Outcomes After First- Versus Second-Generation Drug-Eluting Stent Thrombosis (from the REAL-ST Registry)

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Highlights

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    Limited data exist on the comparison of clinical outcomes after first- and second-generation drug-eluting stent (DES) thrombosis.

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    At 1 year, patients with second-generation DES thrombosis (G2-ST) showed a similar mortality to those with first-generation DES thrombosis (G1-ST; 23.0% vs 22.9%, p = 0.76), highlighting that ST remains a life-threatening complication in the second-generation DES era.

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    Cumulative 1-year incidence of target lesion revascularization was significantly lower in the G2-ST than in the G1-ST (9.7% vs 17.1%, p = 0.01).

Limited data exist on the comparison of clinical outcomes after first- and second-generation drug-eluting stent (DES) thrombosis. From the Retrospective Multicenter Registry of Stent Thrombosis (ST) After First- and Second-Generation DES Implantation registry, this study evaluated 655 ST patients (first-generation DES thrombosis [G1-ST], n = 342; second-generation DES thrombosis [G2-ST], n = 313). After propensity score matching, the final study population consisted of 159 matched patients. The primary end point was the cumulative 1-year incidence of mortality. The mortality after G2-ST at 1 year was similar to that after G1-ST (23.0% vs 22.9%, p = 0.76). Also, the G2-ST group showed a significantly lower rate of target lesion revascularization than the G1-ST group (9.7% vs 17.1%, p = 0.01). Risk factors of 1-year mortality included cardiogenic shock or arrest at the time of ST, multivessel ST, left ventricular ejection fraction ≤40%, advanced age, and final thrombolysis in myocardial infarction flow grade ≤2. In conclusion, patients with G2-ST showed a similar 1-year mortality to those with G1-ST, highlighting that ST remains a life-threatening complication in the second-generation DES era.

Section snippets

Methods

This study was a post hoc analysis of the REAL-ST registry, which was a retrospective multicenter registry of patients with definite ST after first- and second-generation DES implantation at 46 Japanese percutaneous coronary intervention (PCI) institutions (Methods in the Data Supplement). The study design and main results have been reported elsewhere.3 In brief, we retrospectively attempted to enroll patients who fulfilled the following criteria: (1) who underwent PCI with first-generation DES

Results

After PS matching, the final study population consisted of 159 matched patients in each group (Figure 1). Baseline patient and lesion characteristics at the index PCI procedure before and after PS matching are provided in Table 1. Before PS matching, no significant differences in baseline clinical characteristics were observed between G1-ST and G2-ST groups except for current smoking, hemodialysis, prior PCI, LVEF, clinical presentation, lesion characteristics including in-stent stenosis,

Discussion

The main findings of the present study were as follows: (1) the mortality after G2-ST at 1 year was similar to that after G1-ST; (2) patients with G2-ST had a significantly lower incidence of TLR than those with G1-ST; and (3) clinical presentation (cardiogenic shock, cardiac arrest, multivessel ST, and final TIMI flow grade ≤2) at the time of ST, advanced age, and LVEF ≤40% were associated with 1-year mortality.

ST has emerged as a safety concern with first-generation DES in clinical practice

Authors’ Contributions

Kazunori Horie: Conceptualization, Methodology, Data Curation, Writing - Original Draft. Shoichi Kuramitsu: Project administration, Writing - Review & Editing. Tomohiro Shinozaki: Formal analysis. Masanobu Ohya: Investigation. Hiromasa Otake: Investigation. Futoshi Yamanaka: Investigation. Hiroki Shiomi: Investigation. Masahiro Natsuaki: Investigation, Validation. Gaku Nakazawa: Investigation. Norio Tada: Supervision. Kenji Ando: Supervision. Kazushige Kadota: Supervision. Shigeru Saito:

Disclosures

The authors declare that they have no known competing financial interests or personal relations that could have appeared to influence the work reported in this study.

Acknowledgment

The authors appreciate the efforts of the investigators in the 46 participating centers.

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Funding: None.

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