Percutaneous Transluminal Angioplasty Without Anticoagulation

F. Michael Ameli, MB, ChB, Moni Stein, MD, John L. Provan, MS, FRCS, Eugene L. St. Louis, MD, Loraine Legrand, MD, Toronto, Ontar io, C a n a d a

This paper presents the results of a retrospective study of 110 percutaneous transluminal angioplasties done over a period of two years on 110 consecutive patients. Anticoagulation or antiplatelet drugs were not used during or after percu- taneous transluminal angioplasty. Life-table analysis was used to calculate success rates at one and three months following the procedure. Success rates were deter- mined using three criteria: clinical improvement, pre- and post-percutaneous trans- luminal angioplasty Doppler studies, and radiographic appearance. Claudication was present in 87 (79%) patients and severe ischemia in 23 (21%) patients. Sixty-eight (62%) PCTAs were done in the iliac arteries, 35 (32%) in the femoral arteries, and 7 (So/,) in the popliteal artery. The majority of patients (61%) had 50%-75% arterial stenosis and only 18% had complete occlusion. Percutaneous transluminal angio- plasty in the iliac arteries had the best results with cumulative success rates of 90% and 85% at one and three months, respectively. Success rates in the femoral arteries were 83% and 79% and in the popliteal artery 71% and 57% at one and three months, respectively. None of our patients required amputation. Ten patients (9.1%) suffered the following complications within 30 days of percutaneous transluminal angio- plasty: death (2), thrombosis (2), perforation (3), minor hematoma (2), and false aneurysm (1). In conclusion, we have shown that percutaneous transluminal angio- plasty can be performed safely and effectively without the use of anticoagulation and its associated risks.

KEY WORDS: Percutaneous transluminal angioplasty; anticoagulation.

Percutaneous transluminal angioplasty (PCTA) has become a successful treatment modality in the management of peripheral vascular disease. The technique is considered cost-effective, relatively safe, and yielding good results in carefully selected arterial lesions. PCTA is less invasive than surgery but not without complications. There is a wide variation in the reported complication rate which ranges between 5 and 26% [I-51. Some authors

From the Divisions of Vusclrlnr Sirrgeiv and Rudiology , The Wellesley Hospitul, The University of Toronto, Tor- onto, Ontario, Canada.

Reprint requests: F . M. Ameli. M B , 160 Wellesley Street East, E . K . Jones Building, Sirite 313, Toronto, Ontnrio, Canada M4Y-IJ3.

report only major complications [6,7]. The most feared complications of PCTA are distal emboli, arterial rupture, pseudoaneurysm, acute thrombo- sis, reversible or irreversible renal failure, and septicemia [5,8,9]. However, the most common complication associated with PCTA is bleeding, with a reported frequency ranging between 2 and 8% [8-101. Major hematomas require transfusions with further associated risks. The administration of intraarterial heparin during PCTA is a standard practice [2-121 that is thought to prevent thrombus formation [ 131. However, no controlled study has yet shown the benefits of anticoagulation during PCTA. We believe that anticoagulation does not improve success rates of PCTA and is probably

244

VOLUME 3 No 3 - 1989

PCTA WITHOUT ANTICOAGULATION 245

TABLE I.-Level of the lesion

Artery Number (%) Iliac

Common 37 (33.6) External 29 (26.4) Internal 2 (1.8)

Common 5 (4.5) Superficial 29 (26.4) Profunda 1 (0.9)

Popliteal 7 (6.4)

Femoral

responsible for the frequent occurrence of bleeding. This retrospective study involving I 10 consecutive PCTAs over a period of two years was undertaken to examine cumulative success and complication rates of PCTA without anticoagulation.

METHODS

During a two-year period, 110 PCTAs were car- ried out on 110 patients at The Wellesley Hospital, Toronto, for the management of peripheral vascular disease. The data was collected retrospectively. Initial evaluation included history, physical exami- nation, and Doppler ankle/brachial index (ABI), which was used for follow-up after PCTA. Clinical decisions regarding PCTA and further management in case of complications were done in consultation between the vascular surgeon and the radiologist. The radiologic technique was similar to the tech- nique described originally by Gruntzig [ I ] . N o an- ticoagulation or antiplatelet drugs were used before, during, or after the procedure. We used three criteria for the success of PCTA: ( I ) improvement of the clinical grade by at least one level [(a) asymptomatic, (b) claudication, (c) night or rest pain, (d) ulceration or gangrene], (2) increase in the ABI by at least 0.1, and (3) improved radiographic appearance of the lesion by at least 50%.

