Effectiveness of transluminal extraction atherectomy for debulking saphenous vein graft in-stent restenosis

alive after stroke after AMI. After a median follow-up of 18 months, 27.9% of patients with stroke after AMI died. The long-term mortality of patients with stroke was more than twice as high as in patients without stroke (11.7%). After adjustment for age and comorbidity in a logistic regresion model, the multivariate odds ratio was 2.5 (Table 2). In a Cox regression analysis (including all covariates in Table 2), the risk ratio was 2.4 (95% CI 1.2 to 4.6, p ⫽ 0.01). These results show that high long-term mortality is not explained by patient selection. In Figure 2 the poor prognosis of patients with stroke after AMI since admission in the MITRA study is shown by KaplanMeier curves. Owing to the small number of strokes in the follow-up and the high long-term mortality, we could not document a case of nonfatal restroke. We observed 1.2% new strokes after AMI in clinical practice in the late 1990s in Germany (Table 3). The risk factors for stroke after AMI (ischemic and hemorrhagic) in our analysis (previous stroke, atrial fibrillation, old age, heart failure, heart rate >100 beats/min) were more important than treatment with thrombolysis, which was a borderline significant risk factor. Hypertension was not associated with a higher risk of stroke, and early use of aspirin was associated with a lower risk of stroke after AMI. Stroke after AMI has a very poor prognosis. Nearly half of the patients with stroke after AMI died in the hospital. The long-term mortality of patients with stroke was more than twice as high as in patients without stroke. 1. The GUSTO Angiographic Investigators. The effects of tissue plasminogen

activator, streptokinase, or both on coronary-artery patency, ventricular function, and survival after acute myocardial infarction. N Engl J Med 1993;329:1615– 1622.

2. ISIS-2 Collaborative Group. Randomised trial of intravenous streptokinase, oral aspirin, both or neither among 17,187 cases of suspected acute myocardial infarction: ISIS-2. Lancet 1988;2:349 –360. 3. ISIS-3 Collaborative Group. A randomised comparison of streptokinase versus tissue plasminogen activator versus anistreplase and of aspirin plus heparin versus aspirin alone among 41,299 cases of suspected acute myocardial infarction. Lancet 1992;339:753–770. 4. Lopez Bescos L, Calades O’Callaghan A, Castro-Beiras A, Kallmeyer Martin C, Martin-Jadraque L, Garcia-Dorado D, Cruz Fernandez JM. Incidence of vascular stroke in patients with acute myocardial infarction receiving fibrinolytic treatment. Eur Heart J 1999;1(Suppl F):F19 –F23. 5. Maggioni AP, Franzosi MG, Farina MI, Santoro E, Celani MG, Ricci S, Tognoni G. Cerebrovascular events after myocardial infarction: analysis of the GISSI trial. Br Med J 1991;302:1428 –1431. 6. Maggioni AP, Franzosi MG, Santoro E, White H, Van de Werf F, Tognoni G, the Gruppo Italiano per lo Studio della Sopravvivenza nell’Infarto Miocardico II (GISSI-2), and the International Study Group. The risk of stroke in patients with acute myocardial infarction after thrombolytic and antithrombotic treatment. N Engl J Med 1992;327:1– 6. 7. Califf RM, Topol EJ, George BS, Boswick JM, Abbottsmith C, Sigmon KN, Candela R, Masek R, Kereiakes D, O’Neill WW, Stack RS, Stump D. Hemorrhagic complications associated with the use of intravenous tissue plasminogen activator in treatment of acute myocardial infarction. Am J Med 1988;85:353– 359. 8. Gore JM, Sloan M, Price TR, Randall AMY, Bovill E, Collen D, Forman S, Knatterud GL, Sopko G, Terrin ML, and the TIMI Investigators. Intracerebral hemorrhage, cerebral infarction and subdural hematoma after acute myocardial infarction and thrombolytic therapy in the thrombolysis in myocardial infarction study. Circulation 1991;83:448 – 459. 9. Fibrinolytic Therapy Trialists’ (FTT) Collaborative Group. Indications for fibrinolytic therapy in suspected acute myocardial infarction: collaborative overview of early mortality and major morbidity results from all randomised trials of more than 1000 patients. Lancet 1994;343:311–322. 10. Becker RC, Burns M, Gore JM, Spencer FA, Ball SP, French W, Lambrew C, Bowlby L, Hilbe J, Rogers WJ, for the National Registry of Myocardial Infarction (NRMI-2) Participants. Early assessment and in-hospital management of patients with acute myocardial infarction at increased risk for adverse outcomes: a nationwide perspective of current clinical practice. Am Heart J 1998; 135:786 –796. 11. Simoons ML, Maggioni AP, Knatterud G, Leimberger JD, de Jaegere P, van Domburg R, Boersma E, Franzosi MG, Califf R, Schro¨der R, Braunwald E. Individual risk assessment for intracranial haemorrhage during thrombolytic therapy. Lancet 1993;342:1523–1528. 12. Mahaffey KW, Granger CB, Sloan AM, Thompson TD, Gore JM, Weaver D, White HD, Simoons ML, Barbash GI, Topol E, Califf RM. Risk factors for in-hospital nonhemorrhagic stroke in patients with acute myocardial infarction treated with thrombolysis. Circulation 1998;97:757–764.

