Thrombosis is “the most devastating result of drug-eluting stents (DES),” according to Ron Waksman, MD, associate director, division of cardiology at the Washington Hospital Center in Washington, D.C. Waksman presented a DES thrombosis lecture Sunday at the DES Summit during the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, D.C., this week.
Waksman cited from a variety of studies to support his DES findings, including one from a colleague at the Washington Hospital Center, Tina Pinto Slottow, MD, which examined 8,402 patients with unrestricted percutaneous coronary intervention (PCI) and one or more DES implantation. Of these patients, 67 percent had Cordis’ Cypher sirolimus-eluting stent, 28 percent had Boston Scientific’s Taxus palictaxel-eluting stent and five percent had both.
Of the 8,402 patients, 8,192 had no stent thrombosis (ST); 83 had definite ST; and 127 had probable ST. The numbers are relatable for patients with diabetes and for patients with more than one stent.
Waksman also reviewed several European studies that weigh the advantages and disadvantages of DES. Unfortunately, “most of the prior analysis didn’t include angiographic and procedural data, and the studies reported a limited number of ST events,” he said.
In response to the previous inconclusive trials, Waksman announced the introduction of a new U.S. registry trial, DES Event Registry of Thrombosis (DESERT) in November. He said the multi-center, case-controlled registry study will collect data to describe the predictors of DES thrombosis, using an adequately sized and powered study design. The flow of the study has 500 subjects with a follow-up of 30 days, six months and one year to “assess the effects of between 25 to 50 potential predictors,” according to Waksman. The patients will all be treated with FDA-approved DES.
Waksman said that the trial needed more involvement from various U.S. sites and clinicians, but to be eligible, providers must perform 1,000 PCI procedures per year. He encouraged the cardiologists at TCT to become part of the clinical trial.
Waksman concluded by stressing that cases of stent-related thrombosis need a great deal of further analysis.