Author + information
- Received September 30, 2017
- Revision received November 20, 2017
- Accepted December 11, 2017
- Published online February 19, 2018.
- Joo Myung Lee, MD, MPH, PhDa,
- Tae-Min Rhee, MDa,b,
- Joo-Yong Hahn, MD, PhDa,∗ (, )
- Hyun Kuk Kim, MD, PhDc,
- Jonghanne Park, MD, PhDb,
- Doyeon Hwang, MDb,
- Ki Hong Choi, MDa,
- Jihoon Kim, MDa,
- Taek Kyu Park, MDa,
- Jeong Hoon Yang, MD, PhDa,
- Young Bin Song, MD, PhDa,
- Jin-Ho Choi, MD, PhDa,
- Seung-Hyuk Choi, MD, PhDa,
- Bon-Kwon Koo, MD, PhDb,
- Young Jo Kim, MD, PhDd,
- Shung Chull Chae, MD, PhDe,
- Myeong Chan Cho, MD, PhDf,
- Chong Jin Kim, MD, PhDg,
- Hyeon-Cheol Gwon, MD, PhDa,
- Ju Han Kim, MD, PhDh,
- Hyo-Soo Kim, MD, PhDb,
- Myung Ho Jeong, MD, PhDh,
- for the KAMIR Investigators
- aDivision of Cardiology, Department of Internal Medicine, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
- bDepartment of Internal Medicine and Cardiovascular Center, Seoul National University Hospital, Seoul, South Korea
- cDepartment of Internal Medicine and Cardiovascular Center, Chosun University Hospital, University of Chosun College of Medicine, Gwangju, South Korea
- dDepartment of Cardiology, Yeungnam University Medical Center, Daegu, South Korea
- eDepartment of Internal Medicine, Kyungpook National University Hospital, Daegu, South Korea
- fCardiology Division, Department of Internal Medicine, Chungbuk National University Hospital, Cheongju, South Korea
- gDepartment of Internal Medicine, Kyunghee University College of Medicine, Seoul, South Korea
- hDepartment of Internal Medicine and Heart Center, Chonnam National University Hospital, Gwangju, South Korea
- ↵∗Address for correspondence:
Dr. Joo-Yong Hahn, Heart Vascular Stroke Institute, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul 06351, Republic of Korea.
Background Recent trials demonstrated a benefit of multivessel percutaneous coronary intervention (PCI) for noninfarct-related artery (non-IRA) stenosis over IRA-only PCI in patients with ST-segment elevation myocardial infarction (STEMI) multivessel disease. However, evidence is limited in patients with cardiogenic shock.
Objectives This study investigated the prognostic impact of multivessel PCI in patients with STEMI multivessel disease presenting with cardiogenic shock, using the nationwide, multicenter, prospective KAMIR-NIH (Korea Acute Myocardial Infarction-National Institutes of Health) registry.
Methods Among 13,104 consecutive patients enrolled in the KAMIR-NIH registry, we selected patients with STEMI with multivessel disease presenting with cardiogenic shock and who underwent primary PCI. Primary outcome was 1-year all-cause death, and secondary outcomes included patient-oriented composite outcome (a composite of all-cause death, any myocardial infarction, and any repeat revascularization) and its individual components.
Results A total of 659 patients were treated by multivessel PCI (n = 260) or IRA-only PCI (n = 399) strategy. The risk of all-cause death and non-IRA repeat revascularization was significantly lower in the multivessel PCI group than in the IRA-only PCI group (21.3% vs. 31.7%; hazard ratio: 0.59; 95% confidence interval: 0.43 to 0.82; p = 0.001; and 6.7% vs. 8.2%; hazard ratio: 0.39; 95% confidence interval: 0.17 to 0.90; p = 0.028, respectively). Results were consistent after multivariable regression, propensity-score matching, and inverse probability weighting to adjust for baseline differences. In a multivariable model, multivessel PCI was independently associated with reduced risk of 1-year all-cause death and patient-oriented composite outcome.
