C2ccd#060460 1.7

J_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 Catheterization and Cardiovascular Interventions 69:000–000 (2007) Late Stent Thrombosis: Considerations and Practical Advice for the Use of Drug-Eluting Stents: A Report From the Society for Cardiovascular Angiography and Interventions Drug-eluting Stent Task Force John McB. Hodgson,1* MD, FSCAI, Gregg W. Stone,2 MD, FSCAI, A. Michael Lincoff,3 MD, FACC, Lloyd Klein,4 MD, FSCAI, Howard Walpole,5 MD, FSCAI, Randy Bottner,6 MD, FSCAI, Bonnie H. Weiner,7 MD, FSCAI, Martin B. Leon,2 MD, FSCAI, Ted Feldman,8 MD, FSCAI, Joseph Babb,9 MD, FSCAI, and Gregory J. Dehmer,10 MD, FSCAI Key words: Drug-eluting Stent; thrombosis; percutaneous coronary intervention; com-plications occurrence of cardiac death and non-fatal myocardialinfarction in patients treated with DES when compared Recent analyses have suggested that implantation of with bare-metal stents after clopidogrel had been dis- drug-eluting stents (DES) is associated with a higher continued at 6 months [1]. Other meta-analyses of the rate of very late stent thrombosis when compared with existing DES trials also showed an increase in late bare metal stents. This complication is evident with events in the DES cohort although these analyses were both sirolimus-eluting stents as well as polymer-based limited by incomplete data in publications, abstracts, paclitaxel-eluting stents, but the precise magnitude of and Internet sources [2,3]. In October 2006, an inde- this risk and whether this applies to all patients or pendent patient-level meta analysis of the four pivotal only a subset of those who have received DES is randomized Cypher stent trials and the five pivotal incompletely characterized. This alert is designed to randomized Taxus stent trials was publicly presented.
provide the practicing interventional cardiologist with These analyses demonstrated an increased rate of stent practical advice in light of this new information.
thrombosis with both sirolimus-eluting and paclitaxel- It is not the purpose of this document to provide an exhaustive review of the literature on DES and therisk of stent thrombosis; however a brief summary is 1 St. Joseph’s Hospital and Medical Center, Phoenix, AZ appropriate. While exact definitions have been variable in different trials, late stent thrombosis generally refers Cleveland Clinic Foundation, Cleveland, Oh to stent thrombosis occurring at least 1 month follow- Rush University Medical Center, Chicago, II ing stent implantation, while very late stent thrombosis refers to events occurring more than 12 months follow- ing stent placement. Following bare metal stent im- 8 Evanston Northwestern Healthcare, Evanston, II9 plantation, stent thrombosis is rare after 2 weeks, and dual antiplatelet therapy (aspirin and a thienopyridine) Texas A&M School of Medicine, Temple, Tx was typically prescribed for 3–6 weeks. In contrast, *Correspondence to: John McB. Hodgson, MD, Chief, Academic sporadic reports of late stent thrombosis in patients Cardiology, St. Joseph’s Hospital and Medical Center, 350 West receiving DES have occurred over the past few years.
Thomas Road, Phoenix, AZ 85013. E-mail: jhodgson@tsg-ed.com These events often (but not always) occurred in the Received 20 December 2006; Accepted 20 December 2006 setting of premature discontinuation of dual antiplatelettherapy. In March 2006, the BASKET-LATE trial was reported, describing a significantly greater composite Published online in Wiley InterScience (www.interscience.wiley.com).
Path: J:/Production/CCD#/Vol00000/060460/3B2/C2CCD#060460 J_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 eluting stents between 1 and 4 years of follow-up, TABLE I. Academic Research Consortium (ARC) Proposed though the overall incidence of death and myocardial Standard Definitions of Coronary Stent Thrombosis infarction was similar between DES and bare metal Although the process of re-examining data from the Late: after 30 daysVery late: after 12 months pivotal randomized trials of DES continues, there appears to be a clear finding that DES are associated with a higher rate of late stent thrombosis than bare metal stents when used \on-label" (as tested in the l Angiographic confirmation of stent thrombosis or occlusion randomized approval trials). The magnitude of very late stent thrombosis is not well defined, but is in the range of l Pathologic confirmation of acute stent thrombosis 0.2% excess events per year after year 1 through year 4.
