Catheterization and Cardiovascular Interventions 83:1043–1044 (2014)
Editorial Comment DES Equal to BMS in Saphenous Vein Graft Lesions: Back and Forth, and Back Again Jorge A. Belardi,* MD, FACC, FSCAI and Mariano Albertal, MD, PhD, FACC Department of Interventional Cardiology and Endovascular Therapeutics, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina
Percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) lesions accounts for 6% of all PCI performed in the United States [1]. SVG-PCI is often a challenging procedure and even after succeeding, long-term SVG patency is lower than non-SVG lesions [1]. Suboptimal acute and long-term PCI outcome in SVG lesions are likely multifactorial. These type of lesions are often long and the rest of the graft diffusely diseased. Consequently, a large SVG segment is usually stented, leading to high stent thrombosis and restenosis rates. In addition, the presence of a friable material may lead to distal embolization, requiring in times thrombus aspiration, placement of an embolic protection device and aggressive use of antiplatelet and anticoagulation medication. In the moderately large SVG trial “Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?” 610 patients were randomized to first-generation drugeluting stent (DES) or bare-metal stent (BMS) [2]. In this study, the implantation of DES significantly reduced the primary endpoint, namely target lesion revascularization at 12 months follow-up (7% vs. 13%, P ¼ 0.01) [2]. Yet significant controversy still exists regarding the role of DES in the setting of SVG lesions. In this issue of Catheterization and Cardiovascular Interventions, Hougaard et al. present interesting findings from a subanalysis of the Western Denmark Heart Registry (year 2002–2010) [3]. The authors compared DES (n ¼ 348) versus BMS (n ¼ 181) in the treatment of SVG lesions. The endpoints were stent failure (target lesion revascularization, graft occlusion without intervention and stent thrombosis) and allcause mortality. One-year cumulative stent failure rate showed a trend toward benefit with DES (6.6% vs. 10.8%, P ¼ 0.088) and became nonsignificant at 3 years (P ¼ 0.25). Mortality rates were similar at one C 2014 Wiley Periodicals, Inc. V
and three-year follow-up. There are, however, some caveats from the Western Denmark Heart Registry subanalysis that should be highlighted. First, because of its nonrandomized nature, certain amount of selection bias influencing operators’ choice for a specific device is inevitable in the present study. In addition, lesions in the DES group had worst angiographic characteristics (smaller vessel size and more often type B2/C lesion) than the BMS group. To completely control for these angiographic imbalances between groups is extremely difficult, even with sophisticated statistics. Second, in contrast to randomized clinical trials, underreporting has been a vexing problem in many large nonsponsored registries, potentially diluting DES superiority over BMS. Third, the study may be underpowered for clinical outcome and therefore, numerical differences in clinical outcomes could not be statistically corroborated. Fourth, many advantageous developments in coronary stent technology and perioperative medical management took place during the study period (2002– 2010), and therefore, an uneven distribution of DES and BMS procedures throughout the study period could have affected clinical outcome. Furthermore, availability of data regarding specific stent characteristics could have helped understand stent performance in the present study. For instance, as a reader I might ask if only first-generations DES were used in this study. This latter point is particularly important because of the current worldwide uptake of newer-generations DES. Contemporary DES clearly led to improvements in safety and efficacy compared to first-generation DES. A recent PCI study also confirmed second-generation DES superiority in the context of SVG lesions, mainly driven by a very low reintervention rate and absence of stent thrombosis [4]. As to whether reductions in stent failure and mortality would have emerged with the use Conflict of interest: Nothing to report. *Correspondence to: Jorge A. Belardi, MD; Department of Interventional Cardiology and Endovascular Therapeutics, Blanco Encalada 1543, 4th floor, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina. E-mail: [email protected] Received 8 April 2014; Revision accepted 14 April 2014 DOI: 10.1002/ccd.25521 Published online 19 May 2014 (wileyonlinelibrary.com)
