(Circulation. 1999;99:2364-2366.)
© 1999 American Heart Association, Inc.
Brief Rapid Communications |
Effectiveness of Clopidogrel and Aspirin Versus Ticlopidine and Aspirin in Preventing Stent Thrombosis After Coronary Stent Implantation
From Lenox Hill Hospital, New York, NY, and Centro Cuore Columbus, Milan, Italy (A.C.).
Correspondence to Jeffrey W. Moses, MD, Interventional Cardiology, Lenox Hill Hospital, 130 E 77th St, New York, NY 10021. E-mail jmoses{at}idt.net
Abstract
Background—Ticlopidine has been shown to reduce the incidence of stent thrombosis compared with warfarin, but it may cause serious hematological side effects. Clopidogrel, a new thienopyridine derivative, may be a safe alternative to ticlopidine. The aim of this study was to compare the safety and efficacy of clopidogrel and aspirin with those of ticlopidine and aspirin in patients undergoing coronary stent implantation.
Methods and Results—The population of this study consisted of 2 groups: patients who underwent coronary stenting and were treated with ticlopidine and aspirin (TA group, n=1406), and patients who underwent coronary stenting followed by treatment with clopidogrel and aspirin (CA group, n=283). At 1-month follow-up, there was no difference in stent thrombosis (1.5% versus 1.4%, P=1.0) or major adverse cardiac events (3.1% versus 2.4%, P=0.85) between the TA and CA groups, respectively. The probability of any side effect (neutropenia, diarrhea, rash) was significantly higher in the TA group (10.6% versus 5.3%, P=0.006; relative risk, 0.53; CI, 0.32 to 0.86).
Conclusions—These data suggest that clopidogrel may be an effective pharmacological regimen after coronary stent implantation. Furthermore, the simpler dosing regimen, the absence of neutropenia, and the lower frequency of other side effects make it a safe alternative to ticlopidine.
Key Words: clopidogrel • ticlopidine • stents
Coronary stent implantation has become the dominant form of catheter-based coronary interventions on the basis of data demonstrating the efficacy and safety of coronary stenting when appropriate technique and postprocedure antiplatelet therapy are used.1 2 The combination of ticlopidine and aspirin has been confirmed to be superior to aspirin alone or aspirin and coumarin in randomized trials.3 4 Despite the effectiveness of ticlopidine, a small incidence of side effects remains,5 in particular hematological side effects that may occasionally be fatal.6
Clopidogrel, a new thienopyridine derivative, was recently approved for use in patients with atherosclerotic vascular disease to reduce the incidence of ischemic events.7 This antiplatelet agent may potentially be of use after stent implantation to reduce stent thrombosis without the added risks of hematological toxicity. As of this writing, few data are available as to the effectiveness of this agent in preventing thrombosis after stenting. The purpose of this study was to compare the safety and effectiveness of clopidogrel and aspirin with those of ticlopidine and aspirin in a consecutive series of patients undergoing coronary stent implantation.
Methods
Patient Population, Stent Implantation, and Pharmacological
Regimen
Between September 1996 and June 1998, 2057 patients underwent
stent implantation for obstructive coronary artery disease. Of
these, 368 were excluded from this study because of (1) requirement for
oral anticoagulation (57 patients); (2) administration of abciximab
(280 patients); (3) procedural failure: less than TIMI 3 flow (8
patients), residual diameter stenosis >50% (4 patients),
emergency bypass surgery (3 patients), or intracerebral
hemorrhage (1 patient); and (4) patients who received aspirin
alone (14 patients) or ticlopidine alone (1 patient) because of known
allergy to the other agent. The final study population consisted of
patients who underwent coronary stenting between September 1996
and February 1998 and were treated with ticlopidine and aspirin (TA
group: 1406 patients, 1763 lesions) and patients who underwent
coronary stenting between March 1998 and June 1998 and were
treated with clopidogrel and aspirin (CA group: 283 patients, 376
lesions). Stent implantation was performed by use of techniques
previously described,2 and quantitative angiographic
analysis was performed with a computer-based system (CMS
version 3.0, MEDIS).
Ticlopidine was administered as a loading dose of 500 mg followed by 250 mg PO twice a day for 2 weeks.8 Clopidogrel was administered as a loading dose of 300 mg followed by 75 mg PO once a day for 4 weeks. Aspirin was administered as 325 mg PO once a day to both groups. All patients were instructed to follow up with their referring physician in 2 weeks for clinical assessment and blood count analysis. In addition, a dedicated nurse practitioner (R.M.) was performing telephonic follow-up evaluation at 1 month on an ongoing basis.
Statistics
Statistical analysis was performed with StatView
software. Continuous normally distributed data were expressed as
mean±SD and were compared by unpaired Student's t test.
Categorical variables were expressed as numbers and percentages and
compared by the 
2 test. Differences were
considered statistically significant at a value of
P<0.05.