Effectiveness of Transluminal Extraction Atherectomy for Debulking Saphenous Vein Graft In-Stent Restenosis M. Ashequl Islam,

MD, MPH,

James C. Blankenship,

oronary stents have reduced restenosis after percutaneous coronary interventions. However, the C incidence of in-stent restenosis remains high in some patient subsets. Saphenous vein grafts, compared with coronary arteries, are more likely to develop in-stent restenosis, and are more likely to develop recurrent in-stent restenosis.1 Transluminal extraction catheter (TEC) atherectomy (Interventional Technologies Inc., San Diego, California) has been used to treat saphenous vein graft in-stent restenosis,2– 6 but most reports From the Department of Cardiology, Geisinger Medical Center, Danville, Pennsylvania. Dr. Blankenship’s address is: Department of Cardiology, Geisinger Medical Center, 100 North Academy Avenue, Danville, Pennsylvania 17822. E-mail: [email protected]. Manuscript received July 5, 2000; revised manuscript received and accepted October 10, 2000. ©2001 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 87 March 15, 2001

MD,

and Elias A. Iliadis,

MD

of in-stent restenosis fail to mention it as a treatment option.7–14 We describe 4 patients with 6 episodes of TEC used successfully for saphenous vein graft instent restenosis and review other reported cases.2– 6 This experience suggests TEC may be fairly safe and effective for debulking saphenous vein graft in-stent restenosis lesions. •••

Retrospective chart and cine review of all cases of in-stent saphenous vein graft restenosis treated at our institution between October 17, 1995 (when stenting was introduced) and December 31, 1999, were evaluated. During that time 1 operator (JCB) performed TEC atherectomy as preferred therapy for saphenous vein graft in-stent restenosis. All patients were pretreated with aspirin, and hep0002-9149/01/$–see front matter PII S0002-9149(00)01506-X

785

TABLE 1 Procedural Details for Six Episodes of Transluminal Extraction Catheter Atherectomy for In-Stent Restenosis in Saphenous Vein Grafts*

Age/ Patient Sex

Yrs Since Bypass Surgery

1

50/M

12

1

50/M

12

2

64/M

14

3

73/M

13

3

73/M

13

4

72/M

13

Interval TEC Original Since Presentation Initial Lesion Cutter Stent Stenting of In-stent Stenosis Length Size (mm) (mos) Restenosis (%) (mm) (mm) 4.0 ⫻ 15 PalmazSchatz 3.5 ⫻ 15 PalmazSchatz 3.5 ⫻ 20 ACS Multilink 3.5 ⫻ 23 ACS Multilink 3.5 ⫻ 23 ACS Multilink 3.5 ⫻ 15 PalmazSchatz

Ratio Size of TEC Cutter: Stent†

Stenosis Final Adjunctive After Stenosis CK-MB Therapy TEC (%) (%) After PCI

3

Non–Q-wave AMI

62

12

2

0.5:1.0

Restenting

43

15

4

Unstable angina

69

11

2

0.5:1.0

PTCA

33

0

High due to prior AMI —

6

Unstable angina

83

24

2.5

0.7:1.0

PTCA

14

0

Normal

5

Non–Q-wave AMI

74

20

1.7

0.5:1.0

PTCA, 43 Abciximab

15

2

Unstable angina

78

15

2.5

0.5:1.0

Restenting

34

0

6

Unstable angina

82

24

2

0.7:1.0

Restenting

52

14

High due to prior AMI Normal

—

*All patients had normal flow at the beginning of the intervention. † Assumes full expansion of stent to nominal size. AMI ⫽ acute myocardial infarction; PCI ⫽ percutaneous coronary intervention; PTCA ⫽ percutaneous transluminal coronary angioplasty.