Conclusions Of patients with STEMI and multivessel disease with cardiogenic shock, multivessel PCI was associated with a significantly lower risk of all-cause death and non-IRA repeat revascularization. Our data suggest that multivessel PCI for complete revascularization is a reasonable strategy to improve outcomes in patients with STEMI with cardiogenic shock.
- cardiogenic shock
- complete revascularization
- multivessel disease
- percutaneous coronary intervention
- ST-segment elevation myocardial infarction
For ST-segment elevation myocardial infarction (STEMI), primary percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation is a standard treatment strategy. Nearly one-half of patients with STEMI have concomitant stenosis in a noninfarct-related artery (IRA), and those patients have been well known to show worse prognosis than those without non-IRA stenosis (1). Nevertheless, routine multivessel PCI for non-IRA stenosis in patients with STEMI was once considered inappropriate (2). However, in recently published randomized trials, patients with STEMI who underwent multivessel PCI showed significantly better outcomes compared with IRA-only PCI (3–6). Based on these results, the latest European guideline gives multivessel PCI a Class IIa recommendation (7).
Among patients with STEMI, 5% to 10% of patients present with cardiogenic shock and have higher in-hospital mortality than patients without cardiogenic shock (8). Although the guideline emphasizes the importance of complete revascularization in patients with STEMI with cardiogenic shock (7), supporting evidence has been scarce, and the recommendation was mainly based on expert consensus and pathophysiological considerations (9). Indeed, patients with cardiogenic shock were excluded in all randomized trials reported to date (3–6). Although a few previous observational studies compared clinical outcomes between multivessel PCI and IRA-only PCI in STEMI multivessel disease with cardiogenic shock, the results were inconclusive (10–14), mainly due to insufficient sample size and the effect of measured or unmeasured confounders, which were not sufficiently adjusted. Currently, additional evidence based on contemporary practice is needed to inform the treatment strategy for patients with STEMI multivessel disease presenting with cardiogenic shock.
Therefore, we sought to compare clinical outcomes between multivessel PCI and IRA-only PCI in patients with STEMI who had multivessel disease accompanied by cardiogenic shock using a large-scale, nationwide, multicenter, dedicated registry for acute myocardial infarction (AMI).
Study protocols and population selection
The study population was derived from the nationwide, multicenter, prospective KAMIR-NIH (Korean Acute Myocardial Infarction-National Institutes of Health) registry. KAMIR-NIH is a dedicated prospective registry that consecutively enrolled AMI-diagnosed patients at 20 tertiary university hospitals who were eligible for primary PCI from November 2011 to December 2015 without any exclusion criteria. The detailed study protocols were previously published (15). The protocol of the KAMIR-NIH registry was approved by the ethics committee at each participating center and was conducted according to the principles of the Declaration of Helsinki. All patients provided written informed consent upon enrollment.
Among a total of 13,104 patients enrolled in the KAMIR-NIH registry, we selected patients with STEMI with multivessel disease who also presented with cardiogenic shock and underwent primary PCI. STEMI was defined as new ST-segment elevation in ≥2 contiguous leads measuring ≥0.1 mV, or a new left bundle branch block on 12-lead ECG, with a concomitant increase of at least 1 cardiac biochemical marker of necrosis (13,15). The presence of multivessel disease was defined as having additional ≥50% diameter stenosis in at least 1 major non-IRA or in the left main coronary artery, as with the previous trials (3–6). Cardiogenic shock was defined as systolic blood pressure <90 mm Hg for >30 min or the need for supportive management to maintain systolic blood pressure >90 mm Hg; clinical signs of pulmonary congestion; and evidence of impaired end-organ perfusion with at least 1 of the following: cool extremities, decreased urine output, increased lactic acid level, or altered mental status (16). Patients were excluded from analysis if they were diagnosed as non-STEMI, arrived >12 h after symptom onset, did not present with cardiogenic shock, underwent thrombolysis before PCI, had single-vessel disease, underwent suboptimal or failed PCI for IRA, or were lost to follow-up before 1 year. As a result, 659 patients were selected for this analysis. Timeframe of the selected patients was the same as the original population. Among these, patients were classified according to treatment strategy (i.e., multivessel PCI or IRA-only PCI) (Figure 1). Patients who underwent non-IRA PCI at the time of primary PCI or within index hospitalization were included in the multivessel PCI group.
