- Email: [email protected]
Effectiveness of percutaneous coronary intervention in cardiac allograft vasculopathy
Reduced albumin-cobalt binding with transient myocardial ischemia after elective percutaneous transluminal coronary angioplasty: a preliminary comparison to creatine kinase-MB, myoglobin, and troponin I. Am Heart J 2001;141:985–991. 5. Sinha MK, Gaze DC, Tippins JR, Collinson PO, Kaski JC. Ischemia modified albumin is a sensitive marker of myocardial ischemia after percutaneous coronary intervention. Circulation 2003;107:2403–2405. 6. Alpert JS, Thygesen K, Antman E, Bassand JP. Myocardial infarction redefined—a consensus document of The Joint European Society of Cardiology/ American College of Cardiology Committee for the Redefinition of Myocardial Infarction. J Am Coll Cardiol 2000;36:959 –969. 7. Salgado FJ, Calvino SR, Vazquez-Rodriguez JM, Vazquez GN, Vazquez RE, Perez FR, Bouzas ZB, Castro BA. Transradial approach to coronary angiography
and angioplasty: initial experience and learning curve. Rev Esp Cardiol 2003;56: 152–159. 8. Rentrop KP, Cohen M, Blanke H, Phillips RA. Changes in collateral channel filling immediately after controlled coronary artery occlusion by angioplasty balloon in human subjects. J Am Coll Cardiol 1985;5:587–592. 9. Wu AH, Morris DL, Fletcher DR, Apple FS, Christenson RH, Painter PC. Analysis of the albumin cobalt binding (ACB) test as an adjunct to cardiac troponin I for the early detection of acute myocardial infarction. Cardiovasc Toxicol 2001;1:147–151. 10. Quiles J, Roy D, Gaze D, Garrido I, Avanzas P, Sinha M K, Kaski J.C. Ischemia modified albumin (IMA) levels following elective angioplasty are related to duration of balloon induced myocardial ischemia. Am J Cardiol 2003;92:322–324.
Effectiveness of Percutaneous Coronary Intervention in Cardiac Allograft Vasculopathy Amit A. Doshi,
MD,
Joseph Rogers,
MD,
Morton J. Kern,
Twenty-five heart transplant recipients underwent 45 coronary interventions at a mean of 7.8 ⴞ 2.2 years from time of transplant. Periprocedural success was high, and there was a trend toward better outcomes in the group that underwent stent deployment compared with conventional balloon angioplasty. 䊚2003 by Excerpta Medica, Inc. (Am J Cardiol 2004;93:90–92)
he development of cardiac allograft vasculopathy (CAV) is commonplace after heart transplantation; T the reported prevalence is as high as 42% at 5 years. 1
CAV remains a major cause of graft failure and death in patients surviving ⬎1 year after transplantation.2 Pharmacologic3–5 and nonpharmacologic6 approaches have been proposed to either prevent or slow the progression of disease, but multicenter, long-term data have been lacking. Although a pattern of diffuse concentric intimal thickening is characteristic of CAV, many lesions are discrete, located proximally in the major epicardial vessels,7,8 and may be amenable to percutaneous interventions. Unfortunately, the published restenosis rate with percutaneous transluminal coronary angioplasty (PTCA) is high (55% at a mean of 7 months).9 Intracoronary stent placement, which has been shown to be superior to balloon angioplasty in patients with native atherosclerosis,10 has been studied in small cohorts of patients after heart transplantation.11–13 The data from these groups have been limited by the sample size, short follow-up period, and single-center experience. Therefore, we reviewed the experience from 2 adult heart transplant centers (Saint Louis University and Washington University, St. Louis, Missouri) during a 12-year period and compared the outcome of patients who underwent PTCA From the Saint Louis University Hospital, Saint Louis University School of Medicine; and the Washington University School of Medicine, St. Louis, Missouri. Dr. Hauptman’s address is: Division of Cardiology, FDT-15, Saint Louis University Hospital, 3635 Vista Avenue, St. Louis, Missouri 63110. E-mail: [email protected]. Manuscript received June 24, 2003; revised manuscript received and accepted August 27, 2003.
