Left Main Coronary Revascularization at the Crossroads

Abstract

HomeCirculationVol. 113, No. 21Left Main Coronary Revascularization at the Crossroads Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBLeft Main Coronary Revascularization at the Crossroads Dean J. Kereiakes and David P. Faxon Dean J. KereiakesDean J. Kereiakes From The Heart Center of Greater Cincinnati and The Lindner Center at The Christ Hospital, Cincinnati, Ohio (D.J.K.), and Brigham and Women’s Hospital, Boston, Mass (D.P.F.). Search for more papers by this author and David P. FaxonDavid P. Faxon From The Heart Center of Greater Cincinnati and The Lindner Center at The Christ Hospital, Cincinnati, Ohio (D.J.K.), and Brigham and Women’s Hospital, Boston, Mass (D.P.F.). Search for more papers by this author Originally published30 May 2006https://doi.org/10.1161/CIRCULATIONAHA.106.624882Circulation. 2006;113:2480–2484Percutaneous revascularization of left main coronary artery (LMCA) disease has remained controversial for more than 25 years, since LMCA balloon angioplasty was first performed by Andreas Gruentzig in 1978. Summarizing his experience, Gruentzig concluded, “We have not been too successful with dilating left main stems…although the procedure is relatively simple, the potential complications are both sudden and serious.”1 Following the evolution of percutaneous catheter-based therapies to include both bare metal stent and, more recently, drug-eluting stent (DES) platforms in conjunction with advances in periprocedural and postprocedural adjunctive pharmacotherapies, interest in percutaneous LMCA revascularization, particularly unprotected left main, has been renewed. Although studies performed with bare metal stents demonstrated a low rate of in-hospital mortality, the incidence of late coronary restenosis remained high.2–6 In the Unprotected Left Main Trunk Intervention Multi-Center Assessment (ULTIMA) registry, which enrolled 279 patients with unprotected LMCA disease who had percutaneous coronary revascularization (69% bare metal stent), mortality at a 1-year follow-up was proportional to clinical risk stratification (40% in high-risk versus 3.5% in low-risk patient cohorts), and repeated revascularization was required in 34% of cases.6 The experience gleaned from these studies continued to support the American College of Cardiology/American Heart Association (ACC/AHA) guideline recommendations that in reasonable surgical candidates with LMCA disease, coronary bypass surgery is the preferred therapeutic option.7 After the introduction of DES, several small clinical series demonstrated the feasibility and short-term safety of LMCA stenting, while late clinical/angiographic outcomes appeared favorable as compared with historical (nonrandomized) patient cohorts treated with bare metal stents.3,8–11 The cumulative experience with DES treatment for LMCA demonstrated an apparent marked reduction in major adverse cardiovascular events, including target vessel revascularization, during 6 to 12 months of follow-up as compared with the precedent experience after bare metal stent deployment.Article p 2542The clinical experience with DES for LMCA involves a broad spectrum of patients (including those with acute myocardial infarction complicated by cardiogenic shock) with a high prevalence of distal bifurcation disease in whom a variety of branch vessel techniques incorporating current DES were used (the Table).9–13 Patient clinical and angiographic features and the completeness of angiographic follow-up are widely variable in these reports. Not surprisingly, mortality in late follow-up (6 months to 2 years) ranges from 2.8% to 13%, and target lesion or vessel revascularization was performed in 6% to 38% of these cases. Thus, although both early and late clinical outcomes after DES implantation for LMCA revascularization appear favorable as compared with the historical experience with bare metal stents, the pivotally important questions about the relative safety and efficacy of percutaneous DES revascularization versus contemporary coronary bypass surgery remain. Left Main Coronary Revascularization With DESValgimigli et al9 (n=110)Lee et al12 (n=50)Price et al11 (n=50)Chieffo et al13 (n=107)MI indicates myocardial infarction; TVR, target vessel revascularization; and TLR, target lesion revascularization.*All 3 patients had distal bifurcation.†Eighteen of 19 patients had distal bifurcation.