be determined is the relationship between perioperative stroke in regard to the usage of antiplatelet agents and other adjunctive therapies. Regardless, the numeric differences in rates of stroke between the groups had minimal impact on the overall primary end point, but in this case, the clinical relevance of this end point mandates further analyses. The principal driver of the higher primary end point event rate in the PCI group was an excess of repeat revascularizations (13.5% versus 5.9%), consistent with all previous studies comparing CABG with PCI, even in the DES era. This should be considered in the context that the threshold for performing repeat angiography (and thereby angiographically driven repeat revascularization) has historically always been lower after PCI compared with CABG. However, the rates of symptomatic graft or stent closure in SYNTAX were remarkably similar.The SYNTAX study raises an important issue regarding the use of composite primary end points. When used appropriately, composite end points can increase the power of a study by increasing the number of events studied and keeping the total patient population to a minimum. In addition, when no single primary end point can be selected, a composite can help avoid the statistical complexity associated with multiple testing.25 However, the results of a composite end point analysis may be incorrectly taken to apply to individual components. Indeed, this has been illustrated by some of the headline reporting of the SYNTAX study published in the lay press in which individual interpretations of the trial results were, in some cases, diametrically opposite to each other. Composite end points perhaps work best when components are equivalently relevant in terms of impact to the patient. However, when an end point such as repeat revascularization, with its relatively benign and temporary nature is equally weighted with the irreversible end points of death, MI and stroke, the importance of careful interpretation of the composite data cannot be overemphasized. In this regard, it could be argued that other end points, such as rehospitalization and postprocedural atrial fibrillation, are of similar impact to the patient but were not included in the index analyses. Thus, despite the statistically worse performance of PCI assessed by composite primary end point, which gave rise to the conclusion that CABG should remain the standard of care, the findings could be framed in a different manner: there was no statistical difference in rates of death or MI between the groups, but their PCI resulted in 2 less strokes per 100 patients treated, at a cost of 8 more revascularizations.The SYNTAX study used a noninferiority trial design. The absolute difference in rates of primary end point between the groups was 5.5% at 12 months with a 1-sided 95% upper confidence limit for the difference of 8.3%. Because this was more than the prespecified δ value of 6.6%, PCI with the DES was considered to be not noninferior to CABG in the overall randomized cohort. Thus, because the criteria for primary end point noninferiority comparison were not met, strictly speaking comparisons of subgroups are observational and should be hypothesis generating only. Although this caveat must be accepted, there still may be useful information to be gained from observational analyses of subgroups such as 3VD and LMD.Subgroup AnalysesThere were 705 patients in the left main subgroup, making this the largest ever randomized comparison of revascularization modality for LMD. Disease burden crossed the spectrum from isolated LM disease to concomitant 3VD. Somewhat surprisingly, there was no difference in rates of all-cause death at 12 months (4.2% for PCI versus 4.4% for CABG) or MI (4.3% versus 4.1%) between the groups. However, as with the overall randomized cohort, there were fewer strokes after PCI but more revascularizations. There were proportionately fewer revascularizations after PCI for LMD compared with the overall cohort, and the primary composite end point for LMD was not statistically different between PCI and CABG at 1 year. These findings, representing surprisingly good outcomes, seem to confirm results from recent left main registries with DES. Outcome by site (eg, ostial, shaft, distal) and stent technique will be of interest but perhaps most important will be whether the effect of PCI is durable beyond 12 months in comparison with CABG.Isolated LMD was uncommon in SYNTAX, comprising only 13% of the total left main group. In contrast, concomitant 2VD or 3VD was present in 68%. Of interest, there seemed to be an overall numeric (non–statistically significant) major adverse cardiac and cerebrovascular event advantage to PCI in patients with isolated LMD, concomitant single-vessel disease, or low SYNTAX scores. Although CABG offered a numeric major adverse cardiac and cerebrovascular event advantage in patients with concomitant 2VD or 3VD, this was completely driven by fewer revascularizations. Indeed, analysis of the safety composite end point (death stroke or MI) numerically favored PCI.In the 3VD subgroup, there were again no differences in all-cause mortality between the groups overall, and as with the left main analysis, there were fewer strokes after