doi: 10.1161/CIRCINTERVENTIONS.108.810853
Controversies in Interventional Cardiology |
Should dual antiplatelet therapy after drug-eluting stents be continued for more than 1 year?
Dual Antiplatelet Therapy After Drug-Eluting Stents Should Not Be Continued for More Than 1 Year and Preferably Indefinitely
From the Catheterization Laboratory, San Raffaele Scientific Institute, Milan, Italy; and EMO-GVM Centro Cuore Columbus, Milan, Italy.
Correspondence to A. Colombo, EMO-GVM Centro Cuore Columbus, Via Buonarroti 48, 20145 Milan, Italy. E-mail colombo{at}emocolumbus.it
 |
Introduction |
|---|
 Top Introduction A Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
Drug-eluting stents (DES) have significantly reduced the occurrence of in-stent restenosis with a coexistent reduction in revascularization compared with bare metal stents (BMS).1–4 In September 2006, at the World Congress of Cardiology/European Society of Cardiology in Barcelona, a signal appeared of increased risk with DES more than BMS, namely that of late stent thrombosis.5 Although the concerns at that time were overemphasized and hyped6 by the media, when the smoke settled, more rigorous studies7 and standardized definitions of stent thrombosis8 demonstrated real ongoing concerns of late stent thrombosis.9 Potential mechanisms for stent thrombosis are described in Figure 110–15 and in the Table.11,14–28 Subsequent studies then suggested possible benefits from prolonged (>6 months) dual antiplatelet therapy (DAT) after DES implantation in reduction in clinical events.29,30 This prompted the Food and Drug Administration (FDA) to issue a guideline that patients should take DAT for up to 12 months after DES insertion based on indirect data and without a specific prospective study.31 We think the best way to address these issues is with the following Life Scenario.
|
|
Response by Chhatriwalla and Bhatt p 217
|
A Life Scenario |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
Let us assume that I had symptomatic coronary artery disease with stable angina for which I saw my local cardiologists and he performed noninvasive testing and the stress test was positive. I ended up with a percutaneous coronary intervention (PCI) 2 weeks later, and after a load of clopidogrel, I had 2 stents inserted: a Taxus 3.5x20 mm (Boston Scientific, Natick, Mass) implanted in my proximal right coronary artery and a 3.0x33 mm Cypher (Cordis Corp, Johnson & Johnson Company, Miami Lakes, Fla) in the mid portion of my left anterior descending coronary. Everything went well and I am now asymptomatic with a negative exercise test. After 1 year of clopidogrel and aspirin dual therapy with no side effects, except for having to pay for the extra 6-month treatment because not every country may cover the cost of clopidogrel 6 months beyond PCI, I am now faced with the decision of what to do?
|
Why Should I Continue Clopidogrel for 1 Year and Stop It at the End? |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
With 2 DES implanted on 2 major epicardial vessels, there is no question that I should continue DAT for
6 months according to the original guidelines derived from the specific pivotal randomized trials.1–4,32 After having read those trials, I am really perplexed by the evidence supporting the perceived arbitrary decisions of 3 months for Cypher (2 months if you live in Europe)33 and 6 months for the Taxus stent.4 The appearance of late stent thrombosis, occurring after 30 days,8 has made things slightly complicated. First, we ought to step back and try to understand late stent thrombosis. Having continued DAT for 6 months, I am delighted that I did not experience any late stent thrombosis in the seemingly early period. Now, according to the new recommendations of the American Heart Association/American College of Cardiology/Society for Cardiovascular Angiography and Interventions/American Cancer Society/American Dental Association panel, I may have to extend my DAT to 12 months.31 The original question is now rephrased: Should I continue to take DAT to prevent late thrombosis >12 months after DES implantation? Unfortunately, the more I try to unfold the puzzle the less clear it becomes. When I look at reports regarding late stent thrombosis and very late stent thrombosis, I see a lot of events occur during the 6- to 12-month and after the 12-month period from stenting.34–36 Some of them happen in patients who stop clopidogrel, some in patients who still receive DAT,20,34,37–41 and some in patients who stop aspirin and clopidogrel.20,34,38 In our recent study,20 we reported that between 6 and 12 months, the stent thrombosis rate was 0.2% in patients who stopped clopidogrel and continued aspirin and 0.4% in patients taking DAT; between 12 and 18 months, stent thrombosis