Author + information
- Carlos Collet, MD,
- Rodrigo Modolo, MD,
- Adrian Banning, MD,
- David E. Kandzari, MD,
- Rod Stables, MD,
- Ovidiu Dressler, MD,
- Joseph F. Sabik, MD,
- A. Pieter Kappetein, MD, PhD,
- Gregg W. Stone, MD and
- Patrick W. Serruys, MD, PhD∗ ()
- ↵∗Erasmus University Medical Center, P.O. Box 2125, 3000 CC Rotterdam, the Netherlands
Percutaneous coronary intervention (PCI) is an acceptable alternative revascularization strategy to coronary artery bypass grafting for selected patients with unprotected left main coronary artery disease (LMCAD). Concomitant coronary artery disease (CAD) in other epicardial vessels is a frequent finding in patients with LMCAD, and the operator may consider several PCI sessions to optimally complete myocardial revascularization. Staging may also be required to minimize radiation or contrast use, because of procedural complications, operator/patient fatigue, or for reimbursement reasons (1). No randomized trial has investigated the impact of staging PCI in patients with stable multivessel CAD; hence, limited data are available regarding the safety and efficacy of staging PCI procedures.
The Evaluation of XIENCE Everolimus-Eluting Stent Versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) was a multinational, open-label, randomized controlled trial that compared PCI with everolimus-eluting stents (Xience, Abbott Vascular, Santa Clara, California) to coronary artery bypass grafting in patients with unprotected LMCAD and site-reported anatomic SYNTAX score ≤32 (2). We examined the baseline and procedural characteristics and the 30-day and 3-year clinical outcomes of patients undergoing staged versus single PCI procedures from the contemporary EXCEL trial. The protocol was approved by the ethics committee of investigational review boards at each participating center, and all patients signed informed consent.
Among the PCI-assigned cohort, PCI was the first procedure performed in 935 patients, comprising the present study population. Staged procedures were planned in 77 of these patients (8.1%). The baseline characteristics of the planned staged and single-procedure PCI groups were well matched. Overall, the mean number of lesions treated with PCI were significantly higher in the staged procedure group (3.3 ± 1.3 vs. 1.8 ± 1.0; p < 0.001), and more stents with greater total stent length were implanted (4.1 ± 1.8 vs. 2.3 ± 1.3; p < 0.001; 21.9 mm ± 8.9 vs. 19.6 mm ± 8.1; p < 0.001). There was no difference in the residual anatomic SYNTAX between the groups (7.3 ± 7.4 staged vs. 6.2 ± 6.2 single; p = 0.27).
Adverse event rates at 30 days and 3 years were comparable between groups (Figure 1). All-cause mortality was significantly lower in the staged procedure group (1.3% vs. 8.7%; p = 0.03) with no difference in stroke or myocardial infarction. The rates of ischemia-driven revascularization and stent thrombosis were comparable between the staged and single-procedure groups. By multivariate analysis, staged procedures exhibited a borderline predictor of reduced mortality (hazard ratio: 0.14; 95% confidence interval: 0.02 to 1.01; p = 0.051).
In the SYNTAX trial, patients undergoing staged PCI procedures had higher SYNTAX scores, more renal dysfunction, chronic obstructive pulmonary disease, and hypertension (3). Conversely, in EXCEL (in which a more liberal staging strategy was encouraged to reduce procedural complications and foster complete revascularization), baseline clinical characteristics were more balanced between the planned staged and single procedure PCI groups; however, patients undergoing staged procedures had a higher anatomic SYNTAX score (32.9 ± 9.3 vs. 26.3 ± 8.5; p < 0.001). In SYNTAX, the staged group had higher 5-year rates of death, myocardial infarction, stroke, and repeat revascularization (3), in contrast to EXCEL, whereas the 3-year rates of these endpoints in the staged group were not worse, and in fact all-cause mortality tended to be improved by the more cautious approach.
Although the present analysis was pre-specified, the decision to stage was not randomized, and subgroups are inherently underpowered to detect differences in clinical events. In particular, the finding of lower all-cause mortality in the staged procedure group may be caused by unmeasured confounders. The present study findings are reassuring, however, that a staged PCI strategy in patients with anatomically complex LMCAD is safe and is not associated with increased adverse events. Nonetheless, the results of the present study should be considered hypothesis-generating, and ideally would be prospectively evaluated in an adequately powered randomized trial. Lastly, because the protocol was restricted inclusion to patients with LMCAD and a SYNTAX score <33, caution should be exercised when extrapolating these results to patients with more complex CAD.
In conclusion, despite higher anatomic and procedural complexity, a strategy of staged PCI procedures in patients with LMCAD and SYNTAX scores ≤32 were associated with comparable rates of 3-year all-cause death, stroke, or myocardial infarction and lower all-cause mortality. These data support a liberal approach of procedural staging in patients with LMCAD complex CAD undergoing PCI.
Please note: Dr. Modolo has received financial support from the Sao Paulo Research Foundation (FAPESP) (grant number 2017/22013-8). Dr. Sabik is on the Cardiac Surgery advisory board for Medtronic and is North American Surgical PI for EXCEL for Abbott. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- 2019 American College of Cardiology Foundation
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