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Directional Coronary Atherectomy

1998; Lippincott Williams & Wilkins; Volume: 97; Issue: 4 Linguagem: Inglês

10.1161/01.cir.97.4.309

1524-4539

David O. Williams, Mary C. Fahrenbach,

Cardiac Imaging and Diagnostics

HomeCirculationVol. 97, No. 4Directional Coronary Atherectomy Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyRedditDiggEmail Jump toFree AccessEditorialPDF/EPUBDirectional Coronary Atherectomy But Wait, There's More David O. Williams and Mary C. Fahrenbach David O. WilliamsDavid O. Williams From the Division of Cardiology, Department of Medicine, Rhode Island Hospital, Brown University School of Medicine, Providence, RI. and Mary C. FahrenbachMary C. Fahrenbach From the Division of Cardiology, Department of Medicine, Rhode Island Hospital, Brown University School of Medicine, Providence, RI. Originally published3 Feb 1998https://doi.org/10.1161/01.CIR.97.4.309Circulation. 1998;97:309–311Directional coronary atherectomy (DCA) was originally developed as a potential replacement for balloon angioplasty. The design of the catheter used to perform DCA offered several unique advantages. First, it was capable of removing obstructive atherosclerotic lesions. Thus rather than rearranging plaque within an artery as occurs with balloon angioplasty, the obstruction was relieved by reduction of the plaque mass. Second, certain lesions with characteristics unfavorable for balloon angioplasty appeared to be ideally suited for DCA. Since the atherectomy catheter had a cutting window that could be positioned rotationally as well as longitudinally within an artery, eccentric plaque could be removed selectively. Similar benefits were anticipated from lesions located at important coronary bifurcations, such as those involving the left anterior descending coronary artery and origin of the diagonal branch. Finally, tissue removed by DCA was available for analysis to expand our knowledge about coronary atherosclerosis. Samples of coronary atheroma could be examined grossly and microscopically1 and studied by immunohistochemistry.2Initially, the value of DCA was assessed by means of a large registry that catalogued acute and late clinical outcomes.3 When compared with a historical control, the results of DCA appeared comparable to or better than those achieved by balloon angioplasty. There was a sense that the incidence of serious coronary dissection and abrupt occlusion after DCA was less than that after balloon angioplasty.4DCA became the first of the "new" percutaneous, catheter-based devices approved for the treatment of coronary disease in the United States. Interestingly, unlike current "new devices," approval did not require the performance of a randomized, clinical trial. DCA was quickly and enthusiastically embraced by the interventional community. During this early phase of its use, DCA was performed without adjunctive balloon angioplasty; that is, the DCA catheter was used alone and not in combination with any other device.Shortly after commercialization, two randomized, controlled clinical trials comparing the effectiveness and safety of DCA with that of balloon angioplasty were undertaken. One (CCAT) was limited to patients with lesions located in the left anterior descending coronary artery; the other (CAVEAT) included patients with lesions in any of the native coronary arteries. Because of a desire to complete these trials promptly, enrollment was performed at many clinical sites at a time when DCA itself was relatively new and when the operators who performed DCA were early in their learning curves.The results of CAVEAT and CCAT were unexpected. In CAVEAT, DCA was associated with a higher incidence of death and myocardial infarction than balloon angioplasty.56 Alarmingly, multivariable analysis identified "having DCA performed" as an independent predictor of poor outcome. Furthermore, the rates of restenosis were high in both treatment groups, with only a small difference favoring DCA. CCAT, the trial limited to patients with left anterior descending disease, demonstrated a better initial angiographic outcome in the DCA group than in the angioplasty group but no difference in clinical outcome at 6 months of follow-up.7 A third trial evaluated the value of DCA in patients with diseased aortocoronary venous bypass grafts.8 DCA was associated with a higher incidence of embolization of debris to the distal coronary circulation than balloon angioplasty; 6-month restenosis rates were similar. These trials caused interventional cardiologists to question the value of DCA. Accordingly, usage shifted from routine to discretionary, primarily for problematic lesions that were known to respond poorly to balloon angioplasty.A more devastating blow to DCA came with the release of the intracoronary stent. Convincing data showed superiority of stenting over balloon angioplasty in improving both angiographic and clinical outcome.910 Stents made angioplasty safer, predictably more successful, and decreased the incidence of restenosis by about one third. Importantly, stents were particularly well suited for proximal, complex lesions in large coronary vessels, the very same lesions in which DCA seemed most applicable. Although no head-to-head comparison has been performed, one case-matched study demonstrated lower rates of restenosis and need to perform repeat target lesion revascularization in stent patients compared with DCA patients.11We are now presented with new information about DCA. In this issue of Circulation, Baim and coinvestigators report the results of the Balloon Versus Optimal Atherectomy Trial (BOAT).12 This randomized, controlled clinical trial again compares coronary angiographic and clinical outcomes of patients treated by balloon angioplasty with those treated with DCA. In BOAT, DCA was performed differently than in prior trials. Operators attempted to achieve the largest possible arterial lumen by using DCA more aggressively and supplementing it with balloon angioplasty. Stenting in angioplasty patients was restricted to those with suboptimal results.BOAT showed the following. DCA achieved a larger initial lumen and a higher procedural success rate than balloon angioplasty, without an increased risk of death, Q-wave myocardial infarction, and need for coronary artery bypass