Outcome 14 to 18 years after percutaneous transluminal coronary angioplasty

Outcome 14 to 18 years after percutaneous transluminal coronary angioplasty

Outcome 14 to 18 Years After Percutaneous Transluminal Coronary Angioplasty Javier Jimenez, MD, Sheryl F. Kelsey, PhD, Wanlin Yeh, David O. Williams...

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Outcome 14 to 18 Years After Percutaneous Transluminal Coronary Angioplasty Javier Jimenez,

MD,

Sheryl F. Kelsey, PhD, Wanlin Yeh, David O. Williams, MD

efinements have substantially enhanced the acute safety and effectiveness of percutaneous transluR minal coronary angioplasty (PTCA), and the early outcomes of patients treated by PTCA have been well characterized. Because PTCA was introduced only 20 years ago and because procedural volumes during its early use were relatively small, little is known of the late outcome of patients treated with PTCA. The purpose of this study was to determine the clinical status of a consecutive patient cohort in whom ⱖ14 years had elapsed since their first PTCA was performed. •••

Between September 1978 and September 1982, 129 consecutive patients underwent a first PTCA at our institution. Follow-up data on hospital admissions, recurrent acute myocardial infarction, subsequent revascularizations, and vitals statistics were obtained from patients or relatives contacted by telephone, from a professional organization (Equifax, Atlanta, Georgia), or from the National Registry of Death, Washington, DC. Patients were questioned at follow-up as to the need for medications, presence of angina, level of activity and hospitalizations for chest pain, acute myocardial infarction (AMI), PTCA or coronary artery bypass grafts (CABG). Initial PTCA results and baseline characteristics from each patient were obtained from our computerized database. A successful PTCA was defined as a ⱖ20% decrease in luminal stenosis. Mortality was identified by hospital medical records notification from a patient’s relative or confirmation in the National Registry of Death. Recurrent AMI and repeat PTCA or CABG were determined by questioning the patient during the interview and confirming this result in most of the cases through medical records. Univariable analysis was performed to assess differences in death, recurrent AMI, PTCA, or CABG according to gender, anginal status, presence of diabetes mellitus, extent of coronary artery disease, age ⬎60 years, and initial PTCA result. Chi-square analysis and t test were used to perform these comparisons. Life-table survival curves were used to examine time until death, AMI, CABG, and repeat PTCA throughout the follow-up period. Statistical significance was assessed at the 5% level of significance. The characteristics of the 129 consecutive patients From Rhode Island Hospital, Brown University School of Medicine, Providence, Rhode Island; and Graduate School of Public Health, University of Pittsburgh, Pittsburgh, Pennsylvania. Dr. Jimenez’s address is: Cleveland Clinic Foundation, Mail Box 674, 9500 Euclid Ave, Cleveland, Ohio, 44195. E-mail: [email protected]. Manuscript received August 31, 1999; revised manuscript received and accepted December 3, 1999.