in Wiley Online Library
1044
Belardi and Albertal
of newer-generation DES in the present subanalysis is entirely plausible. Today, most PCI operators preferred the use of newer-generations DES in virtually all patient subsets and lesion types, and expect to embrace promising technologies like bioresorbable vascular scaffolds. It would be unadvisable at this time to go back to BMS or first-generation DES, and then eventually forth again. Quite the contrary, future studies should focus on the role of bioresorbable vascular scaffold for the treatment of SVG lesions. REFERENCES 1. Brilakis ES, Lee M, Mehilli J, Marmagkiolis K, Rodes-Cabau J, Sachdeva R, Kotsia A, Christopoulos G, Rangan BV, Mohammed
A, et al. Saphenous vein graft interventions. Curr Treat Options Cardiovasc Med 2014;16:301. 2. Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, et al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): A randomised controlled superiority trial. Lancet 2011;378:1071–1078. 3. Hougaard M, Thayssen P, Kaltoft A, Tilsted HH, Maeng M, Flensted Lassen J, Thuesen L, Okkels Jensen L. Long-term outcome following percutaneous coronary intervention with drugeluting stents compared with bare-metal stents in saphenous vein graft lesions: From Western Denmark heart registry. Catheter Cardiovasc Interv 2014;83:1035–1042. 4. Kitabata H, Loh JP, Pendyala LK, Badr S, Dvir D, Barbash IM, Minha S, Torguson R, Chen F, Satler LF, et al. Two-year followup of outcomes of second-generation everolimus-eluting stents versus first-generation drug-eluting stents for stenosis of saphenous vein grafts used as aortocoronary conduits. Am J Cardiol 2013;112:61–67.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
Editorial Comment DES Equal to BMS in Saphenous Vein Graft Lesions: Back and Forth, and Back Again Jorge A. Belardi,* MD, FACC, FSCAI and Mariano Albertal, MD, PhD, FACC Department of Interventional Cardiology and Endovascular Therapeutics, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina
Percutaneous coronary intervention (PCI) of saphenous vein graft (SVG) lesions accounts for 6% of all PCI performed in the United States [1]. SVG-PCI is often a challenging procedure and even after succeeding, long-term SVG patency is lower than non-SVG lesions [1]. Suboptimal acute and long-term PCI outcome in SVG lesions are likely multifactorial. These type of lesions are often long and the rest of the graft diffusely diseased. Consequently, a large SVG segment is usually stented, leading to high stent thrombosis and restenosis rates. In addition, the presence of a friable material may lead to distal embolization, requiring in times thrombus aspiration, placement of an embolic protection device and aggressive use of antiplatelet and anticoagulation medication. In the moderately large SVG trial “Is Drug-Eluting-Stenting Associated with Improved Results in Coronary Artery Bypass Grafts?” 610 patients were randomized to first-generation drugeluting stent (DES) or bare-metal stent (BMS) [2]. In this study, the implantation of DES significantly reduced the primary endpoint, namely target lesion revascularization at 12 months follow-up (7% vs. 13%, P ¼ 0.01) [2]. Yet significant controversy still exists regarding the role of DES in the setting of SVG lesions. In this issue of Catheterization and Cardiovascular Interventions, Hougaard et al. present interesting findings from a subanalysis of the Western Denmark Heart Registry (year 2002–2010) [3]. The authors compared DES (n ¼ 348) versus BMS (n ¼ 181) in the treatment of SVG lesions. The endpoints were stent failure (target lesion revascularization, graft occlusion without intervention and stent thrombosis) and allcause mortality. One-year cumulative stent failure rate showed a trend toward benefit with DES (6.6% vs. 10.8%, P ¼ 0.088) and became nonsignificant at 3 years (P ¼ 0.25). Mortality rates were similar at one C 2014 Wiley Periodicals, Inc. V
