PTCA following myocardial infarction: Use of bailout fibrinolysis to improve results

PTCA following myocardial infarction: Use of bailout fibrinolysis to improve results

The results of percutaneous transluminal coronary angioplasty (PTCA) in 307 lesions in 235 patients within 60 days of myocardial infarction (MI) were compared with the PTCA results in 591 lesions in 469 patients without recent MI, and the effect of fibrinolysis to treat recurring occlusive clot during angioplasty was studied. In 210 lesions in patients with MI who did not receive fibrinolysis during the MI (group A), 56 lesions were categorized as primary failures; bailout fibrinolysis brought the final failure incidence to 42 lesions (20%). In 97 lesions in patients with MI who received fibrinolysis during the acute MI (group B), 22 lesions were categorized as primary failures; bailout fibrinoiysis resulted in final failures of 16 lesions (16.5%). In 591 lesions in patients without a recent Ml (group C), there were 65 primary failures and 61 final failures after bailout fibrinolysis. Analysis of the PTCA results in each group with respect to whether the lesions were totally or partially occluded showed that more of the lesions attempted in the groups with MI (groups A and B) were totally occluded (TO) and that with use of bailout fibrinolysis the success rate of PTCA in TO lesions was the same In all groups. Similarly, with use of fibinolytic bailout during PTCA the success rate in partially occlusive lesions was not different between the groups. We conclude that bailout thrombolysis during PTCA is usually effective, especially in those who have recently had an MI, and that with availability of bailout flbrinolysis, PTCA in those with recent Ml is not any less successful than in those without recent Ml. The failure rate seems higher only because more patients with recent Ml have total occlusions and totally occluded vessels have a higher incidence of PTCA failure regardless of the presence or absence of a recent Ml. (AM HEART J 1990;120:243.)

Jacob I. Haft, MD, Jonathan E. Goldstein, MD, Munther K. Homoud, MD, and Michael Aaronoff. Newark, N. J.

Recent studies have shown that performance of angioplasty during the peri-infarction period is associated with a high complication rate. Totally occluded vessels that cannot be crossed with a percutaneous transluminal coronary angioplasty (PTCA) balloon are commonly encountered, and in those lesions crossed and dilated, the incidence of recurrent throm- bosis during the procedure is high.l* 2 We report our results of PTCA during the postinfarction period and our use of “bailout” intracoronary fibrinolysis to improve the success rate of PTCA in these patients.

METHODS

Patients. We reviewed the angiopasty procedures on 898 lesions in 724 patients who underwent angioplasty at St. Michael’s Medical Center (SMMC) from 1981 to July 1989. The patients were classified as post myocardial infarction

From the Department of Cardiology at St. Michael’s Medical Center.

Received for publication Feb. 9, 1990, accepted March 28, 1990.

Reprint requests: Jacob I. Haft, MD, Department of Cardiology, St. Michael’s Medical Center, 268 King Blvd., Newark, NJ 07102.

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(MI) patients if they underwent PTCA within 60 days of an MI (307 lesions in 235 patients). Findings in this group were compared with those in patients who had not sus- tained an MI within 60 days of PTCA (591 lesions in 489 patients). The patients in both groups were subclassified into patients who had totally occluded lesions and those with subtotally occluded vessels. The patients with recent MI were further divided into those who had received intravenous fibrinolysis during the acute MI and those who did not.

Procedure. All angioplasties were performed by the same operator (J.G.) using the Judkins or Sones technique with standard left anterior oblique (LAO), right anterior oblique (RAO), and with modified cephalad and caudad views. The grading of the lesions and assessment of the PTCA procedure was performed by the same operator, and by at least one other author. Standard balloon catheters, guiding catheters, and guide wires were used and were continually changed as more sophisticated equipment be- came available between 1981 and 1989.

Bailout fibrinolysis was performed using steptokinase (Kabikinase, KabiVitrum AB, Stockholm, Sweden) 150,000 to 600,000 units administered via the intracoronary route over 1 hour or with tissue plasminogen activator (t-PA) (Activase, Genentech, Inc., South San Francisco, Calif.)

