Abstract
Background:
The usage of platelet glycoprotein (GP) IIb/IIIa receptor inhibitors improves the outcome during high‐risk percutaneous coronary interventions (PCI). The aim of this study was to evaluate the long‐term effects after a planned switch from abciximab to eptifibatide during PCI.
Hypothesis:
A switch from the general use of abciximab to eptifibatide as a GP IIb/IIIa in connection with PCI would not have any negative effects on long‐term clinical outcomes.
Methods:
To reduce costs, a general switch from abciximab to eptifibatide was instituted in 2004 in 2 university hospitals in Sweden. All patients treated 6 months before and 6 months after the switch were followed for 30 months. During the study period, 1038 patients underwent PCI and received a GP IIb/IIIa receptor inhibitor, 481 (46%) before the switch (Group A) and 557 (54%) after the switch (Group B). The 2 groups had similar baseline characteristics. The primary endpoint was the composite of death, myocardial infarction, stroke, or new coronary revascularization (percutaneous or surgical); secondary endpoints were the individual components of this composite. A separate analysis was performed on patients treated for ST‐segment elevation myocardial infarction, non–ST‐segment elevation myocardial infarction/unstable angina, and diabetes, respectively. Data were collected from the Swedish Coronary Angiography and Angioplasty Registry.
Results:
There were no differences between the groups in the primary endpoint (29.7% in Group A vs 29.3% in Group B; P = 0.48) or in any of the secondary endpoints.
Conclusions:
A switch from the general usage of abciximab to eptifibatide as a GP IIb/IIIa receptor inhibitor in connection with PCI did not seem to have any negative effects on long‐term clinical outcomes. Copyright © 2008 Wiley Periodicals, Inc.
The authors have no funding, financial relationships, or conflicts of interest to disclose.
Introduction
Glycoprotein (GP) IIb/IIIa receptor inhibitors improve the outcome in patients undergoing percutaneous coronary interventions (PCI).1, 2, 3 The American College of Cardiology recommend their usage during PCI for patients with ST‐segment elevation myocardial infarction (STEMI), non–ST‐segment elevation myocardial infarction (NSTEMI)/unstable angina (UA), and stable angina (complicated procedures).4, 5, 6 The 3 currently available GP IIb/IIIa receptor inhibitors are abciximab (Eli Lilly & Co., Indianapolis, IN), eptifibatide (Millennium Pharmaceuticals, Inc., Cambridge, MA), and tirofiban (Iroko Pharmaceuticals, Philadelphia, PA). Although all express their beneficial effects by blocking the GP IIb/IIIa platelet receptor, they are characterized by significant differences. There are studies comparing each agent with placebo, but only a few studies with head‐to‐head comparisons between the different agents. Abciximab was the first approved drug, with beneficial effects that are well documented.7, 8 With eptifibatide, one study showed superiority compared with placebo in relatively low‐risk patients.9 Two studies randomizing patients between abciximab and eptifibatide, comprising 582 patients, have produced inconclusive results regarding short‐term clinical outcome.10, 11 Tirofiban is the least‐documented agent among the 3 GP IIb/IIIa receptor inhibitors, and furthermore it failed to present noninferiority in comparison with abciximab.12
In most countries, eptifibatide is cheaper than abciximab, which makes its use attractive to the healthcare system. The cost in Sweden for treating an 80‐kg patient with normal renal function is $967 per procedure for abciximab and $331 per procedure for eptifibatide (calculation was performed using current prices at our institutions). To reduce costs, a switch from abciximab to eptifibatide was instituted in 2004 in 2 university hospitals in Sweden (Sahlgrenska University Hospital, Gothenburg; and Uppsala University Hospital, Uppsala). Previously, we reported 6‐month follow‐up results from that switch in patients treated only in Sahlgrenska University Hospital.13 There was a trend toward a better outcome among patients treated with abciximab as compared with those treated with eptifibatide. The aim of this study was to validate this finding in a larger study population and for a prolonged follow‐up period.