90
©2003 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 93 January 1, 2004
MD,
and Paul J. Hauptman,
MD
versus stent placement with or without the use of atherectomy. •••
We performed a retrospective chart review of angiographic findings and laboratory and clinical transplant records of all heart transplant recipients who underwent the procedure between January 1991 and February 2003. For patients undergoing intervention, the report from the most recent catheterization before the intervention and data from all subsequent catheterizations were reviewed. Periprocedural angiographic success was defined as a decrease in luminal obstruction to ⬍50%; restenosis was defined as ⬎50% diameter stenosis on a follow-up angiogram. The severity of stenosis was defined by visual assessment of the coronary angiograms. Follow-up was determined until the date of retransplantation, date of death, or date the patient was last known to be alive. Continuous variables were expressed as mean ⫾ SD. Differences in outcome between the angioplasty and stent groups were analyzed using Wilcoxon’s test for equality. Institutional review board approval was granted for the study. Twenty-five recipients (21 white and 4 African American) underwent 45 separate procedures. The indications for transplantation were end-stage ischemic cardiomyopathy in 18 patients (72%), idiopathic cardiomyopathy in 5 (20%), and valvular cardiomyopathy in 2 (8%). Donor age was 34.1 ⫾ 7.1 years. Six of the 25 donor hearts were subjected to angiography before the transplant procedure. Two of the donor hearts had nonobstructive (⬍50% luminal diameter stenosis) single-vessel disease at the time of transplantation. Mean age of the recipients at time of transplant was 57.7 ⫾ 8.1 years; all recipients were men. Fortyeight percent of recipients experienced International Society For Heart And Lung Transplantation grade ⱖ3A rejection, but none did so within 5.3 ⫾ 1.1 years of the intervention. Most had hypertension, which was defined as systolic blood pressure ⬎140 mm Hg or use of antihypertensive therapy at the time of intervention, and dyslipidemia, which was defined as low-density lipoprotein⬎100 mg/dl or the use of a 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitor (92% 0002-9149/04/$–see front matter doi:10.1016/j.amjcard.2003.08.075
FIGURE 1. Trend of procedures by year.
months; of 11 lesions subjected to stent deployment, 9 were patent at a mean of 14.2 ⫾ 14.6 months. Ten patients underwent repeat procedures at a mean of 1.4 ⫾ 0.2 years; 7 of these interventions were in different vessels. Two of the patients underwent retransplantation 186 days and 381 days after intervention. Ten patients died during the study period; 7 patients had PTCA, 2 had stent placement, and 1 had both PTCA and stent placement for 2 different lesions during the same procedure. The cause of death was ischemic cardiomyopathy in 7 patients (70%), malignancy in 2 (20%), and unknown in 1 (10%). Overall, the mean postintervention follow-up to death, repeat transplant, or last date known to be alive was 4.4 ⫾ 0.8 years (range 1 day to 9.46 years); 11 recipients were alive ⬎3 years from the time of intervention. Although the sample size was small, postintervention patient survival or freedom from retransplantation, myocardial infarction, or heart failure appears better with stenting (p ⫽ 0.11 by Wilcoxon’s test for equality). •••
FIGURE 2. Location of intervention by artery. LAD ⴝ left anterior descending artery; LCX ⴝ left circumflex artery; PDA ⴝ posterior descending artery; RCA ⴝ right coronary artery.
and 96%, respectively); 40% of patients had the diagnosis of diabetes. Procedures included PTCA (n ⫽ 17), PTCA with atherectomy (n ⫽ 8), stent only (n ⫽ 17), and stent with atherectomy (n ⫽ 3). There was a clear trend toward increasing use of stent deployment, especially since 1998 (Figure 1). The interval from transplant to initial intervention was longer for the stent group (3,890 ⫾ 1,427 days) than for the PTCA group (1,789 ⫾ 1,002 days), but follow-up was longer in the latter (1,021 ⫾ 891 days [range 84 to 3,453]) than in the former (507 ⫾ 779 days [range 1 to 2,613]). The reasons underlying the need for individual interventions were abnormal exercise test results in 26 cases (58% of all procedures), new ventricular dysfunction in 4 (9%), heart failure symptoms in 21 (47%), and/or abnormal finding on an annual posttransplant evaluation in 13 (29%); 19 of the interventions (40%) had ⬎1 indication. The distribution of vessels is depicted in Figure 2. Three-vessel disease was noted in 10 of the recipients at the time of the initial intervention. Nineteen recipients had documented obstructive lesions first noted 1.7 ⫾ 0.4 years before the intervention. Adjunctive intravascular ultrasound was used in 16% and coronary flow measurements were performed in 24% of patients. The periprocedural success rate was 93%. Seven patients underwent multivessel intervention. Seventeen of the patients, accounting for 26 lesions, had follow-up angiography after intervention. Of 15 lesions subjected to PTCA, 7 were patent at the time of angiographic follow-up at a mean of 11.0 ⫾ 26.9
