Comparison of sirolimus eluting stent with bioresorbable polymer to everolimus eluting stent with permanent polymer in bifurcation lesions: Results from CENTURY II trial.

OBJECTIVE: To demonstrate the safety and efficacy of a new sirolimus eluting stent with bioresorbable polymer, Ultimaster, (BP-SES) compared with everolimus-eluting, permanent polymer, Xience stent (PP-EES) in bifurcation lesions with respect to the freedom from Target Lesion Failure at 1-year. METHODS: Within 1,119 patients enrolled in the CENTURY II randomized controlled multicenter trial, 194 patients were treated for bifurcation lesions and randomized to either BP-SES (n = 95) or PP-EES (n = 99). The primary endpoint was freedom from target lesion failure (TLF) composite endpoint [cardiac death, MI not clearly attributable to a non-target vessel, and clinically driven target lesion revascularization (TLR)] at 1-year. RESULTS: Baseline patient demographic, angiographic, and stenting characteristics were similar in both study arms. A single stent technique with provisional or "cross over" stenting were the most widely used in both arms (93.2% BP-SES vs. 92.4% PP-EES). Freedom from TLF at 1-year was 94.7% for BP-SES and 91.9% for PP-EES (P for noninferiority 0.031). The rate of clinically driven target lesion revascularization (TLR) at 1-year was 3.2% for BP-SES and 3.0% for PP-EES (P = 0.95). There were no significant differences detected in any of the individual clinical endpoints or other secondary clinical endpoints between the study arms at 1-year follow up. CONCLUSIONS: The new bioresorbable polymer sirolimus-eluting stent showed safety and efficacy profiles similar to durable polymer everolimus-eluting in the treatment of patients with bifurcation lesions at 1-year follow up. © 2015 Wiley Periodicals, Inc.

An unusual complication of metallic balloon shaft fracture during coronary angioplasty.

We describe two cases of metallic balloon catheter shaft fracture, at a site just proximal to the hemostatic Y-adapter, while attempting to push the stent-balloon assembly through a tortuous left circumflex artery. In both instances, the stent carrying the balloon catheter had a stainless-steel hypotube constituting the proximal stiff portion of the shaft. While no inferences pertaining to this design can be made, our cases call for a closer observation. It would probably be prudent to change the catheter or the dilatation strategy once the shaft started buckling.

A rare, unreported complication during coronary rotational atherectomy.

We describe a rare and unreported complication during rotational atherectomy of a heavily calcified lesion in the left circumflex artery in a 79-year-old man. The Teflon sheath housing the drive shaft fractured, most probably due to overtightening of the Y-adapter hemostatic valve. As a result, there was intense spasm leading to acute ischemia and the procedure had to be abandoned. This case highlights the importance of using familiar and thoroughly tested hardware in technique-intensive procedures.

Sirolimus-eluting stent treatment for isolated proximal left anterior descending artery stenoses. Results from the prospective multi-center German Cypher Registry.

BACKGROUND: Stenting of isolated proximal LAD stenoses is still a controversial issue since it is associated with higher target vessel revascularization (TVR) rate than both bypass surgery using the internal mammary artery, and stenting of other coronary artery territories. The sirolimus- eluting stent (SES) has been reported to significantly reduce restenosis rates in de novo coronary lesions. Therefore, we compared patients from the German Cypher Registry treated with SES for isolated proximal LAD lesions with those stented for isolated lesions in the proximal LCX or RCA. METHODS: A total of 349 patients treated with SES were analyzed. 249 patients were treated for proximal LAD stenosis, and 100 for proximal LCX/RCA stenoses. The combined clinical endpoint was MACCE (death of any cause, non-fatal MI and non-fatal stroke) and TVR at 6 months. RESULTS: In-hospital events (death, MI and TVR) did not differ significantly between both groups (3.2% for the LAD group vs 2.0% for the LCX/RCA-group, p=0.73). The combined end point of death of any cause, non-fatal MI and non-fatal stroke at six months was 2.6% in the LAD group, and 2.2% in the LCX/RCA group (p=1.0). TVR occurred in 4.8% of the LAD group and in 6.5% of the LCX/RCA group at six months (p=0.58). The percentage of patients free from angina at daily activities was 80.6% in the LAD group, and 77.4% in the LCX/ RCA group (p=0.52). CONCLUSION: SES once implanted into isolated proximal LAD stenoses appears as effective as reported in other vessel territories. Accordingly, stenting of the proximal LAD using SES might prove a suitable alternative to surgery.

[Retrograde type A dissection after endovascular stent grafting of type B dissection]. / Retrograde Typ-A-Dissektion nach endovaskulärem Stentgrafting einer Typ-B-Dissektion.

Acute aortic dissection is a disease with high mortality. Whereas acute dissection of the ascending aorta (Standford type A) is treated surgically, acute dissection of Stanford type B (descending aorta) is principally treated conservatively, but surgically in case of complications. Recently, another therapeutical option for the treatment of type B dissection has been developed using endovascular stent-grafts. We report on a 64-year-old woman with typical signs of acute aortic dissection. Computer tomography and transesophageal echocardiography demonstrated Stanford type B dissection. The patient was treated with an endovascular stent-graft, because of malperfusion of the right leg and chest pain. After successful closure of the entry by the stent, the patient developed acute right-sided hemiplegia one day after the intervention due to retrograde dissection into the aortic arch and ascending aorta. Upon immediate operation, the origin of the initially type B dissection was still sufficiently occluded by the endovascular stent-graft; however, there was another entry between the innominate artery and the left carotic artery near one proximal end of the stent's strut. Using deep hypothermia and selective antegrade cerebral perfusion, the ascending aorta and proximal arch were replaced with a 28 mm Dacron-Velour tube and the aortic root was remodelled with a tongue-shaped Dacron graft preserving the valve cusps according to a modified Yacoub procedure. After the operation, neurological symptoms diminished and the patient could walk on the ward on day eleven. This case demonstrates retrograde type A dissection as a complication after interventional treatment of type B dissection using an endovascular stent-graft. The reason for this delayed complication is speculative. Aortic wall damage during stent inserting could be a possible cause. It is also likely that the patient initially had type B dissection with retrograde dissection of the distal part of the aortic arch. Therefore, one of the straight struts of the proximal end of the stent may have caused additional damage to the vulnerable dissected aortic wall in the arch, leading to retrograde type A dissection. Careful patient selection, detailed diagnosis of the aortic arch, improved stent designs and materials, especially regarding the stent's ends and careful insertion of the stent into the aortic arch, could contribute to prevention of the described problems.