243

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American Heart Journal

Table I. Patient characteristics

All lesions Lesions/Patients Primary failure Fibrinolytic bailout Final failure

Group A (MI without Fibr)

Group B (MI with Fibr)

Group C (No MI)

Total occlusions Group A Group B Group C

Partial occlusions Group A Group B Group C

210/155

97180

5911489

68166 pts 16/16 pts 69159 pts

142/111 pts 81166 pts 522/430 pts

58/56 pts (27.6%) 16/22 attempts

22/22 pts (22.7%) 6/8 attempts

85/72 pts (14.4%)

29/29 pts (42.7 “;J ) 13/13 pts (81.5%~) 32/25 pts (46.4%)

29/28 pts (20.4%) 9/9 pts (11.1 Z) 53/48 pts (10.3 ‘;;> 1

4/6 attempts

719 attempts 3/5 attempts o/o

9/13 attempts 3/3 attempts 4/6 attempts

42/40 pts (20% 1

16/16 pts (16.5%)

81/68 pts (13.7’<#)

22/22 pts (32.41&) lO/lO pts (62.5%) 32/25 pts (46.4%)

20/19 pts (14.1 “C ) 6/6 pts (7.45) 49/44 pts (9.6 ‘;a )

MI, Myocardial infarction: Fibr, fibrinolysis; pts, patients.

administered in a 20 mg intracoronary bolus followed by 40 to 60 mg intravenously over the next 2 hours. The decision to administer bailout thrombolysis was made ‘after re- peated balloon dilatations of a lesion that recurrently closed over 3 to 10 minutes with angiographic filling defects indicative of clot. Fibrinolytic agents were not used pro- phylactically, but only when balloon manipulation and prolonged dilatations did not resolve the recurrent closure with clot.

A PTCA procedure was considered successful if the di- ameter of the lesion at the end of the procedure was less than 40% narrowed and the degree of stenosis had been reduced by more than 30 % . PTCA final failure was defined as inability to achieve success as defined above, or reocclusion of the vessel. Primary failure was defined as the sum of those with final failure plus those patients who underwent successful bailout fibrinolysis. Statistical analysis was performed using the chi square test or Student’s t test, where appropriate.

RESULTS

PTCA was performed on 307 lesions in 235 patients who had had a myocardial infarction within 60 days of the procedure (Table I). Two hundred ten lesions were in 155 patients who had not received intravenous fibrinolysis during their MI (group A) and 97 lesions were in 80 patients who had received intravenous t-PA or streptokinase during their MI (group B). Five hundred ninety-one lesions in 489 patients without recent MI also underwent PTCA (group C). Among those with MI (groups A and B), 80 lesions in 78 patients were primary failures: 58 in 56 patients in group A (27.62 % of 210 lesions) and 22 in 20 patients in group B (22.6% of 97 lesions) (N.S., group A versus group B). In group C, 85 lesions in 72 patients were primary failures (14.4% of 591 lesions) (p < 0.001 C versus A + B). Bailout fibrinolysis was

attempted in 22 of the 58 primarily failed lesions in group A (37.9%) and in 8 of the 22 primarily failed lesions in group B (36.4% ). Successful bailout was achieved in 16 group A patients (72.7%) and in six group B patients (75%).

Fibrinolysis was attempted in six lesions in six group C patients (7% of 85 primarily failed lesions) (p < 0.001 group C versus groups A and B), and was successful in 4 (66 % ) (N.S., group C versus groups A and B). Final failure occurred in 42 lesions in 40 patients in group A (20.0% of 210 lesions) and in 16 lesions in 16 patients in group B (16.4% of 97 lesions) (N.S., group A versus group B). Final failure occurred in 81 lesions in 68 patients in group C (13.6% of 591 lesions) (p < 0.05 group C versus groups A and B).

To further define the causes of primary and sec- ondary failure, the results of PTCA were analyzed with respect to whether the vessel undergoing PTCA was totally occluded (T.O.) or only partially occluded. Among patients in group A (post MI without fibrinolysis), 68 lesions in 66 patients were totally occluded and 142 lesions in 111 patients were partially occluded (32.4% T.O.) In group B (post MI who received fibrinolysis during MI), 16 lesions in 16 patients were totally occluded and 81 lesions in 66 patients were partially occluded (16.5% T.O.) (p < 0.01 [x2 = 8.421 group A versus group B). In group C (no recent MI), 69 lesions were totally occluded and 522 were partially occluded (11.6 % T.O.) (p < 0.01, group C versus group A; N.S., group C versus group B). Primary failure occurred in 29 totally occluded lesions in 29 patients in group A (42.65% of 68 lesions), in 13 lesions in 13 patients in group B (81.25% of 16 totally occluded lesions) (p < 0.01 group A versus group B, x2 = 7.73), and occurred in 32 lesions in 25 patients in group C (46%

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Number 2 Bailout fibrinolysis in PTCA after AMI 245

of 69 totally occluded lesions) (p < 0.025 group C versus group B, x2 = 6.26; N.S., group C versus group A). Among patients with recent MI (groups A and B), primary failure was due to inability to cross the lesion in 21 lesions and to thrombus in 18 lesions (three due to other causes); in group C, the primary failure was due to inability to cross the lesion in 27 instances, to thrombus in two, and to other causes in three. (Group C versus groups A and B, p < .Ol; x2 = 9.41 for thrombus.)