The initial experience of PTCA in the treatment of CAV was discouraging; it often resulted in high rates of asymptomatic restenosis.9 Data on surgical revascularization have likewise been limited.14 Since the advent of stent technology, reports have suggested a role in allograft vasculopathy, but outcomes have not been well described or compared with angioplasty.10 –13 We demonstrate in a retrospective review that periprocedural success rates are high and that better long-term vessel patency and clinical outcomes may be achievable with stent therapy. Future studies should be designed to identify which patient subset will benefit most from intervention (e.g., based on angiographic and/or intravascular ultrasound appearance or clinical factors) and whether the use of rapamycin-coated stents or systemically delivered rapamycin15 will favorably impact restenosis or disease progression compared with conventional stent use. 1. Constanzo MR, Naftel DC, Pritzker MR, Heilman JK, Boehmer JP, Brozena SC, Dec GW, Ventura HO, Kirklin JK, Bourge RC, et al. Heart transplant coronary artery disease detected by coronary angiography: a multi-institutional study of preoperative donor and recipient risk factors. Cardiac Transplant Research Database. J Heart Lung Transplant 1998;17:744 –753. 2. Hosenpud JD, Bennett LE, Keck BM, Boucek MM, Novick RJ. The Registry of the International Society for Heart and Lung Transplantation: eighteenth official report. J Heart Lung Transplant 2001;20:805–815. 3. Kobashigawa JA, Katznelson S, Laks H, Johnson JA, Yeatman L, Wang XM, Chia D, Terasaki PI, Sabad A, Cogert GA. Effect of pravastatin on outcomes after cardiac transplantation. N Engl J Med 1995;333:621–627. 4. Wenke K, Meiser B, Thiery J, Nagel D, Von Scheidt W, Steinbeck G, Seidel D, Reichart B. Simvastatin reduces graft vessel disease and mortality after heart transplantation: a four-year randomized trial. Circulation 1997;96:1398 –1402. 5. Fang JC, Kinlay S, Beltrame J, Hikiti H, Wainstein M, Behrendt D, Suh J, Frei B, Mudge GH, Selwyn AP, Ganz P. Effects of vitamins C and E on progression of transplant-associated arteriosclerosis: a randomized trial. Lancet 2002;359: 1108 –1113. 6. Gao SZ, Schroeder JS, Hunt S, Stinson EB. Retransplantation for severe accelerated coronary artery disease in heart transplant recipients. Am J Cardiol 1988;62:876 –881. 7. Johnson DE, Alderman EL, Schroeder JS, Gao SZ, Hunt S, DeCampli WM, Stinson E, Billingham M. Transplant coronary artery disease: histopathologic correlations with angiographic morphology. J Am Coll Cardiol 1991;17:449 – 457. 8. Schoen FJ, Libby P. Cardiac transplant graft arteriosclerosis. Trends Cardiovasc Med 1991;1:216 –223.
BRIEF REPORTS
91
9. Halle AA, Wilson RF, Massin EK, Bourge RC, Stadius ML, Johnson MR,
Wray WB, Young JB, Davies RA, Walford GD, et al. Coronary angioplasty in cardiac transplant patients. Results of a multicenter study. Circulation 1992;86: 458 –462. 10. Fischman DL, Leon MB, Bain DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M. Long-term angiographic and clinical outcomes after implantation of a balloon expandable stent in native coronary artery circulation. J Am Coll Cardiol 1994;24:1207–1212. 11. Jain SP, Rama SR, White CJ, Mehra M, Ventura H, Zhang S, Jenkins J, Collins T. Coronary stenting in cardiac allograft vasculopathy. J Am Coll Cardiol 1998;32:1636 –1640. 12. Redonnet M, Tron C, Koning R, Bouchart F, Cribier A, Soyer R, Bessou JP.
Coronary angioplasty and stenting in cardiac allograft vasculopathy following heart transplantation. Transplant Proc 2000;32:463–465. 13. Sharifi M, Siraj Y, O’Donnell J, Pompili VJ. Coronary angioplasty and stenting in orthotopic heart transplants: a fruitful act or a futile attempt? Angiology 2000;51:809 –815. 14. Halle AA, DiSciascio G, Massin EK, Wilson RF, Johnson MR, Sullivan HJ, Bourge RC, Kleiman NS, Miller LW, Aversano TR. Coronary angioplasty, atherectomy and bypass surgery in cardiac transplant recipients. J Am Coll Cardiol 1995;26:120 –128. 15. Mancini D, Pinney S, Burkhoff D, LaManca J, Itescu S, Burke E, Edwards N, Oz M, Marks AR. Use of rapamycin slows progression of cardiac transplantation vasculopathy. Circulation 2003;108:48 –53.
