|Year : 2018 | Volume
| Issue : 1 | Page : 12-17
Clinical effectiveness of complete revascularization versus infarct-related artery-only percutaneous coronary revascularization for multivessel disease ST-segment elevation myocardial infarction
Joshua Chadwick Jayaraj
Department of Internal Medicine, Yerevan Haybusak Medical University, Yerevan, Armenia
|Date of Web Publication||27-Apr-2018|
Joshua Chadwick Jayaraj
Yerevan Haybusak Medical University, 6, Abelian St., Yerevan 0038
Source of Support: None, Conflict of Interest: None
Objectives: The purpose of this study was to evaluate the event-free survival from major adverse cardiac events for ST-segment elevation myocardial infarction (STEMI) patients with multivessel disease (MVD) as a function of whether they underwent infarct-related artery (IRA)- only percutaneous coronary intervention (PCI) or complete revascularization at index admission.
Background: The optimal management of patients with STEMI and MVD while undergoing primary PCI (P-PCI) is uncertain.
Methods and Results: STEMI patients with MVD undergoing P-PCI between April 1, 2012, and March 31, 2014, were subdivided into those who underwent complete revascularization during index admission (n = 150) and IRA-only revascularization (n = 156). Complete revascularization was performed at index admission of P-PCI. The primary endpoint was a composite of all-cause death, recurrent MI, heart failure (HF), and ischemia-driven revascularization within 24 months. Patient groups were differed at baseline by gender and prevalence of HF. The average door-to-balloon time was significantly higher in the complete revascularization group. The primary endpoint occurred in 11.0% of the complete revascularization group versus in 23% of the IRA-only revascularization group (hazard ratio: 0.51; 95% confidence interval: 0.34–0.93; P = 0.039). There was a significant reduction in death; a nonsignificant reduction in all primary endpoint components was seen.
Conclusions: In patients presenting for P-PCI with MVD, complete revascularization at index admission significantly lowered the rate of the primary composite endpoint at 24 months compared with treating IRA-only.
Keywords: Complete revascularization, infarct-related artery, multivessel disease patients, primary percutaneous coronary angioplasty, ST-segment elevation patients
|How to cite this article:|
Jayaraj JC. Clinical effectiveness of complete revascularization versus infarct-related artery-only percutaneous coronary revascularization for multivessel disease ST-segment elevation myocardial infarction. Heart India 2018;6:12-7
|How to cite this URL:|
Jayaraj JC. Clinical effectiveness of complete revascularization versus infarct-related artery-only percutaneous coronary revascularization for multivessel disease ST-segment elevation myocardial infarction. Heart India [serial online] 2018 [cited 2018 May 26];6:12-7. Available from: http://www.heartindia.net/text.asp?2018/6/1/12/231344
| Introduction|| |
Primary percutaneous coronary intervention (P-PCI) is the treatment of choice for patients with ST-segment elevation myocardial infarction (STEMI). About 40%–60% of the patients undergoing percutaneous revascularization have multivessel disease (MVD), which is an adverse prognostic predictor of long-term outcome. This, notwithstanding, treatment of non-infarct-related artery (IRA) lesions is not recommended by the current guidelines unless hemodynamic compromise or residual ischemia is present. Literature reports give conflicting results, and sufficiently, powered randomized ,,,,,, clinical trials are lacking., The 2015 American College of Cardiology Foundation/American Heart Association focused update on P-PCI for patients with STEMI only gives a Class II b (weak) indication for noninfarct artery intervention at the time of P-PCI. However, randomized controlled trials data are more convincing, and there is substantial evidence supporting complete revascularization. The purpose of this study was to evaluate the strategy of complete revascularization with IRA-only on event-free survival from major adverse cardiac events (MACEs) in patients with STEMI treated with P-PCI.
| Methods|| |
All MVD patients who experienced STEMI within 24 h before undergoing PCI in our institution between April 1, 2012, and March 31, 2014, were included in the study, with an exclusion of patients undergoing PCI for acute occlusion after coronary angioplasty. The study utilized an observational, retrospective cohort design. Diagnostic criteria for STEMI were symptoms consistent with ongoing myocardial ischemia, electrocardiographic evidence of STEMI, or both. MVD defined as the presence of ≥2 major epicardial coronary arteries or their major branches with stenosis of at least 70%, assessed by visual estimation during initial coronary angiography. All patients were written consented to the procedure. The study was conducted according to the Declaration of Helsinki and approved by the Institutional Review Board.