rates were 0.1% and 0.4% in patients without clopidogrel and with DAT, respectively (Figure 2). The perceived constant rise in the risk of very late stent thrombosis as demonstrated in the study of Daemen7 should be evaluated with caution as the main limitation with this conclusion lies in the number of patients at risk, which at 1 year was 5549, whereas at 3 years, it dropped significantly and was 989. The decline in the number at follow-up results in a much larger confidence interval. Having accepted this fact, it means that whatever I do I will never be protected but what I need to understand now is about the possible benefit of continuing clopidogrel beyond the recommendations of American Heart Association/American College of Cardiology/Society for Cardiovascular Angiography and Interventions/American Cancer Society/American Dental Association.31
|
The next area of uncertainty comes after reading the American Heart Association document and trying to figure out why they set the 1 year term. The best answer I can find is by looking at reference 21 of the original article31 by Eisenstein et al, which reported only the incidence of death and MI without any specific mention of ST. As a matter of fact, one interesting finding from this study is that continuation of DAT for
24 months (the time duration of the study) is helpful no matter if you had a DES or BMS implanted. Another study which highlights the concern of very late stent thrombosis is the late follow-up of the Basel Stent Kosten-Effektivitäts Trial (BASKET) trial,30 in which the event rates after discontinuation of clopidogrel between 7 and 18 months were 4.9% after DES versus 1.3% after BMS implantation. Unfortunately, at best, there were only 499 patients with DES and late follow-up (18 months) in the BASKET-LATE study, with 230 patients who had late follow-up in the Eisenstein et al study.29 Now if I turn my attention to the various case reports on late and very late stent thrombosis (occurring after 6 months or 1 year)34 I can see a considerable number of events occurring after 1 year from stenting at variable time intervals from clopidogrel discontinuation. The most important impression that I can glean from examining these studies is that discontinuation of aspirin and clopidogrel, even at a late time, is very frequently associated with stent thrombosis. This conclusion is also derived from clinical experience as we know that the most patients continue with at least aspirin therefore the denominator of the population not taking aspirin and clopidogrel must be quite small. Unfortunately it is difficult to elaborate in the same manner for clopidogrel because we cannot assume as with aspirin that clopidogrel continues to taken indefinitely. So far, I have come to the following conclusion from my literature search: (1) I am not going to ever stop aspirin and (2) despite the American Heart Association/American College of Cardiology/Society for Cardiovascular Angiography and Interventions/American Cancer Society/American Dental Association guidelines and the lack of proof for sustained DAT, I do not feel too comfortable about stopping clopidogrel after 1 year. I am afraid of the unpredictable occurrence of rare events even if not necessarily correlated to clopidogrel discontinuation.
|
Why Should I Continue Clopidogrel Indefinitely? |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
Except for one article published from our group,20 there are no data concerning what happens to patients who stop clopidogrel and to those who continue DAT. Studies have focused on the details in individual patients who stopped clopidogrel then subsequently sustained an adverse event, but basically we lack the common denominator. One study that attempted to estimate the risk of DES thrombosis if one stopped clopidogrel calculated a 90% hazard ratio.21 Moreover, what is frequently overlooked is that the hazard ratio refers to "premature discontinuation," which means stopping clopidogrel before 6 months from stenting,21 and nothing is reported regarding the risk of stopping clopidogrel after 6 months. The study by Airoldi et al tried to answer this question and concluded that the risk of late discontinuation of clopidogrel is probably very low or absent, but this conclusion has limitations as there were a low number of patients evaluated. This highlights the problem that all studies face when trying to tease out the etiology of this event. It is difficult to make definitive statements about a low-frequency event such as late and very late stent thrombosis unless you perform a prospective study aimed to evaluate a difference in stent thrombosis between 1 year and 2 to 3 years. Such a study will need to enroll several thousand patients, depending on the superiority or noninferiority design and on the