Effect of Fluvastatin on Long-Term Outcome After Coronary Revascularization With Stent Implantation Francesco Saia, MD, Pim de Feyter, MD, PhD, Patrick W. Serruys, MD, PhD, Pedro A. Lemos, MD, Chourmouzios A. Arampatzis, MD, Guy R. Hendrickx, MD, PhD, Nicholas Delarche, MD, Dick Goedhart, Emmanuel Lesaffre, PhD, and Angelo Branzi, MD, for the Lescol Intervention Prevention Study (LIPS) Investigators We assessed the impact of long-term fluvastatin treatment on adverse atherosclerotic cardiac events (cardiac death, myocardial infarction, and revascularization excluding repeat interventions due to restenosis in the first 6 months) in 847 patients (fluvastatin [n ⴝ 417] or placebo [n ⴝ 430]) with average cholesterol levels treated with stents in the Lescol Intervention Prevention Study (LIPS). During the 4-year follow-up period, fluvastatin significantly decreased total cholesterol and low-density lipoprotein cholesterol levels and decreased the risk of first adverse atherosclerotic cardiac events by 30% compared with placebo (95% confidence interval ⴚ49 to ⴚ3.4, p ⴝ 0.03). 䊚2003 by Excerpta Medica, Inc. (Am J Cardiol 2004;93:92–95)
nhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase (statins) decrease the risk of death and Imajor cardiovascular events in patients with chronic heart disease, irrespective of clinical presentation and baseline cholesterol level.1– 4 To date, information regarding the impact of statin treatment after coronary stenting is limited and has generally been derived from observational studies.5,6 Results from the Lescol Intervention Prevention Study (LIPS)7,8 have shown that early fluvastatin treatment significantly decreases the risk of major adverse cardiac events in patients with average cholesterol levels after a first successful From the Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands; Istituto di Cardiologia, University of Bologna, Bologna, Italy; Cardiovascular Center Aalst, Aalst, Belgium; Service de Cardiologie, Centre Hospetalier de Pau, Pau, France; Cardialysis BV, Rotterdam, The Netherlands; and Biostatistical Centre, Catholic University of Leuven, Leuven, Belgium. This study was supported by a grant from Novartis Pharma AG, Basel, Switzerland. Dr. Serruys’ address is: Erasmus MC, Thoraxcenter, Kamer Bd 404, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail: [email protected]. Manuscript received June 2, 2003; revised manuscript received and accepted August 27, 2003.
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©2003 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 93 January 1, 2004
percutaneous coronary intervention (PCI). We assessed the effects of secondary prevention with fluvastatin in patients with chronic heart disease treated only with stents in the LIPS. •••
The LIPS population was recruited from 57 interventional centers in Europe, Canada, and Brazil and consisted of 1,667 patients (age 18 to 80 years) with stable or unstable angina or silent ischemia and average cholesterol levels. Major exclusion criteria included previous PCI or coronary artery bypass graft; high blood pressure (⬎180/100 mm Hg) despite drug treatment; poor left ventricular function (ejection fraction ⬍30%); severe noncoronary heart disease; severe renal dysfunction (serum creatinine level ⬎1.8 mg/dl [160 mol/L]); obesity (body mass index ⬎30 kg/ m2); and malignant or other disease resulting in decreased life expectancy. After successfully undergoing their first PCI, patients were randomized to receive either fluvastatin 40 mg twice daily or placebo at hospital discharge for 3 to 4 years. Successful PCI was defined as residual stenosis ⬍50%, with no evidence of myocardial necrosis or need for urgent coronary artery bypass graft. Importantly, decisions regarding revascularization strategy and stenting (elective, for suboptimal result, bail-out) were left to the discretion of the interventional cardiologist. Use of intravascular ultrasound was allowed for diagnostic purposes or for optimization of stent deployment. We evaluated the outcome of the subgroup of patients in whom all lesions were treated with stents. Patients treated with balloon angioplasty alone— or in combination with stenting of ⱖ1 different lesions—and patients in whom percutaneous interventional devices other than balloon or stent were used were excluded from the analysis. The ethics committee at each participating center approved the trial, and all patients provided informed written consent. We evaluated patient survival time free of adverse cardiac atherosclerotic events, which were defined as 0002-9149/04/$–see front matter doi:10.1016/j.amjcard.2003.08.076
and angioplasty: initial experience and learning curve. Rev Esp Cardiol 2003;56: 152–159. 8. Rentrop KP, Cohen M, Blanke H, Phillips RA. Changes in collateral channel filling immediately after controlled coronary artery occlusion by angioplasty balloon in human subjects. J Am Coll Cardiol 1985;5:587–592. 9. Wu AH, Morris DL, Fletcher DR, Apple FS, Christenson RH, Painter PC. Analysis of the albumin cobalt binding (ACB) test as an adjunct to cardiac troponin I for the early detection of acute myocardial infarction. Cardiovasc Toxicol 2001;1:147–151. 10. Quiles J, Roy D, Gaze D, Garrido I, Avanzas P, Sinha M K, Kaski J.C. Ischemia modified albumin (IMA) levels following elective angioplasty are related to duration of balloon induced myocardial ischemia. Am J Cardiol 2003;92:322–324.
