Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions.

Dan, Kazuhiro; Garcia-Garcia, Hector M; Kolm, Paul; Windecker, Stephan; Saito, Shigeru; Kandzari, David E; Waksman, Ron (2020). Comparison of Ultrathin, Bioresorbable-Polymer Sirolimus-Eluting Stents and Thin, Durable-Polymer Everolimus-Eluting Stents in Calcified or Small Vessel Lesions. Circulation. Cardiovascular interventions, 13(9), e009189. American Heart Association 10.1161/CIRCINTERVENTIONS.120.009189

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BACKGROUND

The ultrathin-strut bioresorbable-polymer sirolimus-eluting stent (BP-SES) demonstrated comparable performance to durable-polymer everolimus-eluting stent (DP-EES) in randomized controlled trials. The purpose of this study was to evaluate the performance of a BP-SES compared with a DP-EES in calcified or small vessel lesions, which represent higher risk of restenosis.

METHODS

From the pooled BIOFLOW (BIOFLOW-II, IV, and V; BIOTRONIK - A Prospective Randomized Multicenter Study to Assess the Safety and Effectiveness of the Orsiro Sirolimus Eluting Coronary Stent System in the Treatment of Subjects With up to Three De Novo or Restenotic Coronary Artery Lesions ) randomized controlled trials, a total of 1553 BP-SES and 784 DP-EES patients with valid 1-year follow-up data were available. Coronary lesions were assessed for the presence of moderate-to-severe calcification or small vessels (reference vessel diameter, ≤2.75 mm) by core laboratory analysis. One-year clinical outcomes were assessed with or without the lesion subsets between BP-SES and DP-EES.

RESULTS

Baseline characteristics were similar between the groups. Among patients with small vessel disease, target lesion failure (8.0% versus 12.4%; P<0.01) and target vessel myocardial infarction (4.2% versus 7.6%; P<0.01) were significantly lower in BP-SES than in DP-EES. No difference in the outcome between the stents was shown in patients with non-small vessel lesions. In patients with calcified lesions, target lesion failure (12.2% versus 6.9%; P=0.056), and cardiac death (1.9% versus 0.3%; P=0.081) were numerically higher in DP-EES than in BP-SES. In the noncalcified lesion analysis, target vessel myocardial infarction in DP-EES was significantly higher than in BP-SES. Stent thrombosis was similar between the stents in both lesion groups.

CONCLUSIONS

Among patients with more complex disease representing a higher risk of target lesion failure, the effectiveness of an ultrathin-strut BP-SES compared with a thin-strut DP-EES was maintained through 1 year. Registration: URL: https://www.clinicaltrials.gov. Unique identifiers: NCT01356888, NCT01939249, NCT02389946.

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of Cardiovascular Disorders (DHGE) > Clinic of Cardiology

UniBE Contributor:

Windecker, Stephan

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1941-7632

Publisher:

American Heart Association

Language:

English

Submitter:

Nadia Biscozzo

Date Deposited:

30 Nov 2020 15:44

Last Modified:

06 Dec 2020 02:56

Publisher DOI:

10.1161/CIRCINTERVENTIONS.120.009189

PubMed ID:

32895004

Uncontrolled Keywords:

coronary artery disease drug-eluting stents follow-up studies percutaneous coronary intervention vascular diseases

BORIS DOI:

10.7892/boris.147502

URI:

https://boris.unibe.ch/id/eprint/147502

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