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Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
The predominant use of second-generation drug-eluting stents in the DIVA study may explain why the researchers found no difference in outcomes for bare metal and drug-eluting stents.
Most patients in previous trials were treated with first-generation drug-eluting stents, but second-generation drug-eluting stents perform better than their first-generation counterparts in native coronary artery disease. One might think that this finding should also apply to saphenous vein bypass graft lesions in which atherosclerosis is more aggressive and the progress of the disease much faster, yet this was not the case in DIVA, and the study authors did not provide an explanation for this finding.
One possible reason for the comparability of outcomes in the drug-eluting stents and bare metal stents groups may be that saphenous vein bypass graft lesions may be more favorably disposed to paclitaxel, commonly used in first-generation drug-eluting stents, than the drugs found in the second-generation stents. The DIVA findings may indicate that the second-generation drug-eluting stents performed worse, not that the bare metal stents performed better.
Studies of only first-generation paclitaxel-eluting stents showed a sustained benefit. Any notion that the pathophysiology of saphenous vein grafts might make them more amenable to a bare metal stent while a drug-eluting stent is better suited for native vessels is purely speculative. Further research comparing the effect of different stent types in saphenous vein bypass graft failure is warranted.
Raban V. Jeger, MD, and Sven Möbius-Winkler, MD, made these remarks in an invited commentary. Dr. Jeger is with the University Hospital Basel (Switzerland), and Dr. Möbius-Winkler is with University Hospital Jena (Germany). Dr. Jeger disclosed he is the principal investigator of the BASKET-SAVAGE trial, which received funding from Boston Scientific Germany. Dr. Möbius-Winkler had no financial relationships to disclose.
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
Drug-eluting stents (DESs) and less-expensive bare-metal stents (BMSs) performed equally well in patients with failed saphenous vein grafts after coronary artery bypass graft surgery, based on an analysis of patients in the DIVA trial.
The findings run counter to those of previous clinical trials, which had found drug-eluting stents perform better than bare-metal stents in these situations. “The study results have important economic implications in countries with high DES prices, such as the USA, because they suggest that the lower-cost BMS can be used in SVG [saphenous vein graft] lesions without compromising either safety or efficacy,” lead author Emmanouil S. Brilakis, MD, PhD, of Minneapolis Heart Institute and his coauthors said in reporting the results for the DIVA trial investigators in the Lancet.
The DIVA trial was a randomized, double-blind, controlled trial done at 25 U.S. Department of Veterans Affairs centers. Researchers randomly assigned 599 patients who had previous coronary artery bypass surgery to either the DES or BMS groups, and the study reported data from 597 patients. The combined endpoint comprised cardiac death, target vessel MI, or target vessel revascularization at 12 months and then over the entire length of follow-up, which ranged from 2 to 7 years. Operators used the DES or BMS of their choice.
While BMSs are presumed to be less expensive than DESs, the study authors did not provide prices or price ranges for the stents. Dr. Brilakis and his coauthors acknowledged that the financial implications depend on local stent pricing practices.
The cost-effectiveness of using DESs vs. BMSs has been controversial, with many studies reporting that BMS are cost-effective over the long-term because of the lower incidence of revascularization and later hospitalization. These studies did not differentiate between SVG and native vessels, however. Multiple studies have reported that the overall costs, including the cost for reintervention, are lower for DESs than for BMSs in native vessels. A Wake Forest study reported the average per procedure cost was $1,846 higher for a DES but the cost was offset after 3 years by lower revascularization rates (Circ Cardiovasc Qual Outcomes. 2011. doi: 10.1161/CIRCOUTCOMES.110.960187)
A recent Korean study found the total cost of DESs was about 5% higher (Yonsei Med J. 2014 Nov;55[6]:1533-41). A French study reported BMSs resulted in a cost reduction $217 per case (Open Heart. 2016 Aug 25;3[2]:e000445). But few, if any, studies have directly compared prices hospitals pay for DESs and BMSs.
Pricing aside, Dr. Brilakis and his coauthors reported no statistical differences in terms of outcomes between the DES and BMS groups. Baseline characteristics of both groups were similar, and the vessel failure rates were 17% in the DES group and 19% in the BMS group after 12 months of follow-up. After 2-7 years, “target vessel failure occurred in approximately one in three patients, with no difference between the bare-metal and drug-eluting stents,” Dr. Brilakis and his coauthors said.
There was no significant difference in cardiac death rates – 5% for DES patients and 4% for BMS patients – or in rates of target lesion revascularization, at 9% and 8%, respectively. Postprocedure medication rates were also similar between the two groups. For example, the rates of patients on P2Y12 inhibitors were 89% for both groups at 12 months and, among those who had follow-up at 36 months, 48% for DES and 44% for BMS.
Among the limitations of the study that Dr. Brilakis and his coauthors noted was the high proportion of men in the VA population – only two women, both in the DES group, participated in the study – and the interventionists doing the index SVG intervention were not masked to the type of stent used.
Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
SOURCE: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.
FROM THE LANCET
Key clinical point: Drug-eluting and bare-metal stents had similar outcomes for saphenous vein bypass lesions.
Major finding: Target vessel failure was 17% for drug-eluting stents and 19% for bare metal stents.
Study details: The DIVA trial randomly assigned 599 patients with post-CABG saphenous vein bypass graft failure to drug-eluting or bare metal stents between Jan. 1, 2012, and Dec. 31, 2015.
Disclosures: Dr. Brilakis disclosed relationships with Abbott Vascular, Amgen, Asahi, Boston Scientific, Cardinal Health, CSI, Elsevier, GE Healthcare, Medicure, Medtronic, Nitiloop, InfraRedx, and Osprey.
Source: Brilakis ES et al. Lancet. 2018 May 19;391(10134);1997-2007.