Primary Stenting in Acute Myocardial Infarction
1998; Lippincott Williams & Wilkins; Volume: 97; Issue: 25 Linguagem: Inglês
10.1161/01.cir.97.25.2482
ISSN1524-4539
Autores Tópico(s)Cardiac Imaging and Diagnostics
ResumoHomeCirculationVol. 97, No. 25Primary Stenting in Acute Myocardial Infarction Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBPrimary Stenting in Acute Myocardial Infarction The Promise and the Proof Gregg W. Stone Gregg W. StoneGregg W. Stone From The Cardiovascular Institute, Mountain View, Calif. Originally published30 Jun 1998https://doi.org/10.1161/01.CIR.97.25.2482Circulation. 1998;97:2482–2485With the demonstration that the timely administration of thrombolytic therapy after coronary arterial occlusion results in myocardial salvage and improved survival, the treatment of patients with evolving AMI has forever been changed. To overcome the inherent limitations of thrombolytic therapy (TIMI 3 flow rates of ≈55% at best, and rare but unavoidable life-threatening or incapacitating hemorrhagic complications), mechanical reperfusion by balloon angioplasty without antecedent thrombolysis (primary PTCA) has been adopted at many centers. Ten prospective, randomized trials comparing primary PTCA and lytic therapy in 2606 patients have now been performed and examined in a recent meta-analysis by Weaver et al,1 demonstrating that compared with thrombolytic therapy, primary PTCA results in reduced rates of mortality, reinfarction, and stroke. Other randomized trials23 have shown that primary PTCA, by reducing early and late recurrent ischemic events and facilitating earlier discharge, is as or more cost-effective than thrombolysis.Despite these attributes, balloon-induced medial disruption and platelet activation result in recurrent ischemia in 10% to 15% of patients treated with primary PTCA before hospital discharge, including reinfarction in 3% to 5% of patients.4 Although improvements in operator technique, exclusive use of ionic contrast, and attention to anticoagulation status can minimize these complications,5 the significant residual stenosis remaining in many patients after balloon angioplasty, in concert with intimal hyperplasia, unopposed vessel recoil, and late remodeling, results in angiographic restenosis in 30% to 50% of infarct vessels within 6 months.4 As a result, ≈20% of patients after primary PTCA require TVR with repeat angioplasty or bypass surgery during this time period.4 Furthermore, not all operators have been able to achieve optimal results of primary PTCA at their institutions.With the demonstration that the implantation of balloon-expandable slotted-tube stents can reduce clinical and angiographic restenosis compared with PTCA in patients undergoing elective intervention,67 it might be natural to conclude that shifting from primary PTCA to a primary (routine) stent strategy in patients with AMI would similarly improve late outcomes. However, these early randomized trials of elective stenting were careful to exclude patients with acute ischemic syndromes (including AMI) and lesions containing thrombus, given the prior demonstration that subacute thrombosis rates are increased with the implantation of a metallic endoprosthesis into a thrombotic environment.8 With the reduction in subacute thrombosis rates realized with improved stent technique9 and the application of more effective antiplatelet regimens, including ticlopidine,10 the thrombus-laden lesion no longer represents a strict contraindication to stenting.As a prelude to initiation of randomized trials, the feasibility, safety, and efficacy of primary stenting in AMI have been examined in a number of observational and registry studies, the largest of which is the prospective PAMI Stent Pilot Trial. In this 9-center international cooperative effort, stenting (primarily with the Johnson & Johnson Palmaz-Schatz stent) was found to be feasible in 240 (77%) of 312 consecutive patients undergoing primary PTCA, with