in the incidence of very late stent thrombosis (DAT versus only aspirin). We need to take into account that clopidogrel will be protective against ischemic events not necessarily related to thrombosis of the DES. This situation will increase the prevalence of confounding factors and demand a very large sample size. Figure 3 illustrates this problem: this patient had DES implanted for a totally occluded left anterior descending artery (panel A and B). Eight months later, while still on DAT, he underwent a scheduled routine follow-up angiogram demonstrating a severe stenosis proximal to the stented segment (panel C). It is feasible that without DAT this high-grade stenosis may cause an acute event that could be labeled a definite or probable stent thrombosis. These are the sort of confounding factors present in real life that need to be considered in any prospective study. Moreover, I could get very worried when I look at the 23 500 patients in the Estudio Espanol Sobre Trombosis de Stents Farmacoactivos (ESTROFA) Registry42 and see that in 90 patients with late stent thrombosis and in 62 patients with very late stent thrombosis, more than 60% of them were only taking aspirin. Therefore, I may instinctively conclude that if I continue to take DAT, then I should be at lower risk because only 22% of the patients with late stent thrombosis and 8% with very late stent thrombosis were taking DAT.42 This notion is indeed appealing and reassuring but could be false unless we know the total number of patients taking single, dual, and no antiplatelet therapy who did not sustain a thrombotic event. Paradoxically, if in the whole registry there were only 25 patients taking DAT, this combination would be regarded as fatal with regard to stent thrombosis. The fact that the authors did not have information regarding the status of antiplatelet therapy in people who did not sustain stent thrombosis is apparent because the discontinuation of DAT was not listed among the predictors of late or very late stent thrombosis.42 Among the confounding risk factors for late stent thrombosis, we should consider that over the natural time course, many patients may discontinue DAT.
|
In addition, I have to deal with the risk of bleeding associated with DAT over this extended time period. The largest study I could find that provides me with some robust data is the CHARISMA trial,43 in which the risk of severe bleeding with DAT was 1.7% versus 1.3% on aspirin monotherapy, with an increased relative risk of 1.25; however, the 9-month to 3-year bleeding rate was similar. To conclude on this matter, we need to examine the large network meta-analysis by Stettler,44 which makes me less depressed at having a DES rather than a BMS in my coronary arteries. This is because the overall risk of experiencing a real hard clinical end point such as death or MI is not higher in the DES cohort. In addition, stent thrombosis is not higher compared with BMS. I know that by having a DES, I will secure for myself a longer period of freedom from a second procedure and the inherent risks associated with that. This study unfortunately provides no information on DAT, but I can presume that the practice in Europe at that time was to prescribe DAT for a maximum of 3 months after Cypher and 6 months after Taxus. Interestingly, I note that in our study (data collected from Italy and Germany), 75% of the patients were taking only aspirin and the risk of stent thrombosis after 1 year was
1.5% to 2% per year.20 Unfortunately, I do not know the exact figure if I decide to continue DAT long term. The reassuring part is that the 1.5% to 2% risk over 1 year should not generate too much panic if say I occasionally forget my clopidogrel. |
What Should I Do if I Need Surgery? |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
The worst thing that could happen would be that I need to undergo urgent surgery in the first 6 months following DES implantation. Assuming that the surgery cannot be delayed, I would do my best to find a surgeon who is willing to operate without interruption of DAT. If this goal is unachievable, then I will negotiate that I stop clopidogrel 3 days before surgery and restart 48 to 72 hours after the surgery. The literature has a number of reports even after the implantation of BMS about early discontinuation of DAT and stent thrombosis, MI, and death.45,46 I would certainly not take low-molecular heparin as a substitute to antiplatelet therapy, a strategy commonly perceived by some surgeons as the correct way to bridge antiplatelet therapy around the perisurgical period. Heparin can activate platelets, so without a strong antiplatelet therapy on board, the situation can be compounded and become more deleterious than beneficial.47 If