Effectiveness of Percutaneous Coronary Intervention in Cardiac Allograft Vasculopathy Amit A. Doshi,
MD,
Joseph Rogers,
MD,
Morton J. Kern,
Twenty-five heart transplant recipients underwent 45 coronary interventions at a mean of 7.8 ⴞ 2.2 years from time of transplant. Periprocedural success was high, and there was a trend toward better outcomes in the group that underwent stent deployment compared with conventional balloon angioplasty. 䊚2003 by Excerpta Medica, Inc. (Am J Cardiol 2004;93:90–92)
he development of cardiac allograft vasculopathy (CAV) is commonplace after heart transplantation; T the reported prevalence is as high as 42% at 5 years. 1
CAV remains a major cause of graft failure and death in patients surviving ⬎1 year after transplantation.2 Pharmacologic3–5 and nonpharmacologic6 approaches have been proposed to either prevent or slow the progression of disease, but multicenter, long-term data have been lacking. Although a pattern of diffuse concentric intimal thickening is characteristic of CAV, many lesions are discrete, located proximally in the major epicardial vessels,7,8 and may be amenable to percutaneous interventions. Unfortunately, the published restenosis rate with percutaneous transluminal coronary angioplasty (PTCA) is high (55% at a mean of 7 months).9 Intracoronary stent placement, which has been shown to be superior to balloon angioplasty in patients with native atherosclerosis,10 has been studied in small cohorts of patients after heart transplantation.11–13 The data from these groups have been limited by the sample size, short follow-up period, and single-center experience. Therefore, we reviewed the experience from 2 adult heart transplant centers (Saint Louis University and Washington University, St. Louis, Missouri) during a 12-year period and compared the outcome of patients who underwent PTCA From the Saint Louis University Hospital, Saint Louis University School of Medicine; and the Washington University School of Medicine, St. Louis, Missouri. Dr. Hauptman’s address is: Division of Cardiology, FDT-15, Saint Louis University Hospital, 3635 Vista Avenue, St. Louis, Missouri 63110. E-mail: [email protected]. Manuscript received June 24, 2003; revised manuscript received and accepted August 27, 2003.
90
©2003 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 93 January 1, 2004
MD,
and Paul J. Hauptman,
MD
versus stent placement with or without the use of atherectomy. •••
We performed a retrospective chart review of angiographic findings and laboratory and clinical transplant records of all heart transplant recipients who underwent the procedure between January 1991 and February 2003. For patients undergoing intervention, the report from the most recent catheterization before the intervention and data from all subsequent catheterizations were reviewed. Periprocedural angiographic success was defined as a decrease in luminal obstruction to ⬍50%; restenosis was defined as ⬎50% diameter stenosis on a follow-up angiogram. The severity of stenosis was defined by visual assessment of the coronary angiograms. Follow-up was determined until the date of retransplantation, date of death, or date the patient was last known to be alive. Continuous variables were expressed as mean ⫾ SD. Differences in outcome between the angioplasty and stent groups were analyzed using Wilcoxon’s test for equality. Institutional review board approval was granted for the study. Twenty-five recipients (21 white and 4 African American) underwent 45 separate procedures. The indications for transplantation were end-stage ischemic cardiomyopathy in 18 patients (72%), idiopathic cardiomyopathy in 5 (20%), and valvular cardiomyopathy in 2 (8%). Donor age was 34.1 ⫾ 7.1 years. Six of the 25 donor hearts were subjected to angiography before the transplant procedure. Two of the donor hearts had nonobstructive (⬍50% luminal diameter stenosis) single-vessel disease at the time of transplantation. Mean age of the recipients at time of transplant was 57.7 ⫾ 8.1 years; all recipients were men. Fortyeight percent of recipients experienced International Society For Heart And Lung Transplantation grade ⱖ3A rejection, but none did so within 5.3 ⫾ 1.1 years of the intervention. Most had hypertension, which was defined as systolic blood pressure ⬎140 mm Hg or use of antihypertensive therapy at the time of intervention, and dyslipidemia, which was defined as low-density lipoprotein⬎100 mg/dl or the use of a 3-hydroxy-3methylglutaryl coenzyme A reductase inhibitor (92% 0002-9149/04/$–see front matter doi:10.1016/j.amjcard.2003.08.075
FIGURE 1. Trend of procedures by year.
