Published online before print July 22, 2009, doi: 10.1161/CIRCINTERVENTIONS.109.852178.109.852178
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Original Articles |
Drug-Eluting Stent Thrombosis in Routine Clinical Practice
Two-Year Outcomes and Predictors From the TAXUS ARRIVE Registries
From the Washington University School of Medicine (J.M.L.), St. Louis, Mo; Lehigh Valley Hospital (D.A.C.), Allentown, Pa; Genesys Heart Institute (D.D.), Genesys Regional Medical Center, Grand Blanc, Mich; St. Paul Heart Clinic (K.B.), St. Paul, Minn; Pinnacle Health/Moffitt Heart and Vascular (W.B.B.), Harrisburg, Pa; Cardiology Consultants (E.W.R.), Pensacola, Fla; Krannert Institute of Cardiology (J.A.B.), Indiana University School of Medicine, Indianapolis, Ind; Wisconsin Heart and Vascular Institute (D.H.L.), Madison, Wis; and Boston Scientific Corporation (A.S., R.M.S., S.R.M., K.D.D., D.S.B.), Natick, Mass.
Correspondence to John M. Lasala, MD, PhD, Washington University School of Medicine, Cardiology, Campus Box 8086, 660 South Euclid Ave, St Louis, MO 63110. E-mail jlasala{at}im.wustl.edu
Received January 18, 2009; accepted June 1, 2009.
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Abstract |
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Background— Stent thrombosis (ST) is an uncommon but serious complication of drug-eluting and bare metal stents. To assess drug-eluting stent ST in contemporary practice, we analyzed 2-year data from the 7492-patient ARRIVE registry.
Methods and Results— Patients were enrolled at the initiation of percutaneous coronary intervention with no inclusion/exclusion criteria beyond use of the paclitaxel-eluting TAXUS stent. Two-year follow-up was 94% with independent adjudication of major cardiac events. A second, autonomous committee adjudicated Academic Research Consortium (ARC) definite/probable ST. Cumulative 2-year ARC-defined ST was 2.6% (1.0% early ST [<30 days], 0.7% late ST [31 to 365 days], and 0.8% very late ST [>1 year]). Simple-use (single-vessel and single-stent) cases had lower rates than expanded use (broader patient/lesion characteristics, 2-year cumulative: 1.4% versus 3.3%, P<0.001; early ST: 0.4% versus 1.4%, P<0.001; late ST: 0.5% versus 0.8%, P=0.14; very late ST: 0.4% versus 1.0%, P=0.008). Within 7 days of ST, 23% of patients died; 28% suffered Q-wave myocardial infarction. Mortality was higher with early ST (39%) than late ST (12%, P<0.001) or very late ST (13%, P<0.001). Multivariate analysis showed anatomic factors increased early ST (lesion >28 mm, lesion calcification) and late ST (vessel <3.0 mm); biological factors increased very late ST (renal disease, prior brachytherapy). Although early ST (71.4%) and very late ST (23.1%) patients had dual antiplatelet therapy at the time of ST, premature thienopyridine discontinuation was a strong independent predictor of both.
Conclusions— The relative risks of early and late ST differ. Knowledge of ST risk for specific subgroups may guide revascularization options until the completion of randomized trials in these broad populations.
Key Words: angioplasty • coronary disease • registries • stents • thrombosis
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Introduction |
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Stent thrombosis (ST) is a serious complication following either bare metal stents (BMS) or drug-eluting stents (DES), and its occurrence is associated with significant (40% to 50%) mortality and a composite death/myocardial infarction (MI) rate of 50% to 70%.1–3 The ST risk is greatest in the first 30 days after stenting (early ST) and higher in patients with complex coronary anatomy beyond that studied in pivotal trials.2–4 To better understand the incidences and consequences of early ST, late ST (LST), and very late ST (VLST) in a broad population of DES-treated patients, we evaluated 2-year outcomes of 7492 patients receiving the paclitaxel-eluting TAXUS stent in the ARRIVE registries.5,6
Clinical Perspective on p 285
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Methods |
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Program Design
The TAXUS Express2 stent (Boston Scientific Corporation [BSC], Natick, Mass) and the BSC-sponsored TAXUS Peri-Approval Registry: A Multi-Center Safety Surveillance (ARRIVE) Program have been described previously.5,6 Briefly, ARRIVE 1 (mandated by the US Food and Drug Administration; 2487 analyzed patients, 48 sites), and ARRIVE 2 (voluntary postmarket registry; 5005 analyzed patients, 53 sites) were similarly designed to enroll consecutive consented patients determined by the investigator to be appropriate candidates for a DES. Patients were enrolled under a protocol approved by the local institutional review board in full conformity with the US Food and Drug Administration guidelines and the Declaration of Helsinki at procedure start, to minimize potential bias relating to exclusion of complicated/unsuccessful procedures.
