doi: 10.1161/01.CIR.0000069360.38675.22
(Circulation. 2003;107:2284.)
© 2003 American Heart Association, Inc.
Editorial |
Percutaneous Treatment of Saphenous Vein Bypass Graft Obstructions
A Continuing Obstinate Problem
From Erasmus Medical Centre, Rotterdam, the Netherlands.
Correspondence to Prof Dr P.J. de Feyter, Thoraxcenter, Room Bd 410, Erasmus Medical Centre, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail defeyter{at}card.azr.nl
Key Words: Editorials • veins • bypass • occlusion
Percutaneous coronary intervention has made great strides since its inception and is nowadays the most frequently used modality for revascularization of coronary obstructions. Remaining problems are the treatment of chronic total occlusions, the occurrence of in-stent restenosis (although this may now be resolved, albeit not completely, by drug-eluting stents), and lastly the treatment of saphenous vein bypass graft (SVBG) obstructions.
See p 2331
Percutaneous treatment of SVBG obstructions is notoriously difficult because it often results in inadequate dilatation, a high likelihood of distal embolization associated with mortality and significant morbidity, and a high restenosis rate.1 The difficulties in the percutaneous treatment of SVBG lesions are largely related to the extent and severity of vein graft atherosclerotic disease, which progresses unrelentingly over time, such that 10 years after bypass operation almost 50% of the vein grafts are occluded.
Atherosclerosis of the vein graft is associated with large, soft, and friable plaques containing necrotic debris, cholesterol crystals, foam cells, and blood elements, and there is often overlying thrombotic material, particularly in older degenerated grafts. Occlusive obstructions are often extended over a long segment of the graft, while the remainder of the graft is diffusely diseased.2 Instrumentation of these friable lesions carries a high risk of distal embolization with subsequent myocardial necrosis. Distal embolization is of great concern because there appears to be no adequate treatment, and it must therefore be prevented.
Percutaneous Treatment of Nonocclusive SVBG Obstructions
Percutaneous treatment of SVBG lesions was attempted in the early days of balloon angioplasty. In selected patients with focal lesions, the periprocedural death rate was <1% and the myocardial infarction (MI) rate <4%, predominantly caused by distal embolization of friable material. The overall restenosis rate was approximately 40% but may have been as high as 60% when the lesion was located at the aorta-bypass anastomosis site.1
The 5-year follow-up was poor, and although 74% of the patients were still alive, only 26% were alive and event free with no MI or repeat revascularization.1 Other devices, including directional atherectomy, transluminal extraction, and laser angioplasty, offered no better results, but stent implantation and newer adjunctive medications appeared to improve the immediate and long-term outcomes.3,4 In a recent randomized study, stenting for focal SVBG lesions was shown to be superior to balloon angioplasty, with increased procedural success (97% versus 86%; P<0.01), reduced major in-hospital complications (6% versus 11%; P=0.163), reduced restenosis rate (37% versus 46%; P=0.24), and better 1-year event-free survival (73% versus 58%; P=0.03).5
However, despite the use of stenting, SVBG interventions are still associated with a significant morbidity and mortality. Keeley et al6 reported the results of a single-center experience with treatment of 1142 SVBG lesions in 1062 patients. Interventional devices included balloon angioplasty (42%), atherectomy devices and excimer laser (16%), and stenting (42%). In-hospital death occurred in 8%, Q-wave MI in 2%, and CABG in 3% of the cases. After 3±1 years of follow-up, the event-free survival rate was 46%, and death occurred in 9%, Q-wave MI in 9%, and target vessel revascularization in 36%.
Piana et al7 reported that a second revascularization was necessary in about 50% of the patients, mainly (in 80%) because of disease progression at other sites in grafts and native coronaries so that after 2 years the event-free survival rate was 57%.
de Jaegere et al8 reported a 5-year survival rate of 83±5% and a major event-free survival rate (free from infarction or repeat revascularization) of 30±7%.
