I-LOVE-IT 2 - I-LOVE-IT 2
The current trial sought to compare the safety and efficacy of a biodegradable (PLGA) polymer-coated sirolimus-eluting stent (BP-SES) versus durable polymer-coated SES (DP-SES), both on a cobalt chromium platform. Patients in the BP-SES arm were further randomized to identify the optimal duration of dual antiplatelet therapy (DAPT).
BP-DES would be noninferior to DP-DES in Chinese patients with coronary artery disease (CAD) undergoing percutaneous coronary intervention (PCI).
- ≥18 years of age
- Symptomatic ischemic heart disease and/or objective evidence of myocardial ischemia including chronic stable CAD, or acute coronary syndrome including non-ST-elevation and ST-elevation MI
- Acceptable candidate for coronary artery bypass grafting
- At least one lesion with a diameter stenosis >70% or more suitable for coronary stent implantation in a vessel with a reference diameter ranging from 2.5 mm to 4.0 mm
- Patients with multilesion or multivessel coronary disease, must have successful treatment (<30% diameter stenosis visual estimate) of the first treated lesion prior to treatment of other lesions at the same brand of stent; staged (planned) procedures must be performed within 30 days of the index procedure
Number of enrollees: 2,737
Duration of follow-up: 1 year
Mean patient age: 60.2 years
Percentage female: 31%
Left ventricular ejection fraction: 61%
- Patient has a history of bleeding diathesis or coagulopathy or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated or in which patient will not be able to comply with DAPT for at least 1 year
- Patient has other medical illness (e.g., cancer, known malignancy, congestive heart failure, organ transplant recipient or candidate), or known history of substance abuse (alcohol, cocaine, heroin, etc.) that may cause noncompliance with the protocol, confound the data interpretation, or is associated with a limited life expectancy (i.e., <1 year)
- Left ventricular function <40%
- Cardiogenic shock or hemodynamic compromise requiring pressors and/or inotropes or mechanical support
- Patient has a known hypersensitivity or contraindication to aspirin, heparin, clopidogrel/ticlopidine, stainless steel alloy, cobalt chromium, Rapamycinry, styrene-butylenes-styrene or poly-lactic acid (PLA) polymer, and/or contrast sensitivity that cannot be adequately premedicated
- Existing impairment in liver and kidney
- Extremely tortuous and/or calcification lesions
- Two or more chronic total occlusions in the proximal half of the epicardial coronary artery that cannot be recannalized
- One-year TLF (composite of cardiac death, target vessel MI, and clinically indicated TLR)
- One-year TLF and net adverse clinical cardiovascular event (NACCE) (composite of death, MI, stroke, major bleeding (Bleeding Academic Research Consortium [BARC] ≥ II) between 6- and 12-month DAPT groups after BP-SES implantations
- Individual TLF components, definite/probable stent thrombosis, device/lesion/procedure success rates, and composite of all-cause death, all MI, and any revascularization
Patients were randomized in a 2:1 fashion to receive either BP-DES or DP-DES. Patients in the BP-DES arm were further randomized to either 6 or 12 months of DAPT.
A loading dose of 300 mg of aspirin and 300 mg of clopidogrel was administered before all procedures. All patients were discharged with a prescription for at least 100 mg of aspirin indefinitely and 75 mg of clopidogrel for a minimum of 6 months after index procedure.
A total of 2,737 patients were randomized, 1,829 to BP-SES and 908 to DP-SES. Baseline characteristics were fairly similar between the two arms. About 22% had diabetes mellitus, and 37% were current smokers. The vast majority (74%) were patients with unstable angina. Nearly three-fourths of the patients had single-vessel disease, with a median SYNTAX score of 11.7. There were 33% complex bifurcation lesions, and 12% were total occlusions. The median reference vessel diameter (RVD) was 2.79 mm, with a median lesion length of 21 mm. The median stent diameter was 3.05 mm, with a total stented length per lesion of 31 mm.
The composite target lesion failure (TLF) endpoint was similar between the BP-SES and DP-SES arms at 12 months (6.3% vs. 6.1%, p for noninferiority = 0.0002). Individual components including cardiac death (0.7% vs. 0.6%, p = 0.62), target vessel myocardial infarction (MI) (3.6% vs. 4.3%, p = 0.39), and target lesion revascularization (TLR) (2.6% vs. 2.2%, p = 0.5) were similar between the two arms. Definite/probable stent thrombosis rates were similar as well (0.4% vs. 0.6%, p = 0.55).
The results of the I-LOVE-IT 2 trial indicate that BP-DES is noninferior to DP-SES for clinical outcomes including stent thrombosis at 1 year in patients undergoing PCI. DP-SES is not the same as Cypher DES, which was on a stainless steel platform. This trial adds to the literature on bioresorbable stents.
Although not specifically powered for it and the results were not separately shown, the trial seems to suggest that a shorter duration of DAPT may be safe in BP-SES. This, however, needs to be tested in a dedicated trial. Longer-term follow-up of the current trial is also awaited.
Han Y, Xu B, Jing Q, et al., on behalf of the I-LOVE-IT 2 Investigators. A randomized comparison between novel biodegradable polymer- and durable polymer-coated cobalt-chromium sirolimus-eluting stents. JACC Cardiovasc Interv 2014;Sep 16:[Epub ahead of print].
Presented by Dr. Yaling Han at the Transcatheter Cardiovascular Therapeutics meeting (TCT 2014), Washington, DC, September 16, 2014.
Keywords: Myocardial Infarction, Coronary Artery Disease, Follow-Up Studies, Cobalt, Sirolimus, Percutaneous Coronary Intervention, Stents, Stainless Steel, Thrombosis, Polymers, Chromium, Diabetes Mellitus, Transcatheter Cardiovascular Therapeutics
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