Comparison of PRE-dilatation vs Direct stenting In Coronary Treatment using the Medtronic AVE S670 Coronary Stent System (the PREDICT trial)

Donald S. Baim, Michael Flatley, Ronald Caputo, Charles O'Shaughnessy, Reginald Low, Claude Fanelli, Jeffery Popma, Peter Fitzgerald, Richard Kuntz

Research output: Contribution to journalArticlepeer-review

64 Scopus citations

Abstract

Current stent delivery systems make primary stenting (stent placement without predilatation) possible, but few controlled trials have been performed to evaluate the success, safety, cost saving, and potential benefit of this approach in reducing late restenosis. The Comparison of PRE-Dilatation Versus Direct Stenting In Coronary Treatment using the Medtronic AVE S670 Coronary Stent System trial was a 399-patient study comparing results with the Medtronic-AVE S670 stent to objective performance criteria based on prior approved stents, with subrandomization to direct stenting versus stenting after balloon predilatation. Overall, results with the S670 stent showed excellent success and safety, with delivery success of 99%, a 14-day adverse event rate of 6.8% (including 6.5% non-Q-wave myocardial infarction), and favorable angiographic (20%) and clinical (12%) restenosis rates. Direct stenting was successful in 92% of cases, with a 99.5% secondary success rate including additional pretreatment of initially unsuccessful direct-stenting attempts, and no increase in complications. There were modest (∼10%) savings in fluoroscopy time, contrast use, and a decrease in angioplasty balloon use (0.6 vs 1.3 balloons/case), but no reduction in clinical or angiographic restenosis. Patients treated later in the study, with a device that had less balloon extension beyond the edges of the stent, had slightly lower angiographic restenosis rates (19% vs 23%). In conclusion, the S670 stent showed excellent overall performance. Although direct stenting was safe and highly successful, it offered only modest cost savings, and no reduction in late restenosis compared with stenting after predilatation.

Original languageEnglish (US)
Pages (from-to)1364-1369
Number of pages6
JournalAmerican Journal of Cardiology
Volume88
Issue number12
DOIs
StatePublished - Dec 15 2001

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

Fingerprint

Dive into the research topics of 'Comparison of PRE-dilatation vs Direct stenting In Coronary Treatment using the Medtronic AVE S670 Coronary Stent System (the PREDICT trial)'. Together they form a unique fingerprint.

Cite this