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Intracoronary stenting without anticoagulation accomplished with intravascular ultrasound guidance
EVOLVING
TECHNOLOGIES
procedures (73% versus 21%, P < ,001). Conclusions:
In
dural complications that occurred in 16 patients (4.5%). Intraprocedural complications, however, decreasedto 1% when angiographically appropriately sized balloons were usedfor final stent dilations. There was one ischemicvascular complication that occurred at the time of the procedure and one ischemic vascular complication that occurred at the time of angiographic follow-up. By 6 months, repeat angioplasty for symptomatic restenosiswas performed in 47 patients (13.1%). Conclusions: The Palmaz-Schatz
patients with successful PTCA but reduced luminal diameter demonstrated by repeat angiography at 24 hours, the Gianturco-Roubin stent appears to reduce angiographic restenosis at follow-up.
lntracoronary Stenting Without Anticoagulation Accomplished With Intravascular Ultrasound Guidance A. Colombo, P. Hall, 5. Nakamura, Y. Almagor, L Maiello, G. Martini, A. Gaglione, S.L Goldberg, J.M. Tobis. Centro Coure Columbus, Milan, Italy. Circulation 1995;91:
1676-88. Background:The placementof stentsin coronary arterieshas been shown to reduce restenosisin comparisonto balloon angioplasty. However, clinical useof intracoronary stentsis impeded by the risk of subacutestent thrombosisand complications associatedwith the anticoagulant regimen. To reduce these complications, the hypothesis that systemic anticoagulationis not necessarywhen adequatestent expansion is achieved was prospectively evaluated on a consecutive seriesof patients who received intracoronary stents. MethodsandResults:From March 1993 to January 1994,359 patients underwent Palmaz-Schatzcoronary stent insertion. After an initial successfulangiographic result with <20% stenosisby visual estimationhad beenachieved, intravascular ultrasound imaging was performed. Further balloon dilatation of the stent was guided by observation of the intravascularultrasound images.All patients with adequatestent expansion confirmed by ultrasound were treated only with antiplatelet therapy (either ticlopidine for 1 month with short-term aspirin for 5 days or only aspirin) after the procedure. Clinical success(procedure successwithout early postprocedural events) at 2 months was achieved m 338 patients (94%). With an inflation pressureof 14.9 ? 3.0 atm and a balloon-to-vesselratio of 1.17 + 0.19, optimal stent expansion was achieved in 321 of the 334 patients (96%) who underwent intravascular ultrasound evaluation, with thesepatients receiving only antiplatelet therapy after the procedure. Despitethe absenceof anticoagulation, there were only two acute stent thromboses(0.6%) and one subacute stent thrombosis (0.3%) at 2-month clinical followup. Follow-up angiography at 3 to 6 months documented two additional occlusions (0.6%) at the stent site. At 6-month clinical follow-up, angiographically documented stent occlusion had occurred in 5 patients (1.6%). At 6-month clinical follow-up, there was a 5.7% incidence of myocardial infarction, a 6.4% rate of coronary bypasssurgery, and a 1.9% incidence of death. Emergency intervention (emergency angioplasty or bailout stent) for a stent thrombosis event was performed in 3 patients (0.8%). The overall event rate was relatively high becauseof intraproceACC
CURRENT
JOURNAL
stent can be safely inserted in coronary arteries without subsequent anticoagulation provided that stent expansion is adequate and there are no other flowlimiting lesions present. The use of high-pressure final balloon dilatations and confirmation of adequate stent expansion by intravascular ultrasound provide assurance that anticoagulation therapy can be safely omitted. This technique significantly reduces hospital time and vascular complications and has a low stent thrombosis rate.
A Randomized Comparison of Combined Ticlopidine and Aspirin Therapy Versus Aspirin Therapy Alone After Successful Intravascular Ultrasound-Guided Stent Implantation P. Hall, 5. Nakamura, L Maiello, A. Itoh, 5. Blengino, G. Martini, M. Ferraro, A. Colombo. Centro Cow Columbus, Milan, Italy. Circulation l996;93:215-22.
Background:Previous studieshave shown that it is feasibleto withhold anticoagulation after a successfulintracoronary stent procedure with a low incidence of stent thrombosis. The importance of specific antiplatelet agentswhen stenting is performed without anticoagulation is unknown. Methods and Results:After successfulintravascular ultrasound-guided stenting, 226 patients were randomly assignedto receive either aspirin therapy alone (n = 103) or a combination of ticlopidine and short-term aspirin therapy (n = 123). Primary angiographicand clinical end points were stent thrombosis,death, myocardial infarction, the need for postprocedure coronary artery bypasssurgery or repeatedangioplasty, and significant medication sideeffectsrequiring termination of the medication within the first month of a successful procedure. At 1 month, the rate of stent thrombosis was 2.9% in the aspirin only group and 0.8% in the ticlopidineaspirin group (P = .2). Cumulative major clinical events after successfulstenting occurred in 3.9% of the patients in the aspirin group and in 0.8% in the ticlopidine-aspirin group (P = .l). There were no medication sideeffectsin the aspirin group; in the combined ticlopidine-aspirin group, medication side effects occurred in 3 patients (P = .2). Conclusions: At 1 month, there was no difference in the incidence of stent thrombosis or other clinical end points between the two poststent antiplatelet regiREVIEW
27
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TECHNOLOGIES
procedures (73% versus 21%, P < ,001). Conclusions:
In
dural complications that occurred in 16 patients (4.5%). Intraprocedural complications, however, decreasedto 1% when angiographically appropriately sized balloons were usedfor final stent dilations. There was one ischemicvascular complication that occurred at the time of the procedure and one ischemic vascular complication that occurred at the time of angiographic follow-up. By 6 months, repeat angioplasty for symptomatic restenosiswas performed in 47 patients (13.1%). Conclusions: The Palmaz-Schatz
patients with successful PTCA but reduced luminal diameter demonstrated by repeat angiography at 24 hours, the Gianturco-Roubin stent appears to reduce angiographic restenosis at follow-up.