and three-year follow-up. There are, however, some caveats from the Western Denmark Heart Registry subanalysis that should be highlighted. First, because of its nonrandomized nature, certain amount of selection bias influencing operators’ choice for a specific device is inevitable in the present study. In addition, lesions in the DES group had worst angiographic characteristics (smaller vessel size and more often type B2/C lesion) than the BMS group. To completely control for these angiographic imbalances between groups is extremely difficult, even with sophisticated statistics. Second, in contrast to randomized clinical trials, underreporting has been a vexing problem in many large nonsponsored registries, potentially diluting DES superiority over BMS. Third, the study may be underpowered for clinical outcome and therefore, numerical differences in clinical outcomes could not be statistically corroborated. Fourth, many advantageous developments in coronary stent technology and perioperative medical management took place during the study period (2002– 2010), and therefore, an uneven distribution of DES and BMS procedures throughout the study period could have affected clinical outcome. Furthermore, availability of data regarding specific stent characteristics could have helped understand stent performance in the present study. For instance, as a reader I might ask if only first-generations DES were used in this study. This latter point is particularly important because of the current worldwide uptake of newer-generations DES. Contemporary DES clearly led to improvements in safety and efficacy compared to first-generation DES. A recent PCI study also confirmed second-generation DES superiority in the context of SVG lesions, mainly driven by a very low reintervention rate and absence of stent thrombosis [4]. As to whether reductions in stent failure and mortality would have emerged with the use Conflict of interest: Nothing to report. *Correspondence to: Jorge A. Belardi, MD; Department of Interventional Cardiology and Endovascular Therapeutics, Blanco Encalada 1543, 4th floor, Instituto Cardiovascular de Buenos Aires, Buenos Aires, Argentina. E-mail: [email protected] Received 8 April 2014; Revision accepted 14 April 2014 DOI: 10.1002/ccd.25521 Published online 19 May 2014 (wileyonlinelibrary.com)
in Wiley Online Library
1044
Belardi and Albertal
of newer-generation DES in the present subanalysis is entirely plausible. Today, most PCI operators preferred the use of newer-generations DES in virtually all patient subsets and lesion types, and expect to embrace promising technologies like bioresorbable vascular scaffolds. It would be unadvisable at this time to go back to BMS or first-generation DES, and then eventually forth again. Quite the contrary, future studies should focus on the role of bioresorbable vascular scaffold for the treatment of SVG lesions. REFERENCES 1. Brilakis ES, Lee M, Mehilli J, Marmagkiolis K, Rodes-Cabau J, Sachdeva R, Kotsia A, Christopoulos G, Rangan BV, Mohammed
A, et al. Saphenous vein graft interventions. Curr Treat Options Cardiovasc Med 2014;16:301. 2. Mehilli J, Pache J, Abdel-Wahab M, Schulz S, Byrne RA, Tiroch K, Hausleiter J, Seyfarth M, Ott I, Ibrahim T, et al. Drug-eluting versus bare-metal stents in saphenous vein graft lesions (ISAR-CABG): A randomised controlled superiority trial. Lancet 2011;378:1071–1078. 3. Hougaard M, Thayssen P, Kaltoft A, Tilsted HH, Maeng M, Flensted Lassen J, Thuesen L, Okkels Jensen L. Long-term outcome following percutaneous coronary intervention with drugeluting stents compared with bare-metal stents in saphenous vein graft lesions: From Western Denmark heart registry. Catheter Cardiovasc Interv 2014;83:1035–1042. 4. Kitabata H, Loh JP, Pendyala LK, Badr S, Dvir D, Barbash IM, Minha S, Torguson R, Chen F, Satler LF, et al. Two-year followup of outcomes of second-generation everolimus-eluting stents versus first-generation drug-eluting stents for stenosis of saphenous vein grafts used as aortocoronary conduits. Am J Cardiol 2013;112:61–67.
Catheterization and Cardiovascular Interventions DOI 10.1002/ccd. Published on behalf of The Society for Cardiovascular Angiography and Interventions (SCAI).
