Vascular restoration therapy: what should the clinical and angiographic measures for success be?

Revascularisation by coronary artery bypass surgery (CABG) or percutaneous coronary intervention (PCI) in conjunction with medical therapy in patients with chronic stable coronary artery disease (CAD) was associated with significantly improved survival compared with medical therapy alone (OR 0.74; 95% CI, 0.63-0.88). This benefit was seen for both revascularisation modalities, CABG and PCI separately. Revascularisation was not associated with a significant reduction in non-fatal myocardial infarction compared with medical therapy (OR 0.91; 95% CI, 0.72-1.15). Vascular restoration therapy (VRT) refers to a drug-eluting stent (DES) based percutaneous coronary revascularisation technology whose hallmark is the temporary nature of the biodegradable platform. As other percutaneous coronary revascularisation procedures, its primary goal is the relief of ischaemia by elimination of coronary luminal narrowing. The objective is achieved by temporary scaffolding of the arterial wall with concomitant release of antiproliferative agents. Both properties are required for a short period of time (3-6 months) following which biodegradation takes place with complete resolution of the device over the ensuing months and years. Assessment of endpoints must take into consideration the short- and long-term safety and efficacy of these complex implants. Clinical trials evaluating the safety and effectiveness of this novel drug-device technology play an important role in it's approval and adoption for clinical use. Although surrogate markers may have some role in the definition of device performance, direct measures of clinical outcomes are preferable in the understanding of the