Intracoronary stent implantation without ultrasound guidance and with replacement of conventional anticoagulation by antiplatelet therapy - 30-day clinical outcome of the French Multicenter Registry

Background Stenting reduces both acute complications of coronary angioplasty and restenosis rates but increases subacute thrombosis rates and hemorrhagic complications when used with coumadin anticoagulation. Methods and Results To simplify postcoronary stenting treatment and to reduce these drawbacks, we evaluated the 1-month outcome of a prospective registry of 2900 patients in whom successful coronary artery stenting was performed without coumadin anticoagulation. Patients received 100 mg/d aspirin and 250 mg/d ticlopidine for 1 month. Low-molecular-weight heparin (LMWH) treatment was progressively reduced in four consecutive stages, from 1-month treatment to none. Event-free outcome at 1 month was achieved in 2816 patients (97.1%). Major stent-related cardiac events were subacute closure in 51 patients (1.8%), including death in 12 (0.5%), acute myocardial infarction in 17 (0.6%): and coronary artery bypass graft surgery in 9 (0.3%). Stent thrombosis was more frequent with balloon size of <3.0 mm (less than or equal to 2.5 mm, 10%; 3.0 mn, 2.3%; greater than or equal to 3.5 mm, 1.0%; P<.001), bail-out situations (6.67% versus 1.38%, P<.001), and patients with unstable angina or acute myocardial infarction (2.2% versus 1.12%, P=.02). Bleeding complications that required transfusion, surgical repair, or both occurred in 55 patients (1.9%). Bleeding complications were related to female gender (4.0% versus 1.51%, P<.001), duration of LMWH treatment (3.83% in phase II/III versus 0.69% in phase IV/V P<.001), sheath size (6F, 0.52%; 7F, 1.04%; greater than or equal to 8F, 4.23%; P<.001), bail-out situations (4.76% versus 1.67%, P<.01), and saphenous graft stenting (4.38% versus 1.75%, P=.04). Conclusions These results suggest that poststenting treatment by ticlopidine/aspirin is an effective alternative to coumadin anticoagulation, achieving low rates of subacute closure and bleeding complications. LMWH treatment does not improve subacute reocclusion rates but increases bleeding complications. Furthermore; as bleeding complications were independently related to sheath size, we suggest that stenting with 6F guiding catheters may prevent local complications. Furthermore, the ticlopidine/aspirin combination allows a low-cost stenting strategy without ultrasound assessment of stent deployment and permits short in-hospital stay.