Full metal jacket procedures demonstrate safety out to three years

Data included only patients with treated lesions, however.

TCT 2009

Full metal jacket percutaneous coronary interventional procedures with drug-eluting stents appear safe out to, and even beyond, three years, results of an analysis suggested.

Andrew Sharp, MD, an interventional cardiology fellow at Columbus Hospital and San Raffaele Scientific Institute in Milan, presented 39-month follow-up data on 658 patients at the Transcatheter Cardiovascular Technologies Meeting in San Francisco. For the purposes of the study, full metal jacket procedures were defined as a longer lesions requiring ≥60 mm of overlapping stent. Most of the drug-eluting stents used in the study were sirolimus-eluting stents (Cypher, Cordis Corporation; n=394) and paclitaxel-eluting stents (Taxus, Boston Scientific; n=232). The sirolimus-eluting stent was implanted in 394 patients, and 232 received the paclitaxel-eluting stent.

Sharp reported all-cause mortality in 48 patients (7.3%) and cardiac death in 24 patients (3.6%). Ninety-four patients (14.2%) had periprocedural MI and 23 (3.5%) had out-of-hospital MI. Ejection fraction (P<.001) and diabetes (P=.02) were predictors of cardiac death and MI. Target lesion revascularization was reported in 154 patients (23.4%).

A total of 629 patients (95.6%) received at least six months of dual antiplatelet therapy, and 544 (82.7%) received at least one year of dual antiplatelet therapy. Stent thrombosis was definite in 12 patients (1.8%), probable in five patients (0.8%) and possible in 12 patients (1.8%). Premature discontinuation of dual antiplatelet therapy was cited as an independent predictor of stent thrombosis (P=.04), the significance of which was diminished following a multivariate analysis (P=.13).

Sharp added that while full metal jacket procedures were generally safe, the data were based only on lesions that were treated.

“There must have been more than 658 vessels with diffuse severe disease within five years in two high-volume centers, and the reasons for not treating these patients and their subsequent outcomes are unknown,” Sharp concluded in his presentation. “What we do know is that carefully-selected cases can be tackled without excessive rates of complications.”

For more information:

Sharp A. Oral abstract 38. Presented at: Transcatheter Cardiovascular Therapeutics; Sept. 21-15, 2009; San Francisco.