Of ARRIVE’s 7492-patient population, the majority (4794, 64%) were expanded-use cases whose clinical/anatomic complexity fell beyond the simple-use indications studied in the TAXUS IV pivotal trial.7 Reference vessel diameter and lesion length were determined visually by the implanting physician, and stents were placed according to the directions for use and/or standard percutaneous coronary intervention practices. Dual antiplatelet therapy (DAPT; clopidogrel/ticlopidine and aspirin) was begun before or immediately after the procedure under directions for use recommendations for aspirin indefinitely and clopidogrel/ticlopidine for at least 6 months. Monitors retained by the sponsor reviewed data from all patients in whom subsequent cardiac events were reported plus an additional 10% to 20% patient sampling per site to confirm the accuracy and completeness of data collection; follow-up was 97% through 1 year and 94% complete through 2 years. This accuracy of ascertainment is supported by the observation that clinical outcomes among simple-use ARRIVE patients closely matched those of similar patients recruited in the randomized clinical trial (RCT) TAXUS arms.5 An independent Clinical Events Committee adjudicated and determined the relationship of reported cardiac events to the TAXUS stent, and a second committee at the Harvard Clinical Research Institute adjudicated ST per the Academic Research Consortium (ARC) "definite/probable" definitions.8 The studies are registered with clinicaltrials.gov: NCT00569491 (ARRIVE 1) and NCT00569751 (ARRIVE 2).
Statistical Analysis
Patient/procedural characteristics and event rates were analyzed using descriptive statistics with SAS version 8.0 or higher (SAS Institute, Cary, NC). The 2 ARRIVE registries had similar designs, eligibility criteria, end point definitions, and adjudication processes; data pooling was found to be appropriate. Descriptive statistics (N, mean, SD) were used to summarize continuous variables and frequency tables or proportions for discrete variables. Student t test was used to compare continuous variables and 
2 or Fisher exact test for discrete variables. Kaplan–Meier product method was used to calculate event rates for time-to-event outcomes (log-rank probability value). Rates are provided for 0 to 1 day (acute), 2 to 30 days (subacute), 0 to 30 days (early), 31 to 365 days (LST), and 366 to 730 days (VLST).8 Annualized rates for each period were also computed. To identify predictors of ST, 42 baseline variables (Table 1) were assessed using backward Cox proportional hazards regression model; the threshold to remain in the model was P=0.10.
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The sponsor, the principal investigators, and the US Food and Drug Administration designed the ARRIVE registry. Data analyses, carried out by the sponsor, were assessed in a collaborative effort between the principal and coprincipal investigators and the sponsor, who also assisted with writing the report and is included in the author list. The authors had access to the data and take responsibility for its integrity. All authors have read and agreed to the manuscript as written.
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Results |
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Definite/Probable ST Rates
ST occurred in 184 (2.5%) of 7492 patients; 171 had 1 ST, 12 had 2, and 1 experienced 3 thrombotic events. Overall, 42% were early ST, 28% were LST, and 30% were VLST. Cumulative 2-year ST was 2.6% consisting of 1.0% early ST, 0.7% LST, and 0.8% VLST (Table 2). Rates were higher for the expanded-use versus simple-use cohort (respective 2-year cumulative ST: 3.3% versus 1.4%, P<0.001; early ST: 1.4% versus 0.4%, P<0.001; LST: 0.8% versus 0.5% P=0.14; VLST: 1.0% versus 0.4, P=0.008). Patients who ultimately sustained an ST event differed significantly from those who did not in a number of baseline factors (Table 3).
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The difference between ST incidence in the expanded-use versus simple-use subgroups is illustrated in Figure 1, with 1.0% of the difference (
) becoming evident within 30 days, rising to a of 1.3% at 1 year, and 1.9% at 2 years. If ST risk was normalized for exposure time (Figure 2), the annualized hazard rate in the overall population was highest (41% per year) in the 0 to 1 day interval, falling to a relatively constant 0.8% per year from 31 days to 2 years.