months; of 11 lesions subjected to stent deployment, 9 were patent at a mean of 14.2 ⫾ 14.6 months. Ten patients underwent repeat procedures at a mean of 1.4 ⫾ 0.2 years; 7 of these interventions were in different vessels. Two of the patients underwent retransplantation 186 days and 381 days after intervention. Ten patients died during the study period; 7 patients had PTCA, 2 had stent placement, and 1 had both PTCA and stent placement for 2 different lesions during the same procedure. The cause of death was ischemic cardiomyopathy in 7 patients (70%), malignancy in 2 (20%), and unknown in 1 (10%). Overall, the mean postintervention follow-up to death, repeat transplant, or last date known to be alive was 4.4 ⫾ 0.8 years (range 1 day to 9.46 years); 11 recipients were alive ⬎3 years from the time of intervention. Although the sample size was small, postintervention patient survival or freedom from retransplantation, myocardial infarction, or heart failure appears better with stenting (p ⫽ 0.11 by Wilcoxon’s test for equality). •••
FIGURE 2. Location of intervention by artery. LAD ⴝ left anterior descending artery; LCX ⴝ left circumflex artery; PDA ⴝ posterior descending artery; RCA ⴝ right coronary artery.
and 96%, respectively); 40% of patients had the diagnosis of diabetes. Procedures included PTCA (n ⫽ 17), PTCA with atherectomy (n ⫽ 8), stent only (n ⫽ 17), and stent with atherectomy (n ⫽ 3). There was a clear trend toward increasing use of stent deployment, especially since 1998 (Figure 1). The interval from transplant to initial intervention was longer for the stent group (3,890 ⫾ 1,427 days) than for the PTCA group (1,789 ⫾ 1,002 days), but follow-up was longer in the latter (1,021 ⫾ 891 days [range 84 to 3,453]) than in the former (507 ⫾ 779 days [range 1 to 2,613]). The reasons underlying the need for individual interventions were abnormal exercise test results in 26 cases (58% of all procedures), new ventricular dysfunction in 4 (9%), heart failure symptoms in 21 (47%), and/or abnormal finding on an annual posttransplant evaluation in 13 (29%); 19 of the interventions (40%) had ⬎1 indication. The distribution of vessels is depicted in Figure 2. Three-vessel disease was noted in 10 of the recipients at the time of the initial intervention. Nineteen recipients had documented obstructive lesions first noted 1.7 ⫾ 0.4 years before the intervention. Adjunctive intravascular ultrasound was used in 16% and coronary flow measurements were performed in 24% of patients. The periprocedural success rate was 93%. Seven patients underwent multivessel intervention. Seventeen of the patients, accounting for 26 lesions, had follow-up angiography after intervention. Of 15 lesions subjected to PTCA, 7 were patent at the time of angiographic follow-up at a mean of 11.0 ⫾ 26.9
The initial experience of PTCA in the treatment of CAV was discouraging; it often resulted in high rates of asymptomatic restenosis.9 Data on surgical revascularization have likewise been limited.14 Since the advent of stent technology, reports have suggested a role in allograft vasculopathy, but outcomes have not been well described or compared with angioplasty.10 –13 We demonstrate in a retrospective review that periprocedural success rates are high and that better long-term vessel patency and clinical outcomes may be achievable with stent therapy. Future studies should be designed to identify which patient subset will benefit most from intervention (e.g., based on angiographic and/or intravascular