the surgery is not urgent, then I would do my best to delay it as much as possible ideally for 6 to 12 months, and I would still not stop aspirin and accept a very short window of being without clopidogrel. I may even consider storing my own blood before surgery in case I require a blood transfusion. The possibility to bridge the time without clopidogrel with an infusion of IIb/IIIa as suggested48 is an innovative proposal but may encounter some obstacles from surgeons. Furthermore, one study using a new short-acting antiplatelet demonstrated reduced bleeding in patients who required emergency coronary artery bypass graft after acute coronary syndromes.49 The role that this agent could play in this setting is debatable but may be potentially used in the morning of surgery and started the day after because the half life is only 6 hours and the molecule inhibits the P2Y12 receptor competitively and not irreversibly as clopidogrel.50
|
What Would I Have Chosen if I Could Have Selected My Own Stent? |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
A BMS would have been an option only for a vessel of 3.5 mm diameter or larger requiring a stent <15 to 20 mm. Outside these parameters, I believe the implantation of DES will undoubtedly still be the best option for me, according to most large-scale studies.45,46,51 Some studies report a significantly lower late stent thrombosis after Cypher compared with that after Taxus.44,52,53 Nevertheless, I think we should refrain from drawing firm conclusion from these analyses that were not prospectively designed to evaluate the differences in outcome between the Cypher and the Taxus stents. In addition, specific studies incorporated in meta-analysis may have different definitions of stent thrombosis, which may translate into a higher risk of stent thrombosis for the Taxus stent without a corresponding impact in clinical outcome such as death or MI.53 An interesting alternative that is gaining a lot of attention may be to ask for an Endeavor stent (Medtronic Vascular, Santa Rosa, Calif). This DES seems to be less potent in reducing late loss compared with the Cypher54 or the Taxus55 stent. Despite this weakness in the angiographic end point; the revascularization and MACE rates appear quite similar. In addition, some early reports suggest a very low risk of late and very late stent thrombosis despite 6 months of DAT with a large number of patients with a follow-up for more than 2 years. The Patient Related Outcomes With Endeavor Versus Cypher Stenting Trial (PROTECT) is an ongoing trial on 8000 patients that was designed to evaluate if the Endeavor has indeed a lower stent thrombosis rate. Even if this study would turn out positive, the final decision on which stent to use needs to take into consideration the lesion characteristics such as length and reference vessel size. There are some speculative reports about the low late thrombosis following discontinuation of DAT after 6 months in patients treated with Everolimus-eluting stents (Xience V, Abbott Vascular, Santa Clara, Calif; Promus, Boston Scientific, Natick, Mass),56 I think we need more patients with longer follow-up before emphasizing these findings.
|
Conclusions |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
One year of DAT will be my definite choice. I may then continue beyond 1 year if I tolerate the DAT. However, I certainly will not become overanxious if I have to stop clopidogrel after 12 months and try not to let this issue cloud my later years.
|
Acknowledgments |
|---|
Disclosures
None.
|
References |
|---|
|
TopIntroductionA Life ScenarioWhy Should I Continue...Why Should I Continue...What Should I Do...What Would I Have...ConclusionsReferences |
|---|
1. Moses JW, Leon MB, Popma JJ, Fitzgerald PJ, Holmes DR, O'Shaughnessy C, Caputo RP, Kereiakes DJ, Williams DO, Teirstein PS, Jaeger JL, Kuntz RE. Sirolimus-eluting stents versus standard stents in patients with stenosis in a native coronary artery. N Engl J Med. 2003; 349: 1315–1323.
2. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnar F, Falotico R. A randomized comparison of a sirolimus-eluting stent with a standard stent for coronary revascularization. N Engl J Med. 2002; 346: 1773–1780.
3. Stone GW, Ellis SG, Cox DA, Hermiller J, O'Shaughnessy C, Mann JT, Turco M, Caputo R, Bergin P, Greenberg J, Popma JJ, Russell ME. A polymer-based, paclitaxel-eluting stent in patients with coronary artery disease. N Engl J Med. 2004; 350: 221–231.
4. Colombo A, Drzewiecki J, Banning A, Grube E, Hauptmann K, Silber S, Dudek D, Fort S, Schiele F, Zmudka K, Guagliumi G, Russell ME. Randomized study to assess the effectiveness of slow- and moderate-release polymer-based paclitaxel-eluting stents for coronary artery lesions. Circulation. 2003; 108: 788–794.
