TCT: DES are safe, effective for CTO treatment

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SAN FRANCISCO—An Asian multicenter study found coronary drug-eluting stents (DES) effective for patients with chronic total occlusions (CTOs), and a low rate of acute complications. The data were presented this week at the 2009 Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Also, the results trended well for Cordis’ Cypher and OrbusNeich’s Genous Bioengineered R stent.

Lead author Sunao Nakamura, MD, who reported on the results of the investigation, is vice president and director of the Cardiovascular Center at New Tokyo Hospital in Japan, as well as a clinical and visiting professor at Kumamoto University in Matsudo, Japan.

The researchers undertook a comparison with Cypher sirolimus- (SES), Boston Scientific’s Taxus paclitaxel- (PES), Medtronic’s Endeavor zotarolimus (ZES), BioMatrix’ Flex biolimus A9 (BES), Genous EPC-capture (ECS) and Abbott’s Xience everolimus-eluting stent (EES) to assess the safety and efficacy of these stents in the treatment of patients with chronic total occlusion of cardiac blood vessels.

For the study, the investigators performed a prospective analysis of 1,148 patients with 1,253 CTOs treated with different drug-eluting stents (396 SES, 526 PES, 177 ZES, 66 BES, 41 ECS, and 43 EES) in six high-volume Asian centers after successful CTO re-canalization.

Nakamura reported that the study endpoints were 30 days and nine months major adverse cardiac events (MACE), nine months angiographic and target lesion revascularization.

Although they reported 100 percent procedural success for every stent, the researchers found that the incidence of MACE at 30 days was nearly non-existent in patients with CTO lesions treated with drug-eluting stents (0.4 percent in patients with PES, 0.6 percent in ZES and 0 percent in all other categories).

According to Nakamura, MACE at nine months was 3.6 percent for those receiving SES, 6.7 percent for PES, 10.4 percent for ZES, 4.5 percent for BES, 10.3 percent for ECS and 2.4 percent for EES.

Target lesion revascularization at nine months was 3.6 percent for patients who received SES, 6.7 percent for PES, 10.4 percent for ZES, 4.5 percent for BES, 10.3 percent for ECS and 2.4 percent for EES.

In addition, patients treated with SES, BES and EES showed a lesser rate of angiographic restenosis compared with other drug-eluting stents at nine months (4 percent restenosis for patients receiving SES, 6.7 percent for PES, 12.3 percent for ZES, 4.5 percent for BES, 10.3 percent for ECS and 2.4 percent for EES).

Overall, the researchers concluded that the use of drug-eluting stents in patients with CTO was safe, with low-acute complications. Also, Nakamura noted that patients treated with SES, BES and EES showed a "lesser rate of stenosis compared with other drug-eluting stents."

He concluded that the “study indicates a good clinical performance of the new BES and EES devices.”