November 2019 Issue
ISSN 2689-291X
ISSN 2689-291X
Journal Review
The COMPLETE Trial: Nonculprit Revascularization in STEMI
Abstract
In October of 2019, the COMPLETE Trial [1] was published in New England Journal of Medicine by Mehta et al. This was a randomized control trial that included 4,041 patients, from 140 centers in 31 countries, who underwent primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI).
Patients were randomized within 72 hours of initial successful culprit-lesion PCI to:
Inclusion criteria:
Results
After about 4 years of follow-up:
Discussion
About 50% of patients who present with STEMI have multivessel coronary artery disease (CAD), which places them at higher risk of early and late mortality, along with recurrent MI. Recently, there has been much debate regarding complete revascularization of all angiographically significant arteries in this patient population. In the last five years, key trials have been published suggesting a positive outcome with complete revascularization. The PRAMI trial [2] examined the effect of performing preventive PCI on noninfarct coronary arteries with significant stenosis in STEMI patients with multivessel CAD; the trial was stopped earlier than intended after it was found to have a major benefit on outcomes. The CVLPRIT trial [3] and the Danami 3 Primulti Trial [4] also showed similar positive outcomes of revascularizing all arteries with angiographically significant stenoses, either visually or using FFR guidance. Although these studies were criticized for being underpowered, their impact along with other key clinical trials was immense. In 2015, a focused update was made to the ACC/AHA/SCAI STEMI guidelines [5], with regards to intervention on non-culprit lesions during primary PCI in STEMI patients. The previous Class III recommendation (harmful or no benefit) was modified to a Class IIB recommendation (may be considered).
Clinical Implications
The field of interventional cardiology has witnessed great advances ever since its inception greater than 40 years ago [6]. The development of newer and safer stents [7] was paralleled by the advancement of novel dual antiplatelet agents [8]. With the advent of such advanced interventional therapies, the enthusiasm mounted to perform simultaneous multivessel revascularization, a practice traditionally allocated to coronary artery bypass grafting [9]. The findings from the COMPLETE clinical trial give further credence to the feasibility of such approach in the setting of STEMI in hemodynamically stable patients, and allow the completion of revascularization within 45 day of hospital discharge. Whether these findings, combined with comparable results from other recent trials, will lead to further more favorable reclassification of non-culprit-vessel PCI during STEMI recommendations by the guidelines remains to be seen [10].
References
Authors:
Sarina Sachdev, M.D.
Cardiology Fellow
University of South Alabama
Mobile, AL
Bassam Omar, M.D., Ph.D.
Professor of Cardiology
University of South Alabama
Mobile, AL
In October of 2019, the COMPLETE Trial [1] was published in New England Journal of Medicine by Mehta et al. This was a randomized control trial that included 4,041 patients, from 140 centers in 31 countries, who underwent primary percutaneous coronary intervention (PCI) for acute ST-elevation myocardial infarction (STEMI).
Patients were randomized within 72 hours of initial successful culprit-lesion PCI to:
- No further revascularization (n = 2025)
- Complete revascularization of significant nonculprit lesions (n = 2016)
- During the index hospitalization (n = 1353)
- Within 45 days of discharge (n = 663).