ultrasound appearance or clinical factors) and whether the use of rapamycin-coated stents or systemically delivered rapamycin15 will favorably impact restenosis or disease progression compared with conventional stent use. 1. Constanzo MR, Naftel DC, Pritzker MR, Heilman JK, Boehmer JP, Brozena SC, Dec GW, Ventura HO, Kirklin JK, Bourge RC, et al. Heart transplant coronary artery disease detected by coronary angiography: a multi-institutional study of preoperative donor and recipient risk factors. Cardiac Transplant Research Database. J Heart Lung Transplant 1998;17:744 –753. 2. Hosenpud JD, Bennett LE, Keck BM, Boucek MM, Novick RJ. The Registry of the International Society for Heart and Lung Transplantation: eighteenth official report. J Heart Lung Transplant 2001;20:805–815. 3. Kobashigawa JA, Katznelson S, Laks H, Johnson JA, Yeatman L, Wang XM, Chia D, Terasaki PI, Sabad A, Cogert GA. Effect of pravastatin on outcomes after cardiac transplantation. N Engl J Med 1995;333:621–627. 4. Wenke K, Meiser B, Thiery J, Nagel D, Von Scheidt W, Steinbeck G, Seidel D, Reichart B. Simvastatin reduces graft vessel disease and mortality after heart transplantation: a four-year randomized trial. Circulation 1997;96:1398 –1402. 5. Fang JC, Kinlay S, Beltrame J, Hikiti H, Wainstein M, Behrendt D, Suh J, Frei B, Mudge GH, Selwyn AP, Ganz P. Effects of vitamins C and E on progression of transplant-associated arteriosclerosis: a randomized trial. Lancet 2002;359: 1108 –1113. 6. Gao SZ, Schroeder JS, Hunt S, Stinson EB. Retransplantation for severe accelerated coronary artery disease in heart transplant recipients. Am J Cardiol 1988;62:876 –881. 7. Johnson DE, Alderman EL, Schroeder JS, Gao SZ, Hunt S, DeCampli WM, Stinson E, Billingham M. Transplant coronary artery disease: histopathologic correlations with angiographic morphology. J Am Coll Cardiol 1991;17:449 – 457. 8. Schoen FJ, Libby P. Cardiac transplant graft arteriosclerosis. Trends Cardiovasc Med 1991;1:216 –223.
BRIEF REPORTS
91
9. Halle AA, Wilson RF, Massin EK, Bourge RC, Stadius ML, Johnson MR,
Wray WB, Young JB, Davies RA, Walford GD, et al. Coronary angioplasty in cardiac transplant patients. Results of a multicenter study. Circulation 1992;86: 458 –462. 10. Fischman DL, Leon MB, Bain DS, Schatz RA, Savage MP, Penn I, Detre K, Veltri L, Ricci D, Nobuyoshi M. Long-term angiographic and clinical outcomes after implantation of a balloon expandable stent in native coronary artery circulation. J Am Coll Cardiol 1994;24:1207–1212. 11. Jain SP, Rama SR, White CJ, Mehra M, Ventura H, Zhang S, Jenkins J, Collins T. Coronary stenting in cardiac allograft vasculopathy. J Am Coll Cardiol 1998;32:1636 –1640. 12. Redonnet M, Tron C, Koning R, Bouchart F, Cribier A, Soyer R, Bessou JP.
Coronary angioplasty and stenting in cardiac allograft vasculopathy following heart transplantation. Transplant Proc 2000;32:463–465. 13. Sharifi M, Siraj Y, O’Donnell J, Pompili VJ. Coronary angioplasty and stenting in orthotopic heart transplants: a fruitful act or a futile attempt? Angiology 2000;51:809 –815. 14. Halle AA, DiSciascio G, Massin EK, Wilson RF, Johnson MR, Sullivan HJ, Bourge RC, Kleiman NS, Miller LW, Aversano TR. Coronary angioplasty, atherectomy and bypass surgery in cardiac transplant recipients. J Am Coll Cardiol 1995;26:120 –128. 15. Mancini D, Pinney S, Burkhoff D, LaManca J, Itescu S, Burke E, Edwards N, Oz M, Marks AR. Use of rapamycin slows progression of cardiac transplantation vasculopathy. Circulation 2003;108:48 –53.
