Response to Letter Regarding Article, “Sustained Benefit at 2 Years of Primary Femoropopliteal Stenting Compared With Balloon Angioplasty With Optional Stenting”
We thank Dr Golledge for the important comments. We undisputedly agree that the primary treatment goal in patients with intermittent claudication is the reduction of cardiovascular events by optimal medical treatment. In the future, it may be worth designing a large trial to assess whether durable improvement of patients’ exercise capacity due to revascularization in conjunction with systematic exercise training may have a beneficial effect on cardiovascular morbidity and mortality rates. Unfortunately, a 46% restenosis rate at 2 years within the Balloon Angioplasty Versus Stenting With Nitinol Stents in the Superficial Femoral Artery (ABSOLUTE) trial1 indicates that we currently cannot offer durable endovascular treatment for femoropopliteal disease.
We agree that the 2-year results of the ABSOLUTE trial1 do not provide a rationale for an unrestricted use of femoropopliteal stents. As described previously,2 indications should be limited to patients with severe symptoms who are not ideal candidates for surgery. However, we would like to add 2 points to the discussion. First, addressing patients’ quality of life, we have recently demonstrated that quality of life at 12 months is improved by primary stenting,3 suggesting that intermittent claudication severely impacts patients’ quality of life and that a reduction of restenosis by primary stenting also translates into improvement of quality of life. Second, when analyzing patients’ treadmill walking distances at 1 and 2 years,1,2 a significant and sustained improvement compared with baseline walking capacity can be observed in both the balloon angioplasty with optional stenting and primary stenting groups, indicating that endovascular femoropopliteal revascularization in patients with intermittent claudication offers a measurable clinical benefit until 2 years. The difference between the treatment groups at 2 years was only of borderline significance. This may be due to the reduced sample size (98/104) and the impact of coexistent disease such as shortness of breath, angina, contralateral disease, etc, which increased the “statistical noise” of the exercise test.
In conclusion, the ABSOLUTE trial does not solve the dilemma of indications for revascularization in patients with intermittent claudication, but demonstrates that if endovascular treatment for femoropopliteal disease is administered and the mean lesion length is above 10 cm, nitinol stents offer a morphological and clinical benefit. Nevertheless, a 2-year restenosis rate of 46% is a call for further improvement of the devices.
Schillinger M, Sabeti S, Dick P, Amighi J, Mlekusch W, Schlager O, Loewe C, Cejna M, Lammer J, Minar E. Sustained benefit at 2 years of primary femoropopliteal stenting compared with balloon angioplasty with optional stenting. Circulation. 2007; 115: 2745–2749.
Sabeti S, Czerwenka-Wenkstetten A, Dick P, Schlager O, Amighi J, Mlekusch I, Mlekusch W, Loewe C, Cejna M, Lammer J, Minar E, Schillinger M. Quality of life after balloon angioplasty versus stent implantation in the superficial femoral artery: findings from a randomized controlled trial. J Endovasc Ther. 2007; 14: 431–437.