Databases, data collection, endpoints, and follow-up
Data from all patients with STEMI were prospectively recorded in a computerized database as part of the catheterization laboratory registry, regarding demographic data, preprocedural risk factors, periprocedural complications, types of devices used, an extent of disease, and lesions treated. These data were recorded at the time of the procedure and discharge by catheterization laboratory personnel. A telephone interviewer-administered structured questionnaire was used to collect data about MACE. Telephone interviewers were blinded about which group the patient belonged. The primary endpoint in this study was MACEs comprising all-cause mortality, recurrent MI, heart failure (HF), and ischemia-driven revascularization by PCI/coronary artery bypass grafting at 24 months.
All statistical analyses were performed using a Stata14 software package (StataCorp. 2015. Stata Statistical Software: Release 14. College Station, TX: StataCorp LP. https://www.stata.com/support/faqs/resources/citing-software-documentation-faqs/). For descriptive analyses, continuous variables were presented as means and standard deviations and were compared by the Student t-test. Categorical variables were presented as counts and percentages such as the prevalence of various patient risk factors (comorbidities, left ventricular ejection function, hemodynamic state, vessels diseased, and time since onset of symptoms) and were compared using Chi-square test or Fisher's exact test. The Kaplan–Meier product-limit method was used to estimate the survival from MACE for each group. Multivariable Cox proportional hazards regression analysis was used to compare survival rates between complete and culprit artery-only PCI groups. Differences between patients undergoing IRA-only and complete revascularization during the procedure of P-PCI in the prevalence of various patient risk factors (comorbidities, left ventricular ejection function, hemodynamic state, vessels diseased, and time since onset of symptoms) were tested with Chi-square tests and Fisher's exact tests.
| Results|| |
Of 306 patients with the MVD who underwent angioplasty within 12 h of acute MI, 156 (51%) received IRA-only PCI, and 150 (49%) received complete revascularization. There were more females in the IRA-only PCI group than in the complete revascularization group (26.93% vs. 12.67%, P = 0.001). Regarding existing comorbidities, the complete group was more likely to suffer from HF, cerebrovascular disease, gastrointestinal disease, chronic obstructive pulmonary disease, and diabetes. The average door-to-balloon time was significantly longer in the complete PCI group than in IRA-only PCI group (P < 0.001). The patients in the IRA-only group were more likely to have a history of MI. The groups were similar concerning smoking status, body mass index, stable and unstable angina, left ventricular ejection fraction, and type of stent used during the procedure. Patients' baseline characteristics stratified by PCI procedural types are presented in [Table 1].
Some angiographic characteristics also differed between the two groups [Table 2]. Regarding angiographic characteristics, proximal left anterior descending artery involvement was more often in the IRA-only group (35.06% vs. 14.50%) compared to the complete group (P = 0.15). The total number of stents implanted per patient was significantly higher in the complete group (2.12 vs. 1.12, P < 0.001). There was no patient with more than three vessels affected.
The groups did not differ significantly in the rates of discharge medication prescriptions [Table 2].
Event-free survival rates at 2-year follow-up
The average follow-up time was 27.8 (standard deviation [SD] =1.1) months for the full sample, 28.5 (SD = 1.6) months for the complete revascularization group, and 26.8 (SD = 1.1) months for the IRA-only PCI group (P = 0.039). In total, 51 MACEs occurred during the follow-up period (17 in the complete group and 34 in the IRA-only group) including eight patients with MI, 16 with repeat revascularization, 15 with HF, and ten patients who died [Table 3]. As the Kaplan–Meier curves show [Figure 1], the freedom from MACE at 2-year follow-up was 67.02% in the complete group, compared with 63.84% in the IRA-only group (P = 0.039).
|Table 3: Distribution of major cardiac events between complete and infarct-related artery-only percutaneous coronary intervention|
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|Figure 1: Event-free survival from major adverse cardiac events by complete revascularization|
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Cox proportional hazards model for multivariate predictors
The unadjusted predictors of 2-year survival (MACE) were identified using univariate Cox proportional hazard models [Table 4]. Significant predictors (P < 0.05) were the number of three diseased vessels and hypertension. The final model was developed first by selecting all variables with P < 0.05 from the univariate analysis and then using backward elimination by applying the log-likelihood ratio test. The proportional hazard assumption of the Cox model was tested for the final model.
