ROME
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****IMPORTANT****

Please note that randomization into COMPLETE will end on Monday, March 6, 2017 at 5PM (EST).


Please continue to follow ALL patients for the duration of their visit schedule as final status is required on ALL randomized patients. Thank you very much for your continued support.


Brief Description: A randomized, comparative effectiveness study of complete versus culprit-only revascularization strategies to treat multi-vessel disease after primary percutaneous coronary intervention for ST-segment elevation myocardial infarction


COMPLETE is a randomized, comparative effectiveness study to determine whether, on a background of optimal medical therapy with low dose ASA and ticagrelor, a strategy of complete revascularization involving PCI using drug eluting stents of all suitable non-infarct related artery lesions is superior to a strategy of culprit lesion-only revascularization in reducing the composite outcome of CV death or MI in patients with multi-vessel disease who have undergone successful culprit lesion primary PCI for STEMI.

COMPLETE ELIGIBILITY CRITERIA

INCLUSION CRITERIA

1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a pharmacoinvasive strategy where PCI is performed routinely 3-12 hours after initiation of fibrinolysis

AND

2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has:

EXCLUSION CRITERIA

  1. 1. Planned revascularization of non-culprit lesion
  2. 2. Planned surgical revascularization
  3. 3. Non-cardiovascular co-morbidity reducing life expectancy to < 5 years
  4. 4. Any factor precluding 5 year follow-up
  5. 5. Prior Coronary Artery Bypass Graft (CABG) Surgery