News | September 26, 2014

Biodegradable Polymer-coated Drug-Eluting Stent is not Inferior to Durable Polymer Stents

Results of I-LOVE-IT-2 Trial Reported at TCT 2014; Findings Simultaneously Published in JACC: Cardiovascular Interventions

September 26, 2014 — A first-of-its kind study comparing the safety and efficacy of biodegradable polymer sirolimus-eluting stents (BP-SES) to durable polymer sirolimus-eluting stents  (DP-SES) found that the biodegradable stents were non-inferior to the durable polymer stents after one year of follow-up. 
 
Findings were reported at the Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Results of the trial were simultaneously published today in JACC: Cardiovascular Interventions.
 
To date no randomized trials have been performed comparing the safety and efficacy of BP-SES vs. DP-SES on similar cobalt-chromium platforms, thereby isolating the effect of the polymer type. Furthermore optimal duration of dual antiplatelet therapy (DAPT) after BP-SES implantation remains undetermined. 
 
The I-LOVE-IT 2 trial was an all-comers, prospective, single blinded randomized trial that enrolled 2,737 patients eligible for coronary stenting. Patients were randomly treated with BP or DP-SES in a 2:1 ratio. Those allocated to the BP-SES group (n=1,829) were also randomized to receive six or 12 month DAPT. The primary endpoint was target lesion failure (TLF) between BP and DP-SES groups. Major secondary endpoints were TLF and net adverse clinical events (NACE), a composite of death, myocardial infarction, stroke and major bleeding, between the six and 12-month DAPT groups after BP-SES implantation. 
 
After one year, the primary non-inferiority endpoint was met with similar TLF rates in both the BP and DP-SES groups (6.3 percent vs. 6.1 percent, respectively, p=0.0002). Both groups experienced similar rates of cardiac death (0.7 percent vs. 0.6 percent, p=0.62), target vessel myocardial infarction (3.6 percent vs. 4.3 percent, p=0.39) and clinically indicated target lesion revascularization (2.6 percent vs. 2.2 percent, p=0.50). In the BP-SES group, NACE rates were similar among the six-month and 12-month DAPT groups (8.0 percent vs. 7.4 percent, respectively, p=0.66)
 
“The present I-LOVE-IT 2 trial has demonstrated that BP-SES is non-inferior in terms of efficacy to DP-SES in clinical practice,” said lead investigator Xu Bo, MBBS, director, catheterization lab, Fu Wai Hospital, National Center for Cardiovascular Diseases and Secretary General, China Interventional Therapeutics (CIT). “Whether BP-SES improves safety with respect to lowering stent thrombosis incidence compared with DP-SES remains to be shown in longer-term follow-up of this trial or in future studies.” 
 
The I-LOVE-IT 2 trial was funded by Essen Technology. It was also supported by the National Key Technology R&D program in the 12th Five Year Plan of China and the Key Project of National 12th Five-Year Research Program of China. Xu Bo reported no disclosures.  
 
For more information: www.crf.org, www.tctconference.com
 

Related Content

DISRUPT BTK Study Shows Positive Results With Lithoplasty in Calcified Lesions Below the Knee
News | Peripheral Artery Disease (PAD)| September 20, 2017
Shockwave Medical reported positive results from the DISRUPT BTK Study, which were presented at the annual...
Corindus Announces First Patient Enrolled in PRECISION GRX Registry
News | Robotic Systems| September 18, 2017
September 18, 2017 — Corindus Vascular Robotics Inc.
Two-Year ILLUMENATE Trial Data Demonstrate Efficacy of Stellarex Drug-Coated Balloon
News | Drug-Eluting Balloons| September 18, 2017
Philips announced the two-year results from the ILLUMENATE European randomized clinical trial (EU RCT) demonstrating...
Sentinel Cerebral Protection System Significantly Reduces Stroke and Mortality in TAVR
News | Embolic Protection Devices| September 18, 2017
September 18, 2017 – Claret Medical announced publication of a new study in the...
Marijuana Associated With Three-Fold Risk of Death From Hypertension
News | Hypertension| September 14, 2017
Marijuana use is associated with a three-fold risk of death from hypertension, according to research published recently...
Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Peter Schneider, M.D. presents late breaking clinical trial results at VIVA 17 in Las Vegas. Panelists (l to r) Krishna Rocha-Singh, M.D., Sean Lyden, M.D., John Kaufman, M.D., Donna Buckley, M.D.

Feature | Cath Lab| September 14, 2017
September 14, 2017 — Here are quick summaries for all the key late-breaking vascular and endovascular clinical trials
Medtronic Announces Japanese Regulatory Approval for In.Pact Admiral Drug-Coated Balloon
News | Drug-Eluting Balloons| September 13, 2017
Medtronic plc announced that the In.Pact Admiral Drug-Coated Balloon (DCB) received approval from the Japanese Ministry...
PQ Bypass Reports Positive Results for Detour System in Patients With Long Femoropopliteal Blockages
News | Peripheral Artery Disease (PAD)| September 13, 2017
A subset analysis of the DETOUR I clinical trial showed promising safety and effectiveness results of PQ Bypass’ Detour...
News | Cardiac Diagnostics| September 12, 2017
Contracting shingles, a reactivation of the chickenpox virus, increases a person’s risk of stroke and heart attack,...
Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study in Denmark

Vascular screening for abdominal aortic aneurysm, peripheral artery disease and hypertension during the VIVA Study. Photo credit: Lisbeth Hasager Justesen, Viborg Hospital.

News | Cardiac Diagnostics| September 12, 2017
September 12, 2017 — A new screening program for vascular disease saves one life for every 169 men assessed, accordin
Overlay Init