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Nonculprit Lesion PCI Strategies in Patients With STEMI Without Cardiogenic Shock
Study Overview
Objective. To determine whether percutaneous coronary intervention (PCI) of a nonculprit lesion in patients with ST-segment elevation myocardial infarction (STEMI) reduces the risk of cardiovascular death or myocardial infarction.
Design. International, multicenter, randomized controlled trial blinded to outcome.
Setting and participants. Patients with STEMI who had multivessel coronary disease and had undergone successful PCI to the culprit lesion.
Intervention. A total of 4041 patients were randomly assigned to either PCI of angiographically significant nonculprit lesions or optimal medical therapy without further revascularization. Randomization was stratified according to intended timing of nonculprit lesion PCI (either during or after the index hospitalization).
Main outcome measures. The first co-primary endpoint was the composite of cardiovascular death or myocardial infarction (MI). The second co-primary endpoint was the composite of cardiovascular death, MI or ischemia-driven revascularization.
Main results. At a median follow-up of 3 years, the composite of cardiovascular death or MI occurred in 158 of the 2016 patients (7.8%) in the nonculprit PCI group and in 213 of the 2025 patients (10.5%) in the culprit-lesion-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.60-0.91; P = 0.004). The second co-primary endpoint occurred in 179 patients (8.9%) in the nonculprit PCI group and in 339 patients (16.7%) in the culprit-lesion-only group (hazard ratio, 0.51; 95% CI, 0.43-0.61; P < 0.001).
Conclusion. Among patients with STEMI and multivessel disease, those who underwent complete revascularization with nonculprit lesion PCI had lower rates of cardiovascular death or MI compared to patients with culprit-lesion-only revascularization.
Commentary
Patients presenting with STEMI often have multivessel disease.1 Although it is known that mortality can be reduced by early revascularization of the culprit vessel,2 whether the nonculprit vessel should be revascularized at the time of presentation with STEMI remains controversial.
Recently, multiple studies have reported the benefit of nonculprit vessel revascularization in patients presenting with hemodynamically stable STEMI. Four trials (PRAMI, CvPRIT, DANAMI-PRIMULTI, and COMPARE ACUTE) investigated this clinical question with different designs, and all reported benefit of nonculprit vessel revascularization compared to a culprit-only strategy.3-6 However, the differences in the composite endpoints were mainly driven by the softer endpoints used in these trials, such as refractory angina and ischemia-driven revascularization, and none of these previous trials had adequate power to evaluate differences in hard outcomes, such as death or MI.
In this context, Mehta et al investigated whether achieving complete revascularization by performing PCI on nonculprit vessels would improve the composite of cardiovascular death or MI compared to the culprit-only strategy by conducting a well-designed randomized controlled study. At median follow-up of 3 years, patients who underwent nonculprit vessel PCI had a lower incidence of death or MI compared to those who received the culprit-only strategy (7.8% versus 10.5%). The second co-primary endpoint (composite of death, MI, or ischemia-driven revascularization) also occurred significantly less frequently in the nonculprit PCI group than in the culprit-only PCI group (8.9% versus 16.7%).
The current study has a number of strengths. First, this was a multicenter, international study, and a large number of patients were enrolled (> 4000), achieving adequate power to evaluate for the composite of death and MI. Second, the treatments the patients received reflect contemporary medical therapy and interventional practice: the third-generation thienopyridine ticagrelor, high-dose statins, and ACE inhibitors were prescribed at high rates, and radial access (> 80%) and current-generation drug-eluting stents were used at high rates as well. Third, all angiograms were reviewed by the core lab to evaluate for completeness of revascularization. Fourth, the trial mandated use of fractional flow reserve to assess lesion stenosis 50% to 69% before considering revascularization, ensuring that only ischemic or very-high-grade lesions were revascularized. Fifth, the crossover rate in each group was low compared to the previous studies (4.7% into the complete revascularization group, 3.9% into the lesion-only group). Finally, this study evaluated the timing of the nonculprit PCI. Randomization to each group was stratified according to the intended timing of the nonculprit PCI during the index hospitalization or after hospital discharge (within 45 days). They found that benefit was consistent regardless of when the nonculprit PCI was performed.
