1

Introduction

The advent of drug-eluting stents (DES) has revolutionized the percutaneous treatment of coronary artery disease . However, there are continued reports on DES failure, even in 2nd-generation DES. DES failure usually presents with acute coronary syndrome , with the main culprits being in-stent restenosis (ISR) and stent thrombosis.

Stent fractures (SFs) distort the integrity of the stent and are one cause of stent failure. The mechanisms of SF are multi-factorial, including stent material, stent design, and lesion and procedural factors. Besides these mechanical factors, biological factors, such as polymer hypersensitivity, delayed arterial healing and arterial remodeling, may play important roles in SF . Although advancements in stent design, alloy and polymer technology in 2nd-generation DES have improved their long-term safety and efficacy, SFs in 2nd-generation DES are reported.

There is a paucity of contemporary data on SF. To further our current knowledge on this important topic, we reviewed the Food and Drug Administration (FDA) Manufacturer and User Facility Experience Database (MAUDE) (2005–July 2013) to evaluate the current trends of SF. The MAUDE database acts as a passive surveillance system. This review analyzed results from the MAUDE database and overviews the current literature regarding SF.

2

Incidence

The first reported coronary SF was a bare metal stent implanted in the saphenous vein graft in 2002 . Subsequently, in 2004, Sianos et al. reported two cases of DES SF involving Cipher sirolimus-eluting stents (Cordis, Miami, FL) implanted in the right coronary artery (RCA). The incidence of reported coronary SF varies between 0.5% and 18.6% ( Table 1 ) . In a meta-analysis of eight studies, the mean incidence of SF was 4.0% . However, since the majority of reported SFs from clinical studies were based on routine angiographic follow-up at 6–9 months, late SF may not be included in these studies. The reported incidence of SF was much higher at 29%, from an autopsy study of 200 DES lesions .

From our review of the MAUDE database, we have identified a total of 402 reports of DES SF from January 2005 to July 2013. Of these, 330 SFs involved 1st-generation DES, 71 SFs with 2nd-generation DES, and 1 DES type was not specified ( Fig. 1 ). The median time from index procedure to reported SF was 8 months [IQR 5–20 months], with a longer median time in 1st-generation DES (median time 10 months [IQR 6–24 months]) compared to 2nd-generation DES (median 1 month [IQR 1–5 months]). Fig. 2 shows the distribution of reported SF according to 1st- and 2nd-generation DES based on the duration of stent implantation. We classified SF ≤1 month as early SF, >1 month to 1 year as intermediate SF, and >1 year as late SF.

Reported stent fracture from MAUDE database 2005–July 2013.

Time from stent implantation to reported stent fracture from MAUDE database.

DES, drug-eluting stents.

2

Incidence

The first reported coronary SF was a bare metal stent implanted in the saphenous vein graft in 2002 . Subsequently, in 2004, Sianos et al. reported two cases of DES SF involving Cipher sirolimus-eluting stents (Cordis, Miami, FL) implanted in the right coronary artery (RCA). The incidence of reported coronary SF varies between 0.5% and 18.6% ( Table 1 ) . In a meta-analysis of eight studies, the mean incidence of SF was 4.0% . However, since the majority of reported SFs from clinical studies were based on routine angiographic follow-up at 6–9 months, late SF may not be included in these studies. The reported incidence of SF was much higher at 29%, from an autopsy study of 200 DES lesions .

Table 1

Stent fracture clinical studies

Author (Ref. #)	Study	Patients with follow-up CAG	Stents	Incidence	Imaging	ISR	TLR	ST	Risk factors
Kozuma et al.	Prospective multicenter	525	SES (1.5%) and EES (0%)	1.5% lesions	CAG	50.0%	N/A	No	SES
Kuramitsu et al.	Prospective cohort from 2 centers	1035	EES	2.9% lesions, 3.8% patients	CAG/IVUS	100.0%	25.6%	5.1%	Ostial, hinge points, tortuosity and calcifications
Park et al.	Retrospective, multicenter	1742	Cipher Bx (5.8%), Cipher select (1.7%), Taxus liberte (1.0%), Xience V (1.1%), Endeavor (0%)	2.6% lesions, 3.1% patients	CAG/IVUS	42.1%	47.3%	N/A	Angulation >45°, RCA, total stent length, overlapping stents
Park et al.	Retrospective cohort from 2 centers	3315	SES (0.9%) and PES (0.1%)	0.5% lesions, 0.7% patients	CAG/IVUS	41.7%	33.3%	N/A	Multiple stenting, long stent length, chronic renal failure, RCA, SES
Umeda et al.	Prospective, single center	793	SES	8.0% lesions, 8.7% patients	CAG/IVUS	21.4%	15.9%	2.9%	Overlapping stents, total stent length, RCA, tortuosity
Kawai et al.	Retrospective, single center	558	SES (21)/BMS (2)	3.7% lesion	CAG/IVUS	N/A	22.7%	N/A	Total stent length, angulated lesion >45, RCA
Lee et al.	Retrospective, single center	1009	SES (13)/PES (2)	1.5% patients	CAG/IVUS	58.8%	41.2%	5.9%	SES, RCA
Ino et al.	Retrospective, single center	273	SES	4.9% lesions, 6.6% patients	CAG	33.0%	28.0%	0.0%	Angulation, hinge motion, total stent length
Shaikh et al.	Retrospective cohort from 2 centers	188	SES (29)/PES (6)	18.6% patients	CAG/IVUS	100.0%	N/A	N/A	Excessive bend >75°, SES, overlapping stents
Doi et al.	Retrospective, single center	250	SES (18)/BMS (2)/PES (0)	7.6% lesions, 6.8% patients	CAG/IVUS	75.0%	N/A	10.0%	Hinge point, aneurysmal segment
Kim et al.	Retrospective, from Long-DES II study	415	SES (6)/PES (1)	1.7% patients	CAG/IVUS	14.0%	0.0%	N/A	RCA, SES
Aoki et al.	Prospective, single center	256	SES	2.6% lesions, 3.1% patients	CAG/IVUS	50.0%	50.0%	0.0%	Saphenous venous graft, stent length, RCA, overlapping stents
Chung et al.	Retrospective from 13 centers	4160	SES (35)/PES	0.84% patients	CAG/IVUS	65.7%	28.6%	N/A	Stent length, overlapping stents and severe angulation
Lee et al.	Retrospective, single center	530	SES (10) and PES (0)	1.9% patients	CAG	50.0%	70.0%	10.0%	Vessel tortuosity and overlapping stents

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