calipers in ⱖ2 views. Values reported are from the least foreshortened views with the highest initial percent stenosis. Quantitative analysis included nominal vein graft diameter (compared with the contrast-filled guide catheter), initial and final minimal lumen diameter at the lesion, and lesion length. These are summarized as mean ⫾ SD. Charts were reviewed for acute and late complications. Patients were contacted by telephone to assess long-term outcomes. A Medline search was performed for English language articles published between January 1, 1990, and December 31, 1999, describing TEC for in-stent restenosis. The search was performed using the keywords “extraction atherectomy,” “restenosis,” and “stent.” References in published articles describing FIGURE 1. Saphenous vein graft with in-stent restenosis. Arrows point to the ends TEC procedures were reviewed. of the stent (MULTI-LINK Duet, ACS). TEC was used in 4 patients with 6 different episodes (patients 1 and 3 had 2 separate procedures each) of in-stent rearin was routinely used to obtain activated clotting stenosis in saphenous vein grafts (Table 1). Nominal times of ⬎300 seconds. TEC atherectomy was typi- graft diameter was 3.1 ⫾ 0.5 mm. The target stent cally followed by high-pressure angioplasty with a diameter ranged from 3 to 4 mm (mean 3.5 ⫾ 0.3), noncompliant balloon, with restenting reserved for and clearance (stent diameter minus TEC catheter inadequate results after angioplasty. Patients receiving diameter) ranged from 1.0 to 2.0 mm. Mean lesion a stent were treated for 1 month with clopidogrel or length was 17.8 ⫾ 5.8 mm. TEC decreased initial ticlopidine. Creatine kinase enzymes were not rou- in-stent restenotic lesions from a mean of 75 ⫾ 8% to tinely obtained for uncomplicated procedures. 37 ⫾ 13%. Adjunctive balloon angioplasty (with adTwo reviewers reviewed all cine films. Quantita- ditional stenting in 2 cases) further reduced the final tive analysis was performed with digital electronic lesion to 7 ⫾ 8%. In all cases, the ratio of cutter size 786 THE AMERICAN JOURNAL OF CARDIOLOGY姞

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FIGURE 2. Same vein graft, after transluminal extraction atherectomy (7.5Fr cutter). The 83% stenosis was reduced to 30%.

to stent size was ⱕ0.7:1.0. In all cases the TEC passed easily, with no evidence of obstruction by stent struts. There were no angiographic complications and no instances of no-reflow. Creatine kinase-MB enzymes, checked in 4 of 6 cases, showed no procedure-related elevations. Long-term outcomes were poor, with target vessel revascularization required in 4 of the 6 cases. The angiographic results before and after successful TEC atherectomy with adjuvant angioplasty in 1 of the patients (patient 2 in Table 1) are shown in Figures 1 to 3. During the same period (October 1995 to December 1999), by retrospective review, we identified 4 other cases of saphenous vein graft in-stent restenosis treated without TEC. In 1 case the operator was not qualified in TEC and in 3 cases tortuous peripheral vessels precluded passage of 10Fr TEC guiding catheters. All 4 cases were successfully treated with angioplasty, with or without stenting, and without any complications. None of these patients had repeated angiograms, 2 continued to have class 3 angina in 6 to 18 months and 2 were lost to follow-up. •••

This series of TEC for saphenous vein graft in-stent restenosis is the largest yet reported, supports the safety and acute efficacy of TEC for this indication, and extends the list of stents treated with this technique to include the Advanced Cardiovascular Systems MULTI-LINK (Guidant, Inc., Santa Clara, California). Most discussions of in-stent restenosis fail to mention TEC,7–14 but our experience suggests that TEC should be added to the list of treatment options for saphenous vein graft in-stent restenosis. FIGURE 3. Same vein graft after dilation with a 4.0-mm noncompliant balloon to We identified reports of 7 cases of 18 atm. TEC used to treat in-stent restenosis in saphenous vein graft lesions2– 6 (Table 2). These reports describe TEC atherectomy through PalmazTABLE 2 Reported Cases of Transluminal Extraction Atherectomy for Saphenous Vein Graft In-stent Restenosis* Schatz (Johnson & Johnson Interventional Systems, Warren, New JerInitial Stenosis Final Stenosis sey) Gianturco-Roubin (Cook Inc., Stenosis TEC Size After After PTCA Author Stent type/Diameter (mm) (%) (mm) TEC (%) (%) Bloomington, Indiana) and Strecker (Boston Scientific Ltd., Natick, Mas69 2.0 36 ⫺6 Goods et al2 Gianturco-Roubin 3.0 sachusetts) stents. In all cases TEC 3 Palmaz-Schatz ⫻ 2 4.0 100 2.2 — 0 Patel et al debulking was followed by angioPalmaz-Schatz 4.0 100 2.0 — 15 Patel et al3 Strecker 3.5 — 2.5 — — Virk et al4 plasty with procedural success and Palmaz-Schatz — 55 2.2 0 ⫺14 Hara et al5 no complications. Intravascular ulPalmaz-Schatz — 77 2.0 0 ⫺35 Hara et al5 trasound was used in only 1 case. 90 2.5 20 10 White et al6 Biliary Palmaz-Schatz 4.5 Follow-up was available for 6 pa*All patients underwent adjunctive balloon angioplasty after TEC. All procedures were angiographitients: 4 were asymptomatic at 5 to cally and clinically successful with no complications. 12 months and 2 had restenosis at 3See Table 1 for abbreviation. to 6-month angiography. We also BRIEF REPORTS