Although the COMPLETE study’s design has a number of strengths, it is important to note that patients enrolled in this trial represent a lower-risk STEMI population. Patients with complex anatomy likely were not included, as evidenced by a lower SYNTAX score (mean, 16). Furthermore, no patients who presented with STEMI complicated by cardiogenic shock were enrolled. In the recent CULPRIT SHOCK trial, which focused on patients who had multivessel disease, acute MI, and cardiogenic shock, patients who underwent the culprit-only strategy had a lower rate of death or renal replacement therapy, as compared to patients who underwent immediate complete revascularization.7 Therefore, whether the findings from the COMPLETE study can be extended to a sicker population requires further study.
In 2015, the results from the previous trials, such as PRAMI and CvPRIT, led to a focused update of US PCI guidelines.8 Recommendations for noninfarct-related artery PCI in hemodynamically stable patients presenting with acute MI were upgraded from class III to class IIb. The results from the COMPLETE trial will likely influence the future guidelines, with stronger recommendations toward complete revascularization in patients presenting with hemodynamically stable STEMI.
Applications for Clinical Practice
In patients presenting with hemodynamically stable STEMI, staged complete revascularization, including the nonculprit vessel, should be considered.
– Taishi Hirai, MD, University of Missouri, Columbia, MO, and John EA Blair, MD, University of Chicago Medical Center, Chicago, IL
1. Park DW, Clare RM, Schulte PJ, et al. Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST-elevation myocardial infarction. JAMA. 2014;312:2019-2027.
2. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999;341:625-634.
3. Wald DS, Morris JK, Wald NJ, et al. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013;369:1115-1123.
4. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963-972.
5. Engstrom T, Kelbaek H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386:665-671.
6. Smits PC, Abdel-Wahab M, Neumann FJ, et al. Fractional flow reserve-guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234-1244.
7. Thiele H, Akin I, Sandri M, et al. PCI strategies in patients with acute myocardial infarction and cardiogenic shock. N Engl J Med. 2017;377:2419-2432.
8. 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;67:1235-1250.
Study Overview
Objective. To determine whether percutaneous coronary intervention (PCI) of a nonculprit lesion in patients with ST-segment elevation myocardial infarction (STEMI) reduces the risk of cardiovascular death or myocardial infarction.
Design. International, multicenter, randomized controlled trial blinded to outcome.
Setting and participants. Patients with STEMI who had multivessel coronary disease and had undergone successful PCI to the culprit lesion.
Intervention. A total of 4041 patients were randomly assigned to either PCI of angiographically significant nonculprit lesions or optimal medical therapy without further revascularization. Randomization was stratified according to intended timing of nonculprit lesion PCI (either during or after the index hospitalization).
Main outcome measures. The first co-primary endpoint was the composite of cardiovascular death or myocardial infarction (MI). The second co-primary endpoint was the composite of cardiovascular death, MI or ischemia-driven revascularization.
Main results. At a median follow-up of 3 years, the composite of cardiovascular death or MI occurred in 158 of the 2016 patients (7.8%) in the nonculprit PCI group and in 213 of the 2025 patients (10.5%) in the culprit-lesion-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.60-0.91; P = 0.004). The second co-primary endpoint occurred in 179 patients (8.9%) in the nonculprit PCI group and in 339 patients (16.7%) in the culprit-lesion-only group (hazard ratio, 0.51; 95% CI, 0.43-0.61; P < 0.001).
Conclusion. Among patients with STEMI and multivessel disease, those who underwent complete revascularization with nonculprit lesion PCI had lower rates of cardiovascular death or MI compared to patients with culprit-lesion-only revascularization.
