Author + information
- Damian J. Kelly, MB, ChB, MD,
- Anthony H. Gershlick, MB, BS∗ (, )
- John P. Greenwood, MB, ChB, PhD, MD and
- Gerald P. McCann, MB, ChB
- ↵∗Glenfield Hospital, University Hospitals of Leicester, Glenfield Hospital Groby Road Site, Leicester, Leicestershire LE3 9QP, United Kingdom
The CvLPRIT (Complete versus Lesion-only Primary PCI Trial) (1) investigators welcome the comments of Dr. Agarwal. CvLPRIT was designed as a pragmatic trial of treatment strategies in real-world patients: randomization was carried out therefore on the basis of angiographic assessment of noninfarct-related artery (N-IRA) lesion severity as this remains the most common method for N-IRA lesion assessment during primary percutaneous coronary intervention (P-PCI). Pressure-wire assessment is less commonly performed during P-PCI than during catheterization for stable patients or those presenting with acute coronary syndromes (ACS)/non–ST-segment elevation myocardial infarction (NSTEMI). We recognize, however, the growing evidence regarding the limitation of angiography in defining lesions responsible for ischemia (2).
Although putative mechanisms of widespread coronary inflammation causing plaque instability are recognized, potentially predisposing to ischemic events in N-IRA lesions of even modest severity (for example, those exhibiting thin-cap fibroatheroma), this hypothesis remains unproven. No data have yet emerged suggesting interventionists should make a paradigm shift from the strategy of ischemia reduction to that of “plaque stabilization” of nonischemic bystander lesions during the post-STEMI period (3).
Baseline angiographic characteristics of the 2 treatment groups in CvLPRIT were not significantly different (1). Despite having three times as many stents implanted, the complete revascularization group did not have any increase in stent thrombosis.
However, CvLPRIT was not designed to answer all the questions regarding multivessel disease in patients undergoing P-PCI, only the one that faced us at the time: “if faced in the catheterization laboratory with such a patient, should one even consider complete revascularization?” Design of a single definitive trial to resolve the unanswered questions surrounding STEMI management remains challenging. The consistency of both CvLPRIT and PRAMI (Preventive Angioplasty in Myocardial Infarction) in demonstrating large treatment effects in favor of complete revascularization undoubtedly influenced the American College of Cardiology “Choosing Wisely” advice, which had been against PCI of N-IRA lesions following STEMI (4).
There remain several unanswered questions. The need for a single definitive large study examining the effect of complete revascularization upon hard endpoints, comparing complete revascularization during the index admission with revascularization at an interval of 6 to 8 weeks and determining the utility of fractional flow reserve (FFR) guidance, is urgent.
The CvLPRIT/PRAMI investigators are currently seeking funding for a large multicenter randomized study, the PRIMETIME (PRIMary-PCI&N-IRA Evaluation Trial- In-patient v Medical v dEferred strategies) trial. This trial will recruit 2,750 patients and randomize them to both a treatment strategy (culprit-only, in-patient complete or staged out-patient complete at 6 to 8 weeks) and to an angiographic or FFR-driven N-IRA assessment to determine outcome in terms of hard clinical endpoints. Expanded mechanistic information will be available from a large cardiac magnetic resonance substudy. Other large ongoing trials such as the COMPLETE trial (Complete vs Culprit-only Revascularization to Treat Multi-vessel Disease After Primary PCI for STEMI) are also likely to provide important information in this contentious and unresolved area.
Please note: Dr. Gershlick has received lecture fees and advisory board fees from Abbott Vascular, The Medicines Company, and AstraZeneca. Dr. McCann has received research grants from Servier, Novartis, and Menarini International. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- American College of Cardiology Foundation
- Gershlick A.H.,
- Khan J.N.,
- Kelly D.J.,
- et al.
- Layland J.,
- Oldroyd K.G.,
- Curzen N.,
- et al.
- ↵American College of Cardiology. American College of Cardiology updates heart attack recommendations [press release]. 2014. Available at: http://www.cardiosource.org/news-media/media-center/news-releases/2014/09/choosing-wisely-statement.aspx. Accessed September 1, 2014.