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Among 9 high risk, expanded-use subgroups interval analysis showed numerically higher ST rates in year 1 than year 2 for all but renal disease patients (Table 2). Early or LST was highest among subgroups with complex lesion morphology: small vessels (reference vessel diameter <2.5 mm), longer lesions (>28 mm), bifurcation lesions, or multivessel stenting. Rates of VLST were highest among patients with renal disease (serum creatinine >3.0 mg/dL or patient on dialysis), vein graft stenting, chronic total occlusion, and in-stent restenosis subgroups (including prior brachytherapy), for whom VLST rates actually exceeded the corresponding early ST rates.
Outcomes Postinitial ST Event
Table 4 shows the occurrence of death, MI, or target lesion revascularization within 7 days of the 184 initial ST events. Only 4 additional events occurred 8 to 30 days after the initial ST (3 deaths, 1 target lesion revascularization). The most common events within 7 days were target lesion revascularization (64%) and MI (63%). Mortality within 7 days was higher with early ST (39%) than LST (12%, P<0.001) or VLST (13%, P<0.001).
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DAPT Use
Among ARRIVE patients, 67.7% (4687 of 6927) were on DAPT at 1 year and 53.1% (3487 of 6569) at 2 years. Antiplatelet therapy status at time of initial ST was available for 80% (148 of 184) of patients; 44.6% (66 of 148) were on DAPT, including 56.3% (54 of 96) who experienced ST during year 1 (Table 5). Use at time of event was higher among patients with early ST (71.4%) than LST (35.0%) or VLST (23.1%), for whom DAPT use had fallen below the 67.7% and 53.1% rates, respectively, in the general ARRIVE population. Expanded-use patients were more likely to be taking DAPT at time of ST: 70% (28 of 40) for early ST, 86% (12 of 14) for LST, and 75% (9 of 12) for VLST.
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Multivariate Predictors
Table 6 shows multivariate predictors for early ST, LST, and VLST identified from among 42 assessed variables. Among 15 predictors, only 3 overlapped among time points. Discontinuation of thienopyridine therapy before 30 days was the strongest predictor of early events (14-fold increased risk), whereas discontinuation of thienopyridine before 6 months was associated with a 2-fold risk of LST. Additional factors each associated with increased risk of early or LST included vessel size <3.0 mm, lesion >28 mm, multiple stents and multiple vessels treated and clinical factors such as prior MI and congestive heart failure. In contrast, predictors of VLST tended to be more patient than lesion-based as prior brachytherapy presented the highest risk (7.3-fold, 6.7% rate of VLST [2 of 30]) followed by renal disease (3.9-fold).
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Discussion |
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In the BMS era, ST was thought to be limited to the first 30-day (acute/subacute) period9 and was effectively reduced to <1% by the addition of ticlopidine to aspirin alone.10 In 2004 to 2005, sporadic accounts of LST and VLST were reported with DES11 and attributed to incomplete DES healing.12 A small but significant increase in ST with DES versus BMS was seen from 1 to 4 years using the original protocol definitions, which excluded ST events following repeat revascularization procedures.12 But using the ARC definitions of definite/probable ST,8 data from CYPHER and TAXUS RCTs have shown no significant rate differences between DES and BMS through 1 year, with a similarly low frequency of VLST with TAXUS (0.35% per year) and BMS (0.25% per year, P=0.40) from 1 to 5 years.13 However, these RCT involved mostly "simple-use" procedures with short lesions in vessels of 2.5 to 3.5 mm and avoiding clinical conditions such as acute myocardial infarction (AMI). Yet, as DES were adopted for >80% of percutaneous coronary intervention procedures in the United States, most involved expanded-use situations not included in the pivotal RCTs. In fact, there are few reports of the rates, consequences, and predictors of ST in the more complex patient mix treated in routine clinical practice.