Methods
The switch was instituted in October 2004 at Sahlgrenska University Hospital and in February 2004 at Uppsala University Hospital. These months were considered a transition period for the hospitals, and patients treated during these months at each respective institution were excluded from the analysis. The study population consisted of all patients undergoing PCI and receiving a GP IIb/IIIa receptor inhibitor in a period of 6 months before (Group A) and 6 months after (Group B) the transition period in the 2 hospitals. We chose to minimize enrollment in this study to a relatively short time interval before and after the switch to avoid influence from changes in patient selection and in clinical practice during PCI over time. Furthermore, we wanted to exclude inclusion time after the introduction of bivalirudin as an anticoagulant (July 2005 in our institutions) to avoid selection biases and further changes of the antithrombotic regimen.
Indications for administration of a GP IIb/IIIa receptor inhibitor were, in both institutions, PCI in the setting of STEMI, NSTEMI/UA, or stable angina class above III or IV according to the Canadian Cardiovascular Society classification with a complicated procedure, or in patients not pretreated with clopidogrel. Although the switch was supposed to be general, there were few patients who, for unspecified reasons, received a GP IIb/IIIa receptor blocker that was not the one normally used according to routine during the time when they were treated. These patients were included in the analysis and allocated to the group specified by the time of treatment, irrespective of the actual GP IIb/IIIa receptor blocker that was given. The final decision of administration of a GP IIb/IIIa receptor inhibitor was at the discretion of the operating physician, after evaluating the individual patient's benefit/risk ratio.
Abciximab was administered as a 0.25‐mg/kg intravenous (IV) bolus dose followed by an IV infusion of 0.125 µg/kg/minute for 12 hours. Eptifibatide was administered as a 180‐µg/kg IV bolus dose followed by a second IV bolus after 10 minutes and then an 18‐hour IV infusion of 2 µg/kg/minute. Premature discontinuation of the infusions was initiated in the presence of clinical indications (eg, bleeding complications).
Data on patient characteristics, procedures, and follow‐up were retrieved from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR). A detailed description of the registry is presented in previous publications14 and on the registry site (http://www.ucr.uu.se/scaar). In summary, all Swedish patients undergoing coronary angiography and/or angioplasty are registered by the operating physician in the national registry immediately after the procedure. Clinical details such as the presence of diabetes mellitus (DM), systemic hypertension, treated dyslipidemia, prior myocardial infarction (MI), prior coronary artery bypass grafting, prior PCI, as well as procedural characteristics and outcomes are filled in immediately after the procedure. Medical staff going through the patients' files also recorded complications and adverse outcomes observed in the department. The patients' follow‐up is performed through merging the SCAAR registry with other national registries. Date of death was obtained from the national population registry, and data regarding hospital admissions for MI, stroke, or surgical revascularization were obtained from the Swedish Hospital Discharge Registry. All new percutaneous revascularizations were recorded through the SCAAR registry.
Endpoints
The primary endpoint of this study was the composite endpoint of death, new MI, stroke, or new revascularization (percutaneous or surgical) within 30 months following the procedure; the secondary endpoints were the separate components of this composite. For the combined endpoints, only the first event was included for those with multiple events.
Separate analyses were performed for patients with STEMI, NSTEMI/UA, and DM, respectively.
Statistical Analysis
Continuous variables are expressed as mean ± SD or median (interquartile range) and discrete counts are expressed as frequency counts and percentages. Continuous variables were compared with the Mann‐Whitney test. Categorical variables were compared with the χ2 or the Fisher exact test. For the outcome at 30 months' follow‐up, the Kaplan‐Meier method was used for estimation of cumulative rates and the log‐rank test was used for comparison between groups. For calculation of hazard ratios and corresponding confidence intervals, the Cox proportional hazards regression model was used. An interaction analysis was performed to evaluate whether the outcome after treatment with the 2 GP IIb/IIIa receptor blockers differed with respect to STEMI or NSTEMI/UA as an indication for the procedures. A P value of < 0.05 was considered statistically significant.
Results
During the study period, 1038 patients underwent PCI in the 2 hospitals, receiving a GP IIb/IIIa inhibitor. Group A comprised 481 patients (46%) treated before the switch, and Group B comprised 557 patients (54%) treated after the switch. Baseline characteristics were similar in the 2 groups (Table 1).
