CRISTAL: Mixed Message on Treating DES Restenosis With Cypher Stent

September 29, 2010

September 29, 2010 ( Updated September 30, 2010 ) (Washington, DC) — Treating restenosis of a drug-eluting stent (DES) with a sirolimus-eluting stent (Cypher, Cordis) results in significant improvements in follow-up minimal lumen diameter (MLD), acute gain, and net gain when compared with treatment with percutaneous transluminal coronary angioplasty (PTCA). The Cypher stent, however, failed to have any impact on late lumen loss, the study's primary end point.

The findings, from the CRISTALstudy, were presented last week during TCT 2010by Dr Bernard Chevalier (Institut Cardiovasculaire Paris-Sud, Massy/Quincy, France). According to investigators, it is possible the wrong primary end point was selected when the trial was designed, and "it is likely that post–balloon recoil acts as a confounding factor in the primary-end-point analysis."

Briefly, the investigators enrolled 197 restenosis patients originally treated with Cypher and paclitaxel-eluting stents (Taxus, Boston Scientific) and randomized them 2:1 to the Cypher Select stent or repeat PTCA. Postprocedural and follow-up MLD as well as acute and net gains were significantly improved among the Cypher-treated patients. As noted, late lumen loss was no different between the two treatment approaches. There was a trend toward less clinically driven target lesion revascularization (TLR)--5.9% vs 13.1%, respectively--among the Cypher-treated patients when compared with PTCA.

Commenting on the results of the trial during a panel discussion, Dr Philip Urban (La Tour Hospital, Geneva, Switzerland) said the data suggest that a DES is the best option for treating DES restenosis, and that even though the primary end point was negative, other data go in the right direction, including a trend toward reduced TLR. Dr Ron Waksman (Washington Hospital Center, Washington, DC), on the other hand, was less impressed with the data, saying that DES restenosis is a "different animal" from bare-metal-stent restenosis and that, based on these data, it is impossible to determine the best therapy for restenosis of lesions previously treated with DES.

Also commenting on the CRISTAL results, Dr Martin Leon (Columbia University, New York) said he does not like to put in multiple DES "unless he absolutely has to," and like others on the panel, including Dr Gregg Stone (Columbia University, New York), said he is encouraged by other drug-eluting balloon data, suggesting that future trials will compare DES with these newer balloons in the treatment of restenosis.

Recently, the Intracoronary Stenting and Angiographic Results: Drug-Eluting Stents for In-Stent Restenosis 2 (ISAR-DESIRE 2) study, a trial investigating the best strategy for repeat stenting, showed no advantage or downside for switching stents when a first drug-eluting stent closes up.

Chevalier reports research support from Cordis. Urban consults for Biosensors and Cordis. Waksman receives research support from the Medicines Company, Boston Scientific, and Medtronic and consults for Boston Scientific, Abbott Vascular, and Medtronic. Leon disclosed consulting for Angioscore and Neovasc and holding stock in Angioscore and Sadra Medical. Stone disclosed being on the advisory board for and receiving honoraria from Boston Scientific and Abbott Vascular and being a consultant for the Medicines Company.