Patient management, data collection, and follow-up
Patient management was performed according to current standard guidelines. The choice of treatment strategy; type, diameter, and length of stents; and the use of medications, intravascular imaging devices, thrombus aspiration, or hemodynamic support devices were left to the operator’s discretion. PCI was considered successful if the final residual stenosis was <30% with Thrombolysis In Myocardial Infarction grade 3 flow. Unless there was an undisputed reason for discontinuing dual-antiplatelet therapy, all patients were recommended to take aspirin indefinitely plus clopidogrel or other potent antiplatelet agents, such as prasugrel or ticagrelor, for ≥1 year. Choice of prescribed P2Y12 inhibitor was left to operator’s discretion in accordance with the guidelines and patient bleeding risk. Medications including renin-angiotensin-aldosterone system blockades, beta-blockers, and statins were also prescribed according to practice guidelines.
Demographic features and cardiovascular risk factors were collected by detailed patient interview. During hospitalization, findings of coronary angiography and detailed procedural characteristics of PCI as well as information on the discharge medications were collected. After discharge, patients were followed at 6 and 12 months by the attending physician. If patients did not visit on the day of scheduled follow-up, the outcome data were assessed by telephone interview. All data were collected by independent clinical research coordinators, using a web-based case report form in the Internet-based Clinical Research and Trial management system (iCReaT), a data management system established by the Centers for Disease Control and Prevention, Ministry of Health and Welfare, Republic of Korea (iCReaT Study No. C110016). Clinical events that occurred within 1-year follow-up were analyzed.
The primary outcome was all-cause death, and the key secondary outcome was patient-oriented composite outcome (POCO) (a composite of all-cause mortality, any myocardial infarction [MI], or any repeat revascularization) at 1 year. Other secondary outcomes were the individual components of POCO, non-IRA repeat revascularization, new renal replacement therapy (RRT), and definite or probable stent thrombosis at 1 year, according to the Academic Research Consortium definitions. Clinical outcomes at 30 days were also compared between the 2 groups. All deaths were considered cardiac unless an undisputed noncardiac cause was present. Recurrent MI was defined as the recurrence of symptoms or the presence of electrocardiographic changes in association with a rise in cardiac biomarker levels above the upper limit of normal, and periprocedural MI was not included as a clinical outcome. Clinically driven revascularization that occurred after discharge from the index hospitalization was coded as a repeat revascularization event, according to the Academic Research Consortium definitions.
An extended description of the statistical analysis is presented in the Online Appendix. Cumulative event rates were calculated based on Kaplan-Meier censoring estimates, and comparison of clinical outcomes between the multivessel PCI and IRA-only PCI groups was performed with the log-rank test. Because differences in baseline characteristics could significantly affect outcomes, sensitivity analyses were performed to adjust for confounders as much as possible.
First, a multivariable Cox regression model was used. Covariates in the multivariable model were selected if they were significantly different between the 2 groups or had predictive values (Online Appendix). The assumption of proportionality was assessed graphically by the log-minus-log plot, and Cox proportional hazard models for all clinical outcomes satisfied the proportional hazards assumption.
Second, the Cox proportional hazard regression in a propensity-score matched cohort and inverse-probability weighted (IPW) Cox proportional hazard regression were performed. Propensity score matching yielded 233 patients in the multivessel PCI group and 233 control subjects in the IRA-only PCI group. For the IPW adjustment, the inverse of propensity score was adjusted by the proportional hazard regression model. Balance between the 2 groups after propensity-score matching or IPW adjustment was assessed by calculating percent standardized mean differences. Percent standardized mean differences after propensity-score matching or IPW adjustment were within ±10% across all matched covariates, demonstrating successful balance achievement between comparative groups (Online Table 1).