Commentary
Patients presenting with STEMI often have multivessel disease.1 Although it is known that mortality can be reduced by early revascularization of the culprit vessel,2 whether the nonculprit vessel should be revascularized at the time of presentation with STEMI remains controversial.
Recently, multiple studies have reported the benefit of nonculprit vessel revascularization in patients presenting with hemodynamically stable STEMI. Four trials (PRAMI, CvPRIT, DANAMI-PRIMULTI, and COMPARE ACUTE) investigated this clinical question with different designs, and all reported benefit of nonculprit vessel revascularization compared to a culprit-only strategy.3-6 However, the differences in the composite endpoints were mainly driven by the softer endpoints used in these trials, such as refractory angina and ischemia-driven revascularization, and none of these previous trials had adequate power to evaluate differences in hard outcomes, such as death or MI.
In this context, Mehta et al investigated whether achieving complete revascularization by performing PCI on nonculprit vessels would improve the composite of cardiovascular death or MI compared to the culprit-only strategy by conducting a well-designed randomized controlled study. At median follow-up of 3 years, patients who underwent nonculprit vessel PCI had a lower incidence of death or MI compared to those who received the culprit-only strategy (7.8% versus 10.5%). The second co-primary endpoint (composite of death, MI, or ischemia-driven revascularization) also occurred significantly less frequently in the nonculprit PCI group than in the culprit-only PCI group (8.9% versus 16.7%).
The current study has a number of strengths. First, this was a multicenter, international study, and a large number of patients were enrolled (> 4000), achieving adequate power to evaluate for the composite of death and MI. Second, the treatments the patients received reflect contemporary medical therapy and interventional practice: the third-generation thienopyridine ticagrelor, high-dose statins, and ACE inhibitors were prescribed at high rates, and radial access (> 80%) and current-generation drug-eluting stents were used at high rates as well. Third, all angiograms were reviewed by the core lab to evaluate for completeness of revascularization. Fourth, the trial mandated use of fractional flow reserve to assess lesion stenosis 50% to 69% before considering revascularization, ensuring that only ischemic or very-high-grade lesions were revascularized. Fifth, the crossover rate in each group was low compared to the previous studies (4.7% into the complete revascularization group, 3.9% into the lesion-only group). Finally, this study evaluated the timing of the nonculprit PCI. Randomization to each group was stratified according to the intended timing of the nonculprit PCI during the index hospitalization or after hospital discharge (within 45 days). They found that benefit was consistent regardless of when the nonculprit PCI was performed.
Although the COMPLETE study’s design has a number of strengths, it is important to note that patients enrolled in this trial represent a lower-risk STEMI population. Patients with complex anatomy likely were not included, as evidenced by a lower SYNTAX score (mean, 16). Furthermore, no patients who presented with STEMI complicated by cardiogenic shock were enrolled. In the recent CULPRIT SHOCK trial, which focused on patients who had multivessel disease, acute MI, and cardiogenic shock, patients who underwent the culprit-only strategy had a lower rate of death or renal replacement therapy, as compared to patients who underwent immediate complete revascularization.7 Therefore, whether the findings from the COMPLETE study can be extended to a sicker population requires further study.
In 2015, the results from the previous trials, such as PRAMI and CvPRIT, led to a focused update of US PCI guidelines.8 Recommendations for noninfarct-related artery PCI in hemodynamically stable patients presenting with acute MI were upgraded from class III to class IIb. The results from the COMPLETE trial will likely influence the future guidelines, with stronger recommendations toward complete revascularization in patients presenting with hemodynamically stable STEMI.
Applications for Clinical Practice
In patients presenting with hemodynamically stable STEMI, staged complete revascularization, including the nonculprit vessel, should be considered.
– Taishi Hirai, MD, University of Missouri, Columbia, MO, and John EA Blair, MD, University of Chicago Medical Center, Chicago, IL
Study Overview
Objective. To determine whether percutaneous coronary intervention (PCI) of a nonculprit lesion in patients with ST-segment elevation myocardial infarction (STEMI) reduces the risk of cardiovascular death or myocardial infarction.