787

identified 10 reported cases of TEC for in-stent restenosis in native coronary arteries.2,5,15 All were successful with no complications. Most reported series of treated in-stent restenosis focus on coronary artery lesions. These suggest that compared with balloon angioplasty alone, initial debulking with directional, rotational, or excimer laser atherectomy provides higher long-term success.9,16,17 Another option, stenting within the original stent, is effective, but may require debulking of the lesion first.1,13 Recent studies suggest that intracoronary brachytherapy may be effective,11,14,18 but this strategy depends on initial treatment of the in-stent lesion with angioplasty, atherectomy, or restenting. Saphenous vein graft lesions account for 8% to 23% of all in-stent restenotic lesions.1,14,16 The application of in-stent restenosis treatment strategies to saphenous vein graft in-stent restenosis lesions poses some problems. Simple angioplasty results in unacceptably high recurrent restenosis rates.9,16 Directional atherectomy catheters may snare the stent.19,20 Laser atherectomy is not available in many catheterization laboratories. Rotational atherectomy is seldom used in saphenous vein grafts.16,18 Restenting without debulking the in-stent lesion frequently leads to recurrence, in 100% of cases in 1 study.1 Brachytherapy usually requires lesion debulking first (90% of cases in 1 study).11,14,18 Our experience suggests that TEC may be a useful alternative to excimer laser atherectomy for debulking in-stent saphenous vein graft stenosis lesions before angioplasty, restenting, or brachytherapy. It has several advantages over other forms of atherectomy in that it is commonly available, has a long record of use in saphenous vein grafts, does not require an expensive energy source, and appears to be safe. Several caveats about these observations should be emphasized. More experience with TEC for saphenous vein graft in-stent restenosis will be necessary to demonstrate that it is consistently safe. Secondly, as with all debulking devices, TEC could produce catastrophic deformation of stents if the guidewire should become entangled in stent struts or if an underdeployed stent produced an orifice too small for the cutter to pass. We routinely placed stents that were 0.5 mm larger than the adjacent vessel diameter and postdilated with noncompliant balloons at 14 to 18 atm, which may minimize the likelihood of these problems. Also, performing intravascular ultrasound before TEC atherectomy would allow the operator to anticipate and prevent these problems. Finally, although TEC atherectomy may facilitate other techniques such as brachytherapy, there is no evidence that TEC by itself contributes to long-term freedom from recurrent restenosis. In summary, we report 6 TEC procedures used for in-stent restenosis in saphenous vein grafts and