5. Camenzind E, Steg PG, Wijns W. Stent thrombosis late after implantation of first-generation drug-eluting stents: a cause for concern. Circulation. 2007; 115: 1440–1455;discussion 1455.
6. Colombo A, Corbett SJ. Drug-eluting stent thrombosis: increasingly recognized but too frequently overemphasized. J Am Coll Cardiol. 2006; 48: 203–205.
7. Daemen J, Wenaweser P, Tsuchida K, Abrecht L, Vaina S, Morger C, Kukreja N, Juni P, Sianos G, Hellige G, van Domburg RT, Hess OM, Boersma E, Meier B, Windecker S, Serruys PW. Early and late coronary stent thrombosis of sirolimus-eluting and paclitaxel-eluting stents in routine clinical practice: data from a large two-institutional cohort study. Lancet. 2007; 369: 667–678.[CrossRef][Medline]
8. Cutlip DE, Windecker S, Mehran R, Boam A, Cohen DJ, van Es G-A, Gabriel Steg P, Morel M-a, Mauri L, Vranckx P, McFadden E, Lansky A, Hamon M, Krucoff MW, Serruys PW, on behalf of the Academic Research C. Clinical end points in coronary stent trials: a case for standardized definitions. Circulation. 2007; 115: 2344–2351.
9. Lagerqvist B, James KS, Stenestrand U, Lindback J, Nilsson T, Wallentin L, the SCAAR Study Group. Long-term outcomes with drug-eluting stents versus bare-metal stents in Sweden. N Engl J Med. 2007; 356: 1009–1019.
10. Mintz GS. What to do about late incomplete stent apposition? Circulation. 2007; 115: 2379–2381.
11. Cook S, Wenaweser P, Togni M, Billinger M, Morger C, Seiler C, Vogel R, Hess O, Meier B, Windecker S. Incomplete stent apposition and very late stent thrombosis after drug-eluting stent implantation. Circulation. 2007; 115: 2426–2434.
12. Siqueira DA, Abizaid AA, Costa Jde R, Feres F, Mattos LA, Staico R, Abizaid AA, Tanajura LF, Chaves A, Centemero M, Sousa AG, Sousa JE. Late incomplete apposition after drug-eluting stent implantation: incidence and potential for adverse clinical outcomes. Eur Heart J. 2007; 28: 1304–1309.
13. Hasegawa K, Tamai H, Kyo E, Kosuga K, Ikeguchi S, Hata T, Okada M, Fujita S, Tsuji T, Takeda S, Fukuhara R, Kikuta Y, Motohara S, Ono K, Takeuchi E. Histopathological findings of new in-stent lesions developed beyond five years. Catheter Cardiovasc Interv. 2006; 68: 554–558.[CrossRef][Medline]
14. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug-eluting stents in humans: delayed healing and late thrombotic risk. J Am Coll Cardiol. 2006; 48: 193–202.
15. Nebeker JR, Virmani R, Bennett CL, Hoffman JM, Samore MH, Alvarez J, Davidson CJ, McKoy JM, Raisch DW, Whisenant BK, Yarnold PR, Belknap SM, West DP, Gage JE, Morse RE, Gligoric G, Davidson L, Feldman MD. Hypersensitivity cases associated with drug-eluting coronary stents: a review of available cases from the Research on Adverse Drug Events and Reports (RADAR) Project. J Am Coll Cardiol. 2006; 47: 175–181.
16. Alfonso F. The "vulnerable" stent: why so dreadful? J Am Coll Cardiol. 2008; 51: 2403–2406.
17. Park J-S, Shin D-G, Kim Y-J, Hong G-R, Cho I-H. Acute myocardial infarction as a consequence of stent fracture and plaque rupture after sirolimus-eluting stent implantation. Int J Cardiol. 2008 Mar 25. [Epub ahead of print].
18. Virmani R. Could DES promote formation of vulnerable plaques? Available at: http://www.theheart.org/article/796191.do. Accessed 2007.
19. Finn AV, Nakazawa G, Joner M, Kolodgie FD, Mont EK, Gold HK, Virmani R. Vascular responses to drug eluting stents: importance of delayed healing. Arterioscler Thromb Vasc Biol. 2007; 27: 1500–1510.