Third, because the previously mentioned analyses can only adjust the effect of measured confounders between comparative groups, we performed Bayesian modeling, with internal validation data as an additional sensitivity analysis, to assess the effect of unmeasured confounders on the summary estimates (17). By combining internal validation and main study data, the Bayesian estimators were adjusted for the unmeasured confounding, as previously described (17). The hazard ratios (HRs) and 95% credible intervals were calculated with Cox regression through Bayesian analysis. Credible intervals of the HRs that did not include 1 were considered significant.
To identify independent predictors of all-cause death and POCO, we used a multivariable Cox proportional hazard model. C-statistics with 95% confidence intervals (CIs) were calculated to validate the discriminant function of the model. In addition, comparisons of the primary outcome between multivessel PCI and IRA-only PCI groups according to the exploratory subgroups of interest were followed, and the interaction between treatment effect and these covariates was assessed with a Cox regression model. In all analyses, the participating centers were included as random effects. All probability values were 2-sided, and p values <0.05 were considered statistically significant.
Baseline clinical, lesion, and procedural characteristics are summarized in Tables 1 and 2⇓⇓. Among the total population, 260 patients underwent multivessel PCI and 399 underwent IRA-only PCI. A total of 35.8% of patients presented with cardiac arrest, 41.0% had diabetes mellitus, and 37.0% had chronic kidney disease. Median door-to-balloon time was 62.0 min (quartile 1 to 3: 48.0 to 82.0 min). Regarding lesion profiles, 9.4% of culprit vessels were located in the left main artery, and proportions of type B2/C, small-vessel, and long lesions were 90.3%, 25.5%, and 43.1%, respectively. During the procedure, glycoprotein IIb/IIIa inhibitor was used in 23.4%, and thrombus aspiration occurred in 31.5% of patients. Most of the implanted stents were second-generation DES for both culprit and nonculprit vessels (87.6% and 84.2%, respectively), and 26.7% of patients required hemodynamic support device use. A mean of 2.24 stents were implanted in the multivessel PCI group, and 1.10 in the IRA-only PCI group. Among the 260 patients in the multivessel PCI group, 157 patients (60.4%) underwent immediate non-IRA PCI, and 103 patients (39.6%) underwent staged non-IRA PCI during the same hospitalization. Based on angiographic assessment, 65.8% of multivessel PCI was classified as complete revascularization without residual stenosis, and the remaining 34.2% was classified as incomplete revascularization (Table 2). The median follow-up duration was 359.0 days (quartile 1 to 3: 171.0 to 383.0 days).
Clinical outcomes according to treatment strategy
A comparison of clinical outcomes between the multivessel PCI and IRA-only PCI groups is presented in Table 3 and Figure 2. The risk of all-cause death was significantly lower in the multivessel PCI group than in the IRA-only PCI group (21.3% vs. 31.7%; HR: 0.59; 95% CI: 0.43 to 0.82; p = 0.001) (Figure 2). The risk of POCO was also significantly lower in the multivessel PCI group than in the IRA-only PCI group, mainly driven by significantly lower risk of all-cause death and non-IRA repeat revascularization in the multivessel PCI group (Figures 2 and 3). Clinical outcomes at 30 days also showed a significantly lower risk of all-cause death or POCO in the multivessel PCI group compared with the IRA-only PCI group (Online Table 2).
Sensitivity analyses using multivariable Cox regression, propensity-score matching, and IPW adjustment consistently showed significantly lower risks of all-cause death, POCO, and non-IRA repeat revascularization in the multivessel PCI group compared with the IRA-only PCI group (Table 3). The Bayesian proportional hazards modeling for unmeasured confounders was followed, which demonstrated the same trends as in the original analysis (Online Table 3).
Regarding periprocedural safety outcomes, the overall incidence of new RRT incidence at 30 days was 3.3%, and there was no significant difference between the multivessel PCI and IRA-only PCI groups (3.5% vs. 3.3%; p = 0.887). Similarly, the incidence of new RRT at 1 year also did not differ between the 2 groups (6.5% vs. 7.0%; p = 0.812) (Table 2). When comparing a composite outcome of all-cause death or new RRT, the multivessel PCI group showed significantly lower event rates compared with the IRA-only PCI group, mainly driven by significantly lower rates of all-cause death in the multivessel PCI group at both 30 days and 1 year (Online Figure 1).
