DES evidence and future

Ivo Petrov, MD, PhD

Head of Department Cardiology and Angiology

Tokuda Hospital -Sofia

THE ADVENTURE OF STENTING

• Rationale for stenting

• Improves outcome of angioplasty procedures
• Reduces major adverse events
• Reduces chronic restenosis

• • Rationale for DES stenting

• Significantly improves the stening results
• Significantly reduces the need of reintervention
• More patients can be treated

The Problem of Restenosis

Incidence of in-stent restenosis with BMS: 20-30%
• Need for target vessel revascularization: 10-15%
• > 4 000 000 PCIs worldwide every year
• > 600 000 repeat interventions per year
• > 300 000 recurrent restenosis per year

Estimated cost of first repeat revascularizations -12 Billion US Dollars

Restenosis and Quality of Life
Optimum Balloon Angioplasty Compared With Routine Stenting Trial (OPUS-1)
Weaver WD et al. Lancet 2000;355:2199-203

Key Components of the Sirolimus-Eluting Stent

DES CLINICAL JOURNEY

• RAVEL–the first double-blind, randomized study in Europe evaluating sirolimus-eluting stent

• Presented in 2002, investigators reported at 6 months F/U 0% restenosis vs. 26.6 in BMS

• Study was on 238 pts, in 19 centers with simple de novo lesions (diameter 2.5-3.5, stent length <18mm)

• Dual antiplatelet therapy for 2 months

• Promise of a rosy future

“Every solution breeds new problems “ – Murphy’s Law

Martin B. Leon, at the 15thAnnual Interventional Fellows CourseMay 12, 2009; Miami, FLsaid:

Cypherisa remarkablebiotechnologyplatformwithan excellent overallsafetyprofile and strikinganti-restenosisefficacyin bothon-label and off-label clinicaluse circumstances, nowwith>8 yearsclinicalfollow-up.

The clinicaltrial evidence-basedmedicinedossier includes>100,000 patients studiedin registriesand RCTs(>1000 peerreviewedpublications).

Cypher 2010 –maturity

• Cypher stent stood the test of time–the first 10 year F/U published in JACC, May 2010

• Cypher is tested in all lesion and patient subsets

– Initial data were obtained with only 2 or 3-months DAPT
– Complex indications at present moment have at leat 5 year F/U
– Clinical trail data is supported by a number of big registries like
– e-Cypher and e-Select

The patient, who was treated in 1999 with the CYPHER® stent at the age of 75 after her coronary angiography showed a significant, single, de novolesion in the proximal left anterior descending (LAD) artery, under-went further invasive follow-up revealing a sustained anti-proliferative effect of the CYPHER®stent by both angiography and IVUS examination in 2009. The patient also underwent an optical coherence tomography (OCT) assessment which revealed a complete coverage of over 90% of the analyzed struts. This 10-Year follow-up of the first-ever patient to be treated with CYPHER® took place continuing a tradition of comprehensive testing for the most studied drug-eluting stent in the world and reinforcing the CYPHER® Sirolimus-eluting coronary stent’s reputation for efficacy and safety. The follow-up procedure was broadcast live during the 2009 meeting of the Latin America Society of Interventional Cardiology (SOLACI, Rio de Janeiro -Brazil).