The combined ARRIVE registries offer a unique opportunity to examine this issue. The large size (7492 patients) and lack of specific inclusion/exclusion criteria provide a broad look at DES performance. Data from 184 ST patients allowed analysis of ST rates (early, late, and VLST) and consequences and the influence of various risk factors that would not be possible in smaller patient cohorts. Principal findings include the following: (1) the 2-year cumulative ARC definite/probable ST rate of 2.6%, higher than in RCTs, included 1.0% early ST, 0.7% LST, and 0.8% VLST; (2) ST was higher at each time point for expanded use than for simple use, with a 2-year cumulative rate of 3.3% versus 1.4%, respectively, P<0.001; (3) within 7 days of ST, 23% of patients died and 28% suffered Q-wave MI; (4) multivariate analysis showed that early ST and LST increased with anatomic factors such as long lesions (>28 mm) or small vessels (reference vessel diameter <3.0 mm), respectively, whereas VLST increased with biological factors such as renal disease or prior brachytherapy; and (5) premature discontinuation of thienopyridine use was a strong independent predictor of early ST and LST but offered incomplete protection as 71.4% of early ST and 23.1% of VLST patients suffered ST events while receiving DAPT. The ARRIVE data thus significantly extend our knowledge and highlight factors associated with increased risk of DES early, late, or very late ST, which may be useful to clinicians in estimating relative risk in specific patients.14
The estimates of ST rates in ARRIVE agree well with other published evidence. Simple-use ARRIVE ST rates (0.9% for year 1 and 0.5% for year 2, time-to-event analysis) were thus comparable with those of corresponding patients in the RCT TAXUS arms (0.9% and 0.3%, respectively).5 Expanded-use ARRIVE ST rates also match available data from observational studies, notwithstanding the limitations of different degrees of event ascertainment, monitoring, and adjudication. Thus, higher ST rates at each time point among expanded-use patients in ARRIVE concurs with observations of DES results from the multicenter STENT,15 EVENT,16 and DEScover17 registries as well as smaller studies.18–21 The 18-month ST rate in the SORTOUT II randomized trial was 2.9% for paclitaxel-eluting stents,22 but only 1.9% in a 4-center, prospective, observational European cohort study.23 Conversely, one large US center18 reported higher early ST (1.9% versus 1.0%) and LST (1.4% versus 0.7%) rates than ARRIVE but comparable VLST rates (0.7% versus 0.8%). As seen in ARRIVE, early ST rates were also higher than late ST rates among the 15 157 patients followed for 1 year in the e-CYPHER registry, although the level of monitoring and end-point ascertainment may have led to differences in absolute event rates.24 In a European 2-institutional cohort study of 8146 patients receiving DES, the incidence of early ST was 3.7% with a 2-year cumulative rate of 4.6%, when compared with the 2.6% rate in ARRIVE.25 The STENT registry reported a 1.6% 2-year DES ST rate in the off-label group15 compared with 3.3% in the ARRIVE expanded-use subgroup. The 1-year ARRIVE ST rate of 2.7% in the AMI population is comparable with the 1-year ST rates reported for DES (3.2%) and BMS (3.4%) in the HORIZONS AMI RCT.26 Differences in methodology notwithstanding, these multisource data lend credence that the higher rates of ST seen in the expanded-use cohort of ARRIVE are realistic estimates.
Despite variances in reported rates, the severe clinical consequences of ST remain similar across studies.1–3 In ARRIVE, 23% of ST patients died and 28% suffered a Q-wave MI within 7 days of the ST event. In a recent report from a multicenter registry of 431 patients with a definite ST (BMS and DES), the long-term clinical outcome post-ST was also unfavorable, with a high mortality and recurrence rate.27 Interestingly, in ARRIVE the lethality of later ST seems less than half that of early ST (12% to 13% versus 39%). It is not clear whether this reflects differences in attribution, the fact that sudden death 
30 days is included in the ARC definition of ST, or a true biological difference in ST lethality at different time points. Confirmation from other large experiences will be required.
The 184 ARRIVE ST patients had significant differences in baseline clinical/procedural characteristics (Table 3) compared with patients who did not suffer ST. Early and LST were most common in subgroups with small vessels, long lesions, multivessel stenting, or bifurcation lesions, as would be expected based on the identification of these same risk factors for BMS ST.28 In a recent report on patients with acute coronary syndrome, multivariate predictors of early ST (BMS and DES) included absence of preprocedural thienopyridine, suboptimal angiographic results, and the extent of coronary disease.29 The recognized factors of small stent diameter and long stent length were also important predictors of early and late ST and have been incorporated in a risk score for ST in the first year that has been developed based on the ARRIVE data.30 These anatomic risk factors for early ST, however, had little impact on VLST where biological factors such as prior brachytherapy and renal disease were operative.