When comparing 1-year clinical outcomes among IRA-only PCI, incomplete multivessel PCI, and complete multivessel PCI, only complete multivessel PCI showed a significantly lower risk of all-cause mortality and POCO compared with IRA-only PCI (Online Table 4, Online Figure 2).
Independent predictors of composite outcomes
Multivariable Cox proportional hazard models identified independent predictors of the primary and key secondary outcomes (Online Table 5). Multivessel PCI was independently associated with a decreased risk of all-cause death (HR: 0.524; 95% CI: 0.375 to 0.732; p < 0.001) and POCO (HR: 0.578; 95% CI: 0.404 to 0.828; p = 0.003) at 1 year.
Figure 4 presents the prognostic impact of multivessel PCI among the various subgroups. The significantly lower risk of all-cause death in the multivessel PCI group than in the IRA-only PCI group was consistent across all subgroups without significant interaction p values.
In the present study, we compared 1-year clinical outcomes between multivessel PCI versus IRA-only PCI in patients with STEMI who had multivessel disease and were accompanied by cardiogenic shock using data from a nationwide, multicenter, prospective AMI registry. The main findings were as follows (Central Illustration). First, multivessel PCI showed a significantly lower risk of all-cause death than an IRA-only PCI strategy, which was consistently observed after thorough sensitivity analyses for adjustment of baseline differences. Second, multivessel PCI also showed a significantly lower risk of POCO and non-IRA repeat revascularization. Third, in the multivariable Cox proportional hazard model, a multivessel PCI strategy was independently associated with a decreased risk of all-cause death and POCO. Fourth, the significantly lower risk of all-cause death in the multivessel PCI group compared with the IRA-only PCI group was consistently observed in various subgroups without significant interaction p values.
Limited evidence regarding complete revascularization for patients with STEMI multivessel disease with cardiogenic shock
Multivessel disease is commonly observed in patients with STEMI and adversely affects clinical outcomes, including mortality (1). Nevertheless, the recommendation for non-IRA PCI has been controversial, and earlier guidelines did not support routine multivessel PCI for non-IRA stenosis in these patients (2,18) due to possible additional risks associated with non-IRA PCI, such as procedure-related complications, contrast-induced nephropathy, and the possibility of stent thrombosis. The previous recommendation was primarily based on the results of observational studies and a meta-analysis, which reported significantly worse clinical outcomes following multivessel PCI compared with IRA-only PCI (10,19). Afterward, a series of randomized trials, PRAMI (Preventative Angioplasty in Acute Myocardial Infarction) (3), CvLPRIT (Complete versus Lesion-only Primary PCI Trial) (4), and DANAMI-3-PRIMULTI (The Third DANish Study of Optimal Acute Treatment of Patients with ST-segment Elevation Myocardial Infarction: Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease) (5) reported the benefit of multivessel PCI over IRA-only PCI. With these results, in the 2015 American College of Cardiology Foundation/American Heart Association/Society for Cardiovascular Angiography and Interventions focused update, multivessel PCI received a Class IIb recommendation, but was limited to hemodynamically stable patients (20). In the 2017 European Society of Cardiology guidelines for STEMI, which included the results of the most recent COMPARE-ACUTE (Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD) trial (6), multivessel PCI was upgraded to a Class IIa recommendation (7). Unlike patients with STEMI without cardiogenic shock, both guidelines have recommended multivessel PCI in patients with cardiogenic shock. However, supporting evidence has been limited, and recommendations were largely based on expert consensus and theoretical consideration of physiological benefit on myocardial perfusion and recovery.