Bailout with fibrinolysis was attempted in 9 of the 29 primarily failed T.O. lesions in group A and was successful in seven (77%), was attempted in 5 of the 13 primarily failed T.O. lesions in group B, was successful in three failed T.O. lesions (60%) (NS group A versus group B), and was not attempted in any of the primarily failed T.O. lesions in group C. The final failure rate in T.O. lesions in group A was 32.4% (22 of 68), in group B it was 62.5 % (10 of 16), and in group C it was 46% (32 of 69) 0, < 0.025 group A versus B [x2 = 5.1251; NS, A versus C; NS, B versus C).

In partially occluded vessels in group A, 29 lesions were primary failures, (20.4% of 142 partially occluded lesions), in group B, nine partially occluded lesions were primary failures (11.11% of 81 lesions) (NS group A versus group B), and in group C, 53 partially occluded lesions were primary failures (10.2% of 522 lesions) (p < 0.01 [x2 = 9.911 group A versus C; NS, group B versus C). Bailout fibrinolysis was attempted in 13 partially occluded vessels in group A (44.8% of 29 primarily failed PTCAs) in three partially occluded vessels in group B (33% of nine primarily failed PTCAs) (NS Group A versus B), and in six partially occluded vessels in group C (11.3% of 53 failed PTCAs) (p < 0.001 group A versus C [x2 = 11.551; NS, group A versus B; p < .OOl, C versus A and B [x2 = 11.401).

Bailout fibrinolysis was successful in nine of the failed PTCAs in partially occluded vessels in group A (69% of 13 attempts), in three of the failed PTCAs in partially occluded vessels in group B (100% of three attempts) and in four of the failed PTCAs in partially occluded vessels in group C (66% of six attempts) (NS between groups A, B, and C). Final failure rate of partially occluded vessels in group A was 14.1% (20 of 142 lesions), in group B it was 7.4% (6 of 81 lesions), and in group C it was 9.4% (49 of 522 lesions) (NS, A versus B, A versus C, B versus C, and C versus A and B).

Complications occurred in 23 group A patients, in 12 group B patients, and in 58 group C patients (Ta- ble II). In group A there were four deaths, five emergency coronary artery bypass grafting (CABG) procedures (one died), and three reclosures without

Table II. Complications

Group A Group B Group C 210 lesions 97 lesions 591 lesions

155 pts 80 pts 489 pts

Death 4 0 2 Emergency CABG 5 4 16 Elective CABG 4 1 17 Reclosure without CABG 3 3 2 New MI 2 0 3 V Fib 2 1 1 Groin pseudoaneurysm 1 1 3 Distal clot embolization 1 0 1 Groin hematoma 2 0 8 GI Bleed/CHF/Renal 1 1 2 Groin Staph infection 0 0 1 Other 0 1 2

CABG, Coronary artery bypass grafting (surgery); V Fib, ventricular fibril- lation; GI, gastrointestinal; CHF, congestive heart failure; Staph, Staphy- lococcus sp; other abbreviations as in Table I.

CABG (one small MI), two MIS, and four elective CABG procedures. In group B there were no deaths, four emergency CABG procedures, three reclosures without CABG, and one elective CABG procedure. In group C there were two deaths, 16 emergency CABG procedures, two reclosures without CABG, and 17 elective CABG procedures. There were no significant differences between those with recent MI and those without a recent MI in the incidence of any of these complications.

DISCUSSION

The realization that most MIS are due to acute thrombotic occlusion of a coronary artery3 and the availability of PTCA and of prompt fibrinolysis with intravenous medications has led to a number of possible treatments of patients with myocardial infarction.4p 5 These have included immediate PTCA during acute MI without fibrinolysis,61 7p 8, lo fibrinolysis alone,g fibrinolysis plus PTCA for failed patients,14 fibrinolysis plus routine immediate PTCA,11-13 fibrinolysis plus PTCA only in those with symptoms or signs of ischemia (angina or positive stress test),15 or fibrinolysis plus routine remote PTCA in those without early ischemia. Many of these regimens have been tried in randomly assigned patients, and currently after the Thrombolysis In Myocardial Infarction (TIMI) and Thrombolysis and Angioplasty in Myocardial Infarction (TAMI) studies, it is felt that the best strategy is to utilize intravenous fibrinolysis in all possible patients, to do PTCA immediately only in those who fail fibrinolysis or in whom fibrinolysis is contraindicated and who remain symptomatic, and to do PTCA later only in