Table 1.
Baseline and Procedural Characteristics
| Variable | Group A (n = 481) | Group B (n = 557) |
|---|---|---|
| Age, y (IQR) | 64 (57, 73) | 65 (57, 73) |
| Male sex, n (%) | 344 (72) | 390 (70) |
| Risk factors, n (%) | ||
| DM [6, 7]a | 84 (18) | 89 (16) |
| Prior HL [31, 23], a | 179 (40) | 210 (39) |
| Prior HT [20, 22]a | 181 (39) | 241 (45) |
| Current smoker [100, 83]a | 103 (27) | 151 (32) |
| Previous CABG, n (%) [0, 0]a | 40 (8) | 47 (8) |
| Previous PCI, n (%) [0, 0]a | 72 (15) | 71 (13) |
| Indication for PCI, n (%) [0, 0]a | ||
| Stable angina | 11 (2.0) | 27 (5.0) |
| NSTEMI/UA | 207 (43) | 218 (39) |
| STEMI | 204 (42) | 269 (48) |
| Rescue PCI | 47 (10) | 34 (6.0) |
| Other | 12 (2.0) | 9 (2.0) |
| Angiographic findings, n (%) [0, 0]a | ||
| 1‐vessel disease | 206 (43) | 259 (46) |
| 2‐vessel disease | 164 (34) | 170 (30) |
| 3‐vessel disease | 101 (21) | 130 (23) |
| Left main disease | 23 (5.0) | 15 (3.0) |
| Vessels treated, n (%) [5, 10]a | ||
| LAD | 190 (40) | 230 (42) |
| LCx | 74 (16) | 73 (13) |
| RCA | 181 (38) | 219 (40) |
| Left main | 8 (2.0) | 9 (2.0) |
| Vein graft | 19 (4.0) | 15 (3.0) |
| Arterial graft | 1 (0.02) | 2 (0.05) |
| Treated artery status before PCI, n (%) [22, 17]a | ||
| Occlusion | 206 (45) | 240 (44) |
| No occlusion | 251 (55) | 302 (56) |
| Chronic total occlusion | 3 (0.6) | 11 (2.0) |
| Successful PCI, n (%) | 463 (97) | 538 (96) |
| Complete revascularization [67, 72]a | 207 (51) | 250 (51) |
| PCI with stent, n (%) | 443 (92) | 511 (91) |
| Bare‐metal stent | 417 (94) | 465 (91) |
| Drug‐eluting stent | 26 (6.0) | 46 (9.0) |
| Hospital stay, d (IQR) | 3 (2, 7) | 4 (2, 7) |
| Access site, n (%) [5, 7]a | ||
| Transfemoral approach | 359 (76) | 373 (67) |
| Transradial approach | 113 (24) | 181 (33) |
| GP IIb/IIIa receptor inhibitor used, n (%) | ||
| Abciximab | 477 (99.2) | 2 (0.4) |
| Eptifibatide | 4 (0.8) | 555 (99) |
Abbreviations: CABG, coronary artery bypass grafting; DM, diabetes mellitus; GP, glycoprotein; HL, hyperlipidemia; HT, hypertension; IQR, interquartile range; LAD, left anterior descending artery; LCx, left circumflex artery; NSTEMI, non–ST‐segment elevation myocardial infarction; PCI, percutaneous coronary intervention; RCA, right coronary artery; STEMI, ST‐segment elevation myocardial infarction; UA, unstable angina.
Number of patients with missing data in Group A and Group B, respectively
Procedural variables were similar between the 2 groups, although Group B had more patients treated through the transradial approach. Duration of hospitalization was numerically 1 day shorter for Group A, but this difference was not statistically significant (Table 1).
Clinical endpoints did not differ between the groups (Table 2, Figures 1, 2). Registered bleeding complications during hospitalization did not significantly differ between the 2 groups, experienced by 14 patients (2.9%) in Group A vs 11 patients (2%) in Group B (odds ratio: 0.67, 95% confidence interval: 0.30–1.49, P = 0.42).