As the incidence of multivessel disease in patients with STEMI with cardiogenic shock is higher than those without, additional evidence is needed regarding treatment strategy for non-IRA PCI in these high-risk patients (1). Nevertheless, all previous randomized trials excluded patients with cardiogenic shock (3–6), and there have been a few observational studies with inconclusive results. Most of the previous observational studies reported similar or even significantly higher mortality in multivessel PCI than in IRA-only PCI in patients with STEMI multivessel disease with cardiogenic shock (10–14,21). However, these results should be interpreted with caution, due to insufficient study populations, various study protocols, and the effect of confounding variables. Furthermore, most previous studies reported only in-hospital outcomes (10,11,14), and used bare-metal stents (10,11,14) or first-generation DES (12,13,21), which have been withdrawn from the market. Furthermore, because the use of potent antiplatelet agents or hemodynamic support devices had not been established in their study period, the results of the previously mentioned observational studies were not likely to reflect contemporary practice. In this regard, our study has several strengths, such as a sufficiently large number of patients among studies on this topic, clinical outcome data after discharge up to 1 year, widespread use of second-generation DES, invasive hemodynamic support devices, and secondary prevention with standard medical therapy.
Benefit of multivessel PCI strategy for patients with STEMI with cardiogenic shock
Theoretically, achieving complete revascularization through non-IRA PCI may not only lower the risk of further repeat revascularization, but also improve clinical outcomes by assisting the recovery of myocardial perfusion, and these potential benefits would be more prominent in patients with cardiogenic shock (4,22). Non-IRA revascularization has been reported to improve LV function through recovering flow into the hibernating myocardium (22). It might also promote myocardial salvage by increasing blood flow to the watershed area (4). Although previous trials that compared multivessel PCI for non-IRA stenosis and IRA-only PCI showed consistent benefit of multivessel PCI over IRA-only PCI, their results could not be extended to patients with cardiogenic shock (3–6).
The current study exclusively evaluated patients with cardiogenic shock. Although previous observational studies showed heterogeneous and inconclusive results, the current study showed significantly lower risk of all-cause death as well as non-IRA repeat revascularization in the multivessel PCI group compared with the IRA-only PCI group. In the survival curve, the cumulative incidence of all-cause death showed a tendency to separate from a very early timepoint (about <1 month). This result supports the importance of relieving potential myocardial ischemia in the non-IRA in cardiogenic shock patients, as supported by previous studies (4,22). In addition, it should be also noted that this finding was consistent, even with the multiple sensitivity analyses, including Bayesian modeling to minimize the effects of unmeasured confounders. As real-world data reflecting contemporary practice, the results of this study support the current guideline recommendations (2,7).
Areas of uncertainty that need future clarification
Considering the high mortality and socioeconomic burden of STEMI multivessel disease and cardiogenic shock patients and the lack of dedicated randomized trials for these patients, future trials are definitely required for more robust evidence. Recently, the CULPRIT-SHOCK (Culprit Lesion Only PCI Versus Multivessel PCI in Cardiogenic Shock) trial reported 30-day clinical outcomes of 685 patients with STEMI with multivessel disease and cardiogenic shock who were randomly allocated into an angiography-guided immediate multivessel PCI or IRA-only PCI group (23,24). The primary endpoint was a composite of all-cause death or new RRT within 30 days after randomization. At 30 days, the multivessel PCI group showed significantly higher risk of primary endpoint as well as all-cause death alone compared with the IRA-only PCI group, without any difference in the rates of new RRT between the 2 groups.
Although differences in study population and study design preclude a direct comparison of the results, differences between the CULPRIT-SHOCK trial and the current study, derived from the nationwide multicenter dedicated registry for AMI, might be interpreted in the following context. First, the overall incidence of all-cause death at 30 days was much higher in the CULPRIT-SHOCK trial than in the current study (47.4% vs. 21.9%). However, the use of mechanical support was similar between the 2 studies (28.2% vs. 26.7%). Second, in the CULPRIT-SHOCK trial, in the IRA-only PCI group, 12.5% (43 of 344 patients) underwent immediate multivessel revascularization and 17.7% (61 of 344 patients) underwent staged multivessel revascularization. Overall, 30.2% of the IRA-only PCI group (104 of 344 patients) was actually treated by multivessel PCI. In addition, 9.4% of the multivessel PCI group (32 of 342 patients) was revascularized for the IRA only. Third, 82 patients with chronic total occlusion in the multivessel PCI group (24.0% of population) underwent an immediate attempt for chronic total occlusion revascularization, which might deviate from real-world practice for patients with STEMI with cardiogenic shock. The discrepancy between the 2 studies should be further clarified and validated in future trials.
