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Rotational atherectomy before paclitaxel‐eluting stent implantation in complex calcified coronary lesions: Two‐year clinical outcome of the randomized ROTAXUS trial
Author(s) -
de Waha Suzanne,
Allali Abdelhakim,
Büttner HeinzJoachim,
Toelg Ralph,
Geist Volker,
Neumann FranzJosef,
Khattab Ahmed A.,
Richardt Gert,
AbdelWahab Mohamed
Publication year - 2016
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.26290
Subject(s) - medicine , mace , myocardial infarction , clinical endpoint , stent , target lesion , cardiology , randomized controlled trial , lesion , percutaneous coronary intervention , revascularization , surgery
Background In the randomized ROTAXUS trial, routine lesion preparation of complex calcified coronary lesions using rotational atherectomy (RA) prior to paclitaxel‐eluting stent implantation did not reduce the primary endpoint of angiographic late lumen loss at 9 months compared to stenting without RA. So far, no long‐term data of prospective head‐to‐head comparisons between both treatment strategies have been reported. Methods and Results ROTAXUS randomly assigned patients with complex calcified coronary lesions to RA followed by stenting ( n = 120) or stenting without RA ( n = 120). The primary endpoint of the current analysis was the occurrence of major adverse cardiac events (MACE) at 2‐year follow‐up defined as the composite of death, myocardial infarction, and target vessel revascularization (TVR). At 2 years, MACE occurred in 32 patients in the RA group and 37 patients in the standard therapy group (29.4% vs. 34.3%, P = 0.47). The rates of death (8.3% vs. 7.4%, P = 1.00), myocardial infarction (8.3% vs. 6.5%, P = 0.80), target lesion revascularization (TLR, 13.8% vs. 16.7%, P = 0.58), and TVR (19.3% vs. 22.2%, P = 0.62) were similar in both groups. Conclusion Despite high rates of initial angiographic success, nearly one third of patients enrolled in ROTAXUS experienced MACE within 2‐year follow‐up, with no differences between patients treated with or without RA. © 2015 Wiley Periodicals, Inc.