Figure 1.
Kaplan‐Meier curves for any of the composites of the primary endpoint: (A) death, (B) new AMI, (C) stroke, and (D) new revascularization. Abbreviations: AMI, acute myocardial infarction
Figure 2.
Kaplan‐Meier curves for the combined endpoint of death, new AMI, stroke, or new revascularization. Abbreviations: AMI, acute myocardial infarction
Interaction analysis between outcome on the one hand and indication of STEMI or NSTEMI/UA on the other revealed no difference in outcome between Group A and Group B with respect to any of these indications (P = 0.28 for the composite endpoint; Table 2, Figures 3A, B).
Table 2.
Clinical Endpoints at 30‐Month Follow‐up for the Entire Study Population, Patients With STEMI, Patients With NSTEMI, and Patients With DM
| Group A | Group B | P Value | HR (95% CI) | |
|---|---|---|---|---|
| All study patients, n (%) | N = 481 | N = 557 | ||
| Death | 37 (7.7) | 47 (8.4) | 0.66 | 1.10 (0.72–1.69) |
| MI | 57 (12.2) | 71 (13.2) | 0.64 | 1.08 (0.77–1.54) |
| Stroke | 12 (2.6) | 19 (3.6) | 0.38 | 1.38 (0.67–2.84) |
| New revascularization | 72 (15.5) | 77 (14.4) | 0.70 | 0.94 (0.68–1.29) |
| Any of the above | 143 (29.7) | 163 (29.3) | 0.48 | 1.00 (0.80–1.25) |
| STEMI patients, n (%) | n = 204 | n = 269 | ||
| Death | 23 (11.3) | 25 (9.3) | 0.46 | 0.81 (0.46–1.42) |
| MI | 28 (14.5) | 35 (13.5) | 0.76 | 0.93 (0.56–1.52) |
| Stroke | 5 (2.7) | 8 (3.2) | 0.77 | 1.18 (0.39–3.61) |
| New revascularization | 33 (17.2) | 36 (14.0) | 0.38 | 0.81 (0.51–1.30) |
| Any of the above | 66 (32.4) | 77 (28.6) | 0.40 | 0.87 (0.63–1.21) |
| NSTEMI patients, n (%) | n = 207 | n = 218 | ||
| Death | 10 (4.8) | 16 (7.3) | 0.27 | 1.56 (0.71–3.44) |
| MI | 22 (10.7) | 24 (11.3) | 0.83 | 1.07 (0.60–1.90) |
| Stroke | 5 (2.4) | 8 (3.8) | 0.43 | 1.57 (0.51–4.79) |
| New revascularization | 37 (18) | 41 (19.4) | 0.66 | 1.10 (0.71–1.72) |
| Any of the above | 60 (29.0) | 69 (31.7) | 0.49 | 1.13 (0.80–1.59) |
| Patients with DM, n (%) | n = 84 | n = 89 | ||
| Death | 6 (7.1) | 11 (12.4) | 0.27 | 1.74 (0.64–4.71) |
| MI | 18 (22.3) | 16 (18.7) | 0.51 | 0.80 (0.41–1.57) |
| Stroke | 3 (3.8) | 7 (8.4) | 0.23 | 2.24 (0.58–8.68) |
| New revascularization | 16 (19.9) | 23 (26.8) | 0.25 | 1.45 (0.77–2.75) |
| Any of the above | 32 (38.1) | 45 (50.6) | 0.19 | 1.36 (0.86–2.13) |
Abbreviations: CI, confidence interval; DM, diabetes mellitus; HR, hazard ratio; MI, myocardial infarction; NSTEMI, non–ST‐segment elevation myocardial infarction; STEMI, ST‐segment elevation myocardial infarction
Figure 3.
Kaplan‐Meier curves for the combined endpoint of death, new AMI, stroke, or new revascularization. (A) Patients treated due to STEMI; (B) patients treated due to NSTEMI/UA. Abbreviations: AMI, acute myocardial infarction; NSTEMI, non–ST‐segment elevation myocardial infarction; STEMI, ST‐segment elevation myocardial infarction; UA, unstable angina
Diabetes Mellitus
A subgroup analysis for patients with documented DM was performed. There were 173 patients with DM in the study population (84 in Group A and 89 in Group B). The results for the primary endpoint and for all secondary endpoints for this subgroup population are presented in Table 2.
