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| | | ![]() DG DISPATCH - TCT: Follow-Up Data On Stent Versus PTCA Illustrates Mortality Dilemma By Andrew Bowser Special to DG News WASHINGTON, D.C. -- September 27, 1999 -- Patients who received a heparin-coated stent within 12 hours of an acute myocardial infarction have lower rates of ischemic target vessel revascularization compared to patients who got balloon angioplasty, but that benefit may come at the expense of slightly higher mortality rates for some patients. That’s the possibility raised by one-year follow-up data for the 900 patients enrolled in the Stent PAMI (Primary Angioplasty in Myocardial Infarction) trial, which was presented at the 11th annual congress of Transcatheter Cardiovascular Therapeutics (TCT), being held in Washington, D.C.
Stent PAMI randomized 452 patients to stenting and 448 patients to primary angioplasty. The primary endpoint, event-free survival at six months, showed no difference between the stent and angioplasty patients. The six-month data also showed a significant reduction in ischemic target vessel revascularization (TVR) in favor of the stented patients (7.5 percent versus 17 percent, p < 0.0001). At one-year follow-up, the difference in need for TVR persisted (10.6 percent for stent versus 21 percent for PTCA, p = 0.0001), but surprisingly, a trend in mortality emerged in favor of the balloon arm (3.1 percent versus 5.8 percent, p = 0.08). However, for the subgroup of patients without indicators of high risk (age greater than 70 years, ejection fraction of less than 45, three vessel disease, persistent arrhythmia or suboptimal result after intervention) mortality at one year was not different between the two interventions. For high-risk patients, there was mortality rate was double in the stent-treated group. "This high risk group is where we are seeing the doubling of mortality compared to balloon angioplasty," said Dr. Cindy L. Grines of William Beaumont Hospital, Royal Oak, MI. "Maybe in this group, we should try to consider more selective stenting." Aditional trials will be needed to confirm that before any recommendations can be made. That includes the CADILLAC trial, which includes 2,000 patients to stent or PTCA, with or without abciximab.
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