Real-world experiences suggest that \off-label" use of l Target vessel infarction without angiographic confirmation of drug-eluting stents in more complex lesions such as stent thrombosis or other identified culprit lesion bifurcation lesions and in patients with acute myocardial infarction are associated with an even higher rate of early and late stent thrombosis [5,6]. Moreover, whether the Stent thrombosis may further be considered primary (occurring before late thrombosis risk with DES continues indefinitely or target lesion revascularization) or secondary (occurring after target terminates after 4 years is unknown.
The presumed mechanism of late susceptibility to stent thrombosis is delayed or incomplete re-endotheli-alization and possibly an inflammatory response to the data within these trials were obtained in patients with stent polymer [7], although other factors such as strut less complex lesion subsets. It is estimated that up to fractures and stent malapposition may contribute. The 60% of DES usage now occurs in \off-label" situa- occurrence of stent thrombosis is associated in most tions and lesions subsets not studied in the pivotal tri- cases (some estimates up to 60–70%) with premature als. Some of the combined analyses suggest that death discontinuation of dual antiplatelet therapy (before the and myocardial infarction may be increased in these prescribed course of 3 months for Cypher and 6 more complex lesions subsets which now constitute the months for Taxus stents), though some episodes have majority of DES use. Late stent thrombosis is associ- occurred long after the prescribed duration of antiplate- ated with a high rate of myocardial infarction and mor- let therapy has been completed. Some of these epi- tality [1]. Restenosis after bare metal stenting is also sodes (but not all) occurred in the setting of height- not as benign as previously believed, presenting as an ened platelet reactivity from a surgical procedure or acute myocardial infarction in as many as 10% of major illness requiring the thienopyridine discontinua- patients [9]. A detailed summary of the current data tion; the extent to which this contributed to the stent was compiled for the recent FDA Circulatory Devices It is important to understand when trying to interpret these events that a uniform definition of late stent thrombosis was not in place for the many trials Faithful adherence to dual antiplatelet therapy (aspi- included. Moreover, the pivotal Cypher and Taxus tri- rin and a thienopyridine such as clopidogrel) is diffi- als did not count secondary thrombotic events occur- cult to accomplish. In one multicenter study of patients ring after a target lesion revascularization. Thus, a new with acute myocardial infarction treated with DES, standard definition set for late stent thrombosis has 13.6% of patients discontinued dual anti-platelet ther- been developed (Academic Research Consortium) and apy by 30 days [11]. Patients who discontinued ther- is being applied to further analyses [8] (Table apy before 30 days had a higher rate of re-hospitaliza- ever, even these criteria have been questioned for tion and mortality when compared with those who including \possible" events that may be unrelated to continued therapy. Factors contributing to dual antipla- the original DES implantation and therefore would telet discontinuation included anemia or need for overestimate the magnitude of the problem.
surgery, but importantly also included many socioeco- It is important to re-emphasize that while very late nomic factors (such as education level, cost for stent thrombosis rates are higher with DES, overall prescriptions, understanding of instructions, and mis- death and myocardial infarction rates have been similar information from healthcare professionals). A large to those of bare metal stents in the pivotal randomized single center registry has also found and increase in trials up to 4 years after implantation [4]. However, adverse events in patients with DES who were no lon- Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Path: J:/Production/CCD#/Vol00000/060460/3B2/C2CCD#060460 J_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 ger taking clopidogrel after either 6 or 12 months Finally, consideration must be given to the patient’s (includes both premature and scheduled cessation of ability to comply with long-term dual antiplatelet ther- therapy) when compared with a matched group of apy. Social, medical, and financial barriers to proper patients receiving bare metal stents [12].
adherence must be considered before a DES is selected As many as 50% of patients are either low- or non-res- for implantation, and in particular, the likelihood of ponders to clopidogrel and/or aspirin when assessed in future bleeding risk or need for surgical/invasive pro- vitro [13,14]. Testing is now available for both cedures should be carefully assessed. DES implantation clopidogrel and aspirin responsiveness, but is not widely should be avoided if there is any doubt that the patient utilized. The extent that platelet hyporesponsiveness con- can comply with prolonged dual antiplatelet therapy.
tributes to stent thrombosis is undetermined.