‡All 17 patients had distal bifurcation.Lesion location, % Ostium2542…… Body2620…… Distal70609481Bifurcation stent technique, % Single stent69338… Culotte20……11 T stent1310…… Crush5.5401659 Kissing2.71768· · · V stent………30Late follow-up Duration (mean), mo225.69.212 Death, %134102.8 Nonfatal MI, %5.4…211 TVR/TLR, %10/……/6*…/38†19.6/15.8‡ Stent thrombosis, %0…42 Angiographic follow-up, %66429885The Surgical “Gold Standard”On the basis of mostly randomized clinical trials conducted in the 1970s and 1980s, coronary bypass surgery has long been considered the gold standard for LMCA revascularization. In the cumulative experience of 7 comparative trials, surgical revascularization for LMCA disease was associated with a 65% relative reduction in mortality as compared with medical therapy.14,15 Furthermore, the enhanced durability of surgical revascularization using the internal mammary artery bypass graft has further improved the long-term surgical outcomes for this condition.16 Because 70% to 80% of these patients have concomitant double- or triple-vessel disease, bypass surgery has the potential advantage of providing more complete coronary revascularization than stenting. Indeed, the completeness of coronary revascularization has been correlated with improved long-term clinical outcomes, including less angina, fewer repeat revascularizations, and reduced mortality.17–19 However, information comparing the outcome of contemporary bypass surgery with percutaneous DES for LMCA revascularization has been limited.In a nonrandomized, single-center experience involving 123 patients who had surgery and 50 patients who underwent DES deployment for unprotected LMCA disease, despite higher surgical risk as reflected by the Parsonnet score in the DES-treated patients, major adverse cardiac and cerebrovascular events at 30 days were less frequent after DES implantation than after bypass surgery (2% versus 17%; P<0.01).12 At the 6-month follow-up, this difference in outcomes between treatment strategies was no longer statistically significantly but continued to favor the DES-treated group. The preliminary results of the Prospective, Randomized Trial of Stent Implantation Versus Bypass Graft Surgery in Patients With Left Main Coronary Artery Disease (LEMANS) trial, which were analyzed after enrollment of 105 patients with a limited duration of follow-up, also demonstrated the incidence of major adverse cardiovascular events to be similar after surgery or DES treatment.20The Current StudyIn this issue of Circulation, Chieffo et al13 provide a contemporary, nonrandomized, single-center experience in 249 patients with LMCA disease, 107 treated with DES and 142 surgically revascularized. Using a propensity score analysis to adjust for differences in baseline patient characteristics, Chieffo et al found that DES treatment was associated with a lower occurrence of the composite end points of death and myocardial infarction, as well as death, myocardial infarction, and cerebrovascular events, as compared with surgery. Conversely, surgery was associated with a lower rate of target vessel revascularization in follow-up. Finally, no differences in either mortality or the combined occurrence of major adverse cardiovascular and cerebrovascular events were observed at the 1-year follow-up between these revascularization strategies. How should the observations of Chieffo et al alter our current approach to LMCA revascularization? What important limitations or caveats to this study should be acknowledged?First, neither multiple variable regression analysis nor propensity scoring techniques can provide complete statistical adjustment for confounding variables often present in the comparison of nonrandomized patient cohorts. In addition, differentiating variables between these nonrandomly assigned patient groups that were not considered in the analysis are likely to exist. Furthermore, surgical therapy will be disadvantaged by the limited duration of follow-up (1 year) because the durability of surgical revascularization has been demonstrated to be superior to percutaneous revascularization in both this and prior studies. Longer-term follow-up is required to better determine the relative impact of durable and complete coronary revascularization on late survival. Of note, the somewhat arbitrary definition for non–Q-wave myocardial infarction used by Chieffo et al (elevation of serum creatine kinase-MB isoenzyme ≥5 times the upper limit of normal [>40 ng/mL] in the absence of pathological Q waves) that was applied equally to patients undergoing both surgical and DES revascularization strategies probably advantages the percutaneous approach. Indeed, a more graded relationship between periprocedural creatine kinase-MB elevation after coronary stenting and late mortality has been demonstrated,21,22 and appropriate “cutoff” levels that correlate with late outcomes are less well established after otherwise uncomplicated coronary bypass surgery.23 Thus, “setting the bar” at ≥5-fold the upper limit of normal for creatine kinase-MB (versus ≥2- or 3-fold) after DES treatment may have contributed to the relatively “better” short-term outcomes observed as compared with surgery. Finally, anatomic considerations about the complexity of stenting for distal LMCA stenoses are critically important to both the early and long-term outcomes of percutaneous DES revascularization but have little or no influence on surgery. Indeed, in the cumulative experience for LMCA DES treatment, both stent thrombosis and late restenosis are