Fibrinolvsis (19953 9 Suppl I : 126-128 © 1995 Pearson Professional Ltd

PTCA for Acute Myocardial Infarction in Patients Not Eligible for i.v. Thrombolysis: In-hospital Results

B. Waldecker, W. Waas, H. Heizmann, W. Haberbosch, R. Voss, G. Walker, M. Schafer, P. Kistler, H. Tillmanns

S U M M A R E A total of 38 consecutive patients with acute myocardial infarction (MI) ineligible to i.v. thrombolysis underwent immediate, selective coronary angiography. Thereafter, percutaneous transluminal coronary angioplasty (PTCA) of the occluded artery was attempted if the infarct-related vessel showed TIMI 0, I, or II-flow. All patients were ineligible to i.v. thrombolysis because of advanced age (80 years) or increased risk of bleeding complications.

TIMI-flow HI was restored in 35/38 patients (92%) with a residual stenosis of < $0% in 34 patients. Hospital survival was 84%. LV ejection fraction was 49 + 17% after 2 weeks. Therefore, immediate PTCA in patients with acute MI and contraindications to i.v. thrombolysis appears to yield encouraging preliminary results in a group of high risk patients.

Intravenous (i.v.) thrombolysis has become the standard therapy for patients with acute myocardial infarction (MI). Thrombolytic agents often reopen the occluded co- ronary artery and improve acute and longterm survival of these patients as compared to no-thrombolytic treat- ment.l-9 However, up to 60% of patients with acute MI are excluded from i.v. thrombolysis according to multicenter protocols due to increased risks of hemor-

348 rhage. ' ' Likewise, it has been estimated that only 15- 40% of patients with acute or suspected MI are

10-12 appropriate candidates for i.v. thrombolysis. The list of contraindications to i.v. thrombolysis currently in- cludes: 5'8'10'13 recent major surgery, gastric/duodenal ulcer, arterial puncture, or intramuscular injection, un- controlled arterial hypertension (> 200/110 mmHg), pro- longed and mechanical resuscitation, history of hemorrhagic stroke, age over 75-80 years, etc. Immedi- ate, percutaneous transluminal coronary angioplasty (PTCA) of the occluded artery during acute MI has been attempted by Hartzler et al as early as 1983.14 Sub-

B. Waldecker MD, W. Waas MD, H. Heizmann MD, W. Haberbosch MD, R. Voss MD, G. Walker MD, M. Sehiifer, P. Kistler, H. Tillmanns MD. Abteilung Inhere Medizin/Kardiologie - Angiologie am Zentrum fiir Innere Medizin der JLU, Giessen, Germany. Correspondence to B. Waldecker, MD. Zentrum far lnnere Medizin, Universit~lt Giessen, Klinikstr. 36, 35385 Giessen, Germany.

sequently, PTCA has been shown to be similarly, 15'16 or even more, 17 effective to preserve left ventricular func- tion and to improve in-hospital survival of patients with acute MI when compared to i.v. thrombolysis. Therefore, we prospectively investigated whether immediate PTCA can serve as an alternative treatment for patients with acute MI but not eligible for i.v. thrombolysis.

PATIENTS AND METHODS

This report describes clinical and angiographic data from the in-hospital course of 38 consecutive patients with contraindications to i.v. thrombolysis. All patients under- went immediate coronary angiography with the intention to recanalize the infarct artery using PTCA. Data are ex- tracted from an ongoing, prospective study evaluating the general use of PTCA in patients with acute MI.

The study population consisted of 38 consecutive pa- tients (27 men) with acute MI lasting for < 12 hours. MI was diagnosed on the basis of typical chest pain and ST- segment elevation of > 2 mm in the precordial leads or >1 mm in leads I-avF. Mean age of all patients was 67 + 15 years (range 36--86 years). Anterior MI was present in 17 patients, 7 patients had their 2nd infarct. One patient had had prior bypass grafting.

Contraindications to i.v. thrombolysis were: pro-

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Update in Thrombolysis 1994 127

longed manual resuscitation including repeat transtho- racic defibrillations (n = 14), age > 80 years (n = 12), known malignancy (n = 4), recent major surgery (n = 3), gastric ulcer (n = 3), or i.m. injection (n = 2), and malig- nant arterial hypertension (n = 1) (1 contraindication present in 1 patient).

The clinical diagnosis 'acute MI' prompted thera- peutic i.v. heparinisation, ASS (500 rag), and I]-blockers if appropriate. All patients or their closest available rela- tives gave their written, informed consent to undergo im- mediate coronary angiography and eventual PTCA. Using standard Judkins techniques and 7F catheters se- lective angiography identified the infarct related vessel. PTCA of that vessel was attempted, only if - according to the TIMI-classification 18 - t h e blood flow was 0, I, or II. After successful passage of the occlusion with a guide wire, a variety of inflatable balloons (length: 2 cm, 2-3.5 mm nominal diameter) were expanded. The primary goal was to restore TIMI grade III-flow and a residual ste- nosis of < 50%. Thereafter, the patient was transferred to the intensive care unit. Full heparinisation was continued for 24--48 hours. The catheter sheath was removed after 12-24 hours with the heparin infusion being temporarily discontinued for 2 hours. Otherwise, patients were treated according to conventional guidelines. The indica- tion for re-coronary angiography including ventriculo- graphy after 7-14 days was decided individually.