Results
Patient Characteristics and Procedural Data
Patient characteristics and angiographic measurements are shown in
Table 1
. Similar numbers (1.3+0.6
versus 1.3+0.5, P=1.0) and types (slotted tube, 87% versus
88%; coil, 12% versus 12%; and Wallstent, 1% versus 0%,
P=0.49) of stents were implanted in the TA and CA groups,
respectively. Bailout stenting was performed with similar frequency in
both groups (6% versus 7%, P=0.57).
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Medication Side Effects and Clinical Outcome
During the period of this study, 16 patients in the TA group
(1.1%) and 2 patients in the CA group (0.7%) were lost to follow-up.
Of the study population, 46 patients (3.3%) in the TA group and 8
patients (2.8%) in the CA group (P=0.85) discontinued the
study drug early for reasons other than the occurrence of an outcome
event. Reasons for stopping ticlopidine were rash in 30 patients,
diarrhea in 6 patients, rash and diarrhea in 5 patients, neutropenia in
4 patients, and noncompliance in 1 patient. Reasons for stopping
clopidogrel were rash in 4 patients, diarrhea in 3 patients, and
noncompliance in 1 patient. The incidence of stent thrombosis, cardiac
events, and medication side effects at 1-month follow-up is shown in
Table 2.
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Discussion
Rationale for Use of Clopidogrel After Stent Implantation
Clopidogrel is a thienopyridine derivative that inhibits
platelet aggregation by inhibiting the binding of ADP to its
platelet receptor, which leads to direct inhibition of the binding
of fibrinogen to the glycoprotein IIb/IIIa
complex.9 Although both ticlopidine and clopidogrel
prevent platelet aggregation evoked by shear stress, experimental
studies suggest that clopidogrel is more effective than either aspirin
or ticlopidine in preventing the high-shear-stress–dependent
coronary stent thrombosis.10 Furthermore,
clopidogrel has a favorable safety profile compared with ticlopidine,
for which routine hematological monitoring is mandatory to ensure early
detection of potentially lethal hematological events. The incidence of
neutropenia with ticlopidine is proportional to the duration of
treatment (up to 2.4%), and it may resolve with drug cessation in most
but not all cases.5 Another serious side effect of
ticlopidine is thrombotic thrombocytopenic purpura (TTP). A recent
review6 documented 60 cases of TTP among patients treated
with ticlopidine, with an associated mortality rate of 33%. In this
review, 12 patients developed TTP after receiving ticlopidine for 
3
weeks after stent implantation. Other common but less morbid adverse
effects reported to accompany ticlopidine use are gastrointestinal
symptoms.5 Clopidogrel was developed because it did not
show bone marrow toxicity in tissue culture and animal models. In the
large CAPRIE trial,7 the incidence of severe neutropenia
with long-term use was only 0.05%, which was similar to the rate seen
with aspirin (0.04%). In addition, the proportions of patients with
severe rash and diarrhea while on clopidogrel in this trial were less
than those reported with ticlopidine but twice as high as with aspirin.
Therefore, the combination of a favorable safety profile and a proven
experimental and clinical antiplatelet effect make clopidogrel an
attractive alternative to ticlopidine after coronary stent
implantation.
Clopidogrel: Administration and Clinical Impact
The inhibition of platelet aggregation by clopidogrel is
concentration dependent.9 In this study, clopidogrel was
administered as a loading dose of 300 mg, a dose that provides 80%
platelet inhibition in 5 hours,11 followed by 75 mg PO
daily for 4 weeks. Aspirin was added to clopidogrel because this drug
has no effect on the cyclooxygenase pathway, and
therefore, both agents may work synergistically, as is the case with
ticlopidine.12 In this study, stent thrombosis occurred
with similar frequency in the ticlopidine and clopidogrel groups (1.5%
versus 1.4%, P=NS). Similarly, there was no difference
between the 2 groups in incidence of major adverse cardiac events at
1-month follow-up (3.1% versus 2.4%, P=NS).
With respect to side effects, neutropenia occurred in 4 patients (0.3%) in the ticlopidine group but none of the patients in the clopidogrel group (0%). This rate of neutropenia is similar to those in other stent trials in which ticlopidine was used for 4 weeks.3 4 In this study, rash occurred significantly more often in the ticlopidine group despite the short duration of administration. The incidence of diarrhea was also slightly higher, but not statistically significant. Overall, patients in the ticlopidine group were at twice the risk of having any side effect compared with patients receiving clopidogrel.
Study Limitations
First, this is a nonrandomized comparison between the 2
pharmacological regimens. However, these regimens were used in a
chronologically consecutive manner, an approach that eliminates the
potential for operator bias in selecting one specific regimen over the
other. Second, because the incidence of stent thrombosis with
antiplatelet therapy is very low, a higher number of patients is
necessary to establish equivalence between clopidogrel and ticlopidine.