a 98% procedural success rate.11 Among the stented patients, 93.7% were event-free (alive, without reinfarction or TVR) at 30 days, and 83.3% were event-free at 6 months. When outcomes in the PAMI Stent Pilot Trial were compared with the 1100-patient PAMI-2 trial (99% of patients treated with PTCA only), the routine stent strategy was associated with improved clinical outcomes.12 Similarly favorable results were reported from the 18-center PAMI Heparin Coated Stent Pilot Trial, in which the 30-day and 7-month event-free rates in 101 patients with AMI were 97.0% and 81.2%, respectively, after implantation of heparin-coated Palmaz-Schatz stents.13While the PAMI investigators were toiling with pilot studies, Suryapranata and colleagues from the Hospital De Weezenlanden, Zwolle, The Netherlands, were boldly per- forming the first randomized trial of primary PTCA versus primary stenting (using the Palmaz-Schatz stent), the results of which are published in this issue of Circulation.14 Because this group has previously demonstrated the ability to achieve superb outcomes with primary PTCA alone,15 any findings favoring a primary stent strategy by these investigators would be particularly meaningful. At first glance, it is therefore quite remarkable that among the 227 randomized patients, the 6-month cardiac event–free rates were 95% after primary stenting versus 80% after primary PTCA (P<0.002). This difference in the composite primary end point was driven by reduced rates of reinfarction (1% versus 7%; P<0.04) and TVR (4% versus 17%; P<0.002) in the stent cohort, with no difference in mortality. Does this study represent the proof of the promise of primary stenting in AMI?Before we banish primary balloon angioplasty to the basement of the Museum of Natural History (along with other well-known interventional dinosaurs), the present report must be carefully analyzed in terms of its limitations and questions left unanswered. The authors would be the first to acknowledge the small sample size of the study (resulting in wide CIs) and the fact that it was performed at a single institution by operators highly experienced with acute infarct intervention. As such, the favorable results of the present study must be reproduced in larger, multicenter trials. In addition, the appropriately cautious entry criteria used resulted in a relatively low-risk population being enrolled. In this regard, the authors are to be commended for carefully registering and tracking outcomes of the patients excluded during the course of the study. Of note, only 50% of the patients with AMI undergoing primary PTCA by Suryapranata et al14 were considered to be clinically and anatomically eligible for stenting (in contrast to 77% of screened patients in the PAMI Stent Pilot Trial). As demonstrated in Tables 1 and 2 of their article, randomized patients compared with excluded patients were younger, more frequently male, more likely to have single-vessel disease, and less likely to be hemodynamically unstable. Reference-vessel size, a major determinant of late outcome after percutaneous intervention,16 was also significantly larger in the randomized cohort. Indeed, 124 patients (27%) were excluded for small vessel size or diffuse disease, in contrast to 11% of screened patients in the PAMI Stent Pilot.11 The results of the present study cannot therefore be necessarily extended to the sizable group of patients with excluded characteristics.Perhaps more importantly, given sample-size considerations, the possible play of chance cannot be ignored. In this regard, the 5% incidence of adverse cardiac events at 6 months in the stent arm of the present study (including 4% bypass surgery and 0% repeat PTCA) is among the lowest event rates (if not the lowest) ever reported after stenting in any population, and markedly less than the 17% to 19% rate of 6- to 7-month adverse outcomes in the 341 stented patients from the two PAMI pilot trials, which also used