Randomized evaluation of anticoagulation versus antiplatelet therapy after coronary stent implantation in high-risk patients: the multicenter aspirin and ticlopidine trial after intracoronary stenting (MATTIS).

BACKGROUND Although the association of ticlopidine and aspirin has been shown to be superior to anti-vitamin K agents and aspirin after coronary stent implantation in low-risk patients, the latter combination has remained an unproven reference regimen for high-risk patients until recently. METHODS AND RESULTS We randomized 350 high-risk patients within 6 hours after stent implantation to receive during 30 days either aspirin 250 mg and ticlopidine 500 mg/d (A+T group) or aspirin 250 mg/d and oral anticoagulation (A+OAC group) targeted at an international normalized ratio of 2.5 to 3. The primary composite end point was defined as the occurrence of cardiovascular death, myocardial infarction, or repeated revascularization at 30 days. Patients were eligible if (1) the stent(s) were implanted to treat abrupt closure after PTCA; (2) the angiographic result after implantation was suboptimal; (3) a long segment was stented (>45 mm and/or >/=3 stents); or (4) the largest balloon inflated in the stent had a nominal diameter of </=2.5 mm. The primary cardiac end point was reached for 10 patients (5.6%) in the A+T group and 19 (11%) in the A+OAC group (relative risk [RR], 1. 9; 95% CI, 0.9 to 4.1; P=0.07). Major vascular and bleeding complications were less frequent in the A+T group (3 patients, 1.7%) than in the A+OAC group (12 patients, 6.9%) (RR, 4.1; 95% CI, 1.2 to 14.3; P=0.02). CONCLUSIONS High-risk patients should be treated with A+T rather than A+OAC after coronary stenting because the bleeding and vascular complications are significantly reduced and there is a marked trend suggesting a decrease in cardiac events.

[1]  D. Holmes,et al.  Coronary artery stents. , 2000, JAMA.

[2]  J. Muhlestein,et al.  "Rescue" utilization of abciximab for the dissolution of coronary thrombus developing as a complication of coronary angioplasty. , 1997, Journal of the American College of Cardiology.

[3]  KurtUlm,et al.  Major Benefit From Antiplatelet Therapy for Patients at High Risk for Adverse Cardiac Events After Coronary Palmaz-Schatz Stent Placement , 1997 .

[4]  M. Hadamitzky,et al.  Major benefit from antiplatelet therapy for patients at high risk for adverse cardiac events after coronary Palmaz-Schatz stent placement: analysis of a prospective risk stratification protocol in the Intracoronary Stenting and Antithrombotic Regimen (ISAR) trial. , 1997, Circulation.

[5]  D. Baim,et al.  Stent thrombosis. Closing in on the best preventive treatment. , 1997, Circulation.

[6]  J. Tobis Editorial comment: Not all stents are created equal , 1997 .

[7]  P. D. de Feyter,et al.  Is intravascular ultrasound after coronary stenting a safe procedure? Three cases of stent damage attributable to ICUS in a tantalum coil stent. , 1997, Catheterization and cardiovascular diagnosis.

[8]  A. Colombo,et al.  High pressure assisted coronary stent implantation accomplished without intravascular ultrasound guidance and subsequent anticoagulation. , 1997, Journal of the American College of Cardiology.

[9]  J. Tobis Not all stents are created equal. , 1997, Catheterization and Cardiovascular Diagnosis.

[10]  M. Dennis A randomised, blinded, trial of clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE). CAPRIE Steering Committee , 1996 .

[11]  J. Ambrose,et al.  Do we require a cure for "stentmania"? , 1996, Journal of the American College of Cardiology.

[12]  A. Cribier,et al.  Intracoronary stent implantation without ultrasound guidance and with replacement of conventional anticoagulation by antiplatelet therapy. 30-day clinical outcome of the French Multicenter Registry. , 1996, Circulation.

[13]  C. Leclercq,et al.  Combined antiplatelet therapy with ticlopidine and aspirin. A simplified approach to intracoronary stent management. , 1996, European heart journal.

[14]  Morandini,et al.  Palmaz-Schatz Coronary Stent Implantation Without Intravascular Ultrasound and Without Subsequent Anticoagulation: Clinical Outcome. , 1996, The Journal of invasive cardiology.