observed predominantly in those patients with distal LMCA bifurcation stenosis.8–13 For example, target lesion revascularization after DES deployment involved a distal LMCA bifurcation in 3 of 3 cases reported by Lee et al,12 in 18 of 19 cases reported by Price et al,11 and in all 17 cases reported by Chieffo et al13 in the present series. The challenges of technical approach and operator technical proficiency and the intrinsic limitations in current DES technology for branch vessel application severely limit any attempt to generalize the experience of Chieffo et al to the broader spectrum of interventional practice. Furthermore, advances in stent technologies designed for coronary branch vessel/bifurcation application currently in development may render the observations of Chieffo et al obsolete.The “Crossroads” of Left Main Coronary StentingBoth early and late outcomes after ostial/proximal or mid-LMCA DES implantation are limited only by the available caliber of the DES (3.5 mm in the United States) and the mechanical limitations placed on current DES overexpansion (4.75 mm for Cypher, 4.25 mm for Taxus). Within these constraints and the relatively limited duration of clinical follow-up currently available (<5 years), the experience to date after DES implantation for proximal and mid-LMCA stenosis appears highly competitive with surgical revascularization. However, most LMCA stenoses are distal and have bifurcation or trifurcation involvement at the origins of the left anterior descending, ramus intermedius, and/or circumflex coronary arteries.The complexities of providing mechanical stent coverage for both scaffolding and uniform drug delivery with current DES deployment for bifurcation stenoses are well appreciated.24,25 Inadequate coverage at the ostium of the side branch, particularly opposite the carinum, makes this site the most frequent location for restenosis after conventional stenting of branch vessel stenoses.24,25 Attempts to provide better stent coverage of the side-branch origin by using the culotte, crush, or kissing stent techniques create multiple layers (2 to 3 layers) of metal26 and permanent polymer (4 to 6 layers) and are associated with an increased incidence of stent thrombosis.27 In addition, nonuniform stent strut distribution is associated with variable drug delivery and a subsequent increase in neointimal thickness and restenosis.28,29 Several novel technologies in development for branch-vessel treatment include provisional main branch bifurcation stents (Guidant Frontier,30 MinVasys, Cordis, etc), a side-branch stent (Tryton) that provides a “facilitated culotte” result, a proximal main-branch bifurcation self-expanding nitinol cone (Devax), and dedicated branch vessel stent devices (Boston Scientific’s Petal stent, the Cordis Y-stent, etc). Unlike current DES types, these devices are specifically designed for branch vessel application and thus provide more uniform endoluminal scaffolding/coverage with less stent metal and polymer overlap. The availability of DES devices specifically designed for branch vessel application should render obsolete the clinical and angiographic results obtained with current DES for distal LMCA bifurcation stenoses.Left Main StentingWe believe that the current practice of unprotected LMCA stenting with current DES platforms is highly variable and should be prudently constrained by specific considerations. These procedures are best performed electively by high-volume interventional operators in high-volume institutions with on-site surgical support and with the routine use of intravascular ultrasound both preprocedurally for optimal stent sizing and after DES deployment to ensure optimal stent expansion, symmetry, and apposition. Periprocedural intra-aortic balloon pump support may be used prophylactically in patients with severe left ventricular dysfunction (eg, left ventricular ejection fraction ≤35%) and/or a clinical history of heart failure. Stent deployment and predilatation and postdilatation balloon inflations should be performed rapidly with short total inflation durations. More rapid balloon inflation and deflation cycles can be achieved with contrast-to-water mixtures of <1:1. We endorse the current ACC/AHA guideline Class IIa recommendation for elective coronary angiography to be performed 2 to 6 months after LMCA stenting.31 Indeed, the lack of systematic angiography in late follow-up represents a weakness in the current LMCA DES experience (the Table). At present, patients should be fully informed of the potential risks of the procedure in the context of limited data. Optimally, only patients at increased risk for CABG and those who refuse to undergo CABG should be considered. Percutaneous revascularization of unprotected LMCA stenoses with DES probably should be limited to proximal and/or midshaft stenoses that can be treated with a single stent and more simple distal bifurcation stenoses that can be treated with V, T, or kissing stent techniques