It is important to realize that the clinical and lesion The issues surrounding discontinuation of dual antipla- specific factors predicting an increased risk of early telet therapy are being actively addressed in a forthcom- and late stent thrombosis have not been fully eluci- ing AHA Science Advisory related to the premature dis- dated. Nonetheless, table two lists patient and lesion continuation of dual antiplatelet therapy in patients with characteristics that currently have been associated with DES (expected publication in early 2007).
an increased risk of thrombosis after DES implanta-tion. These factors should be reviewed when selectingstent type in an individual patient. After careful con- sideration of all factors, some high-risk patients may Proper patient selection for percutaneous coronary be best considered for surgical revascularization. Inter- intervention (PCI) must take into account three issues.
ventionalists are encouraged to involve patients, when- First, objective evidence of cardiac symptoms, ische- ever possible, in these discussions and to explain the mia or otherwise generally acceptable indications for benefits and risks of any proposed treatment.
revascularization must be present in accordance withpublished guidelines for the performance PCI. These guidelines should serve as the basis for the selection ofpatients for any revascularization [15]. In patients DES are mechanically similar (if not identical) to without pre-intervention documentation of inducible or their bare metal counterparts. Multiple studies have active ischemia, it is reasonable to measure fractional outlined the risk factors for restenosis and sub-acute flow reserve before intervention to confirm the pres- stent thrombosis in bare metal stents. In nearly every ence of a flow-limiting stenosis appropriate for treat- study, stent expansion was found to be an independent ment. In short lesions located in the proximal third of risk factor for restenosis. Intravascular ultrasound eas- the three major epicardial arteries, intravascular ultra- ily identifies stent under expansion, yet remains infre- sound-determined lesion lumen area of less than 4 quently used (approximately 7% of cases in the United mm2 may also indicate a lesion with a high likelihood States). The recently reported STLLR trial documented of producing inducible ischemia [16].
geographic miss as an additional risk for adverse out- Second, it must be emphasized that the patients comes following drug-eluting stent implantation [17].
included in the major randomized trials of DES had The importance of complete lesion coverage with DES relatively lower risk lesions and clinical characteristics.
has been emphasized since their initial approval; how- This was appropriate for these initial trials, but extrap- ever in the STLLR study, 66.5% of implantations were olation of DES use (and results) to lesion subtypes or associated with geographic miss. Those with geo- patient groups outside those studied in the randomized graphic miss had a significantly higher incidence of trials must be done cautiously. Proper patient selection myocardial infarction during follow-up. Thus, despite a now should involve an assessment of the balance belief that angiographic-guided implantation of DES is between restenosis risk and thrombosis risk (and the satisfactory, the STLLR trial suggests that alternative consequences of restenosis and thrombosis). Many fac- methods to ensure appropriate lesion coverage might tors, such as diabetes, long lesions, small vessels, improve outcomes. In this regard, the use of intravas- chronic kidney disease and lesions in saphenous vein cular ultrasound to document appropriate longitudinal grafts, have been identified that portend a higher risk lesion coverage and adequate stent expansion (>80% of restenosis and may shift the benefit:risk ratio in of the reference lumen area) is reasonable and may favor of DES. These subgroups may also have a higher improve early and late results of DES implantation, risk of very late thrombosis. It is important for the cli- although randomized studies have not been performed.
nician to consider the risk:benefit ratio for each indi- Coronary calcium markedly impairs the ability to vidual patient. This medical decision-making process expand stents. Similar issues may arise in ostial loca- should be carefully documented in the medical record.
tions. Although non randomized studies examining the Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Path: J:/Production/CCD#/Vol00000/060460/3B2/C2CCD#060460 J_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 use of direct stenting without predilation suggest that TABLE II. Patient and Lesion Features Associated with this technique is safe and effective in selected lesions, Increased Risk of Drug-Eluting Stent Thrombosis careful lesion preparation may be important in more complex lesions to ensure stent delivery and complete expansion. This may include balloon predilation, or l Acute coronary syndrome/myocardial infarction occasionally cutting balloon atherotomy, or plaque debulking using rotational atherectomy. Preliminary di- lation of the stenosis before stent placement is a possi- ble safeguard against the unexpected inability to fully expand a stent within a fibrotic or calcific lesion. Pre- intervention ultrasound imaging and a careful fluoro- l Small stent diameter and/or severe under expansion scopic review for calcium before stenting can be use- ful. Under expansion of any stent due to failure oflesion preparation should be avoided.
