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Published on: June 12, 2021
Outcomes among patients with coronary bifurcation lesions undergoing Impella-supported high-risk percutaneous
Aneel S Maini1, Arsalan Abu-Much2, Björn Redfors3
1Department of Internal Medicine, UT Southwestern Medical Center, Dallas, TX; Cardiovascular Research Center, New York, NY.
Insights
Impella support in high-risk percutaneous coronary intervention (PCI) for coronary bifurcation lesions (CBLs) did not increase complications. Patients with CBLs had similar 90-day major adverse cardiac and cerebrovascular events (MACCE) despite higher baseline complexity.
Area of Science:
- Cardiology
- Interventional Cardiology
- Medical Devices
Background:
- Coronary bifurcation lesions (CBLs) are linked to poorer outcomes and increased repeat revascularization after percutaneous coronary intervention (PCI).
- Understanding the role of mechanical circulatory support, specifically Impella, in managing complex CBLs is crucial for improving patient care.
- The PROTECT III study provides valuable data on high-risk PCI patients, including those with CBLs.
Purpose of the Study:
- To evaluate the impact of Impella support on outcomes in patients undergoing PCI for coronary bifurcation lesions (CBLs).
- To compare the procedural success and 90-day adverse events between patients with and without true CBLs treated with Impella support.
Main Methods:
- Analysis of data from the FDA-audited, single-arm cVAD PROTECT III study (NCT04136392).
- Patients with true CBLs (Medina classification 1.1.1, 1.0.1, or 0.1.1) were compared to those without true CBLs.
- The primary endpoint was the 90-day rate of major adverse cardiac and cerebrovascular events (MACCE), adjusted for confounders using Cox regression.
Main Results:
- Out of 1,044 patients, 523 had true CBLs treated. Patients with CBLs were older and had higher pre-PCI SYNTAX scores, more complex disease (left main, triple vessel), and longer procedures.
- No significant differences were observed in post-PCI SYNTAX scores, PCI-related complications, or angiographic success rates between groups.
- After adjustment, patients with CBLs showed similar rates of 90-day MACCE compared to those without CBLs.
Conclusions:
- High-risk PCI with Impella support for coronary bifurcation lesions is feasible, even in complex cases.
- Despite increased baseline complexity, Impella-supported PCI for CBLs was associated with comparable rates of procedural complications and 90-day MACCE.
- These findings suggest Impella support can be safely utilized in patients with complex coronary bifurcation lesions.
Background:
Coronary bifurcation lesions (CBL) are associated with lower procedural success, worse postprocedural outcomes, and greater unplanned repeat revascularization. We sought to better understand the impact of Impella support in patients undergoing percutaneous coronary intervention (PCI) of CBLs.
Methods:
We used data from the cVAD PROTECT III study (NCT04136392), an FDA-audited, single-arm study of patients undergoing high-risk PCI with Impella support, to examine the outcomes of patients undergoing PCI of CBLs. Patients with a Medina classification of 1.1.1, 1.0.1, or 0.1.1 were considered to have a true CBL, and were compared to patients with nontrue CBLs and/or no CBLs. The primary outcome was the rate of CEC-adjudicated major adverse cardiac and cerebrovascular events (MACCE: composite of all-cause death, myocardial infarction, stroke/transient ischemic attack, and repeat revascularization) at 90 days. Cox proportional hazards regression models were adjusted for age, sex, left main disease, and triple vessel disease.
Results:
Of 1,044 patients, 523 had at least one true CBL treated. Baseline characteristics were comparable between groups except for age which was higher in patients with CBLs. Patients with CBLs had a significantly higher pre-PCI SYNTAX scores and number of treated lesions, more left main disease and triple vessel disease, and longer procedure duration. There was no difference in post-PCI SYNTAX score, PCI-related complications, or failure to achieve angiographic success. After adjustment for potential confounders, patients with CBLs had similar rates of 90-day MACCE.
Conclusions:
While patients with CBLs undergoing Impella-supported high-risk PCI had higher complexity, there were similar rates of PCI-related complications and 90-day MACCE.
Trial Registration:
Trial Name: The Global cVAD Study (cVAD), ClinicalTrial.gov Identifier: NCT04136392, URL:https://clinicaltrials.gov/ct2/show/NCT04136392?term=cvad&draw=2&rank=2.