the Palmaz-Schatz stent. Moreover, despite the low-risk nature of the randomized population and the fact that 13% of patients assigned to primary PTCA received stents for suboptimal results, in-hospital reinfarction in the PTCA group still occurred in 3.5% of patients. In contrast, no patient in the first Zwolle randomized trial15 developed reinfarction after primary PTCA, despite enrollment of a higher-risk cohort who were treated with PTCA only without stent availability. Furthermore, intra-aortic balloon counterpulsation was used in 9 more patients (8%) in the stent group than in the PTCA group in the present study, which may also have contributed to the lower incidence of recurrent ischemia.17In addition to requiring that these favorable results be confirmed in other large-scale trials, many additional questions remain to be answered before primary stenting is routinely adopted. What patient and lesion characteristics respond best to acute infarct stenting? Given the obligatory amount of neointimal hyperplasia that occurs after stenting, will certain lesion subtypes, such as small vessels or long lesions, have equivalent or even worsened outcomes after primary stenting compared with PTCA? If an optimal PTCA result is obtained (eg, stenosis 80% of screened patients will be randomized. Patients receiving abciximab in CADILLAC (after either PTCA or stent) will receive no postprocedural heparin and, if stable, will be discharged on the second hospital day (day 3 in high-risk patients), making CADILLAC the most ambitious early-discharge study yet attempted. The CADILLAC trial began enrolling patients in late 1997, and results are expected in 1999. In addition, formal substudies in both PAMI and CADILLAC are examining the usefulness of intravascular ultrasound imaging after mechanical reperfusion of AMI, and the role of thrombectomy in occluded vein grafts is being investigated in CADILLAC.One fact is clear: as the 21st century approaches, we have entered an age in which clinical practice is powerfully influenced by the results of well-designed, prospective randomized trials. It is no small irony that after the introduction of primary PTCA, 17 years were required to randomize 2606 patients with AMI to PTCA versus thrombolytic therapy, whereas in the course of <3 years, ≈4000 patients will have been prospectively randomized to primary PTCA versus stenting. The intense global interest expressed in these ongoing trials attests to the conviction that primary stenting holds promise to be the next major breakthrough in the treatment of patients with AMI. Suryapranata and colleagues deserve credit for being at the forefront of this effort.Selected Abbreviations and AcronymsAMI=acute myocardial infarctionCADILLAC=Controlled Abciximab and Device Investigation to Lower Late Angioplasty ComplicationsPAMI=Primary Angioplasty in Myocardial InfarctionTIMI=Thrombolysis In Myocardial InfarctionTVR=target-vessel revascularizationReprint requests to Dr Gregg W. Stone, The Cardiovascular Institute, 2660 Grant Rd, Mountain View, CA 94040.The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association. References 1 Weaver WD, Simes RJ, Ellis SG, Grines CL, Zijlstra F, Garcia E, Grinfeld L, Gibbons RJ, Ribeiro EE, DeWood MA, Ribichini F. Comparison of primary coronary angioplasty and intravenous thrombolytic therapy for acute myocardial infarction: a quantitative review. JAMA.1997; 278:2093–2098.CrossrefMedlineGoogle Scholar2 Stone GW, Grines CL, Rothbaum D, Browne KF, O'Keefe J, Overlie P, Donohue B, Chelliah N, Vlietstra R, Catlin T, O'Neill WW. Analysis of the relative costs and effectiveness of primary angioplasty versus tissue-type plasminogen activator: the Primary Angioplasty in Myocardial Infarction (PAMI) Trial. J Am Coll Cardiol.1997; 29:901–907.CrossrefMedlineGoogle Scholar3 de Boer MJ, van Hout BA, Liem AL, Suryapranata H, Hoorntje JCA, Zijlstra F. A cost-effective analysis of primary coronary angioplasty versus thrombolysis for acute myocardial infarction. Am J Cardiol.1995; 76:830–833.CrossrefMedlineGoogle Scholar4 Stone GW, Grines CL, Topol EJ. Update on percutaneous transluminal coronary angioplasty for acute myocardial infarction. In: Topol E, Serruys P, eds. Current Review of Interventional Cardiology. 