20. Airoldi F, Colombo A, Morici N, Latib A, Cosgrave J, Buellesfeld L, Bonizzoni E, Carlino M, Gerckens U, Godino C, Melzi G, Michev I, Montorfano M, Sangiorgi GM, Qasim A, Chieffo A, Briguori C, Grube E. Incidence and predictors of drug-eluting stent thrombosis during and after discontinuation of thienopyridine treatment. Circulation. 2007; 116: 745–754.
21. Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantation of drug-eluting stents. JAMA. 2005; 293: 2126–2130.
22. Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, Krumholz HM, Cohen DJ. Prevalence, predictors, and outcomes of premature discontinuation of thienopyridine therapy after drug-eluting stent placement: results from the PREMIER Registry. Circulation. 2006; 113: 2803–2809.
23. Baran K, Lasala JM, Cox DA, Song A, Deshpande MC, Jacoski MV, Mascioli SR. A clinical risk score for prediction of stent thrombosis. Am J Cardiol. 2008; 102: 541–545.[CrossRef][Medline]
24. Angiolillo DJ, Fernandez-Ortiz A, Bernardo E, Alfonso F, Macaya C, Bass TA, Costa MA. Variability in individual responsiveness to clopidogrel: clinical implications, management, and future perspectives. J Am Coll Cardiol. 2007; 49: 1505–1516.
25. Buonamici P, Marcucci R, Migliorini A, Gensini GF, Santini A, Paniccia R, Moschi G, Gori AM, Abbate R, Antoniucci D. Impact of platelet reactivity after clopidogrel administration on drug-eluting stent thrombosis. J Am Coll Cardiol. 2007; 49: 2312–2317.
26. Roy P, Steinberg DH, Sushinsky SJ, Okabe T, Pinto Slottow TL, Kaneshige K, Xue Z, Satler LF, Kent KM, Suddath WO, Pichard AD, Weissman NJ, Lindsay J, Waksman R. The potential clinical utility of intravascular ultrasound guidance in patients undergoing percutaneous coronary intervention with drug-eluting stents. Eur Heart J. 2008; 29: 1851–1857.
27. Alfonso F, Suarez A, Perez-Vizcayno MJ, Moreno R, Escaned J, Banuelos C, Jimenez P, Bernardo E, Angiolillo DJ, Hernandez R, Macaya C. Intravascular ultrasound findings during episodes of drug-eluting stent thrombosis. J Am Coll Cardiol. 2007; 50: 2095–2097.
28. Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004; 109: 701–705.
29. Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari DE, Peterson ED, Schulman KA, Califf RM. Clopidogrel use and long-term clinical outcomes after drug-eluting stent implantation. JAMA. 2007; 297: 159–168.
30. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C, for the BASKET-LATE Investigators. Late clinical events after clopidogrel discontinuation may limit the benefit of drug-eluting stents: an observational study of drug-eluting versus bare-metal stents. J Am Coll Cardiol. 2006; 48: 2584–2591.
31. Grines CL, Bonow RO, Casey DE, Jr, Gardner TJ, Lockhart PB, Moliterno DJ, O'Gara P, Whitlow P. Prevention of premature discontinuation of dual antiplatelet therapy in patients with coronary artery stents: a science advisory from the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons, and American Dental Association, With Representation From the American College of Physicians. Circulation. 2007; 115: 813–818.
32. Stone GW, Ellis SG, Cannon L, Mann JT, Greenberg JD, Spriggs D, O'Shaughnessy CD, DeMaio S, Hall P, Popma JJ, Koglin J, Russell ME. Comparison of a polymer-based paclitaxel-eluting stent with a bare metal stent in patients with complex coronary artery disease: a randomized controlled trial. JAMA. 2005; 294: 1215–1223.
33. Urban P, Gershlick AH, Guagliumi G, Guyon P, Lotan C, Schofer J, Seth A, Sousa JE, Wijns W, Berge C, Deme M, Stoll HP. Safety of coronary sirolimus-eluting stents in daily clinical practice: one-year follow-up of the e-Cypher registry. Circulation. 2006; 113: 1434–1441.