Several major medical societies have recommended DAPT be taken at least 1 year after DES, if tolerated, noting that patients with ST-associated clinical comorbidity (eg, renal disease) or procedural variables (eg, multiple stents) may be candidates for DAPT >1 year.31–33 The ARRIVE protocol recommended minimally 6 months DAPT, but 67.7% (4687 of 6927) and 53.1% (3487 of 6569) were on DAPT at 1 and 2 years, respectively. Premature discontinuation of DAPT poses a significant risk to DES-treated patients as seen in ARRIVE (14-fold risk of early ST if discontinued before 30 days; 2-fold risk of LST if discontinued before 6 months) and reported by others.3,21,23,28,34,35 At the same time, continued DAPT does not confer immunity from ST as most (71%) of ARRIVE patients with early ST were on DAPT at the time of the event, as were 35% of LST patients, similar to another report.25 However, we did not evaluate platelet inhibition and potential resistance to clopidogrel therapy, which has been implicated in BMS ST,36 and may have been applicable here. Altered clopidogrel dosing strategies have been associated with improved platelet responsiveness in 2 recent trials.37,38 Alternatively, a more uniformly effective thienopyridine (prasugrel) may be able to reduce ST events compared with clopidogrel, both for early ST and between 30 days and 15 months.39 Optimal DAPT duration will be examined further in a large (>20 000 patients) industry-sponsored study to evaluate the comparative benefits of 30 versus 12 months of DAPT, in DES and propensity-matched BMS patients.40
It is unknown how many of the ST events observed in ARRIVE were related to potential incomplete DES healing. The high-risk subgroups studied have extensive/aggressive underlying atherosclerotic coronary disease whose progression may lead to plaque rupture that would be indistinguishable from true ST by the ARC definitions or angiography. Distinguishing DES related from non–DES-related etiologies requires randomized or concurrent BMS controls in the same patient sets as seen in the recent HORIZONS study where BMS had the same increased ST rate during the first year after AMI treatment as TAXUS.26 These high 1-year rates with both stent types may reflect underlying biological risks.
Some limitations should be considered when interpreting these results. Constraints inherent to any registry include lack of randomization, absence of a comparison group, a lower monitoring level than is standard for RCT, no detailed medication records between patient visits, use of site visual assessments (rather than core laboratory measurement) of angiographic data, and the absence of mandated intravascular ultrasound data, each of which may have provided greater insight into the role of procedural risk factors. More specifically, the lack of routine intravascular ultrasound data did not allow the study to evaluate the role of suboptimal stent deployment as a contributor to ST. Evaluation of DAPT also was limited in the 20% (36 of 184) of ST patients for whom antiplatelet therapy status at time of initial ST was not available. Additionally, ST estimates are imprecise even in a large registry, given the low frequency of event and potential limitations of the ARC ST definitions. Nevertheless, the close correlation of observed ST rates in ARRIVE with the simple-use RCT data and more recent complex RCT data in AMI (HORIZONS) suggests that these estimates of differential ST rates in high-risk subgroups are reasonable.
In conclusion, ARRIVE affords a unique look at ST in a large, real-world DES treated population. First-year ST risk reflects mostly DAPT compliance and complex anatomic and clinical factors already known to increase BMS ST risk. Protection from ST by ongoing DAPT is significant but incomplete. Risk factors for VLST seem more related to biological markers than to the anatomic factors related to early/late ST and absent BMS controls for many of the expanded-use subsets it is speculative how many of those late events are related to the DES itself rather than progression of diffuse and aggressive atherosclerosis in these higher risk patients. Either way, there may be reason to continue longer term DAPT in such patients—to protect potentially incompletely healed DES or to protect against natural history—until that question is put into better perspective by trials now being initiated. Until that point, the knowledge of ST incidence, outcomes, and risk factors gained from ARRIVE will hopefully help guide physician management decisions.
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Acknowledgments |
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We thank Yun Lu, MS, and Kevin Najarian, MS, for assistance with the statistical analyses and Mary V. Jacoski, MS, for assistance with data assessment (all BSC).
Sources of Funding
This study was supported by BSC.
Disclosures
Dr Lasala reports receiving Speaker’s Bureau fees and consulting fees from BSC; Dr Cox is on the Speaker’s Bureau and Medical Advisory Board for BSC; Dr Breall has received research grants from BSC, is on the Xience and Angiomax Speaker’s Bureaus, has done medical-legal work, and is a consultant on the Siemans Advisory Board; Dr Lewis was on the Speaker’s Bureau for Bristol-Myers Squibb, the manufacturer of Plavix. Drs Baim, Dawkins, Mascioli, Starzyk, and Ms Song are full-time employees and stockholders of BSC. Dr Mascioli has represented BSC as an expert witness. Drs Bachinsky, Baran, Dobies, and Rogers have no conflicts.
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