Discussion
The main finding of this study is that switching from abciximab to eptifibatide during PCI does not affect clinical outcome, even in a long‐term follow‐up. To the best of our knowledge, this is the only study evaluating the effect on patient outcome of switching from abciximab to eptifibatide over such a long term (30 months).
The concept of comparing these regimens was tested in 2 small randomized trials. In the Eptifibatide vs Abciximab in Primary PCI for Acute ST Elevation Myocardial Infarction trial (EVA‐AMI),10 429 patients with STEMI were randomized to periprocedural administration of either abciximab (n = 203) or eptifibatide (n = 226) with the primary endpoint of ST‐segment resolution 1 hour after the intervention. Although there were no differences in clinical outcomes (death, reinfarction, and target‐vessel revascularization), eptifibatide was demonstrated to be superior to abciximab concerning the primary endpoint (5.4% of the patients showed no ST‐segment resolution in the eptifibatide group compared with 14.7% in the abciximab group, P = 0.021). The Prairie ReoPro vs Integrilin Cost Evaluation trial (PRICE)11 was a randomized double‐blind trial evaluating 30‐day economic and clinical outcome in patients undergoing elective coronary stenting with either abciximab (n = 74) or eptifibatide (n = 81) as adjunctive therapy. No differences were observed in the combined clinical endpoint of death, MI, or urgent revascularization (4.9% in eptifibatide‐treated patients vs 5.1% in abciximab‐treated patients by discharge).
The comparison between abciximab and eptifibatide also was tested in retrospective trials, either with consecutive patient series15, 16, 17 or with switch from abciximab to eptifibatide.18, 19 The findings of these studies are contradictory. There are studies showing no difference in clinical outcomes when comparing these 2 regimens, whereas there is a minority of studies showing that abciximab is more effective than eptifibatide in reducing post‐PCI clinical events.17 In the latest and largest of these studies, Long et al16 evaluated the results of consecutive patients treated with PCI and receiving either abciximab (n = 951) or eptifibatide (n = 2123). Eptifibatide was significantly associated with lower risk of the combined endpoint of death or MI at 2 years (15.5% vs 18%, P = 0.013). When patients were matched using a propensity score analysis, this difference disappeared and the choice of agent had no effect on patient outcomes. These findings, as well as the collective results of the above‐mentioned studies, are confirmed by the finding of our study, in which we failed to demonstrate any differences in clinical outcomes between treatments with abciximab or eptifibatide as adjunctive therapy to PCI, even 30 months after the procedure.
We failed to demonstrate any significant difference in outcome between the 2 GP IIb/IIIa receptor inhibitors with respect to indication. In this respect, however, our study was underpowered and differences may still exist, as supported by previous data.20 Thus, the documented positive effects of abciximab as compared with placebo are far more strongly documented among patients with high‐risk PCI but without ongoing STEMI21, 22, 23 than they are in STEMI populations, in which the data have been more conflicting and less convincing.7, 8, 23 Meta‐analyses, however, indicate that abciximab compares favorably with placebo also in the setting of primary PCI for STEMI.24, 25
The subgroup analysis of patients with DM failed to show any significant differences between the 2 groups. There was a trend toward lower rate of clinical events among patients in Group A, but due to the small sample size no further conclusions can be drawn.
The retrospective nature of this study and the sequential allocation of patients to the different GP IIb/IIIA receptor blockers are major limitations. This methodological problem is counterbalanced by the relatively large study size and the long follow‐up term. Small differences of clinical significance between the 2 regimens may still exist. Appropriate evaluation of such differences can only be done in adequately large prospective randomized trials.
Conclusion
In conclusion, a switch from the general usage of abciximab to eptifibatide as GP IIb/IIIa receptor blocker in connection with PCI did not seem to have any negative effects on long‐term clinical outcomes.
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