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in whom balloon angioplasty was attempted are shown in Table I. Mean age was 53 ⫾ 0.9 years (SD) (range 29 to 78). Women were an average 3.6 years older than men. This difference was statistically significant (p ⫽ 0.03). In our cohort, 98 patients (76%) were men, 33 patients (26%) had a prior AMI, and 7 patients (6%) had a previous CABG. Hypertension and current tobacco use were the most prevalent cardiac risk factors. Angiographic data, PTCA results, and events before hospital discharge are shown in Table II. Single-vessel coronary disease was found in 104 of the patients (81%). Angioplasty was attempted in 131 lesions, 75 (58%) of which were performed in the left anterior descending artery. PTCA success was obtained in 80 patients (65%). Mean stenosis severity before PTCA was 80% with an average stenosis reduction of 51% after angioplasty. In-hospital mortality was 0.8%. None of the patients experienced a Q-wave myocardial infarction. In-hospital CABG was performed in 22 of the patients (17%). Follow-up data were obtained during a 12-month period in 123 of the 129 patients. Events at 14-year follow-up are shown in Table III. Kaplan-Meier estimates of freedom from events at 14 to 18 years are shown in Figure 1. Cumulative mortality at 14 years was 26%. There was no difference in mortality according to PTCA result, angina status, age ⱖ60 years, history of diabetes mellitus, or presence of multivessel coronary artery disease. Women had a 42% incidence of death compared with 22% in men (p ⫽ 0.03). Insufficient information was available to determine the cause of death in our patients. During the follow-up period, 16% of the patients experienced a nonfatal AMI. Recurrent myocardial infarction was not influenced by the extent of coronary disease, age, or initial PTCA success. Surgical revascularization was performed in 41% of the patients. The incidence of CABG was greater in patients with an unsuccessful PTCA compared with those with a successful result (63% vs 29%, p ⫽ 0.002). This difference was found early on because most of the patients with a failed angioplasty underwent bypass surgery. Repeat PTCA was performed in 34% of the patients. Information for the indication, site, and results of subsequent angioplasties were not available. Repeat PTCA was not influenced by the initial PTCA result, age, extent of coronary disease, or gender. Among the 123 patients, 24% were free of death, myocardial infarction, CABG surgery, and asymptomatic at 14 years. At follow-up, 89 patients were contacted by telephone. In this group 80% were free of angina, 53% were moderately to highly active and the average number of antianginal medications used was 1.1, including ␤ blockers, calcium channel blockers, and nitrates. 0002-9149/00/$–see front matter PII S0002-9149(00)00736-0

TABLE I Baseline Characteristics of 129 Study Patients No. (%) Women Men Mean ages (yrs) Total Women Men Systemic hypertension Diabetes mellitus Hypercholesterolemia Family history of coronary disease Current tobacco use Prior AMI Prior CABG

31 (24) 98 (76) 52.9 56.5 51.8 41 10 12 27 34 33 7

(1) (2) (1) (32) (8) (9) (21) (26) (26) (5)

TABLE II Angiographic Data and Percutaneous Transluminal Coronary Angioplasty (PTCA) Results No. (%) Indications for angioplasty (n ⫽ 129) Stable angina Unstable angina Unstable angina (post AMI) No. of stenosed vessels attempted (n ⫽ 131) Site of coronary angioplasty Left anterior descending Right Left circumflex Stenosis precoronary angioplasty Stenosis postcoronary angioplasty Primary success In-hospital events (n ⫽ 129) Death Q-wave myocardial infarction CABG

16 98 15 131

(12) (76) (11) (100)

75 (57) 48 (37) 8 (6) (80) (29) 80 (65) 1 (0.78) 0 (0.0) 22 (17)

TABLE III Long-Term Events at 14-Years Follow-Up (n ⫽ 123) No. (%) Death Myocardial infarction Death or myocardial infarction CABG Death, myocardial infarction, or CABG Repeat coronary angioplasty Any repeat revascularization

32 19 46 50 71

(26) (15) (37) (41) (58)

41 (33) 73 (59)

•••

In 1993, King and Schlumpf1 published a 10-year follow-up report of patients treated with PTCA. One year after the first Zurich experience, we started performing angioplasties at our institution. In our study we were able to follow a patient cohort for ⱖ14 years. The patient population undergoing angioplasties at this early time was heavily selected. Most patients were men and most had single-vessel coronary artery disease, and the left anterior descending coronary artery was the predominant artery undergoing angioplasty. At the time of the initial PTCA, we obtained a successful result in 65% of the patients. This success rate was comparable to other studies performed at the beginning of the angioplasty era.2–5 In-hospital com-