Inclusion criteria:
- Multivessel coronary disease (≥ 1 significant nonculprit lesions)
- Amenable to successful PCI
- Vessel diameter ≥ 2.5 mm (not stented during index PCI)
- ≥ 70% stenosis on visual estimation
- 50 - 69% stenosis, with fractional flow reserve (FFR) ≤ 0.80
- Intention, before randomization, to revascularize a nonculprit lesion
- Planned surgical revascularization
- Previous coronary artery bypass grafting surgery (CABG)
- No cardiogenic shock patients were enrolled, though not an exclusion criterion
- Death from cardiovascular (CV) causes, new MI
- Death from CV causes, new MI, or ischemia-driven revascularization
Results
After about 4 years of follow-up:
- Both coprimary composite outcomes were significantly lower in the complete revascularization group (7.8%, 8.9%) compared with the culprit-lesion-only group (10.5%, 16.7%; P < 0.01)
- This difference was driven by a 32% lower incidence of new MI in the complete revascularization group
- The benefit was observed whether nonculprit-lesion PCI was performed during the index hospitalization or within 45 days after discharge
- Number needed to treat (NNT) to prevent one CV death or MI: 37
- NNT to prevent one CV death, MI, or ischemia-driven revascularization: 13
Discussion
About 50% of patients who present with STEMI have multivessel coronary artery disease (CAD), which places them at higher risk of early and late mortality, along with recurrent MI. Recently, there has been much debate regarding complete revascularization of all angiographically significant arteries in this patient population. In the last five years, key trials have been published suggesting a positive outcome with complete revascularization. The PRAMI trial [2] examined the effect of performing preventive PCI on noninfarct coronary arteries with significant stenosis in STEMI patients with multivessel CAD; the trial was stopped earlier than intended after it was found to have a major benefit on outcomes. The CVLPRIT trial [3] and the Danami 3 Primulti Trial [4] also showed similar positive outcomes of revascularizing all arteries with angiographically significant stenoses, either visually or using FFR guidance. Although these studies were criticized for being underpowered, their impact along with other key clinical trials was immense. In 2015, a focused update was made to the ACC/AHA/SCAI STEMI guidelines [5], with regards to intervention on non-culprit lesions during primary PCI in STEMI patients. The previous Class III recommendation (harmful or no benefit) was modified to a Class IIB recommendation (may be considered).
Clinical Implications
The field of interventional cardiology has witnessed great advances ever since its inception greater than 40 years ago [6]. The development of newer and safer stents [7] was paralleled by the advancement of novel dual antiplatelet agents [8]. With the advent of such advanced interventional therapies, the enthusiasm mounted to perform simultaneous multivessel revascularization, a practice traditionally allocated to coronary artery bypass grafting [9]. The findings from the COMPLETE clinical trial give further credence to the feasibility of such approach in the setting of STEMI in hemodynamically stable patients, and allow the completion of revascularization within 45 day of hospital discharge. Whether these findings, combined with comparable results from other recent trials, will lead to further more favorable reclassification of non-culprit-vessel PCI during STEMI recommendations by the guidelines remains to be seen [10].
References
- Mehta SR, Wood DA, Storey RF, et al. Complete revascularization with multivessel PCI for myocardial infarction. N Engl J Med 2019;381:1411-1421.
- Wald DS, Morris JK, Wald NJ, et al. Randomized trial of preventive angio- plasty in myocardial infarction. N Engl J Med 2013;369:1115-23.
- Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion- only revascularization in patients under- going primary percutaneous coronary in- tervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Car- diol 2015;65:963-72
- Engstrøm T, Kelbæk H, Helqvist S, et al. Complete revascularisation versus treat- ment of the culprit lesion only in pa- tients with ST-segment elevation myocar- dial infarction and multivessel disease (DANAMI-3–PRIMULTI): an open-label, randomised controlled trial. Lancet 2015; 386:665-71.
- Levine GN, Bates ER, Blankenship JC, et al. 2015 ACC/AHA/SCAI Focused Update on Primary Percutaneous Coronary Intervention for Patients With ST-Elevation Myocardial Infarction: An Update of the 2011 ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention and the 2013 ACCF/AHA Guideline for the Management of ST-Elevation Myocardial Infarction. J Am Coll Cardiol 2016;67:1235-50.
- Sachdev S, Tahir H, Awan GM, Omar B. Angioplasty Beginnings..40 Years Later. Cardiofel Newslet 2018 September;1(3):17-18.
- Stefanini G, Byrne R, Windecker S, et al. State of the Art: Coronary Artery Stents - Past, Present and Future EuroIntervention, 13 (6), 706-716.
- Bagur R, Jolly S . Dual Antiplatelet Therapy After Percutaneous Coronary Intervention. Circ Cardiovasc Interv, 11 (10).
- Bangalore S, Guo Y, Samadashvili Z, et al. Everolimus-eluting Stents or Bypass Surgery for Multivessel Coronary Disease. N Engl J Med, 372 (13), 1213-22.
- Cuisset T, Noc M. Multivessel PCI in STEMI: Ready to Be the Recommended Strategy? EuroIntervention, 10 Suppl T, T47-54.
Authors:
Sarina Sachdev, M.D.
Cardiology Fellow
University of South Alabama
Mobile, AL
Bassam Omar, M.D., Ph.D.
Professor of Cardiology
University of South Alabama
Mobile, AL