34. Artang R, Dieter RS. Analysis of 36 reported cases of late thrombosis in drug-eluting stents placed in coronary arteries. Am J Cardiol. 2007; 99: 1039–1043.[CrossRef][Medline]
35. Applegate RJ. Incidence of coronary stent thrombosis based on academic research consortium definitions. Am J Cardiol. 2008; 102: 683–688.[CrossRef][Medline]
36. Cinza-Rey R, Moreno R, Macaya C. Very late taxus stent thrombsis and symptom limited exercise testing. Rev Esp Cardiol. 2008; 61: 327–333.[Medline]
37. Kuchulakanti PK, Chu WW, Torguson R, Ohlmann P, Rha S-W, Clavijo LC, Kim S-W, Bui A, Gevorkian N, Xue Z, Smith K, Fournadjieva J, Suddath WO, Satler LF, Pichard AD, Kent KM, Waksman R. Correlates and long-term outcomes of angiographically proven stent thrombosis with sirolimus- and paclitaxel-eluting stents. Circulation. 2006; 113: 1108–1113.
38. Duk-Woo P, Seong-Wook P, Seung-Whan L, Young-Hak K, Cheol Whan L, Myeong-Ki H, Jae-Joong K, Seung-Jung P. Frequency of coronary arterial Late angiographic stent thrombosis (LAST) in the first six months: outcomes with drug-eluting stents versus bare metal stents. J Am Coll Cardiol. 2007; 99: 774–778.
39. Brar SS, Kim J, Brar SK, Zadegan R, Ree M, Liu I-LA, Mansukhani P, Aharonian V, Hyett R, Shen AY-J. Long-term outcomes by clopidogrel duration and stent type in a diabetic population with de novo coronary artery lesions. J Am Coll Cardiol. 2008; 51: 2220–2227.
40. de Korte FI, van Werkum JW, Vijverberg PLM, ten Berg JM. Late coronary stent thrombosis complicating urology surgery. Eur Urol. 2007; 54: 221–225.[Medline]
41. Jamshidi P, Toggweiler S, Erne P. In-stent restenosis and thrombosis 41 months after drug-eluting stent implantation. Int J Cardiol. 2007; 130: e111–e113.[CrossRef][Medline]
42. de la Torre-Hernandez JM, Alfonso F, Hernandez F, Elizaga J, Sanmartin M, Pinar E, Lozano I, Vazquez JM, Botas J, Perez de Prado A, Hernandez JM, Sanchis J, Ruiz Nodar JM, Gomez-Jaume A, Larman M, Diarte JA, Rodriguez-Collado J, Rumoroso JR, Lopez-Minguez JR, Mauri J, for the ESG. Drug-eluting stent thrombosis: results from the Multicenter Spanish Registry ESTROFA (Estudio ESpanol sobre TROmbosis de stents FArmacoactivos). J Am Coll Cardiol. 2008; 51: 986–990.
43. Bhatt D, Fox K, Hacke W, Berger P, Black H, Boden W, Cacoub P, Cohen E, Creager M, Easton J, Flather M, Haffner S, Hamm C, Hankey G, Johnston C, Mak K-H, Mas J-L, Montalescot G, Pearson T, Steg P, Steinhubl S, Weber M, Brennan D, Fabry-Ribaudo L, Booth J, Topol E, for the CHARISMA Investigators. Clopidogrel and aspirin versus aspirin alone for the prevention of atherothrombotic events. N Engl J Med. 2006; 354: 1706–1717.
44. Stettler C, Wandel S, Allemann S, Kastrati A, Morice M-C, Schomig A, Pfisterer M, Stone G, Leon M, Suarez de Lezo J, Goy J-J, Park S-J, Sabate M, Suttorp M, Kelbaek H, Spaulding C, Menichelli M, Vermeersch P, Dirksen M, Cervinka P, Sonia Petronio A, Nordmann A, Diem P, Meier B, Zwahlen M, Reichenbach S, Trelle S, Windecker S, Juni P. Outcomes associated with drug-eluting and bare metal stents: a collaborative network meta-analysis. Lancet. 2007; 370: 937–948.[CrossRef][Medline]
45. Jensen LO, Maeng M, Kaltoft A, Thayssen P, Hansen HHT, Bottcher M, Lassen JF, Krussel LR, Rasmussen K, Hansen KN, Pedersen L, Johnsen SP, Soerensen HT, Thuesen L. Stent thrombosis, myocardial infarction, and death after drug-eluting and bare-metal stent coronary interventions. J Am Coll Cardiol. 2007; 50: 463–470.