Therefore, a large randomized trial is needed to establish the validity
of these data.
Conclusions
These data suggest that clopidogrel may be an effective
pharmacological regimen after coronary stent implantation.
Furthermore, the simpler dosing regimen and the absence of
hematological toxicity make it a potential safe alternative to
ticlopidine.
Received December 12, 1998; revision received March 2, 1999; accepted March 9, 1999.
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 F. Sarrot-Reynauld, L. Bouillet, and J.-L. Bourrain Severe Hypersensitivity Associated with Clopidogrel Ann Intern Med, August 21, 2001; 135(4): 305 - 306. [Full Text] [PDF]
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M. Taniuchi, H. I. Kurz, and J. M. Lasala Randomized Comparison of Ticlopidine and Clopidogrel After Intracoronary Stent Implantation in a Broad Patient Population Circulation, July 31, 2001; 104(5): 539 - 543. [Abstract] [Full Text] [PDF]
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H. Schuhlen, A. Kastrati, J.u. Pache, J. Dirschinger, and A. Schomig Incidence of thrombotic occlusion and major adverse cardiac events between two and four weeks after coronary stent placement: analysis of 5,678 patients with a four-week ticlopidine regimen J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2066 - 2073. [Abstract] [Full Text] [PDF]
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S. C. Smith Jr, J. T. Dove, A. K. Jacobs, J. Ward Kennedy, D. Kereiakes, M. J. Kern, R. E. Kuntz, J. J. Popma, H. V. Schaff, D. O. Williams, et al. ACC/AHA guidelines for percutaneous coronary intervention (revision of the 1993 PTCA guidelines): A report of the American College of Cardiology/ American Heart Association Task Force on practice guidelines (Committee to revise the 1993 guidelines for percutaneous transluminal coronary angioplasty) endorsed by the Society for Cardiac Angiography and Interventions J. Am. Coll. Cardiol., June 15, 2001; 37(8): 2239 - 2239. [Full Text] [PDF]
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U. Rauch, J. I. Osende, V. Fuster, J. J. Badimon, Z. Fayad, and J. H. Chesebro Thrombus Formation on Atherosclerotic Plaques: Pathogenesis and Clinical Consequences Ann Intern Med, February 6, 2001; 134(3): 224 - 238. [Abstract] [Full Text] [PDF]
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H.-K. Yip, C.-J. Wu, K.-H. Yeh, C.-L. Hang, C.-Y. Fang, K. Y.-K. Hsieh, and M. Fu Unusual Complication of Retrograde Dissection to the Coronary Sinus of Valsalva During Percutaneous Revascularization : A Single-Center Experience and Literature Review Chest, February 1, 2001; 119(2): 493 - 501. [Abstract] [Full Text] [PDF]
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C. Patrono, B. Coller, J. E. Dalen, G. A. FitzGerald, V. Fuster, M. Gent, J. Hirsh, and G. Roth Platelet-Active Drugs : The Relationships Among Dose, Effectiveness, and Side Effects Chest, January 1, 2001; 119 (2009): 39S - 63S. [Full Text] [PDF]
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P. D. Stein, J. E. Dalen, S. Goldman, and P. Theroux Antithrombotic Therapy in Patients With Saphenous Vein and Internal Mammary Artery Bypass Grafts Chest, January 1, 2001; 119 (2009): 278S - 282S. [Full Text] [PDF]
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J. J. Popma, E. M. Ohman, J. Weitz, A. M. Lincoff, R. A. Harrington, and P. Berger Antithrombotic Therapy in Patients Undergoing Percutaneous Coronary Intervention Chest, January 1, 2001; 119 (2009): 321S - 336S. [Full Text] [PDF]
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The Clopidogrel in Unstable angina to prevent Recurrent Events (CURE) trial programme. Rationale, design and baseline characteristics including a meta-analysis of the effects of thienopyridines in vascular disease Eur. Heart J., December 2, 2000; 21(24): 2033 - 2041. [Abstract] [PDF]
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P.J. De Feyter and D. Foley Coronary stent implantation: a panacea for the interventional cardiologist? Eur. Heart J., November 1, 2000; 21(21): 1719 - 1726. [PDF]
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 F. L. Paradiso-Hardy, C. M. Angelo, K. L. Lanctot, and E. A. Cohen Hematologic dyscrasia associated with ticlopidine therapy: evidence for causality Can. Med. Assoc. J., November 1, 2000; 163(11): 1441 - 1448. [Abstract] [Full Text] [PDF]
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 J. Al Suwaidi, P. B. Berger, and D. R. Holmes Jr Coronary Artery Stents JAMA, October 11, 2000; 284(14): 1828 - 1836. [Abstract] [Full Text] [PDF]
