Retrospective Comparison of Clinical and Angiographic Outcomes After Sirolimus-Eluting and Bare-Metal Stent Implantation in 312 Consecutive, Nonrandomized Severely Calcified Lesions Using a Rotablator

Abstract

SummaryIn order to compare the long-term clinical and angiographic outcomes after sirolimus-eluting stent (SES) and baremetal stent (BMS) placement in severely calcified lesions using a rotablator under the widespread indication of SES, a nonrandomized examination of 312 consecutive lesions after successful implantation of a BMS (99 lesions in 84 patients; from January 2003) or SES (213 in 167; from September 2004) using a rotablator was conducted. The lesionbased primary endpoints (cardiac death and nonfatal recurrent myocardial infarction) and the secondary endpoint [binary restenosis (BR) (diameter stenosis > 50%) at follow-up angiography] were retrospectively determined in August 2010. The incidence of primary endpoint in the SES group (2.3%; mean follow-up period of 1289 ± 526 days) was significantly lower than that in the BMS group (7.1%; P = 0.043; 1803 ± 887 days), although the several variables related to the endpoints were present in the SES group. Cox proportional hazard model analysis revealed that SES was not significantly related to a primary endpoint [hazard ratio of 0.42 (95% CI, 0.073-2.42; P = 0.33)]. The incidence of BR in the SES group (21.3%) was not significantly different from that in the BMS group (27.1%) (P = 0.33). Multivariate logistic regression analysis revealed that SES was not a significant predictor of BR [Odds ratio of 0.78 (95% CI, 0.41-1.51; P = 0.47)]. Thus, although the results of the present retrospective nonrandomized study demonstrate the long-term safety of SES for calcified lesions using a rotablator in daily practice, SES did not show a benefit for the angiographic outcomes and is one of the complex and challenging targets of percutaneous coronary intervention (PCI). Since calcified coronary lesions are associated with the risk of suboptimal stent expansion, calcification of coronary arteries relates to in-stent restenosis (ISR) and target lesion revascularization (TLR) 2-4) and subsequent stent thrombosis (ST) 5) after sirolimuseluting stent (SES; Cypher Bx Velocity, Cordis, Johnson & Johnson, NJ, USA) implantation. Therefore, it is necessary to evaluate whether SES is consistently beneficial for the treatment of calcified lesions in daily clinical practice with a widespread indication in the field of percutaneous coronary intervention (PCI). However, the impacts of severely calcified lesions on the long-term clinical and angiographic outcomes after successful SES placement in daily clinical practice are still not fully understood.Rotational atherectomy (RA) using a rotablator (Boston Scientific, Natick, MA, USA) is useful for treating calcified lesions. The rotablator facilitates optimal stent implantation by debulking the hard calcified matrix and modifies vessel compliance.6) However, SES implantation with RA for a calcified coronary artery has yielded inconsistent outcomes, 7-9) despite the consistent efficacy revealed in the overall field of PCI using SES. 2,10,11) In the present study, we retrospectively examined whether SES implantation with RA improved clinical...

Comparison of Long-Term Clinical Outcomes Between Sirolimus-Eluting Stents and Paclitaxel-Eluting Stents Following Rotational Atherectomy

“…Several studies have showed that DES implantation after RA reduced the incidences of TLR 21) and MACE. 16,17) Mezilis, et al reported that a combined strategy consisting of RA and DES reduced the rate of MACE combined with TLR, TVR, stroke, MI, and occurrence of death in 150 patients with heavily calcified coronary artery lesions.…”

Significance of Coronary Artery Calcium Score in the Target Lesion Evaluated by Multi-detector Computed Tomography for Selecting Treatment of Rotational Atherectomy in Patients with Coronary Artery Disease

“…Despite the signi cant reduction of restenosis by Drug-eluting stent DES , several factors including diabetes, hemodialysis, and severe calci cation have been reported to be high-risk factors for restenosis after DES implantation [14][15][16][17][18][19][20] . Several studies have shown that DES implantation after the use of Rota reduced in the incident of target lesion revascularization TLR 21 and major adverse cardiac events [22][23][24] . It is that lesion modi cation by the Rota could yield smooth stent delivery, prevent damage to the polymer coating 25 , and provide optimal stent expansion, all of which could help DES be effective, even for calci ed lesions.…”

Retrospective Comparison of the Clinical and Angiographic Outcomes of the Sirolimus-eluting Stent and the Bare-metal Stent in 2031 Nonrandomized Consecutive De Novo Native Coronary Lesions

“…The present study was a lesion-based, retrospective, nonrandomized, single-center study, as largely determined by a historical comparison with the outcomes of BMS in our previous reports (6,7). The rationale of almost unrestricted use of SES has been previously reported (2,(5)(6)(7).…”

“…The rationale of almost unrestricted use of SES has been previously reported (2,(5)(6)(7). From January 2003 to August 2004 (before SES was approved in Japan), BMS was electively, exclusively, and successfully placed in 519 de novo native coronary lesions, excluding patients over the age of 80 years and those with prior coronary artery bypass grafts (CABG).…”