Design. International, multicenter, randomized controlled trial blinded to outcome.
Setting and participants. Patients with STEMI who had multivessel coronary disease and had undergone successful PCI to the culprit lesion.
Intervention. A total of 4041 patients were randomly assigned to either PCI of angiographically significant nonculprit lesions or optimal medical therapy without further revascularization. Randomization was stratified according to intended timing of nonculprit lesion PCI (either during or after the index hospitalization).
Main outcome measures. The first co-primary endpoint was the composite of cardiovascular death or myocardial infarction (MI). The second co-primary endpoint was the composite of cardiovascular death, MI or ischemia-driven revascularization.
Main results. At a median follow-up of 3 years, the composite of cardiovascular death or MI occurred in 158 of the 2016 patients (7.8%) in the nonculprit PCI group and in 213 of the 2025 patients (10.5%) in the culprit-lesion-only group (hazard ratio, 0.73; 95% confidence interval [CI], 0.60-0.91; P = 0.004). The second co-primary endpoint occurred in 179 patients (8.9%) in the nonculprit PCI group and in 339 patients (16.7%) in the culprit-lesion-only group (hazard ratio, 0.51; 95% CI, 0.43-0.61; P < 0.001).
Conclusion. Among patients with STEMI and multivessel disease, those who underwent complete revascularization with nonculprit lesion PCI had lower rates of cardiovascular death or MI compared to patients with culprit-lesion-only revascularization.
Commentary
Patients presenting with STEMI often have multivessel disease.1 Although it is known that mortality can be reduced by early revascularization of the culprit vessel,2 whether the nonculprit vessel should be revascularized at the time of presentation with STEMI remains controversial.
Recently, multiple studies have reported the benefit of nonculprit vessel revascularization in patients presenting with hemodynamically stable STEMI. Four trials (PRAMI, CvPRIT, DANAMI-PRIMULTI, and COMPARE ACUTE) investigated this clinical question with different designs, and all reported benefit of nonculprit vessel revascularization compared to a culprit-only strategy.3-6 However, the differences in the composite endpoints were mainly driven by the softer endpoints used in these trials, such as refractory angina and ischemia-driven revascularization, and none of these previous trials had adequate power to evaluate differences in hard outcomes, such as death or MI.
In this context, Mehta et al investigated whether achieving complete revascularization by performing PCI on nonculprit vessels would improve the composite of cardiovascular death or MI compared to the culprit-only strategy by conducting a well-designed randomized controlled study. At median follow-up of 3 years, patients who underwent nonculprit vessel PCI had a lower incidence of death or MI compared to those who received the culprit-only strategy (7.8% versus 10.5%). The second co-primary endpoint (composite of death, MI, or ischemia-driven revascularization) also occurred significantly less frequently in the nonculprit PCI group than in the culprit-only PCI group (8.9% versus 16.7%).
The current study has a number of strengths. First, this was a multicenter, international study, and a large number of patients were enrolled (> 4000), achieving adequate power to evaluate for the composite of death and MI. Second, the treatments the patients received reflect contemporary medical therapy and interventional practice: the third-generation thienopyridine ticagrelor, high-dose statins, and ACE inhibitors were prescribed at high rates, and radial access (> 80%) and current-generation drug-eluting stents were used at high rates as well. Third, all angiograms were reviewed by the core lab to evaluate for completeness of revascularization. Fourth, the trial mandated use of fractional flow reserve to assess lesion stenosis 50% to 69% before considering revascularization, ensuring that only ischemic or very-high-grade lesions were revascularized. Fifth, the crossover rate in each group was low compared to the previous studies (4.7% into the complete revascularization group, 3.9% into the lesion-only group). Finally, this study evaluated the timing of the nonculprit PCI. Randomization to each group was stratified according to the intended timing of the nonculprit PCI during the index hospitalization or after hospital discharge (within 45 days). They found that benefit was consistent regardless of when the nonculprit PCI was performed.