using current DES platforms. Optimal performance of the more complex culotte or crush branch vessel stent techniques depends more on individual operator experience and technical proficiency, and suboptimal deployment may have catastrophic subacute or late consequences.26,27 Indeed, the presence of distal LMCA stenosis location was an independent predictor of major adverse cardiovascular events after DES deployment by multivariate analysis.32When DES devices designed specifically for branch vessel application are available, greater confidence in the long-term results of percutaneous distal bifurcation LMCA revascularization will accrue, we hope, so that the reliability of percutaneous (versus surgical) revascularization strategies is enhanced. Furthermore, the rapid evolution of catheter-based DES technologies designed specifically for branch vessel application may render the results of ongoing randomized controlled clinical trials comparing DES treatment and surgical coronary revascularization, which include LMCA stenoses (Randomized Comparison of Bypass Surgery versus Angioplasty Using Sirolimus-Eluting Stent in Patients With Left Main Coronary Artery Disease [COMBAT] and Synergy Between PCI with Taxus Drug-Eluting Stent and Cardiac Surgery [SYNTAX] trials), less relevant.Finally, the duration of combination antiplatelet therapies after LMCA DES deployment is inadequately addressed by Chieffo et al,13 who appear to enter unchartered waters with a false sense of security, as reflected by the comment, “We could therefore assume, even if not demonstrated, that the extended 1-year therapy could be sufficient in the more complex anatomic setting such as bifurcational stenting.” Indeed, bifurcation DES deployment has been a significant predictor of subsequent stent thrombosis in multiple analyses,33,34 and the specter of increased late stent thrombosis (6 months to 2 years) after DES placement (versus bare metal stents) has been raised.35–37 Considering the complexities of the distal LMCA bifurcation stent techniques used in the Chieffo et al series (59% crush, 11% culotte), the likelihood of complete stent endothelialization and endoluminal healing is remote. Pathological studies suggest that delayed or incomplete late endothelial coverage is more likely to occur after DES (versus bare metal stent) use, particularly in situations involving stent overlap.38–40 Until better data on the necessary duration of therapy are available, we believe that patients who undergo complex distal LMCA bifurcation DES deployment should be consigned to dual antiplatelet therapy indefinitely. Furthermore, in those patients who are known to be resistant to aspirin and/or are hyporesponsive to clopidogrel, consideration should be given to increasing the dose of clopidogrel (150 mg/d) or changing to another agent(s), particularly if <50% inhibition of platelet aggregation has been demonstrated on once-daily (75 mg) therapy (ACC/AHA Class IIb recommendation).31Within the caveats and constraints intrinsic to a nonrandomized, single-center experience with limited follow-up, the work of Chieffo et al13 is a sophisticated attempt to advance our experience and knowledge base of LMCA revascularization in the current era of DES. This work, by highly skilled interventional operators, also confirms the complexities of distal LMCA bifurcation treatment with current DES platforms. Much longer follow-up is required to ascertain the relative benefits and durability of surgical versus percutaneous revascularization. Nevertheless, one of the final bastions of surgical revascularization therapy, LMCA disease has arrived at the crossroads of our therapeutic paradigm. Percutaneous revascularization has become a viable therapeutic option in selected patients. Furthermore, currently available technologies for percutaneous LMCA revascularization are at the “crossroads” for therapeutic innovation with the introduction of better stent platforms and more effective adjunctive pharmacotherapies close at hand. These developments will likely advantage the percutaneous revascularization strategy for LMCA disease. Nevertheless, at least for the near future, surgical revascularization for more complex bifurcation distal LMCA stenoses continues to represent the most durable and reliable treatment option.The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.DisclosuresDr Kereiakes serves on advisory boards for Cordis J&J, Boston Scientific, Medtronic, and Guidant. Dr Faxon serves on advisory boards for Boston Scientific, Bristol-Myers Squibb, Sanofi, and Cordis J&J.FootnotesCorrespondence to Dean J. Kereiakes, MD, The Heart Center of Greater Cincinnati and The Lindner Center at The Christ Hospital, 2123 Auburn Ave, Ste 424, Cincinnati, OH 45219. E-mail [email protected] References 1 Gruntzig AR, Senning A, Siegenthaler WE. Nonoperative dilatation of coronary-artery stenosis: percutaneous transluminal coronary angioplasty. 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