TCT-750 First Generation Versus Second Generation Drug-eluting Stents for Restenosis with Stent Fracture after Drug-eluting Stents Implantation

Background: The impact of second-generation drug-eluting stents (G2-DES) implantation as compared with first-generation drug-eluting stents (G1-DES) for calcified coronary lesion has not been yet adequately addressed. Methods: This pooled analysis compared 2-year clinical outcomes between G1- and G2-DES according to the presence or absence of coronary lesion calcification, using individual patient-level data from 2 large-scale prospective multicenter randomized trials, RESET (Randomized Evaluation of Sirolimus-Eluting Versus Everolimus-Eluting Stent Trial) and NEXT (Biodegradable Polymer Biolimus-Eluting Stent Versus Durable Polymer Everolimus-Eluting Stent). Among 4583 patients enrolled in the 2 trials, G1-DES (sirolimus-eluting stent) and G2-DES (everolimus- or biolimus-eluting stent) were used in 299 and 1033 patients, respectively, in the Calc stratum (at least 1 moderate to severe calcification), and 1208 and 3550 patients, respectively, in the Non-calc stratum (no or mild calcification). Coronary calcification was assessed by an independent angiographic core laboratory. The primary endpoint of the study was clinically driven target-lesion revascularization (TLR) at 2-year follow-up. Result: In the Calc stratum, the cumulative incidence of clinically driven TLR was significantly lower in G2-DES than in G1-DES (5.7% vs. 9.4%, P=0.03), while it was not significantly different between G1- and G2-DES in the Non-calc stratum (3.6% vs. 4.2%, P=0.35). Cumulative incidence of definite stent thrombosis was not significantly different between G1- and G2-DES in both strata (Calc stratum, 0.6% vs. 1.0%, P=0.44, and Non-calc stratum, 0.2% vs. 0.2%, P=0.98). After adjusting for confounders, the lower risk of G2-DES relative to G1-DES for clinically driven TLR remained significant in the Calc stratum (hazard ratio [HR], 0.55; 95% confidence interval [CI], 0.35-0.87; P=0.01). There was significant interaction between the generation of DES and presence or absence of calcification (P interaction=0.01). Conclusion: G2-DES as compared with G1-DES was associated with lower risk for clinically driven TLR in patients with calcified coronary lesions.

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Abstract 11019: Incidence and Predictors for Late Acquired Stent Malapposition of Drug-Eluting-Stents With Second-Generation Permanent and Biodegradable Polymer-Coatings - A Prospective, Randomized Comparison Using Optical Coherence Tomography

Circulation ◽

10.1161/circ.130.suppl_2.11019 ◽

2014 ◽

Vol 130 (suppl_2) ◽

Author(s):

Christian Roth ◽

Clemens Gangl ◽

Daniel Dalos ◽

Sabine Scherzer ◽

Lisa Krenn ◽

...

Keyword(s):

Optical Coherence Tomography ◽

Biodegradable Polymer ◽

First Generation ◽

Second Generation ◽

Polymer Coatings ◽

Drug Eluting Stents ◽

Optical Coherence ◽

Elective Treatment ◽

Drug Eluting ◽

One Year

Introduction: The polymers releasing the drug of first-generation drug-eluting stents (DES) may induce allergic reactions and inflammation, resulting in late-acquired stent malapposition (LASM) with uncoverage of struts, and risk of stent thrombosis. The incidence and predictors of LASM in DES with different polymers designed to improve biocompatibility are unknown. Methods: Fifty patients with 59 lesions of interest were randomized to elective treatment with Everolimus-eluting stents (EES; n=17, 20 lesions)], Zotarolimus-eluting stents (ZES; n=15, 19 lesions), and Biolimus-eluting stents (BES; n=18, 20 lesions) and underwent optical coherence tomography after implantation and after one year. Results: After implantation 29 early stent malappositions (ESM) were documented in 29 lesions (49% of lesions), distributed to 11 lesions treated with EES (55%), 11 with ZES (58%), and 7 with BES (35%; n.s.). After one year 14 late stent malappositions (LSM) in 14 lesions (24%) were detected; nine ESM persisted (EPSM) after one year (1 EES, 6 ZES, 2 BES), whereas 20 ESM resolved. In addition, 9 LASM were documented (5 LASM in early well-apposed Stents, 4 LASM in Stents which also have EPSM). LASM was present in 7 hydrophilic polymer-coated ZESs (37%), in 2 fluoropolymer-coated EESs (10%), and in none of the biodegradable polymer-coated BESs (p=0.003). Independent predictors of LASM were the vessel treated (RCA as vessel with high motion; p<0.022) and type of polymer (biodegradable or permanent; p<0.035). Conclusion: The incidence of ESM and EPSM were similar, whereas the incidence of LASM was different in second-generation DES with different polymers. Biodegradable polymer prevented LASM, stent locations with significant vessel movement (RCA) enhanced LASM.

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