Effect of Fluvastatin on Long-Term Outcome After Coronary Revascularization With Stent Implantation Francesco Saia, MD, Pim de Feyter, MD, PhD, Patrick W. Serruys, MD, PhD, Pedro A. Lemos, MD, Chourmouzios A. Arampatzis, MD, Guy R. Hendrickx, MD, PhD, Nicholas Delarche, MD, Dick Goedhart, Emmanuel Lesaffre, PhD, and Angelo Branzi, MD, for the Lescol Intervention Prevention Study (LIPS) Investigators We assessed the impact of long-term fluvastatin treatment on adverse atherosclerotic cardiac events (cardiac death, myocardial infarction, and revascularization excluding repeat interventions due to restenosis in the first 6 months) in 847 patients (fluvastatin [n ⴝ 417] or placebo [n ⴝ 430]) with average cholesterol levels treated with stents in the Lescol Intervention Prevention Study (LIPS). During the 4-year follow-up period, fluvastatin significantly decreased total cholesterol and low-density lipoprotein cholesterol levels and decreased the risk of first adverse atherosclerotic cardiac events by 30% compared with placebo (95% confidence interval ⴚ49 to ⴚ3.4, p ⴝ 0.03). 䊚2003 by Excerpta Medica, Inc. (Am J Cardiol 2004;93:92–95)
nhibitors of 3-hydroxy-3-methylglutaryl-coenzyme A reductase (statins) decrease the risk of death and Imajor cardiovascular events in patients with chronic heart disease, irrespective of clinical presentation and baseline cholesterol level.1– 4 To date, information regarding the impact of statin treatment after coronary stenting is limited and has generally been derived from observational studies.5,6 Results from the Lescol Intervention Prevention Study (LIPS)7,8 have shown that early fluvastatin treatment significantly decreases the risk of major adverse cardiac events in patients with average cholesterol levels after a first successful From the Erasmus MC, Thoraxcenter, Rotterdam, The Netherlands; Istituto di Cardiologia, University of Bologna, Bologna, Italy; Cardiovascular Center Aalst, Aalst, Belgium; Service de Cardiologie, Centre Hospetalier de Pau, Pau, France; Cardialysis BV, Rotterdam, The Netherlands; and Biostatistical Centre, Catholic University of Leuven, Leuven, Belgium. This study was supported by a grant from Novartis Pharma AG, Basel, Switzerland. Dr. Serruys’ address is: Erasmus MC, Thoraxcenter, Kamer Bd 404, Dr. Molewaterplein 40, 3015 GD Rotterdam, The Netherlands. E-mail: [email protected]. Manuscript received June 2, 2003; revised manuscript received and accepted August 27, 2003.
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©2003 by Excerpta Medica, Inc. All rights reserved. The American Journal of Cardiology Vol. 93 January 1, 2004
percutaneous coronary intervention (PCI). We assessed the effects of secondary prevention with fluvastatin in patients with chronic heart disease treated only with stents in the LIPS. •••
The LIPS population was recruited from 57 interventional centers in Europe, Canada, and Brazil and consisted of 1,667 patients (age 18 to 80 years) with stable or unstable angina or silent ischemia and average cholesterol levels. Major exclusion criteria included previous PCI or coronary artery bypass graft; high blood pressure (⬎180/100 mm Hg) despite drug treatment; poor left ventricular function (ejection fraction ⬍30%); severe noncoronary heart disease; severe renal dysfunction (serum creatinine level ⬎1.8 mg/dl [160 mol/L]); obesity (body mass index ⬎30 kg/ m2); and malignant or other disease resulting in decreased life expectancy. After successfully undergoing their first PCI, patients were randomized to receive either fluvastatin 40 mg twice daily or placebo at hospital discharge for 3 to 4 years. Successful PCI was defined as residual stenosis ⬍50%, with no evidence of myocardial necrosis or need for urgent coronary artery bypass graft. Importantly, decisions regarding revascularization strategy and stenting (elective, for suboptimal result, bail-out) were left to the discretion of the interventional cardiologist. Use of intravascular ultrasound was allowed for diagnostic purposes or for optimization of stent deployment. We evaluated the outcome of the subgroup of patients in whom all lesions were treated with stents. Patients treated with balloon angioplasty alone— or in combination with stenting of ⱖ1 different lesions—and patients in whom percutaneous interventional devices other than balloon or stent were used were excluded from the analysis. The ethics committee at each participating center approved the trial, and all patients provided informed written consent. We evaluated patient survival time free of adverse cardiac atherosclerotic events, which were defined as 0002-9149/04/$–see front matter doi:10.1016/j.amjcard.2003.08.076