At PCR, How Big is Small?

With each passing year, clinical trials reaffirm the efficacy of drug-eluting stents in reducing or eliminating restenosis. But the devices' success have raised concerns of a different sort: safety, and specifically, the risk of subacute and late stent thrombosis.

When the first clinical trials on drug-eluting stents were reported, the results were breath-taking. The earliest trials, FIM and RAVEL, showed zero-percent restenosis, and though few of the follow-up trials, which have explored more difficult patient sub-groups such as diabetics and patients with long and bifurcated lesions, have demonstrated such absolute results, they've continued to affirm the radical efficacy of drug-eluting stents (DES). But even as DES' efficacy is proven in trial after trial, a new concern has surfaced: do the revolutionary devices cure one large problem, restenosis, only to cause another, and potentially more deadly one, thrombosis? By all accounts, the risk of thrombosis is small. But it's one that interventionalists take seriously, and at this year's Paris Course on Revascularization (PCR) meeting, physicians in a number of sessions debated intently how seriously stent-induced thrombosis should be taken and whether the incidence warrants increased caution in the use of drug-eluting stents.

Even physicians who reported relatively little incidence of subacute (SAT) and late stent thrombosis (LST) seem to be worrying about...

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