While DES offer important benefits in terms of re- Patients with previously implanted DES who are stenosis, clinically acceptable target lesion revasculari- currently taking dual antiplatelet therapy present a sig- zation results can be obtained with bare-metal stents in nificant management challenge to the interventional many low risk lesion or patient groups [18]. Thus, the cardiologist or primary care provider when a situation option of bare metal stent implantation should be care- arises that requires cessation or interruption of anti-pla- fully considered on a case by case basis.
telet therapy (for example, when elective or urgent sur-gery is required). There are no existing studies thatexamine alternative management strategies. Each practi-tioner must therefore rely on personal knowledge of the individual patient, the specific reason(s) for anti-platelet therapy discontinuation and other relevant factors in mak- At the FDA Circulatory Devices Advisory Board ing the recommendation for how to manage the situation.
meeting on December 7th and 8th, 2006 the panel rec- Unlike available recommendations for alternative anti- ommended the continuation of dual antiplatelet therapy coagulant \bridging" strategies when warfarin therapy for 12 months after implantation of drug-eluting stents, must be temporarily discontinued, there are no existing based, in large part, on the ACC/AHA/SCAI Class I data or recommendations for the practitioner to minimize indication already in existence for PCI in patients who risk of stent thrombosis when anti-platelet therapy must are not at high-risk for bleeding [15]. We support that be stopped. Consequently, there has been and continues recommendation. We also recommend operators seri- to be no definitive standard of care for the management ously consider the Class IIb indication that patients in of these patients under these circumstances. Discussion whom stent thrombosis may be catastrophic or lethal, of the risk and benefit with the surgeon or other practi- platelet aggregation studies may be considered and the tioner should be undertaken to determine if the procedure dose of clopidogrel increased to 150 mg per day if could be performed with reasonable safety without dis- less than 50% inhibition of platelet aggregation is continuation of antiplatelet agents. In the patient consid- demonstrated [15], although the clinical utility of these ered at high risk for stent thrombosis involving a large practices is not established. Furthermore, pre-interven- area of myocardium, short acting intravenous glycopro- tion testing of the responsiveness of a patient to anti- tein IIb/IIIa inhibitors have been empirically suggested platelet agents may be considered for higher thrombo- prior to and after surgery for platelet inhibition during the sis-risk patients or lesion subsets as discussed in the period when the patient is \unprotected" between clopi- dogrel discontinuation to re-initiation. The safety and ef- evidence-based medicine presently exists to guide al- ficacy of this practice has not been formally studied, how- ternative drug management or device selection in ever. Similarly, there are no data to support \bridging" patients in whom a point of care test demonstrates pla- telet hyporesponsiveness to aspirin and/or clopidogrel.
There is no evidence to suggest that patients who have received a DES and have completed and discon- tinued their course of dual antiplatelet therapy withoutincident should restart a theinopyridine. These patients Since the issue of late DES thrombosis has been should remain on aspirin indefinitely for secondary publicized, several solicitations for potential class action suits against the stent manufacturers have been Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
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Path: J:/Production/CCD#/Vol00000/060460/3B2/C2CCD#060460 J_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 advertised. It is our opinion that there are no grounds participation by the interventional community. The for valid legal action against physicians or stent manu- HORIZONS-AMI trial is randomizing 3,000 patients facturers related to the implantation of DES and late with acute myocardial infarction to DES vs. bare metal thrombosis. The suspicion that patients with DES may stents. The E-Select Registry and INSIGHT random- be at increased risk for very late thrombosis was only ized trial will be a 30,000 patient global registry incor- very recently described. There was no pre-existing data porating a United States randomized trial of standard to suggest the occurrence of late stent thrombosis.
vs. long duration clopidogrel. The PROTECT random- DES were carefully studied in well-performed random- ized trial will be an 8,000 patient global randomized trial of the Endeavor vs. the Cypher stent with a pri- approved by the FDA. When any suggestion of issues mary endpoint of stent thrombosis. Finally, the STENT with these devices has arisen, prompt alerts were Thrombosis study will enroll at least 10,000 consecu- issued to the medical community. The FDA (twice in tive patients receiving DES in whom aspirin and clopi- 2003, again in early 2006) and the American College dogrel responsiveness will be assessed at baseline and of Cardiology (March 16, 2006) have both issued pub- throughout a 2–5 year follow-up for stent thrombosis.