For the purpose of this study we have focused on follow-up of three months only. All patients had complete follow-up data. Morbidity and mortality that occurred within 30 days of PCTA were consid- ered as complications. The standard life-table anal-

TABLE 11.-Risk factors

Risk factor Number (70) Smoking 88 (80) Diabetes mellitus 23 (20.9) High blood pressure 41 (37.3) Hyperlipidemia 3 (2.7)

Previous vascular surgery 15 (13.6) Coronary or cerebrovascular disease 49 (44.5)

TABLE Ill.-Cumulative success rates at one and three months

Success rate (O/O)

Artery 1 month 3 months Iliac 90 85 Femoral 83 79 Popliteal 71 57 Overall 86 80

ysis was used to calculate success rates at one and three months of follow-up.

RESULTS

Of the I10 patients included in this study 79 (63%) were males and 41 (37%) females. The mean age was 50.5 years with a range of 34-89 years. Claudi- cation only was present in 87 (79%) and severe ischemia (pregangrene) in 23 (21%) patients. The majority of patients (61%) had 50-75% arterial ste- nosis. Complete occlusion was present in 18% and 25-50% stenosis was present in 21% of patients. The maximum present in 18% and 25-50% stenosis was present in 21% of patients. The maximum length of lesion was 5 cm and the minimum length was I cm.

Table I shows the arterial distribution of the lesions. The majority of PCTAs (62%) were done in the iliac arteries, 32% in the femoral arteries and only 6% in the popliteal artery.

Table I1 shows the risk factors present in our patient population. The most important risk factor was smoking which was present in 80% of the patients. Coronary or cerebrovascular disease was present in 44.5% of patients.

Table 111 shows cumulative success rates of PCTA without any anticoagulation at one and three months of follow-up. PCTA in the iliac arteries had the best results with cumulative success of 90% and 85% at one and three months, respectively. Success rates in the femoral arteries were slightly worse (83% and 79% at one and three months, respec- tively). In the popliteal artery PCTA was less effec- tive with cumulative success of 71% and 57% at one and three months, respectively.

Table 1V shows complications of PCTA. Two patients ( I .8%) died from cardiac causes. Puncture site minor hematoma was present in two (1.8%) patients. Thrombosis occurred in two ( I 3%) pa- tients, false aneurysm in one (0.9%) patient and perforation in three (2.7%) patients. There were no amputations or distal emboli. At three months, 18 (16.4%) patients required vascular surgery after failure of PCTA.

246 PCTA WITHOUT A NTICOA GULA TION ANNALS OF VASCULAR SURGERY

TABLE IV.-Complications

Complication Number (“A) Death 2 (1.8) Thrombosis 2 (1.8) Perforation 3 (2.7) Hematoma 2 (1.8) False aneurysm 1 (0.9) Total 10 (9.1)

DISCUSSION

This retrospective study challenges the standard use of systemic anticoagulation during or after PCTA. We have shown that PCTA can be per- formed safely and effectively without systemic an- ticoagulation. The follow-up period of three months was thought to be adequate in the appreciation of the effects of systemic anticoagulation on results and complications of PCTA.

One of the reasons for the controversy associated with PCTA is the wide range of treatment results that has been reported. The wide discrepancies are due to heterogeneous patient populations, variable criteria for success, and a variety of methods for data analysis [ I I , 12,141. Indeed, several studies [7,15,16] have reported significant discrepancies between technical success and clinical improve- ment. Technical success does not necessarily imply hemodynamic or clinical success. We have used three criteria for success: ( I ) clinical improvement, (2) increase in ABI by at least 0. I , and (3) improve- ment of the radiographic appearance by at least 50%. All three criteria were necessary for success.

Anticoagulation at the time of PCTA has been practiced almost universally in spite of the absence of a systematic study proving its benefits. The theoretical benefit of heparin during PCTA is the prevention of acute thrombus formation [ 131, which has been reported to occur with a frequency of 1%7% [8-171 in spite of anticoagulation. Only two (1.8%) of our patients experienced thrombosis and none had distal emboli as complications of PCTA, in spite of the absence of systemic anticoagulation. This suggests that the absence of anticoagulation does not result in an increased incidence of arterial thrombosis or embolism as complications of PCTA.

Blattler and associates [ 181 examined the role of platelets and the coagulation system in reocclusion after PCTA in chronically occluded femoral arter- ies. Two platelet-specific proteins and fibrinopep- tide A were monitored in the blood of 24 patients undergoing PCTA. Early arterial thrombosis was associated with longer lesions, higher basal p- thromboglobulin and fibrinopeptide A levels in the blood and less use of 5000 IU bolus heparin ther- apy. In spite of its small sample size, the above study suggests that there is a patient population

with long lesions or complete arterial occlusions that might benefit from arterial anticoagulation.

Most of our patients (82%) had less than 75% arterial stenosis and none had a lesion longer than 5 cm. This might explain our relatively favorable results without anticoagulation.

The majority of PCTAs in our study were done in the iliac or femoral arteries, which are reported to have better results compared to more distal arteries [8,12,19]. PCTA in the popliteal artery or its distal branches is reported to have an initial success rate in the range of 75-85% [8,10]. Our seven patients who had PCTA in the popliteal artery had an early success rate of 71% which is lower than the above studies which used anticoagulation.

