Endovascular Brachytherapy after Femoropopliteal Balloon Angioplasty Fails to Show Robust Clinical Benefit over Time

Abstract

Purpose:

To determine if the short-term efficacy of adjunctive endovascular brachytherapy (EVBT) is maintained over time in patients undergoing balloon angioplasty (BA) of femoropopliteal atherosclerotic lesions.

Methods:

To evaluate the long-term clinical and angiographic outcome of EVBT, 147 consecutive patients (82 men; mean age 70.8±8.5 years) with 147 treated limbs were randomized to BA with (n=72, 49%) or without (n=75, 51%) adjunctive EVBT (12 or 14-Gy from an ¹⁹²Ir source, no centering, a 5-mm reference depth). Sixty-eight (46%) limbs were treated for de novo and 79 (54%) for recurrent femoropopliteal lesions. Clinical follow-up at 1, 3, 6, and 12 months and annually thereafter included evaluation of symptoms, ankle-brachial index (ABI), and intra-arterial angiography for new/worsening symptoms or at follow-up between 2 and 5 years. Sustained clinical success was defined as improvement in ABI ≥0.1 and/or of symptoms without repeated target lesion revascularization. Angiographic restenosis was defined as ≥50% diameter reduction. Subgroup analysis was performed for de novo versus recurrent lesions.

Results:

Mean clinical follow-up was 32.3±21.5 months. Angiographic follow-up was available in 83 (56%) patients (41 BA and 42 BA+EVBT) at a mean 31.8±20.7 months. Cumulative sustained clinical success rates at 1, 2, and 3 years, respectively, were 84.3%, 82.1%, and 76.4% after BA versus 82.4%, 69.8%, and 67.5% after BA+EVBT (p=0.26 by log-rank). Although the proportion of patients undergoing follow-up angiography was moderate, the freedom from angiographic restenosis at 1, 2, and 3 years was 70.7%, 63.1%, and 47.1% after BA versus 82.7%, 64.3%, and 64.3% after BA+EVBT (p=0.16 by log-rank). No differences were found between BA and BA+EVBT outcomes in patients with de novo versus recurrent femoropopliteal lesions.

Conclusion:

The seemingly beneficial short-term effects of BA+EVBT are not sustained in the longer term, with no robust clinical improvement after angioplasty of atherosclerotic de novo or recurrent femoropopliteal lesions at up to 5 years.

Keywords

atherosclerosis peripheral vascular disease femoropopliteal segment balloon angioplasty endovascular brachytherapy restenosis outcome analysis

Get full access to this article

View all access options for this article.

References

Gallino

Mahler

Probst

. Percutaneous transluminal angioplasty of the arteries of the lower limbs: A 5 year follow-up. Circulation. 1984; 70: 619–623.

Krepel

van Andel

van Erp

. Percutaneous transluminal angioplasty of the femoropopliteal artery: Initial and long-term results. Radiology. 1985; 156: 325–328.

Capek

McLean

Berkowitz

. Femoropopliteal angioplasty. Factors influencing long-term success. Circulation. 1991; 83: I70–80.

Johnston

. Femoral and popliteal arteries: Reanalysis of results of balloon angioplasty. Radiology. 1992; 183: 767–771.

Matsi

Manninen

Vanninen

. Femoropopliteal angioplasty in patients with claudication: Primary and secondary patency in 140 limbs with 1–3-year follow-up. Radiology. 1994; 191: 727–733.

Murray

Hewes

White

. Long-segment femoropopliteal stenoses: Is angioplasty a boon or a bust? Radiology. 1987; 162: 473–476.

Waksman

Robinson

Crocker

. Endovascular low-dose irradiation inhibits neointima formation after coronary artery balloon injury in swine. A possible role for radiation therapy in restenosis prevention. Circulation. 1995; 91: 1533–1539.

Teirstein

Massullo

Jani

. Catheter-based radiotherapy to inhibit restenosis after coronary stenting. N Engl J Med. 1997; 336: 1697–1703.

Gallino

Alerci

. Effects of probucol versus aspirin and versus brachytherapy on restenosis after femoropopliteal angioplasty: The PAB randomized multicenter trial. J Endovasc Ther. 2004; 11: 595–604.

10.

Zehnder

von Briel

Baumgartner

. Endovascular brachytherapy after percutaneous transluminal angioplasty of recurrent femoropopliteal obstructions. J Endovasc Ther. 2003; 10: 304–311.

11.

Minar

Pokrajac

Maca

. Endovascular brachytherapy for prophylaxis of restenosis after femoropopliteal angioplasty: Results of a prospective randomized study. Circulation. 2000; 102: 2694–2699.

12.

Waksman

Laird

Jurkovitz

. Intravascular radiation therapy after balloon angioplasty of narrowed femoropopliteal arteries to prevent restenosis: Results of the PARIS feasibility clinical trial. J Vasc Interv Radiol. 2001; 12: 915–921.

13.

Bottcher

Schopohl

. Endovascular Ir-192 HDR brachytherapy for avoidance of intimal hyperplasia in peripheral vessels after POBA and stent implantation. A 6-year experience [in German]. Strahlenther Onkol. 1998; 174: 115–120.

14.

Potter

Van Limbergen

Dries

. Prescribing, recording, and reporting in endovascular brachytherapy. Quality assurance, equipment, personnel and education. Radiother Oncol. 2001; 59: 339–360.

15.

Rutherford

Baker

Ernst

. Recommended standards for reports dealing with lower extremity ischemia: Revised version. J Vasc Surg. 1997; 26: 517–538.

16.

Wolfram

Pokrajac

Budinsky

. Five-year follow-up after endovascular brachytherapy for the prevention of restenosis after femoropopliteal angioplasty [Abstract]. Circulation. 2004; Suppl 110: III–647.

17.

Krueger

Zaehringer

Bendel

. De novo femoropopliteal stenoses: Endovascular gamma irradiation following angioplasty-angiographic and clinical follow-up in a prospective randomized controlled trial. Radiology. 2004; 231: 546–554.

18.

Waksman

. Endovascular gamma radiation therapy following balloon angioplasty of narrowed femoropopliteal arteries: Clinical and angiographic results of the multicenter randomized double blind study. American College of Cardiology, 52th annual scientific session; Chicago, IL, USA; March 30-April 2, 2003.