[15]  M. Hadamitzky,et al.  A randomized comparison of antiplatelet and anticoagulant therapy after the placement of coronary-artery stents. , 1996, The New England journal of medicine.

[16]  W Rutsch,et al.  Heparin-coated Palmaz-Schatz stents in human coronary arteries. Early outcome of the Benestent-II Pilot Study. , 1996, Circulation.

[17]  A. Colombo,et al.  A randomized comparison of combined ticlopidine and aspirin therapy versus aspirin therapy alone after successful intravascular ultrasound-guided stent implantation. , 1996, Circulation.

[18]  D. Clement A randomised, blinded, trial of Clopidogrel versus aspirin in patients at risk of ischaemic events (CAPRIE) , 1996 .

[19]  Mintz,et al.  Antithrombotic Therapy after Stent Deployment. , 1996, The Journal of invasive cardiology.

[20]  C. Bauters,et al.  Two‐pronged antiplatelet therapy with aspirin and ticlopidine without systemic anticoagulation: an alternative therapeutic strategy after bailout stent implantation , 1995, Coronary artery disease.

[21]  P Hall,et al.  Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance. , 1995, Circulation.

[22]  J. Carlson,et al.  Fatal Neutropenia and Thrombocytopenia Associated with Ticlopidine , 1994, The Annals of pharmacotherapy.

[23]  W Rutsch,et al.  A comparison of balloon-expandable-stent implantation with balloon angioplasty in patients with coronary artery disease. Benestent Study Group. , 1994, The New England journal of medicine.

[24]  E J Topol,et al.  Caveats about elective coronary stenting. , 1994, The New England journal of medicine.

[25]  P. Teirstein,et al.  A randomized comparison of coronary-stent placement and balloon angioplasty in the treatment of coronary artery disease. Stent Restenosis Study Investigators. , 1994, The New England journal of medicine.

[26]  P. Barragan,et al.  Ticlopidine and subcutaneous heparin as an alternative regimen following coronary stenting. , 1994, Catheterization and cardiovascular diagnosis.

[27]  G. Laarman,et al.  Emergency coronary stenting with the Palmaz-Schatz stent for failed transluminal coronary angioplasty: results of a learning phase. , 1993, American heart journal.

[28]  R. Erbel,et al.  Subacute thrombotic complications after intracoronary implantation of Palmaz-Schatz stents. , 1993, American heart journal.

[29]  E. Topol,et al.  Thrombosis of a flexible coil coronary stent: frequency, predictors and clinical outcome. , 1993, Journal of the American College of Cardiology.

[30]  J. Spear,et al.  Electrophysiologic recovery in postischemic, stunned myocardium despite persistent systolic dysfunction. , 1993, American heart journal.

[31]  M. Leon,et al.  Emergent Use of Balloon‐Expandable Coronary Artery Stenting for Failed Percutaneous Transluminal Coronary Angioplasty , 1992, Circulation.

[32]  Larry S. Dean,et al.  Intracoronary Stenting for Acute and Threatened Closure Complicating Percutaneous Transluminal Coronary Angioplasty , 1992, Circulation.

[33]  R. Erbel,et al.  Short and long term results after intracoronary stenting in human coronary arteries: monocentre experience with the balloon-expandable Palmaz-Schatz stent. , 1991, British heart journal.

[34]  R. de Caterina,et al.  Benefit/Risk Profile of Combined Antiplatelet Therapy with Ticlopidine and Aspirin , 1991, Thrombosis and Haemostasis.

[35]  B Meier,et al.  Angiographic follow-up after placement of a self-expanding coronary-artery stent. , 1991, The New England journal of medicine.

[36]  P. Serruys,et al.  Emergency stenting for refractory acute coronary artery occlusion during coronary angioplasty. , 1990, The American journal of cardiology.

[37]  H. Adams,et al.  A randomized trial comparing ticlopidine hydrochloride with aspirin for the prevention of stroke in high-risk patients. Ticlopidine Aspirin Stroke Study Group. , 1989, The New England journal of medicine.

[38]  U. Sigwart,et al.  Emergency stenting for acute occlusion after coronary balloon angioplasty. , 1988, Circulation.

[39]  F Joffre,et al.  Intravascular stents to prevent occlusion and restenosis after transluminal angioplasty. , 1987, The New England journal of medicine.