PCTA is considered a relatively safe procedure, however. a number of potentially serious complica- tions have been reported. The most common com- plication of PCTA is puncture site hematoma (re- ported frequency of 2-8%) [8]. Most hematomas are minor and require only local compression, how- ever, large hematomas can be associated with hy- povolemic shock, transfusion related complica- tions, and prolongation of hospital stay [12]. Another serious, but uncommon complication, is scrota1 hematoma [ 191. The above bleeding compli- cations have been reported by studies which used systemic anticoagulation. In contrast, only two (1.8%) of our patients experienced minor groin hematomas which were easily managed by local compression and did not prolong hospital stay.

In view of our favorable success rates of PCTA without anticoagulation, we recommend that sys- temic heparin be used only in PCTA of distal arteries or in long lesions (> 7 cm) with complete occlusions.

REFERENCES

1. GRUNTZIG A. KUMPE DA. Technique of percutaneous transluminal angioplasty with the Gruntzig balloon catheter. AJR I979:/32:547-552.

Percutaneous transluminal angioplasty for limb salvage. Roclio1og.v 1982;142:337-341.

3. JOHNSTON KW. COLAPINTO RF. BAIRD RJ. Trans- luminal dilatation. Arch Siirg 1982:117: 1604-1610.

4 . SAMSON RH, SPRAYREGEN S. VEITH F. et al. Man- agement of angioplasty complications. unsuccessful proce- dures and early and late failures. Atin Sirrg 1984:199:234- 240.

5 . WEIBULL H. BERGVIST D, JONSSON K. et al. Compli- cations after percutaneous transluminal angioplasty in the iliac, femoral and popliteal arteries. J Vusc Surg 1987; 5:681-686.

6. FREIMAN DB. SPENCE R , GATENBY R. et al. Trans- luminal angioplasty of the iliac and femoral arteries: follow- up results without anticoagulation. Radiologv 1981;141:347- 350.

7. TAMURA S, SNEIDERMAN KW. BEINART C, SOS TA. Percutaneous transluminal angioplasty of the popliteal artery and its branches. Radiology I982 : 143: 645-648.

2. LU C-T. ZARlNS CK. YANG C-F. TURCOTTE JK.

VOLUME 3 NO 3 - 1989 PCTA WITHOUT ANTICOAGULATION 247

8.

9.

10.

I I .

12.

13.

14.

GARDINER Jr GA. MEYEROVITZ MF. STOKES KR. et al. Complications of transluminal angioplasty. Radiology

ST. LOUIS EL, PROVAN JL, GRAY RR. et al. Percuta- neous transluminal angioplasty in peripheral vascular dis- ease: a review. Cunud Fum Phys 198228:291-294. GREENFIELD AJ. Femoral, popliteal and tibia1 arteries: percutaneous transluminal angioplasty. AJR 1980;/35:927- 935. CAMBRIA RP. FAUST G, GUSBERG R. et al. Percutane- ous angioplasty for peripheral occlusive disease. Arch Surg

JOHNSTON KW. RAE M. HOGG-JOHNSTON SA. et al. Five-year results of a prospective study of percutaneous transluminal angioplasty. Ann Surg 1987206:403413. MURRAY PD, GARNIC JD. BETTMANN MA. Pharma- cologic angioplasty and intravascular thrombolysis. AJR

WALDEN R, SIEGEL Y. RUBINSTEIN ZJ. et at. Percu-

1986;159:201-208.

1987 ;122: 283-287.

I982 ;139:795-803.

taneous transluminal angioplasty. A suggested method for analysis of clinical arteriographic and hemodynamic factors affecting the results of treatment. J Vusc Surg 19863:

IS. MURRAY RR, HEWES RC. WHITE Jr RI, et at. Long- segment femoropopliteal stenoses: is angioplasty a boon or a bust'? Rucliology 1987;/62:473476.

16. MILFORD MA, WEAVER FA, LUNDELL CJ, YELLIN AE. Femoropopliteal percutaneous transluminal angioplasty for limb salvage. J Vusc S w g 1988;8:292-299.

17. SPENCE RK. FREIMAN DB, GATENBY R, et al. Long- term results of transluminal angioplasty of the iliac and femoral arteries. Arch Surg 1981;//6: 1377-1386.

18. BLATTLER W, CAPPIUS G, HAEBERLI A, et al. Throm- binemia during percutaneous transluminal angioplasty of chronic femoral artery occlusions. VASA 1986;/5:379-386.

19. ROOKE TW. STANSON AW. JOHNSON CM, et al. Percutaneous transluminal angioplasty in the lower extrem- ities: a five year experience. Muyo Clin Proc 1987;62:85-91.

583-590.

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