Percutaneous Treatment of (Sub)acute Occluded Grafts in Patients With an Acute Coronary Syndrome
Each year, 3% of patients with a previous CABG develop an acute MI, of which about 30% to 50% are due to an acute occlusion of a vein graft. Thrombolysis of the infarct-related vein graft has resulted in a low success rate.
The Global Use of Strategies To Open occluded coronary arteries I (GUSTO-I) trial has demonstrated that in patients with an acute infarction, thrombolysis of culprit occluded vein grafts resulted in a TIMI-3 flow of only 31.7%.9 The outcomes of primary balloon angioplasty, too, were disappointing. Kahn et al10 reported a success rate of 85% (41 of 48 patients) with a mortality rate of 10%. The Second Primary Angioplasty in Myocardial Infarction Trial (PAMI-2) identified 32 patients with an infarct-related bypass graft treated with primary balloon angioplasty. The TIMI-3 flow achieved was 70%, and the in-hospital mortality, re-MI, and repeat revascularization rates were 9.4%, 3.1%, and 13%, respectively. The 6-month mortality rate was 22.6%, and repeat MI occurred in 7.3% of patients.11 A Mayo Clinic study involving 63 patients with primary balloon angioplasty of an acutely occluded vein graft revealed rates of 1-year mortality, repeat MI, repeat procedure, and any major adverse cardiac event (MACE) of 30%, 26%, 20%, and 52.4%, respectively.12 The high adverse event rates could be attributed to the high-risk baseline characteristics of these patients, in combination with the unfavorable lesion characteristics of occluded vein graft, consisting predominantly of extensive thrombus and atherosclerosis with limited distal runoff.
These unfavorable results have prompted the search for alternative, better techniques, such as coronary ultrasound thrombolysis (CUT), which showed promising results in the treatment of thrombus-rich lesions in SVBG in 20 patients with an acute coronary syndrome. In 13 patients, the procedure was successful; another patient suffered a non–Q-wave MI, and distal embolization was noted in 1 patient.13
The efficacy of CUT was further tested in a multicenter randomized controlled trial: ATLAS (Acolysis during Treatment of Lesions Affecting Saphenous Vein Bypass Grafts), which appears in the present issue of Circulation.14 One hundred eighty-one patients were randomly assigned to receive CUT (92 patients) or abciximab (89) followed by percutaneous coronary intervention. Included were patients with either (1) an acute coronary syndrome and angiographic or clinical evidence of thrombus or (2) acute occlusion of a culprit vein graft. Excluded were patients with inability to cross the total occlusion with a guidewire. The trial was prematurely stopped because of a significantly higher incidence of adverse clinical events in the patients assigned to the CUT arm. The primary end point—consisting of a combination of minimum lumen diameter <30%, TIMI-3 flow, and freedom from MACE at 30 days—was achieved in the CUT arm in 53.8% versus 73.1% in the abciximab arm (P=0.014). Angiographic success was achieved in 63% of the patients in the CUT arm versus 82% in the abciximab arm. The occurrence of MACE at 30 days, non–Q-wave MI, and Q-wave MI in the CUT group versus the abciximab group was 25% versus 12% (P=0.036), 19.6% versus 7.9% (P=0.03), and 5.4% versus 2.2% (P=NS), respectively. It was notable that device failure or malfunction of the CUT device occurred in 14 patients, which could partly explain the lower success rate and possibly be responsible for the higher adverse event rate in this group. These disappointing results may most likely be explained by clogging of the microvasculature due to the fragmentation of the thrombus by CUT into smaller particles. The investigators correctly concluded that CUT should not be used during percutaneous coronary intervention of thrombus-containing grafts.