46. Kelbaek H, Klovgaard L, Helqvist S, Lassen JF, Krusell LR, Engstrom T, Botker HE, Jorgensen E, Saunamaki K, Aljabbari S, Thayssen P, Galloe A, Jensen GV, Thuesen L. Long-term outcome in patients treated with sirolimus-eluting stents in complex coronary artery lesions: 3-year results of the SCANDSTENT (Stenting Coronary Arteries in Non-Stress/Benestent Disease) trial. J Am Coll Cardiol. 2008; 51: 2011–2016.
47. Xiao Z, Theroux P. Platelet activation with unfractionated heparin at therapeutic concentrations and comparisons with a low-molecular-weight heparin and with a direct thrombin inhibitor. Circulation. 1998; 97: 251–256.
48. Bavry AA, Bhatt DL. Appropriate use of drug-eluting stents: balancing the reduction in restenosis with the concern of late thrombosis. Lancet. 2008; 371: 2134–2143.[CrossRef][Medline]
49. Cannon CP, Husted S, Harrington RA, Scirica BM, Emanuelsson H, Peters G, Storey RF. Safety, tolerability, and initial efficacy of AZD6140, the first reversible oral adenosine diphosphate receptor antagonist, compared with clopidogrel, in patients with non-ST-segment elevation acute coronary syndrome: primary results of the DISPERSE-2 trial. J Am Coll Cardiol. 2007; 50: 1844–1851.
50. Storey RF, Husted S, Harrington RA, Heptinstall S, Wilcox RG, Peters G, Wickens M, Emanuelsson H, Gurbel P, Grande P, Cannon CP. Inhibition of platelet aggregation by AZD6140, a reversible oral P2Y12 receptor antagonist, compared with clopidogrel in patients with acute coronary syndromes. J Am Coll Cardiol. 2007; 50: 1852–1856.
51. Tu JV, Bowen J, Chiu M, Ko DT, Austin PC, He Y, Hopkins R, Tarride J-E, Blackhouse G, Lazzam C, Cohen EA, Goeree R. Effectiveness and safety of drug-eluting stents in ontario. N Engl J Med. 2007; 357: 1393–1402.
52. Kaltoft A. Two year danish registry results raise red flag for taxus, but experts warn against overreaction. Available at: www.theheart.org/article/866143.do. Accesses 2008.
53. Schomig A, Dibra A, Windecker S, Mehilli J, Suarez de Lezo J, Kaiser C, Park S-J, Goy J-J, Lee J-H, Di Lorenzo E, Wu J, Juni P, Pfisterer ME, Meier B, Kastrati A. A meta-analysis of 16 randomized trials of sirolimus-eluting stents versus paclitaxel-eluting stents in patients with coronary artery disease. J Am Coll Cardiol. 2007; 50: 1373–1380.
54. Kandzari DE, Leon MB, Popma JJ, Fitzgerald PJ, O'Shaughnessy C, Ball MW, Turco M, Applegate RJ, Gurbel PA, Midei MG, Badre SS, Mauri L, Thompson KP, LeNarz LA, Kuntz RE. Comparison of zotarolimus-eluting and sirolimus-eluting stents in patients with native coronary artery disease: a randomized controlled trial. J Am Coll Cardiol. 2006; 48: 2440–2447.
55. Leon MB. ENDEAVOR IV: 9 and 12 months results. Available at: http://www.theheart.org/article/820229.do. Accessed 2007.
56. Stone GW. Spirit III 2 year clinical follow-up results. Available at: http://www.europcronline.com/fo/lecture/view_slide.php?id=4541. Accessed 2008.
|
Footnotes |
|---|
The opinions expressed in this article are not necessarily those of the editors or of the American Heart Association. This article is Part II of a 2-part article. Part I appears on page 217.
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||