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Clinical characteristics of patients undergoing surgical ventricular reconstruction by choice and by randomization
Marian Zembala1, Robert E Michler, Andrzej Rynkiewicz
1Department of Cardiac Surgery and Transplantation, Silesian Center for Heart Diseases/Medical University of Silesia, Zabrze-Katowice, Poland.
Insights
Adding surgical ventricular reconstruction (SVR) to coronary artery bypass grafting (CABG) offers no survival benefit for patients with ischemic cardiomyopathy. The Surgical Treatment for Ischemic Heart Failure (STICH) trial
Area of Science:
- Cardiovascular Surgery
- Clinical Trials
- Heart Failure Management
Background:
- The Surgical Treatment for Ischemic Heart Failure (STICH) trial found no significant benefit in adding Surgical Ventricular Reconstruction (SVR) to Coronary Artery Bypass Grafting (CABG).
- This study aimed to assess the generalizability of the STICH trial's findings to a broader patient population.
Purpose of the Study:
- To confirm the generalizability of the STICH trial's conclusions regarding SVR in ischemic heart failure.
- To evaluate if the addition of SVR to CABG impacts mortality or cardiac hospitalization rates in a wider patient cohort.
Main Methods:
- Utilized baseline clinical characteristics of 1,000 STICH patients and 1,036 STICH-eligible patients from the STS National Cardiac Database.
- Developed a multivariate model to predict mortality, assigning 2,036 patients into 32 Risk at Randomization (RAR) groups.
- Compared RAR profiles between STICH and STS patients to assess treatment arm risks.
Main Results:
- The Risk at Randomization (RAR) methodology demonstrated sufficient accuracy, with 85% of STICH patients sharing RAR groups.
- 75% of combined STICH and STS STICH-eligible patients (1,522/2,036) fell into shared RAR groups.
- No differential treatment effect on survival was observed across low-, intermediate-, and high-risk groups, indicating consistent outcomes regardless of risk stratification.
Conclusions:
- The STICH trial's conclusion that adding SVR to CABG provides no benefit is applicable to a wide range of CABG-eligible patients with ischemic cardiomyopathy.
- These findings reinforce the understanding that SVR does not improve outcomes when combined with CABG in this patient population.
Objectives:
The aim of this study was to confirm the generalizability of the conclusions of the STICH (Surgical Treatment for Ischemic Heart Failure) trial.
Background:
Surgical ventricular reconstruction (SVR) added to coronary artery bypass grafting (CABG) did not decrease death or cardiac hospitalization in STICH patients randomized to CABG with (n = 501) or without (n = 499) SVR.
Methods:
Baseline clinical characteristics of 1,000 STICH SVR hypothesis patients and 1,036 STICH-eligible Society of Thoracic Surgeons (STS) National Cardiac Database patients undergoing CABG plus SVR were entered into a multivariate model equation to predict a mortality that placed these 2,036 patients in 1 of 32 risk at randomization (RAR) groups. The number of patients in each RAR group profiled the risk of STICH treatment arms and of STICH and STS STICH-eligible patients.
Results:
That 85% of the 1,000 STICH patients known to have no significant differences in baseline characteristics between the 2 treatment arms shared the same RAR group suggests that the RAR methodology has sufficient accuracy to compare RAR profiles of STICH and STS patients. RAR group was shared by 1,522 of 2,036 STICH and STS STICH-eligible patients (75%) who underwent CABG plus SVR. Differences in baseline characteristics responsible for more low-risk STICH patients and more high-risk STS patients were modest. Cox proportional hazard ratios of 1,000 STICH patients in 3 RAR groups suggested by STICH and STS RAR differences showed no differential treatment effect on survival across the low-, intermediate-, and high-risk groups.
Conclusions:
The STICH conclusion of no benefit from adding SVR to CABG applies to a broad spectrum of CABG-eligible patients with ischemic cardiomyopathy. (Comparison of Surgical and Medical Treatment for Congestive Heart Failure and Coronary Artery Disease; NCT00023595).