Percutaneous Treatment of Chronically Occluded Vein Grafts
Percutaneous treatment of chronically occluded vein grafts has a bad reputation of low success and high complication rates and a poor long-term prognosis. In fact, our initial results were so disappointing that we, in utter dismay, believed that this disease was "a challenge that should be resisted."1
These disappointing results were also reported by other investigators, with a success rate of 71% to 73% and a major adverse in-hospital event rate of 4% increasing to 13% at 30 days. The distal embolization rate was around 11%, and creatinine kinase elevation occurred in up to 43%. The 3-year survival rate was 72% to 80%, and the 3-year event-free survival rate was as low as 26% to 34%. Repeat angiography demonstrated an occlusion/restenosis rate of at least 44% to even 73%.15,16
Pretreatment with 24-hour infusion of urokinase followed by balloon angioplasty did not really improve the acute results, with an initial patency of 69%, a mortality of 6.5%, a Q-wave MI of 5.0%, emergency surgery of 4%, stroke 3%, and creatinine kinase enzyme elevation in 17%, while repeat angiography showed a 60% restenosis rate.17 So far, no percutaneous modality has demonstrated satisfactory results in the treatment of a chronically occluded vein graft.
Outcome of Current Percutaneous Treatment Modalities and Adjunctive Treatment
Adjunctive treatment with platelet GP IIb/IIIa inhibition failed to improve the outcome of percutaneous bypass graft interventions, but on the contrary, it was associated with a higher incidence of major bleedings (6.8% versus 1.4% in placebo) and minor bleedings (14.9% versus 8.1% placebo).18 Apparently the overwhelming amount and composition of embolized material does render these agents ineffective. Procedural complications are predominantly attributable to distal embolization of friable material, and it seems logical that embolic protection devices, either aspiration or filter capture devices, should prevent this. The Safer study, a multicenter randomized trial, clearly demonstrated the superiority of the GuardWire distal protection device (Medtronic, Inc) compared with no protection device, with a 42% relative reduction of MACE from 16.5% to 9.6% (P=0.004), which was predominantly driven by a reduction of periprocedural MIs (14.7% to 8.6%) at 30 days.19 A recent large, prospective, randomized comparison of stent implantation with or without thromboatherectomy with the X-sizer in thrombotic native coronary arteries or diseased saphenous vein grafts (72%) demonstrated a significant reduction of the occurrence of large MIs with the use of the X-sizer.20
Yet, even with the introduction of stents and distal protection devices, the in-hospital and short-term outcomes of percutaneous treatment of SVBG obstructions remains unsatisfactory (see Table). These poor results are partly due to procedural complications and partly due to the fact that symptomatic post-CABG patients have a higher incidence of cardiovascular risk factors, comorbidity, and more extensive atherosclerotic disease. The long-term prognosis is poor because once saphenous vein graft disease becomes clinically evident, there is usually progression of disease not only in the treated graft but also in other grafts and native coronary arteries.
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Given the poor outcomes of percutaneous treatment of SVBG lesions, which revascularization treatment should we recommend to these patients? First of all, avoid percutaneous treatment of SVBG lesions, and, if possible, attempt to treat the native bypassed coronary arteries even if these arteries are proximally occluded.
Second, seriously consider the alternative of reoperation, which, although associated with a higher mortality and morbidity and less effective relief of angina, may even be the first choice if arterial grafts can be used.
Third, if the decision is made for percutaneous treatment of SVBG lesion, always use a distal protection device and stent implantation. The use of covered stents may reduce the distal embolization rate, and the use of drug-eluting stents may decrease the high restenosis rate, but we have to await significant studies to confirm this. Irrespective of the choice of revascularization, these patients should receive intense medication with aspirin, clopidogrel, lipid-lowering agent, and possibly ACE inhibitors, in a desperate attempt to improve their dismal long-term prognosis.
Research should continue to explore more durable revascularization strategies.
Footnotes
The opinions expressed in this editorial are not necessarily those of the editors or of the American Heart Association.
References
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2. Motwani JG, Topol EJ. Aortocoronary saphenous vein graft disease: pathogenesis, predisposition, and prevention. Circulation. 1998; 97: 916–931.