surgery. Furthermore, DCA resulted in a lower rate of restenosis than did balloon angioplasty. On the other hand, coronary perforation, although infrequent, was observed only in DCA patients, and 34% of DCA patients experienced detectable elevations in serum levels of CK-MB. Despite less angiographic restenosis among DCA patients, DCA did not reduce the chance of needing repeat revascularization.The results of the "optimal" DCA performed in BOAT are different from DCA performed in CAVEAT. Adjunctive balloon angioplasty was used in 81% of BOAT patients assigned to DCA versus none in CAVEAT. Acutely, the coronary lumen after DCA in BOAT was larger than that in CAVEAT, and both the restenosis rate and the need for repeat revascularization were lower in BOAT. Of note, the results of balloon angioplasty in BOAT were also better than balloon angioplasty in CAVEAT, reflecting overall improvements in interventional technique and practice. Perhaps most importantly, BOAT seemed to exonerate DCA from being a "toxic" procedure, as the mortality rate of DCA patients was not higher than angioplasty patients.With the acceptance of this new information, what is the role for DCA at this point? A balanced review warrants reexamining the results of BOAT. DCA and balloon-treated patients had equal rates of death, Q-wave myocardial infarction, and need for repeat revascularization over the course of 1 year. In terms of these major clinical events, there was no superiority of one procedure over the other. DCA patients had a small but real chance for coronary perforation, and one third experienced an increase in CK-MB levels. In acknowledgment of the controversy about the significance of asymptomatic increase in CK-MB levels,13 if all else is equal and balloon angioplasty is technically easier than DCA, then there is little reason to select DCA over balloon angioplasty.BOAT (and DCA) still needs to deal with the issue that contemporary interventional cardiology means aggressive use of stents. As the technique of stenting continues to be refined, clinical results look better and better. Serious bleeding after stenting is now uncommon, since aggressive anticoagulation has been replaced by antiplatelet therapy.14 Certainly subacute thrombosis remains a concern, but this event is now infrequent. Currently, the scope of stenting extends to a broad range of coronary disease settings,1516 and rates of restenosis and repeat revascularization are reported in the single-digit range.17 Adjunctive local radiation promises to further enhance the durability of stenting alone.18The challenge of DCA is not to be better than balloon angioplasty but to be better than angioplasty plus stenting. In the absence of hard data showing either superiority over stenting or the value of combining DCA with stenting, DCA will not be an everyday interventional procedure. DCA will probably remain alive in some laboratories as a "niche" technique. When DCA is used, attention should be paid to incorporating "optimal" techniques to enhance the opportunity for a favorable outcome. Concern exists, however, about the ability of operators to maintain a high skill level for procedures that are performed infrequently.One final but very significant concern emerges as a consequence of BOAT. When in the course of its development should a new, unique treatment be compared with a conventional treatment by means of a randomized controlled clinical trial? It is fair to say that CCAT and CAVEAT evaluated DCA too early. The technique for performing DCA was less than optimal, and DCA suffered as a result. Rather than leaping to an early randomized trial, perhaps a stepwise series of sequential observational studies should be considered as an initial approach. In this fashion, the safety and effectiveness of a new device could be characterized by a process analogous to dose-ranging trials of pharmaceuticals. Gentle probing of the envelope will be necessary to determine the limits of response and toxicity. We would prefer to get the correct answer on the first pass rather than having to be told "but wait, there's more."The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.The authors acknowledge the secretarial assistance of Arlene S. Grant and the critical review of the manuscript by Barry L. Sharaf, MD.FootnotesCorrespondence to David O. Williams, MD, Division of Cardiology, APC 434A, Rhode Island Hospital, 593 Eddy St, Providence, RI 02903. E-mail [email protected] References 1 Waller BF, Johnson DE, Schnitt SJ, Pinkerton CA, Simpson JB, Baim DS. Histologic findings of directional atherectomy samples: a review of findings and their clinical significance. Am J Cardiol.1993; 72:80E–87E.MedlineGoogle Scholar2 Isner JM, Kearney M, Bortman S, Passeri J. Apoptosis in human atherosclerosis and restenosis. 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Abstract.Google Scholar15 Laham RJ, Ho KKL, Baim DS, Kunta RE, Cohen DJ, Carrozza JP. Multivessel Palmaz-Schatz stenting: early results and one-year outcome. J Am Coll Cardiol.1997; 30:180–185.CrossrefMedlineGoogle Scholar16 Mathew V, Hasdai D, Holmes DR, Garratt KN, Bell MR, Lerman A, Melby S, Grill DE, Berger PB. Clinical outcome of patients undergoing endoluminal coronary artery reconstruction with three of more stents. J Am Coll Cardiol.1997; 30:676–681.CrossrefMedlineGoogle Scholar17 Serruys PW, Emanuelsson H, van der Giessen W, Lunn AC, Kiemeney F, Macaya C, Rutsch W, Heyndrickx G, Suryapranata H, Legrand V, Goy JJ, Materne P, Bonnier H, Morice MC, Fajadet J, Belardi J, Colombo A, Garcia E, Ruygrok P, de Jaegere P, Morel MA, on behalf of the Benestent-II Study Group. Heparin-coated Palmaz-Schatz stents in human coronary arteries: early outcome of the Benestent-II Pilot Study. Circulation.1996; 93:412–422.CrossrefMedlineGoogle Scholar18 Tierstein PS, Massullo V, Jani S, Popma JJ, Mintz GS, Russo RJ, Schatz RA, Guarneri EM, Steuterman S, Morris NB, Leon MB, Pripuraneni P. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med.1997; 336:1697–1703.CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetails February 3, 1998Vol 97, Issue 4Article InformationMetrics Download: 500 Copyright © 1998 by American Heart Associationhttps://doi.org/10.1161/01.CIR.97.4.309 Originally publishedFebruary 3, 1998 KeywordstrialsEditorialsatherosclerosissurgeryPDF download