Although the COMPLETE study’s design has a number of strengths, it is important to note that patients enrolled in this trial represent a lower-risk STEMI population. Patients with complex anatomy likely were not included, as evidenced by a lower SYNTAX score (mean, 16). Furthermore, no patients who presented with STEMI complicated by cardiogenic shock were enrolled. In the recent CULPRIT SHOCK trial, which focused on patients who had multivessel disease, acute MI, and cardiogenic shock, patients who underwent the culprit-only strategy had a lower rate of death or renal replacement therapy, as compared to patients who underwent immediate complete revascularization.7 Therefore, whether the findings from the COMPLETE study can be extended to a sicker population requires further study.
In 2015, the results from the previous trials, such as PRAMI and CvPRIT, led to a focused update of US PCI guidelines.8 Recommendations for noninfarct-related artery PCI in hemodynamically stable patients presenting with acute MI were upgraded from class III to class IIb. The results from the COMPLETE trial will likely influence the future guidelines, with stronger recommendations toward complete revascularization in patients presenting with hemodynamically stable STEMI.
Applications for Clinical Practice
In patients presenting with hemodynamically stable STEMI, staged complete revascularization, including the nonculprit vessel, should be considered.
– Taishi Hirai, MD, University of Missouri, Columbia, MO, and John EA Blair, MD, University of Chicago Medical Center, Chicago, IL
1. Park DW, Clare RM, Schulte PJ, et al. Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST-elevation myocardial infarction. JAMA. 2014;312:2019-2027.
2. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999;341:625-634.
3. Wald DS, Morris JK, Wald NJ, et al. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013;369:1115-1123.
4. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963-972.
5. Engstrom T, Kelbaek H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386:665-671.
6. Smits PC, Abdel-Wahab M, Neumann FJ, et al. Fractional flow reserve-guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234-1244.
7. Thiele H, Akin I, Sandri M, et al. PCI strategies in patients with acute myocardial infarction and cardiogenic shock. N Engl J Med. 2017;377:2419-2432.
8. 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;67:1235-1250.
1. Park DW, Clare RM, Schulte PJ, et al. Extent, location, and clinical significance of non-infarct-related coronary artery disease among patients with ST-elevation myocardial infarction. JAMA. 2014;312:2019-2027.
2. Hochman JS, Sleeper LA, Webb JG, et al. Early revascularization in acute myocardial infarction complicated by cardiogenic shock. SHOCK Investigators. Should We Emergently Revascularize Occluded Coronaries for Cardiogenic Shock. N Engl J Med. 1999;341:625-634.
3. Wald DS, Morris JK, Wald NJ, et al. Randomized trial of preventive angioplasty in myocardial infarction. N Engl J Med. 2013;369:1115-1123.
4. Gershlick AH, Khan JN, Kelly DJ, et al. Randomized trial of complete versus lesion-only revascularization in patients undergoing primary percutaneous coronary intervention for STEMI and multivessel disease: the CvLPRIT trial. J Am Coll Cardiol. 2015;65:963-972.
5. Engstrom T, Kelbaek H, Helqvist S, et al. Complete revascularisation versus treatment of the culprit lesion only in patients with ST-segment elevation myocardial infarction and multivessel disease (DANAMI-3-PRIMULTI): an open-label, randomised controlled trial. Lancet. 2015;386:665-671.
6. Smits PC, Abdel-Wahab M, Neumann FJ, et al. Fractional flow reserve-guided multivessel angioplasty in myocardial infarction. N Engl J Med. 2017;376:1234-1244.
7. Thiele H, Akin I, Sandri M, et al. PCI strategies in patients with acute myocardial infarction and cardiogenic shock. N Engl J Med. 2017;377:2419-2432.
8. 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;67:1235-1250.