788 THE AMERICAN JOURNAL OF CARDIOLOGY姞

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summarize 7 other cases reported in the literature. Although not commonly thought of as an option for debulking in-stent restenosis, TEC for saphenous vein graft in-stent restenosis results in good procedural outcomes and appears to be safe. It may be a useful adjunct to intracoronary brachytherapy. 1. Al-Sergani HS, Ho PC, Nesto RW, Lewis SM, Leeman D, Fitzpatrick P, Mittleman M, Waxman S, Shubrooks SJ. Stenting for in-stent restenosis: a long-term clinical followup. Cath Cardiovasc Intervent 1999;48:143–148. 2. Goods CM, Jain SP, Liu MW, Babu RB, Roubin GS. Intravascular ultrasound– guided transluminal extraction atherectomy for restenosis after Gianturco-Roubin coronary stent implantation. Cathet Cardiovasc Diagn 1996;37:317–319. 3. Patel JJ, Meadaa R, Cohen M, Adiraju R, Kaussmaul WG III. Transluminal extraction atherectomy for aortosaphenous vein graft stent restenosis. Cathet Cardiovasc Diagn 1996;38:320 –324. 4. Virk SJ, Bellamy CM, Perry RA. Transluminal extraction atherectomy for stent restenosis in a saphenous vein bypass graft. Eur Heart J 1997;18:350 –351. 5. Hara K, Ikari Y, Tamura T, Yamaguchi T. Transluminal extraction atherectomy for restenosis following Palmaz-Schatz stent implantation. Am J Cardiol 1997;79:801– 802. 6. White HL, Roberts DH, Wright JS. Utilization of transluminal extraction atherectomy in the treatment of saphenous vein graft disease: two case reports. Int J Cardiol 1998;66:11–15. 7. Baim DS, Levine MJ, Leon MB, Levine S, Ellis SG, Schatz RA. Management of restenosis within the Palmaz-Schatz coronary stent (the US multicenter experience). Am J Cardiol 1993;71:364 –366. 8. Reimers B, Moussa I, Akiyama T, Tucci G, Ferraro M, Martini G, Blengino S, Mario F, Martini G, Blengino S, Di Mario C, Colombo A. Long-term clinical follow-up after successful repeat percutaneous intervention for stent restenosis. J Am Coll Cardiol 1997;30:186 –192. 9. Sharma S, Duvvuri S, Dangas G, Kini A, Vidhun R, Venu K, Ambrose JA, Marmur JD. Rotational atherectomy for in-stent restenosis: acute and long-term results of first 100 cases. J Am Coll Cardiol 1998;32:1358 –1365. 10. Mintz GS, Hoffman R, Mehran R, Pichard AD, Kent KM, Satler LF, Popma JJ, Leon MB. In-stent restenosis: the Washington Hospital experience. Am J Cardiol 1998;81:7E–13E. 11. Teirstein PS, Massullo V, Jani S, Popma JJ, Mintz GS, Russo RJ, Schatz RA, Guarneri EM, Steuterman S, Morris NB, Leon MB, Tripuraneni P. Catheterbased radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med 1997;336:1697–1703. 12. Mehran R, Dangas G, Mintz GS, Waksman R, Abizaid A, Satler LF, Pichard AD, Kent KM, Lansky AJ, Stone GW, Leon MB. Treatment of in-stent restenosis with excimer laser coronary angioplasty versus rotational atherectomy. Circulation 2000;101:2484 –2489. 13. Antoniucci D, Valenti R, Moschi G, Trapani M, Santoro GM, Bolognese L, Taddeucci E, Dovellini E. Stenting for in-stent restenosis. Cath Cardiovasc Intervent 1999;49:376 –381. 14. Waksman R, White RL, Chan RC, Bass BG, Geirlach L, Mintz GS, Satler LF, Mehran R, Serruys PW, Lansky AJ, Fitzgerald P, Bhargava B, Kent KM, Pichard AD, Leon MB. Intra-coronary gamma-radiation therapy after angioplasty inhibits recurrence in patients with in-stent restenosis. Circulation 2000;101:2165–2171. 15. Ikari Y, Yamaguchi T, Tamura T, Isshiki T, Saeki F, Hara K. Transluminal extraction atherectomy and adjunctive balloon angioplasty for restenosis after Palmaz-Schatz coronary stent implantation. Cathet Cardiovasc Diagn 1993;30: 127–130. 16. Mehran R, Mintz G, Satler L, Pichard AD, Kent KM, Bucher TA, Popma JJ, Leon MB. Treatment of in-stent restenosis with excimer laser coronary angioplasty. Mechanisms and results compared with PTCA alone. Circulation 1997; 96:2183–2189. 17. Mehran R, Mintz GS, Popma JJ, Pichard AD, Satler LF, Kent KM, Griffin J, Leon MB. Mechanisms and results of balloon angioplasty for the treatment of in-stent restenosis. Am J Cardiol 1996;78:618 – 622. 18. Waksman R, Bhargava B, White L, Chan RC, Meharna R, Lansky AJ, Mintz GS, Satler LF, Pichard AD, Leon MB, Kent KK. Intra-coronary beta-radiation therapy inhibits recurrence of in-stent restenosis. Circulation 2000;101:1895– 1898. 19. Macander PJ, Roubin GS, Agrawal SK, Cannon AD, Dean LS, Baxley WA. Balloon angioplasty for treatment of in-stent restenosis: feasibility, safety, and efficacy. Cathet Cardiovasc Diagn 1994;32:125–131. 20. Bowerman RE, Pinkerton CA, Kirk B, Waller BF. Disruption of a coronary stent during atherectomy for restenosis. Cathet Cardiovasc Diagn 1991;24:248 – 251.

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