2nd ed. Philadelphia, Pa: Current Medicine; 1995:1–56.Google Scholar5 Grines CL, Stone GW, O'Neill WW. Establishing a program and performance of primary PTCA: the PAMI way. J Invas Cardiol.1997; 9:44B–52B.MedlineGoogle Scholar6 Serruys PW, de Jaegere P, Kiemeneij F, Macaya C, Rutsch W, Heyndrickx G, Emanuelsson H, Marco J, Legrand V, Materne P, Belardi J, Sigwart U, Colombo A, Goy JJ, van den Heuvel P, Delcan J, Marel MA, for the BENESTENT Study Group. A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. N Engl J Med.1994; 331:489–495.CrossrefMedlineGoogle Scholar7 Fischman DL, Leon MB, Baim DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M, Clemen M, Heuser R, Almond D, Teirstein PS, Fish RD, Colombo A, Brinker J, Moses J, Shaknovich A, Hirshfeld J, Bailey S, Ellis S, Rake R, Goldberg S, for the Stent Restenosis Study Investigators. A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. N Engl J Med.1994; 331:496–501.CrossrefMedlineGoogle Scholar8 Agrawal SK, Ho DSV, Liu MW, Iyer S, Hearn JA, Cannon AD, Macander PJ, Dean LS, Baxley WA, Roubin GS. Predictors of thrombotic complications after placement of a flexible coil stent. Am J Cardiol.1994; 73:1216–1219.CrossrefMedlineGoogle Scholar9 Nakamura S, Colombo A, Gaglione A, Almagor Y, Goldberg SL, Maiello L, Finci L, Tobis JM. Intracoronary ultrasound observations during stent implantation. Circulation.1994; 89:2026–2034.CrossrefMedlineGoogle Scholar10 Schomig A, Neumann FJ, Kastrati A, Schuhlen H, Blasini R, Hadamitzky M, Zitzmann-Roth EM, Richardt G, Alt E, Schmitt C, Ulm K. A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. N Engl J Med.1996; 334:1084–1089.CrossrefMedlineGoogle Scholar11 Stone GW, Brodie BR, Griffin JJ, Morice MC, Costantini C, St. Goar FG, Overlie PA, Popma JJ, McDonnell J, Jones D, O'Neill WW, Grines CL. A prospective, multicenter study of the safety and feasibility of primary stenting in acute myocardial infarction: in-hospital and 30 day results of the PAMI Stent Pilot Trial. J Am Coll Cardiol.1998; 31:23–30.CrossrefMedlineGoogle Scholar12 Stone GW, Brodie BR, Griffin JJ, Morice MC, Costantini C, St. Goar FG, Overlie PA, McDonnell J, Jones D, Grines CL. Improved short-term outcomes of primary stenting compared to primary angioplasty in acute myocardial infarction: the PAMI stent pilot trial. Circulation. 1997;96(suppl I):I-594. Abstract.Google Scholar13 Grines CL, Morice MC, Mattos L, Stone GW, O'Neill WW, Firth B, Fernandez EG, Kiemeney F, Jones D, Serruys P. A prospective, multicenter trial using the JJIS heparin-coated stent for reperfusion of acute myocardial infarction. J Am Coll Cardiol.1997; 29:389A. Abstract.CrossrefGoogle Scholar14 Suryapranata H, van't Hof AWJ, Hoorntje JCA, de Boer M-J, Zijlstra F. Randomized comparison of coronary stenting with balloon angioplasty in selected patients with acute myocardial infarction. Circulation.1998; 97:2502–2505.CrossrefMedlineGoogle Scholar15 Zijlstra F, DeBoer MJ, Hoorntje JCA, Reiffer S, Reiber JHC, Suryapranata H. A comparison of immediate coronary angioplasty with intravenous streptokinase in acute myocardial infarction. N Engl J Med.1993; 328:680–684.CrossrefMedlineGoogle Scholar16 Keane D, Azar AJ, de Jaegere P, Rutsch W, de Bruyne B, Legrand V, Kiemeneij F, de Feyter P, van de Heuvel P, Ozaki Y, Morel MA, Serruys PW. Clinical and angiographic outcome of elective stent implantation in small coronary vessels: an analysis of the BENESTENT trial. Semin Intervent Cardiol.1996; 1:255–262.MedlineGoogle Scholar17 Stone GW, Marsalese D, Brodie BR, Griffin JJ, Donohue B, Costantini C, Balestrini C, Wharton T, Esente P, Spain M, Moses J, Nobuyoshi M, Ayres M, Jones D, Mason D, Grines L, O'Neill WW, Grines CL. A prospective, randomized evaluation of prophylactic intraaortic balloon counterpulsation in high risk patients with acute myocardial infarction treated with primary angioplasty. J Am Coll Cardiol.1997; 29:1459–1467.CrossrefMedlineGoogle Scholar18 Brener SJ, Barr LA, Burchenal J, Katz S, George BS, Jones AA, Moliterno DJ, Topol EJ. A randomized, placebo-controlled trial of abciximab with primary angioplasty for acute MI: the RAPPORT trial. Circulation. 