|Table 4: Multivariable Cox proportional hazards model for major adverse cardiac event|
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The final model was adjusted for the three-vessel disease in reference to two-vessel disease and hypertension [Table 4]. After adjusting for these covariates, the hazard of developing MACEs was 49% lower in the complete revascularization group as compared to the IRA-only PCI group (hazard ratio = 0.51, 95% confidence interval: 0.34–0.95, P = 0.032).
| Discussion|| |
The study evaluated the differences in 2-year event-free survival from MACE in patients who underwent complete revascularization and IRA-only PCI for MVD after STEMI during index admission between 2012 and 2014. A retrospective cohort study design was utilized for the study where baseline patient characteristics were abstracted from the medical records and postprocedural events established through patient surveys. The final sample included 306 patients, of which 49% had complete PCI and 51% had IRA-only PCI. We found that multivessel PCI is feasible concerning procedural success and associated with lower mortality for multivessel PCI. A caveat regarding this finding is that it is an observational study and this needs to be evaluated in a prospective, multicenter randomized trial. This study could subject to selection bias since it is an observational study whereby patients were chosen for single vessel versus multivessel PCI treatment options because of baseline, and procedural characteristics suggest a specific pattern. In this study, patients who were hemodynamically stable (more preserved left ventricular ejection function) underwent multivessel PCI attributable to lower procedural risk than the sicker patients. We found that at index hospitalization for PCI, complete and IRA-only PCI patients had different baseline profiles. For example, patients in the complete revascularization group had more males, had higher door-to-balloon time, and had higher rates of HF than those in the culprit artery-only PCI group. These findings are consistent with many other many randomized control studies.,,,,
The current study results showed that patients in the complete PCI group had 49% lower MACE rate at the mean follow-up of 28 months compared to patients in culprit artery-only PCI group. This finding agrees with the systematic reviews., Furthermore, in the multivariable analysis, we found that hypertension increased the hazard of developing MACE. This finding is inconsistently documented in the results of the registry study, where hypertension was not reported as a significant predictor of MACE. It came out that compared to having two diseased coronary vessels, having three diseased vessels increases the chance of MACE when controlling for the intervention type (complete/culprit) and hypertension, the vast majority of data to support the same. Patients in the culprit artery-only PCI group had more number of three diseased vessels as was found in the CvLPRIT trial. A 65% reduction in MACE in complete revascularization group compared to IRA-only PCI group became more debatable after the publication of PRAMI trial. In the current analysis, the event-free survival at the end of the follow-up period was higher in the complete revascularization group when compared to IRA-only PCI group. These results are in agreement with other studies, which showed that complete PCI yields to better event-free survival rate.,,
However, a study showed that complete PCI leads to worse clinical outcomes. The reason for a trend toward increased mortality with complete revascularization during index admission in the nonrandomized registry studies is likely attributable to case selection.
One of the possible limitations of the study was that this is a retrospective study comprising nonrandomized patients, subject to selection bias. Importantly, the reason for certain patients underwent multivessel PCI in the acute setting is not known. Only a prospective, randomized study could address the safety and efficacy of multivessel angioplasty during the peri-infarct period. In the scarce of such studies to date, however, the current study results suggest that multivessel PCI strategy should be further explored. The sample represents responders from a single center with modest sample size, indicating that patients who underwent PCI at other hospitals were not included in the study. Hence, the results are more applicable to the center where the study is conducted. The strength of our study was that the interviewers were blinded about which group the patient belonged. Thus, the assessment of the outcomes was blinded.
| Conclusions|| |
The current study assessed the difference in 2-year event-free survival among patients with MVD and STEMI, who had undergone either complete revascularization or IRA-only PCI. The hazard of developing MACE was significantly reduced in the complete revascularization group. Three-vessel disease (compared to two-vessel disease) and hypertension were independent predictors of MACE. Considering the results and the fact that both of the PCI types are still in use, more studies are needed to show the advantages and disadvantages of each type for specific patient populations.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4]