Left ventricular ejection fraction was estimated in all patients using LV-angiography in 17 patients and echo- cardiography in the remaining patients.

RESULTS

Coronary Status Prior to PTCA

proximal LAD in 14 patients (see Table). No flow or TIMI-flow I was present in the infarct artery in 36 pa- tients, TIMI-flow II was seen in 2 patients. No patient had spontaneous TIMI-flow III.

Results of Acute PTCA

Acute, immediate PTCA was attempted in 37/38 pa- tients; in i patient no attempt was made due to the des- perate situation (see above). PTCA restored TIMI-fiow III in 35/37 patients (95%). The residual stenosis was <50% in 34/37 patients (92%).

In-hospital Follow-up

32/38 patients (84%) survived for > 30 days; death oc- curred in 6 patients. This was due to heart failure in 5 and previously unknown cancer in 1 patient (metastatic gall bladder cancer). Two patients died within the first 24 hours in cardiogenic shock. CKmax was 1640 + 2270 U/I (36-13,000). Left ventricular ejection fraction (EF) was 49 + 17% (20-79). Left ventricular function re- mained almost normal (EF > 55%) in 13 patients but was severely depressed (EF < 30%) in 5 patients. No patient presented cerebral stroke or significant bleeding requir- ing blood transfusion.

Repeat coronary angiography was performed in 17 patients. In 8 patients restenosis of > 50% was found and successfully dilated. Another 2 patients were scheduled for elective coronary bypass grafting that was performed successfully later on. In 20 symptom-free patients, stress electrocardiograms and Holter monitoring were normal, and therefore, repeat coronary angiography was not done.

The immediate coronary angiography was completed in 37/38 patients. In one patient, in whom coronary angio- graphy was performed under ongoing manual and unsuc- cessful resuscitation, the procedure was terminated after diagnosis of left main stem occlusion. The majority of patients had multi-vessel disease (n = 26), including 3- vessel disease in 16 patients and main stem disease in 2 patients. The majority had proximal coronary occlusion (n = 30, see Table) including 2 patients with acute left main stem occlusion. The infarct related vessel was the

Table Results of immediate, selective coronary angiography

Site of occlusion Number of patients

Left main stem 2 LAD, proximal 14 LAD. distal LCX 4 RCA, proximal 14 RCA, distal 3 Bypass graft 1

Abbreviations: LAD = left anterior descending coronary artery, LCX = left circumflex coronary artery; RCA = right coronary artery.

DISCUSSION

This prospective study was designed to evaluate the glo- bal use of PTCA in patients with acute MI, and in par- ticular, in patients with acute MI who are not eligible to i.v. thrombolysis. Although the list of contraindications to i.v. thrombolysis has shrunk over the past years, e.g. the GISSI I or ISIS-2 trials as compared to the GUSTO- trial, 19 there is still a significant percentage of patients (about 30%) sustaining an acute MI but who are ex- cluded from i.v. thrombolysis.

We found that in a subset of 38 patients with signifi- cant contraindications to i.v. thrombolysis (see 'Pa- tients'-section) immediate, selective coronary angio- graphy and eventual PTCA is feasible without unaccept- able high risks for the individual patient. This subset in- cluded 14 patients who survived only after prolonged, mechanical resuscitation, 7 patients with refractory, per- sistent cardiogenic shock. The majority of patients (26/38) had severe 2- or 3-vessel disease. Only 1 patient, who was in persistent cardiogenic shock requiring sus- tained mechanical ventilation and massage, died during the invasive procedure. Another death in a patient with a large anterior MI and refractory heart failure was inevit-

128 Acute MI: PTCA if i.v. Thrombolysis Not Possible

able during the first 24 hours after (successful) PTCA. Mortality after 30 days (16%) was higher in our

group of patients as compared to mortality reported from large-scale multicenter i.v. thrombolysis trials (mostly 6-- 10%). 1-9'19 However, as mentioned above and do- cumented in the 'Patients' section, the patient population reported here presented in much poorer condition than the average patient who is currently included in throm- bolysis trials. Actually, most of our patients would have been excluded from most of these trials.

Cragg and co-workers 2° reported a group of 1144 pa- tients with acute MI but who were not eligible for i.v. thrombolysis because of contraindications. Patients were treated conventionally and followed for the in-hospital period. Exclusion criteria were: age > 76 years, bleeding risk including a history of stroke, prolonged resuscita- tion, arterial hypertension (> 180/110), etc., and a variety of other contraindications. Total in-hospital mortality of all patients excluded from thrombolysis was 28% for el- derly patients and 29% in patients excluded for bleeding risks. Thus, a mortality of 16% after 30 days in our co- hort of patients compares favorably with a > 25% mor- tality in a group of patients that was comparable as to baseline characteristics but not treated with the intention

• 20 to revascu la r lze .

Limitations of the Study

Before extrapolations or definite conclusions can be drawn from our data, we urge to keep in mind that the number of patients (n = 38) is very small and the follow- up is short (30 days). Also, results were obtained in a single center performing PTCA routinely. It is unknown whether these results would hold in a larger, multicenter trial and sustain during a longer follow-up period.

CONCLUSIONS

Immediate PTCA in patients with acute MI who are not eligible for i.v. thrombolysis appears to be feasible with- out additional risks for the patient, i.e. stroke or major bleeding. Short-term results of immediate PTCA and in- hospital mortality in a limited number of high risk pa- tients are encouraging but need to be confirmed in subsequent studies.

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