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This study sought to evaluate the clinical outcomes of 6-month and 12-month dual antiplatelet therapy (DAPT) with multiple biodegradable polymer drug eluting stents (BP-DES) on patients undergoing primary percutaneous coronary intervention (PCI) in the I-LOVE-IT 2 trial (Evaluate Safety and Effectiveness of the Tivoli DES and the Firebird DES for Treatment of Coronary).
In the prospective non inferiority randomized I-LOVE-IT 2 trial, 907 patients implanted with multiple biodegradable polymer sirolimus-eluting stents (BP-SES)(>2 stents) were randomized to accepting either 6-month (n=440) or 12-month DAPT(n=467). 922 patients implanted with single biodegradable polymer sirolimus-eluting stent (BP-SES) were randomly assigned to either 6-month (n=469) or 12-month DAPT (n=453) group. The primary end points of this subgroup study were 12-month target lesion failure (TLF) (composite of cardiac death, target vessel myocardial infarction or clinically indicated target lesion revascularization), and the major secondary efficacy end points were 12-month net adverse clinical events(NACE)(composite of all-cause death, myocardial infarction, stroke, revascularization and bleeding).
For the patients implanted with multiple BP-SES, the incidence of 12-month TLF in 6-month DAPT group was comparable with the 12-month DAPT group (9.3% vs. 7.5%, p=0.33). The incidence of NACE was similar between the 2 groups (18.0% vs. 16.9%, p=0.69), as well as their individual end point components. However, 6-month landmark analysis showed that 12-month DAPT was superior to the 6-month DAPT in decreasing the incidence of TLF and revascularization between 6 and 12-months (2.4% vs. 4.8%, p=0.049 and 7.7% vs. 3.9%, log-rank P=0.01, respectively). However, for the patients with single BP-SES, there was no significant difference in the incidence of TLF and NACE between 6-month DAPT and 12-month DAPT group (4.3% vs. 4.2%, log-rank P=0.94; 12.8% vs.13.0%, log-rank P=0.96, respectively). Between-group differences were not seen in the patients implanted with single BP-SES by six-month landmark analysis(log-rank P>0.05).
Compared with 12-month DAPT, 6-month DAPT did not increase the incidence of 12-month TLF and NACE in the patients implanted novel single BP-SES. However, 12-month DAPT decreased the incidence of TLF and revascularization between 6 and 12 months after PCI in the patients implanted with multiple BP-SES.12-month DAPT might be more appropriate in the patients implanted novel multiple BP-SES, unless there are contraindication such as excessive risk of bleeding or unable to tolerate long duration of DAPT.