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I. Malik and M. Poullis Acute Platelet Inhibition With Abciximab Does Not Reduce In-Stent Restenosis Circulation, October 10, 2000; 102 (15): 110e - e110. [Full Text] [PDF]
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F. C. Tong, H. J. Cloft, G. J. Joseph, O. B. Samuels, and J. E. Dion Abciximab Rescue in Acute Carotid Stent Thrombosis AJNR Am. J. Neuroradiol., October 1, 2000; 21(9): 1750 - 1752. [Abstract] [Full Text]
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G. Helft, J. I. Osende, S. G. Worthley, A. G. Zaman, O. J. Rodriguez, E. I. Lev, M. E. Farkouh, V. Fuster, J. J. Badimon, and J. H. Chesebro Acute Antithrombotic Effect of a Front-Loaded Regimen of Clopidogrel in Patients With Atherosclerosis on Aspirin Arterioscler Thromb Vasc Biol, October 1, 2000; 20(10): 2316 - 2321. [Abstract] [Full Text] [PDF]
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K. Moshfegh, M. Redondo, F. Julmy, W. A. Wuillemin, M. U. Gebauer, A. Haeberli, and B. J. Meyer Antiplatelet effects of clopidogrel compared with aspirin after myocardial infarction: enhanced inhibitory effects of combination therapy J. Am. Coll. Cardiol., September 1, 2000; 36(3): 699 - 705. [Abstract] [Full Text] [PDF]
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P. H.N. Oomen, J. E. Tulleken, and J. G. Zijlstra Hemolytic Uremic Syndrome in a Patient Treated with Clopidogrel Ann Intern Med, June 20, 2000; 132(12): 1006 - 1006. [Full Text] [PDF]
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 C. L. Bennett, J. M. Connors, J. M. Carwile, J. L. Moake, W. R. Bell, S. R. Tarantolo, L. J. McCarthy, R. Sarode, A. J. Hatfield, M. D. Feldman, et al. Thrombotic Thrombocytopenic Purpura Associated with Clopidogrel N. Engl. J. Med., June 15, 2000; 342(24): 1773 - 1777. [Abstract] [Full Text] [PDF]
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B. Chandrasekar and J.-F. Tanguay Platelets and restenosis J. Am. Coll. Cardiol., March 1, 2000; 35(3): 555 - 562. [Abstract] [Full Text] [PDF]
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C. Muller, H. J. Buttner, J. Petersen, and H. Roskamm A Randomized Comparison of Clopidogrel and Aspirin Versus Ticlopidine and Aspirin After the Placement of Coronary-Artery Stents Circulation, February 15, 2000; 101(6): 590 - 593. [Abstract] [Full Text] [PDF]
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Y. Yeghiazarians, J. B. Braunstein, A. Askari, and P. H. Stone Unstable Angina Pectoris N. Engl. J. Med., January 13, 2000; 342(2): 101 - 114. [Full Text] [PDF]
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P. H. Grewe, T. Deneke, A. Machraoui, J.u. Barmeyer, and K.-M. Muller Acute and chronic tissue response to coronary stent implantation: pathologic findings in human specimen J. Am. Coll. Cardiol., January 1, 2000; 35(1): 157 - 163. [Abstract] [Full Text] [PDF]
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G. J. Mishkel, F. V. Aguirre, R. W. Ligon, K. J. Rocha-Singh, C. L. Lucore, and for Prairie Cardiovascular Consultants Ltd Clopidogrel as adjunctive antiplatelet therapy during coronary stenting J. Am. Coll. Cardiol., December 1, 1999; 34(7): 1884 - 1890. [Abstract] [Full Text] [PDF]
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P. B. Berger, M. R. Bell, C. S. Rihal, H. Ting, G. Barsness, K. Garratt, V. Bellot, V. Mathew, S. Melby, L. Hammes, et al. Clopidogrel versus ticlopidine after intracoronary stent placement J. Am. Coll. Cardiol., December 1, 1999; 34(7): 1891 - 1894. [Abstract] [Full Text] [PDF]
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L. W. Klein and J. E. Calvin Use of clopidrogel in coronary stenting: what was the question? J. Am. Coll. Cardiol., December 1, 1999; 34(7): 1895 - 1898. [Full Text] [PDF]
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C. Haller and W. Kubler The disappointing results of PTCA in the uraemic patientare stents the answer? Nephrol. Dial. Transplant., November 1, 1999; 14(11): 2582 - 2584. [Full Text] [PDF]
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 {blacktriangledown}Clopidogrel and {blacktriangledown}ticlopidine - improvements on aspirin? DTB, August 1, 1999; 37(8): 59 - 61. [Abstract] [Full Text] [PDF]
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 Clopidogrel as Good as Ticlopidine After Stenting? Journal Watch Cardiology, July 9, 1999; 1999(709): 3 - 3. [Full Text]
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