plications were few. This may represent the highly selected population that underwent this procedure. Follow-up clinical outcome data were obtained in 95% of the patients. The overall 14-year survival was 74%. Survival was independent of initial PTCA success, anginal status, age ⬎60 years, history of diabetes mellitus, or presence of multivessel coronary disease. Prior studies have shown that the presence of multivessel disease is a predictor of death in the both the short or long term.1,6 We were not able to show this difference; this may be due to the small number of patients with multivessel disease in our cohort. This study, however, confirms the excellent long-term prognosis of patients undergoing angioplasty for single-vessel coronary artery disease.1,2,6 – 8 Although the success rate of PTCA was similar between men and women, a higher incidence of death was found in women. In our group of patients, women were an average of 4 years older than men. Cardiac risk factors were similar at the beginning of the study; however, we were unable to control for comorbid diseases during follow-up. At the present time we are unable to provide a reason for this mortality difference between men and women, except for the older age of female patients. Previous studies have suggested that women have a higher in-hospital mortality when undergoing CABG and also have a higher periprocedural mortality during PTCA due to a greater proportion of higher risk patients among women referred for PTCA.9 –11 Progression of coronary disease after PTCA has been documented in many studies.12–14 Early on, recurrent symptoms are likely due to restenosis, but with time, progression of atherosclerosis can be found. Patients develop new lesions, and a steady rate of recurrent AMI, repeat angioplasties, and surgical revascularization are found. At 14 years, 16% of the patients had a recurrent AMI and 60% had a PTCA or CABG. Despite this high incidence of revascularization, 23% of the surviving patients experienced no symptoms of angina at the last follow-up and only 27% maintained a sedentary level of activity. Study limitations include the retrospective nature of the study, the lack of a control group, and the absence of specific information regarding subsequent revascularizations and comorbid diseases that developed during the follow-up period. Postprocedure non– Q-wave infarctions were not detected in this patient cohort, but this absence may be due to limited surveillance methods at that time. Finally, this study was also limited by the small number of patients included; however, there were only a few patients available for long-term follow-up because procedural volumes at the time of the development of angioplasty were low. The results of this study reveal that despite an unrelenting progression of arteriosclerosis in patients undergoing PTCA, the overall prognosis in the long-term is excellent, especially for patients who initially have single-vessel coronary artery disease. The fate of patients undergoing percutaneous revascularizations should improve because of the BRIEF REPORTS