246 Haft et al. August 1990

American Heart Journal

those who have ischemic symptoms or a strongly positive stress test. 15s l6 This leaves many patients after fibrinolysis with high-grade lesions or totally occluded vessels who are not even studied with coronary arteriography. Follow-up data at 1 year suggests that those without symptoms who are managed noninvasively do as well as those who have PTCA,17 although there is an accumulating body of data that suggests that patients after an MI fare better if the artery associated with the area of infarction has been left patent. i2j 18, lg. 22, 23 In all of the controlled studies involving PTCA in the early postinfarction period, there has been a high incidence of unsuccessful or complicated angioplasty-higher than that usually encountered in patients who have had PTCA who did not have a recent MI.13, 16, so This has largely led to the finding that noninvasive management- rather than PTCA-carries with it a better result. The higher failure rate of PTCA soon after MI has been felt to be due partly to reocclusion after dilatation,15 because perturbation of a fresh lesion that is frequently complex and is associated with clot can lead to recurrence of clot and occlusion; i.e., breaking up a clot or disturbing a recently ulcerated plaque creates a situation that is highly locally thrombogenic. 21 Because of this possibility, for sev- eral years now we have been using fibrinolytic agents in the catheterization laboratory in primarily failed PTCA if there was evidence that clot was playing a significant role. To study the causes for failure in patients with a recent MI, we reviewed our PTCA patients, comparing those with recent MI with those without recent MI. On examining the primary failure rate in patients according to the time after MI, we found that primary failure was common up to 60 days after MI, but thereafter the rate was the same as without MI. We compared those with MI < 60 days prior to PTCA with those without recent MI.

Like other investigators, we have also found that patients treated with PTCA within 60 days of an MI are at significantly greater risk of primary PTCA failure than patients who have not had a recent MI 20, 24 regardless of whether fibrinolysis had been use’d during the acute MI. The use of bailout fibrinolysis narrows the difference in percentage of final failures between those with and those without recent MI, but the difference remains significant (18.9% versus 13.8% ).

The difference in the success rate between those with and those without recent MI was partly due to the significantly increased incidence of totally occluded vessels that were subjected to attempted PTCA in the recent MI patients (27.4% versus 11.6% ). This may have been due to the expectation

that T.O. lesions in patients with recent MI might be more likely due to clot and thereby might be softer, more easily crossed, and more easily opened. The fact that those with recent MI had fewer failures because of the inability to cross the lesion suggests that this indeed may have been true. Those who had had thrombolysis during their MI had a lesser incidence of T.O. than those with recent MI who had not had fibrinolysis at the time of infarction, probably because the occluding clot had been lysed in most instances. The primary failure rate of T.O. lesions was about the same in patients with and in those without recent MI, although those with T.O. who had had fibrinolysis during MI had a higher primary failure rate than those without fibrinolysis, possibly because the lesions left totally occluded after fibrinolysis might have been harder and therefore less easy to cross and to open with a balloon.

As expected, the cause for primary failure was different between those with and those without a recent MI. In those without MI, 27 of 32 primary failures were due to the inability to cross the occluding lesion with a balloon and only two were due to thrombus formation, whereas in those with a recent MI, only 21 of 42 unsuccessfully attempted lesions were primary failures because of the inability to cross the lesion, but 18 of the 42 failed lesions were due to recurrent thrombus. Hence use of bailout fibrinolysis was more often appropriate and was more often used in 14 lesions with recent MI (successful in 10 lesions) but was used in none of those without recent MI. Final failure occurred in fewer T.O. lesions with a recent MI than in those without a recent MI.

In patients with partially occluded vessels, the primary failure rate was greater among those with recent MI, but with bailout fibrinolysis the final failure rate was about the same whether there was a recent MI or not. There was no significant difference in deaths, emergency or elective CABG, or other complications between those with or those without recent MI. Hence with the use of bailout fibrinolysis, the success rate of PTCA is the same in partially occluded vessels with or without MI. Also, with the use of bailout fibrinolysis, the final success rate of PTCA in totally occluded vessels is about the same whether there is a recent MI or not; if anything, there is a trend toward more success in patients who have had a recent MI. However, the rate of final failure remains significantly higher in those with recent MI compared with those without MI, because: (1) the final failure rate in T.O. lesions is always higher than in partially occluded lesions and (2) the incidence of T.O. lesions attempted with PTCA in patients with recent MI is very much higher than in patients with-

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Number 2 Bailout fibrinolysis in PTCA after AMI 247

out MI. This latter higher incidence of T.O. lesions is the only reason that the net final failure rate in recent MI patients is higher than the net final failure rate in patients without recent MI, if bailout fibrinolysis is available (Table I).

In conclusion, we have found that if bailout fibrinolysis is used during a PTCA procedure to open vessels closed with thrombus after dilatation, the incidence of PTCA failure in partially occluded vessels and in totally occluded vessels is the same whether the patient has had a recent MI or not. However, because the failure rate is higher in totally occluded vessels than in partially occluded vessels regardless of whether there has been recent infarction, and because totally occluded vessels are subjected to attempted PTCA more often in patients who have had a recent MI, the incidence of PTCA failure is higher in patients who have had recent MI.

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PTCA following myocardial infarction: Use of bailout fibrinolysis to improve results