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Continued benefit of coronary stenting versus balloon angioplasty: One-year clinical follow-up of benestent trial
EVOLVING
TECHNOLOGIES
3.7-month follow-up, 5 of the 28 successfully treated patients (17.9%) had reacceleration of angina and angiographically documented restenosis at the site of stent deployment. Thus, the combined interventions are
show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.
highly efficacious in treating older vein grafts obstructed by both thrombus and atheromatous material, but are also associated with significant procedural complications including stent thrombosis, myocardial infarction, and access-site hemorrhage.
ACCEL EXCERPT Patient Selection for Stenting Hans J. Rupprecht, MD, Maim, Germany. Interviewed by William L Winters, Jr., MD. ACCEL Vol. 27, No. I I, November 1995.
Continued Benefit of Coronary Stenting Versus Balloon Angioplasty: One-Year Clinical Follow-Up of BENESTENT Trial
Dr. Winters: Dr. Rupprecht, our subject is patient selection for stents.This is a broad topic. We might start with the elective placement of stents in coronary vessels. Dr. Rupprecht: Both the BENESTENTand STRESStrials have shown that there is a reduction of acute events with stent implantation compared to percutaneoustransluminal coronary angioplasty(PTCA) aloneand that there is a reduction of restenosisrate with stents.On the other hand, it also hasbeenshown that the initial greatergain achievedby stent implantation is nearly lost at 6 months follow-up. There is evidence that stenting isproducing a large amount of intimal hyperplasia, a larger amount than with PTCA. Accordingly, in my opinion, considering also the fact that there are only scarcedata about the long-term resultsof stenting, such as metal fatigue, strut fractures, endarteritis, the possibility of migration of the stent, the implantation of stentselectively in a large number of patients is not yet justified. Dr. Winters: Are there specific instanceswhere stenting might be indicated? Dr. Rupprecht: Most patients will do very well with PTCA alone, but there may be a subgroup of patients who are at very high risk and in whom stent implantation might be appropriate on an elective basis.Thesemight be patients with a very proximal high grade lesion m a large dominant vessel such as a proximal left anterior descending artery (LAD) or an ostial lesionof the right coronary artery. In these patients the risk of stent implantation is very low becausein larger vesselsthere is a very low rate of subacuteocclusion. Dr. Winters: What happensto the individual who hasa stent implanted for a proximal severelesion and 6 months later the lumen hasshrunk to nearly the preimplant diameter? How does one approach that situation? Dr. Rupprecht: In the small group of patients where stenting might be indicated on an elective basisbecauseit is a large vessel, then the problem of restenosisis not great becausein such a large vesselintimal hyperplasia is not as critical. Restenosisis a greater problem m small vessels. When you implant a stent in a smallervesselyou will have restenosisin about 50% to 60% of thesepatients. Dr. Winters: Would you discusspost-PTCA indications that occur in the laboratory?
C. Macaya, P.W. Sertuys, P. Ruygrok, H. Suryapranata, G. Masf 5. Kiugmann, P. Urban, P. Den Heijer, K. Koch, R Simon, M.-C. Morice, P. Crean, H. Bonnier, W. Wijnr, N. Danchin, C. Bourdonnec, M.-A. Morel. Catheterization laboratory, Thorax Center, Erasmus University Rotterdam, Rotterdam, The Netherlands. J Am Coil Cardiol I996;27:255- 6 I.
Objectives:This study soughtto determine the l-year clinical follow-up of patients included in the BENESTENT trial. Background:The BENESTENT trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreasedrate of restenosisand fewer clinical events in the stent group. It is not establishedwhether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defersrestenosisand its subsequentclinical manifestations.Methods:To clarify this uncertainty, we updated clinical information on all but 1 of 5 16 patients enrolled in the BENESTENT trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascularaccident, myocardial infarction, the need for bypass surgery or a further percutaneousintervention in the previously treated lesion. Results: After 1 year, no significant differencesin mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stentand balloon angioplastygroups, respectively. However, the requirement for a repeatangioplastyprocedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = O.OOl), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differenceswere found betweengroupswith respectto functional classangina and prescribed medication at the time of follow-up. Conclusions: These clinical follow-up data KC
CURRENT
JOURNAL
REVIEW
34
July/Au~ust
1996
TECHNOLOGIES
3.7-month follow-up, 5 of the 28 successfully treated patients (17.9%) had reacceleration of angina and angiographically documented restenosis at the site of stent deployment. Thus, the combined interventions are
show that the benefit of elective native coronary artery stenting in patients with stable angina is maintained to at least 1 year after the procedure and results in a significantly reduced requirement for repeat intervention.
highly efficacious in treating older vein grafts obstructed by both thrombus and atheromatous material, but are also associated with significant procedural complications including stent thrombosis, myocardial infarction, and access-site hemorrhage.
