Evaluating Xience and left ventricular function in PCI on occLusiOns afteR STEMI - EXPLORE
The goal of the trial was to assess the safety and efficacy of staged chronic total occlusion (CTO)-percutaneous coronary intervention (PCI) in improving left ventricular (LV) function in patients undergoing primary PCI (PPCI) for ST-segment elevation myocardial infarction (STEMI).
Contribution to the Literature: Routine CTO-PCI performed within 1 week of PPCI for STEMI does not result in improved LV function or clinical outcomes over 4 months of follow-up.
Patients with STEMI treated with PPCI and with evidence of noninfarct artery CTO were randomized to CTO-PCI within 7 days (n = 150) or conservative management (n = 154).
- Total number of enrollees: 304
- Duration of follow-up: 4 months
- Mean patient age: 60 years
- Percentage female: 15%
Other salient features:
- Three-vessel disease: 43%
- Multiple CTOs: 12%
- Baseline LV ejection fraction (LVEF): 41%
- CTO location: right coronary artery: 47%, left anterior descending (LAD): 25%
J-CTO score: 2
- Number of days between PPCI and CTO-PCI: 5
Successful PCI: 72%
The co-primary endpoints, final LVEF at 4 months for CTO-PCI vs. conservative management, were 44.1% vs. 44.8%, p = 0.6; LV end-diastolic volume (LVEDV) at 4 months: 215.6 vs. 212.8 ml, p = 0.70.
On subgroup analysis, there was a significant improvement in LVEF (p = 0.002) and LVEDV (p = 0.039) in the LAD CTO subset.
- Periprocedural complications in CTO arm: dissections: 13, tamponade 1, emergency coronary artery bypass grafting/stroke/death: 0
- Major adverse cardiac events at 4 months: 5.4% vs. 2.6%, p = 0.21
- Cardiovascular death: 2.7% vs. 0%, p = 0.06
The results of this trial indicate that routine CTO-PCI performed within 1 week of PPCI for STEMI does not result in improved LV function or clinical outcomes over an intermediate period of follow-up. The findings of a possible benefit in patients with LAD CTOs are hypothesis generating and merit further research.
CTOs are commonly observed in patients presenting with STEMI and are associated with adverse clinical outcomes. There are scant randomized data comparing CTO-PCI to medical management overall, but particularly in this patient subset. There are a few caveats to consider: Procedural success in this trial was low (~72%), so it is unknown if a higher success rate would have resulted in better outcomes. There was also no assessment of ischemia or viability in the noninfarct CTOs, which may have helped enrich the population.
Presented by Dr. Jose P.S. Henriques at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2015), San Francisco, CA, October 13, 2015.
Keywords: Angioplasty, Balloon, Coronary, Coronary Artery Bypass, Myocardial Infarction, Percutaneous Coronary Intervention, Stroke, Transcatheter Cardiovascular Therapeutics, Vascular Diseases, Ventricular Function, Left
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