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5. Savage MP, Douglas JS Jr, Fischman DL, et al. Stent placement compared with balloon angioplasty for obstructed coronary bypass grafts. Saphenous Vein De Novo Trial Investigators. N Engl J Med. 1997; 337: 740–747.
6. Keeley EC, Velez CA, O’Neill WW, et al. Long-term clinical outcome and predictors of major adverse cardiac events after percutaneous interventions on saphenous vein grafts. J Am Coll Cardiol. 2001; 38: 659–665.
7. Piana RN, Moscucci M, Cohen DJ, et al. Palmaz-Schatz stenting for treatment of focal vein graft stenosis: immediate results and long-term outcome. J Am Coll Cardiol. 1994; 23: 1296–1304.[Abstract]
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9. Labinaz M, Sketch MH Jr, Ellis SG, et al. Outcome of acute ST-segment elevation myocardial infarction in patients with prior coronary artery bypass surgery receiving thrombolytic therapy. Am Heart J. 2001; 141: 469–477.[CrossRef][Medline] [Order article via Infotrieve]
10. Kahn JK, Rutherford BD, McConahay DR, et al. Usefulness of angioplasty during acute myocardial infarction in patients with prior coronary artery bypass grafting. Am J Cardiol. 1990; 65: 698–702.[CrossRef][Medline] [Order article via Infotrieve]
11. Stone GW, Brodie BR, Griffin JJ, et al. Clinical and angiographic outcomes in patients with previous coronary artery bypass graft surgery treated with primary balloon angioplasty for acute myocardial infarction. Second Primary Angioplasty in Myocardial Infarction Trial (PAMI-2) Investigators. J Am Coll Cardiol. 2000; 35: 605–611.
12. Al Suwaidi J, Velianou JL, Berger PB, et al. Primary percutaneous coronary interventions in patients with acute myocardial infarction and prior coronary artery bypass grafting. Am Heart J. 2001; 142: 452–459.[CrossRef][Medline] [Order article via Infotrieve]
13. Rosenschein U, Gaul G, Erbel R, et al. Percutaneous transluminal therapy of occluded saphenous vein grafts: can the challenge be met with ultrasound thrombolysis? Circulation. 1999; 99: 26–29.
14. Singh M, Rosenschein U, Ho KLL, et al. Treatment of saphenous vein bypass graft with ultrasound thrombolysis: a randomized study. Circulation. 2003; 107: 2331–2336.
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16. Berger PB, Bell MR, Grill DE, et al. Influence of procedural success on immediate and long-term clinical outcome of patients undergoing percutaneous revascularization of occluded coronary artery bypass vein grafts. J Am Coll Cardiol. 1996; 28: 1732–1737.[Abstract]
17. Hartmann JR, McKeever LS, O’Neill WW, et al. Recanalization of chronically occluded aortocoronary saphenous vein bypass grafts with long-term, low dose direct infusion of urokinase (ROBUST): a serial trial. J Am Coll Cardiol. 1996; 27: 60–66.[Abstract]
18. Roffi M, Mukherjee D, Chew DP, et al. Lack of benefit from intravenous platelet glycoprotein IIb/IIIa receptor inhibition as adjunctive treatment for percutaneous interventions of aortocoronary bypass grafts: a pooled analysis of five randomized clinical trials. Circulation. 2002; 106: 3063–3067.
19. Baim DS, Wahr D, George B, et al. Randomized trial of a distal embolic protection device during percutaneous intervention of saphenous vein aorta-coronary bypass grafts. Circulation. 2002; 105: 1285–1290.
20. Stone GW, Brodie BR, Griffin JJ, et al. Clinical and angiographic outcomes in patients with previous coronary artery bypass graft surgery treated with primary balloon angioplasty for acute myocardial infarction. Second Primary Angioplasty in Myocardial Infarction Trial (PAMI-2) Investigators. Circulation. 2002; 106 (suppl II): 1676.Abstract.
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