1997;96(suppl I):I-473. Abstract.Google Scholar19 Stone GW. Stenting in acute myocardial infarction: observational studies and randomized trials. J Invas Cardiol.1998; 10:16A–26A.MedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Machado-Duque M, Gaviria-Mendoza A and Machado-Alba J (2020) Real-World Effectiveness of Therapy With Rosuvastatin Combined With Fenofibric Acid in a Sample of Colombian Patients With Mixed Dyslipidemia, Journal of Primary Care & Community Health, 10.1177/2150132720977733, 11, (215013272097773), Online publication date: 1-Jan-2020. Chiadika S, Shobayo F, Naqvi S, Saraykar S, Ambrose C and Rianon N (2019) Lower femoral neck bone mineral density (BMD) in elderly women not on statins, Women & Health, 10.1080/03630242.2019.1567646, 59:8, (845-853), Online publication date: 14-Sep-2019. Dobesh P and Kasiar J (2002) Administration of Glycoprotein IIb-IIIa Inhibitors in Patients with ST-Segment Elevation Myocardial Infarction, Pharmacotherapy, 10.1592/phco.22.11.864.33632, 22:7, (864-888), Online publication date: 1-Jul-2002. Hong M, Park S, Lee C, Rhee K, Song J, Kang D, Song J, Kim J and Park S (2001) Six-month angiographic follow-up after intravascular ultrasound-guided stenting of infarct-related artery: Comparison with non–infarct-related artery, American Heart Journal, 10.1067/mhj.2001.114200, 141:5, (832-836), Online publication date: 1-May-2001. Herrmann H (2000) Triple therapy for acute myocardial infarction: combining fibrinolysis, platelet IIb/IIIa inhibition, and percutaneous coronary intervention, The American Journal of Cardiology, 10.1016/S0002-9149(00)00817-1, 85:8, (10-16), Online publication date: 1-Apr-2000. Herz I, Assali A, Solodky A, Shor N, Ben-Gal T, Adler Y and Birnbaum Y (2016) Coronary Stent Deployment Without Predilation in Acute Myocardial Infarction: A Feasible, Safe, and Effective Technique, Angiology, 10.1177/000331979905001104, 50:11, (901-908), Online publication date: 1-Nov-1999. Ochiai M, Isshiki T, Toyoizumi H, Eto K, Yokoyama N, Koyama Y, Takeshita S and Sato T (1999) Efficacy of transradial primary stenting in patients with acute myocardial infarction, The American Journal of Cardiology, 10.1016/S0002-9149(98)01050-9, 83:6, (966-968), Online publication date: 1-Mar-1999. Ryan T, Antman E, Brooks N, Califf R, Hillis L, Hiratzka L, Rapaport E, Riegel B, Russell R, Smith E, Weaver W, Gibbons R, Alpert J, Eagle K, Gardner T, Garson A, Gregoratos G, Russell R, Ryan T and Smith S (1999) 1999 update: ACC/AHA guidelines for the management of patients with acute myocardial infarction, Journal of the American College of Cardiology, 10.1016/S0735-1097(99)00351-4, 34:3, (890-911), Online publication date: 1-Sep-1999. Colombo A and Briguori C (1999) Primary stenting and glycoprotein IIb/IIIa inhibitors in acute myocardial infarction, American Heart Journal, 10.1016/S0002-8703(99)70336-4, 138:2, (S153-S157), Online publication date: 1-Aug-1999. Gersh B (1999) Optimal management of acute myocardial infarction at the dawn of the next millennium, American Heart Journal, 10.1016/S0002-8703(99)70342-X, 138:2, (S188-S202), Online publication date: 1-Aug-1999. June 30, 1998Vol 97, Issue 25 Advertisement Article InformationMetrics Copyright © 1998 by American Heart Associationhttps://doi.org/10.1161/01.CIR.97.25.2482 Originally publishedJune 30, 1998 KeywordstrialsEditorialsstentsmyocardial infarctionangioplastyPDF download Advertisement
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