lic health alerts emphasizing the need for strict antipla- In addition, at the recent FDA Advisory Board telet therapy adherence and proper implantation tech- meeting, questions were raised about the appropriate- nique. In fact, the American College of Cardiology ness of multivessel stenting, especially in comparison clearly recommended \patients taking PlavixTM for any with coronary artery bypass surgery. This question is reason should consult with their cardiologist or other also under rigorous investigation. The FREEDOM trial health care provider before stopping this medication." is randomizing 2,400 patients with diabetes mellitus In addition, the AHA issued a press release \Stopping and multivessel disease to DES implantation vs. bypass medication too soon after receiving a drug-eluting stent surgery. The SYNTAX trial is randomizing 1,700 raises the risk of death" in June, 2006.
patients with triple vessel or unprotected left main dis- The standard of care has been 3–6 months of clopi- ease to DES implantation vs. bypass surgery. Until dogrel following DES implantation (dependent on the such time as these trials produce clear data for further type of stent implanted) as approved by the FDA and recommendations we advise the practicing interven- recommended in the directions for use included with tionalist to thoughtfully document the indications for each stent. The FDA, physician investigators, and intervention and the medical decision making process industry representatives around the world have been by which the specific revascularization strategy was carefully evaluating and considering the new concern about very late DES thrombosis. Recommendations arebeing communicated to physicians objectively and The practitioner is advised to carefully discuss the In light of the observed small increased incidence of risks and benefits of the selected stent (or surgical) very late thrombosis seen after DES implantation we procedure, why it is believed superior to other revascu- larization options, and clearly document this thoughtprocess in an accepted consent form. Patient education 1. Prior to any stent implantation, patients should meet regarding the importance of uninterrupted dual antipla- criteria for PCI according to published guidelines.
telet therapy is also critical. As with all therapies in 2. The decision to implant a DES vs. an alternative re- medicine, the best protection against legal action vascularization strategy (including bare metal stents should complications arise is close communication or surgical revascularization) must be made on an between the physician and patient, with careful docu- individual patient basis after consideration of the mentation of the decision process in the medical re- relative risks and benefits of each therapy.
cord. This is especially important when considering 3. Careful evaluation of the patient with respect to compliance and the risks of long-term dual antipla-telet therapy must be performed prior to implantinga DES.
4. Careful attention must be paid to stent implantation The safety of DES is of concern to everyone, physi- technique. The use of intravascular ultrasound, cian, manufacturer and patient alike. To better address screening for calcification, and careful lesion prepa- ongoing, and several others will begin recruitment 5. Following DES implantation, dual antiplatelet ther- soon. We applaud this approach and encourage active apy should be prescribed for no less than 3 months Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Path: J:/Production/CCD#/Vol00000/060460/3B2/C2CCD#060460 J_ID: Z7V Customer A_ID: 06-0418 Cadmus Art: CCI 21093 Date: 5-JANUARY-07 (Cypher) or 6 months (Taxus) for patients meeting 6. Bavry AA, Kumbhant DJ, Helton TJ, Borek PP, Mood GR, the FDA approved indications. In such patients who Bhatt DL. Late thrombosis of drug-eluting stents: A meta-analysisof randomized clinical trials. Am J Med 2006;119:1056–1061.
are not at high risk for bleeding, we strongly recom- 7. Joner M, Finn AV, Farb A, Mont EK, Kolodgie FD, Ladich E, mend the continuation of dual antiplatelet therapy Kutys R, Skorija K, Gold HK, Virmani R. Pathology of drug- for 12 months. Until the issue of very late stent eluting stents in humans: Delayed healing and late thrombotic thrombosis is further studied, we recommend that risk. J Am Coll Cardiol 2006;48:193–202.
patients at higher risk for stent thrombosis be con- 8. Cutlip D. Presented at TCT on October 25, 2006. Available at www.medscape.com/viewarticle/546575. Accessed December 13, sidered for dual antiplatelet therapy for longer than 12 months after careful review of the risks and 9. Chen M, John J, Chew D, Lee D, Ellis S, Bhatt D. Bare metal stent restenosis is not a benign clinical entity. Am Heart J 2006; 6. The discontinuation of dual antiplatelet therapy (ei- ther transiently or permanently) requires careful con- www.fda.gov/ohrms/dockets/ac/06/briefing/2006- 4253b1-index.htm. Accessed December 13, 2006.
sideration of the relative risks of continuation (pri- 11. Spertus JA, Kettelkamp R, Vance C, Decker C, Jones PG, marily bleeding and cost) and the potential risks of Rumsfeld JS, Messenger JC, Khanal S, Peterson ED, Bach RG, late stent thrombosis. This decision must be individ- Krumholz HM, Cohen DJ. Prevalence, predictors, and outcomes ualized. There are no tested \bridging" strategies.