ACCEL EXCERPT Patient Selection for Stenting Hans J. Rupprecht, MD, Maim, Germany. Interviewed by William L Winters, Jr., MD. ACCEL Vol. 27, No. I I, November 1995.
Continued Benefit of Coronary Stenting Versus Balloon Angioplasty: One-Year Clinical Follow-Up of BENESTENT Trial
Dr. Winters: Dr. Rupprecht, our subject is patient selection for stents.This is a broad topic. We might start with the elective placement of stents in coronary vessels. Dr. Rupprecht: Both the BENESTENTand STRESStrials have shown that there is a reduction of acute events with stent implantation compared to percutaneoustransluminal coronary angioplasty(PTCA) aloneand that there is a reduction of restenosisrate with stents.On the other hand, it also hasbeenshown that the initial greatergain achievedby stent implantation is nearly lost at 6 months follow-up. There is evidence that stenting isproducing a large amount of intimal hyperplasia, a larger amount than with PTCA. Accordingly, in my opinion, considering also the fact that there are only scarcedata about the long-term resultsof stenting, such as metal fatigue, strut fractures, endarteritis, the possibility of migration of the stent, the implantation of stentselectively in a large number of patients is not yet justified. Dr. Winters: Are there specific instanceswhere stenting might be indicated? Dr. Rupprecht: Most patients will do very well with PTCA alone, but there may be a subgroup of patients who are at very high risk and in whom stent implantation might be appropriate on an elective basis.Thesemight be patients with a very proximal high grade lesion m a large dominant vessel such as a proximal left anterior descending artery (LAD) or an ostial lesionof the right coronary artery. In these patients the risk of stent implantation is very low becausein larger vesselsthere is a very low rate of subacuteocclusion. Dr. Winters: What happensto the individual who hasa stent implanted for a proximal severelesion and 6 months later the lumen hasshrunk to nearly the preimplant diameter? How does one approach that situation? Dr. Rupprecht: In the small group of patients where stenting might be indicated on an elective basisbecauseit is a large vessel, then the problem of restenosisis not great becausein such a large vesselintimal hyperplasia is not as critical. Restenosisis a greater problem m small vessels. When you implant a stent in a smallervesselyou will have restenosisin about 50% to 60% of thesepatients. Dr. Winters: Would you discusspost-PTCA indications that occur in the laboratory?
C. Macaya, P.W. Sertuys, P. Ruygrok, H. Suryapranata, G. Masf 5. Kiugmann, P. Urban, P. Den Heijer, K. Koch, R Simon, M.-C. Morice, P. Crean, H. Bonnier, W. Wijnr, N. Danchin, C. Bourdonnec, M.-A. Morel. Catheterization laboratory, Thorax Center, Erasmus University Rotterdam, Rotterdam, The Netherlands. J Am Coil Cardiol I996;27:255- 6 I.
Objectives:This study soughtto determine the l-year clinical follow-up of patients included in the BENESTENT trial. Background:The BENESTENT trial is a randomized study comparing elective Palmaz-Schatz stent implantation with balloon angioplasty in patients with stable angina and a de novo coronary artery lesion. Seven-month follow-up data have shown a decreasedrate of restenosisand fewer clinical events in the stent group. It is not establishedwhether this favorable clinical outcome is maintained for longer periods or whether coronary stenting defersrestenosisand its subsequentclinical manifestations.Methods:To clarify this uncertainty, we updated clinical information on all but 1 of 5 16 patients enrolled in the BENESTENT trial (257 in balloon group, 259 in stent group) at least 12 months after the intervention. Major clinical events (primary clinical end point) were tabulated according to the intention to treat principle and included death, the occurrence of a cerebrovascularaccident, myocardial infarction, the need for bypass surgery or a further percutaneousintervention in the previously treated lesion. Results: After 1 year, no significant differencesin mortality (1.2% vs. 0.8%), stroke (0.0% vs. 0.8%), myocardial infarction (5.0% vs. 4.2%) or coronary bypass graft surgery (6.9% vs. 5.1%) were found between the stentand balloon angioplastygroups, respectively. However, the requirement for a repeatangioplastyprocedure was significantly lower in the stent group (10%) than the balloon angioplasty group (21%, relative risk [RR] 0.49, 95% confidence interval [CI] 0.31 to 0.75, p = O.OOl), and overall primary end points were less frequently reached by stent group patients (23.2%) than those in the balloon group (31.5%, RR 0.74, 95% CI 0.55 to 0.98, p = 0.04). No differenceswere found betweengroupswith respectto functional classangina and prescribed medication at the time of follow-up. Conclusions: These clinical follow-up data KC
CURRENT
JOURNAL
REVIEW
34
July/Au~ust
1996