CORRESPONDENCE: LETTERS TO THE EDITOR
Should we use the cutting balloon in patients with in-stent restenosis?
Fernando Alfonso, MD, PhD
H Clinico San Carlos, Interventional Cardiology, Plaza Cristo Rey, Madrid 28040, Spain
(Email: falf{at}hotmail.com).
We read with great interest the elegant randomized study of Albiero et al. (1) comparing cutting balloon with conventional balloon angioplasty in a large cohort of patients with in-stent restenosis (ISR). The researchers found that recurrent restenosis rate (29.8% vs. 31.4%) and major adverse cardiac events at seven months (16.4% vs. 15.4%) were similar in the two groups.
In-stent restenosis constitutes a major clinical problem and a therapeutic dilemma with a high recurrence risk (2). In this challenging setting, published retrospective studies have consistently demonstrated the favorable outcome provided by different mechanical strategies that have emerged as attractive alternatives to conventional balloon angioplasty. Therefore, systematic use of these specific devices (laser, rotational atherectomy, cutting balloon, and restenting) has been advocated for selected patients with ISR. Furthermore, such devices have been rapidly embraced by the interventional cardiology community as the result of their highly appealing mechanistic properties.
Nevertheless, uniformly, all large-scale randomized trials have been unable to confirm the suggested benefit of these alternative mechanical interventions (1,3,4).
In this regard, Albiero et al. (1) should be congratulated for carrying out the definitive study on the use of cutting balloon in patients with ISR. The associated procedural-related advantages, including a lower incidence of balloon slippage, however, remain of major interest. In a previous study (5) we found that, in patients with ISR, balloon slippage was associated with poorer acute and long-term angiographic results. In the study by Albiero et al. (1), although this phenomenon was not a predictor of restenosis in the overall patient population, it would have been of great interest to know the implications (both acute and long-term) of this finding in patients treated with conventional balloon angioplasty. It is quite possible that the appearance of this technical problem could explain suboptimal results or residual dissections and, therefore, the higher requirement of additional stenting in the balloon group.
Finally, although the cutting balloon was not superior to conventional dilation in the entire series it would be of major interest to know whether any specific subgroup of patients benefited from the technique. Despite inherent problems with subgroup analyses, identification of a subset of ISR patients likely to benefit from this technique would be of enormous practical value.
Currently, most investigators favor the use of cutting balloon during brachytherapy procedures to prevent geographical miss and subsequently edge-restenosis. Nevertheless, once again, a recent study failed to demonstrate long-term benefits after the use of this device in ISR patients undergoing brachytherapy (6). Whether the reported procedural advantages of using cutting balloon will translate into clinical or angiographic benefit for patients with ISR treated with drug-eluting stenting (7) remains speculative but deserves prospective evaluation. Above all, it becomes clear that in the rapidly evolving field of interventional cardiology the impetus for adopting new devices, strategies, and ideas should be tempered and balanced out by the so-called "evidence-based medicine."
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References
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1. Albiero R, Silber S, Di Mario C, et al. Cutting balloon versus conventional balloon angioplasty for the treatment of in-stent restenosisResults from the Restenosis Cutting Balloon Evaluation Trial (RECUT). J Am Coll Cardiol 2004;43:943-949.[Abstract/Free Full Text]
2. Alfonso F, Pérez-Vizcayno MJ, Hernandez R, et al. Long-term outcome and determinants of event-free survival in patients treated with balloon angioplasty for in-stent restenosis Am J Cardiol 1999;83:1268-1270.[CrossRef][Medline]
3. von Dahl J, Dietz U, Haager PK, et al. Rotational atherectomy does not reduce recurrent in-stent restenosisResults of the Angioplasty versus Rotational atherectomy for Treatment of diffuse In-Stent restenosis Trial (ARTIST). Circulation 2002;105:583-588.[Abstract/Free Full Text]
4. Alfonso F, Zueco J, Cequier A, et al. A randomized comparison of repeat stenting with balloon angioplasty in patients with restenosis after coronary stenting J Am Coll Cardiol 2003;42:796-805.[Abstract/Free Full Text]
5. Gómez-Recio M, Morís C, Insa L, et al. Implications of the "watermelon seeding" phenomenon during coronary interventions for in-stent restenosisInsights from the Restenosis Intrastent Balloon angioplasty versus elective Stenting (RIBS) randomized trial (abstr). J Am Coll Cardiol 2004;43:78A.
6. Kobayashi Y, Mehran R, Mintz GS, et al. Acute and long-term outcomes of cutting balloon angioplasty followed by gamma brachytherapy for in-stent restenosis Am J Cardiol 2003;92:1329-1331.[CrossRef][Medline]
7. Degertekin M, Regar E, Tanabe K, et al. Sirolimus-eluting stent for treatment of complex in-stent restenosis: the first clinical experience J Am Coll Cardiol 2003;41:184-189.[Abstract/Free Full Text]
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