Key result
First-generation drug-eluting stents had similar 5-year rates of major adverse clinical events compared to second-generation stents (36.8% vs 38.6%; adjusted HR 1.28, 95% CI 0.94-1.74).
Why the study?
Long-term clinical outcomes after PCI for unprotected left main coronary artery stenosis comparing first-generation to second-generation DES were largely unknown.
Do second-generation drug-eluting stents improve long-term clinical outcomes compared to first-generation drug-eluting stents in patients undergoing PCI for unprotected left main coronary artery stenosis?
Cohort (n=656)
No
Do second-generation drug-eluting stents improve long-term clinical outcomes compared to first-generation drug-eluting stents in patients undergoing PCI for unprotected left main coronary artery stenosis?
Hazard Ratio: 1.28 (95% CI 0.94–1.74)
Absolute Event Rate: 36.8% vs 38.6%
p-value: p=0.79
In patients undergoing PCI for unprotected left main coronary artery stenosis, second-generation DES showed similar long-term safety and efficacy compared to first-generation DES at 5 years.
Must use cautious language and LEAVES OPEN framing.
Objective and background The study aim is to provide long‐term clinical outcome after percutaneous coronary intervention (PCI) for unprotected left main coronary arteries (ULMCA) stenosis with the first‐generation (1st‐gen) drug‐eluting stents (DES) in comparison to 2nd‐gen DES, since this is largely unknown. Methods Between May 2002, and December 2014, a consecutive series of 656 all‐comer patients underwent a PCI for ULMCA stenosis at the Erasmus Medical Center. A total of 235 patients were treated with 1st‐gen DES, while a total of 421 patients were treated with 2nd‐gen DES. Results Overall, the population consisted of 73% males and 58% presented with an acute coronary syndrome. Median follow‐up time was 1,361 days (range from 0 to 5,031). At 5 years, the cumulative incidence of major adverse clinical events (the primary composite endpoint of all‐cause death, any myocardial infarction or target lesion revascularization; MACE) did not differ between 1st‐ and 2nd‐gen DES (36.8 vs. 38.6%, respectively, Log Rank p = .79, adjusted hazard ratio [HR] = 1.28 [95% confidence interval (CI) 0.94–1.74]). No difference was found in the individual endpoints of all‐cause mortality (29.5 vs. 29% respectively, p = .88, adjusted HR = 1.19 [95% CI, 0.84–1.68]), target vessel myocardial infarction (5.0 vs. 8.4%, p = 0.17, adjusted HR = 1.75 [95% CI, 0.78–3.96]) and target lesion revascularization (8.1 vs. 9.8%, p = .94, adjusted HR = 1.16 [95% CI, 0.59–2.29]) between the 1st‐ and 2nd‐gen DES cohorts, respectively. Conclusions In this large cohort of consecutive patients treated for ULMCA stenosis, no significant differences were found in the safety and efficacy of 1st versus 2nd‐gen DES at 5 years follow‐up.
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Zandvoort et al. (2019) conducted a cohort in Unprotected left main coronary artery stenosis (n=656). First-generation drug-eluting stents vs. Second-generation drug-eluting stents was evaluated on Major adverse clinical events (composite of all-cause death, any myocardial infarction or target lesion revascularization) (adjusted HR 1.28, 95% CI 0.94-1.74, p=0.79). First-generation drug-eluting stents had similar 5-year rates of major adverse clinical events compared to second-generation stents (36.8% vs 38.6%; adjusted HR 1.28, 95% CI 0.94-1.74).
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