CLINICAL RESEARCH
Comparable Clinical Outcomes With Paclitaxel- and Sirolimus-Eluting Stents in Unrestricted Contemporary Practice
John Cosgrave, MD*,
Gloria Melzi, MD*, ,
Simon Corbett, PhD*,
Giuseppe G.L. Biondi-Zoccai, MD ,
Pierfrancesco Agostoni, MD ,
Rade Babic, MD*,
Flavio Airoldi, MD*,,
Alaide Chieffo, MD,
Giuseppe M. Sangiorgi, MD*,
Matteo Montorfano, MD,
Iassen Michev, MD*,,
Mauro Carlino, MD and
Antonio Colombo, MD, FACC*,,*
* EMO Centro Cuore Columbus, Milan, Italy
San Raffaele Scientific Institute, Milan, Italy
Abano Terme Hospital, Abano Terme, Italy
Antwerp Cardiovascular Institute, AZ Middelheim, Antwerp, Belgium.
Manuscript received December 5, 2006;
revised manuscript received February 2, 2007,
accepted February 19, 2007.
* Reprint requests and correspondence: Dr. Antonio Colombo, EMO Centro Cuore Columbus, 48 Via M. Buonarroti, 20145 Milan, Italy. (Email: info{at}emocolumbus.it).
Objectives: This study was designed to compare the outcomes of paclitaxel-eluting stents (PES) and sirolimus-eluting stents (SES) in a contemporaneous cohort of real-world patients.
Background: A number of randomized comparisons of PES and SES have shown unequivocal advantages for SES in angiographic end points such as late loss. However, the data on clinical outcomes are less consistent.
Methods: All consecutive patients successfully treated with only SES or PES in de novo native vessel lesions between March 2003 and March 2005 were analyzed. Our end points were major adverse cardiac events (MACE), a composite of death, myocardial infarction (MI), target vessel revascularization (TVR), and target lesion revascularization (TLR). We also analyzed late loss and angiographic restenosis.
Results: There were 609 patients (1,064 lesions) treated with PES and 674 patients (1,205 lesions) treated with SES. Diabetes mellitus was present in 26.8% of patients and multivessel disease in 75% of patients. Bifurcations made up 16.3% of lesions, chronic occlusions 9.5%, left main 4.8%, and American Heart Association/American College of Cardiology type B2/C 75.4%. Despite a higher late loss in the PES group (p = 0.0001), there were no differences in angiographic restenosis (PES 18% vs. SES 17.8%, p = 0.95), TLR (PES 11.9% vs. SES 11%, p = 0.47), or MACE (PES 21.3% vs. SES 21.1%, p = 0.95). The relative risk of MACE for the PES group was 1.02 (95% confidence interval [CI] 0.78 to 1.33). Multivariable analysis confirmed the lack of association of stent type with MACE (odds ratio 1.03 [95% CI 0.77 to 1.38], p = 0.83) and TLR (odds ratio 1.08 [95% CI 0.81 to 1.44], p = 0.61).
Conclusions: In this complex cohort, both stent platforms demonstrated similar clinical outcomes despite different late loss.
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Abbreviations and Acronyms
| | AHA/ACC = American Heart Association/American College of Cardiology | | CI = confidence interval | | DES = drug-eluting stent(s) | | IQR = interquartile range | | MACE = major adverse cardiac events | | MI = myocardial infarction | | MLD = minimal lumen diameter | | OR = odds ratio | | PES = paclitaxel-eluting stent(s) | | SES = sirolimus-eluting stent(s) | | TLR = target lesion revascularization | | TVR = target vessel revascularization |
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