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4. Gruentzig AR, King SBd, Schlumpf M, Siegenthaler W. Long-term follow-up after percutaneous transluminal coronary angioplasty. The early Zurich experience. N Engl J Med 1987;316:1127–1132. 5. Ruygrok PN, de Jaegere PT, van Domburg RT, van den Brand MJ, Serruys PW, de Feyter PJ. Clinical outcome 10 years after attempted percutaneous transluminal coronary angioplasty in 856 patients. J Am Coll Cardiol 1996;27:1669 –1677. 6. Faxon DP, Ruocco N, Jacobs AK. Long-term outcome of patients after percutaneous transluminal coronary angioplasty. Circulation 1990;81:IV9 –13. 7. Ten Berg JM, Gin MT, Ernst SM, Kelder JC, Suttorp MJ, Mast EG, Bal E, Plokker HW. Ten-year follow-up of percutaneous transluminal coronary angioplasty for proximal left anterior descending coronary artery stenosis in 351 patients. J Am Coll Cardiol 1996;28:82– 88. 8. Talley JD, Hurst JW, King SB, Douglas JS Jr, Roubin GS, Gruentzig AR, Anderson HV, Weintraub WS. Clinical outcome 5 years after attempted percutaneous transluminal coronary angioplasty in 427 patients. Circulation 1988;77:820 – 829. 9. Kelsey SF, James M, Holubkov AL, Holubkov R, Cowley MJ, Detre KM. Results of percutaneous transluminal coronary angioplasty in women. 1985–1986 National Heart; Lung:and Blood Institute’s Coronary Angioplasty Registry (see comments). Circulation FIGURE 1. Freedom of events at 14 to 18 years in all patients after initial PTCA. 1993;87:720 –727. 10. Keelan ET, Nunez BD, Grill DE, Berger PB, Holmes DR Jr, Bell MR. Comparison of immediate and long-term outcome of coronary angioplasty performed introduction of stents, aggressive lipid manage- for unstable angina and rest pain in men and women (see comments). Mayo Clin Proc 1997;72:5–12. ment, and the use of GPIIb/IIa antagonists. 11. Malenka DJ, O’Connor GT, Quinton H, Wennberg D, Robb JF, Shubrooks S, Kellett MA, Jr, Hearne MJ, Bradley WA, VerLee P. Differences in outcomes between women and men associated with percutaneous transluminal coronary angioplasty. A regional prospective study of 13,061 procedures. Northern New 1. King SBd, Schlumpf M. Ten-year completed follow-up of percutaneous England Cardiovascular Disease Study Group. Circulation 1996;94:II99 –104. transluminal coronary angioplasty: the early Zurich experience. J Am Coll Car12. Sharaf B, Riley RS, Drew TM, Williams DO. Late (five to eight years) diol 1993;22:353–360. clinical and angiographic assessment of patients undergoing successful percuta2. Kent KM, Bentivoglio LG, Block PC, Bourassa MG, Cowley MJ, Dorros G, neous transluminal coronary angioplasty. Am J Cardiol 1992;69:965–967. Detre KM, Gosselin AJ, Gruentzig AR, Kelsey SF, et al. Long-term efficacy of 13. Webb JG, Myler RK, Shaw RE, Anwar A, Murphy MC, Mooney JF, Mooney percutaneous transluminal coronary angioplasty (PTCA): report from the NaMR, Stertzer SH. Bidirectional crossover and late outcome after coronary angiotional Heart, Lung, and Blood Institute PTCA Registry. Am J Cardiol 1984;53: plasty and bypass surgery: 8 to 11 year follow-up (see comments). J Am Coll 27C-31C. Cardiol 1990;16:57– 65. 3. Kadel C, Vallbracht C, Buss F, Kober G, Kaltenbach M. Long-term follow-up 14. Blackshear JL, O’Callaghan WG, Califf RM. Medical approaches to prevenafter percutaneous transluminal coronary angioplasty in patients with singlevessel disease (see comments). Am Heart J 1992;124:1159 –1169. tion of restenosis after coronary angioplasty. J Am Coll Cardiol 1987;9:834 – 848.

Resolution of Coronary Thrombus With Rescue Stenting Harold L. Dauerman,

MD,

Ross Prpic, MBBS, Costa Andreou, Jeffrey J. Popma, MD

oronary thrombus has been associated with adverse procedural outcomes with both conventional C angioplasty and new device interventions. A num1– 4

ber of techniques have been developed to reduce the risk of abrupt closure and embolization associated with thrombus. These techniques include thrombus extraction with the transluminal extraction5,6 or angiojet catheter,7 and pharmacologic therapy with urokinase8 or glycoprotein IIB/IIIA inhibitors.9,10 All the From the Cardiovascular Division, University of Massachusetts-Memorial Medical Center and University of Massachusetts Medical School, Worcester; and the Cardiovascular Division, Brigham and Women’s Hospital, and Harvard Medical School, Boston, Massachusetts. Dr. Dauerman’s address is: Cardiovascular Division, University of Massachusetts-Memorial Medical Center, 55 Lake Avenue North, Worcester, Massachusetts 01655. E-mail: [email protected]. Manuscript received October 20, 1999; revised manuscript received and accepted December 2, 1999.

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studies examining the above-mentioned thrombus dissolution techniques were done using conventional balloon angioplasty alone. It is possible that the thin mesh metal design of coronary stents could trap thrombus and improve coronary flow causing dissipation of residual thrombus without the need for additional thrombectomy devices or pharmacotherapy. Although coronary stenting has been shown to improve the management of abrupt closure and reduce longterm restenosis rates in a variety of coronary lesions,11–13 its role in the treatment of coronary thrombus has not been established. One of the highest risk situations for thrombotic lesions, abrupt closure, and adverse outcomes is rescue coronary intervention.14,15 To determine the role of stenting in the resolution of thrombus, we performed quantitative coronary angiography in 37 consecutive patients treated with rescue stenting. 0002-9149/00/$–see front matter PII S0002-9149(00)737-2