In addition, there are other aspects related to this patient subgroup that warrant future research. First, the threshold or criteria to justify non-IRA stenosis should be clarified. The PRAMI and CvLPRIT trials adopted an angiographic percent diameter stenosis >50% as the revascularization threshold (3,4), and the DANAMI-3-PRIMULTI and COMPARE-ACUTE trials adopted a fractional flow reserve–guided decision, using a current cut-off value of ≤0.80 (5,6). The CULPRIT-SHOCK trial used 70% diameter stenosis as the treatment threshold (24). Given these heterogeneous criteria, the optimal treatment threshold should be better clarified. Second, the optimal timing of non-IRA revascularization also needs better clarification. Although recent meta-analysis showed the benefit of staged over immediate non-IRA revascularization (25), there was no randomized trial for this comparison. More than two-thirds of the population in the meta-analysis were derived from retrospective analysis, while the rest of the population was derived from observational studies with individual sample size <100 patients. Therefore, the potential benefit and risk of immediate non-IRA revascularization, especially in cardiogenic shock patients, need more clarification.
First, this study has an innate limitation regarding its observational nature with registry data. Using physician discretion to determine treatment strategy inevitably introduces the possibility of selection bias. However, with the extensive sensitivity analyses, the measured or unmeasured confounders were adjusted to minimize the bias from different baseline characteristics. Second, we assessed lesion severity of the non-IRA by angiographic assessment alone. As shown in the DANAMI-3-PRIMULTI and COMPARE-ACUTE trials, nearly one-half of visually significant non-IRA lesions were physiologically insignificant, with FFR values >0.80 (5,6). However, in the setting of cardiogenic shock, the clinical relevance of FFR has never been validated. Third, although data regarding whether non-IRA PCI was performed immediately or in a staged manner were systematically collected, information regarding the mean duration of staged multivessel PCI was not available. However, all staged non-IRA PCI procedures were performed within index hospitalization. Fourth, for clinical outcomes determined by completeness of revascularization, the decision regarding the revascularization timing, extent, and completeness were left to the operator’s discretion. Fifth, incidence of hospitalization due to heart failure or recovery of LV function were not collected as pre-specified outcomes. Moreover, procedure-related risks, such as procedure time, total radiation dose, amount of contrast dye used, and occurrence of contrast-induced nephropathy, other than new RRT, were not evaluated. Last, the information and number of patients with individual components used to define cardiogenic shock were not available. However, the KAMIR-NIH registry used standardized definitions for all of the collected variables, which were regulated and monitored by the National Institutes of Health.
Multivessel revascularization for non-IRA stenosis in patients with STEMI multivessel disease with cardiogenic shock showed a significantly lower risk of all-cause death, compared with IRA-only PCI at 1 year. As real-world data reflecting contemporary practice, the results of this study might support the current recommendation of the guidelines.
COMPETENCY IN PATIENT CARE AND PROCEDURAL SKILLS: In a registry of patients with STEMI and multivessel coronary disease complicated by cardiogenic shock, complete percutaneous revascularization was associated with lower all-cause mortality at 1 year than intervention limited to the IRA.
TRANSLATIONAL OUTLOOK: Randomized trials are needed to compare the strategies of multivessel revascularization at the time of primary PCI or staged procedures versus intervention limited to the IRA for patients with STEMI and cardiogenic shock, to complement the available data on revascularization for those without shock.
This research was supported by a fund by Research of Korea Centers for Disease Control and Prevention (2016-ER6304-01). The authors have reported that they have no relationships relevant to the contents of this paper to disclose. Drs. Lee and Rhee contributed equally to this work.
- Abbreviations and Acronyms
- acute myocardial infarction
- drug-eluting stent(s)
- inverse probability weighted
- infarct-related artery
- myocardial infarction
- percutaneous coronary intervention
- patient-oriented composite outcome
- ST-segment elevation myocardial infarction
- Received September 30, 2017.
- Revision received November 20, 2017.
- Accepted December 11, 2017.
- 2018 American College of Cardiology Foundation
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