of premature discontinuation of thienopyridine therapy after 7. The medical decision making process, risks and ben- drug-eluting stent placement: Results from the PREMIER regis-try. Circulation 2006;113:2803–2809.
efits of all appropriate therapies, and the need for 12. Eisenstein EL, Anstrom KJ, Kong DF, Shaw LK, Tuttle RH, dual antiplatelet therapy should be discussed with Mark DB, Kramer JM, Harrington RA, Matchar DB, Kandzari the patient and documented in the medical record.
DE, Peterson ED, Schulman KA, Califf RM. Clopidogrel use 8. Patients should be reassured that the implantation of and long-term clinical outcomes after drug-eluting stent implan- a DES, after careful consideration with their physi- tation. JAMA 2006, Dec 5; [epub ahead of print].
13. Nguyen TA, Diodati JG, Pharand C. Reisitance to clopidogrel: A cian, remains a very effective method for the treat- review of the evidence. J Am Coll Cardiol 2005;45:1157–1164.
ment for symptoms associated with the disabling 14. Michos ED, Ardehali R, Blumenthal RS, Lange RA, Ardehali H. Aspirin and clopidogrel resistance. Mayo Clin Proc 2006;81:518–26.
15. Smith SC Jr, Feldman TE, Hirshfield JW Jr, Jacobs AK, Kern MJ, King SB III, Morrison DA, O’Neill WW, Schaff HV, Whitlow PL, 1. Pfisterer M, Brunner-La Rocca HP, Buser PT, Rickenbacher P, Williams DO. ACC/AHA/SCAI 2005 guideline update for percuta- Hunziker P, Mueller C, Jeger R, Bader F, Osswald S, Kaiser C, neous coronary intervention: A report of the American College of for the BASKET-LATE investigators. Late clinical events after Cardiology/ American Heart Associan Task Force on Practice clopidogrel discontinuation may limit the benefit of drug-eluting Guidelines (ACC/AHA/SCAI Writing Committee to update stents. J Am Coll Cardiol 2006;48:2584–2591.
the 2001 Guidelines for Percutaneous Coronary Intrervention) 2. Camenzind E. Safety of drug-eluting stents: Insights from meta American College of Cardiology Web Site. Available at www.
analysis. Available at www.escardio.org/knowledge/congresses/ acc.org/clinical/guidelines/percutaneous/update/index_rev.pdf congressreports/hotlinesandctus/707009_Camenzind.htm Accessed 16. Nishioka T, Amanullah AM, Luo HUAI. Clinical validation of intravascular ultrasound imaging for assessment of coronary ste- 3. Nordmann AJ, Briel M, Bucher HC. Mortality in randomized nosis severity: Comparison with stress myocardial perfusion controlled clinical trials comparing drug-eluting vs. bare metal imaging. J Am Coll Cardiol 1999;33:1870–1878.
stents in coronary artery disease: A meta analysis. Eur Heart J 17. Costa MA. Impact of stent deployment techniques on long-term clinical outcomes of patients treated with sirolimus-eluting 4. Leon MB, Stone GW. Presentation at TCT October 25, 2006.
stents. Presentation at TCT 10-2006. Incidence of geographical Available at www.tctmd.com/csportal/appmanager/tctmd/main?_ miss in patients treated with sirolimus-eluting stents: Insights nfpb¼true&_pageLabel¼TCTMDContent&hdCon¼1453648.
from the STLLR trial. Am J Cardiol 2004;94(suppl 6A):206E.
18. Ellis SG, Bajzer CT, Bhatt DL, Brener SJ, Whitlow PL, Lincoff 5. Serruys P. Presentation at the European Congress of Cardiology AM, Moliterno DJ, Raymond RE, Tuzcu EM, Franco I, Dush- in Barcelona (September 2006). Discussed in Clappers and Ver- man-Ellis S, Lander KJ, Schneider JP, Topol EJ. Real-world heugt. Hotline sessions of the 28th European Congress of Cardi- bare metal stenting: Identification of patients at low or very low ology/World Congress of Cardiology. Eur Heart J 2006;27: risk of 9-month coronary revascularization. Catheter Cardiovasc Catheterization and Cardiovascular Interventions DOI 10.1002/ccd.
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