lntracoronary Stenting Without Anticoagulation Accomplished With Intravascular Ultrasound Guidance A. Colombo, P. Hall, 5. Nakamura, Y. Almagor, L Maiello, G. Martini, A. Gaglione, S.L Goldberg, J.M. Tobis. Centro Coure Columbus, Milan, Italy. Circulation 1995;91:
1676-88. Background:The placementof stentsin coronary arterieshas been shown to reduce restenosisin comparisonto balloon angioplasty. However, clinical useof intracoronary stentsis impeded by the risk of subacutestent thrombosisand complications associatedwith the anticoagulant regimen. To reduce these complications, the hypothesis that systemic anticoagulationis not necessarywhen adequatestent expansion is achieved was prospectively evaluated on a consecutive seriesof patients who received intracoronary stents. MethodsandResults:From March 1993 to January 1994,359 patients underwent Palmaz-Schatzcoronary stent insertion. After an initial successfulangiographic result with <20% stenosisby visual estimationhad beenachieved, intravascular ultrasound imaging was performed. Further balloon dilatation of the stent was guided by observation of the intravascularultrasound images.All patients with adequatestent expansion confirmed by ultrasound were treated only with antiplatelet therapy (either ticlopidine for 1 month with short-term aspirin for 5 days or only aspirin) after the procedure. Clinical success(procedure successwithout early postprocedural events) at 2 months was achieved m 338 patients (94%). With an inflation pressureof 14.9 ? 3.0 atm and a balloon-to-vesselratio of 1.17 + 0.19, optimal stent expansion was achieved in 321 of the 334 patients (96%) who underwent intravascular ultrasound evaluation, with thesepatients receiving only antiplatelet therapy after the procedure. Despitethe absenceof anticoagulation, there were only two acute stent thromboses(0.6%) and one subacute stent thrombosis (0.3%) at 2-month clinical followup. Follow-up angiography at 3 to 6 months documented two additional occlusions (0.6%) at the stent site. At 6-month clinical follow-up, angiographically documented stent occlusion had occurred in 5 patients (1.6%). At 6-month clinical follow-up, there was a 5.7% incidence of myocardial infarction, a 6.4% rate of coronary bypasssurgery, and a 1.9% incidence of death. Emergency intervention (emergency angioplasty or bailout stent) for a stent thrombosis event was performed in 3 patients (0.8%). The overall event rate was relatively high becauseof intraproceACC
CURRENT
JOURNAL
stent can be safely inserted in coronary arteries without subsequent anticoagulation provided that stent expansion is adequate and there are no other flowlimiting lesions present. The use of high-pressure final balloon dilatations and confirmation of adequate stent expansion by intravascular ultrasound provide assurance that anticoagulation therapy can be safely omitted. This technique significantly reduces hospital time and vascular complications and has a low stent thrombosis rate.
A Randomized Comparison of Combined Ticlopidine and Aspirin Therapy Versus Aspirin Therapy Alone After Successful Intravascular Ultrasound-Guided Stent Implantation P. Hall, 5. Nakamura, L Maiello, A. Itoh, 5. Blengino, G. Martini, M. Ferraro, A. Colombo. Centro Cow Columbus, Milan, Italy. Circulation l996;93:215-22.
Background:Previous studieshave shown that it is feasibleto withhold anticoagulation after a successfulintracoronary stent procedure with a low incidence of stent thrombosis. The importance of specific antiplatelet agentswhen stenting is performed without anticoagulation is unknown. Methods and Results:After successfulintravascular ultrasound-guided stenting, 226 patients were randomly assignedto receive either aspirin therapy alone (n = 103) or a combination of ticlopidine and short-term aspirin therapy (n = 123). Primary angiographicand clinical end points were stent thrombosis,death, myocardial infarction, the need for postprocedure coronary artery bypasssurgery or repeatedangioplasty, and significant medication sideeffectsrequiring termination of the medication within the first month of a successful procedure. At 1 month, the rate of stent thrombosis was 2.9% in the aspirin only group and 0.8% in the ticlopidineaspirin group (P = .2). Cumulative major clinical events after successfulstenting occurred in 3.9% of the patients in the aspirin group and in 0.8% in the ticlopidine-aspirin group (P = .l). There were no medication sideeffectsin the aspirin group; in the combined ticlopidine-aspirin group, medication side effects occurred in 3 patients (P = .2). Conclusions: At 1 month, there was no difference in the incidence of stent thrombosis or other clinical end points between the two poststent antiplatelet regiREVIEW
27
July/.hgust
IYYh