PCI. However, in contrast, there were statistically more MIs and numerically more revascularizations after PCI compared with CABG. However, as is often stated, not all 3VD is the same, with complexity varying from short-segment stenoses in 3 noncalcified arteries to diffuse calcified disease involving trifurcations and multiple chronic occlusions.The SYNTAX score, established from a synthesis of multiple established coronary lesion complexity scoring systems, was designed to take this in to account and to determine whether anatomic complexity correlates with clinical outcome,26 and it is expected to be widely used after the publishing of the Web-based scoring tool in May 2009. Indeed, in the highest tertile SYNTAX score subgroup, representing those with the most extensive and complex anatomy, major adverse cardiac and cerebrovascular event rates in patients who underwent PCI were significantly higher compared with CABG. On the other hand, subgroups with low or middle tertile scores had comparable outcomes after PCI or CABG. The differences observed in outcomes according to SYNTAX score tertile may also explain some of the unadjusted findings of observational studies such as the New York State registry. These findings suggest that PCI might be a reasonable option in patients with multivessel coronary disease with less complex anatomy. Intuitively, it would seem that those with more complex anatomy and more extensive disease would be less likely to achieve complete revascularization by PCI, perhaps underlying the better outcomes after CABG in the high SYNTAX score subgroup. It may well be that the derivation of the SYNTAX score turns out to be one of the more valuable contributions from this trial, and this may depend on the extent to which its use permeates into clinical practice.Final CommentsThe complexity of disease in the trial is worthy of discussion. When one considers that in the United States, the mean number of stents deployed per procedure is ≈1.6, the fact that the mean was 4.6�2.3 stents per patient in the SYNTAX trial, with 48% of patients having received ≥5 stents is highly noteworthy. In addition, the overall stented lengths are notable. In the ARTS-I and ARTS-II multivessel comparisons with CABG, mean stented lengths were 48 and 73 mm, respectively. In the SYNTAX trial, mean stented length was 86�47.5 mm, with one third of stented lengths being ≥100 mm, making this a study of the most complex coronary disease. This complexity may underlie the fact that the rate of stent thrombosis was 3.3% at 12 months in SYNTAX. Although this may compare with the rate of symptomatic graft loss over the same period (3.4%), this rate is only achieved after 4 years after PCI for conventional disease.27 Moreover, previous studies with DES would suggest that very late stent thrombosis will likely be relevant in the SYNTAX population in subsequent years, underscoring the critical importance in longer follow-up. That patients with such complex anatomy were entered into this trial is a testament to the technological advances that have characterized the last decade of PCI. Nonetheless, the long-term follow-up will be pivotal to the final verdict. The impact of multiple stents on endothelial function, coronary vasomotion, and subsequent clinical events, including the results and methods of repeat revascularization, requires rigorous scrutiny over the next few years. One also hopes that focus on secondary prevention does not wane over time.The SYNTAX study has been remarkable for a number of reasons. The all-comers design, complexity of disease, mandatory incorporation of a heart team, and use of methodology designed to generate meaningful answers applicable to individual patients will serve as a yardstick for future trial designs. Although it cannot be emphasized enough that data at 12 months must not be extrapolated over the longer term, the comparative safety of PCI compared with CABG in patients with very complex coronary disease is noteworthy, as is the demonstration that repeat revascularization remains the Achilles heal of PCI. Although it seems likely, it remains to be determined whether refinements in PCI performance, for example through the use of fractional flow reserve guided revascularization,28 newer stent iterations, and improved antiplatelet pharmacology, will strengthen the role for PCI in complex coronary disease. Without doubt, SYNTAX is a landmark trial and, like all good trials, has provided some answers but has also generated important new questions.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.DisclosuresNone.FootnotesCorrespondence to Bernard J. Gersh, MB, ChB, DPhil, FRCP, Department of Medicine, Division of Cardiovascular Diseases, Mayo Clinic, 200 First St SW, Rochester MN 55905. E-mail [email protected] References 1 Murphy ML, Hultgren HN, Detre K, Thomsen J, Takaro T. Treatment of chronic stable angina. a preliminary report of survival data of the randomized Veterans Administration Cooperative study. N Engl J Med. 1977; 297: 621–627.CrossrefMedlineGoogle Scholar2 Long-term results of prospective randomised study of coronary artery bypass surgery in stable angina pectoris. European Coronary Surgery Study Group. 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